Barcelona European Council: Commission launches proposal for comprehensive biotechnology policy

Brussels, 23 January 2002

The European Commission today adopted a major policy initiative for the development of life sciences and biotechnology in Europe.

This is one of the main building blocks of the Commission's contribution to the Barcelona European Council in March 2002. This strategy paper includes an action plan with recommendations for Member States, local authorities, industry and other stakeholders. It aims to help Europe master the frontier technologies that could make a major contribution to the goal, set at the March 2000 Lisbon European Council, of becoming the world's most competitive, knowledge-based and sustainable economy within a decade.

The strategy's co-operative and consistent approach to fostering sustainable development is designed to address the complex ethical and societal concerns and support the broad public debate. In line with the principles of governance, the initiative is based on a wide public consultation that included a conference with a broad range of stakeholders.

Commission President Romano Prodi said: "It is of key importance for Europe to master the new frontier technologies which will be at the core of a knowledge-based economy. Life sciences and biotechnology are developing rapidly and globally and have given rise to intense public debate. Europe needs to address the challenges of biotech by developing responsible policies to exploit these new opportunities in a manner that is consistent with European values and standards. Commitment to fundamental ethical values will be crucial to build confidence and foster public acceptance of new biotechnology. With this initiative, the Commission sends a strong signal to the public and private actors who must work together for Europe to be successful."

Europe is faced with a major policy choice: either we accept a passive role, and bear the implications of the development of these technologies elsewhere, or we develop pro-active policies to exploit them in a responsible manner. Life sciences and biotechnology are widely recognised to be, after information technology, the next wave of technological revolution in the knowledge-based economy, creating new opportunities for our societies and economies.

By 2005 the European biotechnology market could be worth over € 100 billion. By 2010, global markets, including sectors where life sciences and biotechnology constitute a major portion of new technology applied, could amount to over € 2,000 billion, excluding agriculture. There are now more dedicated biotechnology companies in Europe (1,570), than in the US (1,3).

But the European biotech sector is made of relatively small companies, whereas the US biotechnology industry started earlier, employs many more people (162,000 against 61,000), is much more strongly capitalised and in particular has many more biotech products in the pipeline(1). The Commission has proposed to spend € 2,150 billion on biotechnology within the next research framework programme that starts in January 2003.

Europe does not have a single policy for life sciences and biotechnology but a patchwork of many sector-specific and overall policies at international, EU, Member State and local levels. In Europe, relevant responsibilities are spread across a broad range of policies and actors. In the absence of a shared vision of what is at stake and without common objectives, Europe has therefore only slowly and with difficulty addressed the challenges and opportunities of these new technologies.

Life sciences and biotechnology offer a considerable potential in many areas:

Health care: biotechnology already enables cheaper, safer and more ethical production of a growing number of traditional as well as new drugs and medical services. These include personalised and preventive medicine based on genetic predisposition, targeted screening, diagnosis, and innovative drug treatments.

Agriculture/food: biotechnology has the potential to deliver improved food quality and environmental benefits through agronomically improved crops. Food and feed quality may be linked to disease prevention and reduced health risks, to reduced use of chemical pesticides, fertilisers and drugs - and hence more sustainable agricultural practices, reducing soil erosion and benefiting the environment. Life sciences and biotechnology are likely to be one of the important tools in fighting poverty, hunger, and malnutrition.

Industrial uses: biotechnology also has the potential to improve non-food uses of crops as sources of new materials such as bio-degradable plastics.

The environment: new ways to protect and improve the environment are offered by biotechnology, including bioremediation of polluted air, soil, water and waste as well as development of cleaner industrial products and processes, e.g. based on use of enzymes.

Priorities of the biotechnology action plan include:

Harvesting the potential

Reinforcing the resource base (enhancing education in life sciences, promoting the mobility of, and retaining, Europe's scientists, fostering entrepreneurial management skills, access to risk capital and intellectual property right protection)

Networking Europe's biotechnology communities and operators to facilitate open access to knowledge, skills and best practices

A pro-active role for public authorities in monitoring the impact on competitiveness of the existing policy framework and to anticipate emerging issues and pro-actively adapt policies

Responsible governance

The public debate on life sciences and biotechnology, fundamental values affected, and the complex issues raised demonstrate the need for responsible policies to help steer these fast-moving technologies, and the need for particular attention to involvement of the general public. The debate needs to be broadened far beyond the current focus on genetically modified foods and stem cells. All key stakeholders have stressed the importance of governance, i.e. attention to the way public authorities prepare, decide, implement and explain policies and actions.

Societal dialogue and scrutiny should accompany and guide the development of life sciences and biotechnology;

Life sciences and biotechnology should be developed in a responsible way in harmony with societal values;

Informed choice should facilitate demand-driven applications;

Science-based regulatory oversight should enjoy public confidence;

Fundamental regulatory principles and legal obligations should be respected to safeguard the EU Internal Market and international obligations.

International dimension

The EU should continue to take a leading role in developing international guidelines, standards and recommendations based on international scientific consensus.

Europe has a particular responsibility to support developing countries in dealing with the risks, challenges and opportunities, and to facilitate the safe and orderly development of these new technologies at the global level, in accordance with the choice of individual countries.

Implementation

To monitor progress in policy development and on the ground, and to anticipate emerging issues in this fast-developing area, the Commission will present a regular Life Science and Biotechnology Report, including a rolling work programme for related legislation. The Commission will, as part of its Life Science and Biotechnology reports, review the consistency of EU policies and legislation affecting life sciences and biotechnology and launch initiatives and proposals as appropriate.

Where different levels of competence apply, the strategy should be a reference for co-operation between the different actors. To facilitate transparency and dialogue on the further development and implementation of the proposed strategy for life sciences and biotechnology, the Commission will organise a broadly-based Stakeholders' Forum.

The Commission now invites other EU institutions and bodies, Member States, regional authorities, the private sector and the public to help refine and implement the proposed strategy. In this process, defining detailed measures under short- and medium-term actions and their agenda will be a first decisive step towards an effective and coherent European biotechnology policy.

For further information:

http://europa.eu.int/comm/biotechnology/introduction_en.html

European Competitiveness Report 2001, Luxembourg 2001 http://europa.eu.int/comm/enterprise/enterprise_policy/competitiveness/doc/competitiveness_report_2001/index.htm

Industrial competitiveness in biotechnology. A European perspective, Enterprise Papers N°7, 2002 http://europa.eu.int/comm/enterprise/library/enterprise-papers/paper7.htm

DN: IP/02/122 Date: 23/01/2002