Accession Countries issue declaration on EU pharma review

Health ministers of the 10 new Member States decided to issue a declaration on 5 September, on the margins of the informal meeting of EU health ministers in Milan, Italy, to draw attention to their fears over the new medicines legislation’s provisions on data exclusivity.

The Italian Presidency has stated that they want to make as much progress as possible on the pharma review package with a view to its final adoption before the impending EU enlargement in May 2004.

In the Declaration, health ministers complain about their marginalisation in the legislative process on pharmaceuticals.

They refer to the "lengthy and difficult" accession negotiations which preceded the adoption of current EU legislation on pharmaceuticals, which "Review 2001" aims to amend.

The group of health ministers highlight, in particular, the extension of the data exclusivity period up to 10 years, changing current legislation in force, which allows data exclusivity for only for 6 years.

These amendments will "influence significantly" the national health systems and the public health situation in the 10 countries, say the health ministers, by negatively affecting patients, the national health insurance fund and the pharmaceutical industry in these countries.

As a result, the 10 ministers call on the EU to maintain the six-year protection period.

The Health Council’s next meeting is scheduled for 20 October 2003.

 The Acceeding Countries Declaration.

 EPHA’s related article.

 EurActive’s article.

EPHA MEMBERS ONLY

 Minutes of the discussion on this issue in the Policy Coordination Group will be available soon.