52002AE0192

Opinion of the Economic and Social Committee on the "Communication from the Commission - Towards a strategic vision of life sciences and biotechnology: consultation document"

(2002/C 94/07)

On 6 September 2001 the Commission decided to consult the Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the above-mentioned 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 25 January 2002. The rapporteur was Mr Bedossa.

At its 388th Plenary Session of 20 and 21 February 2002 (meeting of 21 February), the Economic and Social Committee adopted the following opinion by 83 votes to two with three abstentions.

1. Introduction

1.1. At the European Council in Lisbon in March 2000, the European Union set itself a new strategic goal for the next decade: to become the most competitive and dynamic knowledge-based economy in the world capable of sustainable economic growth with more and better jobs and greater social cohesion.

1.2. At the Stockholm European Council, which followed Lisbon, the Commission again drew attention to the economic, social and environmental potential of life sciences and biotechnology. It is with the aim of articulating this strategic vision and implementing it by 2010 and beyond that the Commission is initiating a broad and open discussion on the basis of this communication.

1.3. First, in accordance with the new principles of governance in Europe, and in order to adapt this comprehensive and forward-looking approach to meet future challenges and the Lisbon objectives, the Commission is now launching a broad public debate on the issue, with the aim of reaching a consensus if possible.

1.4. To start with, it should be pointed out that the current biotechnology boom is almost exclusively concentrated in developed countries, namely northern America, Europe and Japan and more recently China and Australia, too (and perhaps other parts of Asia in the future).

1.5. The developing world is largely a spectator, for reasons which have to do with a lack of scientific know-how, with the amount of financial resources available and with the scarcity of "risk-taking" entrepreneurs.

1.6. All countries, and especially developing countries, are concerned with the need to increase food resources and with the problem of environmental pollution. There is a risk of them being relegated to the role of observers without the reassurance that the products being tested (e.g. medicines) are being developed with their particular needs in mind. There is a risk that their rich genetic heritage (animals or plants) that helps to make up the planet's biodiversity will be exploited without payment by third parties or sold to the highest bidder.

1.7. Life sciences and biotechnology raise countless questions that must be addressed at the appropriate level, on the basis of subsidiarity; in the case of life sciences for which ethical principles must be defined, for instance, responsibility lies with the Member States.

To avoid problems, it must be possible to design a European framework. The Council of Research Ministers reached a political agreement on this on 10 December 2001.

1.8. This open, comprehensive, transparent and cross-disciplinary debate concerns everybody: public authorities, scientists, economic players, consumers, the general public, organised civil society and social players.

1.9. Every kind of issue must be addressed:

- broad scientific knowledge;

- improving health and increasing food resources;

- competitiveness;

- research;

- innovation;

- opportunities and risks;

- social context and ethical basis.

These issues shape public perceptions and must therefore be considered rationally and honestly.

2. General comments

Biotechnology is certainly a fascinating topic: it has a long tradition since it is one of the oldest human farming skills, used for example to produce bread, beer, wine, cheese and other products of fermentation; to rear new species of animals and cultivate new types of plants; to produce vaccines, antibiotics, etc. The term "biotechnology" has been used for several decades owing to the rapid advances made in the field.

2.1. What is biotechnology?

2.1.1. To be logical and chronological, we should first consider what has been discovered in the field of life sciences, especially genetics.

2.1.2. Considerable progress has been made in understanding the structure, function and reproduction of living cells. But the concept of genetic heritage must be precisely defined because genetic determination has not yet been completely elucidated.

2.1.3. Much work remains to be done in terms of understanding, decoding and interpreting genetic interactions in order to improve human health.

2.1.4. Very quickly, in just a few years, genetic research has developed the technical capacity to identify, isolate, reproduce and transfer one or more genes to another living organism. This is what is referred to as genetic engineering, which has the pejorative connotation of genetic manipulation.

2.1.5. The next stage is to use molecular biology and genetic engineering in practical applications, especially in biotechnology, whose main applications are in human health (diagnostics and/or therapeutics) and agriculture (genetically modified organisms, or GMOs). This must be broadened to include new areas, such as production of fine chemicals and bioremediation.

2.2. Biotechnology: an everyday reality

2.2.1. Biological techniques have existed for a very long time, and biological science has given the human race considerable capabilities: in the past microbiology, in the form of vaccines, was used to treat diseases; now genetic science and its applications are marking a real break with the past, and public opinion is only gradually becoming aware of this (vaccines, new medicines).

2.2.2. Genetic diagnosis is now becoming common.

2.2.3. However, GMOs in foodstuffs are provoking a very strong public reaction.

2.2.4. Biotechnology is now relevant to human health, feeding the population and combating pollution. The role of biotechnology is certain to expand; 25 % of new medical active substances are now produced by biotechnology, and this will increase to 50 %.

2.2.5. There are considerable economic implications in terms of competitiveness, economic growth and employment.

2.2.6. The financial costs are high and return on investment slow, requiring involvement of strong economic players, as in most economic sectors that use new high-potential technologies.

2.2.7. In many respects biotechnology is ultimately, like information technology, one of the spheres of scientific application likely to produce profound upheavals in our developed societies in future decades.

2.2.8. Public opinion is thus confused and increasingly vocal: it is difficult for the general public to follow scientific advances, but there is a realisation that discovering the human genetic heritage is a major breakthrough. This positive and negative interest is expressed in language that is not always adequate for the necessary task of informing and familiarising. Generally speaking, the gulf between scientific experts and the general public with respect to available information and knowledge is very wide. This problem and others were addressed by the Committee in a previous opinion entitled "Science, society and the citizen in Europe"(1) (points 3.1.3, 7.1 and 7.3).

2.2.9. Beyond this often highly emotional response, people are weighing up the importance of the ethical and political issues raised by the very rapid progress and development of biotechnology. Obviously this is nothing new in science, where for a long time precautionary measures and regulations have been required to protect researchers against the risks they face when conducting their activities or to ensure rigorous restrictions on human experimentation.

2.2.9.1. What are the answers to these questions and who should give the answers? The question must be presented with all its implications, especially since the ethical issues are acquiring an extra dimension in the form of a legitimate concern to protect human beings and the environment.

2.2.10. Thus the almost limitless possibilities that genetic engineering seems to offer and the substantial growth in genetic diagnostics are generating an ethical debate of unprecedented intensity (e.g. on cloning, prevention of genetic abnormalities). How can these questions be answered and who should provide the answers to them?

2.3. The implications of biotechnology for Europe

2.3.1. There are implications for the quality of research in the life sciences and the extent to which it meets current social expectations:

- competence and quality of scientists concerned, their organisations and education systems;

- effectiveness of the innovation process;

- the role of public authorities in promoting the development of life sciences and biotechnology;

- definition of "valuable" research: the pharmaceuticals industry for health, agri-foodstuffs industry for GMOs;

- compatibility with the legal framework:

- supervision of research

- marketing authorisation

- industrial property rights;

- amount of information provided, involvement of and acceptance by the general public; the extent to which advances that are problematic are acceptable to a general public behaving like a cat on a hot tin roof: enthusiastic about the distribution of genetically engineered insulin but fearful and full of wild ideas when it comes to consumption of GM cornflour, as if it were easier to inject a medicine than to eat a fruit or salad;

- ethical limits imposed on society.

2.3.2. Here, too, the Committee refers to its opinion "Science, society and the citizen in Europe"(2). This opinion formed the basis for an action plan.

3. Specific comments

3.1. This lengthy consultation document from the Commission is based on 25 years of policies and texts relating to life sciences and biotechnology. The Commission, the European Parliament, the Council of Europe, the Organisation for Economic Cooperation and Development (OECD) and the European Group on Ethics have produced a raft of opinions, documents, rules and guidelines that join the many contributions from the Member States, and from the numerous professional players concerned.

3.2. The Commission is relaunching the consultation and debate, to which it attaches primary importance. The European Commission, in which several Commissioners and departments are responsible for biotechnology, invites comments from citizens, consumers, as well as organised civil society, scientists, public authorities and players with economic interests in industry, agriculture or the services sector to contribute to the Commission's reflections on the policy paper in preparation.

3.3. Europe lagging behind

3.3.1. The debate is needed now because Europe is lagging behind the United States in this area.

3.3.2. Several European countries have played a key role in crucial discoveries in molecular biology. Life sciences research in Europe is not inadequate, either quantitatively or qualitatively: although publications may be slightly inferior in the sphere of basic science, they are far superior in medical research. An important indication is Europe's contribution in terms of completed sequencing of whole genomes.

3.3.3. It is Europe's research culture that has been more relevant, such as the tradition of knowledge-sharing which discourages patent applications, and the weakness of links between research and industry, which produces misunderstanding.

3.3.4. Certain governments in Europe have been slow to grasp the implications of biotechnology in terms of competitiveness, growth and employment, whereas the European institutions were much quicker on the uptake.

3.3.5. Thus the development of biotechnology applications in health was slow. The pharmaceuticals industry in Europe also took a long time to become interested in active substances produced by biotechnology.

3.3.6. Lack of risk capital put a brake on the development of new technologies, including biotechnology.

3.4. Europe wakes up

3.4.1. The Commission played an important role in providing a "wake-up call".

- In 1970 a first directive was issued, followed by a recommendation:

- 1978: the FAST programme

- 1982: the BEP programme

- 1984: the first RDFP (Research and Development Framework Programme) with specific measures in the spheres of health, agri-foodstuffs and chemicals.

3.4.2. These measures were intended to provide a framework for demonstration projects facilitating the transition between research and marketing. They were implemented cross-sectorally in research and training in basic biotechnology, the aim being to systematically relieve bottlenecks that were blocking the application of genetics, biochemistry and microbiology in both agriculture and industry.

- Discussion of rules and standards.

- A European approach to industrial property rights, providing an opportunity to reconsider the Community patent and its advantages over the European patent.

- Coordinating national and Community policies within a specialised body.

3.4.3. Awareness grew gradually at Member State level, with the UK taking the lead, perhaps because of its intellectual affinity with the United States, reinforced by the ultra-liberal policies of the British government with respect to science.

3.4.4. The first specific programmes to promote biotechnology were set up. The Dechema study was carried out in Germany in 1972; France set up its own special programme in 1982; the Netherlands based its measures on the Schelperoort Report; and Denmark launched a programme in 1987.

3.4.5. More recently, European efforts have borne fruit and the gap with the US has narrowed:

- "Biotech" companies have developed rapidly, doubling in number and number of staff between 1995 and 1998, and they now occupy a growing number of market niches;

- risk capital companies are being developed and markets adapted to high technology companies are being established;

- an appropriate legal framework with respect to market authorisation (MA) and industrial property rights (IPR) is being established at European and/or national level.

3.5. Community research funding policy

- regulatory basis for Community action and the RTD& Ds.

The Single European Act in 1989 was the first piece of legislation to establish Community competence in the sphere of research by codifying rules and principles for action and coordinating intervention mechanisms; the framework programmes established on this basis set out scientific and technological objectives and broadly define the measures to be taken to achieve these objectives, which must complement action taken by the member states.

- biotechnology was a key element of the 4th and 5th RTD& Ds (framework programmes for research, technological development and demonstration activities) of the European Community.

Biotechnology is also an important part of the proposal relating to the 6th RTD& D. However, the Committee feels that the scope of research should not be too narrow, e.g. restricted to medical applications only, but should also include foodstuffs, fine chemicals and the environment.

Work under the 4th RTD& D was intended to focus on improving basic biological knowledge of living systems (the "cell factory", genome sequencing). Some projects are on a shared cost, others on a concerted action basis. SMEs are crucial in this area and so their involvement has been encouraged.

- evaluation data.

Implementing these programmes has led to the setting up of "industrial platforms", which are defined as groups of companies involved in specific technology projects; this has made it possible to promote collaborative efforts between research and industry, to facilitate contacts between SMEs and researchers, to better identify certain areas of interest for industry and to bring about broader participation of companies in these RTD& Ds. The competitiveness of these high-risk - and sometimes high-profit - companies has often been stymied because the social and legal framework tends to discourage risk-taking and business start-ups.

- developing a European research agenda.

3.6. Legal framework for developing biotechnology

- What precautions should be taken and limits set so that research does not endanger researchers themselves and/or human beings and the environment?

- What specific framework should be set up for in vivo studies, whether human or animal?

- Where does free access to new knowledge end and researchers' right to legal protection for their discoveries begin?

- These questions are very important since we are talking about the very sensitive area of the genetic heritage of plants, animals and humans, which is the memory and history of the species.

- Because progress is very rapid, in terms of genetic engineering possibilities, i.e. applications, it is difficult to keep track of the threshold between knowledge and research.

- There are considerable economic and financial implications in this sphere, which affects all questions of industrial property.

- One specific issue is that of pathogenic micro-organisms, their manipulation, and protection of the general public.

- These factors explain the significance of the ethical implications of biotechnology. The purpose of the ethical debate is to draw up a framework of reference and this involves deciding on the dividing line between what is morally acceptable and what is not.

3.7. In vivo studies and market authorisation

3.7.1. The role of government is to enact adequate rules and application provisions to protect research and researchers, and to ensure that there is no risk of toxic substances or pathogens escaping into the environment and that in certain cases a cautious approach is adopted in developing clinical trials.

3.7.2. As a general rule it is recommended that "good manufacturing practice" be observed when using "low-risk" recombinant organisms, a principle that has been the basis for national safety rules in most OECD countries.

3.7.3. This approach has usually been maintained in the health sphere, whereas in agricultural applications (GMOs), precautions and a special framework are required as soon as substances are being handled outside of a closed environment and there is therefore a risk of release into the environment. The European directives adopted fall into two categories: the first type establish a framework for the safety measures applied in laboratories and industry, while the second specifically concern genetically modified organisms. They also reflect not just a difference in terms of government and public sensibilities, but also an objective difference in terms of risk. Medical applications of biotechnology have become widely accepted alongside non-genetic techniques, whereas this is clearly not the case for GMOs. The problem is that in the United States this distinction is not made: although genetic engineering applications require special attention in view of the scientific, economic and risk assessment factors, they are all covered by the standard legal procedures administered by the big federal agencies: the FDA (Food and Drugs Administration), the EPA (Environment Protection Agency), the Department of Agriculture, NIH, etc. The situation in Japan is the same.

3.8. Marketing authorisations

In all countries, clinical trials comprise three successive phases which are lengthy and laborious. This illustrates the long-term and risky nature of the investment required to research and develop an active substance, and means that the sometimes premature declarations of success on the part of biotechnology companies should be treated with caution.

3.9. Industrial property rights and the concept of patenting living organisms

3.9.1. The rapid development of science and technology, and the proliferation of research and discoveries, are promoting changes in industrial property law because in addition to traditional concerns, questions are being asked about the nature of innovation and whether it is moral or immoral to patent a given development.

3.9.1.1. Property rights are intended to be international, so as to protect inventions as effectively as possible. Agreements on intellectual property rights in the business context establish a set of rules, some of which explicitly concern biotechnology.

3.9.2. In addition to the World Intellectual Property Organisation (WIPO), there is the European Patent Office (EPO), which only provides for a joint patent issuing procedure, with different application procedures remaining at national level.

3.9.2.1. A single Community patent must therefore be introduced without delay.

3.9.3. The main difference between European and US patent law is that in the United States only the original inventor has the right to take out a patent, rather than the first applicant.

3.9.4. Positive law and patentability in biotechnology

Three levels have to be considered: national, European and global. European law takes precedence over the other levels, since a European directive prevails over national law, which must conform with the directive.

3.9.5. There is no doubt that US decisions and the position of the European Patent Office, which obviously bases itself on the provisions of the European Patent Convention, have complicated the situation against a background of intensified economic competition. America has a competitive advantage, which may be an obstacle to innovation in Europe or even encourage relocalisation of European research activity. There is fierce global competition in the life sciences sector between American and European research laboratories and a race to protect discoveries; this can be confirmed by considering applications lodged with the EPO.

3.10. The European directive

After many setbacks, Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 now stipulates that a clear distinction must be drawn between discoveries that are by their nature unpatentable and inventions that are. Thus the human body, at any stage in its formation or development, including germ cells, cannot be patented. The directive sets out certain exceptions based on considerations of public policy and morality.

These are:

- human cloning processes;

- processes for modifying the germline genetic identity of human beings;

- use of human embryos for industrial or commercial ends;

- processes for modifying the genetic identity of animals that cause them unnecessary suffering.

The directive tasks the European Group on Ethics with evaluating the ethical aspects of biotechnology, e.g. by fixing the scope of protection granted, taking many of the European Parliament's concerns into account. This directive should have been transposed into Member States' national law by 30 July 2000. It has many implications, given its binding nature, both in terms of the European Patent Convention and at international level.

3.11. Biotechnology and bioethics

The Committee again refers to its opinion "Science, society and the citizen in Europe"(3).

3.11.1. Since the 1975 Asilomar Conference, a large number of bioethics committees have addressed issues relating to all life science studies or medical applications that are likely to pose problems of respect for human dignity, the right of consent or the principle of non-discrimination. Such committees will now have a significant influence on positive law because they provide answers to often anxious questions from the public and because, since their pronouncements are consensus-based, they express the state of the "collective conscience" on bioethical problems.

3.11.2. In 1997 the International Bioethics Committee (IBC) drew up the Universal Declaration on the Human Genome and Human Rights.

In 1997 the Council of Europe drew up the "Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine".

3.11.3. Since 1998, the European Group on Ethics has regularly issued opinions on Community directives or regulations. The "doctrine" evolving from these opinions is analogous with that of the Council of Europe, with prime importance placed on human dignity, and on banning patents on the human body, IPRs, reproductive cloning, etc.

3.11.4. The international approach to these bioethical questions demonstrates that an international awareness, also at European level, is evolving with regard to these many and very vexed issues.

3.11.5. But questions need to be asked about the emergence of a bioethics law that reflects both modern value systems and a perceived need to erect safeguards in the path of scientific progress.

3.11.6. As the chairman of the European Group on Ethics noted in a recent statement: "There surely cannot be a level playing field between an all-powerful and prevailing science, even if it is contested, and a disarmed and uncertain ethical stand, even if it is strongly represented in the political debate"(4).

3.12. Biotechnology and public opinion

3.12.1. It is difficult to discern a single global public opinion about the implications of biotechnology; cf. the divergence between American and European consumers on GMOs.

3.12.2. Sensitivity to certain issues varies between countries depending on philosophy, religion or historical experience (cf. the Nordic and Mediterranean countries).

3.12.3. There are some points of convergence, however:

- People have a keen interest in and awareness of biotechnology applications. In Europe, public opinion is split between hope and anxiety.

- Europeans consider the benefits to outweigh the risks with respect to developing biotechnology for health purposes, including genetic diagnostics. On the other hand, public opinion in Europe is unfavourable towards transgenic foodstuffs. Other applications - such as fine chemicals production and bioremediation - are less controversial.

- Another trait that seems to be typical of the public debate in Europe generally is the low level of education and information of ordinary people. This is exacerbated by the timid and overcautious, or abstruse, debate conducted by most researchers, or by pseudo-experts.

- Only if all people become engaged in the ethical and political debate on biotechnology can there be smooth progress without the upheavals and polemic generated throughout Europe by the GMO debate.

4. Specific comments

4.1. Challenges

4.1.1. To mobilise research so as to capitalise on the opportunities provided by new and traditional technologies.

4.1.1.1. Plant transgenesis offers many potential benefits: a wide range of applications, meeting new needs, reducing the use of phytosanitary products and the possibility of developing new products.

4.1.2. To harness the economic benefits of GMOs while conforming with the European agricultural model.

4.1.2.1. Farmers must be guaranteed access to these new techniques, but they should maintain some independence from agrochemical companies while assuming the responsibility that falls to them in this connection.

4.1.3. To provide a response to the legitimate concerns of consumers and the general public in Europe. The technical and economic aspects of research and research findings must be explicitly separated in the minds of the general public.

4.1.3.1. The European Union must allow its consumers to benefit from the potential of transgenetic techniques by providing guarantees of the safety, origin and nature of food products.

4.2. Strategy

4.2.1. To create a context in which consumer support can be won.

4.2.1.1. This strategy means dispelling fears that are sometimes unfounded, offering a choice of products and involving consumers and the general public in the debate.

4.2.2. To manage the use of biotechnology.

4.2.2.1. The European Union must master the scientific aspects of genetic engineering to ensure that discoveries are used for the maximum benefit of people.

4.2.3. To clarify responsibilities.

4.2.3.1. Public authorities, businesses, farmers and consumers must be made accountable in the spheres that are relevant to them: the precautionary principle must prevail(5).

4.2.4. There must be a strategic vision of the life sciences and biotechnology in the context of a knowledge-based Europe.

4.2.4.1. The ESC considers the task of informing the general public of the European Community regularly and creatively about developments and the pace of progress in life sciences and biotechnology to be of paramount importance; in the medium and long term this is certainly consistent with the key Community objective of establishing a knowledge-based society.

4.2.4.2. Within the above framework, management of the relationship between European society and life sciences and biotechnology must be consistent with the Community action plan on learning which is in the pipeline, a plan that is based on the principle of life-long learning and its development using information technologies.

4.2.4.3. The action plan will require various integrated Community policies in the sphere of education, in particular:

- 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 and the ethical code relating to it.

4.2.4.4. The Committee believes in particular that obstacles can be removed and that this requires a system of lifelong learning which gives everybody the means of interpreting information and checking the validity of their knowledge(6); this will enable all Europeans not only to access and acquire knowledge, but also to be involved in:

- assessing the validity of relevant knowledge;

- monitoring its scope and rate of application;

- defining a bioethical code in this sphere.

4.2.4.5. In any event, the Committee expects the Commission strategy to provide for:

- responsibility for developing pilot education programmes to inform the general public about progress achieved in the life sciences and biotechnology, and the avenues opened by these advances;

- a minimum obligation to coordinate related measures taken at national and European level in order to establish and apply certain rules in research, both in the public and private sector.

4.3. General principles

- Prevention and precautionary principle: the precautionary principle must prevail and be applied at every stage, also in the context of biomonitoring. This principle must be recognised and applied at international level.

- Information and transparency: transparency at every stage by providing information makes it possible to dispel fears and include the general public in the democratic process.

- Accountability: measures must be taken and those who take decisions about the production of an approved GMO must bear the cost of damage or inconvenience.

4.4. Proposals

4.4.1. Evaluate

4.4.1.1. Agree on an internationally recognised and accepted definition of the precautionary principle.

4.4.1.1.1. The meaning and scope of the precautionary principle must be better clarified at Community level, with the aim of establishing a single definition in order to facilitate application of the principle and avoid disputes and problems of consistency between national, Community and international rights.

4.4.1.2. Ensure the legitimacy of committees and European expert committees by guaranteeing independence, multidisciplinarity and transparency.

4.4.1.2.1. The human, financial, material and logistical resources of these committees must be strengthened so that cases can be properly evaluated. If the consultation process is broad-based and collective it will be independent. Participation of qualified representatives of the social groups involved in the debate will provide assurance with respect to procedures and the appointment of experts.

4.4.1.3. Improve the method of evaluation and carry out studies on:

- environmental impact: experts must have exact information about the environment in which GMOs are to be introduced in order to eliminate grey areas in environmental issues;

- agri-foodstuff and industrial procedures.

4.4.1.4. Widen committees' evaluation remit.

4.4.1.4.1. Civil society requests information on the impact of GMOs on the environment, fauna, animal stock, nutritional risks and real economic gains.

4.4.1.5. Formalise the global and multidisciplinary approach.

4.4.1.6. Regularly evaluate issues and ensure that decisions are reversible.

4.4.1.7. The various committees must be interlinked and there must be a system for socially validating their work.

4.4.1.8. Harmonise and guarantee the complementarity of evaluation and authorisation procedures.

4.4.1.8.1. It is crucial that agreement be reached on evaluation methods in order to avoid incoherence and to check the compatibility of evaluation and decision-making criteria.

4.4.1.9. Strengthen the role of the Council of Ministers as the ultimate decision-maker.

4.4.2. Encourage

4.4.2.1. Ensure that the European Union is involved in GMO research.

4.4.2.1.1. Transgenesis and genomics are scientific and economic challenges for public and private research, agriculture and the food sector, independence from international groups.

4.4.2.2. Open new fields of research:

- respond to questions still being raised about GMOs: detection of GMOs with fixing of European standards; environmental assessment;

- give priority to quality initiatives: Europe must give priority to strategies designed to improve food quality in order to maintain its autonomy, ability to choose and food heritage.

4.4.2.3. Guarantee the status and independence of the European Community by promoting a balance between spheres of research.

4.4.2.3.1. The European Union must encourage the development of a balance between traditional research, alternative solutions and understanding of the genome by discussing issues of biosafety in more detail.

4.4.2.4. Involve developing countries in the opportunities provided by transgenetic research.

4.4.2.5. Protect the assets of European intellectual property.

4.4.3. Monitor, hold accountable, control

4.4.3.1. Practise and step up biomonitoring.

4.4.3.1.1. Biomonitoring is a system for biological monitoring of plant cultures produced from genetically modified organisms that are on the market.

4.4.3.2. Establish an intermediate stage between field studies and authorisation for national cultivation by creating special geographical zones where the impact of GMO can be evaluated under real conditions.

- Collect and collate basic agronomic and environmental reports.

- Take specific measures.

- Establish new methods of managing cultivation practices.

- Study the impact of GMOs on the environment, health and farming practices.

4.4.3.3. Guarantee farmers access to new and traditional techniques, and allow them to remain autonomous vis-à-vis funding bodies.

4.4.4. Define responsibilities

- European institutions.

- State: public authorities must define responsibilities before decisions are taken and shoulder these responsibilities once decisions have been taken.

- Experts, whose advice supports decision-making processes.

- Industry, which must meet public expectations in respect of strategies, transparency and guarantees.

- Farmers: a general debate must take place and legal measures be introduced to clarify the responsibility of producers.

- Consumers: must be provided with choices, educated and informed about GMOs and their applications.

4.4.5. Inform and provide choice

- Aim to achieve transparency: this applies to every stage in research relating to food applications.

- Ensure clear and legible labelling and traceability for all agricultural and food products in the European Union containing GMOs.

- Establish traceability: a safety feature that is relevant for every stage of production.

- Implement statutory labelling provisions:

- set a threshold beyond which production will be considered GM or non-GM;

- adopt approved analytical methods and harmonise at the international level.

- Supplement European legislation:

- adopt Community rules on:

- seeds

- animal feedstuffs containing GMOs

- Label intermediate products.

- Discuss the future of non-GMO production.

- Recognise consumer expectations at the international level: Europe must call for risk-benefit criteria to be adopted in all negotiating forums: Codex Alimentarius Commission, the World Trade Organisation (WTO) and the Biosafety Protocol.

- Continue the debate:

- establish an ongoing debate on scientific advances;

- define a communication strategy to enhance the coherence and transparency of communication policy;

- initiate and broaden discussions;

- sensitise and educate young people about life sciences;

- provide objective information: government must guarantee the plurality of the debate.

5. Conclusions

5.1. An extraordinary range of issues is at stake - scientific, financial, legal, ethical and political - in relation to biotechnology applications.

- Current breakthroughs concern only the developed countries: the United States, Europe, Japan and, in the future, parts of Asia.

- The developing world is an onlooker, for reasons that have less to do with scientific knowledge than with the amount of financial resources that are needed. This situation is all the more worrying since developing countries are also affected by the need to increase food resources, by health requirements and by problems of pollution and the environment.

- It is very important that this global dimension of biotechnology should not be obscured by the debate between developed countries. The ethical debate is driven above all by the question of respect for human dignity in the face of advances in scientific knowledge and of economic competition. It must also address the issue of solidarity as an essential criterion: solidarity between rich and poor countries and solidarity with regard to the accepted responsibility to protect the environment, which will require more public funding to combat poverty and food insecurity.

5.2. 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 a Community patent. A creative approach is called for, with greater emphasis than before on stimulating and providing incentives and opportunities. In conclusion, ensuring the EU's place in the biotechnology sector means acting with determination and resolve.

5.3. The Committee is prepared to play a role here by providing information, initiating an ongoing debate, ensuring a rational choice of objectives to promote the creation of jobs and new businesses and maintaining links with civil society.

Brussels, 21 February 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) OJ C 221, 7.8.2001, p. 1.

(2) OJ C 221, 7.8.2001, p. 1.

(3) OJ C 221, 7.8.2001, p. 1.

(4) Ms Lenoir, President of the European Group on Ethics, EGE opinion, 1998.

(5) See ESC opinion, OJ C 268, 19.9.2000, p. 6.

(6) OJ C 157, 25.5.1998.