Originally published as Covington E-Alert on March 1st, 2012

Today the European Commission published its long awaited proposal for the revision of the so-called Transparency Directive. The Directive lays down procedural guarantees for the systems that regulate the pricing and reimbursement (“P&R”) of medicines in the thirty EU and EEA Member States. The revision aims at modernizing the current rules, which date back to 1989 and no longer reflect the practical realities of the national schemes.

The proposal will now be reviewed by the European Parliament (EP) and the Council, the body grouping the Member States. It is likely that it will be significantly amended before it is finally adopted. Adoption is foreseen during the course of 2013 or in early 2014 and the new rules may take effect one year later.

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.