BioWorld International Correspondent

BRUSSELS, Belgium - The European Agency for the Evaluation of Medicinal Products announced a full program of work for its biotechnology working party for 2003 and 2004. The envisaged work of the European Union's principal advisory body on new biotechnology-derived medicines relates both to handling specific new products, and to providing general guidance on the preparation of marketing authorization applications.

The EMEA is anticipating a growing workload in the processing of marketing authorization applications for biotechnology products: some 50 demands for scientific advice to applicants, assistance in product assessment, and help in settling post-authorization issues in 2003, rising to more than 60 in 2004.

And in terms of guidance, the committee is envisaging new advice on production of biotechnological and biological medicines, vaccines, and gene therapy and cell therapy, as well as more recondite subjects such as animal spongiform encephalopathies and plasma-derived medicines. Highlights of the initiatives that are likely to have the most impact on firms developing biotechnology medicines in Europe include updates to the existing guidance on comparability of medicines containing biotechnology-derived proteins as drug substance (as well as contributing to meetings of the EU ad hoc group dealing with clinical and preclinical issues of comparability); training on assessment of viral safety data of rDNA biotechnology products produced in mammalian cell lines; a revision of the advice on the use of transgenic animals; and new advice on using transgenic plants in the manufacture of medicines.

For vaccines, the working party will finalize guidelines on the development of live attenuated influenza vaccines and on pharmaceutical aspects of product literature for human vaccines, and it will create new position papers on cumulative stability requirements for vaccines, and on evaluation of new immunological adjuvants. And as a sign of the times, the working party also will provide input into guidance documents on use of medicines "for treatment and prophylaxis of biological agents that might be used as weapons of bioterrorism."

In terms of gene therapy and cell therapy, the plans include further advice on the quality and the preclinical and clinical aspects of gene transfer medicines (particularly for lentiviral vectors), on xenogeneic cell therapy products, and on the manufacture and quality control of human somatic cell therapy medicines.

There also are a host of other issues on the program, ranging from development of a common assay methodology for interferons and neutralizing antibodies in multiple sclerosis to development of assays for neutralizing antibodies for biotech medicines; from contributing to international guidance (under the International Conference on Harmonization of regulation) on comparability of biotechnological products subject to changes in their manufacturing process to proposing the strain composition of the influenza vaccine for the forthcoming EU vaccination campaign, and providing expert views on the need for an EU legal framework on human tissue-engineered products.

At the same time, there are a series of ongoing exercises to be pursued relating to the impending enlargement of the European Union (10 new member states, mainly from the former communist east Europe, are due to join the EU in 2004), and to the continual consultation process the EMEA now conducts with the pharmaceutical industry and patient and medical associations.

U.S. Trade Rep Continues Criticism Of Europe

U.S. Trade Representative Robert Zoellick has kept up his attack on European Union rules on biotechnology. Following his accusations early in January of the "immorality" of what he termed European biotech obstructionism in refusing to allow new products on its market, he has pounced on the EU's attempt to justify its "indefensible position."

He contended in the Wall Street Journal Friday that the EU's defense of its ban on new GMO products is little more than an elaborate play on words, concealing serious divisions within the EU itself. "Since 1998, the EU has refused even to consider approving biotech applications, ignoring favorable risk assessments by the EU Scientific Committee," he said. And "at least four EU member states have banned imports of biotech products approved by the EU in years past - and the [European] Commission abstained from challenging these violations of EU law."

Zoellick repeated his allegations that "the European fog of misinformation and protectionism resulting from EU biotech policies has had life-and-death consequences," with African countries declining food aid for fear of GMOs. He criticized "the activities of the anti-biotech non-governmental organizations the Commission funds," and insisted: "The need for Europeans to debate the costs of their acquiescence to biotech fear-mongering is long overdue."