BioWorld International Correspondent

BRUSSELS, Belgium - Biotechnology-based medicines in Europe face additional controls in 2006. The European medicines agency has multiplied the expert panels that advise it on product evaluation and aims to improve the regulatory framework, but European biotech executives fear tightening of the operating environment for new products.

A permanent gene therapy unit has been created in the agency, as it is expected that products in clinical development in the European Union shortly will be up for approval. The agency said that gathering knowledge from across a broad spectrum of European clinical use and preclinical development is necessary to support the development of the products with scientific advice and to evaluate their properties authoritatively.

The agency also said it wants to build a stronger European position and be able to influence international discussions of gene therapy regulations - most notably through the gene therapy discussion group established within the International Conference on Harmonization on drug regulation, which brings together the U.S. FDA, the Japanese ministry of health and welfare, and the European medicines agency.

The working party will be composed of a core group of a dozen experts selected for their specific scientific or regulatory experience in the field. It also will include one contact person from each of the current 25 EU member states "to ensure that information of the activities of the group is disseminated at national level." There is provision for attendance by observers from other European countries.

The agency said it wants "a dynamic relationship" with academia, industry and others, and it made specific provision for the inclusion of experts from patient organizations and of health care professionals. The working party also is mandated to establish contacts to obtain advice from "parties concerned with the use of medicinal products, in particular patient organizations and health care professionals' associations."

But, as industry executives have said, there could be less secure lines of contact for companies. The industry will be allowed to comment in writing on draft guidelines and general regulatory developments during the public consultation periods, but companies will have the right to make oral presentations only "when considered appropriate by the working party."

Also, the members and experts "shall not have any direct interests in the pharmaceutical industry, which could affect their impartiality," and "all indirect interests, which could relate to the pharmaceutical industry," must be disclosed in a public register.

At the same time, the agency has set up a new working group with an intensive 2006 program producing rules on approval of biosimilars.

And the agency's longstanding working party on biotechnology has been reconstituted and renamed (as the working party on biologicals), with a broader and tougher mandate to advise the agency on "all matters relating directly or indirectly to quality aspects and safety in relation to quality of biological and biotechnological medicinal products." Again, while the proclaimed intention is to assist new product development by helping to maintain consistent evaluation of the pharmaceutical dossier of biotechnological and biological medicines, European industry executives are voicing concerns that the impact may limit rather than widen the scope for innovative product development.

EU Presidency Sparks Concerns On Biotech

As Austria took over the rotating six-month chairmanship of the European Union on Jan. 1, it revealed plans to hold a policy debate on genetically modified organisms at the meeting of EU environment ministers scheduled for March 9. Austria has strenuously opposed the marketing of new biotechnology products, and the announcement provoked concern in European industry circles. A clash is feared between the objectives - announced by the incoming Austrian presidency - of fostering innovation and enterprise in European industry, and the specific targeting of biotechnology as a sector to be reviewed as presenting more risks than benefits.

Industry anxieties have been intensified by formal Austrian statements, which suggest it will take a cautious approach on advanced therapies and tissue engineering - on which the EU now is developing new regulations - during its presidency.