Opinion of the Economic and Social Committee on the "Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions: Life sciences and biotechnology - A Strategy for Europe"

(2003/C 61/04)

On 25 January 2002 the Commission decided to consult the Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the above-mentionned communication.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 11 September 2002. The rapporteur was Mr Bedossa.

At its 393rd Plenary Session of 18 and 19 September 2002 (meeting of 18 September), the Economic and Social Committee adopted the following opinion by 124 votes to none with one abstention.

1. Introduction

1.1. As part of its follow-up to the consultation document on a strategic vision of life sciences and biotechnology, to which the Committee contributed with its opinion of 21 February 2002(1), the Commission is now briefing the EU institutions on its definition of this strategy.

1.2. The Committee welcomes this initiative, noting that the strategy is accompanied by a well-constructed, precise, dynamic and proactive action plan.

1.3. The comprehensive consultation underpinning the Commission's action of course forms part of the rules of governance which are intended to bring EU bodies closer to organised civil society, NGOs and all actors in the life sciences: the relevant public and private professional sectors, institutions, and national and European organisations.

1.4. The Committee's analysis matches that of the Commission: it is clear that analysing the strategy cannot be a simple task since the many challenges must be looked at one by one if a response is to be formulated.

1.4.1. The essence of the communication lies in its wide-ranging approach, seeking to create sufficient impetus for all actors to focus on identifying strengths and weaknesses and agree on what action should be taken immediately and what action needs further discussion and fine-tuning. This global approach is the only one possible in this field.

1.4.2. However, the political authorities must have the final say in sounding out and taking the necessary strategic decisions.

1.4.3. The Committee stresses that it is vitally important to create a structure for the governance of the life sciences and biotechnology, integrated into the Union's broader system of democratic government. This structure will, in any event, have to be compatible with Europe's scientific heritage and clearly acceptable to European society.

1.5. The challenges relate to the quality of research in the life sciences in the various EU countries, and the extent to which it meets current social expectations; the effectiveness of the innovation process, translating discoveries into practical development of applications and the obstacles to the process; the role of public authorities in promoting the development of life sciences and biotechnology; the situation of the downstream sectors, which have a vital part to play in developing "valuable" research - the pharmaceuticals industry for health, agri-foodstuffs industry for GMOs; compatibility with the legal framework, particularly for all aspects concerning (i) supervision of research and placement on the market, and (ii) industrial property rights (one part of the wider body of intellectual property); the amount of information provided, involvement of and acceptance by the general public; and society's necessary ethical limits.

1.6. The EU fell behind significantly during the 1980s, but is now attempting, with some success, to catch up. Where human health or agriculture are concerned, countries which are either on the move or experiencing upheavals are as much concerned as the richer countries, even if they are currently (China, Australia, etc.) in a marginal position in this field. This gap should be highlighted, as it represents a new form of inequality regarding the "right to life".

1.7. Where biotechnology is concerned, scientific and industrial developments - and, of course, the markets - are played out at a global level, as for all leading-edge technologies. It is therefore logical that they should be paralleled by the growth of a body of legal standards, especially at European level. Two areas are involved: supervision of experimental research and clinical trials in human health; and industrial property rights, especially the thorny problem of how far living organisms can be patented.

1.8. A debate focused on the ethical issues arising from advances in biology and biotechnology developed early on - largely at the initiative of the scientific community itself. The debate has been on an international scale from the outset, but has underscored significant differences in approach between the EU and the United States.

1.9. A technological revolution is taking place with regard to biotechnology, the economic consequences of which are reshaping certain features of our society:

- freedom of research may only be allowed within a framework of well-defined rules;

- guidelines are needed in order to give education and training an interdisciplinary character;

- the administrative requirements for pursuing research must be simplified.

2. General comments

2.1. The Committee notes that the Commission gives a precise description of the problems arising from the need to implement a genuine, useful and effective strategy in response to this technological revolution, to which a political response must be provided:

2.1.1. The implications are profound and far-reaching: the response must be political.

- New scientific disciplines and their applications represent a common foundation of knowledge.

- The prospective applications may produce profound upheavals in our societies and economies, far beyond GMO crops.

- These sciences seem likely to help achieve the objective set at Lisbon of making the EU a leading knowledge-based economy, as confirmed by the Stockholm Council.

2.2. The EU seems to be holding back.

2.2.1. Securing public backing for these sciences is difficult: the EU must therefore devise a responsible policy with a worldwide focus on the future. The EU must have a part to play. Its voice will only be heard if it is a major player in this sphere.

2.3. The European Commission notes that responsibilities are fragmented, but that respecting the subsidiarity principle should not prevent Europeans from working together towards common goals. The Committee shares this view.

2.4. The three strategic priorities which the Commission identifies should enable sustainable and responsible policies to be developed:

- The opportunities provided by the life sciences must harness human, industrial and financial resources in order to boost competitiveness.

- The support of informed, educated public opinion is essential, consequently ethical and societal concerns must be addressed.

- The EU faces a global reality, and must be capable of responding in the way most appropriate to its best interests. The Commission therefore proposes an integrated strategy, deploying a concrete, realistic action plan, flanked by recommendations which respect the subsidiarity principle.

2.5. New solutions to real problems are brought to bear in the following areas:

- health care;

- the agri-food sector;

- non-food uses of crops;

- improving the environment.

2.6. Harvesting the potential of the life sciences and biotechnology is likely to engender a new economic dimension, creating wealth and skilled jobs.

2.6.1. In order to bring this about:

- the knowledge base must be mastered, disseminated and new knowledge applied;

- in the context of effective and innovative research, the EU's leadership in this field should be restored, and European efforts should focus on the new prospects opened up through multi-disciplinary research, since biotechnology is yielding innovative approaches in all these areas;

- if research must be based on the needs of citizens, then it must enjoy societal consensus;

- applying science in practical terms is essential. Developing new capacity involves encouraging the entire research and innovation process. The fragile condition of SMEs is evident.

2.6.2. In this regard, the Commission points to a number of problems:

- the insufficient supply of skilled personnel must be remedied;

- the need to eliminate all bottlenecks.

2.6.3. Three areas for action are identified:

- reinforcing the (financial or human) resource base for this knowledge-based sector;

- networking Europe's biotechnology communities;

- a pro-active role for public authorities.

2.7. Managing the life sciences

2.7.1. The Committee fully agrees with the conditions described by the Commission. This technological revolution calls for governance based on the following:

- Inclusive, informed and structured dialogue with society.

- Developing these sciences in harmony with ethical values and societal goals, balancing benefits against disadvantages, guided by the Charter of Fundamental Rights.

- Giving consumers and economic operators the information to make free choices. The new, revised framework legislation on GMOs, applicable from October 2002, should overcome the present standstill in authorising new products.

- All actors making the necessary efforts to build confidence, with science-based regulatory oversight.

2.7.2. The Committee welcomes the Commission's stance that patent protection is the only effective means of creating a crucial incentive for R& D and is essential for protecting investment.

2.7.3. In order to reconcile the policy objectives in regulation of life sciences, the Commission puts forward four principles:

- risk governance and product authorisation;

- safeguarding the internal market;

- proportionality and consumer choice;

- predictability, modernisation and impact assessment.

2.8. The EU in the world

2.8.1. The Commission describes its agenda for international collaboration, in response to international diversity. The Committee agrees that open, multilateral and rules-based trading systems should be set up. The EU already possesses a wealth of experience in this area, particularly in connection with the OECD and the Codex Alimentarius. The role and efficiency of EU participation should be enhanced.

2.8.2. The Committee notes with satisfaction that the Commission considers the EU to bear a special responsibility towards the developing world to meet its urgent needs and to put Europe's capacities to the service of these countries.

2.8.2.1. For this purpose:

- the EU should support negotiated multilateral frameworks;

- the EU should contribute to technical assistance, capacity-building and technology transfer;

- the EU should encourage equitable and balanced North-South partnerships;

- the Committee believes, as does the Commission, that dispersed responsibilities must be overcome, on the basis of a shared vision for a cooperative approach.

2.8.2.2. This strategy should be implemented through:

- monitoring of progress;

- coherence of EU policies;

- coordination and benchmarking;

- and, above all, ongoing attention entailing vigilance and political impetus.

2.8.2.3. The Committee endorses the Commission's proposal to set up a permanent forum, if possible involving stakeholders, to which the Committee would aim to contribute.

2.9. The action plan

2.9.1. After describing the challenges raised by the life sciences and biotechnology strategy, the Commission sets out its 30-point action plan, explaining the commitments and tactics required if the strategy is to attain its goals. The Committee appreciates the helpful way in which each action comprises:

- a detailed description;

- a list of implementers;

- a specific and/or open-ended timeframe.

2.9.2. The Commission's proactive approach is the more remarkable in that the action plan takes account of the subsidiarity principle.

3. Specific comments

The Committee welcomes the strategic plan, the scope of which can be gauged from the description. However, in the Committee's view two particular aspects are not made completely clear:

3.1. Life sciences research

3.1.1. In the biological sciences, a key role is played by public research, conducted by:

- major public scientific or technological establishments;

- large associations, largely in receipt of private funding;

- businesses, usually in the pharmaceuticals, seed production or agro-chemical sectors.

3.1.2. However, the accelerating rate of knowledge, and the speed with which the potential applications of scientific progress are subject to intellectual appropriation, oblige more and more entrepreneurs to engage in upstream research, which is not necessarily located in the EU.

3.1.3. In order to meet the challenge laid down by the Commission, the examples drawn from the United States - even if they are not directly transferable to the EU - point out the way to develop biotechnology. Biotechnology must be developed vigorously and in closer cooperation between players and the EU.

It is necessary to:

- stimulate life sciences research, particularly in the area of applied genetics;

- improve the link between research and innovation by generating the right legal, financial and even psychological conditions for rapid progress from knowledge to innovative applications;

- intensify industrial involvement at the upstream stages, by expanding cooperation with outside laboratories and with biotech industries;

- ensure the EU plays its intended role: to give impetus to biotechnological development without trying to control everything, to remove statutory and regulatory obstacles and cut through red tape deterring or hampering initiative, to ensure that industrial choices are consistent and, above all, to organise for a united, dynamic and durable policy.

3.2. Challenges relating to ethics and acceptability

3.2.1. Biotechnology raises major and complex ethical issues.

3.2.1.1. These ethical questions relate firstly to the very nature of genetic research and its applications, particularly with regard to human health: the stakes are life itself, our genetic heritage which is gradually revealing its wealth and complexity, the potentialities it heralds, and the almost unlimited horizons it offers in particular to medical applications and to the cognitive sciences.

3.2.2. Thanks to the breakthroughs of the last few decades, the discoveries and initial applications are accelerating at a rate which encapsulates the race underway to complete the sequencing of the human genome and commence unlocking the secrets of the human proteome.

3.2.3. Differences of ethical approach extend beyond the bounds of biotechnology, and often involve more than bioethics alone. They concern the values, stated or underlying, of different human societies. A distinction is often drawn between western European society's Kantian, normative approach and the more utilitarian approach of the English-speaking world, which is suspicious of pre-established principles, preferring to judge the morality of an act in the light of its practical consequences. This difference in the hierarchy of values is an example of why American government and opinion is reluctant to introduce specific legislation governing biotechnology.

3.2.4. Even within the EU, sensibilities vary appreciably according to historical background:

- one of the great unknowns of the future ethical debate on biotechnology is the stance which countries such as China or India will adopt once they are directly involved;

- the ethical debate has become simultaneously more necessary and more difficult as a result of fiercer scientific and economic competition. This applies to the ethics of both scientific communication and experimentation. Since Dolly's birth, the many declarations on the "progress" of cloning clearly point to the need for more urgent and deeper ethical reflection.

3.3. Transgenesis, the environment and public perceptions

3.3.1. It is in order to wonder why transgenesis provokes so much questioning, whereas conventional selection has never aroused any reaction. This may be explained by the particular features of transgenesis. Being faster, and able to cross the species barrier, it is more likely to upset the ecosystem. For some, however, environmental problems are simply a pretext for rejecting all GMOs without admitting their real motives, which may be ethical, religious or ideological.

3.3.2. Environmental protection is a matter of concern to a growing number of consumers. They are no longer interested only in the quality and price of food, but also in how it is produced and its environmental impact. The BSE saga has suddenly revealed to them that agriculture is capable of leaving behind material contingencies in order to satisfy the requirements of downstream industries. They have lost some of their faith in science, and attach greater importance to the risk factor. They are demanding guarantees.

3.3.3. The problem lies in knowing where to draw the line between the safeguards which the public is entitled to demand and those which researchers cannot provide. Scientific progress entails risk which is difficult to evaluate. Society accepts risk when it can discern its own interest in such techniques, describing this as "acceptable risk".

3.3.4. In the case of plant and animal transgenesis, the risk/benefit ratio is unclear: hence the complex nature of the debate.

3.3.5. It would seem crucial that a case-by-case social evaluation of the risk/benefit ratio be made for each OMG if they are to possess legitimacy and hence be accepted by the general public.

3.4. Education

3.4.1. The Commission's strategy, however, does not appear to take sufficient account of the pressing need to make all the peoples of Europe, and young people in particular, aware of this body of knowledge. The entire educational system should reflect this need.

3.4.2. As in its opinion on the Communication from the Commission - Towards a strategic vision of life sciences and biotechnology: consultation document(2), the Committee suggests that the Commission:

- assume responsibility for encouraging pilot education programmes to inform the general public about progress achieved in the life sciences and biotechnology;

- devise a plan involving a range of Community policies, in particular by means of:

- measures to introduce a school curriculum that is more open to the life sciences and biotechnology;

- efforts to remove obstacles that prevent European citizens having access to this knowledge.

4. The Committee's proposals

4.1. While the Commission's communication appears balanced and well-structured, and the action plan clearly set out, proactive and practical, a certain number of principles and objectives are either understated or insufficiently explicit in the light of the overall objective, which is of vital importance to the EU's future and especially sensitive in terms of public opinion, mainly due to the questions and polemics it arouses in all the EU Member States and all sectors of society.

4.2. The Committee calls for two general principles to apply before detailed responses are framed, and for consolidation to ensue.

4.2.1. Prevention and the precautionary principle(3)

4.2.1.1. The precautionary principle must prevail and be applied consistently, also in the context of biomonitoring. It must be applied at every stage. The difficulty is that it must be recognised in the same way by the entire international community, and be applied uniformly at international level. This is clearly not the present picture. The EU should propose an international conference to consolidate application.

4.2.2. Accountability

4.2.2.1. This principle (damage/inconvenience) should be appropriately stated in the Proposal for a Directive of the Parliament and of the Council on environmental liability with regard to the prevention and remedying of environmental damage(4).

4.2.3. The Committee considers that the proposed action plan should be fleshed out with the following points, which it considers to be of major significance:

4.2.3.1. Educating all young Europeans to be aware of these sciences, by setting up a framework programme and earmarking the necessary funds.

4.2.3.2. The responsibilities of each of the players must be more precise, specifying those of:

- the European institutions;

- the Member States, in keeping with the subsidiarity principle. The public authorities must define their responsibilities before making any decisions and ensure the decisions are implemented once taken;

- experts or expert groups on which the decision-making process relies.

4.2.3.3. Information for choice:

- aiming to achieve transparency at every stage in research;

- ensuring the establishment of traceability and clear and legible labelling for all products;

- implementing statutory labelling provisions;

- supplementing European legislation by adopting Community rules on seeds and animal feedstuffs containing GMOs;

- labelling intermediate products;

- ensuring that consumer expectations are recognised at international level, calling for risk-benefit criteria to be adopted in all negotiating forums.

4.2.3.4. An ongoing debate:

- to ensure proper evaluation and assessment of scientific advances;

- to define a communication strategy to enhance the coherence and transparency of EU policy in this area, which must be constantly renewed and broadened, especially by informing and educating young people;

- information must be objective, and the public authorities must guarantee the plurality of debate.

4.2.3.5. The duty to share must be recalled at every stage.

- the developing world is unfortunately more of an onlooker than a direct participant. This is all the more worrying since these countries are affected by food insecurity, health requirements and by problems of pollution and the environment;

- the EU must address the issue of solidarity as an essential criterion: solidarity between rich and poor countries, and solidarity with regard to the shared responsibility to protect the environment, which will require more public funding to combat poverty and to ensure food self-sufficiency.

4.3. A Community patent

4.3.1. Rapid scientific and technical progress, coupled with the explosion in research, is helping to drive developments in industrial property law, as questions about innovation and about the morality of "patenting" various advances are added to more traditional questions.

4.3.1.1. Property law is geared to protecting inventions internationally as effectively as possible. Trade-related intellectual property rights agreements lay down a set of rules, some of which specifically address biotechnology.

4.3.2. In addition to the World Intellectual Property Organisation (WIPO), there is a European Patents Office (EPO), which however provides only a common procedure for filing patents: implementation procedures remain in the hands of individual countries.

4.3.2.1. A single Community patent must therefore - at last - be brought into being as a matter of urgency.

4.3.3. The essential difference with American patent law is that in the USA, only the "first to invent", rather than the "first to file", is entitled to a patent.

5. Conclusion

5.1. It is essential that the EU play its part: its voice will only be heard if it is a major player in the sphere of biotechnology and it is imperative that there should be greater awareness in the EU of the implications for competitiveness, growth and job creation. Thus the various stakeholders must mount a strong and sustained effort to cooperate, and there must be a shared strategy and instruments, such as, in particular, a Community patent. Innovation clearly demands new, dynamic, constructive and transparent forms of management in order to reflect the scale of the new fields being opened up by research and the speed at which this is occurring. A creative approach is called for, with greater emphasis than before on stimulating and providing incentives and opportunities. Ensuring the EU's place in the biotechnology sector means acting with determination and resolve.

Brussels, 18 September 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) OJ C 94, 18.4.2002.

(2) OJ C 94, 18.4.2002.

(3) OJ C 268, 19.9.2000.

(4) COM(2002) 17 final.