The European Commission has launched a public consultation with a view to modernising rules covering the transparency of member states' decisions on drug pricing and reimbursement.
The regulations are contained within Council Directive 89/105/EEC - the "Transparency Directive" - which has not been amended since 1989, despite the substantial changes which have taken place in the European Union (EU) pharmaceutical market since then. While drug pricing and reimbursement decisions are taken at individual EU member state level, the purpose of the Directive is to facilitate the free movement of medicines within the EU.
"Transparency in pricing and reimbursement procedures contribute to maintaining a dynamic pharmaceutical market and can help diminish the strain on public health budgets," said Antonio Tajani, European Commission vice president and Commissioner for Industry and Entrepreneurship. "The time has come to rejuvenate the existing framework - public authorities, companies and, above all, citizens will benefit from a more modern set of rules," he added.
The Commission says that the public consultation will help it determine how best to update the existing rules in order to reduce drug prices, guarantee that national procedures are transparent and facilitate broader and timely access to medicines.
Some of the issues which will be examined through the consultation include: - delays in pricing and reimbursement procedures, as highlighted in the Commission's competition inquiry into the pharmaceutical sector of July 2009; - consistency between existing transparency rules and both the development of increasingly innovative products and the evolution of pharmaceutical cost-containment mechanisms within EU member states; - the role of European Court of Justice case-law which, says the Commission, has "always provided an extensive interpretation of the existing rules in order to guarantee their effectiveness"; - the opportunity and feasibility of extending the scope of the Transparency Directive to include medical devices; and - exploring the possibility of an EU-wide system of penalties for delays in pricing and reimbursement decisions.
The pricing and reimbursement measures implemented by EU member states affect the capacity of drugmakers to sell their products in national markets and are capable of creating barriers to trade within the EU, says the Commission. The Transparency Directive aims to mitigate the potential impact of national rules by ensuring that pricing and reimbursement decisions follow transparent procedures and discriminate between medicines produced nationally and those imported from other member states and, ultimately, it benefits patients by facilitating trade in medicines within the EU, it adds.
The deadline for submitting contributions on the review of the Directive is May 25.