Europe has an advanced basic research sector for biotechnology but “does not excel in turning research into commercial applications”, says the European Commission.
This observation will strike a familiar chord with the biotech industry. It also underpins a new communication that redraws the Commission’s strategic priorities in biotechnology and the life sciences to encourage market development, knowledge transfer to industry, more consistent implementation of legislation and better uptake of new technologies – but also societal debate on the benefits and risks of those technologies.
Launching a mid-term review of its Strategy on Life Sciences and Biotechnology for 2002-2010, the Commission said: “Despite many successful European biotech start-ups, the companies tend to grow slowly and depend on external finance for their research and development. Sufficient amounts of risk capital are often difficult to raise and the European patent system makes it expensive to file and defend patents, especially for SMEs [small and medium-sized enterprises].”
Moreover, it warned, investment in life sciences and biotechnology research was accelerating worldwide while new competitors emerged from countries such as China, Brazil and India.
The Commission’s remedy is not to overhaul the broad-based strategy it adopted in January 2002, which “has been successful and is still relevant”, but rather to re-align and prioritise certain elements of the strategy’s 30-point action plan with the aim of maximising its impact. Implementation of the plan will continue up to 2010, with a new emphasis on “a focused set of biotech-specific priority actions”.
While annual progress reports on the life sciences and biotechnology strategy were issued in 2003, 2004 and 2005, the EU member states have been taking another look at the document over the last couple of years. Last July a stakeholder consultation was launched to inform the mid-term review.
The Commission has also drawn on the Bio4EU study conducted by its Joint Research Centre, which examines the potential applications of biotechnology in Europe, as well as their social, economic and environmental impact. The main findings of this study, which was requested by the European Parliament, are due to be presented at a symposium in Brussels on 20 April.
The communication on the mid-term review of the Strategy on Life Sciences and Biotechnology consolidates the action plan under five headings:
- Promote research and market development for life sciences and biotechnology applications and the Knowledge-Based Bio-Economy (KBBE). This includes actions such as mobilising public and private research, and reinforcing the co-ordination of research, in co-operation with industry, member states and other funding bodies. It also takes in implementation of the Joint Technology Initiative on Innovative Medicine piloted by the Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
- Foster competitiveness, knowledge transfer and innovation from the science base to industry. Into this category would fall, among other issues, developing best practices for the responsible licensing of genetic inventions; promoting knowledge transfer by improving links between research organisations and industry; and monitoring the implementation of Directive 98/44/EC on the legal protection of biotechnological inventions, as well as exploring ways to facilitate the patenting system for SMEs.
- Encourage societal debates on the benefits and risks of life sciences and biotechnology. Among the measures discussed here are exploring the possibility of an “institutionalised interface” with different stakeholders on the benefits and risks of life sciences; and developing proposals on improving co-operation with all stakeholders to ensure input into the Commission’s activities.
- Ensuring a sustainable contribution of modern biotechnology to agriculture. This covers various activities around genetically modified organisms (GMOs) and GM crops – much to the ire of Friends of the Earth Europe, which said the Commission was “ignoring the wishes of the majority of the European public and asking for looser regulation and more taxpayers’ money for genetically modified crops”.
- Improve the implementation of the legislation and its impact on competitiveness. This includes reinforcing existing networks with member states to monitor the implementation of the biotechnology strategy and address regulatory obstacles to competitiveness; and improving policy co-ordination, with a particular focus on newly emerging issues.
The European Union Association for Bioindustries (EuropaBio), which recently called for a coherent EU policy agenda for industrial biotechnology, welcomed the review, saying the refocused actions were “an important step towards building the bio-economy”. But it also regretted the “lack of implementation” of the strategy in a number of member states, adding that the review and the new action plan should be brought into effect throughout Europe “without a biased pick and choose approach”.
The recent BioImpact study by France Biotech, EuropaBio and the French pharmaceutical industry associations, LEEM and LIR, had found that most of the top-performing biotech medicines for breast cancer, heart disease and inflammatory diseases were developed in the US, EuropaBio pointed out. And here it echoed the Commission: “Europe is great in science and knowledge but when it comes to translating that science and knowledge into products – the innovation part – the fragmented European legal, financial and regulatory environment is not as fertile as other regions,” commented secretary general Johan Vanhemelrijck.