BioWorld International Correspondent
BRUSSELS, Belgium - Last week saw both of the major European organizations representing biotechnology firms calling for new initiatives to boost the sector.
The European Union's new legislation on orphan drugs is not working well enough for Europe's biotechnology firms, said Emerging Biopharmaceutical Enterprises, a specialized group within the European Federation of Pharmaceutical Industries and Associations. The two-year-old incentive plan to develop treatments for rare diseases - "orphan" drugs - is not delivering, and needs more focus on bringing products through to the market, it said. Although 150 medicines have been formally designated with special value by the scheme, so far just 11 of them have received marketing authorization.
That means that many of the rare diseases, each of which affects fewer than five in 10,000 people, or up to 185,000 individuals per disease in the entire EU, remain without adequate treatment, the industry grouping said. Biopharmaceuticals - medicines derived from biotechnology - can, EBE said, often provide the answer to these disorders, mostly genetic, that affect a very small population, even where conventional medicines cannot.
Meanwhile, demands for new European action came from EuropaBio, which numbers among its members some 35 major biotech companies, as well as 20 national industry associations. During its annual meeting in Brussels, EuropaBio called for the creation of an EU stock market to support growth of technology companies. It said there should be an end to the fragmentation of Europe's stock exchanges and the wide differences in securities regulations. Recent European attempts to create an equivalent of the U.S. Nasdaq market leave the biotechnology sector without adequate sources of finance, it said.
"With the failure of the Neuer Markt [in Germany], Nasdaq Europe, an anemic Euronext, and a London Stock Exchange isolated from continental Europe, we need to build a powerful European stock market that will provide fund-raising, investment and exit opportunities for companies, entrepreneurs and investors in innovative fields," it said. "The whole growth chain - academic research, technology transfer, seed financing, venture capital, growth of successful companies - depends on an effective stock market."
It issued a clear request to European governments "to achieve harmonized securities regulations by 2004."
EuropaBio also urged the creation of special fiscal status for new biotech firms to boost innovation. Its proposed scheme, involving a formal category of European Young Innovative Company, and related benefits, "could help make Europe the most attractive continent for entrepreneurs and investors," said Philippe Pouletty, chairman of the Emerging Enterprise Board at EuropaBio. The French and German governments already are discussing similar national schemes.
EU Says GM Laws Comply With International Rules
Faced with strong international opposition to its rules on genetically modified organisms, the European Union last week was still insisting that its authorization system is not in conflict with the World Trade Organization.
On Thursday, the EU held consultations with two of its principal opponents, the U.S. and Argentina, and it stressed that it was entitled to make its own decision on what GMOs are put on its market. It also underlined that all applications for marketing of GMOs are currently being assessed on the basis of the EU regulatory regime in place, with each application considered on its own merits, on the basis of the EU regulatory framework.
The consultations were an attempt to head off a clash at the WTO, following the repeated complaints by the U.S. and other countries that the de facto moratorium on GMO authorizations in the EU constituted a barrier to trade. The EU described the talks as "constructive," and claimed it had responded to all the questions raised both on the EU regulatory framework for GMOs, and on the status of pending applications for approval.
The EU said that, like any WTO member, it has "a legitimate right to establish a regulatory regime to ensure that GMOs are put on the market only on the basis of a careful assessment of risks, appropriate control and monitoring measures, and proper information to consumers." And it added that each pending application is being considered on its merits on the basis of its new regulatory framework, which came into effect in October 2002. "WTO litigation will certainly not influence this process," it said.
EU Finalizes Rules On GMO Exportation
European Union environment ministers last week adopted the new EU regulation on the transboundary movements of genetically modified organisms. Meeting in Luxembourg, the EU Environment Council gave the final go-ahead to rules implementing the provisions of the Cartagena Protocol on Biosafety, a UN agreement that aims to ensure, on a global scale, the protection of biodiversity and of human health, and which is scheduled to come into effect in September.
The European Commission welcomed the move. Environment Commissioner Margot Wallström said it "confirms the commitment of the European Union to the objectives of the Biosafety Protocol," which she described as "a global issue, which needs global action." The new EU regulation complements the existing regulatory framework, in particular for exports of GMOs. It will require EU member states to notify exports of GMOs intended for deliberate release into the environment, and to secure express consent from the authorities of the importing country prior to a first transboundary movement.