Copenhagen, 21 October 2002

Ladies and Gentlemen:

Biotechnology will be the next wave of technological revolution. Like every powerful new technology, some of its applications raise genuine concerns about possible abuses of its power. Equally - like every powerful new technology - it has huge commercial potential, and should have a momentously beneficial impact on our economies and societies.

This conference addresses one of the major challenges facing Europe: How to harness biotechnology's potential, in a way that is consistent with our values.

This is also the basic challenge that we at the European level of policy-making are seeking to help overcome. We believe that we can do so by pursuing the comprehensive strategy for the life sciences and biotechnology that we set out earlier this year. It is this strategy and the need for you to be actively involved in its development that I'd like to talk about today.

Background

First of all, let's look back at what happened in Europe during the 1990s. The potential of biotechnology was widely realised and most European countries put measures in place to support research and innovation. Public funds supported young start-ups and a vast number of biotechnology SMEs were created. In parallel, there was a feeling of unease in society about what biotechnology could bring and various measures were taken to limit such developments. The end result was a piecemeal approach that both promoted and restricted the development of biotechnology, often without any coherent underlying vision.

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Europe's choices about biotechnology were becoming increasingly clear. We could either accept a passive and reactive role to developments elsewhere, or we could work out proactive policies to develop biotechnology's potential here in Europe (and to shape its development internationally) in a way that is consistent with European values and standards.

Over the past few years, European leaders and policy-makers have become increasingly aware of this choice. We are all sensitive to the concerns of those who fear that certain applications of biotechnology might affect their lives in harmful, or ethically offensive, ways. At the same time, none of us has ever wanted the EU to be left behind while the development of the life sciences and biotechnology continues in the rest of the world.

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Life Sciences and Biotechnology are a key building block of the knowledge-based economy and society and so the Commission set about the task of drawing up a comprehensive and coherent set of policies for life sciences and biotechnology in Europe.

Overview of the Strategy and Action Plan

When we drew up the strategy, we actively consulted the various stakeholders to make sure that their concerns were addressed. Public consultation is a key element in the development of European biotechnology, because strong links between science and society are a prerequisite for the development of any radical new technology. In today's world of free-flowing information, science cannot simply move ahead and expect society to follow. Consensus and coalitions of interests are required. This requires inclusive, well-informed and structured dialogue and on-going societal scrutiny.

We based our approach to biotechnology on a thorough analysis of its strengths, weaknesses and particular needs in Europe, and aimed to set out a comprehensive and coherent vision of what policy-makers and stakeholders need to do.

Our proposal includes a 30-point Action Plan, each action covering a specific aspect of relevance to the development of European biotechnology. Actions can be grouped in two categories: those which aim at strengthening the value creation chain and those which improving effective governance.

Action Plan (1): Strengthening the value creation chain

Research

Several actions concern Europe's capability to transform our knowledge base into products and jobs. Europe has a tradition of first class research, but we traditionally also have had a difficulty exploiting the result of that research. The major Community tool for supporting research is the 6 th Framework Programme for Research and Technological Development. Bruno Hansen from the Research Directorate General will speak about that later.

Several actions in the strategy relate to encouraging technology transfer from academia to biotechnology SMEs, and also to established industries. We also want to encourage support to new biotechnology companies in their access to the best management and the best legal advice possible.

Skills and Education

But biotechnology is not only a sector of research activity. It also represents a diverse set of technologies that have already begun to revolutionise some industries (such as pulp and paper processing) and require new skills among the work force. Harnessing biotechnology's potential will be key to the competitiveness of many other sectors, which is why it is so important to widen education in the life sciences. Europe needs not only its top researchers, but also a much broader literacy in the life sciences.

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Another key issue in the development of commercial biotechnology is the effectiveness of intellectual property rights. There is hardly any other area of commercial and economic activity that depends more on its knowledge base than biotechnology: Knowledge and intellectual property are at its very heart.

Back in 1998 the Council of Ministers and the European Parliament adopted the Biotechnology Patent Directive. It is now urgent for all Member States to transpose it into their national legislation so that legal uncertainties can be minimised. I would here like to congratulate Denmark as one of the first Member States to have done so.

The Commission has also presented a proposal for an affordable and accessible Community Patent, valid in all Member States. This vital proposal is under consideration in the other EU institutions and it is important that their process comes rapidly to an end.

G10

We have also launched an initiative, the G10 Medicines Group, to improve the competitiveness of the European-based pharmaceutical industry while encouraging high levels of social and public health protection. The Group recently published a report which highlighted the critical contribution that biotechnology makes to the industry. There will be a presentation of the report and its recommendations later this afternoon.

Networks

Several actions are aimed at overcoming the fragmentation that has been identified as a specific problem for European biotechnology. They include the use of networks, exchange of views, early identification of emerging issues and other measures that help the actors have a broader view.

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Action Plan (2): Improving effective governance

There will always be aspects of biotechnology that will raise ethical questions. Europe does share basic values, but is a very diverse and pluralistic society. Consequently there is a great variety in the specific ethical considerations. The Commission will support a dialogue to make easier the identification of different ethical standpoints. This can contribute to mutual understanding of their basis and lead to an exploration of where common views are possible and desirable.

The Strategy for Life Sciences and biotechnology is comprehensive and involves the responsibility of many actors, public and private, at the European, national and regional levels. We must remember, however, that a strategy is only as good as its implementation. After all the preparatory work, we have now reached the stage where the Commission is inviting all the various actors to make commitments in their own areas.

Throughout this process, it is vital that the actions are as transparent as possible. They must be accompanied by a real dialogue with society. The Commission will establish a broadly based stakeholders' forum as part of a framework to provide an information exchange on life sciences and biotechnology at the European level. Similar fora are appearing in Member States and at other levels. Together with the scientific community and other stakeholders, the Commission will promote public awareness of the science paradigms that form the basis of regulatory oversight. We also encourage industry and academia to engage themselves in a dialogue with their communities to explain the aims and methods they use in their research.

Naturally, the strategy must also consider the situation regarding GMOs in Europe. Last week the new Directive concerning deliberate release into the environment of genetically modified organisms became fully applicable in the EU. This Directive, supported legislation concening Traceability and Labelling, on one hand, and GM Food and Feed, on the other hand, provides for a strengthened and transparent approval system in the EU. The Commission considers that the conditions are now in place to activate the approval process.

The response to the strategy

The Strategy should be seen as a process, where policy-makers and stakeholders shape the development of biotechnology in Europe. I am happy to say that, since we proposed the strategy, the response from the various actors involved in biotechnology has been quite impressive. I believe that there is now a growing awareness and a new commitment to biotechnology's development in Europe.

The private sector's role in the development and commercialisation of biotechnology is obviously important. Although the future economic value of biotechnology is predicted to be high, it will depend heavily on the scientific research and inventiveness of commercial biotechnology innovators and entrepreneurs.

The vast majority of specialised biotechnology companies are small innovative companies, often with their origins in academic research. Of course, the Commission understands that a company with 10 or 20 employees has limited resources and is extremely busy developing its business. Yet this should not preclude some practical engagement, both in industry issues and in dialogue with the community. In our view, such engagement brings long-term confidence and benefits that can prove very valuable.

Indeed, few specialised biotechnology companies are able to operate in a vacuum. Practically all are financially dependent on external sources of finance, with investors that regularly need explanations of what they are funding. And practically all biotechnology companies are also members of regional and national biotechnology trade associations. Active engagement in dialogue with the wider community can take many forms, and may be valuable or even essential to a company's public relations and marketing strategy.

Our Member States' national governments are already preparing their responses to our proposal: I expect the Council of Ministers to provide a "road-map" with practical measures, priorities, timetable and responsibilities for implementation. The European Parliament is working on a draft report. Both the Council's road-map and the Parliament's report are likely to be adopted in November. The Economic and Social Committee has already given their very positive and encouraging response.

These developments are not confined to a few buildings in Brussels. Several regions with biotechnology industries have already started exploring how to exchange information and collaborate. In this way they can gain from each other's knowledge and experience. Academic institutions and the authorities responsible for public schooling are also trying to explore ways of improving teaching of the life sciences. This aims at both young and advanced students, as well as training new generations of researchers

Much of this work and other initiatives are carried out autonomously and with the aim to satisfy the specific local or regional needs. This is exactly the way it should be. At the same time, it fits in well within a comprehensive and coherent European Strategy for Life Sciences and Biotechnology.

Let me clarify, the Commission is not aiming to centralise the development of biotechnology in Europe. Our aim is more modest: we are not so concerned with questions of competence what we want is for policy-making to be effective.

We want to facilitate a process, where everyone involved in European biotechnology can find partners, identify interesting research, take part in a debate on where we want biotechnology to go, and generally be part of a broader network. Only in this way can everybody involved make his or her decisions based on the best possible information.

This will happen if the actors in European biotechnology - governments, finance institutions, academia, industry and civil society - feel that they have a stake in the process and that they are prepared to commit themselves to making it happen.

It is of course impossible to say when the process will be finished. I have no doubt that many of the new actions that will be needed will be developed by the participants - many of them without any specific reference to the biotechnology strategy. Several of the initial actions may also turn out to no longer be needed, as the problems they seek to address are one by one resolved.

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Conclusion

What will develop, if we succeed in our task, is a dynamic and vibrant European biotechnology sector, as competitive as any in the world. It will be backed by first class science and research, and a work force that is literate in the life sciences. And finally, it will also be developed according to the choices we have made ourselves and providing the products and services we demand as users and consumers.

DN: SPEECH/02/502 Date: 21/10/2002