EU2002 Biblio Entry

Reference: EC 2002
Title: Life Sciences and biotechnology - A Strategy for Europe
Authors: Commission of the European Communities
Publisher: Biotechnology European Commission, Rue de la Loi, 200 , Wetstraat, Bruxelles -1049 – Brussels, Belgium
Publication details: 23 January 2002, 35p

Life sciences and biotechnology are widely recognised to be, after information technology, the next wave of the knowledge-based economy, creating new opportunities for our societies and economies. They also raise important policy and societal issues and have given rise to a broad public debate, as confirmed in the comprehensive public consultation carried out by the Commission during autumn 20011. These issues must be addressed with great care and sensitivity. In Europe, however, the relevant responsibilities fall across a broad range of policies and actors. In the absence of a shared vision of what is at stake and without common objectives and effective coordination, Europe has therefore only slowly and with difficulty addressed the challenges and opportunities of these new technologies.

Our democratic societies should offer the necessary safeguards and channels of dialogue to ensure that the development and application of life sciences and biotechnology take place respecting the fundamental values recognised by the EU in the Charter of Fundamental Rights. Europe is faced with a major policy choice: either accept a passive and re-active role, and bear the implications of the development of these technologies elsewhere, or develop pro-active policies to exploit them in a responsible manner, consistent with European values and standards. The longer Europe hesitates, the less realistic this second option will be.

A revolution is taking place in the knowledge base of life sciences and biotechnology, opening up new applications in health care, agriculture and food production, environmental protection, as well as new scientific discoveries. This is happening globally. The common knowledge base relating to living organisms and ecosystems is producing new scientific disciplines such as genomics and bioinformatics and novel applications, such as gene testing and regeneration of human organs or tissues. These in turn offer the prospect of applications with profound impacts throughout our societies and economies, far beyond uses such as genetically modified plant crops.

The expansion of the knowledge base is accompanied by an unprecedented speed in transformation of frontier scientific inventions into practical use and products and thus also represents a potential for new wealth creation: old industries are being regenerated and new enterprises are emerging, offering the kind of skill-based jobs that sustain knowledge-based economies. As probably the most promising of the frontier technologies, life sciences and biotechnology can provide a major contribution to achieve the European Community's Lisbon Summit’s objective of becoming a leading knowledge-based economy. Europe's current performance in life sciences and biotechnology is not facilitating the achievement of that objective.

The European Council in Stockholm in March 2001 invited the Commission, together with the Council, to examine measures required to utilise the full potential of biotechnology and strengthen the European biotechnology sector's competitiveness in order to match leading competitors while ensuring that those developments occur in a manner which is healthy and safe for consumers and the environment, and consistent with common fundamental values and ethical principles.

In Europe and elsewhere, intensive public debate has emerged. While the public debate has contributed to awareness and concrete improvements on important issues, it has also focused narrowly on genetically modified organisms (GMOs) and specific ethical questions, on which public opinion has become polarised. In the Community, like in other regions and countries, the scientific and technological progress in these areas raises difficult policy issues and complex regulatory challenges. Uncertainty about societal acceptance has contributed to detract attention in Europe for the factors that determine our capacity for innovation and technology development and uptake. This has stifled our competitive position, weakened our research capability and could limit our policy options in the longer term.

Europe is currently at a crossroads: we need to actively develop responsible policies in a forward-looking and global perspective, or we will be confronted by policies shaped by others, in Europe and globally. The technology and its applications are developing rapidly – the Commission believes that Europe’s policy choice is, therefore, not whether, but how to deal with the challenges posed by the new knowledge and its applications.

The European Commission launched a broad public consultation in 2001 (EC 2001) to develop sustainable and responsible policies to address the following three questions:

1. How can Europe best attract the human, industrial and financial resources to develop and apply these technologies to meet society’s needs and increase its competitiveness?

2. How can Europe deliver effective, credible and responsible policies which enjoy the confidence and support of its citizens?

3. How can Europe best respond to the global challenges, develop its domestic policies with a clear international perspective and act internationally to pursue its interests?

The Commission proposes a strategy to respond with responsible, science-based, and people-centred policies on an ethical basis. This strategy aims to allow Europe to benefit from the positive potential of life sciences and biotechnology, to ensure proper governance, and to meet Europe’s global responsibilities. This is a proposal for an integrated strategy – its different elements are interdependent and mutually reinforcing.

Implementing this strategy requires an open, collaborative and sustained process to develop coherent and credible policies. The Commission also proposes an Action Plan for concrete measures by the Commission and the Community, as well as recommendations for other public and private actors, respecting the subsidiarity principle.

1. The strategic challenges 3
1.1. Technology revolution and policy response 3
1.2. A European Strategy 4

3. Harvesting the potential 7
3.1. The knowledge-base 8
3.2. Europe’s capacity to offer scientific and technological solutions 9

4. A key element for responsible policy: governing life sciences and biotechnology 11
4.1. Societal scrutiny and dialogue 12
4.2. Developing life sciences and biotechnology in harmony with ethical values and societal goals 12
4.3. Demand-driven applications through informed choice 14
4.4. Confidence in science-based regulatory oversight 14
4.5. Regulatory principles 16

5. Europe in the world - responding to global challenges 17
5.1. A European agenda for international collaboration 17
5.2. Europe’s responsibilities towards the developing world 18

1 Commission Communication "Towards a Strategic Vision of Life Sciences and Biotechnology: Consultation Document", COM (2001) 454 of 4.9.2001. The Communication, public web-comments and results of a Commission Stakeholder Conference held 27-28 September 2001 are available at http://europa.eu.int/comm/biotechnology.