A4-0027/96

Resolution on the Commission Communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage (COM(94)0219 - C4-0246/94)

The European Parliament,

- having regard to the Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee on Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage (COM(94)0219 ((OJ C 276, 3.10.1994, p. 5.)) - C4-0246/94),

- having regard to the chapter on Biotechnology and Its Diffusion, from the Commission's White Paper on Growth, Competitiveness and Employment (COM(93)0700 - C3-0509/93) ((OJ C 20, 24.1.1994, p. 7.)) and to Parliament's resolution of 9 March 1994 on the White Paper ((OJ C 91, 28.3.1994, p. 24.)),

- having regard to the Commission Communication to Parliament and the Council on Promoting the Competitive Environment for the Industrial Activities Based on Biotechnology within the Community (SEC(91)0629),

- having regard to the Convention on Biological Diversity, ratified by the European Union in December 1993 ((OJ L 309, 13.12.1993, p. 1.)), and to Parliament's opinion of 25 June 1993 on the proposal for a Council Decision concerning the conclusion of the Convention ((OJ C 194, 19.7.1993, p. 401.)),

- having regard to the report of the Committee on Research, Technological Development and Energy and the opinions of the Committee on Budgets, the Committee on Economic and Monetary Affairs and Industrial Policy, the Committee on Legal Affairs and Citizens' Rights and the Committee on the Environment, Public Health and Consumer Protection (A4-0027/96),

A. whereas it is vital to the Community, its economic development and to the process of shaping public opinion, which exerts a key influence on that development, that the Commission should give its views on the topic of Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage,

B. whereas biotechnology encompasses not only genetic engineering but a range of other areas important to the development of the European economy, ecology and public health; whereas consequently other areas should be included in the consideration given to biotechnology and appropriate research or support programmes developed,

C. whereas ethical aspects must be safeguarded in biotechnology policy,

D. whereas the biotechnology policy of the European Union as a key area of research, innovation and production can make an important contribution to sustainable development, competitiveness and employment, but must at the same time be in line with other policy objectives of the Union, particularly in the fields of agriculture, the environment, health, research, technological development and competitiveness,

E. whereas there is a clear recognition at both European and international level that biotechnology is one of the most promising technologies to promote environmentally sustainable development and contribute to solving environmental problems, and whereas the conclusions of the Essen European Council called for full account to be taken of the need for health and environmental protection and the need for European industry and agriculture to be competitive,

F. having regard to the observations in the Commission Communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment and the observations to which the Council subscribes that:

(a) biotechnology has become one of the most promising and important technologies with a view to sustainable development in the next century,

(b) modern genetic engineering, on which biotechnology is in part based, is a key technology for the next century and can be of even greater benefit in meeting human needs in the fields of agriculture, food and health,

(c) the combination of traditional and modern biotechnologies makes it possible to develop new products and extremely competitive procedures for numerous industrial and agricultural activities,

(d) this can be a powerful source of radical changes in competitive position and growth potential in many activities,

(e) the significant potential of biotechnology is particularly evident firstly in the pace of international innovation and secondly in the demonstrable increase in productivity and value creation in the case of products produced using biotechnology,

(f) this significant potential of biotechnology can help to improve the environment by reducing pollution and to improve health by preventing or curing diseases or other physical problems,

(g) biotechnology is already in use in many fields - agriculture, processing of agricultural products, mass and special chemicals, pharmaceuticals, plant protection products, decontamination and waste treatment and disposal,

(h) modern biotechnology will be capable of making significant and lasting contributions to new energy and fuel markets and industrial marketing opportunities for agricultural commodities,

(i) biotechnology will play an extremely important role in these fields by improving productivity and creating an employment market for highly qualified workers and will contribute to maintaining or even increasing local activity and employment,

G. whereas enterprises take into account various criteria in decisions on the location of their investments in research and development or production activities, particularly the existence of an economic, social and regulatory environment favourable to biotechnology, such as availability of venture capital, nearness to the market, qualifications of the labour force, scientific environment and global innovation management,

H. whereas the communication does not take account of the fact that legislation on safety and product assessment in the EU is not the only factor responsible for the fact that industry in the EU is at a competitive disadvantage vis-à-vis the United States and Japan,

I. whereas the European Union must equip itself with an effective policy on biotechnology incorporating the great potential demonstrated by the most recent scientific discoveries,

J. whereas the positive, cost-effective development of biotechnology is chiefly contingent on the social acceptability of biotechnology and its products and public confidence in those products,

K. whereas

(a) a coherent, clear legal framework valid throughout Europe is needed in order to improve the competitiveness of the European biotechnology industry and increase consumer confidence in European Union policy in this sphere,

(b) the legal framework for biotechnology must be constantly brought into line with the latest scientific findings, and whereas a flexible, uniform and speedy application of the relevant legal provisions is needed in order to guarantee the positive development of biotechnology and, in particular, plant location decisions by the industry which will be beneficial for the EU,

(c) the experience gained with the application of Community law in the sphere of biotechnology will pave the way for its modernization with no increased safety risk, and whereas a simplification of the procedures, above all those to promote the activities of small and medium-sized undertakings (SMUs) in the sphere of biotechnology, is desirable,

(d) current legislation, in order to keep it up to date, has to take account of technological progress and international standards,

L. whereas the licensing or marketing of biotechnological products and processes should take into account overriding public interests,

M. whereas an analysis of society's needs and the socio-economic impact of new production methods and products helps to increase acceptance and prevent undesirable developments, thereby creating a sound basis for investment decisions and competitiveness,

N. whereas the Commission communication almost exclusively considers 'modern biotechnology', i.e. genetic engineering, which leads to a misleading evaluation of biotechnology as a whole,

O. whereas all internal and external changes to Directives 90/219/EEC and 90/220/EEC must be based on the principle of maintaining or improving safety for people and the biosphere and must be consistent with the spirit and the letter of the relevant European Parliament decisions,

P. whereas the European Union must promote the development or creation of biotechnology centres and networks of excellence to enable close collaboration to be established between the research and industry sectors,

Q. whereas Communication COM(94)0219 is based on a recognition that none of the indicators currently used - such as job creation and the number of patents - places the Community's biotechnology industry in the vanguard in relation to international competition and whereas this is associated with massive disinvestment in Europe, to the benefit of the United States and Japan,

R. whereas

(a) the majority of biotechnology products licensed for marketing in the Union are of non-Community origin,

(b) experience and scientific evidence acquired to date at both European and international level have served to better evaluate the safety of biotechnological techniques, in particular genetic engineering, for human health and the environment,

(c) the experience gained so far has allowed academia and industry to improve existing competent and safety-ensuring practice in the use of biotechnology,

S. whereas the Union must adopt statutory provisions as quickly as possible to protect intellectual property rights in respect of inventions in the biotechnology sector,

T. whereas the regulatory reform outlined in the Communication is based on Member States' experience with existing Directives 90/219/EEC and 90/220/EEC, and that of international competitors, which confirms that much can be done to streamline and simplify the existing system without compromising effectiveness or safety,

U. whereas specific, product-related regulations in the sphere of biotechnology must on no account be less strict than the practical requirements laid down in horizontal regulations, in particular the environmental impact assessment pursuant to Directive 90/220/EEC; horizontal regulations must be retained as catch-all provisions,

V. whereas, while it has constantly maintained the need for horizontal legislation, the European Parliament has also taken the view that it is important to adapt Community legislation in the light of modern biological techniques which are currently in use in many sectors of production,

W. whereas public health and environmental safety must be protected,

X. whereas enterprises operating in Europe actively promote the development of basic research, particularly by means of increased participation in the drawing up of research programmes and in pursuing 'useful' research - which is likely to produce practical results - and by seeking ever closer cooperation between industry and its basic-research partners; and whereas the EU should encourage industry and technological innovation,

Y. whereas an innovation network encompassing publicly-funded research, industrial research and manufacturing undertakings, including SMUs, is needed to promote biotechnology in the Community,

Z. whereas

(a) determination of the research agenda must significantly enhance European strength in the basic life sciences whilst encouraging the ability to exploit technological innovations,

(b) the research agenda should not be determined by industry alone, to ensure that the freedom of basic research is preserved,

1. Calls on the Commission urgently to review the EU biotechnology policy as set forth in the above-mentioned and other communications on the basis that:

(a) the White Paper acknowledges that biotechnology is not only one of the most promising and crucial technologies for sustainable development but also of general importance to Europe's economic and social future;

(b) the regulatory process must be objective, proportionate and science- based;

(c) the proposed regulatory revisions must result from a wide consultation with the competent authorities who must be responsible for the approval procedures under Directives 90/219/EEC and 90/220/EEC so as to safeguard consumer interests, ethical interests and the competitiveness of European producers;

(d) proposed changes will help to increase the certainty of existing regulatory rules, requirements and competence from the laboratory to the market;

(e) the proposed changes must not lead to increased uncertainty and legal instability for the biotechnology industry or run the risk of adding to bureaucracy;

(f) the new rules must not reduce harmonization;

(g) streamlining must strengthen European competitiveness by better aligning the European regulatory system with other international commitments, including those covering trade and other international practice;

(h) the proposed changes must provide an adequate explanation of the remedies to be adopted to increase competitiveness;

(i) the proposed changes must not only reflect the experience gained so far but also aim to turn the EU regulatory system into an international reference point for quality and efficiency;

(j) further evidence must be gathered concerning the safety of GMOs;

(k) effective measures are needed to support biotechnology in order to secure jobs in this field in the face of international competition, to provide an indication of investment dynamism and to halt the process of deindustrialization in Europe;

2. Calls on the Commission to submit a supplementary communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage in which the importance for growth, competitiveness, employment and environmental protection in the EU of the areas of biotechnology glossed over in communication COM(94)219 final is outlined in detail and corresponding proposals for the promotion of those areas are put forward. In that connection, the Commission should set priorities, indicating in which areas measures and investments are most urgently needed and how they could best be carried out. Special emphasis should be placed on the following biotechnological possibilities:

(a) environmental protection, e.g. soil and water purification by organisms and other ecologically sound biological decontamination processes, and the reduction of fertilizer and pesticide use in plant production through the development of suitable varieties

(b) energy production from biomass and exploitation of its energy potential through fermentation and/or combustion in local combined heat and power plants,

(c) raw material extraction (bioproducts, ore leaching from natural deposits and spoil),

(d) health and therapeutics,

(e) food production,

(f) recycling and waste disposal.

The importance of risk and technology impact assessment should also be evaluated.

3. Further calls on the Commission in order to create a stable and predictable policy and regulatory climate for EU-based biotechnology, thus enabling it to open up new prospects, to promote its international competitiveness, to favour investment within the European Union, and in particular to:

(a) improve the certainty of the law and thus the likelihood of positive plant location decisions in the sphere of biotechnology in the Community by ensuring the resolute and, as far as possible, uniform enforcement of the relevant Community legislation throughout the Community (certainty and uniformity of enforcement), inter alia by initiating legal proceedings against all those Member States which have not yet properly transposed Directives 90/219/EEC and 90/220/EEC into national law;

(b) keep all regulations under constant review for their relevance and effectiveness and ensure that regulatory structures are based on scientific evaluation of real and measurable risk;

(c) develop a transparent consultation process with all participants in regulation before putting forward new regulatory proposals;

(d) make any decisions on regulatory regimes on grounds of proportionality and in full compliance with existing public health and safety rules;

(e) inform the European Parliament regularly of biotechnology products which have satisfied regulatory requirements through scientific examination and pose no health or environmental risks under Directive 90/220/EEC;

(f) keep horizontal legislation, above all the binding environmental impact assessment in product-related legislation, intact as well and adjust it in the light of the latest advances in knowledge in order to guarantee safety;

(g) present to the Parliament and Council without delay a proposal for a legal instrument to provide oversight for export of GMOs to non-Member States, based on a system of prior informed consent, as well as legislation on the safe transport of GMOs within the EU and identify existing legislative gaps such as tolerated release of GMOs in waste streams and secondary environmental impacts;

(h) in connection with the proposed revision of Directive 90/219/EEC, not to propose a procedure whereby licences are granted automatically following the expiry of a time-limit, but rather to create the legal conditions which enable the authorities responsible for granting licences to comply with the time-limits set;

(i) outline the proposed changes to the legal provisions laid down in Directives 90/219/EEC and 90/220/EEC at a public hearing, thereby establishing an open climate of dialogue in the EU and fundamental public confidence in the policies and legal framework of the EU in the sphere of biotechnology;

4. Calls on the Commission

(a) to take into account the conclusions of Parliament's aforementioned opinion of 25 June 1993 on the need for a legally binding protocol to the Biodiversity Convention to ensure capacity building, particularly for developing countries, incorporating the mechanisms best suited for national purposes to evaluating safety and managing foreseeable risks including monitoring, research and the exchange of information;

(b) to entrust the European Environment Agency with the task of reviewing long-term changes in European biodiversity due to released species, in order to obtain reliable data and bases for decision-making, particularly before the release of pest-resistant plants and organisms;

(c) to take into account the positions adopted by Parliament when representing the European Union on international fora in which policies concerning biotechnology are developed;

5. Calls on the Commission to promote better information on biotechnology and on the decision-making procedures of the various committees responsible;

6. Restates the principle, expressed many times, that the purpose of biotechnological innovations must be to achieve an objective improvement in the quality of life and to ensure that no harm is done to public health;

7. Calls on the Commission and the Member States actively to encourage public dialogue by providing comprehensive, accurate and readily understandable information on genetic engineering research and production, its prospects and risks, rather than merely trying to secure public acceptance, thereby enabling citizens to express informed political views on the social desirability of genetic technology and its products;

8. Takes the view that it is essential to ascertain the competence of experts and assessment committees, now that the Commission has explicitly stated - although it only applies to product evaluation - that it will as a rule follow expert scientific advice. The Commission should give the European Parliament comprehensive information about the competence and composition of committees of experts on biotechnology who are already working or are to be called upon in the future. It must be ensured that their activity is confined to giving an expert opinion and does not interfere with the competence of democratically legitimized legislators;

9. Calls on the Commission

(a) to promote public understanding of the benefits and risks inherent in biotechnology and of the work of the Group of Advisers on the Ethical Implications of Biotechnology and take account of their recommendations to improve EU policy and the legislative process;

(b) to encourage the Group of Advisers to address concerns raised by the European Parliament;

(c) continually to update its own instruments for analysing and evaluating the ethical aspects of the application and development of biotechnologies and to report annually to the European Parliament;

10. Calls on the Commission to bring about comprehensive labelling of genetically modified products, including genetically modified seeds, in accordance with the principles of veracity and clarity;

11. Considers the placing of safety regulations for laboratory and industrial applications of gene technology on the same footing as unacceptable in view of the different risk levels involved;

12. Calls on the Commission, in collaboration with the Member States, to set up a database accessible to everyone on products derived from biotechnological techniques and licensed for marketing within the European Union; this database must, inter alia, indicate the type of product, the possible active principles, the suggested use and the result of the environmental impact assessments;

13. Calls on the Commission to include in the Explanatory Memorandum on its proposals for amending Directives 90/219/EEC and 90/220/EEC a detailed comparative study of existing legislation in these fields and possible trends leading to changes in Japan, the USA and the EU;

14. Calls on the Commission to extend product liability legislation to goods and services issuing from genetic engineering as a means of reinforcing the responsibility of research and industrial enterprises;

15. Calls on the Commission to strengthen relations between universities, major research institutes, the industry and SMUs in the sphere of biotechnology in order to make the Community-wide innovation system more flexible and more efficient, i.e. to make it a proper innovation network;

16. Calls on the Commission and the Member States to create a more favourable policy climate for biotechnology companies, especially those in the SMU sector, which are an essential vehicle for innovation, growth and job- creation; this should include providing them with advice on innovation, sound financial management and funding and cooperation, and the development of a holistic approach which includes start-up capital funds, open capital markets (adopting a longer-term approach), streamlined and proportionate regulatory regimes, adequate protection of inventions, and supportive tax and other fiscal measures; where licensing procedures are concerned, SMUs should receive explicit support from the authorities and exemption from handling fees;

17. Calls on the Commission to support and motivate European research institutions to strengthen their expertise in the basic life sciences, in particular through increased funding for biotechnology research within the 5th Framework Programme;

18. Calls on the Commission to consider the possibility of establishing, as part of the specific EU biotechnology aid programme, a special aid scheme for small and medium-sized biotechnological undertakings which would assist SMUs in particular with research, development and marketing, and, possibly in connection with the review of the EU framework research programme scheduled for 1996, to put forward a corresponding proposal;

19. Considers greater emphasis on research into risks, environmental compatibility and appraisal of the implications of technology to be necessary;

20. Calls on the Commission to submit the study announced in the communication on the assessment of the need for networks, the type of networks most conducive to the optimal functioning of science parks and cooperation among technology parks in the European Union, together with a report on the initiative in the sphere of biotechnological training referred to in the communication;

21. Calls on the Commission to submit a communication on the socio-economic impact of genetic engineering in the various sectors, on the basis of which the use, risks and desirability of products of genetic engineering can be debated, together with a study of the employment potential of genetic engineering, comprising the following aspects:

- the number of people directly employed in the field of genetic engineering by enterprises;

- the number indirectly employed;

- the number of people employed at universities, research establishments and laboratories in the field of genetic engineering;

- an analysis of the impact of genetic engineering on employment in agriculture, the food industry, the chemical industry, the pharmaceuticals industry and medicine, taking account of various scenarios;

22. Calls on the Commission to establish, in a democratic manner, criteria for the environmental, social, socio-economic and legal safety of modern biotechnology.

23. Calls on the Council to reassess the Commission Communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage (COM(94)0219) in the light of the European Parliament's position as outlined in this report, to confirm that the substance of Directives 90/219/EEC and 90/220/EEC must be maintained intact, and to accept proposals to amend them only if they seem justified and necessitated by advances in knowledge;

24. Calls on the Member States to fully implement Directives 90/219/EEC and 90/220/EEC, and

(a) to make the results of their experiences available in order to encourage transparency with regard to any undesirable effects on human health and the environment;

(b) when transposing them into national law, to ensure that damaging effects on human health and the environment are avoided, ethical interests and hence public acceptance are taken into account and favourable industrial and research policy conditions are created for genetic engineering;

(c) to encourage mutual recognition where possible;

25. Instructs its President to forward this resolution to the Commission, the Council and the governments of the Member States.