Brussels, 25 January 2002

Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions
Life sciences and biotechnology ¨C A Strategy for Europe

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4.5. Regulatory principles

Community regulation currently governs such diverse aspects such as the patenting of biotechnological inventions, the authorisation of pharmaceutical products, contained use of genetically modified microorganisms, and release and marketing of products consisting of or derived from GMOs, including foods, feeds and seeds. This regulatory framework has evolved gradually over the last 25 years, with major developments in recent years.

In order to improve the coherence, transparency and efficiency of Community regulation, the Commission suggests that Community regulatory activity should respect the following principles:

? Risk governance and product authorisation: Products of biotechnology should, in accordance with the established regulatory principles and frameworks, be authorised on the basis of a comprehensive scientific risk assessment if found to be safe for human, animal or plant life and health and the environment. In cases where scientific evidence is insufficient, inconclusive or uncertain, and where possible risks are judged to be unacceptable, risk management measures should be based on the precautionary principle. Risk management should take into account the results of risk assessment and other factors legitimate to the matter under consideration in order to achieve the chosen level of protection.. Procedures for authorisation should be transparent, risk assessments should be published and made available for public comment as part of the authorisation procedures. Communication needs to be an integral part of risk assessment and risk management activity.

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? Safeguarding the Internal Market: To secure the functioning of the Internal Market and legal certainty, Community legislation should be drafted and periodically reviewed to ensure coherence and efficiency, including with regard to its practical feasibility and enforceability. Implementation of and compliance with Community law should be carefully monitored, and any problem of compliance should be addressed and resolved among concerned parties according to existing procedures in a transparent and predictable manner.

? Proportionality and consumer choice: Community regulatory requirements should be proportionate to the degree of identified risk and should conform with the Community's international obligations. As proposed by the Commission, Community legislation should facilitate consumer choice through ensuring that consumers/users are informed in cases where a food, feed or seed is genetically modified or derived from GMOs.

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? Predictability, modernisation and impact assessment: The Commission should periodically publish a rolling regulatory work programme (see point 6 below) to improve predictability, transparency and quality of regulation. Regulation should continue to be regularly reviewed to be up-to-date with scientific and technological progress, for evaluation of impacts and for conformity with the present principles.

5. EUROPE IN THE WORLD - RESPONDING TO GLOBAL CHALLENGES

The revolution in life sciences and biotechnology is global. Research is fundamentally international - knowledge and experts circulate throughout the world.

A growing number of countries are actively pursuing biotechnologies, and the resulting productsand serviceswillincreasingly betraded on global markets,with a premium for first innovators.

It is also clear that great diversity exists between countries and regions with respect to their capacities to develop, regulate and apply the new products and services. Even greater diversity may emerge with respect to the priorities and societal values that will shape the approaches and choices to developing and using these new technologies.

European policies should not be developed in isolation. We need to embrace the wider international context which shapes both challenges and opportunities for Europe, and we must respond with responsible and proactive policies at the global level. A main objective must be to ensure that the EU maintains competitiveness vis-¨¤- vis major industrialised countries such as the US and Japan. Moreover, whatever policies Europe will decide regarding life sciences and biotechnology, they will have important international impacts, in particular for developing countries. The interests of these countries must also be taken into account. We must integrate the international dimension into all relevant policies, and we need to develop an international agenda, based on our fundamental values and long-term objectives, to actively promote balanced and responsible policies globally, in particular towards the developing world.

5.1. A European agenda for international collaboration

International collaboration is required to manage the novel issues raised by life sciences and biotechnology and the diversity of capacities and policies in different countries and regions towards their applications.

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Trade in goods and services is already being affected due to divergent product approval rates. International trade friction may also emerge if countries and regions adopt divergent regulatory frameworks. There is a need for international dialogue on regulatory issues to develop mutual understanding of basic principles and values underlying regulatory developments in different countries.

The Community is committed to open, multilateral, and rules-based trading systems.

We should therefore promote respect and implementation of existing international agreements. Given the particular issues raised by life sciences and biotechnology, the Community should promote solutions and dialogue at international level that:

? Ensure mutual supportiveness between relevant international agreements and in particular between the WTO agreements and the Biosafety Protocol.

? Support a coherent, comprehensive, effective, transparent and inclusive approach to biotechnology across the relevant international fora in order to avoid overlaps and make the best use of their respective expertise (including FAO, UNEP, CBD, WTO, WHO and UNCTAD 10 ).

Europe should continue to play a full part, in particular in the OECD and the Codex Alimentarius, and notably its Ad Hoc Intergovernmental Task-Force on Biotechnology, to promote within these organisations the development and periodic review of harmonised guidelines with respect to the risk analysis, the labelling and the traceability of products derived from modern biotechnology.

The role and efficiency of EU participation in international discussions should be enhanced, including through discussions with developed and developing countries. Dialogue should promote mutual understanding of concerns and objectives of different countries and regions, such as the EU/US Biotechnology Forum which delivered its final report in December 2000.

Early policy dialogue about forthcoming legislation may reduce the potential for international friction.

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7. A FRAMEWORK FOR DIALOGUE AND ACTION

It is time to clarify the strategic opportunities and challenges facing Europe. Life sciences and biotechnology are a global reality and essential for the objective of developing dynamic and innovative knowledge-based economies. We have to face the difficult questions and identify our strategic objectives to avoid the pitfalls of short-term solutions to long-term challenges and of local solutions to global challenges.

Recognising that life sciences and biotechnology raise particular challenges, the Commission undertook to propose a strategy and concrete actions. It now presents this initiative for a coherent, collaborative and sustained effort. The present initiative draws on a thorough analysis 13 of the strengths and weaknesses of European biotechnology, and a broad public debate and the specific public consultation launched by the Commission in September 2001.

The initiative should, in turn, itself inspire further dialogue. The attached action plan suggests a broad scope of measures according to the orientations set out in chapters 3 to 6 of this Communication. It constitutes a framework, within which some actions can be launched in the short-term while other actions for the medium and longer term are identified and suggested for further development in collaboration with Member States and stakeholders.

The Commission now invites the Community institutions and bodies, the Member States, protagonists and the public to contribute to refine and implement the proposed strategy by defining detailed measures under both short- and medium-term actions and the time-plan for their deliverables, as a first decisive step towards an effective and coherent European biotechnology policy.

PART II: ACTION PLAN

1. HARVESTING THE POTENTIAL

THE RESOURCE BASE
Investing in People

Action 1
The Commission will together with competent authorities in Member States 1 ident ify the education needs in life sciences within the 10-year Objectives for Learning in the Knowledge Society 2 and:

a) strengthen a broad education and understanding of life sciences,

b) develop and train a skilled workforce in life sciences, by issuing recommendations for curricula and teacher training. Community support can be provided under the Comenius and Erasmus programmes.

c) As set out in its Communication on the European area of Lifelong learning 3 ,the Commission will work with Member States, industry, academia and others to identify measures to promote continuing education and refresh the current competence of the scientific workforce. Community support can be provided under the Leonardo programme.

d) The Commission and Member States should support discussion fora for specialist scientists, with the objective of stimulating an exchange across disciplines.Vital discoveries frequently happen at the point where disciplines intersect. Community support can be provided under the Erasmus programme.

Implementer: Member States, Commission, private sector
Timeframe: 2003-2010

Action 2
The Commission will explore with Member States

a) the opportunity and best way to establish efficient methods to match a skilled workforce with job opportunities, involving effective communication of open positions, collaboration with established companies and a labour force aware of available employment options.

b) possible measures to attract and retain scientists andavoidbrain drain.In achieving this, specific reference will be paid to the initiatives launched under the Communication ? A Mobility Strategy for the Research Area¡±4 , which aims at improving the overall environment of researchers and their families in the EU. Due attention will also be paid to the increased mobility opportunities offered by the forthcoming Sixth Framework Programme (2002-2006), and more particularly to the measures aimed at attracting foreign researchers and supporting the return of EU researchers established in other parts of the world.

Implementer: Member States, Commission
Timeframe: 2003 onwards

Generating and exploiting knowledge
Research

Action 3
The Commission will enhance its support for life sciences and biotechnology research, technological development, demonstration and training activities under the next Framework Programme 2002-2006 aimed at contributing towards the creation of the European Research Area.

Biotechnology research will be supported under the thematic priorities, including:

1: Genomics and biotechnology for health
3: Nanotechnologies
5: Food quality and safety
6: Sustainable development
7: Citizens and governance

Specific measures will be provided to encourage SME participation, international cooperation and mobility and training of researchers.

The new instruments of Networks of Excellence and Integrated Projects will facilitate the objectives of Europe-wide collaborations, attaining critical mass and simplification of administrative procedures.

The Commission and the Member States should also in collaboration with the European Investment Fund (EIF) develop a competitive bioinformatics infrastructure in support of biotechnology research and focus support for the development of research in computational biology and bio-medical informatics.

Implementer: Member States, EIF, Commission
Timeframe: 2002-2006

Management and legal services
Action 4
Enhancing the supply of specific management and legal skills:

a) Member States and national biotechnology associations should examine the opportunity of creating self-sustained networks of biotechnology company managers at the national level.

b) Member States and the Commission should promote collaboration between law schools, law firms and companies for the development of specific legal competence needed by biotechnology companies.

Implementer: Member States, academia, professional associations, Commission
Timeframe: 2003 onwards

Exploitation of intellectual property
Action 5
A strong, harmonised and affordable European intellectual property protection system, functioning as an incentive to R&D and innovation will be finalised by:

a) Member States urgently transposing into national laws the Directive on the Legal Protection of Biotechnological Inventions EC/98/44.

b) Council adopting the Community Patent Regulation.

c) Member States and the Commission clarifying rules on ownership of intellectual property stemming from public research and monitoring the effect of implementation of patent legislation on research and innovation.

d) encouraging awareness training in the strategic use of IPR during the entire research and innovation process and raising awareness among academics of the commercial potential of their research, encouraging entrepreneurship and movement between academia and companies.

e) taking steps to promote international dialogue and co-operation with a view to work towards a level playing field with industrialised countries in patent protection on biotechnology inventions, ensuring an effective level of protection for innovation in this field.

Implementer: Member States, Council, Commission
Timeframe: 2002 onward

Capital base
Action 6
The Commission should together with the European Investment Bank (EIB) and the European Investment fund (EIF) strengthen the capital base for the biotechnology industry,by:

a) seeking to stimulate investments in research and technological innovation via complementary financing on the basis of the co-operation agreement signed in June 2001 between the Commission and the EIB group.

b) seeking to stimulate investments in business incubators through the EIF Start Up Facility

c) studying measures to support technology transfer mechanisms, such as financing of patent pools or other methods for patent exploitation.

d) studying measures to encourage commercial financing of companies based on a medium-term investment perspective.

Implementer: EIB Group, Commission
Timeframe: 2002 onwards.26

Action 7
The Commission will strengthen the work of the Biotechnology and Finance Forum by the inclusion of relevant major stakeholders to provide advice into policy development in the field of capital supply.

Implementer: Commission
Timeframe: 2002

NETWORKING EUROPE¡¯S BIOTECHNOLOGY COMMUNITIES
Networks in Europe

Action 8
The Commission will:

a) support creation of a commercial biotechnology web portal for Europe that will help free access to information and networking available Internet platforms. The contents of such a portal will have to be defined based on the requirement of economic viability and sustained demand.

b) develop its newly created Commission web site to provide a broad entry platform into the Commission¡¯s work on biotechnology.

Implementer: Commission
Timeframe: 2002-2003

Action 9
Member States, their regions, the Commission and EIB should support:

a) stronger interregional co-operation, e.g. through a network of biotechnology regions. Crossborder and interregional co-operation can receive funding from the Interreg programmes (notably Interreg IIIB and IIIC).

b) networks of biotechnology clusters. In addition, the Commission will organise a European competition between Biotechnology Innovation clusters, to highlight their capability to develop a cluster with a focus of excellence in a specific scientific field.

Implementer: Member States, Regions, EIB, Commission
Timeframe: 2003-2006.

A PROACTIVE ROLE FOR PUBLIC AUTHORITIES
Action 10

The Commission will establish
a) a competitiveness monitoring function and a contact network with Member States ministries with responsibility for competitiveness in biotechnology. Monitoring should include impact on European competitiveness of legislation and policy measures.

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b) a Competitiveness in Biotechnology advisory group with industry and academia to assist in identification of issues affecting European competitiveness. The Group will provide input into the Commission¡¯s regular reports on Life Sciences and Biotechnology.

Implementer: Member States, Commission
Timeframe: 2002

Action 11
Transparency in the administrative process:

a) The Commission and Member States ,as regulatory authorities, should aid applicants, especially from start-up companies and SME¡¯s, requesting approval through the regulatory process.

b) The Commissionwillissue aguide to Community regulation for users and for entrepreneurs who have limited staff and expertise in the regulatory and legal fields. Such a guide should also benefit non-EU (e.g. developing world) applicants and the general public.

Implementer: a) Member States, Commission. b) Commission
Timeframe: 2003 onwards

Action 12
In collaboration with the involved actors, the Commission will benchmark good practices in clustering biotech companies and in the work of business incubators and disseminate results. The Commission will also establish with Member States a programme for benchmarking relevant elements of biotechnology policies, in addit ion to exist ing benchmarking structures.

Implementer: Commission
Timeframe: 2003 onwards.28

2. A KEY ELEMENT FOR RESPONSIBLE POLICY: GOVERNING LIFE SCIENCES AND BIOTECHNOLOGY
SOCIETAL SCRUTINY AND DIALOGUE

Action 13
The Commission, Member States, organisations, institutions and other actors should engage in a structured dialogue at various levels to develop an understanding and information exchange on life sciences and biotechnology. The Commission will in particular help mobilise all key actors in the public debate and facilitate participation of stakeholders with limited resources.

In particular:
a) The Commission will propose a framework for a process of dialogue and follow-up with stakeholders as a result of the European strategy for life sciences and biotechnology. The framework will notably include a broadly based Stakeholders¡¯ Forum. In this process, the Commission will take the initiative to better explain Europe¡¯s regulatory approach (including the application of the precautionary principle, the role of risk management, monitoring, safeguards and reversibility of regulatory decisions).

b) The Commission will take initiatives, and invites the scientific community and other stakeholders to assist, to promote awareness of key scientific paradigms underlying regulatory oversight such as scientific uncertainty, absence of zero risk, comparative risks, that science is continuously evolving and therefore continuously improves our reference points, and the articulation between the steps in the risk analysis process. Within their respective fields, the European Food Safety Authority and the European Agency for the Evaluation of Medicinal Products will play an important role in general risk communication, including the scientific background for their conclusions of risk assessments.

c) Beyond these two specific initiatives, the Commission will also encourage public debates on biotechnology between scientists, industry and civil society, including specific interest groups, such as patients groups, farmers and consumers, focussing on specific technological developments, to raise public interest in such developments and offer early information on potential benefits and risks. Developers in the scientific community and in industry have a specific responsibility in actively explaining the background and the benefits of their products.

Implementer: Member States, Industry, Academia, Civil society, EFSA, EMEA, Commission
Timeframe: 2002 onwards.29

DEVELOPING LIFE SCIENCES AND BIOTECHNOLOGY IN HARMONY WITH ETHICAL VALUES AND SOCIETAL GOALS

Action 14
The Commission will strengthen and focus Community support for research into socio-economic and ethical issues and dissemination of results, including criteria for assessing the benefits of using biotechnology in agri-food production, to facilitate future reporting and to provide a good basis for societal decisions on the applicat ion of biotechnology and life sciences. The Commission will program research support to a more systematic mapping of benefits and disadvantages/risks which should include a strong component for dissemination of information and debate.

The Commission will ensure that ethical, legal and social implications are taken into account at the earliest possible stages of Community supported research by means of funding bioethics research and of providing an ethical review of research proposals received.

Implementer: Commission
Timeframe: 2002-2006

Action 15
The Commission proposes to enhance the role of the European Group on Ethics. In addition, the Commission will launch a separate consultation of the other Community institutions on possible structural and procedural improvements. The Commission will also promote collaboration between Community, national and local levels by promoting networking of national and local ethical bodies and elected representatives.The Commission will organise a network of academic and professional experts for ad-hoc advice on specific socio-economic aspects.

Implementer: Ethical bodies, Legislatures, Commission
Timeframe: 2002

Action 16
The Commission will develop, jointly with the EP, outreach measures to inform about the analysis of ethical issues at the EU level.

While respecting cultural pluralism, the Commission will work with public and private partners to identify areas where it is possible to establish consensus on ethical guidelines/standards or best practise. Areas might include stem cell research, biobanks, xenotransplantation, genetic testing and use of animals in research. Such guidelines could, when appropriate, take the form of self-regulatory initiatives in the scientific community and industry.

Implementer: European Parliament, Member States, Regions, Industry, Institutions, Commission
Timeframe: 2002 onwards.30

DEMAND-DRIVEN APPLICATIONS THROUGH INFORMED CHOICE

Action 17
The Commission will take initiative to develop, in partnership with Member States, farmers and other private operators, research and pilot projects to clarify the need, and possible options, for agronomic and other measures to ensure the viability of conventional and organic farming and their sustainable co-existence with genetically modified crops. Moreover, the Commission recognises the importance of safeguarding the existing genetic resources in agriculture. It will launch a new action programme for the conservation, characterisation, collection and utilisation of genetic resources in agriculture in the Community.

Implementer: Member States, professional associations, other operators, Commission
Timeframe: 2002 onwards

CONFIDENCE IN SCIENCE-BASED REGULATORY OVERSIGHT
Pharmaceutical legislation

Action 18
Parliament and Council are invited to speed up the adoption of the three legislative proposals, revising the Community pharmaceutical legislation, including measures:

a) to develop and reinforce the system of giving scientific advice and to increase the access of the European Agency for Evaluation of Medicinal Products¡¯ (EMEA) scientific committees to high level expertise through the creation of expert panels and permanent working groups. The increased level of expertise will also help the revision and development of European guidelines on the quality, safety and efficacy aspects of biotechnological medicinal products.

b) to introduce an accelerated procedure for products with a major public health interest that will allow the assessment and authorisation of a medicinal product within a shortened time scale

c) to introduce a procedure allowing a conditional authorisation valid for one year, but renewable. This will allow products of major public health interest but for which certain studies are still in progress to be given a conditional access to the market during the finalisation of the studies.

Implementer: European Parliament, Council
Timeframe: 2002.31

Genetically modified organisms (GMO) legislation
Short-term regulatory actions

Action 19
Parliament and Council are invited to speed up the adoption of the two following legislative proposals:

a) Proposal for a European Parliament and Council Regulation on Traceability and Labelling of Genetically Modified Organisms and Traceability of Food and Feed derives from Genetically Modified Organisms.

b) Proposal for a European Parliament and Council Regulation on Genetically Modified Food and Feed.

Implementer: European Parliament, Council
Timeframe: 2002

Action 20
The Commission continues its work with a view to finalising the legislative proposals which have already been announced, such as initiatives concerning GM plant propagating material, environmental liability and the implementation of the biosafety protocol. Implementer: European Parliament, Council, Commission

Timeframe: 2002-2003
Implementation and enforcement activities

Action 21
The Commission will ensure that legislation is enforced in a uniform and effective way across the Community and adopt appropriate implementing measures required under relevant legislation, including the necessary guidance for detection and sampling methodology. The Commission will also establish a molecular register that is accessible to the public, containing information on events of genetic modification.

Implementer: Commission
Timeframe: 2002-2003.32

Specific long term regulatory actions

Action 22
The Commission will report on the feasibility of options to improve further the consistency and efficiency of the framework for authorising GMO¡¯s for deliberate release into the environment, including a centralised Community authorisation procedure.

Implementer: Commission
Timeframe: 2003

Action 23
The Commission will support the development of methodologies for monitoring potential long-term environmental impacts of GMO¡¯s as compared with conventional crops, and methodologies for the monitoring of effects of genetically modified food and feed as compared with conventional food and feed. With the establishment of the European Food Safety Authority, the work on the early identification of emerging risks will be reinforced and upgraded.

Implementer: Commission
Timeframe: 2002 onwards

3. EUROPE IN THE WORLD - RESPONDING TO GLOBAL CHALLENGES
A EUROPEAN AGENDA FOR INTERNATIONAL COLLABORATION

Action 24
The Commission should continue to play a leading role in developing international guidelines, standards and recommendations in relevant sectors, based on international scientific consensus and, in particular, push for the development of a consistent, science-based, focused, transparent, inclusive and integrated international system dealing with food safety issues.

Implementer: Commission
Timeframe: 2002 onwards.33

EUROPE¡¯S RESPONSIBILITIES TOWARDS THE DEVELOPING WORLD
Agriculture

Action 25
The Commission will in co-operation with Member States support:

a) the redefining of national research towards an appropriate mix of traditional techniques and new technologies, based on priorities developed with local farmers.

b) the establishment of effective research partnerships between public and private research organisations in developing countries and in the EU, and the adequate capacity and infrastructure for developing countries to enter into such partnerships, in accordance with international commitments under the Conventions.

c) sub-regional, regional and international organisations, in particular the International Agricultural Research Centres.

Implementer: Member States, Commission
Timeframe: 2002 onwards

Genetic resources

Action 26
The Commission and the Member States will support the conservation and sustainable use of genetic resources in developing countries and their equitable sharing of benefits arising from their use by:

a) supporting the development and enforcement of effective measures to conserve, to use sustainably and to provide access to genetic resources and traditional knowledge, as well as to share equitably the benefit arising from them, including income generated by intellectual property protection. Support for local communities is vital to conserve indigenous knowledge and genetic resources.

b) supporting the participation of delegates from developing countries in the negotiations of relevant International Conventions.

c) supporting measures to promote greater regional co-ordination in legislat ion to minimise disparities in access, benefits and also trade in products derived from genetic resources, in accordance with international commitments.

Implementer: Member States, Commission
Timeframe: 2002 onwards.34

Health

Action
The Commission and the Member States should work with the international community to concretise the commitment to research to combat HIV/AIDS, Malaria, TB and other main poverty-related diseases and also identify effective measures to support developing countries in establishing the structures needed to deploy a health policy.

Implementer: Member States, Commission
Timeframe: 2002 onwards

Responsible and careful use

Action 28
The Commission should support:

a) the safe and effective use of modern biotechnologies in developing countries, based on their autonomous choice and on their national development strategies.

b) measures to increase the capacity of developing countries to assess and manage risk for man and the environment, under conditions prevailing in the country.

c) the development of appropriate administrative, legislative and regulatory measures in the developing countries, for the proper implementation of the Cartagena Protocol.

d) that international research on social, economical and environmental impacts are effectively adapted to take into account conditions prevailing in developing countries and that the findings are subsequently disseminated to them in an appropriate format.

e) that the international regulatory requirements remain manageable by developing countries, so as not to impede their trade and production prospects.

Implementer: Commission
Timeframe: 2002 onwards.35

4. IMPLEMENTATION AND COHERENCE ACROSS POLICIES, SECTORS AND ACTORS
Action 29

The Commission will enhance
a) the general foresight function across Commission services, and in particular its role in technology foresight through its Institute for Prospective Technological Studies (IPTS), for early identification of newly emerging issues andof elementsof apolicy response

b) its monitoring and review function to assess
- the relevance, coherence and effectiveness of legislation and policy
- the extent to which policy objectives are achieved and legislation enforced
- the societal and economic impact of legislation and policy measures.

In pursuit of these objectives and to further strengthen policy coherence, the Commission
c) will reinforce continuous co-ordination between its services and calls upon Member States to also provide enhanced foresight/review functions and a co-ordinated interface for a dialogue on these issues.

Implementer: Commission, Member States
Timeframe: From 2002 onwards

Action 30
The Commission will present a regular Report on Life Sciences and Biotechnology to monitor progress and indicate possible specific proposals to ensure policy and legislative coherence. The report will draw on the conclusions under actions 11 and 30.

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Implementer: Commission
Timeframe: 2003 onwards

Brussels, 23.1.2002 COM(2002) final