A Handbook for Responsible Innovation

Jonny Hankins

Foreword by Francesco Samorè

I libri della Fondazione Giannino Bassetti 2012

Acknowledgements This book would not have been possible without the help and support of Cristina Grasseni, Piero Bassetti, Bertilla Corti, Tommaso Correale Santacroce, Francesco Samore’ and all at the Bassetti Foundation in Milan. A special thanks also goes to the interviewees Professor Mario Biagioli, Congressman Michael Capuano, Pallavi Phartiyal and Professor Andrew McMeekin who so kindly dedicated their time.

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Preface

By Francesco Samorè, Scientific Director, Bassetti Foundation, Milan

The articles collected by Jonathan Hankins – a selection of his work that appeared between 2010 and 2012 on the Bassetti Foundation website and beyond – are organized into ‘macro arguments’: Synthetic Biology and Nanotechnology, Bioethics and Information and Knowledge. We therefore find a synthesis of some of the realities of frontier innovation presented in the style of a handbook. The frontier in question is that of the interaction between an additional injection of power that coincides with one of added knowledge that allows a discovery to be made, achieving the improbable and in some cases changing history. The point of view taken in the first chapter – Responsible Innovation, an Overview – represents the 15 year mission of the Bassetti Foundation. The opening section of the book is where Hankins delineates an itinerary that represents the thoughts that the Foundation has produced or promoted (in primis through the work of its President and a consolidated tradition of lectures) over this period of time. The accent falls upon responsibility precisely because nanotechnology, genomics and robotics are intrinsically inherent with risk and have a potentially incalculable impact upon society. Just to give a single example, we know that the responsibility that Fermi, Oppenheimer and Truman held in the creation of the atomic bomb was not equal, but we need to know what that means today, in a glocal world that is guided by technoscience. Without a doubt all of this leads us into looking within business, because it is here that power – capital – and specific knowledge or even culture meet and live side by side. But following on from John Dewey’s reasoning and intuition from the 1920’s (technological societies generate problems that resist attempted solutions by existing institutions) the social question of responsibility transcends the confines of these institutions of modernity. Avoiding the pretence of writing an organic theory of responsibility in innovation himself, Hankins chooses to dedicate a large portion of the book to the presuppositions for the elaboration of such. He selects certain arguments, describes brief case studies (chapters 2 and 3), asks himself which might be the ‘new’ sources that could

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allow an understanding of the social impact of technoscience (chapter 4) and proposes interviews with scientists, politicians and institutional employees (chapter 5). Although today the pioneers of responsibility in innovation can look with satisfaction at the growing number of university and research centres that have gravitated to the theme, this development makes a fine and rigorous description of events ever more necessary. This will only be possible if the sources, as well as the debate forums, operate at the highest level. The book demonstrates that the Bassetti Foundation and its website has been until today, and will become ever more, one of the most qualified of these forums. This however does not exhaust or even tie down a theme which is much wider and directed towards all ‘forthcoming events’; to understand, beyond the traditional academic disciplines, which areas of innovation are more sensitive to the category of responsibility. One filter is certainly the concept of risk, not a new concept but one that has been overturned by technoscientific innovation. Hankins tackles the issue both in referring to the work of the Bassetti Foundation (see the title Innovation and Risk in the first chapter) and to the documents of the International Risk Governence Council (Without Risk there is no progress, in the second chapter). Those immersed in risk are more so than ever forced into thinking about consequence: from the insurance companies, that take on risk as a mission and ask if the traditional approach – historical precedence and mathematical models – need to stand side by side with a model of foresight; to the institutions of knowledge and ‘action’ working to re-frame the category of responsibility in order to address the impact of risk upon society. We must therefore understand that around responsibility in innovation a community of thought and action is growing. It is above all, but not exclusively to this world that Hankins aims his handbook. Without the ambition of being exhaustive it represents both a map and an educational tool for anyone interested in the many debates surrounding responsibility and innovation.

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Contents

Introduction

Chapter 1

Responsible Innovation, an Overview

Processes of Innovation

The Politics of Innovation

Innovation and Risk

Chapter 2

Synthetic Biology and Nanotechnology

An Introduction to Synthetic Biology

Science: Special Edition on Synthetic Biology

An Ethics for Emerging Technologies

Governance and Participation in Nanotechnology

Without Risk there is no Progress

Oversights in Oversighting Nanotechnology

A Research Strategy for Engineered Nanotechnologies

Nano-pollutants and a Research Strategy

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Chapter 3

Bioethics

Decision Making During a (Possible) Flu Pandemic

Drugs for People, Not for Profit

Home DNA Testing for all the Family

Home genetic testing and the law

Architectures for Life with 23andMe, a Report

23andMe Awarded Their First Patent

Sequencing the Genome of Unborn Babies

Prosthetic by choice?

Chapter 4

Information and Knowledge

Itinerary: Communicating Science

Harvard's Journalist's Resource Center

The Royal Society, a font of information

Citizen Science

Is Citizen Science Coming of Age?

The problem of cold nuclear fusion

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Chapter 5

Interviews

Professor Mario Biagioli

Congressman Michael Capuano

Pallavi Phartiyal of the Union of Concerned Scientists.

Professor Andrew McMeekin

Concluding Remarks

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Introduction The articles present in this handbook offer the reader an outline of the work of the Bassetti foundation and a selection of my publications on the website and beyond over the last 3 years. The aim of the Foundation is to promote debate around the problem of responsible innovation, and to make the further move into action, to imbue the decision-making process with responsibility. We might like to start for the point of view that technoscientific innovation is a maker of history, and as such should be responsibly designed, implemented and used, and this view underlies my writing. A responsible innovation process requires responsible behaviour. Regulation and adherence to rules will not in themselves work, a culture of responsibility within the scientific, entrepreneurial and public worlds is needed. If this goal is to be reached, access to information, informed debate, involvement in the decision-making process and political will all be required. The articles have almost all been published on the Bassetti Foundation website, with the exception of those in chapter 1. I have divided them into groups as represented by the chapters, but many threads intertwine them all. The subject matter may be different but many of the underlying issues are similar. As the articles were written as independent entities they stand freely of one another. They have all been updated and reviewed so differ slightly from their original form. Many of the articles refer to others in the volume, giving the reader the possibility of starting anywhere in the book while gaining an overall understanding of how individual and related arguments have been treated. What I hope to present is a practical approach to generating debate about issues surrounding responsible innovation. Chapter 1 outlines some of the Bassetti Foundation's ideas and interpretation of the Responsible Innovation arguments. The articles are intended to introduce the reader to the philosophy that underpin our work, as well as an overview of some of our approaches.

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Chapter 2 deals with synthetic biology and nanotechnology, starting with introductory pieces that describe the technology in lay terms, the present state of the art and looking into what the future may bring. Chapter 3 gathers articles under the broad umbrella of bioethics, including medicine, DNA and ethical decision making. Chapter 4 addresses problems surrounding the dissemination of scientific information and public participation in scientific matters in general. Chapter 5 is a collection of interviews with leading players in the field, verbatim transcriptions of our discussions that clearly present the individual participants' views and roles within the arguments addressed.

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CHAPTER 1

Responsible Innovation

Processes of Innovation

The Bassetti Foundation, Milan

The Bassetti Foundation in Milan Italy has been working for more than 15 years to promote the idea of responsibility in innovation, pioneering thought around the question as probably the first institution to make it the objective of its mission. The debate has included issues of definition, goals and aims, the role of politics, innovation as politics and the role of technology and innovation in society today. One of the first ideas that comes to mind when we talk about innovation is technology, although innovation is obviously not bound to its use.

The first thing to do therefore is to open a debate into definition. What for example is ‘technology’?

Mario Bunge (Bunge, 1976) [1] defines technology as ‘ a body of knowledge that is compatible with science and demonstrable through scientific methodology, that can be used to control, transform or create natural or social things or processes for any practical, useful use’. Richard Nelson (Nelson, 2006) [2] describes it as ‘composed of a body of techniques and practices and by a body of theoretical or practical notions, results of the co-evolution of technical and scientific understanding’.

Foundation president Piero Bassetti prefers the definition of those who see technology as the incarnation of the ways by which a theoretical understanding becomes concrete and as such usable for something, and therefore as an action. An action because a ‘technologist’ allows a particular understanding (theoretical or technical, new or old) to be put into practice, and therefore used by the person that transforms it into products or processes. From this

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point of view technology can be clearly seen as the thing that contributes to the process of knowledge by transforming it from theoretical to practical. [3]

Thus defined, technology can be seen as delimited within its true role as a vehicle for the transformation of knowledge from scientific to operative, but also as an indispensable instrument for the creation of ‘prototype’, if not yet ‘production’ models.

And what about innovation, how does the use of technology become innovative? We know in fact that the injection of an additional quantity of power and capital is necessary for (even technologically complete) knowledge to be transformed into the production of innovative objects or processes with their added value. The introduction of this added value is the work of a third party, the industrialist or entrepreneur, or the person that is able to combine scientific and technological factors with the other ‘production factors’ – capital, workforce and organization – necessary to arrive at a result that is economically and socially relevant.

And here we bring in the problem of responsibility, because without bearing the above in mind the question of responsibility cannot be raised, or will be incorrectly framed. It is difficult to imagine that a simple transformation of knowledge implies the taking of responsibility if it is without practical application because it is not finalized through ‘the achievement of the improbable’ that the innovation process requires. The ‘achievement of the improbable’ is the working definition that we use at the Bassetti Foundation for innovation. Innovation is not just seen as discovery, or invention as the following shall hope to demonstrate.

Innovation is not only determined however by an additional quantity or quality of scientific-technological knowledge. It requires that the ‘additional quantity of knowledge’ is joined by an ‘additional quantity of power’ for which different forms of knowledge, such as those tied to the management of ‘risk’ and ‘uncertainty’ – whose management is the specific responsibility of the industrialist – are equally necessary. New scientific and technological knowledge can provide impetus for the creation of something that is objectively relevant – new products or new services – and bring to life that which was previously unknown or non-realized, but only if real capital and

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power are directed towards the goal of achieving the improbable. In other words to achieve the improbable is not the same thing as to discover.

On the other hand not all things produced using new technology can be described as innovations in a true sense. A lot of products and processes derived from the use of new technologies refer to already existing uses and practices. And actors of different types of knowledge transformation – researchers, technicians and industrialists or entrepreneurs – cannot always be seen as distinct elements, as each can take on different or multiple roles.

The organization of concepts and roles described above allows us to say that because technology is not ‘neutral in the sense that it can be applied to every chosen proposal and produce non neutral collateral effects’, responsibility cannot be ascribed to the technologist herself ‘tel quel’. Responsibility taking will vary according to modes of execution, uses and product type, but also to the subjective position of its operator, i.e. according to the distribution of roles that the productive system under discussion involves.

Moreover, the concept of responsibility, especially within its relationship to ethics, can never be seen without thinking about complexity. This not only touches upon the difficulty involved in ascribing responsibility to different subjects involved, but also to the criteria that those who are concretely held responsible should be aware of and follow.

Regarding this argument Hans Jonas (Jonas, 1984) [4] acutely states that ‘all ethics (being) a question of responsibility for the future consequences of a present action’ and ‘modern technology (an instrument that) is able to influence future conditions in a way that is difficult to predict, we must air on the side of caution if we want to avoid a mistake’. Here we face the old sociological problem of our inability to foresee the future. We may produce something, an incredible advancement in scientific and social culture, but once the genie is out of the bottle we lose control of our process, as novel applications for our innovative product are discovered. Examples are everywhere, some arguably positive, such as the production of energy from nuclear power, others may be less so. The

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sequencing of the human genome may be seen as a great leap forward, possibly allowing us to develop new medicines and treatment forms ad persona, but when your children are asked for a sample of DNA before the insurance company grants them life or medical cover we may begin to see it in a different light. All things potentially have many unforeseen uses.

And this leads us on to the transfer of knowledge and techniques. The truth is that it is difficult to schematize processes of knowledge transfer and it is not always easy to define the responsibility that derives from these transformations. The technologist that adds technological understanding to scientific knowledge and therefore contributes to making an innovation possible cannot be ascribed the same level of responsibility as someone who by adding power to knowledge is the real actor of the innovation in question. It is one thing to supply an extra quantity of knowledge to generate innovation, but another to provide the power necessary to implement its creation. The responsibility that Fermi, Oppenheimer, and Truman hold for the production of the bomb is not equal.

On the other hand, and above all in the field of the modern organization of scientific institutions in which the scientist becomes both the technician and industrialist of herself, the figure of the person that transforms knowledge or technology is often superimposed upon that of whoever provides the will and power needed for the innovation whose effects are the interest of responsibility. All of this said, the differences in quantity and quality of responsibility involved remain and cannot be ignored. If we take the example of a multinational company that has its seat in the US, produces in 13 different countries and employs researchers all over the world, where do you start if you want to address the argument of responsibility. If there is an industrial accident, or a product causes health problems, or is discovered to be incredibly useful at something that it was not designed to do, who is responsible?

In his 2004 paper entitled New science and new politics, Piero Bassetti summarizes the argument perfectly when he argues that the separation of the role of the search for knowledge – including experimental – from applications of that knowledge in practice, and of the necessarily instrumental nature of these applications, that always lead to the choice of means and not ends mean that the

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formerly accepted ideas of the boundaries of science are no longer relevant. [5]

Innovation is a complex phenomenon combining science, technology, finance, management, enterprise and organisations to achieve a goal that is not only scientific but also entrepreneurial and political. Its ultimate use will be outside science, even though it greatly needs the contribution of science. However innovation is a continuous process.

Taken literally, it is something that comes about when an advance in knowledge, which is a result of a discovery, is accompanied by and combined with technology and the power to put it into practice (capital). It is not simply discovery. It is something more than that. It is part of a new historical situation arising from a combination of knowledge, technology, know-how, and the risks/opportunities developed and implemented by business or other powers. That is, it is something that was not there before and which has come about through a “new” combination of knowledge and power, bringing change. Innovation, however, is also creativity, which necessarily implies unforeseeable change. Accordingly, Schumpeter and Nelson state that innovation implies increased risk/opportunity and social power. For precisely this reason we may define innovation as the "achievement of the improbable"; as risk and opportunity; as something that unpredictably changes the world: unpredictability in the socio-political field (new institutions, types of relationship, of production, of war, and new powers), the technical and economic realms (new materials, sources of energy, tools and categories of goods), and the cultural-aesthetic field (new styles, fashions, tastes and habits).

A conclusion seems therefore deductible: the abstract ascription of responsibility to the technology or the science itself surely has little sense. Specific ascription to the scientist, the technologist or the industrialist could however have sense, based upon the way in which each of these people have participated in determining the productive phenomena that provoke consequences that can be judged in terms of responsibility.

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References:

1] Bunge M. (1976), The Philosophical Richness of Technology in PSA: Proceedings of the Biennial Meeting of the Philosophy of Science Association, vol. 2, Symposia and Invited Papers, The University of Chicago Press, Chicago 1976, p.154. 2] Nelson R. (2006) La difficoltà di trasformare la conoscenza in innovazione in M. Bucchi (editor) Sapere, Fare, Potere. Verso un’innovazione responsabile, Soveria Mannelli, Rubbettino, 2006, pp.33-66. 3] Bassetti. P (2006) Responsibilita’ Nei Processi di Innovazione in Andrea Bonaccorsi, Massimiliano Bucchi (ed) (2011) Trasformare conoscenza, trasferire tecnologia Dizionario critico delle scienze sociali sulla trasformazione produttiva, Marsilio 2006 4] Jonas H. (1984), The Imperative of Responsibility: In Search for an Ethics for the Technological Age, University of Chicago Press, Chicago, 1984 5] Bassetti P (2004) New Science and new politics in Scienza e Technologia: al di la’ dello specchio, Libri Scheiwiller, Milano (2004)

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The Politics of Innovation

At the Bassetti Foundation for Responsible Innovation we have long been debating the links between innovation and politics. In 2006 the Foundation successfully lobbied for a change to the Statute of the Region of Lombardy in Italy so that local government would work to promote responsible innovation, in the belief that innovation excellence is by definition responsible innovation.[1]

Our argument departs from the starting point that innovation is politics, to innovate is a political act in that it changes people’s lives, and moves to the position of politics as innovation, or more simply innovation as the goal of politics.

These two points of view are of course intertwined, innovation is often carried out in the name of improvement for society, but recently this in-house debate has taken a turn.

The turn relates to the relationship between politics, knowledge and power, with innovation tied to all three principal actors. I could summarize our debate in the following lines: What we are addressing is the problem of politics and knowledge, with knowledge no longer being within the realm of power and politics. Roles have been reversed, power resides in knowledge and therefore in innovation. Power does not create knowledge but knowledge creates power, and therefore innovation creates power.

To quote President Piero bassetti “if a man wants to control history he must control innovation. Innovation is politics”.

This thinking seems to be reflected in political action and a look at the proposed US budget for research into innovation demonstrates its importance as a theme. As a recent article [2] in Science News demonstrates, President Obama is urging companies and research institutions to spend ever more money on Research and Design, with state spending racked up to 140 billion dollars. Within this fund the non-defense portion is growing fast, but it is also worth pointing out that a huge amount of the bio defense budget is spent in non military

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operations such as the construction and maintenance of bio tech and innovation centers. Their work benefits local educational institutions, surrounding laboratories, equipment suppliers, related industries and the job markets as a whole. The budget also includes 2.2 billion directly for manufacturing investment.

The idea is not new to the Obama administration of course. Back in 2000 President Clinton addresses the California Institute Technology proposing investment in nanotechnology, an act that led to the creation of the National Nanotechnology Initiative. [3] The goals of this initiative were to coordinate federal agency investment in nano-research and investment, and their work really set the pace for developments over the next 10 years.

The field of nanotechnology is vast and currently pervades various types of industry and our daily life, and I would argue that a lot of this is down to agency investment that flows into society through the release of new innovative applications. A look at the figures is also instructive. In 2005 US agencies invested 34.8 million dollars into nanotechnology research, in 2012 President Obama asked for 123.5 million, an increment that demonstrates the importance of the sector for the economy in general.

Local initiatives in the form of state subsidies also play an important role. States or countries that offer tax incentives for clean energy production or car replacement (see the European schemes over recent years offering money for scrapping older cars), and rules that they enact to charge less road tax for cleaner vehicles all push (and help) companies to innovate and develop new systems. Improved sales does no harm either, freeing funds to use in researching the specific fields that lead to achieving government quality standards and the implied good publicity and subsidies.

So we might argue that if you are in the innovation game then it would pay to have national and local politicians who appreciate your goals and understand how to help. Recently I was fortunate enough to interview [4] Congressman Michael Capuano, representative for Cambridge and large parts of Boston in Massachusetts. As the slogan goes round here, “Innovation is what we do in Massachusetts” and a look around Greater Boston demonstrates the truth in the line. This small area is home to many of the world’s

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greatest innovation companies. During my interview Congressman Capuano went into some detail about his position on innovation and I would like to quote a couple of lines:

“I am interested in high wage jobs to maintain the quality of life that we have here. You have seen the house prices in Cambridge. Now that is good and bad, don’t get me wrong, but I don’t want those houses to lose their value. They will lose their value if people can’t afford them or if people no longer want to come here, and they can continue to afford them if we pay them better. The only way we can pay them better is to provide jobs that no-one else in the world can do”.

The way Cambridge can do that is through maintaining its position at the cutting edge of innovation, and that requires political will and intervention. This is not a risk free line to follow though, as a look at recent events surrounding the creation and construction of the new Boston Biodefense Complex shows. Congressman Capuano was involved in bidding for the creation of the complex (for all the reasons above) and it was built on his territory in Boston. After spending somewhere in the region of 140 million dollars on its construction and several years of wrangling the centre is still unopened. Local members of the community have succeeded in their battle to postpone its opening (for the time being) through legal action. The building lies empty, and to quote Mr. Capuano again “that is good for no-one”.

But this problem aside Congressman Capuano seems to be the type of congressman you want if you are looking towards innovation, although I leave the reader to ponder the advantages and possible pitfalls of an innovation at all costs approach. A full transcription of the interview can be found in chapter 5 of this volume.

All of the above however does not take into account the Steve jobs approach. [5] Mr Jobs as we all know was extremely successful as an innovator, and succeeded not only in building an empire but also in changing the way we live, a fine example of innovator as politician. He however was extremely unwilling to pursue government favor and in fact reports state that it was president Obama who asked for their meeting in 2010 so that he could talk to Jobs about the economy,

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innovation, technology and education. It appears that Mr Jobs just wanted to do it his own way and on his own terms.

Recently the continent of Africa has been toted as a hotbed of innovation, as much of the continent has been hooked up to fiber optic cables that arrive via the sea bed. The news in February of 2012 was not good, as one of these cables was damaged [6] by a ship dropping anchor in a restricted area slowing down much of the continents internet download speed, but this problem can be fixed and this technology is very new to Africa.

The first fiber optic connections came in 2010, and politics was once more a player. The cable was laid along with much of the internal infrastructure currently in use to service the needs of the hoards of journalists sent to the continent to cover the FIFA football (soccer) World Cup Finals. The staging of the World cup finals is like many other global events hotly disputed. Bids require government support, personalities at the helm and most of all money.

Events such as these require masses of infrastructure, and the results are not always popular, but the growth of internet use and the innovation possibilities it creates can be seen as a direct result of the first fiber optic cable and its effect on society and business that was central to South Africa’s bid for one of the largest sporting events on Earth.

Interested readers might like to read the following articles. In 2007 an article by Ralph Hermansson [7] entitled The Interaction Between Politics and Innovation appeared. The author was an Innovation Journalist Fellow at the time and in four pages it offers a nice summary of many related arguments.

In September of 2008 Maria Antonietta Foddai, Professor of the Philosophy of Law in the faculty of law at the University of Sassari in Italy was interviewed for the Bassetti Foundation. In the publication related to the meeting entitled 'Responsibility and uncertainty: new perspectives upon responsible action' she explained how she interprets responsibility and addresses the problem of responsibility towards future generations.[8]

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References:

1] Techno-Scientific innovation, innovation in democracy, IReR Lombardia - Fondazione Giannino Bassetti, Guerini e Associati, 2006; 2] http://www.sciencenews.org/view/generic/id/338453/title/Despite_lean_times%2c_Obama_wants_R%2BD_hikes 3] http://www.nano.gov/ 4] http://www.fondazionebassetti.org/en/focus/2011/10/a_discussion_with_congressman.html 5] http://spectrum.ieee.org/at-work/innovation/in-the-politics-of-innovation-steve-jobs-shows-less-is-more 6] http://www.popsci.com/technology/article/2012-02/under-sea-age-wireless-cant-we-do-better-intercontinental-fiber-optic-cables 7] http://www.innovationjournalism.org/ij4/presentations/ralphhermansson.pdf 8] http://www.fondazionebassetti.org/en/focus/2008/09/responsibility_and_uncertainty.html

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Innovation and risk

Innovation is on everyone’s lips today. However, people often confuse innovation with discoveries or new developments, and little thought is given to the conceptual difference between innovation and change. And we rarely have a clear idea of the relationships between innovation, change, risk and responsibility. Only very occasionally do we consciously address the serious political problems that the management, or non-management, of innovation can engender. Far too often, the problem of the independence – and hence responsibility – of research is erroneously confused with the independence and responsibility of innovation.

These are two very different problems: research and discovery are not the same thing as innovation. A discovery becomes innovation only when the increase in “knowledge” implicit in every discovery becomes technology and the actuating power (that is, social capital) that the discovery implements. As Schumpeter and Nelson have argued, it is only then that we obtain an increase in social power, which is in itself a factor of change and, thus, of social risk.

Real innovation is neither discovery nor novelty, but rather the agent of a new scenario, the result of a new combination of knowledge and power.

For it to qualify as “creativity” as well, change must also be to some extent unpredictable. It is for this reason that we at the Bassetti Foundation for Responsible Innovation speak of innovation as the “achievement of the improbable”. It combines risk and opportunity, changing the world around us but doing so in an intrinsically unpredictable direction. It may be an unpredictable change at the political or social level (such as new institutions, new approaches to relations, production, war or power) or at the technical and economic level (new materials, new energy sources, new instruments, new kinds of goods) or even at the cultural level (new styles, fashions, tastes and attitudes).

Innovation does not involve unpredictability alone. It also encompasses a second theme, that of social risk.

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We use this in the same way as well-known thinkers such as Ulrich Beck or Anthony Giddens: Beck has written that the concept of risk is a modern concept, which assumes the presence of danger, while Giddens has noted that it replaces the concept of chance. A society of innovation, and therefore a society of risk, is forced to make difficult choices aimed, as Beck writes, at making the unpredictable consequences of choices, made in the name of progress, predictable and controllable.

This brings us to a third element, political responsibility.

The concept of responsibility has at least two meanings: one moral, the other objective. We have elected to stand apart from the ethical debate and focus our attention on the decisions that regard the political implications of innovation.

Of course, this does not exempt us from examining the difficult choices that Beck refers to. On the contrary, it leads us to the heart of the problem of who is responsible for assessing social risk in innovation: the scientist who discovers, the intellectual who invents, the technologist who builds, the capitalist who finances, the entrepreneur who combines the factors of production, the legislator drafting laws or the politician wielding the tools of executive power?

As Beck rightly points out, Parliaments do not vote on the use and development of microelectronics, genetic engineering and so on. At most, they vote on supporting all of this. Nor is political power always able to assume political responsibility for the actions of the entrepreneur or firms, if it is precisely the intimate connection between decisions regarding technological development and investment that forces companies to forge their projects in secret for competitive reasons. As a result, the decisions reach politicians and the public only after they have already been taken.

In other words, are the decision-making methods of existing democratic institutions, which are based on the achievement of majority consensus, appropriate for prior assessment of situations like innovations, which by definition involved changes in “improbable” social powers and knowledge? This problem for democracy is not only constituted in method however, but also in political choice and

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decision-making. For a further discussion see the Bassetti Foundation Lecture by Daniel Callahan in which he addressed the problem of sustainability in innovation and the interview conducted by Cristina Grasseni.[1]

But if they are not, and politics is specialized in legitimizing consequences that it did not cause and could not realistically prevent, who is responsible?

Our thesis could be reformulated as follows: if innovation is change, if it introduces new opportunities, but also new risks, into social life, if it changes history, then the agent of that innovation (a person, a firm or an assembly) is acting politically and the related responsibility cannot be removed from democratic control.

However, in reality this is often not the case.

Can we allow politically irresponsible innovation in a democratic society? Can such responsibility be distributed indiscriminately between the entrepreneur (whose responsibility is at most implicit, namely that linked to success in the market) and the market in all its indeterminacy?

Maybe that the best way to respond to the sweeping questions raised by reality is to look for answers in the tangibility of experience.

One possible approach is to look at these issues from the point of view of an insurance company. We are probably all familiar with Allianz: a major insurance group that, not only in terms of size but also in its long traditions, can be considered one of the leading actors in managing social risk through insurance methods.

We might take the terrible example of the events of 11 September 2001.

Allianz had a major exposure towards the World Trade Center and the business conducted within it, which obviously generated significant losses. The total of all insured claims related to the September 11 terror attacks were somewhere around 40 Billion US Dollars while the sum of Allianz Group’s obligations stemming from

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the attacks is estimated at 1.5 billion US Dollar net of reinsurance. However, these are just estimates. For further discussion and estimates see this article on CBS News Money Watch [2] by Lindsay Blakely.

The initial question for the insurance executives was: “Can Allianz insure skyscrapers any longer?” The event called into question the entire framework of social risk and the collateral effects associated with the new vulnerability of buildings like the Twin Towers and, more generally, buildings with symbolic value.

The attack had irreversibly changed the responsibility to stakeholders of an insurance company exposed to risks such as skyscrapers or other symbolic buildings. The episode revealed that the liabilities in this case were not just the settlement of the various claims for damages but also the simultaneous fall in the market value of the assets backing those risks. As Lutz Cleemann notes, “in financial terms the loss in investment far outstripped the insurance loss.”

Cleemann’s comment is really the crux of my argument in this piece, as I believe it is relevant to many other forms of innovation.

Although this example is fortunately out of the ordinary, I would argue that the issues raised by this particular innovation are analogous to issues raised by innovation in general. The questions posed by Allianz in the case of the Twin Tower attack are the same as those raised by nanotechnology, banking, pharmaceutical research trials and many other forms of business innovation.

When we look at social risk and political responsibility in innovation, we are obviously not talking about terrorism, but as the banking debate and global slowdown demonstrate, innovative approaches to business can have serious consequences, some of which although unseen and unintended have global effect and responsibility.

We at the Bassetti Foundation would argue that the meeting between the knowledge and the power of an act leads the traditional concept of responsibility into crisis. The lines upon which

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responsibility can be drawn are blurred, and the future effects of any action are by definition unknown.

The ecosystems within which innovators live are imbued with risk, and this factor leaves them outside the “cages” of operational standards. Our mission is, therefore, to help risk takers inject awareness and intelligence into their innovation processes.

After all, without risk there is no innovation!

Note: Much of this article is based upon a lecture deliverd by Piero Bassetti at the London School of Economics on 14th May 2003.

References:

1] http://www.fondazionebassetti.org/en/pages/2012/11/innovation_responsibility_and.html

2] http://www.cbsnews.com/8301-505123_162-57292565/cost-of-911-in-dollars/

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Chapter 2

Synthetic Biology and Nanotechnology

An Introduction to Synthetic Biology The first question must be what is synthetic biology? Variously touted as pertaining to the discipline of engineering, biology, genetics, nanotechnology or computing, the most common description is that of applying the concept of engineering to biological organisms. But what does that actually mean?

In order to understand more about the techniques I would like to take a look at a report entitled Synthetic Biology: scope, applications and implications [1] published in London by The Royal Academy of Engineering in May of 2009.

The report explains that “Synthetic biology aims to design and engineer biologically based parts, novel devices and systems as well as redesigning existing, natural biological systems”. Practitioners use a systems approach, with the aim of seeing the organism as an complete functional entity and not just as a series of isolated elements, this approach then used as the basis for engineering applications. The system is described in terms of mathematical equations, allowing the reduction of the system to biological parts (bioparts) whose function is expressed in terms of input/output characteristics. Once these parts have been described in terms of their function, isolated, standardized and synthetically reproduced, they can then be combined to from new organisms, very much in the way that an engineer would build a machine using standard devices built from standard parts.

These standard parts are themselves defined by their DNA, and this can be manipulated in order to make the perfect part for the perfect device. Create the part, put in it a carrier cell (known as chassis) and Bob’s your Uncle, you can start to construct your organism.

The Biobricks Foundation [2] is a not for profit organization that aims to keep a register of these standard parts, maintaining open access and promoting technical standardization, something that is seen as holding the key to the further development of synthetic biology.

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Obviously to do this you require technical expertise, the process requires computational modeling in order to analyze the complexities of biological entities and to predict system performance. You require DNA sequencing in order to describe the genome and then of course DNE synthesis, to re-produce either part of or the entire genome itself.

But what are the potential areas of application for this technology, and what can they actually do now?

One of the main fields is undoubtedly medicine and health. Drugs can be produced that are more effective or have fewer or even no side effects, as the genomes of their active components can be adjusted and synthesised.

An example is the development of a synthetic version of the anti-malarial drug Artermisinin that could be industrially and cheaply mass produced. In the near future antibiotics could become much more efficient.

An existing application is water that changes colour when in contact with different polluting agents making them instantly recognizable.

Switches already exist that react to certain types of input. An example could be a cell that is part of a person’s body that reacts to the stimulus of a certain chemical that in turn stimulates the production of another.

Imagine for example a device that reacts to a chemical produced by a cancerous cell. This input causes a reaction that produces another chemical to counteract this presence. All working naturally using the body’s energy to function.

Other developments involve the energy sector, the production of plants for bio mass that are not as wasteful as those used today and even the development of synthetic aviation fuels.

In other fields a synthetic form of the silk produced by the Golden Orb spider is under development. This is an extremely strong, fine and lightweight material that could lead the way towards new specialist engineering materials.

The report concludes with a chapter on ethics, but seeing the enormity of the problem I would like to leave the ethical discussion to my second posting, that I will purely dedicate to reports addressing this problem.

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In general this report does not make light reading, some parts are extremely technical and it is nearly 70 pages in length. It does however offer a 5, 10 and 25 year vision of developments and possible applications, while giving examples of present working practices and an outline of global funding and organizations.

One aspect that I find interesting but that also makes comprehension difficult is the use of engineering language in all of the publications I have read during my preparation for these postings. Speaking about ‘switches’ and ‘machines’ and ‘devices’ or ‘computer memory’ but referring to a very small living, biological object certainly pushes my conceptual capabilities to their limits. References:

1] http://www.raeng.org.uk/news/publications/list/reports/Synthetic_biology.pdf 2] http://bbf.openwetware.org/ 3] http://www.fondazionebassetti.org/it/segnalazioni/2009/07/an_introduction_to_synthetic_b.html

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Science: September's special edition on synthetic biology On September 2nd, 2011 the US based journal Science published a special edition on synthetic biology [1], a topic that has been debated through several article on the bassetti Foundation website and to which this chapter is dedicated. The journal was not entirely devoted to this single argument, although it contained several articles and reviews addressing the problem in a special edition section. The following is a selection of those articles that address problems most directly associated with the interests of the Bassetti Foundation. The introduction is entitled "The Allure of Synthetic Biology" and is the only section freely available through the Sciencemag website. In the introduction authors Valda Vinson and Elizabeth Pennisi offer a general overview of the world and working practices of synthetic biology before giving a brief description of the articles to follow. After the introduction the section hosts an article written by John Bohannon, in which the author narrates the life and works of Harvard Scientist George Church [2]. Church is a leading light in synthetic biology and has made many breakthroughs over the years. He is currently experimenting with a machine of his own construction called MAGE. The machine takes bacteria on a large scale and alters their genomes, and he believes that it could pave the way for cheaply manufacturing industrial chemicals from biomass. His great goal is different however, he believes that he will one day be able to "hack into a cell's genetic code and make the cell impervious to viruses". The issue continues on the theme of biofuels with an article by Robert F. Service in which he describes how synthetic biology techniques are revitalizing the field of biofuels in the US. Investment is flooding into the sector, both from private companies and the state, as new techniques promise to make oil extraction from algae a much more viable proposition.

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One of the techniques described involves making the algae behave differently towards one another. In a natural setting they take all the sunlight they can, which means the density of production is very limited, but researchers have successfully engineered algae that only absorb the light they actually need to produce oil, raising growth potential by 30%. The addition of a human gene that helps regulate carbon dioxide in blood cells can improve photosynthesis rates by up to 136%. The author also raises the issue that these companies are proceeding in "poorly disclosed ways", hinting at the problem of secrecy in such a potentially lucrative market. Church himself hopes that one day his machine will be worth billions of dollars, and this factor leads to the secrecy and patent issues that have been addressed many times on this website. In an article entitled "A Lab Of Their Own", Sam Kean recounts the story of a small group of do it yourself biologists that have set up a community lab in new York. This article makes for very interesting reading and raises several ethical questions. The group has their own lab and practice "citizen science" of several types, including genetic engineering. The lab is cobbled together from various sources, and offers classes for budding scientists (both children and adult) in order to fund itself. The members are very wary of their obligations towards society, and screen all materials and projects before passing them, but the project demonstrates how "easy" it is to conduct these types of experiments, and raises the issue of security in what seems to be an ethically complex position. It would seem that genetic manipulation and modification can be done by interested persons with a little easily obtained equipment, and that serious regulation is either already impossible or soon will be. In "Visions of Synthetic Biology", Sara Reardon describes the current "state of the arts" in synthetic biology. Artists are experimenting with synthetic biology personally in labs, but are also representing it through their art as they see it, in some cases the savior of humanity and in others a great threat. She argues that artists not only embrace

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but also critique science, and that their production is one way to propose the ethical issues involved for discussion to the general population. Art can create debate within society about ethical issues and artists tend to be rightly or wrongly critical and sensitive to these types of debate. Some examples are absurd but poignant, such as the "suitcase full of colored poo". In the artist's vision people can be engineered so that their feces changes color according to their illness. See the article Science Meets Art: Bacterial Culture [3] for an explanation. The issue concludes with a series of technical reviews and other articles that are geared towards a professional reading of synthetic biology problems. Topics such as the degree to which biology can actually become synthetic, synthetic biology in medicine and regulating industry use of biotechnologies are addressed, but some of these articles are much more technical in nature and require specialist knowledge. References: 1] http://www.sciencemag.org/content/333/6047.toc#SpecialIssue 2] http://en.wikipedia.org/wiki/George_Church 3] http://www.torontostandard.com/foreign-desk/bacterial-culture

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An Ethics for Emerging Technologies As a follow on from my previous introduction to synthetic biology I would like to take a look at a report entitled Ethical Issues in Synthetic Biology; a review of the debates. [1] The report published in June 2009 is co-authored by Erik Parens, Josephine Johnston and Jacob Moses, all of The Hastings Center [2] in Garrison New York, as part of the Synthetic Biology Project at the Woodrow Wilson International Centre for Scholars [3] in Washington DC. In the preface the Director of the project David Rejeski states that 'Ethical concerns are too often addressed after investments in science have been made and technologies are already mature and in the marketplace. At that point, neither the research community nor policymakers have a strong incentive to address ethical issues for fear that any debate may stifle technological advance and innovation. But given the rate at which new technologies are emerging and converging, this paper argues that a comprehensive ethical approach is needed early to best foster the wide public acceptance and support of new technologies such as synthetic biology'. Following on from this argument the executive summary proposes a move away from thinking of ethic issues as being valid for small sectors of technological advancement, for example ethics for nano-technology or an ethics for engineering practices. The authors argue that as these emerging technologies tend to converge it would be more correct to think about an ethics for emerging technologies. For the purpose of the report ethical concerns are divided into 2 broad categories, those concerning physical harm and those concerning non-physical harm. There are also 2 types of framework sited through which the problem can be addressed, one described as 'pro-actionary' and the other 'pre-cautionary'. An individual's positioning within these frameworks is largely down to their view of the technologies involved.

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The taking of either a generally positive or on the other hand generally negative standpoint will affect the type of actions seen as correct and justified. An explanation of 'who is doing what, where, and how is it funded?' follows, with an explanation of the somewhat intertwined strands of research being carried out by the 4 major players. The report continues by discussing the interconnectedness of various emerging technologies, promoting the argument that 'Recognizing the interconnectedness of the science can also help us recognize the interconnectedness of the ethical issues'. The authors go on to the discuss potential benefits and harms posed by synthetic biology using their previously defined categories of physical and non-physical harm, and then discuss the pro-actionary and pre-cautionary frameworks. The discussion raises questions of regulation from outside or inside the community, trust, public participation and perception, giving several case study examples. The final section before the conclusion discusses the problem of perceptions of non-physical harm. Non-physical is much more difficult to define than physical harm as an individual's perception is greatly affected by their philosophical starting point. An individual does not come to a conclusion purely on the basis of logic, but other aspects such as religion and beliefs about well-being and lifestyle choices come into play when deciding if a possible outcome should be seen as positive or negative. The conclusion outlines the arguments presented in the report, arguing that although the issue of physical harm is being addressed, the issue of non-physical harm has received 'short shrift' in the discussion of synthetic biology. The problem stems from the lack of agreement between scientists about the precise nature and legitimacy of these concerns, let alone what might be done to address them.

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The authors go on to suggest that 'those who fund and lead synthetic biology seek to respectfully and carefully describe, and critically evaluate, concerns about both physical and non-physical harms. In so doing, they should draw on our experience of these concerns in the context of other emerging technologies, including genetics, neuroscience and nanotechnology. How were these concerns conceptualized, what values were appealed to in their description, how were the concerns addressed and what lessons can be critically applied to the case of synthetic biology?' They argue that these problems can be clarified through discussion and through referring to previously gained experience in the related fields outlined above, but that time may be needed leading to a possible slowing down of scientific advancement. Substantial financial investment will also be necessary. They conclude however that 'Experience with other emerging technologies strongly suggests that this would be time and money well spent'. This report is very easy to read and offers plenty of food for thought. The references throughout the text offer anyone interested plenty of reading matter and the breadth of publications demonstrates that the problem of ethics in emerging technologies is being widely addressed. References: 1] http://www.synbioproject.org/library/publications/archive/synbio3/ 2] http://www.thehastingscenter.org/ 3] http://www.wilsoncenter.org/

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Governance and participation in nanotechnology

A look at Wikipedia [1] gives a thorough if not quite technical description of what nanotechnology is or could be defined as. The description opens with "Nanotechnology is a highly multidisciplinary field, drawing from fields such as applied physics, materials science, interface and colloid science, device physics, supramolecular chemistry (which refers to the area of chemistry that focuses on the noncovalent bonding interactions of molecules), self-replicating machines and robotics, chemical engineering, mechanical engineering, biological engineering, and electrical engineering". The article also states that the use of the umbrella term is not unproblematic, as these disciplines cited above are autonomous and do not necessarily communicate between each other. The only thing they share is the use of technology that allows them to work on a nano-scale. The article offers an explanation of the two main working practices in the field, bottom-up and top-down, and an explanation of the advantages of working on a nano-scale. The applications are less Frankensteinian than one might imagine, suntan lotions and common pharmaceuticals for example are produced using this technology. The Wikipedia article also hints at some of the possible ethical concerns that these technologies may raise such as the effect that industrial-scale manufacturing and use of nanomaterials would have on human health and the environment. Longer-term concerns center on the implications that new technologies will have for society at large, and whether these could possibly lead to either a post scarcity economy, or alternatively exacerbate the wealth gap between developed and developing nations. The effects of nanotechnology on the society as a whole, on human health and the environment, on trade, on security, on food systems and even on the definition of "human", have not been characterized or subjected to political debate. The European commission homepage [2] is an interesting starting point for anyone interested in the governance of and political intervention in nano science. It offers amongst other things a

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compilation of the commissions communications and resolutions regarding nanotechnology, a code of conduct for responsible nano science research and project and funding information.

There is also a list of events [3] past and present regarding nano technologies, including a debate on governance initiatives for the European nanotech community [4] that took place in Brussels in December 2007, the forthcoming summer school on the ethics of nanotechnology [5] and access to an EC consultation paper "towards a code of conduct for responsible nano science and nano technologies research" [6] that follows on from the nanotechnologies action plan 2005-2009 published on 07/06/2005. "Citizen participation in science and technology" (CIPAST) produce a nanotechnology newsletter[7]. The CIPAST-Project, which started on April, 1st 2005 and is coordinated by Cité de la Sciènces et de l'Industrie, Paris, aims at bringing together organisations which have significant experiences in the use of participatory procedures in scientific and technological issues, or belong to the different families of experienced actors in that field such as parliamentary offices, research institutes, science shops or science museums, or are already structured in European networks.

Project partners are: Rathenau Institute (Den Haag, NL), Danish Board of Technology (Kopenhagen, DK), University of Westminster (London, Centre for Studies of Democracy, UK), Université de Lausanne (Science and Society Interface, CH), Città della Scienza (Naples, I), Deutsches Hygienemuseum (Dresden, D), INSERM (Paris, F), INRA (Paris, F), ARMINES (Paris, F), Fondation Nationale des Sciences Politiques (Paris, F) and the Bonn Science Shop.

Their stated aims and interests are as follows:

"The development of initiatives, which extend the social basis for deliberation and decision-making in scientific-technological fields, has its roots in various arenas and bodies which belong to different spheres and are not always linked together. Bringing these actors together, pooling their various capacities, and integrating their various contextual perspectives through a common platform, will provide an opportunity to disseminate useful practices more efficiently. It will boost innovation and foster the emergence of a

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European culture of participatory democracy in scientific and technological issues".

A special issue of the newsletter [8] was recently published on the CIPAST website. The newsletter was prepared by Nicolas Baya Laffite at L'institut National de la Recherche Agronomique (The French National Institute For Agricultural Research) INRA/TSV. It provides a summary of 60 participatory processes in nanotechnology governance in countries where they have developed significantly as a result of political initiatives, namely in the United States, in the UK and in other Member States of the European Union.

The newsletter draws on the CIPAST database, the 2007 final report of the Nanotechnology Engagement Group (NEG) and extensive Internet research. Their fist stated aim is to give access to data as complete as possible - although not exhaustive - on individual participatory experiences in nanotechnology. The gathering of this information allows one to put these individual experiences into perspective and to open a discussion on the roles of public participation so far in different national and regional political contexts.

Following Sherry Anstein ("A Ladder of Citizen Participation," JAIP, Vol. 35, No. 4, July 1969, pp. 216-224.) they use a participation ladder analysis to measure the level of public participation.

The newsletter is well researched and very informative. The initiatives are presented through geographic categories with a description of the initiatives in each zone of interest and at the end of each section there is a bibliography. It is an enormous document and over the coming weeks I aim to look at it more deeply and post some more articles on my findings.

There are a host of possible takes on the issue of nanotech just by looking at the Internet coverage of it. One is the commercial one.

Nanoposts.com [9] offers nanotechnology for license or potential sale and also provide a weekly news bulletin. They state that Nanoposts.com is the only online tool available that allows you to access the latest leading-edge research and development in nanoscience and nanotechnology. Nanoposts.com also provides

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technology scouting and consultancy services for government bodies and some of the world's leading multinational companies.

Nanoposts.com enables users and members to find new ideas, technologies, products and services from outside their organisation quickly and - they say - inexpensively by connecting them to the best technology providers from around the world. Nanoposts.com offers the largest and most comprehensive network of nanotechnology providers worldwide.

The Institute of Nanotechnology[10] also offers another large site. For a membership fee they promote conferences and various education and training courses as well as providing advertising and marketing opportunities; they sell reports and various other literature, and offer a contact making service.

References: 1] http://en.wikipedia.org/wiki/Nanotechnology 2] http://cordis.europa.eu/nanotechnology/home.html 3] http://cordis.europa.eu/nanotechnology/src/events.htm 4] ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/agenda_programme_codeevent(05122007)_2.pdf 5] ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/prethicschool_101007.pdf 6] http://ec.europa.eu/research/consultations/pdf/nano-consultation_en.pdf 7] http://www.cipast.org 8] http://www.cipast.org/download/CIPAST%20Newsletter%20Nano.pdf 9] http://www.nanoposts.com/index.php?mod=nanotech 10] http://www.nano.org.uk

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Without risk there is no progress

"Without risk there is no progress", and this should be borne in mind when speaking about innovation and responsibility. If we accept the statement above made by the International Risk Governence Council [1] then we must accept that innovation is not a risk free business.

The International Risk Governance Council (IRGC) is an independent foundation based in Switzerland whose purpose is to help the understanding and management of important, emerging global risks that impact on human health and safety, the environment, the economy and society at large by:

• developing concepts of risk governance that have relevance across different risk types, problem areas, organizations and countries

• anticipating major risk issues and improving the understanding and assessment of them and the ambiguities involved;

• providing policy recommendations to key decision makers in government.

In 2005 they published the White Paper "Risk Governance - Towards an Integrative Approach" and this year published both an introduction to the white paper on their web site and the book "Global Risk Governance - Concept and Practice Using the IRGC Framework" (Springer Academic Publishers 2008), a description of the IRGC's risk governance framework, critiques of the framework by internationally renowned experts on risk governance, seven case studies which apply the framework to specific risk issues and a chapter in which Ortwin Renn - who leads this area of IRGC's work - itemises the lessons learned from the various critiques, case studies and experiences of using the framework since its publication.

My interest in the Council is in their interest in the governance of potential nanotechnology risks and the publication earlier this year of the policy brief "Nanotechnology Risk Governance. Recommendations for a global, co-ordinated approach to the governance of potential risk".

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This Policy Brief is targeted at policy makers engaged in the planning, oversight, and funding of nanotechnology regulation, research and practical applications.

In order to distinguish between different types of nanotechnology applications and the benefits and risks that might accompany each type, IRGC has identified four generations of nanotechnology products and production processes. We can divide these into two frames, passive:

• First Generation: Passive (steady function) nanostructures (as from 2000). The main applications are intermediary system components such as particles, wires, nanotubes and nanolayers whose properties allow for improvements to the performance of existing materials and products

And active:

• Second Generation: Active (evolving function) nanostructures and nanodevices (as from 2005). These products can change their state during operation.

• Third Generation: Integrated nanosystems (systems of nanosystems) (After 2010). In this generation, it is anticipated that synthesis and assembly techniques will allow for: forms of multiscale chemical and bio-assembly; networking at the nanoscale; and, scaled, hierarchical structures. In nanomedicine.

• Fourth Generation: Heterogeneous molecular nanosystems (after 2015). The system components and devices are reduced to molecules and supramolecular structures that have specific structures and play different roles within the nanosystem.

In Frame Two, the active frame, new capabilities are expected to be developed to both create new molecules by design and change the structure of the existing molecules; together with their increased complexity and dynamic behaviour, this could directly increase the risks associated with these active nanomaterials and nanodevices. The active and more complex nanotechnology applications of Frame Two may, therefore, require a far greater level of knowledge and

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ability to control nanostructure behaviour and to assess potential risks. Additionally, a large number of the potential Frame Two applications involve genuinely new products and the social, economic and political consequences are expected to be more transformative. This greater level of novelty could, IRGC has concluded, heighten the potential for societal concern.

The risks outlined are the following:

Human health risks; environmental risks; manufacturing risks; political and security risks; educational gap risk; and human misuse.

Governments, industry, academia and NGOs worldwide are looking for the best risk assessment, management and governance practices with respect to nanotechnology.

However, innovation in the field of nanotechnology development is far ahead of the policy and regulatory environment, which is fragmented and incomplete at both the national and international levels. IRGC has identified several areas of governance gaps that ideally should be addressed in a coordinated fashion at the international level.

These deficits include:

Environmental, health and safety; institutional issues; and social and political issues.

This document raises some critical issues and an appendix detailing how to apply the IRGC risk governance framework to nanotechnologies. It raises a lot of questions about the unexpected or seen but unprepared for effects upon society of nanotechnology developments raising the obvious ethical concerns and questions of responsibility.

References:

1] http://www.irgc.org/

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Oversighting Nanotechnology

In this article I would like to follow up on my series of postings on nanotechnology by taking a look at the recent report entitled Oversight of Next Generation Nanotechnology [1] written by J Clarence Davies and published by The Woodrow Wilson International Centre for Scholars [2] as part of their project on emerging nanotechnologies. The author of this report, J Clarence Davies [3] is one of the foremost authorities on environmental research and policy, he served under the first Bush administration and was co-author of the plan that lead to the creation of the US Environmental Protection Agency [4]. In his executive summary he argues that over the last 25 years "the capability of the federal agencies responsible for environmental health and safety has steadily eroded" and that "the agencies cannot now perform their basic functions" and are "completely unable to cope with the new challenges they face in the 21st century". An interesting premise! He states that the paper will describe some of the challenges faced and offer some suggestions that could revitalize the health and safety agencies, and in fact proposes a new federal department of environmental and consumer protection. The paper opens by describing the current oversight approach to nanotechnology in the US as inadequate, and as science advances the problems increase and the system becomes ever more so. He argues that for the good of society and also to enable the growth of nanotechnology a new system must be put into place. The paper goes on to describe present nanotechnology applications and various future possibilities, including a four stage development process that I have previously described in the last article in this publication.

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Current research includes injecting gold coated nano-particles into subjects suffering from cancer that can then be heated using radio waves in order to kill cancerous cells and yet avoid damaging healthy cells. The US army are working on a new nanotechnology battle suit for soldiers, and major computer companies are exploring the possibility of using nanotechnology to improve current flow in microchips. Other research is studying applications in battery, renewable energy and glue production. The section entitled Characteristics of nanotechnology (p 17) makes for interesting reading as it broaches some interesting technical and ethical problems. How can the public be involved in decision-making when the level of expertise required to meaningfully participate in any debate is so high? How can any governing body be expected to understand the problems addressed by a small number of highly specialized scientists? How can risk be assessed and managed in such a field? Should nanotechnology be used in food production and if so should it be labeled as such? Could self assembly and self replication lead to Bladerunner or 2001 Space Odyssey type scenarios with humans losing control over machine reproduction? In the second section of the report entitled Existing Oversight and Next Generation Nanotechnology the author analyzes the current oversight situation both in the US and in Europe arguing that the situation is not as grave in Europe due to the fact that the regulating body (REACH) is a much newer and broader organization, and although still failing in effective regulation this is mainly down to problems of definition and categorization of what actually need to be regulated, and in some measure down to the lack of an all encompassing comprehensive and coordinated oversight system. The third section of the report entitled The Future of Oversight is a description of what a more adequate overview system might look like. From the standpoint that the current system is inadequate for the enormity of the task ahead the author advocates the complete scrapping of the current system and the creation of a more integrated system and proposes the new federal department of

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environmental and consumer protection sited above, for whom problems do not have narrow definitions but are seen as intertwined with all the other results of the process The proposal is that it is products that should be regulated and not their components. Arguing that if certain types of nanotubes for example are found to be damaging to health they could be combined with other products, modified or used in a way that negates this potential threat, a form of evaluation that is not possible if the nanotubes themselves are regulated. The author proposes that at each manufacturing level the producer must publish a report on the possible risks involved in their product. Failure to do this must carry heavy sanctions, but the result would be a type of family tree for the finished product, containing the geniality of all its components, the burden of proof always being held by the manufacturer. Regarding technology the report proposes three important factors that are currently overlooked: Assessment of the technology's impacts, especially unintended impacts; ways for the public to understand the technology's impacts and register its views; and ways for the government to translate the public's views into actions. The report goes on to discuss the practicalities of the proposal outlined above, paying attention to the problems of foreseeing potential problems, risk assessment, monitoring, enforcement, public involvement and government intervention and the resulting stifling of innovation. The report concludes with a line that seems to me to hit the nail squarely on the head. "The paper is an exercise in both technology forecasting and policy envisioning. If the forecasts are even roughly accurate, then thinking about new policies is urgently needed".

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References: 1] http://207.58.186.238/process/assets/files/7316/pen-18.pdf 2] http://www.wilsoncenter.org/ 3] http://www.rff.org/researchers/pages/researchersbio.aspx?researcherid=25 4] http://www.epa.gov/ 5] http://www.fondazionebassetti.org/en/focus/2008/07/without_risk_there_is_no_progr.html 6] http://www.fondazionebassetti.org/it/segnalazioni/2009/07/oversights_in_oversighting_nan.html

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A Research Strategy for Engineered Nanotechnologies

In January of 2012 the National Research Council of the National Academies published a document entitled 'A Research Strategy for Environmental, Health and Safety Aspects of Engineered Nanotechnologies' [1]. The document was prepared by the Committee to Develop a Research Strategy for Environmental, Health and Safety Aspects of Engineered Nano-Materials, within the National Research Council and a pre publication copy is available from the National Academic Press [2] for downloaded here [3] . This is a long and detailed document written with the help of a host of academics, and it raises some very important points about an industry that Barak Obama has placed at the forefront of his innovation policy. In this year's budget Obama is asking for 123.5 million dollars to invest in nano-tech research, which if seen next to the relatively small investment of 34.8 million in 2005 signals the importance attached to this form of innovation. But all of this investment is made in a technology that is as yet practically unregulated and severely lacking in health and safety legislation, with the problem being that exposure limits and contamination issues have yet to be formalized. All of this is despite the ever growing use of such particles in our everyday life. The National Research Council document aims to develop such a research strategy starting from a conceptual framework for considering environmental, health and safety risks, through critical questions to understanding the problem, tools and approaches for identifying properties that may cause risk, resources needed and how to implement the strategy once it has been described. The document is extremely thought provoking. The fact that safe (or dangerous) exposure levels to such particles have never been determined nor possible environmental release dangers quantified or analyzed seems to paint a picture of an entire industry that operates

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without a clear understanding of how to manage the risks involved in their work. One of the collaborators involved in the preparation of the report is Andrew Maynard of the University of Michigan, and his 2020 Science blog really is a must for anyone interested in keeping a breadth with developments in nanotechnology. The review [4] of the finished research strategy as published in January, and his blog's nanotechnology section [5] contains a series of posts about the development of the project including an insightful look at how public participation and comment affected (or may not) the final publication. Several cities in the US have started to draw guidelines regarding nano-technology research even before this strategy has taken off, with Cambridge (here in Massachusetts where I myself currently reside) at the forefront. In a phrase that very much reflects the work of the bassetti Foundation, Cambridge city joins Berkley in California in stating that it "Intends to promote the responsible development of nano technology....." The Bio Ethics blog [6] offers more details. The topic of nanotechnology has been addressed several times on the Bassetti Foundation website and the following citations offer just a flavour of our work here. In 2007 Jeff Ubois interviewed NanoMarkets co-founder Lawrence Gasman and Christina Peterson of the Foresight Institute. The conversation with Gasman touched upon the reporting of nano technology in the press, possible regulation and its effects, discontinuity in near future development and responsibility.[7] Peterson talked about the framing of the nano problem and differences between the European and US approaches to its regulation.[8] In 2008 I myself wrote two articles about nanotechnology both of which are in this chapter.

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The first entitled Governance and Participation in Nanotechnology [9] is a review of on-line literature broadly relating to governance and is also available in this publication. The second is a review of a white paper published by the International Risk Governance Council [10] about global risk governance, also in this collection. In 2009 I followed up on these posts with a review of the Oversight of Next Generation Nanotechnology report [11] published by The Woodrow Wilson International Center for Scholars. In 2009 Brice Laurent posted an article [12] in which the author raised the question of nanotechnology regulation through private actors. The article addresses the insurance company perspective and includes links to Lloyd's emerging risks team report and another article from Lloyds entitled Nanotechnology: An insurer's perspective, both of which make interesting reading. References: 1] http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13347 2] http://www.fondazionebassetti.org/it/segnalazioni/2011/06/national_academic_press_a_host.html 3] http://www.nap.edu/catalog.php?record_id=13347 4] http://2020science.org/2012/01/25/national-academy-publishes-new-nanomaterials-risk-research-strategy/ 5] http://2020science.org/category/nanotechnology/ 6] http://blog.bioethics.net/2008/07/not-waiting-for-the-feds-on-nano/ 7] http://www.fondazionebassetti.org/en/ubois/2007/03/responsibility_in_innovation_a.html

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8] http://www.fondazionebassetti.org/en/ubois/2007/02/christine_peterson_of_the_fore.html 9] http://www.fondazionebassetti.org/en/focus/2008/04/governance_and_participation_i_1.html 10] http://www.fondazionebassetti.org/en/focus/2008/07/without_risk_there_is_no_progr.html 11] http://www.fondazionebassetti.org/it/segnalazioni/2009/07/oversights_in_oversighting_nan.html 12] http://www.fondazionebassetti.org/en/focus/2009/02/regulating_nanotechnology_thro.html

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Nano-pollutants and a Research Strategy I would like to point readers towards an article published in Science News. The Science News article written by Janet Raloff is titled "Nanonpollutants Change Blood Vessel Reactivity" [1], and describes new research that demonstrates that exposure to nano-sized particles can impair the responsiveness of very tiny blood vessels in animals. Microvascular physiologist Timothy Nurkiewicz of West Virginia University in Morgantown has been conducting experiments on rats, exposing them to nano-particles to see if their blood vessels dilate in the same way as rats with no exposure, and he has found changes that although small "equate to a level of impairment that would preclude affected tissues from functioning normally". The particles he used were of Titanium Dioxide and are commonly used in cosmetics and sunscreen. The doses were not considered to have been given at toxic levels, but a difference in dilation was measured that seems to "offer further demonstration that air pollutants can impair cardiac function". Further details of Dr Nurkiewicz's work can be found on his website [2], including an explanation of these very tests. In a line taken from his website he states that nanoparticle toxicity is under-investigated although the particles are in every-day use, an argument that the authors of the Research Strategy also made and a problem that should be addressed.

References: 1] http://www.sciencenews.org/view/generic/id/339240/title/Nanopollutants_change_blood_vessel_reactivity 2] http://www.hsc.wvu.edu/ccrs/Investigators/nurkiewicz.asp

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Chapter 3

Bioethics

Ethical Decision Making During A (Possible) Flu Pandemic

As a first introduction to the complex problems of bio-ethics and scenario planning I would like to signpost an article published in the bioethics forum of an interesting website run by The Hastings Centre, a non partisan research centre dedicated to bioethics and public interest issues. The article is entitled "When Endemic Disparities Catch the Pandemic Flu: Echoes of Kubler-Ross and Rawls" [1] and written by Joseph J. Fins, Professor of Medicine and Public Health and Chief of the Division of Medical Ethics at Weill Cornell Medical College and a Fellow of the Hastings Center. The article recounts the author's experiences as a participant in panels considering the clinical and ethical challenges posed by pandemic flu, addresses the problems presented by a possible pandemic, and makes interesting reading in the light of the current problems in Mexico and the USA with swine flu. Several different scenarios are addressed, with different strains of flu provoking different levels of hospital entry and resource consumption. The author poses the question of how to distribute limited resources amongst the population in times of acute crisis, using data about the number of ventilating machines that are currently available in the different districts of the city of New York. In a nutshell the problem is this, when the crisis reaches its peak there may not be enough machines for the number of people that require them, so how can a decision be made as to whom to give the machines to? Any prioritizing has potentially devastating consequences for post virus social life, not to mention an individual's survival, as some

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people will not receive adequate treatment and as a consequence may die. If for example priority is given to medical staff with the aim of maintaining an adequate health care system, other people, including children, may not receive the ventilator they need. The document also contains a draft for public comment [2] that makes for harrowing reading in parts. The draft takes the problem of bird flu as its case study as this was seen as the main threat at the time of publishing, although other types of influenza viruses are mentioned and discussed. It concludes that machines must be distributed upon the basis of clinical evaluation, but describes how the removal of one machine from a patient to allocate to another on the basis of this evaluation would cause ethical and emotional problems not only to the family involved, but also to the medical personnel that have to take the decision and physically carry out the action. The article also contains a link to another piece posted on the same website entitled "Planning for an Influenza Pandemic: Social Justice and Disadvantaged Groups", [3] written by Lori Uscher-Pines, Patrick S. Duggan, Joshua P. Garoon, Ruth A. Karron, and Ruth R. Faden. This article presents an analysis of different governments' pandemic influenza emergency planning, and argues that an influenza pandemic "would create the most serious hardships for those who already face most serious hardships", and that people living in developing countries or in poor conditions in developed countries are much more likely to suffer and die than others, but that little is being done to address this fact. These arguments are not new to the foundation website as a call for comments [4] published in January of 2005 shows. The issue here is a call by Daniel Callahan (Director and founder of the Hastings Centre) for "sustainable medicine" in order to offer affordable health care to all.

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The call for comments was followed by Callahan's visit toMilan, a paper delivered at the Catholic University of Milan [5] in which he argues the need for a change in medical research philosophy, and a seminar conducted in the Bassetti Foundation conference suite in February of 2005 References: 1] http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3390&blogid=140 2] http://www.health.state.ny.us/diseases/communicable/influenza/pandemic/ventilators/docs/ventilator_guidance.pdf 3] http://www.thehastingscenter.org/Publications/HCR/Detail.aspx?id=790 4] http://www.fondazionebassetti.org/en/enframeset.php?content=http://www.fondazionebassetti.org/06/cfc-callahan/000347.htm 5] http://www.fondazionebassetti.org/en/pages/2008/01/sustainable_medicine_two_model.html

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Drugs for People, Not for Profit.

On Saturday 29th September 2009 an article appeared in the Guardian [1] one of the UK's wider read broadsheets entitled 'Soaring Drugs Bill Threatens to Bankrupt NHS'. The article refers to a report published on the same day by left leaning think-tank Compass, an organization that describes itself as 'Direction for the Democratic Left'. It reports amongst other things that innovation within the pharmaceuticals industry is in decline, with the majority of new medicines in the market place neither improving on older versions nor offering new lines of treatment and aimed solely at gaining market share for their producers. The authors argue that this model does not represent a sustainable way to proceed. One of the co-authors of the report Zoe Gannon argues that the industry is in need of regulation due to its social importance, and the other co-author Jon Cruddas MP believes that government intervention is necessary to 'stop biased clinical trials and excessive influence over the medical profession'. Finding this argument interesting and extremely relevant for the foundation I contacted Compass who kindly sent me a press copy of the report and the following is an outline of the findings. A PDF version is available from the Compass website [2] at a cost of £5.00 but I will try to cover all the points raised in this article. The report is in fact entitled 'A Bitter Pill To Swallow, Drugs for people, not just for profit', and the executive summary begins by comparing the present state of the pharmaceutical industries (the third largest industry in Britain) to the state of the financial industry (the second largest) before the crash, stating that lack of regulation and drop in productivity but a rise in profits and executive pay are already visible warning signs of a looming social and economic disaster. Although the cost for the NHS of buying medicines has rocketed by more than £7.5 billion over the last 15 years drugs companies are

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producing fewer new drugs that improve upon those already existing with more than half of all new medicines offering no improvement over the older versions. The number of new molecular entities introduced each year has halved since the 1960's and this lack of innovation leads to non-sustainability within the industry. The report continues by stating that this industry cannot be allowed to fail as this would have a direct effect upon the welfare and health of the population, and therefore these things cannot just be of interest to the various boards of directors but must be of interest to society at large. The summary continues by describing how drug companies fund and regulate their own trails and also spend huge amounts of money on trying to influence choices made by medical practitioners, in fact these companies spend 300 times as much money as the UK government on post graduate doctor training aimed according to the authors at guiding their prescription choices. The report makes 5 priority policy proposals:

• Make a greater investment in publicly funded science with £1 billion of extra funding between 2010 and 2011

• Make clinical trials open to public scrutiny • Educate doctors through public funding • Review progress made since the 2005 Health Select

Committee Report [3] • Control pay and bonuses

After the introduction that gives a background to current situation including government policies in the post war NHS years the report is presented in 7 large sections, the first entitled 'The Problem, The cost of drugs and declining innovation'. This section begins by offering some data regarding the cost of medicine to the NHS. As noted above the medicine bill is exploding, shooting from £2.5 billion in 1991 to almost £11 billion today. These rises are accompanied by a rise in profits for the drug companies, but these very companies seem to have changed their approach to the market.

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Each year the number of drugs offering marked therapeutic advantages declines, and although new drugs are placed in the market they are more and more new versions of older drugs with no therapeutic innovation. One of the causes is given as the way that trials are adjudicated. As the drugs are tested and the results are processed, a decision is made as to whether to continue the trail. This decision is not however solely based upon the efficiency of the drug in question but on its profitability. The result is that the re-marketing of older medicines is seen as a better financial option, little difference in efficiency but an already tried and tested waiting market. The companies are also searching for what the report calls 'blockbuster drugs', medicines that are for long term use and can gross large profits for their manufacturer, and this obsession conditions the types of research carried out. The authors claim that this is not a sustainable model and that investment in research and design (R&D) must increase. Investment in R&D is not however only carried out by drugs companies, and although public investments amounts to less in terms of money more than 70% of new molecular organisms that have entered the market over the last decade are the results of publicly funded science. The report offers some suggestions already mooted by the UK government including a pricing scheme that reflects the therapeutic value of the medicine to its end user and a scheme in which the companies agree to lower the prices of less effective drugs in the short term, but allowing for a possible price rise if they can demonstrate that the product was more efficient than at first thought. The second section is entitled 'Bias in Industry Sponsored Clinical Trials' and the content is easy to imagine. The industry conducts its own drugs trials and the authors claim that it is easy to hide unwanted data. Unfavourable trial results are under-published or delayed and favourable results are over-published. The design of the trial can also contain bias. If the trial does not look for side effects then no side effects will be found. One study reported

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that independent research is 8 times less likely to reach favourable qualitative conclusions than industry sponsored research. Obviously there are enormous ethical implications here but also enormous economic implications for the companies. The report recommends the mandatory disclosure of research results, the setting up of a National Standards Committee and the creation of independent research trials to counter the above problems and allow greater transparency. The third section is entitled 'The medical professional and the pharmaceutical industry'. The influence that pharmaceutical companies can exert upon medical practitioners seem to be much greater in America with many doctors conducting what they describe as a relationship with drug companies and their representatives. The equivalent of almost half of the R&D budget is spent on relationships with doctors with the aim of changing their prescribing practices. This includes lectures and postgraduate education, and some studies show that doctors that attend lectures in which certain drugs are highlighted tend to prescribe that drug more. Also in the UK more than 30% of post grad training is funded by drugs companies and so could potentially be biased towards those company’s products. Possible solutions include the 'no free lunch' pledge by which doctors do not accept gifts and promotions from drug companies, the on-line publishing of gifts received by doctors, the funding of medical training by the taxpayer instead of by drugs companies and training for trainee doctors on how to deal with drug reps. The section entitled 'The pharmaceutical industry and the public' goes on to show that the industry's influence within the public sphere does not just end with doctors. Burgeoning advertising budgets prevail not only here in the UK but throughout the world. The problem that the authors feel should be

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highlighted in the UK is the industry's growing involvement in the funding of patients' groups. It would appear from the report that the majority of these groups in the UK take money from drugs companies, and this has obvious implications for their status as independent when offering advice to patients. The report recommends that all sponsorship should be made transparent, additional funding should come from the government with the aim of lowering the drug company's influence in this sphere and that funding should go into a blind pool so that it can be distributed independently of industry influence. The next section entitled 'The human consequences of market failure in the pharmaceutical industry' offers 4 case studies in which bias in science and ineffective regulation have had human consequences. The first is the story of the development and use of SSRI drugs such as Prozac. Prozac for example provides its manufacturers Eli Lilly with more than 25% of its $10 billion a year revenue. These types of drugs have been criticised for their effectiveness (studies have found that in most cases a placebo has the same effect) and damaging side effects (including suicides) but they are still prescribed to millions of people across the globe and seen as wonder drugs. The description of the clinical trials for Vioxx that follow would make your toes curl. 6 years after its introduction as a safe alternative to non-steroidal anti inflammatories the drug was removed from the market because it significantly increased the risk of cardiovascular incidents. It appears that there had been suggestions that this might have been the case before the trials were started and that they were designed to not reveal this possible problem. It is estimated that between 88 and 130 000 Americans had heart attacks in the 5 years that this drug was on the market as a result of its consumption.

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A further example is of Baycol (only 52 deaths though) manufactured by Bayer as an anti cholesterol drug and prescribed to millions of people. Legal claims over the health implications of taking this drug have resulted in Bayer having to pay out (so far) $872 million in compensation, something that the report argues could have been avoided through better trials procedures. Retalin and Concerta are amphetamines for children. In the UK about 1% of children take these drugs (at a cost of £28 million for the NHS) as treatment for Attention Deficit Hyperactivity Disorder, but in the US it is estimated that 10% of all children take it. The original study into the efficiency of these drugs found that after 1 year's use the effects were better than behavioural therapy, but one of the co-authors stated in 2007 that benefits were being exaggerated and that in the long run there were 'no beneficial effects'. It is also becoming clear that there are side effects in growth patterns associated with their use. Other alternative treatments that have been found effective are diet and exercise but they are apparently not favoured over the chemical approach. And on to the interestingly titled 'Why is the pharmaceutical industry getting away with it?' section. The authors open this section by laying the blame at the feet of neo-liberalist economics, the idea that the market regulates itself through profit making and so regulating reforms are not seen as a priority. The authors also criticize the funding system of The Medicines and Healthcare Products Regulatory Agency (MHRA) that is funded through licensing fees for the pharmaceutics industry. In giving licenses however the agency is in competition with The European Medicines Agency so in some way has to attract license applications. This obviously has implications for the agency's independent status and one visible effect of the pressure that the industry can lay to bear on the agency could be the shortening of the time needed to grant a license.

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Other problems cited are that the MHRA does not put pressure on companies to demonstrate that their new drug is therapeutically more effective than existing drugs and is also under funded and so cannot effectively regulate already licensed medicines. The Pharmaceutical Price Regulation Scheme also comes under fire as a recent Office Of Fair Trading report argued that there is a serious question as to whether value for money is being secured. The authors propose the replacement of the scheme with a value-based system that could incentivise innovation and save money. The report praises the work of the National Institute for Clinical Excellence but also makes several recommendations including that the institute should receive more funding, have access to all licensing data, should assess the data it receives and be more transparent in its decision making process. The final section entitled 'policy recommendation' outlines the report's recommendations as given at the beginning of this article:

• Make a greater investment in public funded science funded through the savings that a value-based pricing scheme would generate.

• Make clinical trials open to public scrutiny with all phase 3

trials carried out independently of the industry. • Educate doctors through public funding in order to avoid

possible industry bias. • Review progress made since the 2005 Health Select

Committee report. • Control pay and bonuses so that pay awards do not disfigure

the product market. And finally to the report's conclusion. The conclusion states that the industry is of great socio-economic importance and that it cannot be allowed to fail in the way that the financial services industry has, as this would wreak serious consequences for society as a whole.

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Innovation must improve but this will only happen when the industry looks less towards profit and more towards therapeutic improvement as its goal. We cannot expect the industry to act as a charity while the health market is determined by profitability and not by need, so this needs to change. This report is interesting to me as it raises all kinds of questions regarding the institutional role and ethical and social responsibilities of an industry governed by profit making. As noted in previous articles and in the Hastings Centre's dedicated blog [4] , Medicare and Medicaid are also struggling under the weight of drugs bills and the difference in advertising laws can only make the problem worse (in the USA all types of medicine can be advertised on TV, in the UK only those that do not require a prescription). I imagine that people present themselves at the doctor's surgery already knowing the trade name of the product they 'require'. Drugs prices also vary throughout the world and the US is the most expensive market and this certainly will not help the government budget. On a personal note I see the difference between Italy and the UK. Medicines in Italy cost a lot more than they do in the UK, in many cases 4 times the price, and a trip to the chemist is a dear do here. In the US however the prices seem to be 5 fold that in Italy! The fact that many of the patents for the so-called superdrugs are about to expire means that generic copies of some of the most profitable medicines will come onto the market next year, so large drug companies will lose a lot of their profits exacerbating the current situation. Cost-cutting exercises and mergers may not plug the gap and action needs to be taken that employs long-term thinking and policy-making.

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References: 1] http://www.guardian.co.uk/business/2009/aug/29/nhs-drugs-bill-pharmaceutical-compass 2] http://www.compassonline.org.uk/ 3] http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf 4] http://www.thehastingscenter.org/HealthCareCostMonitor/Default.aspx

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Home DNA Testing for all the Family On 17th November 2009 home DNA testing kits went on over the counter sale for the first time in high street chemists in the UK. These kits allow the DNA testing of a child's paternity and involve the taking of saliva from both the child and the 'alleged father's' mouth (their terminology) and its analysis. The kits are produced by a company called International Biosciences [1] and cost £30, with the lab analysis costing a further £119, samples can be taken at home using something that looks like a cotton bud and once received by the lab the results arrive within 5 days. The kit is also available through the company website but at no cost. In a BBC radio interview [2] Ian Meekins the CEO of International Biosciences made some rather interesting comments that are worthy of reporting as they offer a little food for thought. He claimed that the test was 100% accurate (absolutely 100% were his exact words) and that it was not his position to stand as moral guardian when discussing either the ethical implications of marketing this product or the rights of the child involved. He in fact stated that in the case of a child under 16 years of age their consent is not legally required (in fact only the consent of one of their parents or legal guardians is required). He answered a question about the possible consequences of the use of his product by saying that his company goes to great lengths to make customers think about the possible consequences of administering the test and provide contacts 'of various bodies that exist should the information be unfavorable and them not be able to handle it very well'. This service is provided over the telephone or through their website but the client has to actively go and look for it. He goes on to state that the test has been available via Internet for several years and that there is enormous demand for the service offered. When asked about the results he stated that in about 50% of the tests carried out the result is negative and the 'alleged father' is

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found not to be the biological father, but that this does not always 'cause upset' and sometimes leads to relief and 'immense satisfaction'. The national press however have been fairly unanimous in their critical reporting of the story. The Daily mail carries a report entitled "First over-the-counter paternity test goes on sale amid claims it will encourage DNA theft" [3] by David Derbyshire and Claire Ellicott in which they state that a spokesman for the Human Genetics Commission, the Government's advisory body on genetics said: 'We have serious concerns about over-the-counter genetic tests of this kind'. They also quote Dr Helen Wallace of Genewatch UK [4] as saying 'It is going to be devastating for a child to suddenly find out their father is not who they think he is - or to be treated differently by a parent just because of a test. People need to sit back and ask themselves whether taking a paternity test is in the best interest of the child.' The BBC follow a similar line [5] quoting Josephine Quintavalle, director of Ethics of Reproduction "We don't think DNA samples should be taken from a vulnerable child when it is not for the child's benefit. The result of a test is likely to be harmful - the child will either be rejected or become part of the whole dispute between the parents. What are you going to tell the child when you are taking the sample - 'I don't know if you are my child or not? If it is proved the child is not the father's what will they say then? I have loved you for seven years but now I don't want you? I just can't see any benefit for the child." References: 1] http://www.ibdna.com/regions/UK/EN/ 2] http://www.ibdna.com/regions/UK/EN/?page=international-biosciences-bbc-radio-kent-interview 3] http://www.dailymail.co.uk/news/article-1228681/Paternity-tests-goes-sale-counter-amid-claims-encourage-DNA-theft.html#ixzz0YcjzQRPe 4] http://www.genewatch.org/ 5] http://news.bbc.co.uk/2/hi/uk_news/england/london/8363535.stm

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Home genetic testing and the law I would like to take a brief look at the way in which the legal community and governmental regulatory organizations view the problem of home genetic testing by looking at several Internet publications. The main problems addressed throughout the following articles are those of regulation (or the lack of it), quality assurance and guarantees and the moral and personal implications of the sale of a technique that may be used and analyzed without any involvement from a professional doctor. For an overview of the current situation an article entitled "One Step At a Time: ethical barriers to home genetic testing and why the US health care system is not ready [1]" published in Legislation And Public Policy by Rebecca Antar Novick of the New York University School of Law is a good starting point. Novick argues that the health system is not ready to incorporate home testing as legislation governing in hospital genetic testing is incomplete and there is a complete lack of legislation for tests carried out in the home. The article offers a description of the history of genetic diagnosis and the laws and regulations that currently govern this aspect of the health care system, the types of genetic home tests currently available on the market and the ethical concerns that arise from home testing. She raises some interesting points about the inappropriate use of such techniques, difficulties in interpreting the results and the lack of follow up expertise. She concludes that home genetic testing should be outlawed until legislation can be passed that address some of the problems outlined in the paper. A recent article in the Genetic Engineering and Biotechnology News [2] journal explains the findings of a recent FDA (US Food and Drink Administration) hearing regarding the regulation of the industry. The

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article does state however that any regulation will take time due to the complex nature of the issues involved. One noteworthy section of this article takes the line that regulation and the possible imposition of having to see a doctor for some tests (recommendations are that some types of test would only be available on prescription) would put up costs and stifle innovation in the development of such technologies. The problems of test accuracy and the need for validation are also raised. The online journal Medpage also carries an article [3] that follows the FDA panel meetings mentioned above. Genomics Law Report carries a summary [4] of the meeting and links to the report and classification regarding FDA involvement in the issue so far. One problem that these reports touch upon (as do many others) is the fact that although the FDA and several states have ruled that the companies that offer these tests may not be in compliance with the law they can do very little, as kits are freely available via Internet and can be (and are) shipped anywhere in the US. For anybody requiring more reading material see the bibliography and links provided by the Council for Responsible Genetics.[5] References: 1] http://www.law.nyu.edu/ecm_dlv4/groups/public/@nyu_law_website__journals__journal_of_legislation_and_public_policy/documents/documents/ecm_pro_060329.pdf 2] http://www.genengnews.com/keywordsandtools/print/3/22440/ 3] http://www.medpagetoday.com/Genetics/GeneticTesting/25280 4] http://www.genomicslawreport.com/index.php/2010/07/22/from-gulf-oil-to-snake-oil-congress-takes-aim-at-dtc-genetic-testing/ 5] http://www.councilforresponsiblegenetics.org/projects/PastProject.aspx?projectId=1

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Architectures for Life with 23andMe, a Report

On the 17th of April I attended a lecture given by Anne Wojcicki, CEO of direct to consumer genetics company 23andMe [1] . The event which was entitled "Deleterious Me: Whole Genome Sequencing, 23andMe, and the Crowd-Sourced Health Care Revolution" was part of the Science and Democracy lecture series [2] , organized by Sheila Jasanoff [3] at the John F Kennedy School of Government here in Cambridge Massachusetts. The series is "aimed at exploring both the promised benefits or our era's most salient scientific and technological breakthroughs and the potentially harmful consequences of developments that are inadequately understood, debated, or managed by politicians, lay publics, and policy institutions". The lecture was followed by comments and questions to a distinguished panel and followed by a workshop hosted at the Harvard School of Engineering and Applied Sciences. In this article I would like to narrate the proceedings and look at some of the issues raised over the two days. Ann Wojcicki's lecture opened by asking for a show of hands from the audience about how many people had had their genome sequenced either partially or fully. To my great surprise a large percentage of the people in the room raised their hands to the partial sequencing question, and a few had been fully sequenced. It should be noted however that many of the world's leading authorities on the subject were present, including George Church and other members of Harvard Faculty and these seemed to be the only ones that had conducted a full sequence, but I would say that at least 30% had a partial sequencing. During her lecture the CEO repeatedly stated that her company was a research organization, stating that they could do statistical analysis of data in a very short period of time because they had collected an

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enormous data bank. Her stated goals are to improve health care by conducting research using this data bank and through collaborations with both drug companies and education and research establishments. The lecture was very much a sales pitch for the product, Wojcicki spoke in purely business terms, product and service terms were abound, and users described as customers. She explained that the service she offers helps people to understand their ancestry, percentage of different types present in their DNA (Neanderthal, Asian, African for example) and to determine who in the family they had inherited certain traits from. The tests carried out on the DNA data also tell an individual if they are carriers for certain diseases and tell them about mutations in their DNA. What she showed next in her Power Point could be of great interest to readers, as the customer is given access to a data sheet about mutations and the statistical relationship to a disease due to that mutation. The data is presented in percentages, mutation A leads to 20% rise in probability that the customer will develop Parkinson's Disease, or 0.1% risk of breast cancer or any other disease you might like to mention. I must admit that I could not really understand the data as presented however. The lecture was well received and roundly applauded. The panel intervention took the form of a short speech delivered by each member followed by a discussion. The first speaker was Jeremy Greene [4] of the Harvard Medical School, a historian of science. He described the 23andMe project as revolving around the problem of how we feel about risk. He talked about the debate surrounding Pan Ethnic Carrier Screening [5] and the ethical implications of giving someone the information that both this and DNA analysis produces, arguing that we have moved from an externally visible sphere to an internal one. He also talked about the implication of risk moving into the sphere of population and public health.

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He finished by making several clear points and I would express them as the following.

• What we are witnessing here in the convergence between risk and disease.

• The problem is in how to assign value to the information given.

• What are the limits of the crowdsourcing model that 23andme use to statistically analyze their data?

• What agency do they (23andMe) have as a company, do they become producers of knowledge, and if so what rights do their customers and DNA donors have over this knowledge?

The second panelist Jonathan Zittrain [6] of Harvard Law School argued that the widespread marketing and use of the techniques under debate might lead to an increase in the patenting of genes and gene testing techniques, as owners of the patents can then claim money from people offering tests and diagnosis on the basis of their patented entities. He went on to say that the database collected did however allow research on a grand scale, and called for a kind of hacker culture with individuals tweaking models to see if they can see relationships that would otherwise go unnoticed. The third panelist Archon Fung [7] of the Harvard Kennedy School raised the problem of false certainty in the results seen by customers and mentioned the work of Stephen Pinker [8] . He also raised the issue of how the information will be received and interpreted by the customer. He went on to accuse 23and Me of exploitation in taking people's DNA material and using it for research purposes that may lead to someone making a lot of money. He in fact suggested that they should pay their customers for their DNA data. His third major point touched upon the problem of equal opportunities, stating that large 0rganizations (insurance companies for example) might use the information to create in-opportunity, treating certain types of individuals differently based upon the information discovered. His fourth and final point was one that is often very close to the interests of the Bassetti Foundation, that of governance. He asked if

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large scale projects and data bases such as these should be governed purely by the logic of profit. He brought in the ethics of bio banking and their goals, mentioned similarities to the University of Columbia's giant bank and asking whether the general population didn't have a right to generate the norms governing their use and storage rather than the organizations themselves. Sanford Kwinter [9] of the Harvard Graduate School of Design, the fourth and final panelist, delivered by far the most scathing attack of the evening however. He mentioned problems that Spencer Wells [10] experienced with his Genographic project [11] despite working with what he described as a tight ethical framework, something that 23and me were not described as doing. He claimed that the UN Permanent Forum on Indigenous Issues [12] no longer participated in the project because of diffidence: The data extracted from DNA analysis could easily be used in a negative way. He talked about the tests offered by 23andMe as analogous to a betrayal of ourselves. He said that the business strategies were aimed at making us surrender the very raw materials of existence to corporations, stating that through the project DNA had become socially invested. He argued that through the logic and strategies followed by 23andMe DNA is no longer an object but a social arena. He went on to say that the client is a resource and should be protective of their lives and implicitly called her a predator. He stated that the mandate to communicate was being exploited and raised issues of contractual rights, liabilities and privacy, stating that all of the above were being in some way usurped by a commercially constructed logic. In her response the 23andMe CEO said 3 things that I feel are of particular significance. She used the China argument (well they are doing it in China, we don't know what their policies are and we could be left behind, a logic of non-ethics that I have heard before and do not support), that the information was useful because you could make provisions by buying the right type of health insurance and that doctors were sidestepped in the process because they are the bottleneck that slows her research production down. From my point of view these could all be seen as contentious remarks.

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References: 1] https://www.23andme.com/ 2] http://sts.hks.harvard.edu/events/lectures/ 3] http://sts.hks.harvard.edu/people/director.html 4] http://www.extension.harvard.edu/about-us/faculty-directory/jeremy-greene 5] http://healthland.time.com/2011/10/27/before-egg-meets-sperm-a-new-consideration-do-all-women-who-want-to-get-pregnant-need-genetictesting/ 6] http://cyber.law.harvard.edu/people/jzittrain 7] http://www.hks.harvard.edu/about/faculty-staff-directory/archon-fung 8] http://stevenpinker.com/ 9] http://www.gsd.harvard.edu/#/people/sanford-kwinter.html 10] https://genographic.nationalgeographic.com/staticfiles/genographic/StaticFiles/ProjectUpdates/SpencerWells-BioonLetterhead-6-07.pdf 11] http://bigthink.com/ideas/1299 12] http://social.un.org/index/IndigenousPeoples.aspx

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Day 2 (Continues from the previous entry [1]).

On the following day the Harvard STS program hosted a workshop entitled Architectures for Life [2] to continue the debate. Guests and speakers included many world leaders in the field of genetics including George Church [3] of the Harvard and Wyss Institute, who took part in the opening panel of the day entitled New infrastructures of Knowledge and moderated by Lawrence Lessig [4] of the Harvard Law School. For biographies of all of the day's participants see the Harvard University biographies section [5] . This panel was primarily interested in oversight of the genetics industry and possible uses for the materials and data gathered in the rapidly expanding databases currently held by various universities, hospitals and private companies. Tania Simoncelli was present as representative of the Federal Drug Administration and she spoke about the work of the institution and the regulatory problems involved in managing such a field. The role of the expert within the industry was a repeated theme, as was the issue of the availability of information. Discussion about the possibility of maintaining privacy was abound, as some believe that it is not possible to guarantee anonymity within such databases, a problem that many argued the users understand and accept. Some advocate using the data without anonymity, as such an enormous amount of information and variables actually offers enormous potential regarding testing on large numbers of people in a relatively short time. Panelist Ben Heywood spoke about projects within which people make their names and all other possible information freely available in the belief that this will help research into diseases that they suffer from. Geneticists in fact seem unanimously in favour of these current developments as they see these possibilities unfold before their very eyes.

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The panel went on to discuss the GENA legislation [6] , although their conclusions that the law would protect patients and others who chose to be tested was challenged by members of the audience who claim that the current legislation is only partial and needs to be built upon and expanded. The panel was followed by reflections from Charles Rosenberg and then Wojcicki herself. Rosenberg argued that what we were seeing was a way of thinking about risk, with the data presented interpreted differently by each recipient in each individual case. Wojcicki spoke about her personal history and interests within genetics, and then the floor was opened to questions. One of the most interesting came from Sheila Jasanoff, who asked about how to protect society from mental chaos if an individual is seen as responsible for themselves as well as their own actions, an argument that was repeatedly cited throughout both Wojcicki's opening speech and remarks during the workshop (an individuals right to their DNA in order to act upon the information revealed). Another question followed the same line, asking that if this is the new model for society we need to reflect upon who has access to the means and the capability of interpreting the data. Lunch was taken with each table hosting an expert from the panel. I sat with Tania Simoncelli, George Church and others. The discussion revolved around recent decisions taken about patent law regarding genes (as written about here [7] ) and the possibility that having such genetic information about oneself could effect behaviour and may at some point legal or technical decisions that hold consequences for the individual. An example might be the argument that withholding known risk from an insurance company might lead them to withhold payment. The issue of the need and obligation to disclose or withhold information was also raised, as was informed consent and access to information. Lunch was followed by a panel entitled Implications for society, and once more an interesting group of people were involved. Several issues were raised about the use of the genetic data, 23andMe's

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user agreements and business model and possible effects upon society from a sociological perspective. During the afternoon panel Sharon Terry of the Genetic Alliance [8] explained her interest in creating partnerships between genetic databases in order to use the massive number of participants and wealth of genetic materials available but currently divided between different databases. She talked about the need to move the information about and to ship materials and findings between research institutions in order to best use it, something that the Genetic alliance project is currently promoting and doing. Sociologist Ruha Benjamin talked about how groups are conducting their own informal drug trails using the information and medication they can now access and through online communication. She mentioned an informal trail into breast cancer treatment and the effects that online activity has on drug testing, with people asking each other about side effects and symptoms in order to gain information about their positions within the trails. In the cases discussed the spread of available information can really be seen as playing a role (both socially and scientifically) for those participating in drug trials or suffering from diseases that involve well organized groups pooling resources and information. She also mentioned the Prop 71 project [9] in California and the social system that the funding helped to create and maintain. Patricia Williams of Columbia Law School went into some detail in her analysis of the contract that customers of 23andMe sign in order to obtain their services. She stated that the contract was very difficult to understand even for her. One thing that is clear is that the data obtained from the DNA analysis can be exploited for commercial gain. It can also be given to other organizations (ideally for research purposes) but not rented or sold, and that the company itself is not legally responsible for anything, has no liability whatsoever for uses made or effects caused even to the point of including quality of their analysis. One question raised was to ask in the case of bankruptcy what would happen to the data, defined as it is as asset of the company?

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Her analysis was quite brutal. She said that the company had included everything possible in their disclaimer and had also given themselves the right to change the contract at any time after it had been signed, merely by publishing the new version on its website. A member of the audience did however point out that all internet based contracts are of this type, and that this contract was no worse than others, although the debate did make me (and others including legal experts present) wonder about the real value for the customer of such a document. The concluding remarks raised some interesting points, not least the question "what is 23andMe?' Is it a corporation, a product, a research institution or a product? How can we define ethical guidelines if we do not know how to classify it when different definitions require different frameworks and responsibilities? Is it an individual's right to know their DNA analysis when it could in fact be seen as a very shared experience? Who should be in charge of large databases of genetic information and which logic should they adopt in their management (an implicit criticism that the logic of commerce may not be right)? An interesting couple of days that raised a lot of questions about responsibility and innovation on the whole, the role of commercial bodies in science, regulation of fast moving areas of discovery, interpretation of personal data, citizen science and rights, responsibility to the whole of society and data protection, openness and privacy, to name just a few. References: 1] http://www.fondazionebassetti.org/en/focus/2012/05/architectures_for_life_with_23.html 2] http://sts.hks.harvard.edu/events/workshops/architectures-for-life.html

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3] http://arep.med.harvard.edu/gmc/ 4] http://cyber.law.harvard.edu/people/llessig 5] http://sts.hks.harvard.edu/biographies/ 6] http://www.genome.gov/24519851 7] http://www.fondazionebassetti.org/it/segnalazioni/2012/04/more_medical_patent_problems.html 8] http://www.geneticalliance.org/ 9] http://science.kqed.org/quest/2012/04/02/prop-71-overhyped-but-worth-it/

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23andMe Awarded Their First Patent Following on from my previous article [1] about my attendance at the Architecture for Life conference at the Kennedy School of Government I would like to direct readers to a very interesting and informative article. The article entitled 'Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions'[2] appears on the Genomics Law Report blog and is authored by Dan Vorhaus, and a look at his posts on this blog[3] reveal an extremely well informed and interesting character. The article announces the news of 23andMe's first patent, granted for a system of using gene mutation information and personally offered data about lifestyles and family history in order to predict probabilities for an individual to develop Parkinson's Disease. It raises and answers a series of important questions such as where the patent comes from and what it covers and asks the more important question of how the company is going to use its patent. The problem narrated in the article involves the company's public claims (aimed towards its customers) and its need to make money, and highlights several rather unsteady and possibly contradictory responses given by the CEO Ann Wojcicki regarding company philosophy. The company's goal is described as 'to provide the public with affordable, unfettered access to their genomes' and as I described in my previous post there is a lot of rhetoric regarding freedom of information, research sharing, creating a database and giving access to the information held to research companies looking for cures for diseases and the likes, but the patent issue seems in some ways to contradict these goals. The article goes on to offer links to several blog posts from 23andme users and interested parties that raise serious ethical questions and imply that some people were not aware of the company's aims in this

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field, that they may not be comfortable with the move after donating their own genetic materials, and suggesting that the company should behave responsibly in using its patent. The author asks a further question. Why has the company not been more engaged with its customers in its profit seeking? Several interesting models are cited that could lead to a profit sharing and shared interest in results for those involved through 'genetic donation'. The author concludes that 23andMe are unsure of what to do with their patent and how it should be used, but are thrilled with the milestone and the validation that it provides for a fledgling company. For a look at how 23andMe customers reacted via the company blog see this post [4]. The comments are well sourced and display certain trepidation on the part of the company's customers, as well as the official 23andMe announcement that sparked the debate. For a further look at how the patent issue has been addressed on the Bassetti Foundation website see this post [5]. References: 1] http://www.fondazionebassetti.org/en/focus/2012/05/architectures_for_life_with_23.html 2] http://www.genomicslawreport.com/index.php/2012/06/01/patenting-and-personal-genomics-23andme-receives-its-first-patent-and-plenty-ofquestions/ 3] http://www.genomicslawreport.com/index.php/author/dvorhaus/ 4] http://spittoon.23andme.com/news/announcing-23andmes-first-patent/ 5] http://www.fondazionebassetti.org/it/segnalazioni/2012/04/more_medical_patent_problems.html

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Sequencing the Genome of Unborn Babies

As a follow on from my article about 23andMe [1] and genetic testing I would like to point readers towards a story here in the US. The New York Times carried a story [2] on its front page on 7th June 2012 that is rapidly spreading, in which it reported that an unborn baby's DNA was sequenced with 98% accuracy using the mother's blood and father's saliva. The testing was done when the fetus was 18.5 weeks old. The accuracy was tested after the baby was born with a full sequence conducted on blood taken from its cord. A second experiment involving blood taken from a mother much earlier in the pregnancy (8 weeks) showed similar results although slightly less accurate. The findings were published this week in Science Translational Medicine, part of the Science group of publications, and authored by a host of scientists. The full article is only available to subscribers but the abstract can be downloaded here [3] . In purely practical terms the authors point out that this system of testing for genetic disease is completely non-invasive, and this will save the lives of many unborn children. Presently amniocentesis or chorionic villus sampling are the preferred means for conducting tests for genetic disorders, but these techniques lead to the loss of the baby in about 1% of all cases as they both require the insertion of a needle. The ethical implications of such a breakthrough are being widely discussed however, as this article from ScienceMag shows [4] . Much of the debate revolves around the idea that parents may choose to abort a fetus because it may not carry the traits they desire, and not only in terms of possible genetic diseases. There is also a serious problem of false positives, as some mutations were missed in the experiment and other positives given that at birth were found not to be present.

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The Huffington Post [5] also carries the same article and the comments section is worth a browse. An argument that recurs involves the identification of a so called gay gene, and questions about giving information to parents about the sexual orientation of their unborn child. The issue is also raised about diseases that may affect the individual in late life such as dementia. The scientific reliability of such comments is obviously hugely suspect and the language used rather crass, but it does raise the question of rights to information and the ethical implications of withholding it (or even the testing in the first place). In this world of information however I imagine that there will soon be a market for such tests in the style of 23andMe, and as the price comes down many people will want to see the probable health future for their unborn children, whether they will be tall, blond or have blue eyes. This will have practical consequences for society. If the model follows the 23andme path of offering statistical analysis of the chance of developing diseases in life the problem becomes even more complex. What might the effect be of telling the parents of an unborn child that it has a 40% increased possibility in developing for example Alzheimer's disease? I leave the reader to ponder these complexities in terms of responsibility and ethics. References: 1] http://www.fondazionebassetti.org/en/focus/2012/05/architectures_for_life_with_23.html 2] http://www.nytimes.com/2012/06/07/health/tests-of-parents-are-used-to-map-genes-of-a-fetus.html?pagewanted=all 3] http://stm.sciencemag.org/content/current 4] http://news.sciencemag.org/sciencenow/2012/06/sequencing-the-unborn.html 5] http://www.huffingtonpost.com/2012/06/07/fetal-genome-dna-sequenci_n_1578353.html

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Prosthetic by choice? Following on from the arguments raised during the discussion with Italian athlete Marta Milani (1) posted in video form on the Bassetti Foundation website (in Italian), this article looks at some of the issues posed by advances in prosthetic technology, and the issue of a patient's choice to amputate a hand in order to have a prosthetic version fitted. The BBC World News channel recently carried a report (2) that raises several interesting points for discussion regarding the use of technology in prosthetic limbs. The case in question involves a young man called Milorad, who lost most of the use of one of his hands in a motorbike accident 10 years ago. His hand regained some movement but he describes it as non functioning, and from the video we see that it is of limited use. Milorad took the decision to have his hand amputated and a mechanical hand fitted, and the video follows his amputation in a clinic in Vienna. Both he and the surgeon believe that the prosthetic hand will improve the use he makes of his hand. Prosthetic technology is advancing extremely quickly. Mechanical hands are generally made to move using existing muscle structures in the arm, performing a pre-set number of movements in a similar way to a human hand. The user takes some time to learn the commands but once learned controls the hand through the existing muscle system. At the cutting edge of this type of technology however a revolution is underway. Scientists at the University of Rome are experimenting on the Life Hand Project [3], and have successfully demonstrated that a bio-mechanical hand connected to a human nervous system can be directly controlled by the brain. The patient had electrodes fitted into his arm and learned to control the hand by sending stimuli through the electrodes to the non connected hand. A similar project is run in the US at the John Hopkins University [4] and funded by the Defence Advanced Research Agency. The

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research involves implants in the brain that send signals to the hand, and they are about to test the technology on humans for the first time. The brain sensors have the advantage that they can receive as well as send impulses, so the hand can send signals back to the operator, helping the user to actually feel the object and making the movement much more sensitive. All of the above raises some interesting ethical questions. In the first article cited Milord chose to have his defective hand removed in order to replace it with a substitute that functioned better. This is very different from fitting a mechanical hand to a person that has lost their natural hand or was born without it, as it moves us into a philosophy within which an improvement of functionality may lead to elective amputation. As technology advances and mechanical substitutes become more and more lifelike and efficient, more people might see the option as offering physical enhancement and not merely a solution for a missing limb. How different is this to currently acceptable medical practices? The now completed Ethicbots project website [5] offers some food for thought on this subject, and Jeff Ubois has several articles on his blog on the Bassetti Foundation website [6] in which he addresses the argument of artificial enhancement in more general terms. Also see the articles about sport on the Bassetti Foundation website and in particular about the South African athlete Pistorius, his carbon fibre feet [7] and related discussion and the roboethics blog [8]. References: 1] http://www.fondazionebassetti.org/en/focus/2011/07/an_discussion_with_marta_milan.html 2] http://www.youtube.com/watch?v=y0_a_sbEglw 3] http://news.discovery.com/videos/tech-man-controls-robotic-hand-with-mind.html

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4] http://neurosciencenews.com/darpa-thought-control-prosthetic-limbs/ 5] http://ethicbots.na.infn.it/index.php 6] http://www.fondazionebassetti.org/en/ubois/ 7] http://www.fondazionebassetti.org/it/focus/2007/07/le_lame_di_pistorius.html 8] http://www.fondazionebassetti.org/en/roboethics/

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Chapter 4

Information and Knowledge

Itinerary: Communicating Science In light of the Bassetti Foundation's announcement of their involvement in the 2012 Public Communication of Science and Technology Network [1] conference and related call for abstracts for funding, I would like to review some of the related materials available on the foundation website. The problem of the communication of science and innovation has been addressed many times over the years on the Bassetti Foundation website, and as the following review will show, it crops up in many articles covering a wide range of topics. In 2002 Massimiano Bucchi published an interesting article in the journal 'Nature' [2] (also available here [3]) that aims to analyze the relationship between exposure to science in the media, information on biotechnologies and trust in science and attitude towards biotechnologies. The findings are interesting and some serious issues are raised about the effectiveness of science communication in the media and the difficulties encountered in trying to inform public opinion. In 2003 Margherita Fronte conducted an interview with French philosopher Bruno latour [4] in which the issue of a beneficial and possibly misleading portrayal of technology is raised, a problem that touches upon issues of obtaining funding and communicating complex scientific processes in lay person terminology. In 2006 Foundation president Dr Piero Bassetti published an article in the journal "Impresa & Stato" entitled 'Comunicazione dell' innovazione' [5] (the communication of innovation) in which he addresses the problems of innovation, knowledge and communication. The article is complex and addresses various aspects related to communication.

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One question raised is that of the nature of communication related to copyright application and intellectual property rights. Another casts the spotlight on consumers. If a product is to be successful it must be accepted by members of society and governing and regulating institutions alike, and this implies choice taking, which in turn implies the communication of knowledge upon which decisions can be taken. In 2007 Jeff Ubois touched upon the problem in his conversation with Lawrence Gasman [6] . The discussion is about nanotechnology and concludes with some thoughts about the reporting of such technologies in the press. 2007 also saw the publication of the European Commission report 'Taking European Knowledge Society Seriously', a document that was later translated into Italian and published through Rubbettino in 2008. To celebrate the Italian publication a conference was held at the Foundation at which authors bryan Wynne and Prof Mariachiara Tallachini discussed the project and publication. There are several articles related to this event and the related conference at the University of Bergamo available in Italian [7] and also in English through this page. [8] 2008 also saw the Bassetti Foundation collaborate with the University of Bergamo and SISSA of Trieste on a related conference entitledBuilding a bridge between science and society; Searching for the foundations of the communication of science [9] (Costruire un ponte tra scienza e società; Alla ricerca dei fondamenti della comunicazione della scienza [10]). The proceedings are described in the link above and video of the papers delivered is also available here [11]. The unedited transcription of the paper delivered at the conference by Silvano Tagliagambe entitled 'Le nuove frontiere e strategie della comunicazione scientifica' is also available here, [12] and directly and thoroughly addresses the problem of the role of scientific communication in a knowledge society. 2009 was the year in which The Hastings Center published The Bioethics Briefing Book for Journalists, Policymakers, and

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Campaigns [13] . The book aims to enhance knowledge and provoke debate, and the introduction offers an interesting description of the problems regarding science communication today. 2010 saw the publication of an article looking at Ben Goldacre's journalism work [14] and his analysis of science reporting in the press. Goldacre's book entitled 'Bad Science' is a well informed critique of medical (but not only) science reporting in the mainstream press. In the same year Robert Winston published his book entitled 'Bad Ideas' that was reviewed on this website [15] . He argues the need for broader dialogue between science and society. He states that this must be a 2 way dialogue, that lay people should understand more about science in order to make informed choices and decisions about change, but that scientists also have to listen to the public. 2011 saw two articles directly related to communication. The first investigates the work of the Royal Society [16] (in this volume) and its free publications and the second the choice made by the National Academic Press [17] to make all of their publications freely available for online consultation. Both articles aim to show that high quality science information is freely available to those who look for it. The review above is by no means meant to be exhaustive. Various other articles have the problem of communication running between the lines. The recently published article on cold fusion [18] (also in this collection) highlights the mass publication of unqualified press releases as scientific facts and Lennard Davis talked at length about science communication during his round table meeting here in Milan [19] just to name but two examples. Anybody requiring further reading might like to take a look at a 1985 report by e Royal Society ad hoc group entitled Public Understanding of Science [20] and the BIS Science and Society website [21] .

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References: 1] http://www.fondazionebassetti.org/it/segnalazioni/2011/06/travel_grants_for_junior_parti.html 2] http://www.nature.com/nature/journal/v416/n6878/full/416261a.html 3] http://www.fondazionebassetti.org/0due/docs/biotech/nature-bucchi-neresini.htm 4] http://www.fondazionebassetti.org/06/docs/fronte-intervista-latour-engl.htm 5] http://www.fondazionebassetti.org/it/focus/2006/12/comunicazione_dellinnovazione.html 6] http://www.fondazionebassetti.org/en/ubois/2007/03/responsibility_in_innovation_a.html 7] http://www.fondazionebassetti.org/it/eventi/2008/02/science_and_governance_il_rapp.html 8] http://www.fondazionebassetti.org/en/events/2008/03/science_and_governance_the_rep.html 9] http://www.fondazionebassetti.org/en/focus/2008/02/building_a_bridge_between_scie.html 10] http://www.fondazionebassetti.org/it/focus/2008/02/costruire_un_ponte_tra_scienza.html 11] http://www.fondazionebassetti.org/it/focus/2008/02/comunicare_la_scienza_responsa.html 12] http://www.fondazionebassetti.org/it/focus/2008/03/le_nuove_frontiere_e_strategie.html 13] http://www.thehastingscenter.org/Publications/BriefingBook/Default.aspx 14] http://www.fondazionebassetti.org/it/rassegna/2010/09/bad_science_and_ben_goldacre.html

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15] http://www.fondazionebassetti.org/it/rassegna/2010/07/bad_ideas_a_history_of_discove.html 16] http://www.fondazionebassetti.org/en/focus/2011/01/the_royal_society_a_font_of_in.html 17] http://www.fondazionebassetti.org/it/segnalazioni/2011/06/national_academic_press_a_host.html 18] http://www.fondazionebassetti.org/it/rassegna/2011/05/the_problem_of_cold_nuclear_fu.html 19] http://www.fondazionebassetti.org/en/focus/2010/07/a_man_his_history_and_his_dna.html 20] http://royalsociety.org/Public-Understanding-of-Science/ 21] http://interactive.bis.gov.uk/scienceandsociety/site/documents-and-links/

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Harvard's Journalist's Resource Center

One of the issues has been repeatedly raised at the Bassetti Foundation is that of finding and communicating reliable scientific information. Journalists are often non-specialized and lack scientific training, and the reprinting of press releases that may not be unbiased is common. Here at the University of Harvard, staff have created a Journalist's Resource Center [1], in order to provide writers with access to reports that may help them in their work.The project is based at the Shorenstein Center, and the stated aim is to establish and promote the concept of "Knowledge Based Reporting". Anyone interested in policy and public affairs is invited to use the online facility, all materials are all free and published under a Creative Commons license. The objective is to provide succinct and condensed quality information on topics of public interest, and bring journalism closer to the research world. The site is run by staff and graduate students at Harvard Kennedy School's Joan Shorenstein Center on the Press, Politics and Public Policy [2], as part of the Carnegie-Knight Initiative on the Future of Journalism Education [3]. In addition to providing access to scholarly reports and papers on a wide range of topics, it makes available syllabi for educators and skills-based reference material. The site also contains links to other databases [4] that may be of interest to communicators of science such as the Social Science Research Network, Harvard's DASH repository and the Public Library of Science, other sources of peer reviewed research documents. One topic that has recently been addressed by the Bassetti Foundation is that of risk, and looking through the resources I find the following report about cultural predispositions and their effect upon how risk is viewed and perceived [5].

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The summary page is a good example of other pages on the site. Its conclusion is worthy of note; "cultural cognition should be taken into account in public deliberations about risk. It is not enough to assure that scientifically sound information -- including evidence of what scientists themselves believe -- is widely disseminated," they write. "To overcome this effect, communicators must attend to the cultural meaning as well as the scientific content of information." For other articles on the Bassetti Foundation website related to the communication of science see the following, several of which are in this volume : The Royal Society, A Font of Information [6] (also in this collection), Bad Science by Ben Goldacre [7] From Here to Infinity [8] Is Ethics a Branch of Politics? [9] Notes on the International Public Communication of Science Conference [10] Building a Bridge Between Science and Society [11] A conversation with Pallavi Phartiyal [12] Launch of the UCS Center for Science and Democracy [13]. References: 1] http://journalistsresource.org 2] http://shorensteincenter.org/ 3] http://journalistsresource.org/about/carnegie-knight-initiative/ 4] http://journalistsresource.org/reference/research/introduction-studies-academic-research-journalists/ 5] http://journalistsresource.org/studies/environment/climate-change/cultural-cognition-scientific-consensus/ 6] http://www.fondazionebassetti.org/en/focus/2011/01/the_royal_society_a_font_of_in.html 7] http://www.fondazionebassetti.org/it/rassegna/2010/09/bad_science_and_ben_goldacre.html 8] http://www.fondazionebassetti.org/it/rassegna/2011/08/from_here_to_infinity_a_book_r.html

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9] http://www.fondazionebassetti.org/it/rassegna/2009/06/is_ethics_a_branch_of_politics.html 10] http://www.fondazionebassetti.org/en/focus/2012/04/international_public_communica.html 11] http://www.fondazionebassetti.org/en/focus/2008/02/building_a_bridge_between_scie.html 12] http://www.fondazionebassetti.org/en/focus/2012/04/a_conversation_with_pallavi_ph.html 13] http://www.fondazionebassetti.org/en/focus/2012/06/ucs_center_for_science_and_dem.html

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The Royal Society, a font of information In 2010 the Royal Society [1] celebrated its 350th anniversary, a festival in which the Bassetti Foundation participated in the form of Cristina Grasseni's visit to London and involvement in the Harvard University Science and Democracy Network [2] international meeting, part of the celebrations. In the run up to this celebration the Royal Society established its Science Policy Centre [3] 'in order to strengthen the independent voice of science in UK, European and international policy'. The centre organizes its work under 4 themes: sustainability, diplomacy, innovation and governance, all themes that I feel may be of interest to Bassetti Foundation website readers. Since its inception the policy centre has published a series of reports both in hardback form and also through its website, several of which address problems that we have touched upon on the foundation website and contain contributions from several of our acquaintances and friends. One of the most recent reports published in September 2010 is entitled 'Climate Change: a summary of the science' [4] , and it makes for interesting reading. The report opens with an introduction to the problem followed by a series of statements about the current scientific understanding of climate change. The argument is grouped into 3 broad categories; aspects of climate change upon which there is wide agreement, aspects of climate change where there is a wide consensus but continuing debate and discussion and aspects that are not well understood. The report is easy to read and written in lay terminology. As we would imagine it paints a detailed picture of the current state of scientific understanding and agreement regarding the broad issue of climate change. The penultimate section entitled Developments in Climate Science outlines many of the technical problems affecting a debate of this type and also points out errors made in the past and their causes. The conclusion addresses the problem of consensus both in theoretical modeling and in formulating a plan of action, and argues that given the degree of uncertainty involved in predicting

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future changes that 'policy changes have to be made in the absence of perfect knowledge'. An earlier and related report published in September 2009 is entitled 'Geoengineering the climate, Science, governance and uncertainty [5] ' and it also makes for a very interesting read. The report addresses both the technical and the ethical issues involved in searching for, experimenting and implementing engineered solutions to global warming. Possible approaches are grouped into 2 basic classes, carbon dioxide removal techniques and solar radiation management techniques. The first involves the removal of carbon dioxide from the atmosphere through means such as ocean fertilization, changes in land use, afforestation, bio energy, enhanced weathering and direct mechanical air capture techniques. The second involves surface albedo, cloud enhancement, stratospheric aerosol and space based methods. The first addresses the perceived cause of the problem, while the second attempts to alleviate the problem by reflecting some of the heat from the sun back into space. Once the technicalities have been explained the report goes on to discuss governance problems of the implementation of these techniques, addressing risk, uncertainty, ethics and public and civil society engagement and involvement in the decision making process. The governance of research is also addressed and in the final chapter a series of recommendations regarding these issues are laid out. The society has also announced this year that it would undertake a major new initiative to ensure strict governance of any plans for solar radiation management geoengineering and published its recommendations in the spring of 2011 [6]. A third major document addresses another topic that I have broached in the past on this website. Entitled 'Symposium on Opportunities and Challenges in the Emerging Field of Synthetic Biology' [7] , this synthesis report details the findings of an international symposium entitled "Opportunities and Challenges in the Emerging Field of Synthetic Biology" held in Washington DC in

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July 2009 under the auspices of the OECD, the US National Academies of Science and the Royal Society. This is a hefty document that opens by offering the reader an overview of both the scope and the language used in synthetic biology taken from a session moderated by long time friend of the foundation Sheila Jasanoff, before describing current international public policy and various aspects involved in promoting the field of research. As in the reports described above the final sections are dedicated to governance and public engagement and participation, and raise interesting questions including the problem of the rapid change in the context that scientists find themselves working in and the open debate on the purpose and efficiency of regulatory practices. The Society is also developing a series of reports under the umbrella title 'Brain Waves, Neuroscience, Society and Policy' [8] and the first to be published contains an essay from another friend of the Bassetti Foundation Professor Andy Stirling entitled 'Governance of Neuroscience: challenges and responses'. Amongst many other issues in this piece Stirling talks about responsibility within neuroscience research. He mentions research and practice reversibility in neuroscience, a problem that is also addressed in the report about geoengineering described above. In the case of deciding whether to proceed along a certain pathway, the degree of reversibility of the process in act must be seen as a positive factor. Technical reversibility is however only part of the story as commercial factors are also involved. Heavy investment leads to pressure to continue a project in order to not lose money and momentum. Large interests also constitute a problem. As in the above cases he also closes his argument with a discussion of engagement and public participation in the research process. The fourth report in the series is to be entitled 'Neuroscience, Responsibility and the law' and judging from the published abstract and list of working group members it will be worth reading once published.

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The Royal society website contains reports dating back to the 1980's and the above selection is merely a fraction of those published by the policy centre in the last 18 months, and this wealth of scientific information leads to an argument that has recently touched upon at the foundation, namely public access to unbiased science reporting. On this site last year I posted an article about Ben Goldacre's book entitled 'Bad Science' [9] that also contained criticism of science reporting in the press and links to groups interested in this argument [10] . This problem has also been referred to in several other pieces by various other foundation contributors and the need for impartial reporting is a constant issue in the need to create a more science literate society, leading to greater participation in the decision making process and a heightened awareness of the idea of innovation in responsibility. The Royal Society conduct high quality science projects conducted by world renowned academics and all the reports are free to download in PDF. They are not impossibly technical, maintain a critical stance towards scientific research and consistently address the problems of public participation, responsibility, risk assessment and governance. All of the requisites for a balanced scientific education. A mine of free and well informed information for anyone that wants it. References: 1] http://royalsociety.org/ 2] http://www.hks.harvard.edu/sts/about/sdn.html 3] http://royalsociety.org/policy/ 4] http://royalsociety.org/climate-change-summary-of-science/ 5] http://royalsociety.org/Geoengineering-the-climate/ 6] http://royalsociety.org/policy/projects/solar-radiation-governance/report/ 7] http://royalsociety.org/Synthetic-Biology-report/

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8] http://royalsociety.org/policy/reports/brainwaves1/ 9] http://www.fondazionebassetti.org/it/rassegna/2010/09/bad_science_and_ben_goldacre.html 10] http://sciencebrainwaves.com/blogs/brainwaves/?tag=/Science-reporting

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Citizen Science

In a posting on the Bassetti Foundation website I looked at the work of Ben Goldacre [1] and in particular his book Bad Science. My argument also drew upon subject matter from previous postings, namely the work of Robert Winston [2] and Lennard Davis [3] . All of these authors argue that there is a need to educate the general public into the ways of science, be that in order to better interpret newspaper or TV reports in order to make political and personal decisions, improve the relationship between science and society or to promote the idea of responsibility in innovation. Lennard Davis has a particularly interesting stance. Through his book Go Ask Your Father he presents scientific data about the problems and possibilities of DNA coding through an autobiographical novel. His hope is to draw the reader into the novel so that they take on the technicalities of the process almost without thinking of them in terms of science. This rather spuriously leads me on to the phenomena of citizen science as an educational tool, as some people argue that involvement in these projects can educate participants and improve the relationship between science and society. Citizen science is not a new phenomena. The idea behind the notion is that non scientific members of the public either gather or analyze scientific data. The earliest large scale projects involved monitoring the movement of migratory birds, with information being sent in to a central point by post. The technology is simple, when you see the first throated humming bird of the season you send in details of the sighting and somebody pins a model of bird with a date attached to a wall map of the world. The migration path becomes visible and measurable. Today obviously we have the internet. This means that things can be plotted in real time as sightings can be transmitted instantly, but it also means that data can be posted that can then be analyzed by a large number of people.

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An example of this is the Galaxy Zoo project [4], part of the Sloan Digital Sky Survey [5]. The Galaxy Zoo project has been running for several years, and involves hundreds of thousands of people. One of the problems for scientists today is the analysis of the enormous amounts of scientific data generated. This example is that of The Hubble telescope. It captures such a large amount of images that they risk never being studied, but one way of getting round this problem is to invite non scientists to view the pictures online and classify what they see. The tutorial on their website is simple to follow and in a few minutes you are away and participating in scientific discovery. There is always the possibility of finding something new too, as in the example of the dutch primary school teacher Hanny Van Arkel who now has an object known as "Hanny's Voorwerp" named after her, an object that would probably never have been noted had it not been for Ms Arkel's lay interest in star gazing. Involvement in such a project offers benefits for everyone. Science obviously gains an enormous workforce enabling the analysis of such huge amounts of data that would otherwise lie unused, but through their participation people are exposed to science and different methodologies and educated into the empirical way of thinking. They also deal with scientific institutions and scientists and this could as Winston hopes bring scientists and society together and enable the two sides to communicate better. In many cases involvement leads to becoming part of a community, and blogs and forums give participants the chance to speak to and educate each other. There are also many examples of sub groups forming through blogging communities that carry out their own projects outside the official line. The Stardust project at Berkley [6] is also well worth a look, with the opening line on their website perfectly describing the benefits to science of such projects. These kinds of projects involve much more than stars and searching for dust particles. The COCORAHS (The Community Collaborative Rain, Hail and Snow Network) is interested in measuring and plotting traits in the

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weather. Regis et al describe educational benefits derived from participation in the project in this online article. [7] National Geographic run a project that involves mapping Mongolia [8] from satellite images. They are interested in the country from an archaeological point of view and so participants are asked to classify geographic features but also human structures so that the team on the ground can then decide which are worthy of further investigation. The Science for citizens website [9] offers links to dozens of projects based all over the world with access to blogs and various other resources. An article by Raddick et al published by the National Academies [10] offers a nice overview of both the history of citizen science and benefits offered to all parties involved and goes into more detail about the arguments outlined here. Raddick has also conducted research and published an article looking into people's motivations for engaging in citizen science projects [11] . I have one personal reservation about using the population at large to analyze data. Would it not be easy to manipulate a population into conducting work that they might not understand the consequences of? Could a public that was used to such participation be manipulated into participating in other forms of mass data analysis? Imagine that a wealthy country found itself bogged down in a long and difficult war in an inhospitable and mountainous area. This entire area cannot be effectively patrolled but could however be photographed from above at high definition. The amount of data produced would be enormous and the military might not have the human power to hunt through the images looking for insurgents or minute changes on the ground, but large numbers of members of the public could possibly be mobilized in the name of helping the war effort. Do old posters of 'YOUR COUNTRY NEEDS YOU' come to mind?

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References: 1] http://www.fondazionebassetti.org/it/rassegna/2010/09/bad_science_and_ben_goldacre.html 2] http://www.fondazionebassetti.org/it/rassegna/2010/07/bad_ideas_a_history_of_discove.html 3] http://www.fondazionebassetti.org/it/rassegna/2010/02/go_ask_your_father_about_dna.html 4] http://www.galaxyzoo.org 5] http://www.sdss.org/ 6] http://stardustathome.ssl.berkeley.edu/ss_findingsd.php 7] http://www.cocorahs.org/Media/docs/AMS2008_Reges_CoCoRaHS_17AppClim_2.3_FINAL.pdf 8] http://exploration.nationalgeographic.com/mongolia/content/one-million-tags-reached-thanks-peterz9 9] http://scienceforcitizens.net/ 10] http://www8.nationalacademies.org/astro2010/DetailFileDisplay.aspx?id=454 11] http://arxiv.org/abs/0909.2925

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Is Citizen Science Coming of Age?

The previous entry in this collection is an introductory article to citizen science [1], something that I again touched upon in a newer article about synthetic biology [2] (also in this collection), and recently have been following some interesting developments in the field. One of these developments involves a game called 'Fold. It' [3] and gamers appear to have made a breakthrough in scientific understanding. The Foldit game is all about creating protein like structures. Read the official publication of the process here [4]. The article begins with the following statement: 'Following the failure of a wide range of attempts to solve the crystal structure of M-PMV retroviral protease by molecular replacement, we challenged players of the protein folding game Foldit to produce accurate models of the protein. Remarkably, Foldit players were able to generate models of sufficient quality for successful molecular replacement and subsequent structure determination. The refined structure provides new insights for the design of antiretroviral drugs'. The foldit game has existed for a couple of years now. Players create protein structures, with the most stable and low energy structures scoring the most points. As we see the game was used in this particular case to predict structure and mutation, with the aim of producing better antiretroviral medicines. The gamers in general are not scientists and they manually manipulate the model presented to them. They have a variety of tools but the most important thing is that they have better spatial reasoning skills than computers. Computer models had tried to solve the problem cited above for 10 years without success, gamers produced an adequate model that was then refined by scientists and is precise enough to use in further research in just 3 weeks.

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We could call this citizen science, although the gaming format is very different from the more traditional forms. Citizen science projects for mapping bird migration and classifying galaxies are well known and reported and Just last month the Sky and Telescope journal [5] was entitled 'Citizen Science'. They describe it as the future of astronomic discovery. The gaming process is an interesting innovation though, as it uses skills that may not be particularly associated with science, but reveal themselves to be extremely important. Other interesting projects are underway, one of which is more of a second attempt than an entirely new ideas. In a recent post on Technology Bloggers [6], Author Christopher Roberts cites the project entitled LHC@Home 2.0, with LHC representing Large Hadron Collider. Once more and as is the case with the Galaxy Zoo project cited in my previous article, scientists are in the possibly enviable position of generating enormous amounts of data through their experiments. So much data in fact that they find themselves unable to analyze it all. The researchers need more computing power, and are once again trying (a similar project was launched in 2004) to find people that are willing to loan them their spare computing power when their computer is not in use. The LHC website [7] explains everything, but also states that they have had so many offers that they are having to use a lottery system to choose which volunteers can actually participate. The Technology Bloggers article also cites a University of Berkley project entitled SETI@Home [8], with SETI representing Search for Extra Terrestrial Intelligence. In this case participants download software that uses a screensaver to access the computer's storage, bandwidth and computing capabilities. The programs involved were developed by the University of California, but careful reading of terms is required, as they accept no liability for any problems to your computer provoked by participation in this project, and state that participation can cause computer

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overheating. For more citizen science projects see the Scientific American website [9]. The citizen science section describes scores of projects including Facebook virus mutation experiments [10], radiation level testing in Japan [11] and the Encyclopedia of Life project [12]. References: 1] http://www.fondazionebassetti.org/en/focus/2010/10/citizen_science.html 2] http://www.fondazionebassetti.org/it/rassegna/2011/09/science_septembers_special_edi.html 3] http://fold.it/ 4] http://www.cs.washington.edu/homes/zoran/NSMBfoldit-2011.pdf 5] http://www.shopatsky.com/product/sky-and-telescope-november-2011/new-arrivals 6] http://www.technologybloggers.org/science/want-to-do-your-bit-for-science-lhchome/ 7] http://lhcathome.web.cern.ch/lhcathome/ 8] http://setiathome.ssl.berkeley.edu/ 9] http://www.scientificamerican.com/citizen-science/ 10] http://www.aftau.org/site/News2?page=NewsArticle&id=14976 11] http://www.scientificamerican.com/citizen-science/project.cfm?id=safecast-open-information 12] http://eol.org/

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The problem of cold nuclear fusion

On 14th January of this year an article appeared in La Republica [1] (a well respected Italian broadsheet) in which 2 scientists report that cold nuclear fusion [2] (also known as a low energy nuclear reaction or LENR) has been achieved and demonstrated. The article explains that for the first time the process has been achieved using nickel and hydrogen, opening the doors to abundant clean energy. Engineer Andrea Rossi and Physicist Sergio Focardi made this fantastic discovery. They have requested (and reports claim been granted) a patent for their invention that they successfully demonstrated to an invited group of scientists and journalists at their laboratory/factory in Bologna. Due to their patent pending at the time of the demonstration however they could not divulge the exact mechanics of the process that produced the energy and their secret ingredient, for fear of losing commercial rights over their invention. Guests included physicists from several different institutions who were allowed to inspect their prototype machine as it worked. The national Italian TV network RAI produced a long video report (here [3] and below dubbed in English) (qui in italiano [4]) for their RAI 24 news channel in which they rather unproblematically described the process that the two scientists had demonstrated as the future of energy and even went as far as raising political questions regarding the safety of the two scientists involved. Could their lives be at risk if they are the only people that know how such a potentially planet changing discovery could be harnessed? The Corriere Etrusco newspaper has also published an article [5] claiming that the scientists had replicated their demonstration with success and the inventors state that their machine will be in full production and on sale by the end of the year, with reports abound [6]that they have been granted a patent in Italy until 2028. In October they say they will demonstrate a much larger working model in Greece, capable of generating enough energy to power a factory.

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In April of this year Swedish scientists confirmed their findings [7] that part of the nickel used to power the experiment had been turned into copper, proof they say that a nuclear reaction had taken place. The Swedish aleklett wordpress website [8]offers a description of the processes involved in both the reaction and the analysis process, written by a colleague of the specialist that carried out the analysis mentioned above. As I followed the story I found that reports in English in general are not in the mainstream press but mainly found on specialized alternative energy and cold nuclear fusion websites. See The Oil Drum blog [9] for example or this LenrCanr site [10] for an online bibliography of publications on this topic. The most comprehensive reporting in English can be found in The Journal Of Nuclear Physics [11], a rather nice looking glossy website offering what they describe as 'high quality peer reviewed articles', and the favoured means of communication of our two favourite scientists. During my hunt for reliable information I made some discoveries myself, and not just about cold fusion. Cold fusion is the holy grail for physicists, the promise of cheap, clean power for generations to come. Research has a long history, but one common thread, experiments that have reportedly demonstrated cold fusion in action have been impossible to replicate, and are therefore not accepted by the mainstream scientific community. So maybe this is why the mainstream press does not report on this invention. But what about all these science journals? Well it turns out that the impressively titled Journal of Nuclear Physics was created by the very same scientists that are currently using it to claim this incredible breakthrough. There are many other journals reporting on cold fusion but they are also produced by (and for) outcast scientists working in this field. But here lies a problem, scientists are making claims through what is in effect their own website about an experiment that nobody can explain in terms of physics, and that they themselves are not willing to explain in terms of materials because of the patent issue. Evidence might point to pseudoscience, a hoax or publicity stunt, but many of the issues raised in such a case mirror those addressed on

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this website. Problems such as the private ownership of knowledge, innovation as politics, poor science reporting in the press, access to reliable scientific information and the communication of science and its relationship to society all play a part in events such as these. We should also bear in mind that these scientists may work outside the accepted scientific community but they are well educated physicists and engineers that believe in what they are doing, and that they will one day achieve a 'low energy nuclear reaction' and change the world forever for the better. Let's just hope they do. References: 1] http://bologna.repubblica.it/cronaca/2011/01/14/news/fusione_nucleare_a_freddo_a_bologna_ci_siamo_riusciti-11237521/ 2] http://en.wikipedia.org/wiki/Cold_fusion 3] http://nickelenergy.wordpress.com/2011/05/10/the-rai-news-coverage-video-of-e-cat-dubbed-in-english/ 4] http://youtu.be/ZGI12A3SWJ4 5] http://www.corriereetrusco.it/2011/05/02/fusione-fredda-ok-anche-il-nuovo-esperimento/ 6] http://freeenergytruth.blogspot.com/2011/05/cold-fusion-device-e-catalyzer-granted.html 7]http://www.nyteknik.se/nyheter/energi_miljo/energi/article3144827.ece 8] http://aleklett.wordpress.com/2011/04/11/rossi-energy-catalyst-a-big-hoax-or-new-physics/ 9] http://www.theoildrum.com/node/7942 10] http://www.lenr-canr.org/ 11] http://www.journal-of-nuclear-physics.com/ 12] http://youtu.be/ZGI12A3SWJ4

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Chapter 5

Interviews

Professor Mario Biagioli

Professor Mario Biagioli is a Distinguished Professor of Law and Science and Technology Studies (STS), and Director of the new Center for Innovation Studies at University of California, Davis. To quote the website the Innovation studies center’s research “engages the many dimensions of the process of technoscientific innovation, from those that make it possible to those that constrain it. We focus predominantly on the upstream spectrum of innovation - from the design, articulation, and funding of research programs to the patenting and publication of their outcomes - paying particular attention to the process, practices, instruments, and techniques of innovation and to the conceptual and practical problems of knowledge transfer”. At the law school, he teaches courses on intellectual property in science, and on the history and philosophy of intellectual property. Professor Biagioli was kind enough to dedicate some of his time to the Foundation in the form of a conversation with Jonny Hankins. Topics covered were varied, but the major theme running through the discussion is responsibility in the patenting process. Many extremely interesting points came up, from how to lessen constraints on scientific research brought about by Intellectual Property and patent enforcement, to possible shifting goals and objectives in University and private research, and how to define and measure the responsibility implied in the taking or granting of a patent. What follows is a transcription of the conversation.

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The Debate Over IP MarioBiagioli. I think I should say something about the state of the debate over Intellectual Property (or IP), just to frame things. Among progressive commentators on intellectual property, by progressive commentators I mean people like Larry Lessing , James Boyle and Peter Jazsi and various others, there has been a sustained discussion about how to conceptualize but also almost visualize the large-scale implications of IP protection, to make sure that people who rely on intellectual property come to understand the impact that IP protection is going to have on future knowledge producers, writers, artists and so on. Their argument is quite interesting because it draws on the vocabulary of the environmental movement. Boyle for instance argues that before the development of environmentalism, people conceptualized the impact of development, (industrial development, housing development and so on), in terms of economic models, but those models did not have a way to account or literally to visualize, to represent and give immediacy to environmental costs. So the standard argument would be you go to the gas station and pay to fill up the tank of your car, but while the cash transaction between you and the oil company accurately represents your purchase of gas, it does not take into account the environmental cost produced by the pollution that you will produce as a result of driving. The environmental cost - the cost of your activities to people and things that are not part to your purchase of gas - is not represented within the transaction, and that is what economists called an externality, a negative externality in this case. The point that people like Boyle and Lessing have made is that what the environmentalists did was to make people realize that the environment was not represented by those models and in the policies that followed from them, that nobody was accounting for the environment in the context of these transactions but that instead it needed to be factored in, and prominently so. The environment that used to be effectively just a kind of shadow entity in the context of economic models has become the thing that we all agree that needs to be protected.

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They now say very much the same thing about intellectual property. We should think of culture as something like the environment, so when we patent inventions or we copyright our work, effectively we are developing a certain part of the cultural environment, and we need to make sure that we leave enough of it undeveloped, so that future knowledge and artistic and cultural production can take place. Now at least there is a vocabulary to talk about responsibility in intellectual property, and it is a vocabulary very similar to that of environmentalism. We basically need to think in terms of impact statements. If you build a dam you will have to provide an impact statement of the dam on the environment, and the tendency now in progressive IP discourse is that we need to do the same thing. We should assess the impact of IP protection on the public domain before we apply intellectual property protection because effectively every time we do that we are taking out a piece of nature – a piece of the public domain -- and “developing” it. What intrigues me about this is that responsibility is often a very murky notion, but that the environmental framing of IP clarifies it a bit, maybe just a little bit. It is often difficult to figure out exactly what one is responsible for and to whom or what, or even to define responsibility as a concept. So the new discourse of IP and these analogies it develops between the public domain and the environment are important and useful because they at least provide a vocabulary to talk about responsibility. What I think remains a completely open question is how can you quantify that responsibility? What kind of matrix can you use? To play on the analogy of the environment you might say “well if I develop a certain housing project here I should create a certain number of acres of wetland to offset the impact”. It is not clear what the analogue would be in the case of IP. Can we come up with something like a “carbon footprint” analog for IP? I don’t think that you can… JH. Free something in return? M.B. Well it is a different kind of object. Mostly we think of damage to the environment in terms of the quantity of pollutants that are dumped or the acreage, surface, of the land that gets developed and taken away from nature for good, but in the case of IP the damage is related to time. I don’t think it’s so much about how much text or how many inventions you patent; it is more about how long you keep

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those texts and inventions out of the free reach of other people. Because that is the nature of the constraint that IP poses to creativity. The constraints that are produced are about the fact that once something has been patented it cannot be touched or copied for 20 years. Environmental metaphors make you think in terms of shielding land from development or limiting the flow of pollutants into the environment, but that’s not the right response to the damage that IP does to the public domain because it doesn’t involve pollutants. You can say that there’s an awful lot of bad literature, art, film, scholarship, and science out there that’s stinking up our cultural environment, but I don’t think you can blame IP for that. IP doesn’t pollute the public domain -- it chokes it by making it private. And while once you have developed or industrialized a piece or land it is pretty difficult and very costly and time consuming to bring it back to natural park quality, as soon as you make patents or copyrighted work publicly available and useable, the damage, so to speak, is gone. They go back into the public domain instantly. So I really don’t think that protecting the public domain is like protecting nature or the environment. Patent Terms as Constraints J.H. Do you think that it would lessen the constraints if the length of patent terms were shortened? M.B. Certainly. Even if you agree that some level of IP is necessary, and I am an agnostic on that. I don’t have demonstrative arguments against it but I don’t have terribly good arguments in favour either. So if you set aside that big question about the general legitimacy of IP and just say OK we have an IP system, would reducing the terms of protection help? I’d say, yes, for sure. I think that a lot of the critics of IP but also a lot of innovators and culture producers would be quite happy if the terms were reduced, especially in the case of copyright where now they can be for over a century, and that seems harsh. J.H. Well if we look at the things that might have been copyrighted for a century 100 years ago the view-points were different. We might think that it doesn’t make sense to copyright something for a century now, because in 5 years time many things will more that probably be obsolete.

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M.B. Definitely, but there’s a lot of resistance to that argument. There has been the Eldred case at the US Supreme Court where Eldred and various legal scholars that supported his case argue that this steady increase in the terms of copyright protection is effectively turning copyright into perpetual property while the Constitution says very clearly that excusive rights for authors and inventors have to be limited in time. But the Supreme Court didn’t agree with them, so Hollywood, the music industry, and media conglomerates are happy. To go back to the question of responsibility, in a sense the length of the term of protection is really the core of the cost that IP imposes on the public, and therefore that is where the discussion of responsibility should focus. And switching from copyright to patents, in some industries there is awareness that patent protection could be shorter, because of the pace of technological development, or at least that the length of the term should be industry-specific. So for instance a kind of industry that is very interested in long patent terms and actually would be very happy to have them extended is the pharmaceutical industry. Their argument is that because they need to invest billions to come up with one successful drug they need to go through thousands of potential leads that don’t go anywhere, so the development costs are represented as enormous. Some people question the accounting that generates those figures, but the logic is that you invest so much, and come up, if you are lucky, with one molecule with good therapeutic value. Then they need to recover all their research costs through that single patent, and so they argue that they need all the 20 years that the law gives them and perhaps more. J.H. Well in many cases they do in effect get more M.B. Yes there are some creative tricks to extend them. But on the other hand the software industry feels differently and at least some of it claims that patent protection for 20 years is not needed. Very few pieces of software maintain value for 20 years. Also, just one piece of software may entail hundreds of functions, each of which could be potentially patented. So they say they would have to patent a lot of functions which would cost a lot of money and time for a period of protection that would probably last longer than they need. So paradoxically the software industry is not a great friend of patent law,

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showing that there’s no simple equation between innovation and intellectual property. The Open Source Model J.H. Well open source has really grown out of that position hasn’t it? M.B. Yes, open source, I believe is a real success story, also because it is not just open source and free software. That model now has been taken up by creative commons and initiatives like that, so basically it is a model that can be applied to anything that can be copyrighted. It is no longer just software, it can be music, texts, art, whatever. And so that is a very successful model which in many ways reframes the discussion of responsibility because most people would that say that you are not really imposing any constraints or costs on other producers or on society at large … Well the only constraint that you impose on the users is that you are telling them that if they want to use, say, your text they are free to do so, in most case even commercial uses are allowed, but it has to remain open under the same conditions that they have taken it from you, in a sense the person who puts a work out under creative commons, free software or open source license puts constraints on the users, but they are constraints about keeping the work open, so most people would say that actually that is really not a constraint at all. Nobody’s property rights are violated, and nobody forces you to use anything you don’t want to use. I think that the success of the open source model is something that has taken people by surprise. I don’t think that even 10 years ago people would have imagined that it would have spread so fast and wide. One of the great limitations of the model, though, is that it really does not work for patented inventions. It works OK with tangible property – think about the privately supported land banks and nature reserves you see in the US – but only as a preservation tool. Instead when you use it in copyright-based creative practices the free software model preserves the public domain and allows for the development of more culture at the same time. Pretty neat. The constraints that patents and tangible property pose to knowledge and cultural production are tougher to work around. Take for example the large empirical study that was done by Wesley

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Cohen. Ashish Aurora and others based on interviews with hundreds of scientists, asking them if they had encountered constraints in their work as the results of patents. In the past there used to be a doctrine called ‘research exemption’, something like the equivalent of fair use for patents. Certain unlicensed uses of patented inventions were considered legal if they were done for noncommercial research. So if you were an academic scientist you could copy a patented invention just for your own research purposes. This came to an end, however, because while universities continue to be not for profit, they do a lot of their research in collaboration with or for the private sector, so if a scientist copies an invention for their research it is possible that that research might be commercially motivated or may end up producing commercially valuable results. That has eroded the justification for the research exemption. So Wes Cohen and his collaborators studied the impact of this, and the picture is quite interesting. A number of scientists did report constraints posed by patents and that in a few cases they had to drop their research projects altogether because they could not get the appropriate licenses to use patented inventions, but this happened less frequently than people expected. The reason, however, was not that patents were not that constraining, but that a lot of scientists reported that they just didn’t care! They just go ahead and infringe and say, well if you want to sue me go ahead! The other surprising result of their study was that a lot of scientist who dropped their research projects did so not because of patent constraints but because they could not convince a colleague to share a reagent or cell line. The problem was their inability to get certain very specific things, not intellectual property licenses. If the scientist said no, the scientist who was doing the asking would have great difficulty in reproducing that thing, otherwise she would not have asked. So if I ask you to license your patent to me for free, and you say no, I have the option of infringing and then see if you sue me. If instead I say I need your unique cell line and you say no, I’m stuck. So while IP is often presented as a constraint to academic research because it produces what Eisenberg and Heller call “anticommons,” good old tangible property may be as much of a problem. Unfortunately neither problem can easily solved through the creative commons or open source model based on copyright because of the much higher costs involved. It is cheap to register copyright but

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expensive to obtain and maintain patents, which makes it very, very difficult to develop a patent commons. (You may have heard of patent pools, but they are a very different thing). And even assuming that scientists would be willing to share their most prized reagents and cell lines, setting up a physical publicly accessible depository for such things would be neither cheap nor simple. I’m not saying it’s impossible, though. Foundations could play a key role in this. Think about the Open Courseware Project at MIT where they make their syllabi of all their courses open, including the readings. The initial phase was funded not by MIT itself but the Hewlett and Mellon foundations, and the programs still continues with donations from private corporations and foundations. I don’t know whether, along the same lines, the private sector and the philanthropic world could jump in to key technologies and create this open patent commons. Anyway I am just thinking aloud, I don’t know whether it would be feasible or sustainable. It would probably depend on how big a patent commons it would have to be to make a difference in that specific field, or whether it could be set up quickly before the private sector comes in and starts taking out key patents, leaving only the spoils for a possible patent commons. I have digressed a bit but now at least we have a better sense of the many different ways in which one can talk about responsibility in IP. We may be able to conceptualize what responsibility means in IP through Boyle’s environmental metaphors, but I think that the metrics for assessing that responsibility would have to be mostly developed by thinking about IP as a temporal, rather than a purely spatial-environmental set of practices. That would be very complicated, but also extremely timely and relevant. I cannot think of a lot of contributions within the range of scholars and intellectuals more relevant than a framework for responsibility in the knowledge economy. The Problem of Responsibility J.H. The Bassetti Foundation has been debating the problem of responsibility within innovation for more than 10 years, long debates about how responsibility can be ascribed to individuals, to technology. Can you ascribe responsibility to technology itself? I

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would say not. To whom then? The researcher, to the person who builds it? To the politician who raises the money and pays for someone to do it? It is an endless question, what is responsibility and who takes that responsibility? M.B. Certainly who or what is responsible for what and to whom and is a big question, and now that STS has rediscovered the material agency of things, it is possible to think about things having responsibility in ways that go beyond old technological determinism. As far as I can tell that has not yet happened, though. A lot of STS literature is happy to talk about the agency of things, the contribution of nonhuman agents to the construction of certain assemblages, but not so much about the kind of responsibility that goes with that agency. I can’t come up, on the spot, with an explanation for that. But if by responsibility in innovation you mean the responsibility for turning innovation into a legal object and a bundle of property rights – the kind of thing you do when you patent an invention – then I think that the question of how you assess or perhaps quantify responsibility is more urgent that determining the location of that responsibility. Think about an insurance scheme, you pay X amount of money and the insurance company will cover you for certain things up to a certain amount of money. The riskier the things you do, the higher your premium will be. The premium you pay and the coverage you get are indexes of how responsible or irresponsible you are and what responsibility the insurance companies assumes toward you. But if you come up with a scientific discovery or invention and you patent it, what is the social cost of your action? You can quantify how valuable that patent was to you by looking at the revenue from its use and licensing over the period that you held that patent, but not what that patent’s cost to society was – the social costs of preventing other people from using and producing more innovations from it. We don’t have actuarial tables for that. That is an extremely complicated question but I think a fundamental one if we want to develop a policy about responsibility in IP. Again just thinking aloud, time would have to be a big factor in that assessment, the length of the term of protection, but also how upstream or downstream that invention is located within the stream of innovation so as to assess how much innovation was precluded by the protection of the invention over the life of the patent.

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Suppose that you come up with a unique instrument that is just for you to measure something only you want to measure. Well, even if you patent it you are not going to exclude a lot of people because your invention is extremely specialized. But suppose you come up with a new instrument that could be of use to a variety of scientific disciplines, then the social cost of the patent would be much higher is different. But I would not be surprised if that question could be answered only a posteriori and, even then, only partially. We don’t know what developments a certain patent would preclude at the time it was patented because that would be like predicting the future. All we can do (and it’s not clear we can do that well either) is to assess post facto, working like historians, which innovations were indeed foreclosed by the presence of that given patent. If we can come up with some assessment of responsibility, it would most likely be of past responsibility – of the effects that a patent had, not the responsibility it will have. Innovation is emergent which means that you cannot have a notion of ethics or responsibility based on first principles because things change all the time, and in ways that are inherently unpredictable. That’s what I think I was trying to convey earlier when I was saying that it will be extremely difficult to develop a framework for responsibility in IP. In a strict sense, that task is impossible rather than simply difficult. We can’t assess responsibility a priori. At the same time, we can probably map out the contours of such a framework, and use it to make local, time-specific assessments. It is an interesting question and I thank you for bringing it up. I hadn’t realized that in intellectual property we now have a vocabulary to talk about responsibility, but there isn’t much of a discussion about exactly what authors and inventors should be responsible for, and that is a very interesting question, which of course I cannot answer…(laughter) The patent as a scientific goal J.H. Well we are not really here for answers are we? I have a rather critical question for you, would you agree that in certain circles the goal of science has become the patent? This question refers amongst other things to a book that I recently reviewed on the website, Deadly Monopolies by Harriet Washington, not about science in general in this case but medicine, and it feeds back into what you said before about patents being so long.

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M.B. I am not a friend of the pharmaceutical industry and find their lobbying for even stronger patent protection problematic. That said, there is a point to be made about the fact that secrecy can be as deleterious as commercial monopoly. There is a huge amount of scientific research carried out in the private sector and some of it (maybe much of it, we don’t know) is not patented but kept as trade secrets. People who believe that academic science should be in the service of the public interest complain that more and more knowledge is being privatized through patents, but people who like the patent system will tell you that patents serve the public because they amount to publications, as opposed to trade secrets that are never disclosed. This is of course a self-serving argument, but it follows a certain logic. Companies and individuals are entitled to keep their technoscientific knowledge secret, and they often do. But patents will at least provide the public with a disclosure of the invention as part of the application process. 20 years later the patent goes back into the public domain, but even before that you can read its description and use it for your own innovations, provided they are significantly different. Pro patent people would even say that patenting spurs innovation by telling you what you need to invent around. Patents should be seen as publications with a delayed effect so to speak. That is the discourse of patent supporters but it is also the original logic of patent law based on an exchange between the inventor and the public. The public through elected officials and the government, grants the inventor the patent, but in exchange the inventor has to communicate the knowledge of the invention to the public. In sum, patents can be seen as tools for commercial monopoly, but not for secrecy. They don’t let you copy the invention, but they tell you what it is about. They are not normal scientific publications, but they are some kind of publications nevertheless. So in this sense the opposition between science and patenting is not absolutely sharp But to go back to your question. Yes in some cases patenting is or is becoming a main goal of scientific research. Things are particularly complicated in the context of the university where until a few decades ago patents were seen as inappropriate to the general mission of the institution. In the past (at least in the US) a lot of the

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research universities would pass their patents to a consortium. They wouldn’t even handle them. But now, because of the crisis of public funding of the public universities such as we see in California, administrators make the argument that the university needs to patent to generate revenue to make up for the money the state does not provide anymore (and perhaps will never provide again). So paradoxically there is almost this Thatcherite push toward privatization and enhanced patenting efforts by the public universities, but it is done in the name of saving the public university. It is a paradoxical and perhaps perverse situation in which we need to patent and privatize knowledge to hopefully save the public universities and its mission of public service. That’s a tough argument for me. I see the problem, I see the very few options available to public research institutions to save themselves but, to go back to your question about responsibility, I am not sure these policies are anchored on the right notion or long-term view of responsibility. Suppose I put the Thatcherite hat on, I would say. Well, is this a good business model? Is the university really generating a lot of money by patenting? Is the revenue we generate offsetting the constraints we are producing for present and future scientists in terms of delayed or curtailed publications, or the costs and delays associated with the licensing process some scientists may have to go through in order to use some of these patents for their research? The only responsible way to answer this question is not by making assumptions either way but to look at the evidence, which is ambiguous at the present time, but may become clearer in the future when the effects of more patenting will be better recognizable. But the first part of the question can be answered now as most universities are really not making a lot of money from patents. There are a handful of cases where universities make serious money in royalties and licensing fees but most of the time they don’t. So the question is if you are not going to make a lot of money is it worth it? Or are you just basically creating constraints to future scientists for little financial reward in the present? It’s a bit like a problem of intergenerational equity. If the university takes a fully presentist

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perspective, it may make sense to patent aggressively and get whatever royalties they can, however limited they may be. Maximize short-term revenue because you need to balance this year’s budget. But if they think long term, to the generations of academic scientists and graduate students who will become scientists down the line and who will have to negotiate increasingly complex patent thickets resulting from the collective efforts of all universities to patent all their more or less promising inventions, or to put less knowledge out in the public domain due to the proprietary arrangements they have made with the private sector, then different strategies may be more reasonable. Companies come and go, emerge, collapse, or are sold, and their patent portfolios go where their stock goes. But universities have a tendency to stick around for centuries, not quarters. So even thinking just in economic terms do these patent policies make sense or are they a seriously sub-optimal arrangement that is going to foreclose a lot of future research and innovation? I keep finding myself going back to the question of whether one could reliably assess this kind of responsibility toward future scientists, students, and citizens. I agree with James Tobin that "the trustees of endowed institutions are the guardians of the future against the claims of the present,” but in the case of IP policies responsible to future generations. I don’t know what kind of tools those trustees could use to get their job done right. J.H. Sounds like a perfect conclusion to me, thanks very much. The Bassetti Foundation would like to thank Professor Biagioli for his time in giving this interview and it subsequent revisions and wish him well in his work as Director of the new Center for Innovation Studies at University of California, Davis.

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Congressman Michael Capuano In this interview Jonny Hankins talks to Congressman Michael E. Capuano, whose territory in Boston hosts some of the biggest names in research and innovation today. Arguments surrounding the role that politics plays in innovation, and innovation as politics, have long been debates within the Bassetti Foundation project. If we view innovation as a political act, requiring will, technique, technology and infrastructure then we can also argue that responsibility lies within the political domain. Innovation can also be seen as a political act in itself, as it brings change and effects society in both positive and negative ways. In one of my preceding posts entitled ‘Government Investment and Cuts in Biodefense Research’ I touched upon various current issues within the US science and innovation community, including the forthcoming cuts in scientific research, problems with some of the new high security biodefense labs including the unopened complex in Boston, and biodefense spending in general. The transcription below is of a conversation that took place between myself and Congressman Michael E. Capuano as a follow up to that posting, and addresses many of the issues raised therein. The discussion offers a fascinating insight into the working life of a politician who represents the interests of probably the highest concentration of scientists and innovators in the world today. US Congressman Michael E. Capuano represents the Eighth Congressional District of Massachusetts, a position that he has held since January of 1999. He is a trained lawyer, whose district includes Boston University, MIT and Harvard University, to name but three of his more than 30 world renowned education and research facilities. The Boston University Biodefense Complex is also within his district, a high security complex that has yet to open due to legal action taken by citizens against the complex.

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On behalf of the Bassetti foundation I would like to thank him for the time he generously dedicated to this interview, and also to warmly thank his press department for organizing the meeting. Our discussion addressed the following issues: Boston University Biodefense Complex Responsibility towards society Access to scientific information Proposed research budget cuts The law and best practices External pressures The following is an unedited transcription of the conversation. Boston University Biodefense Complex J.Hankins. As well as being interested in responsibility in innovation, the Bassetti Foundation is also interested in public participation in politics with the argument that larger public participation might lead to more responsible decision making in innovation, and one of the issues I would like to address is the problem at the Boston University Biodefense Complex. A lot of money has been invested and it has not opened yet, do you think it will open? Michael.Capuano. I don’t know. J.H. Could you just give me your interpretation of the problem with the complex please? M.C. Well we are dealing with potentially dangerous research that has to be conducted with the very highest level of security, and they have not dotted all the I’s and crossed all the T’s in the way that they should have. Some people in the community are opposed to it, not all, but some are, but that is really secondary. It doesn’t matter if one person is opposed to it or not, the numbers of people opposed are really of secondary importance. The society has a specific level of security that is required at that level of lab and it has to be met. And

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that is the controversy. They have recently asked to open up the lab (it is not just a level 4 lab)…. J.H. yes they have recently asked to open it up as a level 3 lab M.C. We have many level 3 labs in the Greater Boston area and I think that Boston University already has one, so I don’t anticipate any problems with that request but I don’t know, every one of those labs has to meet certain requirements as well. Once those requirements are satisfied it will open. Responsibility towards society J.H. This leads me to the question of the trade off between responsibility to the collective and the society and the obvious need and economic advantages of this kind of technology and research. M.C. There are always trade offs, there are trade offs driving the car down the street, it pollutes the air and you can get hit by one, but we make those trade offs every day and on every issue and this is no different. J.H. And what is your interpretation of responsibility? M.C. It depends on the issue, different things carry different levels of responsibility, I do not impose my definition upon anybody else. J.H. Do you feel that your definition of responsibility changes over time, through experience? M.C. It depends on the issue, it depends on how it impacts my constituents, every issue is different and I approach it differently. I cannot be the main champion of every single issue so I look to see if there is somebody else that I can hand over responsibility to on a given issue and if there is, fine, we don’t need 10 cooks in the kitchen. If not, I jump in. And even then I don’t jump in every issue, I can’t. I jump in on issues that I feel qualified to handle, or at least more qualified than anybody else so it always depends on the issue, I do not have a generic approach and there are no easy answers.

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J.H. In Texas, they have had some problems with some of their bio labs, so where do you feel responsibility lies when these events occur? My question is, does responsibility lie with the decision-makers that make the decision to put these operations into practice or does it lie with technicians? M.C. Everywhere. You can have the best program in the world but if people don’t adhere to the program it means nothing. So it lies with the people that set the program, you know this is what you need to do, it lies with the people that do the day to day work, because even if you have the best enforcement in the world there is going to be somebody that falls asleep at some point, so the people who work in the lab and everybody else have some degree of responsibility. They are different types of responsibility but that is the back up of checks and balances that a good system has, and the redundancies, and there should be redundancies when it comes to potentially dangerous situations. Driving a car down the street, you have to have a license, the car has to be certified, the brakes have to work, the manufacturers have to make brakes that work so everybody has responsibility. The driver takes responsibility as well, and so does the pedestrian crossing the street. You are supposed to look both ways. So it is no different. There are different types of responsibility at different levels, some of it is redundant but that is intentional. J.H. And the responsibility that you or somebody in your position takes in terms of your promotion or negation of such an issue? M.C. My responsibility is that if it is going to get done, is it good for the community that I represent, of 700,000 people, and if it is good for it, is it safe for it? And that is my responsibility, to make sure that it can be as safe as possible and not only that it meets current standards but also that current standards are adequate. That is what I have been focused on. Access to scientific information J.H. And in order to help you make these extremely important decisions you must rely on scientific evidence, but one problem as far as I can see is that everybody tends to just tell their side of the story.

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M.C. In politics that is every situation that has ever walked through the door. And it will be every situation that ever does. Not that people necessarily mean it that way, it is just human nature to see things from your own perspective, and that’s fine. So my job is to try to get through that and get to what I think is the appropriate thing, it is all based on my judgment. There is no book that I can go to that says here is the final answer to any question, so my judgment has to be based on experience. In this case I am not qualified to know what is safe but you are in my district so… And this is one of my institutions, I have 34. I have some of the most intelligent people in the world within a phone call at any given moment. And one good thing about being a member of Congress is that when we pick up the phone we generally get the calls answered and we can find out who the best person in the world to tell me what the appropriate safety levels at a bio-4 lab are. And we won’t find just one, we will find 10, and we have. We have reached across the world for this. We have asked: Does it work? Do you think our standards are OK? And little by little you build a conclusion. But I have never just relied on one person. I would never do that for anything, especially in this area! I am not a scientist, I don’t want to be a scientist, I wasn’t trained for it and I don’t know anything about it. I have been through the Bio-4 lab and had a look around but I couldn’t find my way around it, it is like a rabbit warren so I am not qualified at all. I am qualified to get on the phone to a lot of very intelligent people and draw a picture for myself, to determine whether this can be safe, and if so, how? And that is what we have done. But when it is a scientific issue I rely on scientists and on a transportation issue I rely on transportation experts, but not one, never one, always multiples and the more the merrier. And the BL-4 because it is so controversial and because it is so unique we have had a pretty broad input, world renowned people that I wouldn’t have known before this had started. I didn’t know who the world renowned BL-4 people were, but I do now. And even that, world renowned is very interesting but it doesn’t make you the sole and unique person to answer the question It does mean that you have an input, a knowledge and insight that I wouldn’t know. It is a very simple question. Would you, Mr Scientist from France, would you live next to a BL-4 lab? If it was done properly, and if the answer is no well…I have a problem, but the answer has never been no from a scientist working and respected in the field. In fact some of the scientists I know live within walking distance from a BL-4 lab, and they know better than I do, they do it every day, as to what are

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appropriate procedures, how they get enforced, they tell me, and we learn it and see if it is being applied. But at the same time and make no bones about it, they could be the best procedures in the world but if they are not enforced they don’t mean anything. So that comes on to BU (Boston University) and BU has had some trip ups in the past and they also know that if they mess it up that place will be locked up and never used. And that is not good for them and it is not good for Boston. So everybody I think knows what is at stake here. Proposed research budget cuts J.H. I wanted to ask you about the recent budget cuts and what you feel the effects will be upon innovation. M.C. It is going to be terrible, I firmly believe that basic research is what the government should be investing in, corporations cannot and will not do it, especially in difficult times. They do applied research, not basic. But you cannot have applied research until you have had basic research and if the government doesn’t do it? It doesn’t pay, you have to make a hundred mistakes before you get one thing that might one day become commercialized. It is a very expensive thing to do, but I believe that when an innovation is made it is good for society, even if some company may reap the specific benefit, that company will spin off other companies, and hire thousands of people and on and on. So for me I think the government should be involved in basic research and yet because the failure rate is so high, as it must be, and always has been, and because you don’t even know most of what may result, what insights may arise, and because it’s only done in certain areas, basic research is associated with large institutions, Universities, not all of it but most of it, and those large universities don’t tend to be in the middle of cornfields but they tend to be in urban areas, not all, but again exceptions to the rule, and because of that it becomes a very easy thing to cut in the short term, and scientists don’t tend to be a very big political force. Because of that it is a wonderfully easy issue to cut. But the problem is once you cut it you put yourself five or ten years or whatever the number is going to be behind the curve, because somebody else is going to do it. J.H. China?

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M.C. China won’t do too much of it, they will do some of it but they are not really ready, but Israel is, Europe is. You know half of the Europeans that are doing biotech scientific research are doing it with American scientists, many of whom came from the Greater Boston area, and that’s OK it is the normal course of business. They are not stupid, they are not some third world country, they are breathing down our necks all the time and sometimes they are ahead of us. Europe is the most important in this field, China has some and India has some but it is Europe with the real cutting edge stuff. But if you give up on it for five years, just pick a time-frame, the others are not going to stop. Some will, Greece probably won’t be doing a lot of cutting edge research but Germany will be, and who knows, there is no way to tell. And that is the business end of it. But from the humanity end of it don’t you want the next discovery to be made, to make your life better? The history of mankind is based on scientific research and discovery. Why wouldn’t you want every advancement? But corporations won’t be doing it, and nor should they, they have never done it. The best scientific research has always been funded by privates and not-for-profits, or by the government. So for me, I think it’s a huge mistake if we make cuts in scientific research, because we do the basic stuff and no-one else will do it. Yet I think it is also inevitable that they will make those cuts. They are an easy political cut to make. I will not have 10000 people screaming at my door, and I come from a district where basic research is done, yet if I cut senior housing I will have 100000 people outside, as will every other member of Congress, so it is an easy target. But it is a short sighted target. The law and best practices J.H. One of the Foundation’s aims is to try and promote best practices within innovation, but my interpretation is the belief that best practices can be upheld through the law and that the law can maintain ethically correct practices is flawed. I may follow the law but not behave responsibly. How do you feel about this argument, in your position as both a lawyer and a law maker? M.C. I agree with you, but it is human nature to cut costs. Those issues are not a problem when they are done in America or Europe for the most part. But the same oil companies that may be doing wonderful things in the North Atlantic or USA will go to the Congo

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and couldn’t care less about polluting the country, because they cut corners, nobody is there to enforce it so they may be a wonderful company in one place but the way they act in another place is probably not so good. In the final analysis I think it is all good to say we should, but there has to be a government to enforce it, or a society (which is a form of government) to enforce whatever rules there are. We had BP in front of us after the Gulf oil spill, and everybody was concerned about some kind of blow out gasket, but I was only interested in one thing. I said now let me ask you a question, this gasket that you say costs 500 000 dollars and so you didn’t use, because you weren’t required to use it here in America, (I knew the answer anyway, I am a lawyer, I don’t ask questions I don’t know the answer to), are you required to do it in the North Sea? Are you required to do it in Canada? And the truth, as I know, is yes. And did you do it? And the answer is yes. And did you make money on those fields or were they charitable donations? And the answer is well of course they made money. And so why don’t we have those best practices here, there is no argument not to have it imposed in the Gulf. If you can do the exact same thing in the North Sea, being required to do so by the government of Norway, and make money, well good for you, and you should be required to do it in the Gulf, and you can still make money, you cannot make any business argument against doing it here. It is a classic example: the company followed a best practice when they were required to do a best practice. No questions. They did not say ‘well I’m sorry I’m not coming to Norway because you make us do this’. So in the final analysis responsibility is a good thing to set forth, but the exception makes the rule, and there will always be someone that is not willing to be responsible unless required to be responsible. That is what governments do. External pressures J.H. You represent the cutting edge of the scientific world, MIT to name just one, do you feel pressure, or do people apply pressure to promote or to come some way towards appeasing their particular needs? M.C. Nobody applies pressure, I cannot think of anybody that has ever applied pressure in a successful way, it is not the way to approach me. At the same time, when you are running for office… I knew what was in the district before, they didn’t just spring up

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yesterday, and you tell people how you feel. When it comes to scientific research I look at it as two things, the great esteem of humanity, I like it, but it is an economic engine here. That is what we do here. We used to be a textile manufacturing area, shoes especially; we were a meat slaughtering capital, all kinds of things. We are a high tech capital now, but we used to be the only high tech capital, now we are not the only one. Everything we do here is based upon scientific innovation, and it wasn’t done in the pursuit of some kind of scheme, it just grew out of habit. We have the right mix of universities, and hospitals, and venture capitalists and the physical location, all kinds of things that just happened to come together. And like it or not, intellectual capital is our economy now, it is what we do, and which politician wouldn’t or shouldn’t be involved in protecting the economic interests of their district. Scientific research is a major part of the economic activity here. Without it I don’t know what we would do. We don’t have oil here, we don’t have wheat fields and we don’t have gold. We don’t have any of those things but we have one thing that we have almost more of than anybody else in the world and that is intellectual capital, the ability to attract people like you. For me the only thing I would change is that I would make you stay here. I figure that if you want to come here and get an education we want you to do that, but then we want to keep you. We are stupidly doing just the opposite. We bring people here and then we kick them out, which again is incredibly short sighted. I remind people all the time that Einstein, Fermi, Marconi, they weren’t born here. But they came here and they created their great things here. And I want the next guy, whose name I don’t know, and comes from some corner of the world, and I don’t care where they come from if they are the brightest. I have sciences going on here that I can’t even pronounce. They are doing some type of scientific work that I don’t know what it is, but I don’t have to. I have photonics going on. They have explained 20 times what photonics is and I understand it, then I forget it and I can’t remember what it is. And there are other things going on and I have no clue, but I know one thing, that the photonic people might find some answer to cheap reliable energy going forward. They may not, but if it happens I want the chances of it happening here to be greater than anywhere else. Not because it is going to become the photonics capital of the world. It will for a short period of time, we are the bio capital of the world for the moment, but it won’t last. Pick a time frame, it has already spread but it started here, just like high tech. The high tech world started here, and now it

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has spread and everyone thinks about Silicon Valley. But Silicon Valley was second. They advanced over us because we held back in certain things and because it is very expensive to do business here. I don’t want it to be cheap! Cheap to do business you can do anywhere. It is cheap in China, cheaper than it will ever be here, but China isn’t the cheapest anymore, we’ve got Vietnam and Bangladesh. This is why we no longer do textiles, not because we are not good at it, it is just because you can make a shirt cheaper in a million different places. The Bassetti company probably don’t make their sheets in Italy any more, I have no idea but they probably make them in Bangladesh or India, and that is the nature of business, it will happen in bio, it will happen in every new field, and I am not worried about that. Those are low wage jobs. I am much more interested in high wage jobs to maintain the quality of life that we have here. You have seen the house prices in Cambridge. The quality of the housing is no better than it is in 90% of the developed world, but they are a lot more expensive. Now that is good and bad, don’t get me wrong, but I don’t want those houses to lose their value. They will lose their value if people can’t afford them or if people no longer want to come here, and they can continue to afford them if we pay them better. The only way we can pay them better is to provide jobs that no-one else in the world can do. Right now that happens to be life sciences. But we are not the only ones that do it, and little by little the rest of the world is going to catch up and my hope is that by that time we are on to the next thing, whatever it is going to be, and we don’t know what it is going to be. But if not then this place will suffer. But if we can stay ahead of the curve and I think we have a very good chance of staying ahead of the curve, if people like me understand our economy, and our economy is intellectual capital, it is part of my job to maintain the competitive edge in what we do. I feel no external pressure, only pressure from myself. It is not that hard. People help me do it all the time.

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Pallavi Phartiyal of the Union of Concerned Scientists. Cambridge Massachusetts hosts one of the main offices of the Union of Concerned Scientists, described on their own website as “the leading science-based nonprofit working for a healthy environment and a safer world” They go on to state that “UCS combines independent scientific research and citizen action to develop innovative, practical solutions and to secure responsible changes in government policy, corporate practices, and consumer choices”. The Union is about to open its new ‘Center for Science and Democracy’, and I was fortunate enough to meet and record a conversation with the centre’s Program Manager Pallavi Phartiyal. The conversation touched upon the following themes (amongst others): The work of the union The role of politics in innovation The new Center for Science and Democracy Politics in the global warming debate The work and responsibility of the media The aims and objectives of the Science center The work of the Organization Jonny.Hankins. Can you tell me about your organization please? Pallavi Phartiyal. My organization is the Union of Concerned Scientists and we are one of the leading science based organizations. We pride ourselves in taking scientific knowledge and converting it into practical solutions to implement change. We are working on several programmatic areas and they are where most of our efforts are focused. Primarily we are working on climate and energy, on clean vehicles, food and environment, scientific integrity and global security. These are just the titles of programs and they of course contain a very broad swathe of individual topics. For instance the global security program ranges from security of nuclear reactors to space security so it is really very broad, but these are the

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programmatic areas. As an association we are membership based so all of our support comes either from individual donors or foundation support. We have over 85000 members that actually give money to us and over 400000 people that we call supporters. They are signed up to hear from us through our publications or e-mails but are not directly funding us. But more than 85000 people actually write cheques to us, and that is how we raise the money to carry out our work. J.H. The organization seems very much US geared looking at the website. P.P. Yes it is, of the supporters that I talked about roughly 10 000 of them are international but other than that the majority are US based. Some of it is an active decision because the kinds of issues we are working on are these huge issues that are very closely tied to politics, making change in policies or advocating for more US based solutions. We have to work either directly with regulators or citizens who talk to their legislators about making changes, and that is a huge lift as it is. We are an organization of 150 staff members or so we can only do so much, and it is often an active decision that we have to make, even though a lot of the issues that we work on cannot be defined by national boundaries (for example climate and energy). Our staff members are actively involved in international conferences, they go to them, they inform our reports but the focus of our work is mainly US based. J.H. One of the things that I find very interesting looking at your website, and that we are very involved in at the Foundation, is politics and its role within innovation, and something that we might be able to describe as innovation as politics. Can you tell me about the Science Under Attack project. P.P. Yes, one of the programs that I mentioned is scientific integrity. This is the program that most directly interfaces with the political side, the political interference in science, or manipulation of science by the government officials, and we have had great success through that program. We have worked with federal agencies that through our doggedness over the last 7 or 8 years have now put out scientific integrity guidelines (or are in the process of finalizing their guidelines) which basically minimize the restrictions placed on

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scientists to inform the public about the federal research that they are conducting. A lot of the Scientific Integrity program looks at science under attack in federal agencies. That is the most direct link, although there are other campaigns that we run such as the ‘Weight of the Evidence’ campaign where our expert team (we have a network of more than 18000 experts including scientists and economists) are paired up with media so that they can inform them about what is right and what is not, scientifically, and point out mischaracterizations. We have also done some work aimed at preventing harassment of scientists within institutions, such as the case you read on our website on science under attack- a harassment campaign launched by the Attorney General of Virginia on a climate scientist who was employed at the University of Virginia. All of this is under the broad umbrella of science and scientific integrity. The Center for Science and Democracy J.H. And tell me about your job and the new center. P.P. This is a brand new initiative that the Union of Concerned Scientists is undertaking called the ‘Center for Science and Democracy’. We are in the very early stages of launching this initiative. Internally we have been working on it for some time, and we will formally launch it in May on the East Coast in Cambridge Massachusetts at the American Academy of Arts and Sciences, and on the West Coast on June 13th at the Scripts Institute of Oceanography. The idea behind the center is to go beyond thematic topics in science, beyond just environment, and climate and global security or evolution (that we don’t directly work on) and take everything that comes under the broad umbrella of science, technology and innovation and really integrate it into the democratic process, into the governance and policy making process. We want to do it by mobilizing the public, mobilizing scientists and also through direct conversation with the media and policy makers to re-emphasize the importance of science and science-based decision making in the policy process. We understand that given a specific person’s political views, solutions might be very different, but we would like the conversation to start at a facts-based level so we at least have a conversation

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based upon a consensus about what the scientific facts say and what the evidence says. Then, there can be several policy solutions to a given challenge. So we are really trying to emphasize what has been historically true in the US; if you go back all the way to the founding fathers they were from the enlightenment era and they really talked about how science belongs in the democratic process and how we should think about the principles of science and the value of evidence-based decision making. That is the kind of thinking we want to bring back through the work of the Center and try to make citizens more aware of what science has done for the public, how science and technology play a part in everyday lives and then gain vocal support for science-based decision making. J.H. And what methodology are you proposing to use? P.P. That is the hard part because it is such an ambitious undertaking and the problems that we are facing are enormous. Some of the biggest issues at play in this area are political agendas, corporate interference in politics and the influence of money, and these are really huge issues. An organization like ours cannot claim to say that we can solve them all, and I would say that this is a work in progress because it is a new initiative, but one of the things that we are thinking about is holding 2 or 3 problem-solving public forums across the country. They would not be purely academic in nature but will include experts from academia, but also several kinds of stakeholders. They will address a problem that is affecting a community or a problem that is science based and requires policy solutions. We want to involve the public in informing what the problem is, and then bring in experts to interface with the public. We want to include media and people from the business community, from faith communities, and youth, to really diversify the people who have a voice in talking about one specific problem. This would be a 2 to 3 day forum and really have a public nature to it, and at the end it would come up with actual solutions for the problem that was identified and then use the media and citizen action to take it forward. Over the last couple of months we have been brainstorming about what the follow on of a gathering like this should be. And how should we institutionalize the forum setting so that we have the barebones of the forum in place, which can then be used in service of different issues as they present

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themselves? We want to have the basic structure to say these are the wide range of stakeholders that we want to bring to the table, these are the different elements that we want to have within the forum and these are several kinds of follow up activities that follow from it. Some of these are more obvious than others, it depends on what stage that specific problem is at. If you are looking at fracking, for example, in a particular geographic area that topic might be more immediate than say the teaching of evolution in classrooms, that might require engaging educators from K through 12 and that might not necessarily have an immediate obvious action associated with it. We would hope to come up with solutions however that would then be released back into the community and into the decision making process. J.H. You have done some forums before haven’t you? P.P. Yes, we have done 2 forums that specifically inform the work of the Center, so we are going to use them to inform how we design this whole program. Again, this is one element of what the center will try to do but the better defined than the other elements at this point. We recently held two forums that will inform the future forums of the Center. One was on the challenges facing the Food and Drug Administration (FDA) and discussed policy considerations tied to the upcoming reauthorization of the prescription drug user fee act in congress. The other was using the advances in the social science research to communicate about risks of climate change to people. There is a big divide as you know in this country between people who believe in climate change and those who don’t, and this forum really targeted stakeholders from different communities. It brought business leaders who have understood that climate change is happening and that we need to do something about it. It brought policy leaders from both sides of the isle, democrats and republicans. It brought leaders from the faith community who view people as stewards of the Earth, responsible for preserving it, from a faith-based perspective. We had a public event where we brought in social scientists who talked about why it is hard to communicate about the challenges in thinking about the risks associated with climate change. So those were some of our initial forums that will inform the way we go

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forward, and what we have learned, and will help in the design of what we do in the future. The Role of Politics in the Global Warming Debate J.H. Global warming or climate change is a political problem here. If you come from outside the US global warming is a political debate but here it fundamentally seems to be a political debate, why is that? P.P. Well in some ways it goes back to the influence of money. Science used to serve the interests of industry and corporations a long time back, and that relationship has evolved over the years. The kinds of changes that addressing climate change needs today requires action from the business community which is not that easy for them to undertake. It comes with some real costs but it comes with a long term benefit, but both the political community (our leaders in Washington DC) and the corporate leaders are looking at short term gains. The culture today is to look for immediate gains as opposed to long term gains for society. Also over the years there has also been this evolving philosophy and ideology that sees all government regulation as a bad thing. The minute you say ‘regulation’, there is instant opposition, and that has a lot to do with the problems that we are facing in climate change. The instant repulsion to anything that government does in terms of regulation quickly ignores the fact that so many science-based regulations in the past have improved our standard of living today. LA used to be a city in which people could not breathe, there was a time when there was smog all over the city, and the fact that today people can go on morning and evening walks without thinking about it is due to the environmental regulations that were put in place there. I think that it will need a kind of ideological change for us to get back to our roots and say that we have to have a longer term vision. We have to give up on short term gains, be they monetary or political. The rift between people who believe in climate change and those who actively reject it is really one of ideology and financial interest. J.H. It doesn’t seem to me that rejection is a realistic argument. P.P. Neither to us (laughter), but it is actively out there. Over 95% of the scientific community agrees that there is climate change. I think

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the media has to play a greater role in this. Part of the problem also lies in the fragmentation of the media. There are so many voices out there that it is easy to drown the signal in the noise. If I am a lay person trying to find out what is happening with global warming or climate change and I am not an informed citizen, it is very easy to say that there are 5 people saying one thing and 5 people denying it so it must not be true. That plays into the work of our Center. Not specifically regarding climate change, which is one of the issues that we will be concerned with, but how to have a more informed citizen community that can determine that not all voices are equal. Every voice does not carry the same weight, and experts who have been working on this topic for a very long time, maybe over decades, and who have to go through a very rigorous peer review process, carry a bit more weight that a commentator on the radio for example who has just picked up a sensational news piece and has a personal agenda to promote. A lot of people both in media and in politics are funded by corporations that want to advance their agenda and I think that we need the public to be aware of these intricacies and interferences and to ask why a certain community is saying something. What is the evidence behind it? And I think that the work of the centre will be a success if we can get people to question the origins of arguments a little bit more. The Information Problem J.H. Do you know anything about the Mapping Controversies project? P.P. Yes I do, and one of the challenges of any project such as Mapping Controversies is how to get information into the hands of people who do not want to look at information very analytically and in an unbiased way? The Internet is a great thing but it has also empowered us to seek information that we want to seek, so how do you reach communities who won’t necessarily come to the MIT or the Union of Concerned Scientists website and have their own sources of seeking information. That is the really a big challenge for any sort of project of this type, how do we push information to people who won’t necessarily go seeking that type of information? It is a very logical project that says here are the different arguments

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surrounding an issue so let me synthesize these arguments for myself but how do you reach the very far flung sectors of society? J.H. They are not even far flung, they are the 99% that read newspapers and use other sources of news. P.P. Yes and a question that I constantly pose is that beyond the people who support us, beyond the people who already believe in this, champions of science etc, how do we reach out to those people who don’t think about this on a daily basis? That is a problem to solve, because people have a lot of power, and if exercised properly we could actually bring about changes that benefit society for years to come, but just the donside of the possibilities that media and internet have given us for seeking out our own information is a challenge to solving a lot of the big problems that we face today. J.H. Do you think that educating the population into the ways of science, an idea behind various project today, would be efficient? P.P. It can be efficient to a certain extent but I think we need something more and different. There are all kinds of polls that people have done to assess who is a true believer in (for example) climate change, and it is not that certain that a population with more degrees will certainly believe in climate change and those who do not go to college will not. So it is not completely a given that the more educated you are the more open minded you are to different view points or that you seek information in a logical or balanced way. It might solve some of our problems but I don’t think it will resolve everything. Also when we talk about educating in science and technology we have to be mindful about when we are reaching out to people, at what point in their lives, at what age. If they have already formed all of their opinions at home, probably before they even reach school then any amount of science and technology education teaching is not necessarily going to change their cultural or ideological beliefs, particularly if they have someone who is completely denying it at home. So I think we have to diversify when we reach people, not only say educate everyone to a PhD, that is not going to work, it requires a cultural mind shift. I don’t think that just getting more scientists or engineers out there will solve everything, it would be great but people have values and cultures that they hold on to no matter what they study.

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J.H. There seems to be a lot to do with power, political power, media power, monetary power, probably more so than scientific argument. P.P. Yes, and media does have a very large role to play here. I think that there is another thing that we should be mindful of. This philosophy in journalism schools for example, of covering both sides of the story. This is the way that we have trained this wave of journalists to cover a story, to say well here are both sides. So this is not necessarily a power of the media argument rather a media coverage argument. I think that is a practice that has really hurt the climate debate. Journalists traditionally try to cover both sides of a story but how do you cover a story that has such lopsided ends? So you say well I am covering both sides but 5% of scientific disagreement does not equate 95% of scientific consensus. Say, if I am watching local news at 6 in the evening I might not know what the difference is if expert A says well this is happening and expert B says no this is not happening and I don’t know the difference between expert A and expert B. The Wall St Journal recently carried an editorial piece that was signed by “16 scientists” who were talking against climate change and the kinds of actions that we have to take. They are all scientists and but if you looked at the credentials of the people who had signed that opinion piece they came from all kinds of unrelated scientific disciplines. Then look at the credibility of people at the National Academies and IPCC and what they have been saying for so many years,the numbers of scientists and kind of peer review they go through and compare it to somebody from computer science making an argument about climate change. It is not the same. So you can always find dissenting voices but as an informed citizen the weight that you assign to them is extremely important. We published a response to the WSJ piece on our blog ‘The Equation’ which was picked up in a lot of media outlets. Concluding Remarks J.H. Is there anything else you would like to add in conclusion? P.P. I would like to say that through the Center we are also trying to reach people we traditionally have not been able to reach, the youth communities, science educators, people in the media who have a

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very large following and are actually in a position to influence how people think about certain issues. We are limited as a relatively small organization in how much undertake ourselves so we have to be careful about the expectations that we set up for ourselves and for others with this initiative. Therefore, we are actively looking for partnerships in trying to engage the public, engage the media, engage scientists and policy makers to really bring back science and science based decision making into the American democracy. This means we are seeking partnerships with all kinds of people that are either already working in this field or a component of it or have already done it in a successful way, so that we can catalyze, we can build upon it and propagate their work. These can be museums, science cafés, federal agencies, anyone who believes in the notion that science is integral to solving the problems of the future. We are open and keen to talk to people about these issues and talk about partnerships that we can forge. J.H. Thank you very much.

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Professor. Andrew McMeekin.

Prof Andrew McMeekin works at the Manchester School of Innovation and is involved in the Sustainable Consumption Institute based at the same university. In March 2011 he was kind enough to participate in a conversation with Jonny Hankins in which he discussed (amongst other things) innovation, responsibility, sustainability and governance. The following is a transcription of the conversation. Some very interesting point were raised that really open up the argument of responsibility and innovation within and from a business or economic perspective.

Jonny Hankins. Can you just tell me what you do here at the University of Manchester please?

Andrew McMeekin. I have several affiliations, I am employed by the Manchester Business School, that is my school home. We are now in the Manchester school of innovation and innovation is a long standing interest of mine, and I am also heavily involved in the university's new sustainable consumption institute which was set up with an initial grant from TESCO supermarket chain, where I am trying to develop the sustainability in innovation agenda. I am also the deputy director of a large ESRC grant called 'the state of the practice research group' which is a consortium of 7 or 8 UK universities looking at consumption behaviour and how it could change to become less environmentally damaging. I also teach on a masters course called 'Innovation and the Knowledge Economy'.

J.H. In your PHd you wrote about the effect of economic demand upon sustainability within innovation, could you outline your ideas please?

A.M. The PHd was looking at the innovation sustainability relationship and trying to understand how sustainability concerns become part of the demand signal that stimulates what the market might or might not do. This is something that I am still working on in

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a new project, my focus has changed quite a lot since the PHd but my focus is upon the fact that there needs to be some sort of economic demand for whatever type of innovation might occur in relation to environmental sustainability challenges. We might think that innovation responds to a burgeoning demand for environmental concerns and that is one type of trigger, there is already an existing demand that sends a signal to entrepreneurs to innovate. In many cases however (as we know from innovation studies) entrepreneurs do things and are creative before economic demand is created within the economy, so it is not in this case that economic demand is not important, but that it then has to be created as part of the innovation process. Either way innovation as I understand it is about the co construction of new knowledge both in terms of innovation and in terms of market demand. Not all innovation occurs within the market sphere of course, but that is a starting point anyway. The reason I make that last point is that it is equally interesting (and we are doing this as part of our current work) to look at how public demand, ie demand via the public purse, can be used to stimulate innovation. We have got some work on public procurement for sustainable innovation and this is a slightly different channel from the market innovation system. The PHd looked at some of the actual mechanisms by which firms go about trying to understand what demand is actually out there. This is actually an under-researched aspect of innovation studies in general let alone in the sustainability area. It is well recognized that innovations do well if user needs are attended to, and this is one of the stylized factors of innovation, and well recognized theoretically that this feeds back into the market to create further innovation. What is less clear is what that mechanism actually is, how do firms learn about what consumers and customers want, and how do they interpret that information if they can go out and collect it for future innovation? I looked at the strategies that firms actually use to gather information about customer needs in relation to sustainability

Another aspect was to look at how demand is socially constructed by various actors, so I looked in detail at one of the environmental controversies of the time around chlorine and PVC. I tried to follow the process by which the issues surrounding chlorine were negotiated by various actors to try to define what the problem was and in the case on the NGO's to mobilize various social sectors either against certain actors such as the PVC industries or mobilize

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innovation or entrepreneurial actors that were trying to do things differently. In this case it was refrigeration technologies, so NGO's were constructing demand and constructing innovation in response to environmental issues that were always subject to massive amounts of uncertainties, because the science was not clear. So it was a political process and I guess you see that all around us now, bio-fuels would be an example, for some activists it has the chance to solve some of the problems of diminishing oil stocks and climate change while for others it is worse that oil itself. You see the construction process in demand the whole time.

J.H. Here you are speaking about sustainability, but how can we really measure sustainability?

A.M. Well, it is in some ways a buzz word. One of the problems is that it has come to mean a lot of different things to different people, you have the Bruntland definition, widely used as securing the future for future generations, but this is a sort of mission statement without defined concrete principals. economics has developed a series of concrete principals such as maintaining stocks of certain types of capital, natural, physical etc, and that seems like a reasonable starting point, but this becomes a bit woolly again when we say it is about mutually enforcing economic or social development, so I suppose it is about maintaining stocks of social and economic capital. In terms strictly of environmental sustainability it is about humanity and society reproducing itself within the limits of the Earth’s capacity, something we are not doing now and our trajectories are taking us well beyond that point.

J.H. How would you define innovation?

A.M. I follow the old fashioned broader view of innovation, new products, new organization forms, new market forms, not just technology or hardware but also service innovation and innovation of entire markets, new business models, so quite a broad approach.

J.H. Foundation President Piero Bassetti says 'our perspective on innovation is not economic but political, and therefore we have abandoned schumpeters line', could you comment this point of view?

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AM. Well I don't know what is meant by political in this statement, but there is a very strong part to Schumpeters theory that is left out from most analyses. Most focus on the economic part of the innovation story and the view of combinations changing economic borders, and that was principal in scumpeter. The missing part is at the very core of his analysis, the issue of resistance and the notion that entrepreneurs have to posses the drive to overcome resistance in the incumbent system. This isn't just economic resistance, it is also cultural and social Resistance to new ideas, and I think that that is very much as important a part of his theory of entrepreneurship is the classic economic understanding. I would take some of that overcoming of resistance to be what you might call the politics of it, it is about mobilizing political allies in order to overcome some of the institutional block issues that might otherwise stand in the way of a good idea. The other insight on power relations is the difference between innovation that comes from very powerful players in the system versus the more creative construction side. This is about people from outside the current regime invading and perhaps even overthrowing it, something that must be difficult. On the one hand large firms have access to very large economic forces but also political resources in terms of the links that have that can be mobilized around their innovation activities. When we are talking about a new start up in the garage they are parting from a different basis, they don't have access to similar resources either economically or politically, although they do seem to always be next to big universities so there is some sort of connection to more enduring institutional arrangements I think, so I am not sure that there is a conflict between a view of being political and a Schumpaterian view.

J.H. On the Manchester University website one of your interests is described as 'the sociological study of innovation processes', very interesting, what does it mean?

A.M. I think that my reading of progress in understanding science technology and innovation over the last 30 or 40 years is that there has been a break between the sociologists, whose focus has been principally round science and technology so what I would call science and technology studies on the one hand, and on the other the economics of innovation that has focused on the economic institutions of capitalism and how they provide incentives and

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opportunities and the institutional basis for the innovation process. It seems to me that this divide has been a little bit unfortunate as it has meant that the sociological approach has tended not to look at the economic institutions within which science, tech and innovation occur. That is a broad statement because there are exceptions, but when I talk about the sociological analysis of innovation it is to say that this is innovation in an economic sense, but it is about creating demand, it is about markets and how they are formed and that itself should be much more open to sociological inquiry. In other words it shouldn't just be left to the economists that don't have a particularly detailed view of how markets are created or change over time, and this seems to me to be an opportunity to send STS and innovation studies in a new direction.

I suppose that it comes from my reading of economic sociology as either a new field or the consolidation of a long thread of the last 100 years that uses sociological approaches to look at economic institutions and how they work. It is really a programmatic statement about interests, also I think that a lot of the stuff on innovation systems in the best analysis under that heading would draw on both sociological end economic insight. So it is about re-combining ideas from different disciplines with a focus on the creation and development of markets for innovation or as part of the innovation process itself.

J.H. We are also interested in promoting public participation in scientific debate, do you teach anything about the wish to make society more scientifically literate.

A.M. I don't actually. There is as we know a vast literature on the public understanding of science and participation and I was up to speed with the debates about a decade ago, but Intuitively I think it is really important, I don't have much expertise on this though.

J.H. The foundations perspective might be that innovators themselves are the people that should be worrying about this and not sociologists, what do you think?

A.M. I think that is right because of some of the mistakes that large and small innovation societies have made over the last years.

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Thinking maybe about genetic modification or even bio-fuels again where not being sensitive to the cultural and social dynamics that might exist in relation to an emerging area causes hold ups and fouls, so there might be strong business reasons to ensure that there is a more thorough communication process between those bringing new ideas to society and those whose lives might change as a result or might be affected. On the one hand there is a rather hard nosed business aspect to needing to be involved in a kind of dialogue, but ethically I think it is more profound that that, there is a responsibility upon innovators to communicate the perceived effects and risks of anything that they want to introduce. But of course again a whole innovation process is ridden with uncertainty and it always will be, it is the nature of the innovation process, and somehow that needs to be communicated, alongside the fact that risk means that not all of the arguments can be heard, not all of the risks or benefits are known. I believe that innovation is a progressive force for society and so you can't just stop it. The hard line views of the cautionary principal which is that we only pursue something if we are absolutely certain that the risks are absolutely minimal frustrate me. The problem with this is that you would really cut progress dramatically because risk simply cannot be known.

J.H. Without risk there is no progress?

A.M. Yes that is right, but along with progress unfortunately there is very often pain. The unintended consequences of innovation are just that, and there will always be unintended consequences of any form of action. The worst thing one can do is to have no action in my view, but clearly what is needed are systems to be but into place that at least try to minimize the potential risks and I think that there are ways to do that even in the context of massive uncertainties. A willingness to respond very quickly when signals emerge that something might not be quite right for example, and I don't know exactly what the right institution is for that. I think that some particular innovation processes do gain some momentum to use Thomas Hughes's language and it can be very hard to stop. So you can see that somehow retaining diversity, not getting locked into single paths in innovation terms would seem to me to be for the common good of society, quite a good way to operate, retaining diversity as a buffer against future risks.

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J.H. One of the great debates within the foundation is about responsibility and the idea of trying to instill some form of responsibility within those who innovate, which presents a series of problems. Who are those that innovate? If we are talking about a large conglomerate where is the figure that actually has to take responsibility? In your creative commons article you talk about the dispersion of innovation and the innovation process. Can you explain?

A.M. Yes innovation is now organized beyond the boundaries of a single firm, in almost all areas, and that means (that to use your language) responsibility for those innovations is somehow distributed as well. In governance terms that is quite a problem, so we have some new departures in governance and responsibility, we have the establishment of corporate social responsibility groups within firms. You might ask if they are the right people, in their position do they exert the right type of control and governance over the innovation process, and I would question that. I think that a lot of the work of corporate social responsibility is disconnected from the innovation process in firms. So then the question arises of what governs the innovation process within firms, or even individual entrepreneurs who have a new idea.

J.H. Do you think that some form of external governance could work?

A.M. A well there is external governance, there is government regulation which does play a role. The state plays a major role here, but if anything the trend is going in the other direction now, it is to roll back the influence of the state over business. From the point of environmental issues in UK for example the interest is much more in voluntary agreements where government sits round the table with businesses and says that we need to meet these challenges in this sector, but we are not going to legislate, we are not going to regulate, we would like you to find the solutions yourselves. I think it is too early to say if this is going to deliver the magnitude of response that is required for some of the big issues and I think that there are a lot of businesses that are recognizing that they need to do something in relation to sustainability issues for their reputation. In the longer term it is possible that whole areas of business will be jeopardized by some kind of environmental catastrophe, so in a way it is about long

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term business survival for these firms, but I am concerned about whether they can meet the scale of the challenges right now and understand it. These are firms that operate in particular institutional contexts and so very often this is about short term financial reporting to shareholders. Sometimes I ask myself as well as other people, what do we expect firms to do according to the context within which they operate. Recently I have spent a lot of time speaking to TESCO about this, there is an internal commitment and I don't doubt the personal commitment of those involved in those parts of the business to try to make profound changes, but on the other hand it is a business with a particular business model and approach to business and to change that radically very quickly would expose them to risks in relation to their shareholders, so in some ways some third party involvement might be very important and perhaps required. I personally think that governments need to show very strong leadership in that respect.

J.H. And do you think that there could be some kind of promotion as something that we could define as best practices, or does this go too far, or is it too generic?

A.M. One of the problems with best practice is that it implies that there is a single correct trajectory, but if we were to go out today and look at a bunch of firms in the food sector we might identify which one we think is behaving in the most environmentally sustainable way at the moment. Following the best practice logic you would then say, well lets look at what they do, their strategies and their systems and processes and suggest that other businesses or organizations try to copy them, but that process is very difficult because there is embedded culture in organizations and simply trying to transpose another organizations processes and systems upon your own is not a trivial matter. As I said before one of the ways that progress occurs is through variation rather that convergence so I think that convergence to a single best practice might be stifle an idea that is better than the existing best practice but that just hasn't developed enough yet, so I am not sure. On the other hand I think that the exchange of good practice and learning about good practices is probably a good thing, not as an idea that this should become a target to imitate, but to provide learning across different contexts. Different contexts probably mean that the same practice won't be appropriate everywhere, so there is a strong basis for wanting to

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make good practices more visible but not that there is an attempt to imitate them. It is time to show the various possibilities that are out there in order to stimulate further experimentation to create divergence rather than convergence to a particular best practice.

J.H. We speak a lot about innovation within food at the foundation. Cristina has written about the reinvention of food and I know that food is one of your main interests. Can you speak about innovation in food?

A.M. food is a fascinating area because it is one of the few areas about which we can safely say that we can't do without it. In other areas you can say that! You can look at aspects of the economy and say that we do not actually need that part and we can substitute it with other things, but food, well we have to have food. So my interest now is what are the dynamics that help us to understand how to shift the food provisioning system, including from before the field ie the seeds, chemicals etc right the way through to distribution, retail and consumption. What is going to actually happen in those areas to shift to a more sustainable food system? My reading of the debates are that a lot of people are actually imagining very profoundly different systems. A lot of people are interested in reversing the trend towards globalization and in other cases there is a sort of rejection of modern biological scientific knowledge in favour of discovering traditional farm practices and perhaps enhancing those again. Also the worry that there is too much economic concern in the supply chains of food and that this might inhibit progress towards an imagined new type of food system. In theses cases it is impossible to predict what sorts of transition will occur. One project that we have at the moment involves rather than assuming that all of the innovation is going to come from outside of this large and rather large player dominated system, so we are actually looking at what the large players are doing, not with a view that they are necessarily the agents that can bring about the required change but because people have actually forgotten to look at them. There is an assumption that the big players are simply the block to the change that is required and that they cannot deliver the local organic system that is preferred by lots of people who write in this area. I am not sure that that is the case anyway, I think that supermarkets for example would have no problem in offering short circuit delivery of organic produce if there was sufficient consumer demand. They very quickly became the

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largest retailers of organic produce. I think they are ambivalent almost to the food system that is in their supply chains, particularly when they can charge a premium for it as they did with organics. So I think it is a mistake to rule them out as major actors but I also think that there are situations when they can act as obstacles to the right speed or direction of change in the food systems. So there are lots of interesting cultural issues tied to the consumption of food and what it means to us. We seem to have a more heightened appreciation of what food means for us now in our daily lives than 20 years ago and whether that is the platform for building cultural sensitivities towards the environmental impact of food remains to be seen, but I think that it is promising.

J.H. In Italy there is a phenomena called 'gruppo aquisto solidale', ideas range from groups of families that have simple informal agreements with a local food producer to buy their produce, to others that have business plan involvement within the firm and seed or animal buying.

A.M. Yes I think it is impossible to say what the likely transitions will be though, because there are lots of groups like this and that is a good thing, but I would say that this behaviour is likely to be constrained to a particular type of person. It is very much a niche. Chorlton (university and artistic zone of Manchester) has a disproportionate amount of people like this so if you live there you could labour under the illusion that everybody is like that now, but in other areas you put out this plan and say well you can only have cabbages today and hear 'well I've had enough of cabbages so I'm going to go to the supermarket'. I think that there are some interesting things within our cultural responses to food, and from some points of view that is one of trying to get control over our food, where it is coming from, and I understand that there are some big societal challenges out there that maybe this type of system might help to meet. But if you go to Ardwick (inner city zone) cultural dispositions towards food are completely different, it is not reflected upon that chicken is so cheap, it is just there so you can have a roast every week, and if you take that away from someone there might be a lot of unrest, so I find it difficult to see how that cultural change would occur generally across the population but you cannot rule it out. History has shown us that the most unlikely things over time actually gain momentum and who knows what is required or needed

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to take a set of principles or principles like those that are in Chorlton and make them into common sense ways of understanding the world in Ardwick. I think there is a lot of inertia in the system to stop that from happening and that includes the large organizations that have their businesses reliant on all these different forms of demand. So I find these sort of alternative food networks very interesting and enchanting but I find it hard to see how these types of ideas could scale up in order to feed 9 billion people in 40 years time. Strangely in a globalized food system that is highly centralized in few hands brings a great deal of efficiency in the way it operates and as much as there are concerns about the control of that system resting in the hands of a few companies I think that that degree of control over food production creates the opportunity to transfer good practices or best practices very quickly from one place to another, and if we are talking about environmental sustainability reaching a crisis point over the next several decades then we need some urgent responses to these problems and I think that dismantling the global political economy around food would take much longer that it would take to develop the new technologies and diffuse them via the existing organization of food production. I am not entirely happy about that but I think that the position of the moment to underplay the dominance and power of these key players is a mistake. They are there and their businesses will not be swept away from underneath them so I think there can be experimentation outside the system to see what might be learnt and that should not be instead of working with the large players and trying to change the way they work to deal with the most urgent environmental problems.

J.H. In the commons article you say that private growth is interdependent with growth in the public domain talking about bio-informatic software, can you explain what you mean by that?

A.M. Here we are talking about the knowledge domain and we were trying to make the point that the knowledge domain are mutually reinforcing and intertwined. When we started that research we came across a dichotomized view that there was university research, freely published and publicly available on the one hand and proprietary knowledge, subject to patents on the other, and one is what businesses do while the other is what universities do. The system is however much more complex that that dichotomized depiction might suggest. Firms do not patent everything they do, quite a lot either

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just leaks out of their system or is made freely available. Equally it turns out that not everything that universities do is readily available or published the moment that it is produced and so there are ways in which the universities protect their knowledge as well. and after the recent acts in the US and in Europe, universities have become more propriety about their knowledge including patenting things, so part was about trying to point out that there are not 2 distinct systems, one proprietary and the other public. The second part was to say that they fuel off each other, so the knowledge flows in both directions and we have in a sense a multi modal knowledge economy, both growth of knowledge and growth of public and private resources together.

You can have a situation in which a publicly available database or bio-informatic pool for example will actually prevent there from being a market for the privately owned one, which in a sense is what happened around the human genome. There was this famous battle between Solera and the International Human Genome Project and there is no doubt that overall progress on genome science sped up as a result of the competition between a private company and a consortium, so we could say that the involvement of the private sector on this issue brought about socially beneficial progress. But of course when Solera started up there was a great worry that they might try to make the human genome information proprietary , you could only access it if you payed that company for access to it, so privatizing the genome was the big concern and as a result of that the global public sector economy reacted by investing heavily in speeding up their process and although Solera technically published at the same time this was political, and they were not able to establish a business upon it because of the public sector involvement. So it is very much about the dynamics between what is proprietary and non proprietary in terms of knowledge. Well competition certainly does drive innovation and we normally think of that as within the market sphere, firm A competing against firms b and c, we don't normally think of it as being publicly funded activities in a non prop environment competing with privately funded things in a proprietary environment for profit. So this is public versus private competition as opposed to the way we usually understand competition within markets.

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J.H. And could this feed into an idea of responsibilization? If you have a broader field of people working on each particular thing the decision making process might become more democratic or accountable?

A.M. Yes I think it can, some of the things that came after the human genome story probably show that rather than it always being competition driving the process forward.... one of the interesting aspects of the aftermath of all that was the establishment of new public private collaborations for example the Single Nuclei Polymorphism Consortium, a particularly interesting low hanging fruit from the genome project. Here you had a group of large pharmaceutical companies partnering with the welcome trust. on this basis of pooled investment the burden and risks associated are lessened, but the results had to be non proprietary, so in a way the idea was that this knowledge is for the common good. So rather than having it as an object of our competition we should pool our resources and accept that this is pre-competitive, we can produce it together and then use it and find different things to compete on in a market sense. I do wonder if that is something that could be fostered in relation to environmental concerns. There are some challenges out there and some areas of economic activity that are so obviously at odds with what is needed, you would think that those firms involved in those types of technologies rather than competing with each other and sometimes being in denial in relation to what could be done could say that this really could be hell for us so why not make things easy and say that we are not going to compete on this. The only excuse for not dealing with it is that someone might undercut us so we can't afford to invest in it, but if all the main competitors were entering into this in a pre-competitive sense then that argument is removed. Some of the big players in the food industry are pooling their resources in tangible ways, for example on developing natural refrigeration in a pre-competitive way. I think there is a consortium of companies like Coca Cola and Unilever, Pepsi, TESCO and others raising the profile of natural refrigeration and trying to give an explicit message to potential innovators about this technology, so that when it is developed there will be a guaranteed market for it because these companies will collectively adopt them. This is the right signal to make an entrepreneur think that it is worth putting money in it is worth the risk. I think that could be enhanced even more if you could align public and private

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procurement of innovation. There must be all sorts of refrigeration procured by the government so why don't governments align with this as well and say that they guarantee to procure a refrigeration technology that is considerably less energy dependent than current systems and so the market is created and that financial risk is removed from the innovation process.

Concluding remarks

Prof McMeekin addressed many issues during this conversation that may be of interest to the Bassetti Foundation readership. I feel the most important point was tied to the idea of pre-competitive research carried out by groups of companies, institutions and government bodies. The transfer of knowledge between such stakeholders should I believe lead to a more democratic and open decision making process, and this could be a move towards responsibility.

Another interesting point was that of guaranteeing a market so that innovators know that if they can produce a new more energy efficient of less environmentally damaging technology they will recoup their investment in research costs. This might in some way steer innovation towards a positive role taking position although the unintended consequences problem is still not fully addressed.

His argument about resistance is also closely related to the above, as are his remarks about governance, public versus private knowledge, risk management and the role of public institutions in research and publication, because all of these problems are political issues, related to power and capability as well as technological innovation.

On behalf of the Bassetti Foundation I would like to thank Prof Mcmeekin for his time and involvement in this interview and article.

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Concluding Remarks.

This collection represents the development process of a project that began in Milan and at the time of writing resides in Boston in the USA. Its aim is to promote debate throughout many different sectors of society, in the hope that the debate will resonate and broaden to encompass the broadest base possible, so that society as an entity demands responsible behaviour from its decision-makers. The pretence for this work is Piero Bassetti’s argument that “if you want to control history you must control innovation. Innovation is politics”. If we accept the above we would hope for a responsible use of such a powerful tool, but the question arises of how to ascribe and promote responsible behaviour and who we expect to implement responsible thinking. Innovation is a multi-player process and a collective endeavour, and we could blandly say that all of the players must take responsibility for their own actions, but this is a superficial statement. Responsibility must lie within the process itself. As I cited in my first chapter Hans Jonas (Jonas, 1984)[1] argued that ethics is responsibility-taking for future consequences of present actions. In his opinion modern technology influences future conditions in ways that are difficult to predict, therefore purely technological-instrumental rationality is potentially destructive. He introduced a “principle” of responsibility that refers to the future instead of the past, arguing that we must operate according to a precautionary approach if we want to avoid irreversible mistakes. One problem seems to lie in the simple fact that innovators cannot predict or control how their developments will be used, as novel applications may well be discovered. Legislation and restriction do not seem to be viable approaches. We may be able to stipulate that software can only be used for the advancement of humankind, or that processes must only be used for their intended purposes, but

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these are subjective requests and can we really guarantee any of these wishes. Having said this, if we want to instill responsibility into a process with a lot of actors to address, we may well conclude that decision-makers hold the key. They play the pivotal role in directing the process and should be the most reflexive and conscious of their role within the larger society. They come in many shapes and sizes throughout the process though, and we want to address these playmakers at each crucial developmental point, in order to socialize them into thinking and behaving responsibly. Decision-makers are not the only important players in this process. We also need to forge a new cultural framework of responsible innovation so that it becomes common sense to question the innovation process, its objectives and outcomes, so that it is the general public who demand a responsible approach. The strategy that I will outline below and followed by the Bassetti Foundation aims at what Cristina Grasseni describes as ‘instilling a sensitivity for this argument in policy and opinion makers as well as the general public, independently of disciplines, creeds or methods’ Any process that advocates reflection and deliberation needs to be reflexive and deliberative itself. The Bassetti Foundation in Milan first addressed the issue of how to define and promote responsible innovation with a seminal workshop in Alz on January 30th, 1999[2]. Since then the main body of thought of the Foundation has revolved around its website which hosts a full fourteen years of reflections, workshops, interviews, reviews, news, events, and online publications[3]. The website represents the work of the foundation through the postings it hosts, but there are many other parallel projects run by the Foundation. One of the longest standing is the bassetti Foundation Lecture Series. The series has run throughout the foundation’s development, and has brought thinkers from many different fields into the affray. Early Lecturers included US bioethicist Daniel Callahan, French philosopher and sociologist Bruno Latour and Columbia University

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economist Richard Nelson (also cited in the first chapter), who all addressed the issue of innovation and its social, political and cultural implications, and hence that of responsibility. The Foundation went on to publish a book entitled "Sapere, fare, potere, Verso un'innovazione responsabile" edited by Massimiano Bucchi and published by Rubbettino, available through the publications link cited above.

As the series continued the Foundation hosted many other influential speakers including Dan Sperber at the European Congress of Analytic Philosophy[4], Sheila Jasanoff, professor of Science and Technology Studies at the Kennedy School of Government of Harvard University[5], Daniel Mulhollan, Director of the US Congressional Research Service of the Library of Congress[6] and most recently Michael Bruch, Head of R&D and Risk Consulting at Allianz Global Corporate & Specialty AG, and risk expert at the Allianz Center for Technology[7] discussing topics related to democracy, science and governance and risk, to name just a few.

The Foundation also has a long history of publications[8], with a series of books including collections of articles, monographs and the Italian translation of the of the European report "Taking European Knowledge Society Seriously"[9]. A further project revolves around the concept of responsibility within design, and involved the commission of a theatrical piece entitled "Mani Grandi, Senza Fine" by Laura Curino [10]. The show is part of a much larger project and has had an extremely successful run in Milan and performed elsewhere. Almost a decade and a half of research and policy work has contributed the idea that innovation does not simply mean novelty but rather “something previously improbable, now made real”. Furthermore, innovation forges new links between knowledge and power that bring into existence previously unknown objects, relations or situations. Innovation thus does not coincide with invention (which is often science and capital intensive), but with the ability to transform lifestyles. In particular, Poiesis-intensive innovation refers to the cultural aspects of work practices, such as beauty and taste, logistics and

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design. In other words innovation is not an individual creative act, but a social process that permeates politics and institutions and, in turn, depends on them. A praxis approach to responsible innovation is favoured by the Bassetti Foundation in the belief that responsibility must lie within the innovation process. Responsibility lies in the day-to-day operating practices of all actors involved as much as in the reflexive deliberation of decision-makers.

One way to try to stimulate this reflexive deliberation is through online publication and blogging, and the articles in this book represent my efforts at doing just that. There are many other blogs dedicated to Responsible Innovation and related topics, Jack Stilgoe’s Responsible Innovation[11] and Richard Jones’ Soft Machines[12] to name just two. Blogging can play some part in promoting debate around this issue, but there are obviously many other avenues to follow in terms of communication, particularly with a view to sensitizing decision-makers. One imperative must be to involve the public in decision-making processes. This obviously requires an opening up on the part of both the public (the aim described above) and those working towards innovation, as well as achieving a shared understanding between all parties involved. This requires a public that is willing and able to converse about science, innovation and ethics and push politicians and regulators into action. For this they need to have the cultural baggage necessary for an informed debate, which given much of the subject matter involved and the effect of political interference in the reporting process may be no easy objective. These are some of the issues that I have tried to raise in this handbook. If we agree that education is the key to responsible thinking then we must think about how to further disseminate the argument into schools and Universities. We must ask ourselves however a serious question: is it a skill in professional deliberation that we wish to instill, or a greater awareness of the histories, cultures, and normative frameworks that have led and regularly lead to the ethical conundrums of an “irresponsible” innovation? Many institutions have recently latched on to the idea of responsible innovation. Universities such as Exeter and Ecoles des Mines have

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dedicated departments, and, there are many centres in the US with interests spanning the issues around Responsible Innovation (such as the Hastings Center and the Arizona State University Center for Nanotechnology in Society etc). The Netherlands is coming to the fore in governmental investment with its ambitious Responsible Innovation project and conference. I hope that these institutions will work together, share ideas and resources, cut across academic non-academic boundaries and disciplines and bring the wider society into what is certainly an extremely important debate. References: 1]

Hans Jonas, (1984) The Imperative of Responsibility: In Search of an Ethics for the Technological Age, University of Chicago Press, Chicago

2] http://www.fondazionebassetti.org/it/pagine/2009/02/workshop_sulla_fondazione_gian.html

3]

http://www.fondazionebassetti.org/en/events/

4] http://www.fondazionebassetti.org/en/focus/2011/08/dan_sperber_at_the_european_co.html

5] http://www.fondazionebassetti.org/en/focus/2008/04/the_politics_of_science_and_th.html

6] http://www.fondazionebassetti.org/en/events/2008/12/daniel_p_mulhollan_in_fgb.html

7] http://www.fondazionebassetti.org/it/segnalazioni/2012/11/risk_and_responsibility_in_inn.html

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8] http://www.fondazionebassetti.org/en/publications/

9] http://www.fondazionebassetti.org/en/events/2008/03/science_and_governance_the_rep.html

10] http://www.fondazionebassetti.org/it/segnalazioni/2012/04/le_mani_dellitalian_design.html

11] http://jackstilgoe.wordpress.com/

12] http://www.softmachines.org/wordpress/