New EU states' fears over data protection

The health ministers of 10 states due to join the European Union next year have adopted a declaration opposing new EU rules increasing data protection for medicines.

While the current Italian Presidency of the EU has said it is determined to make as much progress as possible on the review of pharmaceutical legislation (Review 2001), aiming for final adoption before enlargement in May 2004, the new states' health ministers say they have been "marginalized" in this process.

Their declaration, which was issued during an informal meeting of EU health ministers in Milan, Italy, this month, notes the "lengthy and difficult" accession negotiations preceding the adoption of current EU drug legislation, which Review 2001 aims to amend. The ministers highlight in particular the extension of the data exclusivity period up to 10 years from the current for six years.