Philippe Busquin, European Commissioner in charge of Research
Biotechnologies in the European Research Area

Speech to the General Assembly of EuropaBio

Ladies and gentlemen,

It is an honour for me to be with you today.

I would like to take this opportunity to address three issues today that are of relevance to the biotechnology sector :

• The progress that has been made in the last year concerning the action plan regarding the European strategy on life sciences and biotechnology.
• The concept of technology platforms and how it can contribute to strengthen the European Research and innovation area in biotechnology.
• An outlook on the next framework programme and its relevance for the European biotechnology industry.

The European strategy for life sciences and biotechnology :

• The second progress report on the European strategy for life sciences and biotechnology was adopted by the Commission on the 7th of April 2004. This report will be discussed in more detail in the Competitiveness Council in their September 2004 meeting.
• As in the last year, the progress report is accompanied by a Commission working document, which contains other detailed information as well as a timetable for the implementation of the action plan.
• Important progress has been made :
• The 6^th Framework Programme for Research and Development (6FWP) strongly encourages research in the life sciences and biotechnology domain;
• The revision on pharmaceutical legislation has been adopted at the beginning of this year;
• The regulatory framework for genetically modified organisms has been completed and guidelines on co-existing in farming have been published;
• The Member States have chosen different strategies for implementing policies that strengthen the evolution of biotechnologies and have opted for different instruments to support its development. A number of Member States have strengthened relations between universities and industry/society ; one example being the French Innovation law of 2000. Other activities have been taken to improve the financial situation of young enterprises: : the French « Jeunes entreprises innovantes «JEI » initiative launched by France Biotech, and which is effective since last January, strongly favours investments into research intensive biotechnology companies just as the research tax credits in the United Kingdom.
• The European Investment Bank has recently allocated an additional €500 million to the European Investment Fund in order to increase the EIF risk capital mandate. This followed recommendations of a working group of the Biotech and Finance Forum, a group that regularly brings together researchers and representatives of finance and industries.

The progress report also underlines delays in numerous areas, as already signaled in last years report 

• Public and private investments in research need to be increased urgently ;
• Biotech companies’ access to finance needs to be further improved ;
• Member States need to progress in the implementation of important measures to which they have committed themselves. One example is the area of intellectual property. Due to delays in the implementation of directive 98/44/EC regarding the legal protection of biotechnological inventions, enterprises working with novel biotechnologies do not know if they are fully allowed to reap the commercial benefits of their work. This hampers growth of the sector by discouraging not only the innovators themselves but also potential investors from providing the necessary finance.

In addition, the lengthy process of adopting a Community Patent regulation has led numerous enterprises to adopt a strategy of obtaining patents only in the US and some EU Member States. It is important for the growth of the biotech industry that these two problems find a solution.

EuropaBio and its national associations can play an important role in this respect by convincing their national policy makers about the importance of a harmonised and affordable patent system for supporting innovation in their sector.

• The contribution of the research sector is important:
• The implementation of the 6^th Framework Programme for Research and Development (FP6) has effectively led to an increase of the Community support to Life Sciences and Biotechnology research by some 20% compared with the previous Framework Programme. Following the first call for proposals, more than €810 million were allocated to actions in the two thematic priorities “Life sciences, genomics and biotechnology for health” and “Food Quality and Safety” mobilising more than 2700 laboratories including about 400 SMEs. As a result of the first call for proposals, about 10% of the budget (approximately €80m) will be allocated to SMEs. We are doing our best to further raise this figure to 15%.
• The Commission has also taken a more pro-active role concerning human resources; from promoting and financing various initiatives to attempting to simply legislation in order to improve the environment of researchers and make the European Research Area more attractive for scientists, both for those inside and outside of the EU.
• The budget foreseen for the Structuring Activity “Human resources and mobility” under the 6^th Framework Programme for Research has been almost doubled from the 5th Framework Programme value. As a result of the first calls for proposals €47 million (13% of the budget) has been allocated to “Human resources and mobility”/”Marie Curie” actions in Life Sciences and Biotechnology. There are also possibilities for industrial fellowship grants, which should be used much more by industry.

Much rests to be done to improve the situation of European biotechnology and its competitiveness. Biotechnology is characterised by a rapid development (nanobiotechnology ; industrial biotechnology, etc.) and we have to constantly face new emerging questions. It is therefore important that the strategy continues to evolve further.

• It is also important to point out that the biotechnology strategy involves numerous subjects and actors. The union must ensure the coherency of their efforts. It therefore has to reinforce the co-operation between the Member Staes and the Commission. The Commission has therefore proposed in the 2^nd progress report to reinforce the role of the existing Member States network on competitiveness in biotechnology.

Technology Platforms:

Another important aspects to integrate stakeholders and actors in the different sectors of biotechnology towards a coherent vision and action plan are the technology platforms. This concept, which was first demonstrated successfully for the sector of Aeronautics, is now being adapted to a wider range of technologies.

The Spring European Council of March 2003 under the heading “Building the European knowledge base” called “for the European Research and Innovation Area to be strengthened to the benefit of all in the enlarged Europe by creating European technology platforms bringing together technological know how, industry, regulators and financial institutions to develop a strategic research agenda for leading technologies, in areas such as plant genomics or the transition to hydrogen as a fuel”.

The Commission and stakeholders are engaged in the establishment of a number of European technology platforms to stimulate more efficient and effective RTD and to boost private sector investment, four of them relevant for the biotechnology sector.

• The European technology platform on plant genomics and biotechnology, is the first one, and it is expected to be fully operational in the second half of 2004. In fact, Feike Sijbesma and myself had the pleasure to present the vision paper of this platform just two hours ago to the public. This platform will bring together key stakeholders from research, industry, farmers, regulators, consumers and policy markers at regional, national and EU level. Its key objective is to formulate a strategic research agenda defining medium and long term targets, priorities, and building up the necessary public-private-partnership, including the mechanism to mobilize private and public investments.
• As noted in the strategy and in the recent “Environmental Technology Action Plan” of the Commission, there is a strong potential for the use of biotechnology in industrial processes and new materials. This so called “white biotechnology” or industrial biotechnology may well represent a significant portion of the whole biotechnology industry in the coming years, and it is a sector where European companies hold a strong position. Because of its large potential for transforming the chemical industry, industrial biotechnology will be one of the major pillars of the “sustainable chemistry platform”. for which a concept paper will be made public on 6^th of July. A detailed vision paper for European industrial biotechnology, highlighting the role of this technology not only for sustainable chemistry, but also other important sectors such food, textile and paper&pulp, is expected to be ready by October 2004.
• Another platform concerns nanobiotechnologies. The “European Nanomedicine Technology Platform” has the goal of strengthening innovation in nano-biotechnologies for medical use. A large workshop is planned for October 2004 in Berlin.
• The “Innovative Medicines for Europe Platform”, involves EuropaBio, EFPIA, EUFEPS and EMEA. Its objective is to enhance and accelerate the development process of medicines to ensure rapid translation of scientific breakthroughs to approved medicines. This is to be achieved by stimulating integrated forms of cooperation for R&D, in particular reinforced public-private partnerships between the private research sector, innovative biotech companies and pharmaceutical industry.

Europe needs to strengthen its science and biotech industry sector to become more attractive partners for the European and even global pharmaceutical industry and investors, in view of increasing the rate and number of innovative medicine development in Europe and thereby providing the European population with early access to new, more targeted medicines.

The major objective of technology platforms are to develop a long term strategic research agenda as a way to secure (or regain) long-term competitiveness of major European industrial sectors. Active and committed participation of industries – and organisations such as EuropaBio- is therefore vital.

The strategic research agenda should be implemented through national and European research programmes, using all kinds of instruments from basic research to large collaborative research projects and public-private partnerships with substantial investment from the private sector, making full use of all financing instruments, be they structural funds or coming from the European Investment Bank. An important component in this plan will be the 7^th Framework programme:

Outline of FP7:

In line with 3% initiative to raise investments in research to 3% of GDP by 2010, the European Commission has proposed on the 16th of June to increasing the European Union’s research funding to an average of €10 billion a year for the duration of the next framework programme, i.e. twice as much as today.

In its strategy document entitled “Science and technology, the key to Europe’s future”, the Commission aims to provide a concrete response to the objectives of the Lisbon strategy and to support the European Research Area project.

The six major objectives of EU action

• to create European centres of excellence by means of collaboration between laboratories (similar to integrated projects and networks of excellence in FP6);
• to launch technological initiatives on an EU scale in promising industrial sectors by creating joint undertakings (Joint European Technology Initiatives initiated through Technology Platforms);
• to boost the creativity of basic research by means of competition between individual teams at European level (European Research Council);
• to make Europe more attractive to the best researchers by increasing support for them;
• +to develop research infrastructures of European interest based on the example of the trans-European networks;
• to strengthen coordination between national research programmes.

The Commission also intends to identify the topics on which European research should focus. Two new topics have already been identified: space and security. It is important that the biotechnology industry will voice its priorities for community research in order to have an impact on FP7. This can be done through their associations or through other channels, like the technology platforms.

Conclusion:

The implementation of the strategy has started and taken up speed. However, there is no doubt that there is a lot to be done to improve the situation for European biotechnology and its competitiveness.

The circle of decision-makers who are actively involved in implementation of the Strategy is continuing to widen, going beyond the EU Institutions to include Member States’ policy-makers and the private sector. To help ensure coherent implementation, the Commission proposes a more concerted effort between the Commission, the Member States and the private sector to make better progress in areas where responsibilities are less centralised. Technology platforms can play an important role to align the interests of stakeholders and to develop a coherent long term research strategy for Europe.

As the EU Competitiveness Council of last May has pointed out, life sciences and biotechnology are important for the development of a knowledge-based economy and are key enabling technologies for future industrial development and innovation. Effective governance, the need for strengthened collaboration between Member States and the Commission and the continuous dialogue between the relevant stakeholders are key to exploiting the potentials of biotechnology. The Competitiveness Council will analyse the recommendations given in the progress report in order to set out priorities at its meeting later this year.

Thank you for your continued co-operation and I hope we can maintain and even strengthen our dialogue in the future in order to support the important target of creating a European knowledge-based bio-economy.