towards a bioeconomy? opportunities and challenges for policy

Towards a Bioeconomy? Opportunities and

Challenges for Policy

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The OECD

Unique structure: about 200 committees, working groups and expert groups

Attended by some 40,000 senior officials from national administrations

Supported by OECD Secretariat (about 1600 people), committees and working groups discuss wide range of policy areas (economic, scientific, health, education, trade, agriculture, development, etc.)


Main Aims of Organisation

• Help create conditions for sustainable economic growth in member countries

• Seek to facilitate sustainable economic growth in non-member countries

• Champion free trade and liberal market economics.


What Do We Do?

(i) Develop and agree international indicators

(ii) Collection and analysis of data

(iii) Policy analysis

(iv) Provide a forum for broad debate

(v) Agree international policy recommendations

(vi) Develop best practice guidelines – “Rules of the Game”


BIOTECHNOLOGY BIOTECHNOLOGY

DIVISIONDIVISION

OECD Activities - Biotechnology

Internal Coordination Group on Biotechnology(ICGB)

STI ENV AGR

BiotechnologyDivision

Health

Industry & Sustainability

Infrastructure

IPR

Biological Resources & Biosecurity

Environmental Health & Safety

Biosafety

Agriculture and Environment

Biomasss

Novel Food and Feed

Statistics and Indicators

International Futures ProgrammeBIOECONOMYBIOSECURITY

“Bioeconomy”

“an economy in which the latent value incumbent in biological products and processes is captured through economic, health, environmental and other gains”.

Mandate (2004) from OECD S&T Ministers to take steps to manage the transition to a

bioeconomy.


Health

Key Drivers• quality, safety, efficacy and efficiency of products.• demographics, life style, economic/ cost issues• business competition and consolidation –structural change• Asian market expansion • Genetics & genomics, biomarkers, EBM Focus of effort• Incremental change• Cost containment• Health technology assessment


Health

Major Policy Issues

• Increase quality & efficacy as well as efficiency of research and innovation enterprise

• Reduce R&D time scales and raise npvs or lose opportunities• Overcome market failure – win the npv game! • Move to more evidence based medicine• Regulatory developments around access, use and linkability

of data and on whether public/ private policies can co-develop.

• Value based reimbursement

BIOTECHNOLOGYBIOTECHNOLOGY DIVISIONDIVISION

OECD Ministerial Priorities

• Create a match between demand and supply side measures to deliver health innovation that meets needs.

• Deliver a policy environment that captures the potential health benefits from genetics and genomics in line with expectations of society.


Policy Challenges in Genetics and Genomics

• Development of high quality, trusted clinical genetics services.

• The balance between access to and rights over genetic data and inventions.

• Ownership of genetic data and inventions• Establishment, management and governance

of genetic databases


www.oecd.org/biotechnology


Increase access to IPR protected products and processes

• System seems to function mainly as intended, but needs to be monitored.

• OECD principles for licensing genetic inventions. International soft law (target December 2005).

• Role of cooperative mechanisms (patent pools etc) and impact on markets and competition legislation (with ESRC Genomics Forum)

• Experimental use/ research exemptions


Genetic Databases

• Fundamental tension between research and privacy• Range of issues around consent (opt outs, blanket

consents, making right to withdraw work, repeat consents)

• Limits to which the paradigms of the 20th century fit the new genetics in the information age.

• Need for transparent framework for governance that deals with and reconciles different interests (LEC, regional, national, international

• Engender public trust and engagement


Biotechnology, Innovation & Health Policy

• Decision making in health technology – how to take account of biomedicines. Challenge of polymorphisms.

• Negotiating the opportunities and challenges from pharmacogenetics and EBM.

• Understand new research models that integrate across the innovation cycle.


What is considered by technology assessment (top 5)


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20%

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100%

Effectiveness Quality/Safety Cost-effectiveness

Professionalimplications

Additionalcosts/savings

What is considered by technology assessment? (bottom 5)


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5%

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15%

20%

25%

30%

35%

40%

45%

Waiting times Equity Patientperspectives

Lack of alternativetreatment

Industry/R&D

Who is involved in decisions?


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20%

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Funding

Investment

Facilitating and Impeding conditions

• Facilitating conditions:– Trust in the evidence.– Additional funding.– Flexibility in shifting resources (away from silo).

• Impeding conditions:– Lack of additional funding.– Inflexibility of budget.– Payment mechanisms. Policy alignment.


Challenges to Decision Making from the New Genetics

• value of genetic testing• assessing pharmacogenetics/ selective approvals• addressing uncertainty (data and investment)• high cost/ high benefits• avoiding stagnation through policy vacuums • capturing and diffusing innovation for better

outcomes


Pharmacogenetics – opportunity or hype?

• PGX is here now – one manifestation of biomarkers• Pharmacokinetics impacts probably less far reaching than

pharmacodynamics• Clinical practice adopting slowly, impact on dosing, cohorts

and drug design• Genotyping v. phenotyping – clinical effectiveness case by

case• Clinical utility uncertain in scope• Delivery and Uptake rates uncertain• Investment situation uncertain• No regrets policy making


Policy Priorities for Pharmacogenetics

1 - Address how to meet specific regulatory challenges from pharmacogenetics (trials, reviews, tandem/ selective approvals,

2 – Integration of Regulatory Developments (with biobanks, accreditation, development of databases)

3 – Cooperation and Capacity (data sharing, rare diseases, education, national capacity)

4 – Broader policy lacking


Getting Regulation “Right”

• Crowded set of actors• Application of outdated paradigms to new

genetics in information age• Need to reconcile regulations/

operationalization of policy within and between nations

• How to develop meaningful engagement of society

• Create policy instruments/ environment that able to deal with increasing use of genetic data.


DEVELOPMENT

IDENTIFICATION of NEED

DIFFUSION

DELIVERY

Research Policy-Guidelines-eghuman subjects, consent, privacy.-Research Ethics Boards

RESEARCH

Industry Policy-Feasibility-Trials-Formulation-IPR

Healthcare Policy-Accessible-Affordable-Cost-effective

Regulatory/LegislativePolicy-Patient safety-Standards-Medical guidelines

Decisions

Match innovation and health needs

Enabling environment?Making Demand and Supply Work Together

COMMERCIALISATION

Industry and EnvironmentKey Drivers/Opportunities

• advances in the science (enzymology, pathway engineering, gene shuffling, metabolomics),

• desire to move to ecoefficiency and decouple growth from environmental degradation

Focus of Effort

• Policy action to leverage transition. Micro-level policies focused on supply or procurement.

Major Policy Issues

• Broader scope analysis with focus on key barriers.

• Development of indicators and metrics

• Meet the supply side challenges


Industrial BiotechnologyRange of Activities

Biobased Products Manufacturing Nanotechnology

Bioenergy and Synthesis Biotech Interface


Pollution

(e.g., CO2 , toxic chemicals)

Economic Growth (e.g., employment, GDP)

Conventional technology

Sustainability via the biobased economy

Eco-efficiency &

renewable feedstock


Measuring the Bioeconomy

Country strategies: visions, roadmaps, foresight. Goal setting

Measuring activity: eg investment, jobs, numbers of firms, churning, patents. Definitions, methodology and comparability.

Measuring impact: productivity, sustainability, demand and acceptability. Small impacts so far, pervasive sector.

Measuring cause and effect: Activity or Policy? Do we need to know.


Conclusions• Broad medium- long term perspective of opportunities

offered by biotechnology and the biosciences – and the challenges to ensuring these are captured – is necessary and by and large missing.

• Particular focus needed on opportunties for sustainable growth, innovation, valuation and access to intellectual assets, globalisation and regulation.

• Implications for policy beyond so-called biotechnology policy, and the trade offs involved, need to be thought through and articulated.

• Solid metrics and indicators are necessary to underpin progress and any emerging roadmap.


Towards a Bioeconomy?

• Growing strategic interest in the bioeconomy in (OECD and non-OECD areas)

• Potential for significant global economic, social and environmental benefits

• Considerable uncertainties facing both public and private actors

• Need for a broad-based forward-looking policy-oriented review of future developments in the sector


Policy RequirementsIndustrial and R&D policies – what rules should apply so as to ensure that

public support is fully effective without distorting competition

Business and value chain models – what is needed to ensure the financial viability and market success of new applications

Legal and regulatory framework – what changes should be made to existing legal and regulatory provisions both at the national and international levels so as to facilitate the future development of the bioeconomy

Institutional arrangements – is there a need at the international level to change institutional arrangements impacting on the bioeconomy? At the domestic level, what institutional arrangements might be appropriate for ensuring that national policy fully takes into account the interest of all stakeholders?


Project Objectives

• Building scenarios for the development of the bioeconomy

• Identifying technical, financial, human capital, regulatory bottlenecks

• Providing as much as possible a quantifiable benefit analysis of the main segments

• Providing a road map of necessary policy choices ahead


OECD’s Role

“…… on the road to globalisation ……OECD member countries need to take their share of responsibility…..and provide the engine for the train of sustainability……..”

Donald J JohnstonOECD Secretary General

World Summit on Sustainable Development

BIOTECHNOLOGY DIVISIONBIOTECHNOLOGY DIVISION

towards a bioeconomy? opportunities and challenges for policy

Documents

biotechnology divisionmain

biotechnology divisionwhat

sustainable economic

health innovation

ownership of genetic

efficiency of research

policy environment

oecd secretariat