BioWorld International Correspondent

BRUSSELS, Belgium - The European Union's new rules on clinical trials received their final approval, after more than a decade of discussion, from European ministers last week.

So by 2003 there will be some standardization in the processes for obtaining ethical and regulatory approvals for new medicines across the 15 EU member states. Biotechnology products will, however, be subject to tougher controls than other pharmaceuticals.

The more restrictive rules on biotechnology-derived medicines allow for longer delays before trial start-ups, and requirements for written prior authorization for start-ups with medicines containing biological ingredients.

This new directive aims to rationalize the documentation and administrative procedures for clinical trials on medicines, and at the same time to guarantee the same level of protection for patients across the EU. Until now, EU standards on good clinical practice were expressed only as guidelines, and were not binding, so member states had adopted national rules of their own, with some wide variations. Agreement was not universal. The Netherlands voted against, because it felt that protection offered to patients was still not as high as it should be.

MPs Say EU Fails To Provide Enough Research Support

Many members of the European Parliament accused European research commissioner Philippe Busquin of running an underfunded research program when they grilled him at a meeting last week of the Parliament's research committee.

The Commission recently announced its plans for a five-year research framework program, with a budget of EUR17.5 billion (US$16 billion). That is 17 percent higher than the previous program, but is still much smaller than equivalent U.S. spending, Euro-MPs said.

Genomics and biotechnology are up at the top of the seven priority areas the Commission has proposed. There were loud calls from some Euro-MPs for money to be focused more on sustainable development, renewable energy sources, and cooperation with developing countries.

Ministers Call For Interim Labeling Measures

European Union ministers meeting in Brussels last week again discussed the need for interim measures to require the labeling of animal feed containing genetically modified plant products.

Italy brought the subject up at the EU Agriculture Council, and insisted that new rules should be in place by July 2001 at the latest. In their discussion, ministers reaffirmed their commitment to bringing in common rules for GMO labeling of feeds without delay. They urged the European Commission to speed up its preparatory work and to make formal proposals.

Commission Favors Biodiversity Effort

The European Commission has announced strong support for the new Global Biodiversity Information Facility, the international project to provide wide access to data on the planet's flora and fauna. The first meeting of the GBIF governing board will take place this week in Ottawa, Ontario.

The main point will be to decide on where to establish its permanent secretariat. Several countries are preparing bids to host the secretariat, including three EU Member states: Denmark, Spain and the Netherlands.

European Research Commissioner Philippe Busquin said Monday, "It is very important, in this context, to coordinate existing activities and tackle the problems at the European level."

The European Commission has joined GBIF as an associate member.