REPORT 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) Part A: Motion for a resolutionOpinions
9 February 1996
Committee on Research, Technological Development and Energy
Rapporteur: Mrs Hiltrud Breyer
By letter of 13 June 1994 the Commission forwarded to Parliament a Communication on Biotechnology and the White Paper on Growth, Competitiveness and Employment: Preparing the Next Stage.
At the sitting of 12 December 1994 the President of the European Parliament announced that he had referred this communication to the Committee on Research, Technological Development and Energy as the committee responsible, and to 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 for their opinions.
At its meeting of 30 November 1994 the Committee on Research, Technological Development and Energy appointed Mrs Hiltrud Breyer rapporteur.
The committee considered the White Paper and the draft report at its meetings of 23 February 1995, 21 March 1995, 27 September 1995, 14 November 1995, 22 November 1995, 20 December 1995 and 5-6 February 1996.
At the last meeting it adopted the motion for a resolution unanimously.
The following took part in the vote: Adam, chairman and vice-chairman; QuisthoudtRowohl and McNally vice-chairmen; , Breyer, rapporteur; Ahern, Argyros, Arroni (for Pompidou), de Gaulle, Desama, Estevan Bolea, Ferber, Graenitz (for Nencini), Heinisch (for Mombaur), Holm, Izquierdo Collado, Jouppila, Lange, Linkohr, Malerba (for Scapagnini), E. Mann (for Rothe), Marset Campos, Plooij-van Gorsel, Stockmann (for West), Tannert, Trakatellis (for Soulier) and W.G. van Velzen.
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 are attached. The explanatory statement will be published separately.
The report was tabled on 9 February 1996.
The deadline for tabling amendments will appear in the draft agenda of the sitting at which the report is to be considered.
A. MOTION FOR A RESOLUTION
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[1] - 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)[2] and to the Resolution of the European Parliament concerning the White Paper[3], adopted on 9 March 1994,
- 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[4] by the European Union in December, 1993, and to its resolution[5] adopted on 25 June 1993,
- 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;
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 must not run counter to specific, 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 the intellectual property rights arising from discoveries and inventions in the biotechnology sector which will reward the talent and inventiveness of researchers funded by charities, national and European, and companies, and which will lay a secure foundation for future funding of research,
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 European regulatory system into an international reference point for quality and efficiency;
j) further evidence must be gathered concerning the safety of GMOs;
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 the European Parliament's report 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 Member States.
B. EXPLANATORY STATEMENT
The explanatory statement will be published separately.
OPINION
of the Committee on Budgets
Letter from the chairman of the committee, Mr Detlev SAMLAND, and the rapporteur, Mr Olli REHN, to Mr SCAPAGNINI, chairman of the Committee on Research, Technological Development and Energy
Brussels, 19 July 1995
Subject: 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 final - C4-0246/94 - COS 0204)
Dear Mr Scapagnini,
At its meeting of 18 July 1995 the Committee on Budgets considered the above proposal and came to the following conclusion.
The present communication represents the Commission's response to the recommendations of the White Paper on Growth, Competitiveness and Employment concerning modern biotechnology. In this document the Commission acknowledges modern biotechnology as one of the fields offering the greatest potential for innovation and growth and considers that many areas could benefit from its application such as healthcare, industrial chemicals, food and feed services, agriculture and the environment. The Committee on Budgets would support this view.
The proposal outlines the Commission's present activities in this field and measures to be taken in the near future and beyond.
On the budgetary implications of the Union's activities to enhance modern biotechnology, the communication refers to the appropriations of the Community budget to be committed to three specific programs in the Fourth Framework Programme (Biotechnology; Biomedicine and Health; Agriculture and Fisheries) which amount to ECU 1572m. This sum represents an increase of ECU 741m compared to the Third Framework Programme.
With respect to this budgetary programming and taking into account the wide range of measures and activities proposed, which have considerable financial implications, the Committee on Budgets would like to stress that the financing of all measures in the field of biotechnology has to be undertaken within the limits of the present allocations committed for research in general and the mentioned programs in particular.
The implications of the communication for the application of biotechnologies in industry can quite deliberately not fully be taken into account in the 4th Framework Programme. The new proposals to refinance the programme with targeted actions may respond to that need, but the 4th Framework Programme refinancing has not yet been considered within the Financial Perspectives.
Although the Committee on Budgets does understand that there may occur further financial needs for the support of biotechnology in the future, there is no specific mention of such increased demands in the communication. The Committee therefor supports the approach taken in the report but reminds the committee responsible that any future modifications of the financial commitments of the Community must undergo the procedures established in the Treaty and the Financial Regulation.
Yours sincerely,
Detlev Samland Olli Rehn
The following were present for the vote: Samland, chairman; Tillich and Porto, vicechairmen; Rehn, draftsman; Bébéar, Bösch, Brinkhorst, Christodoulou (for Bourlanges), Colom i Naval, Fabre-Aubrespy, Giansily, Gredler, Haug, Joens (for Krehl), McCartin, Miranda, Müller, Rusanen (for Böge), Sandberg-Fries, Wemheuer (for Dankert) and Wynn.
O P I N I O N
(Rule 147 of the Rules of Procedure)
of the Committee on Economic and Monetary Affairs and Industrial Policy
for the Committee on Research, Technological Development and Energy
Draftsman: Mr Carlo Secchi
At its meeting of 25 January 1995 the Committee on Economic and Monetary Affairs and Industrial Policy appointed Mr Secchi draftsman.
At its meetings of 23 March, 30 May and 21 June 1995 it considered the draft opinion.
At the last meeting it adopted the conclusions as a whole unanimously.
The following took part in the vote: von Wogau, chairman; Katiforis and Theonas, vicechairmen; Secchi, draftsman; Areitio Toledo, Argyros (for Christodoulou), Barton (for Caudron), Billingham, Blokland (for de Rose), de Bremond d'Ars, Cassidy (for Friedrich), Cox (for Larive), Donnelly, Falkmer, Furustrand (for Moscovici), Garriga Polledo (for Imaz San Miguel), Gasoliba I Böhm, Glante, Harrison, Haug (for García Arias), Hautala, Hendrick, Herman, Hoppenstedt, Langen, Mezzaroma, Miller, Murphy, Peijs, Pérez Royo, Persson, Peter (for Kuckelkorn), Randzio-Plath, Rapkay, Read, Rönnholm, Schreiner, Skinner (for Ruffolo), Soltwedel-Schäfer, Starrin, Tappin (for Metten), Thyssen, Torres Marques, Valdivielso de Cué (for Spindelegger) and Watson.
Introduction
The White Paper on Growth, Competitiveness and Employment identifies biotechnology as one of the new sectors of research and product development which has great potential for our future in terms of economic growth, the development and dissemination of innovative ideas, contribution to employment and improvement of the quality of life. The Commission Communication to the Council, the European Parliament and the Economic and Social Committee, COM(94) 219 final of 1 June 1994, seeks to examine the situation in the sector and 'prepare the next stage' with particular reference to the regulatory framework and its suitability in the light of developments in the sector and the competitive situation within the Union and worldwide.
On 1 March 1995 the European Parliament voted against the proposal for a Council directive on the legal protection of biotechnological inventions, rejecting the conclusions of the Conciliation Committee which met on 23 January 1995.
However, this opinion will also take account of the new situation, and will therefore consider the main problems arising, including the possibility of patenting the results of biotechnological research.
As we have noted, the White Paper stresses that biotechnology can contribute greatly to Europe's economic future, in terms of employment and the quality of life. However, its development depends on the existence of a favourable economic, social and regulatory environment. Though there is a widespread consensus on this, the various needs and views in play make it difficult to arrive at broadly acceptable general positions. The undoubted immense potential of the sector and the increase in competition worldwide - with the risk that European industry may lose ground - are matched by fears concerning consumer protection and public safety and very delicate ethical questions. The Commission Communication examines some of these. However, this opinion will not enter into the debate, as the Committee on Economic and Monetary Affairs and Industrial Policy should concentrate on the aspects which concern it, though without losing sight of the ethical dimension.
However, given that biotechnology is still a controversial area, and is still little known to the public and often viewed in emotive terms, it would seem appropriate to emphasize the need for a public information and awareness campaign, to publicize achievements and to fuel a calm and objective debate. At the same time, more attention needs to be paid to the potential of the sector, the implications of its development from various points of view (consumer protection, safety, environment, possibilities for employment, change and improvement in lifestyles, etc.) so that not only the scientific community and industry but also the general public may form a calm, objective and informed view of the whole area. The Commission should set up a plan of action, in addition to the action already envisaged under the Fourth Programme of Community activities in the field of research and technological development (1994-1998).
1. Strengthening of research and development
The prospects for the sector also depend to a large extent on basic research, the successful development of new processes and new products, the dissemination of innovation in production, the involvement of as many undertakings as possible, particularly SMUs, the maintenance of a healthy competitive framework and the development of a knowledgeable and informed market sensitive to demand.
Basic research activities must involve all those who could work together effectively to produce joint results: universities, independent research laboratories and undertakings. Just as important is the dissemination of innovation, the passage from basic research to the application and marketing of new products. Tried and tested formulae (such as scientific and technological parks) and new approaches which facilitate the link between basic research and undertakings must be given maximum attention at the various levels of aid and support, including at European level.
For the European Union, the Fourth Programme of Community activities in the field of research and technological development (1994-1998) also takes biotechnology into consideration.
Over the five-year period, of an overall total of ECU 12,300 million, ECU 552 million is set aside for biotechnology, which corresponds to roughly 4.5%. This is certainly a very inadequate figure, although it should be borne in mind that financing from the European Union may have a multiplier effect, and that it will be supplemented by aid from the Member States.
The Fourth Programme of Community activities in the field of research and technological development (1994-1998) must therefore be monitored closely, in order to fine tune a suitable strategy for current and future developments in the sector in preparation for a further Union programme, in particular with regard to the following:
- identification of the strategic areas on which to concentrate in terms of innovative potential and general support for the objectives of the White Paper;
- coordination of action at Union level and national level;
- amount of resources available and mobilization of additional sources of support.
Finally, in support of research and development, special attention must be paid to involving SMUs. Small and medium-sized undertakings are not only already working independently (in niches) or in conjunction with larger undertakings, but they have considerable potential for the development of the sector, not least as seed-beds for new business activities.
2. Development of the regulatory framework
The current regulatory framework is based mainly on Directive 90/219/EEC on the deliberate release of genetically-modified microorganisms to the environment. There are also other 'horizontal' directives which cover the whole of the sector, which are still in the process of being transposed, a few specific directives on products (food additives, medicines derived from biotechnology, plant health products, bovine somatotropin (BST)). There are also various other proposals which have not yet been adopted.
The White Paper on Growth, Competitiveness and Employment stresses the need to reexamine the existing legal framework, both in the light of scientific progress and knowledge and in the light of experience.
Knowledgeable sources say that, the possibilities of rationalization and simplification are considerable, without any risk of compromising safety. Greater flexibility, which makes it possible to take account of technical progress and to respond appropriately to possible risks, could provide better consumer and environmental protection and at the same time encourage the competitiveness of undertakings.
The revision of these two directives and of the entire regulatory framework (the question of which was raised at the Corfu European Council where the Commission was asked to produce a report) should therefore be speeded up, with due regard also for the regulatory framework of our main competitors (principally the United States and Japan).
The proposal for a Council directive on the legal protection of biotechnological inventions, rejected by the European Parliament on 1 March 1995, was responding to the basic need to provide the Union as a whole with a homogeneous legal framework on the possibility of patenting the results of research in the sector. The fact that this proposal was not approved means that there is still confusion because of the different ways the subject is dealt with under the laws of the Member States, which leads to considerable discrimination and conflict, and which in effect obstructs the movement of patents within the Union. This is a glaring case in which the single market is not only at risk but in effect does not exist, not least because the Council of Europe's Strasbourg Convention on patents of 1963 (which did not envisage the patenting of animal breeds or plant varieties) makes it difficult to use the 1973 Munich Convention as a basis for registering biotechnological inventions with the European Patent Office.
The result is that European industry is penalized compared with its competitors, as demonstrated by the trend in research and development activities and the registration of patents in recent years. Available figures show that a significant amount of investment by European industry in research and development and in new products is being diverted, principally to the United States.
This situation, which is damaging to European industry, does not mean better protection of the consumer or the environment, since biotechnological products are in any case imported from countries (such as the United States) which have a more flexible regulatory framework and much greater legal protection of the results of research.
It therefore seems necessary to take a fresh look at the whole subject, taking note of the debate in the European Parliament, and to explore all those aspects which have emerged as controversial or at least unsatisfactory, in order to come up with a new proposal which would provide the necessary guarantees for consumers, the environment and safety in general without sacrificing a sector which is so promising for European industry, simply to the advantage of our competitors.
The Commission should therefore take all appropriate measures to encourage the exchange of ideas among all the parties concerned (industry, universities and research institutes, consumers, etc.), with the active involvement of the European Parliament, to avoid any further delays.
3. The prospects for European production in the global market
As we said in the beginning, the White Paper on Growth, Competitiveness and Employment recognizes the key role of biotechnology in the Union's economic and social development. In order to be able to exploit the potential of the sector to the full, various lines of action are identified, in addition to support for research and development activities and improvement of the regulatory framework, as described above. Emphasis is placed on measures such as tax incentives on investments, on how to find ways of offsetting the costs of research and development (as well as how to support these activities and improve coordination), on the need to clarify ethical questions, and so on. In the end, the basic problem is how to create a more favourable environment in which undertakings may develop and strengthen their competitive position.
The most important sectors involved are currently agri-foods, pharmaceuticals, veterinary products, plant health products, and in the near future organic chemistry.
In the light of the global competitive framework, which also dictates competition in the internal market, European industry must be in a position to meet two major challenges:
- competition in the internal market from foreign producers, and
- greater competitiveness in exports, which is all the more important given the major role of the agri-foods sector.
It would certainly be much better if business could take up these challenges within the European Union, rather than be forced to invest and produce in third countries because of the obstructions described above. Essentially, the problem is this: the European Union must choose whether to be simply a consumer, and therefore an importer of biotechnological products (since it is unlikely it can do without them) or also a producer, and therefore an exporter of such products, thanks to the competitiveness of a viable business structure with good prospects of development.
Conclusions
The Committee on Economic and Monetary Affairs and Industrial Policy therefore calls on the Committee on Research, Technological Development and Energy to take account of the following conclusions:
The Committee on Economic and Monetary Affairs and Industrial Policy,
1. In the light of the European Commission White Paper on Growth, Competitiveness and Employment, recognizes that biotechnology is one of the key sectors in the Union's economic and social development and in strengthening the competitive position of European undertakings in the world market;
2. Welcomes the Commission's Communication (COM(94)0219 final of 1 June 1994) and considers that the lines of action it contains should be updated in the light of recent developments and the considerations set out below;
3. Considers that structured development in the biotechnology field may well have a positive effect on employment, if it is possible to create a favourable climate for the development of undertakings: apart from greater legal certainty and a clearer framework for planning, this includes greater acceptance by society, which can be achieved by comprehensive information and debate;
4. Expresses its concern that European industry may lose ground to its foreign competitors because it is penalized by an obsolete and ambiguous legal framework;
5. In particular, considers that the legal framework should be improved and made more flexible in response to continuing developments in biotechnology and to experience, in order to encourage production which continues to comply with the demands of safety, consumer protection and the environment. This should, however, be achieved by updating without deregulating the Directive on the contained use of genetically modified micro-organisms (90/219/EEC) or the Directive on the deliberate release into the environment of genetically modified organisms (90/220/EEC);
6. In particular, with regard to possible patenting and legal protection of biotechnological inventions, calls on the Commission to draw up new proposals on the basis of a wideranging debate involving publicly the relevant groups in society, in order to seek a new broad consensus on unambiguous patent legislation following the negative vote by Parliament in March 1995;
7. Calls on the Commission to look more closely at the potential of biotechnology and to take suitable steps to inform the public, in order to avoid misconceptions arising from an incorrect grasp of the subject. This should be done by means of public involvement in preparatory and advisory bodies, and the involvement of the Group of Advisers on the Ethical Implications of Biotechnology and relevant groups representing society in decision-making processes, in order to make decisions transparent;
8. Calls on the Commission to undertake a similar awareness programme for SMUs and to take measures to ensure that programmes for SMUs also give due attention to the potential of biotechnological production;
9. Calls on the Commission to draw up proposals to improve industry's research and development effort and to encourage better cooperation with universities and research institutes, with particular attention to the involvement of SMUs, and calls on the Commission to arrange for more substantial financial support, not least in the light of experience in the implementation of the Fourth Framework Programme of Community activities in the field of research and technological development (19941998).
10. Calls on the Commission to establish, in a democratic manner, criteria for the environmental, social, socio-economic and legal safety of modern biotechnology.
O P I N I O N
(Rule 147 of the Rules of Procedure)
of the Committee on Legal Affairs and Citizens' Rights
for the Committee on Research, Technological Development and Energy
Draftsman: Mr Wolfgang ULLMANN
At its meeting of 2 February 1995 the Committee on Legal Affairs and Citizens' Rights appointed Mr Ullmann draftsman.
At its meetings of 26 June 1995 and 17/18 July 1995 it considered the draft opinion and at the latter meeting adopted the eight conclusions.
The following were present for the vote: Casini, chairman; Rothley, first vice-chairman; Palacio Vallelersundi, 2nd vice-chairman; Barzanti, 3rd vice-chairman; Ullmann, draftsman; Alber, Añoveros Trias de Bes, Cederschiöld, Crowley, Gebhardt, Hlavac, Janssen van Raay, Krarup, Linzer (for Malangré), Martin, Medina Ortega and Verde i Aldea.
Introduction
1. In its communication, the Commission states that it carried out a review of the regulatory framework in order that the "full potential of modern biotechnology for jobs, investment and growth can be realised". The review carried out by the Commission has resulted in a number of specific proposals concerning the need to amend the regulatory framework for biotechnology in the European Union only five years after the adoption of the principal directives 90/219/EEC and 90/220/EEC. Such an approach is questionable on two accounts: Firstly, the Commission communication does not provide the actual results of its investigations, particularly as regards the environmental compatibility of releasing genetically-modified organisms to the environment. Secondly, and more importantly, it is less than five years since the adoption of these directives, which were only implemented by most Member States in 1992 and 1993, which is not a sufficiently long period of time to offer a basis for experience in the field of gene technology such as to warrant changes to the regulatory framework at this time.
Socio-economic and necessity criteria
2. A further shortcoming of the communication, which reflects the one-sided approach adopted by the Commission in its considerations, focusing only on the needs of industry, is the fact that no attempt whatsoever is made to draw up socio-economic or necessity criteria with regard to experience with the authorization of biotechnologically or genetically modified products. To date, such criteria have not been legally incorporated in the regulatory framework. It would be desirable if in authorizing new products these criteria were taken into account, along with the traditional criteria of safety, quality and efficacy, particularly as this would represent a dual safety mechanism: Society could thus be better protected in good time against consequences, the disadvantages of which would only become apparent when they can no longer, or only at great cost, be rectified. In this way industry would be protected against potential misinvestment.
Horizontal or product specific regulations
3. It is also important to question to what extent the route taken by the Commission to increasingly provide for product specific regulations for certain products is appropriate. This would mean the end of the approach hitherto adopted of binding horizontal regulations to cover the specific risks associated with gene technology, and in particular those posed by the release of genetically-modified organisms capable of reproduction. The essential element in this horizontal approach is the legislator's obligation to protect people and nature against the potential dangers of genetechnology. If, however, individual product groups, which in order to be placed on the market require the release of genetically-modified organisms, are to be exempted from the general arrangements established under the directive on the release of genetically-modified organisms, and are instead to be subject to product-specific regulations, the original objective of affording protection is compromised - at least in part, in the interest of industrial users. Such an approach is not only questionable, because of the associated creeping deregulation, but also detrimental to the necessary legal certainty for industry and the public due to the concomitant creation of a bewildering array of individual regulations. In the past, the European Parliament has never approved of such an approach. Your draftsman is therefore of the opinion that, in the interest of clarity and legal certainty, no further vertical regulations should be adopted.
Aspects of legal protection for inventions in the field of biotechnology
4. In the draftsman's opinion, the claim that the competitiveness of European industry in the field of biotechnology is being impaired due to insufficient patent protection and that there is a legal vacuum is not justified. A binding regulatory framework in this field for the Member States of the European Union and beyond is provided by the European Patent Convention and the activities of the European Patent Office.
5. It is the draftsman's opinion that consideration should be given to the question of whether the European Union should strive, within the framework of the European Patent Convention, to revise Article 53 of the Convention in order to better define what exactly constitutes an infringement of 'public order' and ethics. Another option open to the European Union in order to meet the European Parliament's demands for clarity as regards the patentability of biotechnological inventions, would be the creation of a specific instrument for the protection of living organisms or parts thereof against patenting and economic exploitation.
Legal loophole: The transport of genetically-modified organisms
6. The legal framework contains a significant loophole as regards the transport of genetically-modified organisms within the European Union and in third countries where the two directives overlap. There is manifestly no control of any kind on the transport or sending of genetically-modified matter, so that transport could result in inadvertent release of such organisms into the environment.
Liability
7. A further aspect which is legally important and which should be given consideration in view of the explanations, or rather the lack thereof, in the Commission communication, is the question of liability for damage caused to the environment or to individuals by gene-technology products, experiments or processes. Your draftsman attaches great importance to extension of the Directive on Product Liability of 25 July 1985 to cover the field of bio- and gene-technology. The necessary review of legislation on liability should take account of the specific nature of the risks posed by gene technology. Given that, in the field of gene technology, it is extremely difficult to adduce the usual proof that the party which has allegedly caused damage has actually done so, it would be in the interest of the people concerned to reverse the burden of proof.
Conclusions
The Committee on Legal Affairs and Citizens' Rights calls on the Committee on Energy, Research and Technology as the committee responsible to take account of the following considerations and to include the following demands on the Commission in its report:
1. Considers that in the sector of biotechnologies the certainty of the legislative context is an important factor for the competitiveness of the industrial system. It must however ensure an appropriate level of protection to guarantee respect for the dignity, integrity and health of human beings at all stages of their development and respect for environmental balance;
2. Placing safety regulations for laboratory and industrial applications of gene technology on the same footing is unacceptable in view of the different risk levels involved;
3. The Commission should not proceed with any further product-specific regulations which would exempt individual product groups involving the release into the environment of genetically-modified organisms from the horizontal provisions of Directive 90/220/EEC on the release of genetically-modified organisms;
4. Considers that the Commission, after a wide-ranging consultation of experts and all the categories involved and taking into account the results of the debate held in the European Parliament, should submit a new proposal for a directive on the legal protection of biotechnological inventions, defining clearly and unambiguously the distinction between discoveries, which cannot be patented, and inventions, which can be patented;
5. The existing loopholes in the legal framework as regards transport and liability should be closed as soon as possible and the Commission should take appropriate legal initiatives;
6. In order to promote public understanding of biotechnology there is a need for greater transparency. This must include comprehensive labelling of genetically-modified products when they are licensed;
7. Considers it essential to conduct a public information campaign to explain what biotechnologies are and the actual effects they may have, so that citizens may adopt a conscious approach to the provisions governing the sector;
8. Since the Commission has explicitly stated - although it only applies to product evaluation - that it will as a rule follow expert scientific advice, it is essential to ascertain the competence of experts and assessment committees. 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.
O P I N I O N
(Rule 147 of the Rules of Procedure)
of the Committee on the Environment, Public Health and Consumer Protection
for the Committee on Research, Technological Development and Energy
Draftsman: Mrs Evelyne Gebhardt
At its meeting of 20 December 1994 the Committee on the Environment, Public Health and Consumer Protection appointed Mrs Gebhardt draftsman.
It considered the draft opinion at its meetings of 30 May and 27 June 1995.
At the latter meeting it adopted the conclusions unanimously.
The following were present for the vote: Collins, chairman; Jackson, Dybkjær and Jensen, vice-chairmen; Gebhardt, draftsman; Alber (for Gaigg), Blokland, Bowe, Breyer, De Coene (for Van Putten), Díez de Rivera Icaza, González Alvarez, Gredler, Graenitz, Johansson, Kokkola, Kuhn, Lange (for Waddington), Lannoye, Leopardi, Liese (for Schnellhardt), McKenna, Needle (for Marinucci pursuant to Rule 138(2)), Pollack, Roth-Behrendt, Schleicher, Virgin, White and Whitehead.
1. No critical examination of the socio-economic and environmental benefits of biotechnology
This Commission communication is highly significant for the evaluation and shaping of policy on biotechnology, since it shapes the context in what is a very sensitive area for public debate.
The communication, which is totally geared to improved research and development, the application of findings made thereby in e.g. science parks, easier testing procedures and slimmed-down directives, deals only with the formal aspects of biotechnology.
If the communication had moved away from the formal aspects of dealing with the subject, there would have been room for much-needed debate. In addition to a debate about employment and health considerations, which do not feature at all in this communication, other really fundamental questions should also have been clarified. For example, which products are genuinely worth promoting? All of them? Should there not also have been some analysis of whether, given existing over-production in the European Union, developments in biotechnology that boost yields are questionable? Again, might developments regarding environmental clean-up services lead to a shift from preventive to purely palliative measures? Should research projects seeking herbicide resistance in plants actually be supported?
2. The value of a range of experience
There is unfortunately no indication in the communication of the kind of experience which has led the Commission to its assumption that Directives 90/220/EEC and 90/219/EEC can be simplified. In terms of biological research, five years is a negligible time-span. Where the release of genetically modified plants, animals and micro-organisms is concerned, for example, experience gained over a period of 10, 20 or even more years is needed. Only then can it be claimed with maximum certainty that no side-effects worth mentioning can be occasioned by release. The experience on which we are currently able to rely has not been gained in genetic engineering but in the field of traditional biology. It took some 30 years for it to be recognized that the introduction into Australia of rabbits and clover from Europe (i.e. an involuntary release) led to a plague of rabbits and to European clover displacing other indigenous plants. Research into ways of combating the clover is now being carried out there. It took a comparable period for it to be recognized that the introduction of dogs into New Zealand has led to the indigenous Kiwi being threatened with extinction. The problem caused by the introduction of African beehives into South America (killer bees) falls into the same category. Such experiences are not directly applicable to genetic engineering, but they show how important research into risks, environmental compatibility and appraisal of the implications of technology are where biotechnology is concerned. The Commission should devote as much space to reflection on these branches of research as it does to the promotion of biotechnology.
3. Directive on the deliberate release into the environment of genetically modified organisms: deregulation on shaky foundations
In its communication the Commission cites experience gained with regard to plants (p. 5). It is impossible to draw general conclusions applicable to the Directive on the release of genetically modified organisms from experiences gained with cultivated plants. Such organisms do not just cover the sphere of cultivated plants, but also micro-organisms such as bacteria for the treatment of waste water.
Admittedly, constantly improving technology means that more accurate risk assessment is possible, but it would be a mistake to use experience from the past to predict future measures and project experience gained with cultivated plants on to the sphere of microorganisms. This is even more applicable to the release of genetically modified organisms (GMOs). The risk associated with genetically modified micro-organisms (GMMs) must be assumed to be generally higher than that associated with plants. The draftsman therefore considers it to be fundamentally unsound to change Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms. The Commission itself admits that it does not yet have sufficient experience to improve the Directive (p. 6). A risk which has not occurred cannot be equated with proof of safety, but at most with a presumption of safety.
4. Feeble justification for deregulation of the Directive on the contained use of genetically modified micro-organisms
The changes to Directive 90/219/EEC proposed by the Commission show major weaknesses.
The proposed replacement of 'consent requirements' by 'notification for information purposes' shifts the determination of risk in favour of the notifier, i.e. monitoring mechanisms may be evaded.
The replacement of 'explicit consent requirements' by 'implicit consent' runs the risk of leading to consent by time default on the part of the monitoring authority. Since this also goes hand in hand with a 'reduction of time periods involved in implicit/explicit consent procedures', the effect would be to neutralize any monitoring procedures.
The removal of the differentiation between laboratory and production activities is also irresponsible. It must be borne in mind that production plants produce organisms which have undergone a range of monitoring, in accordance with existing rules, so that minimization of risk can be assumed, since changes to the organisms themselves are no longer so likely. In research laboratories the organisms are still in the development stage, and risk assessment must always keep level with such development work.
As for the amount of experience that we can draw upon, the draftsman points to the problems referred to under 3. This experience is complicated by the fact that we are dealing here with micro-organisms which are even less amenable to monitoring than plants or animals.
5. Unambiguous patent legislation is needed
The Commission considers that appropriate patent protection for inventions is necessary. This view is correct. It must lead to the early presentation of a new proposal on the protection of biotechnological inventions incorporating the clearly-stated expression of Parliament's will and satisfying the following (summarized) criteria: patent legislation that is clear and unambiguous, includes clear definitions and draws a clear distinction between discoveries, which are not patentable and inventions, which are.
6. An unacceptable distinction between scientific advice and ethics
The distinction drawn between scientific advice and ethics is questionable. Both scientific and ethical advice must be incorporated into the various decision-making stages and bodies. The absence of formal arrangements and involvement at the various levels of decision-making is accentuated by the statement in the Annex that the Commission will normally follow scientific advice and only take a different view in exceptional cases. One wonders what the establishment of round tables and ethics advisory groups or the involvement of the public are then meant to mean. It is therefore essential to make formal arrangements for the latter, and it would make sense to set up a network of various ethics institutions, roughly comparable to the R&D networks proposed by the Commission, so that the ethical debate can keep pace with current research to some extent.
7. Publicity work aimed solely at creating acceptance
A critical debate about publicity work, which would certainly not be intended to call genetic engineering into question, would also be very important as far as the aim of 'raising public awareness', was concerned. However, it is not the role of the Commission or public authorities to provide one-sided support for the promotion of 'understanding' and 'public reassurance' or the 'acceptance' of any technology. Admittedly, the Commission refers to 'impartial information', but it also claims that without such information the technology 'may not be well understood'. The concept of publicity work is thus taken to mean creating acceptance. It is true that issues of safety, ethics and environmental protection are to be considered, but in the end these areas have no regulatory significance.
It is far more crucial to step up information to the public, so that it can actually freely make appropriate decisions in full knowledge of all the factors involved. It has been shown that if an open, lively and public debate actually takes place, the public is quite capable of forming a wide range of opinions.
8. Silence about education and training and consumer protection
Although the need for education and training and the 'facilitation of [public understanding and[ consumer choice' are mentioned in the introduction to the communication, further details are completely lacking.
Nothing is said about consumer protection; there should be some indication of the form that such protection might take, such as a consistent, comprehensive labelling requirement for products made using genetic engineering methods or incorporating ingredients obtained through genetic engineering. Consistent labelling is necessary for several reasons: consumers wish to know what they are buying, allergics need to know whether they can tolerate a product, or there may be religious reasons - Muslims obviously need to know for certain whether a tomato, for instance, contains a pig gene or not, in order not to transgress their religious beliefs.
9. Conclusions
The Committee on the Environment, Public Health and Consumer Protection requests the Committee on Research, Technological Development and Energy, as the committee responsible, to incorporate the following demands to the Commission in its report:
(a) greater emphasis in research on research into risks, environmental compatibility and appraisal of the implications of technology;
(b) no relaxation of the Directive on the contained use of genetically modified microorganisms (90/219/EEC) or the Directive on the deliberate release into the environment of genetically modified organisms (90/220/EEC) until sufficient experience has been amassed and assessed and environmental safety has been proved;
(c) presentation of unambiguous patent legislation;
(d) public involvement of all social groups, and especially the European Parliament, in preparatory and advisory bodies, and the involvement of the European Parliament in decision-making processes;
(e) transparency of decisions;
(f) transparency concerning the introduction of genetically modified products, notably through comprehensive product labelling;
(g) the establishment of criteria for the environmental, social, socio-economic, legal and democratic safety of modern biotechnology.