Brussels, 23 January 2002
1. The potential of biotechnology
The potential for Europe of Biotechnology was clearly acknowledged in Stockholm last year. On this occasion, the European leaders endorsed the Commission's plans to draw up a comprehensive strategy for life sciences and biotechnology.
Today, the Commission presented its vision for such a policy.
The time is ripe and we have no time to lose if we are to catch up with other regions of the world.
In Lisbon two years ago, European leaders endorsed the Commission's eEurope Action Plan which was our road map for making Europe catch up in the IT-world. Two years after this Action Plan has yielded good results and Europe is well on its way in this field.
It is broadly believed that after IT - biotechnology will be the next wave of technological revolution. As with IT - it will have a considerable growth potential and a broad impact on our economies and societies.
We therefore hope that Barcelona will endorse this strategy.
As outlined by President Prodi, the potential benefits are huge in areas such as health care, food, industrial uses and the environment. And our estimates of the size of the future size of the biotechnology market in Europe and globally also demonstrates the urgency of Europe becoming a player in this field.
Today, Europe faces a major policy choice: the technology exists, and so it is not a question of whether, but how Europe takes the challenge.
We can either accept a passive role, reacting to developments elsewhere, or develop pro-active policies to exploit the potential in a responsible manner consistent with our societal values.
One notable difference between Europe and the US so far has been that, while in the US a new researchintensive industry in the life sciences has continued to develop, there has not been a specialisation in entrepreneurial biotechnology in Europe of the same dimension.
Partly reflecting this difficulty in developing an industry of dedicated biotechnology firms, the perception has emerged that the US has a competitive advantage over Europe in biotechnology.
The US biotechnology industry has, over the past two decades, created a large number of new jobs, and at least a dozen new worldclass companies.
If Europe is to catch up with this lead by the US, we must act now.
2. Biotechnology in Europe today
Today's Communication draws on a thorough consultation process and analysis of the strengths and weaknesses of European biotechnology.
In September last year the Commission held a conference with a broad representation of stakeholders and published a comprehensive consultation document.
In addition, we have just concluded a major analysis of the competitiveness of Europe's biotechnology sector that has helped us identify strengths and weaknesses. We have copies available for you today.
Our analysis shows that there is a recent rapid growth in the number of biotechnology companies in Europe, mostly SME's.
However, Europe's biotechnology industry is still at an early stage of development.
In comparison, the US biotechnology industry is maturer, has three times the revenues of the European industry, employs many more people (162,000 against 61,000), is more strongly capitalised and has many more products in the pipeline.
Europe is rather a late starter in biotechnology with rapid expansion in the second half of the 1990s.
The vast majority of European biotechnology firms are of very small size.
European companies tend to organise in regional clusters, mostly around centres of scientific excellence. Research co-operation among regions of member states is still quite weak.
Our main problem in Europe is that we do not have a single policy for life sciences and biotechnology but a patchwork of many sectoral and horizontal policies at international, EU, Member State and local levels.
If Europe wants to reap the benefits of life sciences and biotechnology, we need a shared vision for a co-operative and coherent approach.
There are complex societal issues involved. We need continuous social scrutiny and an inclusive, comprehensive, well-informed and structured dialogue.
3. The strategy
Our comprehensive strategy proposal pursues 30 specific action points which focus on 4 main areas. These are:
how to "harvest the potential",
how to govern life-sciences and biotechnology,
how to respond to global challenges, and finally
how to implement this Strategy.
Area 1: How can Europe can harvest the potential that biotechnology represents?
Apart from focusing on education and research which my colleague Commissioner Busquin will outline in more detail we need to develop entrepreneurial management skills in our enterprises to take advantage of the challenges ahead.
In addition, biotech is notoriously capital hungry. Europe will have to develop risk capital sources that take into account the specificity of the sector.
In this field we have many start-ups and SMEs. The area of biotechnology poses particular difficulties for such companies to grow since they face long development times, heavy authorisation procedures.
This leads to a substantial risk of company failure.
Also, intellectual property in Europe is still expensive and fragmented. Europe must complete a coherent and accessible patent system.
Area 2: We also need a proactive role for public authorities.
The fast development of biotechnology and the broad range of potential applications require a pro-active role for public authorities to monitor the impact on competitiveness and to anticipate emerging issues and adapt policies.
A key issue to pave the way for a genuine proactive European biotech policy is to ensure responsible governance in biotechnology. And here societal dialogue and scrutiny is of utmost importance.
The public debate on life sciences and biotechnology raises fundamental values and complex issues. This demonstrates the need for responsible policies and the need to continuously involve the public.
The debate needs to be broadened far beyond the current focus on genetically modified foods and stem cells.
We have therefore proposed to establish a broadly based Stakeholders Forum to facilitate transparency and dialogue on further development and implementation of the proposed strategy.
Another key element in this regard is the need for "Informed choice". If consumers can exercise a clear and informed choice about their use and purchase of biotechnology products, the market will deliver the desired applications. Freedom of choice for economic operators includes safeguarding the sustainability and diversity of agriculture in Europe.
Finally, confidence in regulatory oversight is crucial.
The EU should complete the regulatory framework in the areas of GMOs and pharmaceuticals as soon as possible to ensure such confidence.
Public trust in the role of science in our societies needs to be enhanced, also through better communication on EU regulation of these new technologies.
All stakeholders, including the private sector, have a responsibility here.
Another important issue in this regard is which regulatory principles we apply when legislating on biotech issues.
The Commission suggests that legislation respect the following basic principles:
Risk governance and product authorisation on the basis of a comprehensive and transparent scientific risk assessment of the highest standard
Safeguarding the Internal Market
Community regulatory requirements to be proportionate and commensurate with the degree of identified risk and in conformity with the Community's international obligations
Periodical review of regulations to ensure predictability, updating and impact assessment
Area 3: On the international dimension, the scientific and technological revolution of biotechnology is a global reality that creates new opportunities and challenges for all countries in the world, rich or poor.
The Community should continue to take a leading role in developing international guidelines, standards and recommendations.
Europe has a particular responsibility to support the developing world, in particular, to ensure that they deal with the risks, challenges and opportunities that biotechnology brings.
Area 4: Regarding the implementation of this Strategy, the Commission will ensure implementation of the strategy and the action plan through:
A regular Life Science and Biotechnology Report, including a rolling work programme for legislation.
Reviewing and enhancing coherence across Community legislation and policies impacting on life sciences and biotechnology (regulatory framework, innovation and competitiveness, research and other Community policies and objectives)
Using the strategy as a reference for collaboration between different actors where different levels of competence apply. 4. Conclusion
The time has come to launch a European policy on biotechnology to be able to harvest the great potential benefits that this sector may generate in the future. Such benefits are: growth, employment but also better drugs and health care, more resistant food and agricultural products and cleaner technologies to the benefit of the environment.
For such a policy to take off, we must take a balanced look at all issues relating to biotechnology also the difficult ethical and environmental ones. For this we need a broad and transparent dialogue with all stakeholders so that we can move forward.
The Commission is now looking forward to work with all concerned actors to further refine and implement the proposed strategy.
DN: SPEECH/02/18 Date: 24/01/2002
DN: SPEECH/02/18 Date: 24/01/2002