EPF to contribute to the revision of the EU Transparency Directive

The European Commission recently published a proposal to revise the so-called “Transparency Directive” (Council Directive 89/105/EEC). It sets rules for the administrative procedures relating to pricing and reimbursement decisions at national level. While EU legislation provides a harmonised framework for the authorisation of medicinal products, Member States remain responsible for setting national pricing policies and conditions for reimbursement, in the context of national health insurance systems.

The revision of this Directive is important for patients for several reasons. There are currently wide and unjustifiable delays in access to new medicines across the European Union. To address this, the Commission is proposing tighter time limits within which national authorities must make their decisions. It also wants to introduce sanctions to ensure that Member States comply with the time limits.

The review is also an opportunity to introduce more genuine transparency and public access to information on decisions taken by national authorities. Note that currently the “transparency” in the Directive only applies to relations between national authorities and pharmaceutical companies.
Having responded to the Commission’s public consultation in May 2011, EPF has analysed the legislative proposal and liaised with the Commission, key MEPs and other stakeholders to share our views and concerns based on feedback from our members. We are currently inviting our members’ comments on a formal position statement. Please make sure you send your comments to us by 31 July 2012!

The dossier is scheduled to be voted in Committee in November 2012 and in plenary in January 2013. The Council has held initial discussions, but it is likely that the deliberations will continue into the Irish presidency in 2013.