It's all about patient safety

The challenge will be to make sure the framework being sketched out by the European Commission does not lose its focus on the safety of the end-user. The suggestion by Matias that the legal basis for the proposed Directive should be extended from Article 95 of the EC Treaty, addressing the internal market, to Article 152 on human health protection was a welcome restatement of first principles.

We need a co-ordinated approach to keep counterfeit medicines out of the European Supply Chain. There are a number of crucial details left to fill in, and these are likely to be the subject of vigorous and continued debate among stakeholders as the proposed directive transitions through the European Parliament to the Council.