Pricing And Reimbursement For Pharmaceuticals In The European Union: European Commission Proposes Revised Transparency Directive

Today, the European Commission adopted its proposal for a new Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of public health insurance systems ("Transparency Directive" or "Directive"), which is set to replace the current Transparency Directive 89/105/EEC in place since 1989. The Transparency Directive sets the framework for national authorities in EU Member States' pricing and reimbursement ("P&R") decisions for pharmaceuticals and has in the past proven to be an important tool to support transparent market access rules in the EU.

1. The Commission's Proposal

   The proposal's draft Directive maintains the Directive's core principles: The draft Directive still lays down a number of procedural safeguards for pharmaceutical companies to ensure transparency and due process in national P&R procedures of EU Member States (e.g. specific time limits for Member States to decide on reimbursement and mandatory statement of reasons based on objective and verifiable criteria for each P&R decision, cf. Art. 3-7).1 Following a stakeholder consultation in early 2011 ("Consultation"), the Commission's draft overhauls a number of the Directive's provisions, and clarifies its scope in line with case law of the Court of Justice of the European Union ("Court of Justice").

   The most important aspects of the proposal can be summarized as follows:

   Extended scope of the Transparency Directive: The Commission proposes to explicitly extend the scope of the Directive to: so-called "demand side related measures" such as financial incentive schemes of public payers to influence the prescription behavior of physicians, e.g. towards the prescription of generic substances (Art. 11 of the draft Directive, cf. Court of Justice, case C-62/09, ABPI); and national Health Technology Assessment ("HTA") procedures as part of reimbursement procedures (e.g. by NICE in the U.K., or by the German Institute for Quality and Efficiency in Healthcare (IQWiG) in the recently established mandatory "early benefit assessment" for innovative products in Germany) (Art. 7(5) and 12). No mandatory EU price list: The Commission has not installed a mandatory EU price list to compare listed/discounted prices for pharmaceuticals across Member States. However, Member States remain free to compare prices and to maintain reference pricing systems (which are in place in almost all Member States). No application...