BioWorld International Correspondent

BRUSSELS, Belgium - The coming year is threatening further drama for the European biotech medicines industry, said the Emerging Biopharmaceutical Enterprises (EBE) group - the specialist association within the European Federation of Pharmaceutical Industries and Associations.

Its just-agreed action plan for 2004 highlights particular challenges from impending new rules on cooperation agreements and tissue engineering, and continued government neglect of existing European rules on biotech patents.

EBE has criticized proposed EU restrictions on technology transfer in co-operations. The 20 percent ceiling for joint market share for companies working together is too low, and will hamper the biopharmaceutical industry, it told European Commission officials. The association also insists on the need for early action to provide a regulatory framework for tissue-engineered products.

"EU legislation must keep pace with developments if patients are going to be able to continue to benefit from revolutionary advances in technology," it argued. Meanwhile, eight EU member states continue to defy the rules on biotech patents they put their names to by refusing to put them into effect at a national level. This is "to the detriment to our interest in promoting stable and sensible regulation," the EBE said.

The biotech medicines sector will be further affected by new rules on clinical trials and pediatric medicines; by reviews of the EU's orphan medicines system; and the rules on technology transfer, licensing agreements and co-marketing. And the implementation of the major update of the EU's overall pharmaceutical rules will need close monitoring. While the update has "secured some good improvements to the system for approving biotechnology medicines and contains particularly important provisions regarding how and when other companies can copy these innovations," the EBE said, "it is vital that we remain involved in the implementation phase, to make sure that these benefits are retained in the final legislative texts."

In addition, the EBE said, major structural changes in the European Union - the addition of 10 new member states in May, the election of a new European Parliament in June and the appointment of a new European Commission in October - will impose new demands on the biotech medicines industry. The EBE stressed education for new decision-makers. It is awaiting the contents of the progress report the EU is finalizing on promoting biotechnology in Europe, due in March.

EBE is aiming to take advantage of EU initiatives planned this year on cardiovascular disease, osteoporosis and lung disease. A major educational exhibition on breakthroughs by the pharmaceutical industry is to be held in the European Parliament in October, with a special focus on the role of biotechnology in health care advances. And EBE is aiming to formalize a new cooperation agreement with the U.S. Biotechnology Industry Organization during 2004.

"We do not act in a vacuum," said EBE's president, Peter Heinrich, CEO of MediGene AG, insisting on the need for the sector to be ready to respond to impending European regulatory developments. "The year will provide many opportunities to spread the word about the benefits of the biopharmaceutical industry."

EuropaBio Supporting Biotech Sweet Corn

The European biotechnology industry is throwing its weight behind the bid to win approval for biotech sweet corn in the European Union. Now that senior officials in the European Commission have recommended the all-clear, the next move lies with ministers from the EU's 15 member states. In the run-up to their decision, there is energetic lobbying under way in the corridors of Brussels. (See BioWorld International, Feb. 4, 2004.)

EuropaBio, the industry's chief European trade association, is supporting the authorization of Sygenta AG's Bt11, which is genetically modified to protect itself from corn borer insect damage. The approval is not being sought for cultivation in Europe, instead for food use of imports, as corn on the cob, or processed for freezing or canning. Such authorizations already have been granted as far back as 1996 in Australia, Canada, Japan, Switzerland and the U.S., and food products derived from Bt11 field maize (such as corn meal or corn oil) already are approved for use in the EU. However, the sweet corn has been awaiting EU approval since 1998, even though it has been assessed as safe by the EU's Scientific Committee on Food.

The lobbying is all the more energetic because ministerial approval for Bt11 would mark an end to the five-year EU moratorium on authorization of biotech products. Industry executives hope that the deadlock is on the point of resolution, as pressure builds on recalcitrant member states. "If the dam breaks, the logjam of products could turn into a flood," one senior European executive told BioWorld International.