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Regulatory concerns and prospects in the European Union: an industry view Andrew Dickson

Address Senior Advisory Group on Biotechnology, Avenue de rArm6e 6, B1040 Brussels, Belgium

Current Opinion in Biotechnology 1996, 7:273-274

© Current Biology Ltd ISSN 0958-1669

Abbreviations EC European Commission SAGB Senior Advisory Group on Biotechnology SME small/medium-sized enterprise

Before joining the Senior Advisory Group on Biotech- nology (SAGB) last summer, I was an Assistant Director in the UK's Deregulation Unit. Two years of experience the re - -p receded by a career of dealing with many European issues for the UK in Brussels--should have prepared me for the regulatory labyrinths of biotechnology. But since arriving in Brussels, even my worst experiences have been as nought. For a grouping of developed economies and experienced policy/decision makers who have collectively recognized the important contributions modern biotechnology can bring to European competi- tiveness [1,2], actions at the European level have so far been largely inept and in contradiction to stated policy objectives.

As an ex-deregulator and an economist, I am all too aware that the burden of regulation damages the competitiveness of individual firms and affects the lives of Europe's citizens as well as the trading prospects for the European economy. Equally, in pressing for regulatory simplification and reform in Europe, we must not seek to reduce levels of environmental, social or consumer protection. It is our belief, however, that through targeted regulatory reform, Europe can create an environment that enhances compet- itiveness and encourages enterprise by ensuring that the regulations in place are both necessary and proportionate. Achieving the goal of high-quality regulation will bring benefits to industry and consumers alike.

European Commission (EC) President Santer has called for "less action, but better action". His personal leadership is welcome, but to deliver this will require a commitment to regulatory reform from the entire EC. Ultimately, we are looking for a change in the regulatory culture in Brussels. This will not happen overnight, but is essential to deliver significant longer-term benefits.

At the heart of this culture change has to be action to improve the way regulatory proposals are developed. In particular, the SAGB would like to see action on the following fronts:

• Systems for assessing the likely costs and benefits of proposals, using risk assessment and a sepa- rate assessment of the impact on small-sized and medium-sized enterprises;

• Consultation with business from the earlier stage of the development of new proposals, and in iden- tifying our priorities for reviewing and simplifying existing regulatory burdens;

• A commitment that, wherever possible, new regulations are goal-based and avoid the use of over-prescriptive measures;

* Clear analysis at the outset of any new proposal on why action is required at Community level rather than by Member States.

Such an approach should ensure that full account is taken of each new proposal's impact on competitiveness, innovation, investment and job creation. All of these are crucial issues for European biotechnology.

The EC's Communication on Industrial Competitiveness Policy for the European Union said:

"The growth prospects in the field of healthcare and, more generally, industrial applications of biotech- nologies, are extremely promising. The European Union has all the capacity needed to remove the remaining obstacles to the development of these markets."

Fine words, indeed, as an expression of political will. But the political will has failed, all too frequently, to be matched by concrete action.

So, a reiteration of what industry wants in Europe as the criteria for a regulatory system for biotechnology bears restating:

1. The regulatory regime should be proportion- ate, scientifically risk based and focused on the pathogenicity of organisms.

2. Regulation must enhance commercial operabil- ity and competitiveness. It must be 'user f r i e n d l y ' - that is, practically based such that both regulators and those regulated can act efficiently to ensure its effect is achieved.

274 Regulatory affairs

3. It must take account of, and be broadly com- patible with, the existing regulatory systems in, for example, the USA and Japan. It should not create unnecessary trade barriers nor conflict with international obligations.

4. All regulatory aspects, including further amend- ments, must take account of relevant existing EC legislation (e.g. Directive 90/679 on the protection of workers from risks related to exposure to biological agents at work) and should avoid duplication.

5. It must be flexible enough to adapt to advances in science. Technical progress must be reflected in a regulatory system that is scientifically sound and can be adapted expeditiously.

6. The scope of the regulatory system must be clear and its terms unambiguous.

7. Any required disclosure of information must take into account the fact that intellectual property rights could be affected by excessive disclosure requirements.

8. It should enhance standardization and safe operating procedures.

9. Product safety aspects should be covered by vertical (i.e. specific) product legislation rather than horizontal regulation.

It is welcome, therefore, that 1996 has seen the beginnings of the much-needed process of change. First, the majority of participants to the Inter-Institutional Conference on Biotechnology on 11 January recognized not only the importance of biotechnology and the need for an appropri- ate regulatory environment, but also its interactions with European competitiveness.

The EC dec i s ion- -we lcome, but b e l a t e d - - t o bring forward the revision of Directive 90/219 that will, at last,

move European systems for 'contained use' more into line with that of our international competitors. Similarly, the belated recognition by the EC that Directive 90/220 on 'deliberate release' is not working at all well reflects industry's experience. At the time of writing, Europe has just approved only the second product under the Directive compared with more than a dozen in the USA.

This second approval exemplifies European industry's concerns because the company concerned is not only a biotechnology company, but also a small/medium-sized enterprise (SME). Yet, the approval of its product has taken 2 years. Hardly a ringing endorsement of the Union's policy commitments to SMEs or biotechnology!

Other welcome initiatives have been the proposed Regu- lation on Novel F o o d s - - w h i c h will create a harmonized system at the European level and help complete the Internal M a r k e t - - a s well as a new proposal on legal protection for biotechnological inventions. At the time of writing, it is too soon to say what the outcome will be for either of these important dossiers. But any failure by Member States or the European Parliament to provide industry with these vital policy instruments will signal that policy and decision makers want Europe to be a consumer and importer of biotechnology rather than a producer and exporter. European industry's fate is in the balance. We will be doing everything we can to ensure that, as Mark Twain put it, "news of our death is premature".

R e f e r e n c e s 1. European Commission: Growth Competitiveness and Employment:

the Challenges and Ways Forward into the 21st Century. White Paper. Brussels: European Commission; 1993. [COM(93).700.]

2. European Commission: Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage. Brussels: European Commission; 1994.