New EU members demand patent legislation changes

The health ministers of the 10 governments in eastern and southern Europe due to join the European Union next May have joined together to demand changes to legislation now under discussion that would extend the protection of patent protection for new medicines to 10 years across the EU.Gathering at an informal EU health council in Milan, Italy, the would-be member states complained about being 'marginalised' from the ongoing negotiations to update directive 2001/83/EC on the community code relating to medicinal products for human use. The ministers said that they were particularly upset about the extension of data exclusivity to 10 years from the existing six years, saying it would 'influence significantly' the budgets of their national health systems by reducing the quantity of cheaper generic drugs that they can buy. This, they said in a joint statement, would damage public health by harming patients, national health funds and local pharmaceutical manufacturers. The eastern and southern Europeans called on the EU to freeze the current six-year protection. Their complaints came as the European Agency for the Evaluation of Medicinal Products (EMEA) and heads of their medicines agencies met to prepare for the enlargement of the EU. EMEA wants to ensure enlargement does not slow its centralised procedures. The meeting focused on a number of problems, including the requirement to bring existing marketing authorisations into compliance with current EU pharmaceutical laws. Discussions also focused on integrating the agencies of these new members with the EU's EudraVigilance safety reporting system and the EudraNet secure IT system linking national authorities, the European Commission and EMEA.