BioWorld International Correspondent
BRUSSELS, Belgium The European biotechnology industry has given an enthusiastic welcome to the European Union’s latest attempt to bring order to the often-chaotic regulatory environment for biotechnology.
After months of reflection and consultation, the European Commission set out a proposed strategy for the sector late last month, and EuropaBio, the European association for bioindustries, greeted the announcement as a potential “new beginning for biotechnology.” The thinking also won approval of the Emerging BioPharmaceutical Enterprises of the European Federation of Pharmaceutical Industries and Associations. But the plan does not address one of the key issues for the pharmaceutical industry in Europe: tight government controls on prices.
The proposed strategy focuses on how the EU should govern life sciences and biotechnology, and how it could effectively harvest their potential. It includes recommendations for EU member states, local authorities and industry. Academia and industry would benefit from measures to promote education. Genomics and biotechnology research would receive special funding, and have access to a new bioinformatics infrastructure. A new report would be compiled on how to improve the coherence and efficiency of the authorization system for genetically modified organisms. The EU’s European Investment Fund would offer assistance to new firms through a special start-up aid mechanism. And the Commission is proposing an Internet portal on commercial biotechnology in Europe.
Now the European Commission is hoping that the Barcelona summit of EU leaders on March 15-16 will endorse the strategy. There is a lot of political capital invested in this Commission proposal: European Commission President Romano Prodi himself dignified its launch, with complimentary words about biotechnology’s “huge” potential benefits in health care, food, industrial uses and the environment. “Europe needs to address the challenges of biotech by developing responsible policies to exploit these new opportunities in a manner that is consistent with European values and standards,” he said.
Recent rapid growth in the number of biotechnology companies in Europe means there are now more dedicated biotechnology companies in Europe (1,570) than in the U.S. (1,273). But, concludes the Commission’s analysis, Europe’s biotechnology industry is still at an early stage of development, with only 61,000 staff, lower revenues and capitalization, and a more limited product pipeline.
Erkki Liikanen, the Finnish member of the European Commission who is responsible for industry affairs and who has largely piloted the creation of the new strategy, said, “The time is ripe and we have no time to lose if we are to catch up with other regions of the world. Our estimates of the future size of the biotechnology market in Europe and globally demonstrate the urgency of Europe becoming a player in this field.” Europe faces a policy choice, he said. “We can either accept a passive role, reacting to developments elsewhere, or develop proactive policies.” But if Europe is to catch up with the U.S. (where the biotechnology industry has created many jobs and established a dozen new world-class companies over the past two decades), “We must act now.”
“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,” Liikanen said. In addition, there has not been a specialization in entrepreneurial biotechnology in Europe, and there is difficulty in developing an industry of dedicated biotechnology firms. Europe also suffers because of the lack of consensus over biotechnology at the level of the population. “There are complex societal issues involved. We need continuous social scrutiny and an inclusive, comprehensive, well-informed and structured dialogue,” Liikanen said.
And, in a full-dress presentation of the proposals, Research Commissioner Philippe Busquin also spelled out the EU need for more education and research. Reinforcing the EU resource base also includes promoting the mobility of European researchers while retaining them in Europe, Busquin said, pointing out that the Commission is proposing that the EU should spend $2.15 billion on biotechnology in the next five-year research framework program, which starts in January 2003.
The Commission formula for success includes developing entrepreneurial management skills, risk capital sources that are sensitive to the sector’s special needs, and a coherent and accessible European patent system. Public authorities will have to monitor the impact of their actions on competitiveness, and adapt policies to take account of the sector’s needs.
But to ensure that European society feels comfortable with biotechnology, “responsible governance” also will be needed. “Societal dialogue and scrutiny is of utmost importance,” said Liikanen, urging “the need to continuously involve the public.” To show how seriously the EU takes this point, the Commission is proposing the creation of a “Stakeholders Forum” to ensure that real dialogue takes place among all interested parties.
Consumers must also be able to exercise choice about their use and purchase of biotechnology products, and “confidence in regulatory oversight is crucial.”
The biotech industry said it was satisfied with the acknowledgement of biotechnology as a major source of innovation, but that it had come just in time, as Europe’s fledgling biotech industries are struggling to keep pace with their international rivals. “We have more companies than the U.S. but we generate far fewer products,” said Hugo Schepens, EuropaBio’s secretary general.
Schepens went on to say that energies at EU and national levels will still have to be mobilized and coordinated to make the strategy a reality.
“Supportive measures must be coherent, synergistic and attractive, and the regulatory process must be science-based, consistent and workable in all areas,” he said. “This has been Europe’s weakness.”
A spokesman for the European Federation of Pharmaceutical Industries and Associations said the proposals also largely responded to the aspirations of its biotechnology-based firms. They have been calling for many of the measures now proposed by the Commission: boosting public understanding, backing research, improving protection of innovative data and creating a better investment climate.
The one area that is conspicuously missing from the proposals, however, is one of the deepest felt of the pharmaceutical industry in Europe the need to reward innovation through pricing policies. EFPIA Director General Brian Ager said last week that current EU efforts to improve industry prospects are still not confronting what he termed “the core problem faced by the research-based industry in Europe”: the vulnerability of the sector to Europe’s fragmented pricing and reimbursement system for medicines, and to the unilateral price cuts imposed by member states as part of national cost-containment plans.