BioWorld International Correspondent
BRUSSELS, Belgium - The European biopharmaceutical industry received a promise of support March 11 from the man who has just taken over as the top European Union official responsible for medicines legislation.
European Commission Vice President Günther Verheugen said during a presentation at the European Medicines Agency in London: "The industry needs a clear regulatory framework for new technologies so that it can design its studies and develop products for the benefit of patients."
That was Verheugen's first major pronouncement on his vision for the pharmaceutical sector since he became the EU's industry chief at the end of 2004. Speaking at the 10th anniversary celebrations of the medicines agency, he particularly welcomed the European industry's capacities for gene therapy, cell therapies and tissue engineering, and he explicitly acknowledged that unclear rules "increase uncertainty and risks for industry and reduce innovation." He promised to make a priority of providing a clearer operating environment "for these advanced therapies" so as to help stimulate industry innovation.
"It is no secret that the historical dominance of the European pharmaceutical industry has been eroded, particularly by the growth of the industry in the United States," he said.
"We look forward to evolution" in the EU's rules, responded one of the European pharmaceutical industry's leading figures, Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations. He insisted on the need not only for a high-quality regulatory system, but also for a Europe-wide marketplace "which rewards innovation."
Medicines Agency Unveils New Plans For Biotech
The European Medicines Agency announced a five-year strategy that includes special measures for innovative medicines, technologies and therapies, and efforts to stimulate research and innovation in the EU's pharmaceutical, biotechnology and health care industries. Coinciding with its 10th anniversary celebrations, the agency promised to provide a better service to the industry it regulates.
By the end of 2005, new procedures will be in place to provide early scientific advice to companies developing innovative products. By the end of 2006, new mechanisms will be in place to raise the level of scientific expertise in reviewing new medicines - and in peer-reviewing the evaluation procedures.
To meet the particular challenges of evaluating new high-technology medicines, the creation of a cell therapy working party within the agency is envisaged, and actions already under way include discussion on preclinical and clinical issues in relation to the comparability of biotechnology products. Dedicated information on emerging therapies and technologies will be published routinely on the agency's website by the end of 2005, and a strategic plan for new technologies will be established in early 2007.
Meanwhile, an accelerated assessment procedure will be introduced in 2005, bringing the time for scientific evaluation down to 150 days, and new mechanisms will be introduced for conditional authorization and compassionate use. The agency also plans to become more closely involved in broader dialogue with the innovative pharmaceutical industry, with a view to promoting research and product innovation in Europe.
Delay Confirms European GM Caution
The European Union has failed yet again to reach a decision on an application for a biotechnology product - this time, 1507 maize, developed by the DuPont subsidiary Pioneer Hi-Bred International and by the Dow AgroSciences subsidiary Mycogen Seeds. The March meeting of the specialized committee, which is supposed to give approvals, could not reach agreement and deferred its decision, despite three reports from EU experts that already had cleared the product on safety grounds.
To the dismay of the European biotechnology industry, the move confirms the trend toward caution among the EU's 25 member states. As Simon Barber, director of plant biotechnology at EuropaBio, told BioWorld International, for more than five years, not a single GM product has been approved directly through the EU system.
"1507 maize has met all the safety and other EU regulatory requirements, and we are disappointed that we still see delays," he said.
In every case, the committee - made up of member state experts - has hesitated, and referred applications up to ministerial level. And in every case, ministers also have failed to reach a decision - leaving products to be approved only through further lengthy administrative procedures that bypass the member states altogether when they cannot agree. That has lead to long delays in marketing.
The 1507 maize is genetically modified with a Bt gene, making it resistant to certain insects. It already has been approved in 11 other countries, including the U.S. in 2001. The application to the EU is for import and processing of the product, including animal feed use. Experts in the EU's own food safety authority adopted an initial positive safety opinion in September, and additional positive safety opinions on its use as food and for cultivation in January this year.
EuropaBio said that deferring the vote on new GM products that meet all the EU regulatory requirements, including a positive safety opinion from the European Food Safety Authority, has shown that the EU approval system is "still not functioning as it should."
EuropaBio is worried that if products aren't approved in a timely fashion, Europe risks further loss of research and investment in the new technologies, meaning the EU's attempt to rebuild its international industrial competitiveness will be hurt. EU heads of government will meet in Brussels March 22 regarding a strategy to boost growth by raising research investment and improving the environment for business, but "member states are jeopardizing the key goal of this growth campaign by failing to approve safe products that result from such research," said EuropaBio's Barber. He worries that EU governments would wake up too late, only when Europe has been overtaken in biotechnology by China, India or Malaysia.
But European environmentalist groups take a different view. Eric Gall, from Greenpeace's European affairs unit, said the EU's earlier safety assessments of 1507 were "superficial," and relied too much on data supplied by the companies.