BioWorld International Correspondent

BRUSSELS, Belgium - The European Commission has modified its proposed changes to the European Union rules on authorizing new medicines - the vast package of proposals aimed at speeding new products, and particularly biotechnology-derived products.

After extensive and intensive debate during 2002 in the European Parliament and among ministers from EU member states, the Commission has published a revised version of how it believes the new system should operate.

The modified proposals retain the objectives of a high level of public health protection, and of simplifying the system. But it takes on board some of the amendments proposed by the Parliament late last year.

Some of the changes will permit faster processing of applications - cutting to just 15 days the delay for the European Agency for the Evaluation of Medicinal Products to send draft decisions on authorizations to the member states, and for the Commission, which is legally responsible for the final decision, to act. The Commission also agreed to make provision for information about all refusals, and the reasons for them, to be made publicly accessible. And while it retains its plan to annul the authorization of a product that has not been marketed within three years, it will now allow companies to challenge such decisions "in exceptional circumstances and on public health grounds."

Some additional expert focus on assessment of new high-technology products could result from the Commission's endorsement of a Parliament call for more scope for the EMEA to set up specialist panels "in order to secure, in connection with the evaluation of medicinal products, the benefit of expertise focused in particular on a specific type of medicinal product or treatment." The Commission also accepted the Parliament's argument that more money for the authorization system will be needed to cope with the additional challenges of adapting the system for the 10 new member states - mainly the former communist countries of central and eastern Europe - scheduled to join the EU in 2004.

But some of the changes could make conditions tighter for companies marketing their products. They would allow, for instance, for withdrawal of products if the envisaged tighter post-marketing studies show they have a negative benefit/risk analysis. They could permit additional inspections of manufacturing sites, even unannounced. And companies would not be allowed to communicate any information concerning post-marketing data on their products to the general public without the consent of the EMEA.

In addition, there is still no clear solution in what the Commission is proposing to the perennial problem of conflicting views on advanced areas of science, something that has been repeatedly criticized by high-technology European pharmaceutical firms as holding back the industry's development. The best the Commission has been able to come up with is an untidy compromise that said, "Where there is a fundamental disagreement over scientific points and the body concerned is an EU agency or a scientific committee, the agency and the body concerned shall work together either to solve the disagreement or to submit a joint document to the Commission clarifying the scientific points of disagreement. This document shall be published immediately after its adoption."

These changes will now be debated by member state ministers in early 2003, and later in the year will go back to the European Parliament for its final view.