Brussels, 28/03/2011 (Agence Europe) - On Monday 28 March, the European Commission launched a public consultation with a view to modernising transparency rules on national procedures for pricing and reimbursement of medicines. Directive 89/105/EEC, often referred to as the transparency directive has not been amended since 1989 despite substantial changes in the pharmaceutical market. Although the prices of medicines and reimbursement are decided at national level, the transparency directive is aimed at facilitating the free movement of medicines in 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. The time has come to rejuvenate the existing framework”, said Industry and Entrepreneurship Commissioner Antonio Tajani.
The consultation, which is to run until 25 May 2011, will help the Commission determine how to best update the existing rules to reduce pharmaceutical prices, guarantee transparent national procedures and facilitate a broader and timely access to medicines. Some of the issues covered in the consultation include: 1) delays in pricing and reimbursement procedures highlighted by the European Commission competition inquiry into the pharmaceutical sector; 2) consistency between existing transparency rules; 3) the development of increasingly innovative products; 4) the evolution of pharmaceutical cost-containment mechanisms in the member states; 5) the role of the case-law of the European Court of Justice, which has always provided an extensive interpretation of the existing rules in order to guarantee their effectiveness; 6) the timeliness and feasibility of extending the scope of the transparency directive to include medical devices; 7) the possibility of a community-wide system of penalties in case of delays in pricing and reimbursement decisions.
In the EU, medicinal products can only be placed on the market after they have been authorised by the European Commission or the competent national authorities, and in accordance with common EU rules intended to ensure the quality, safety and efficacy of medicines. Member states are responsible for monitoring the price and reimbursement of medicines so as to promote the health of their citizens and the financial sustainability of their social security systems. Pricing and reimbursement measures affect the capacity of pharmaceutical companies to sell their products in national markets and are capable of creating barriers to trade within the EU. The transparency directive aims to mitigate the potential impact of national rules by ensuring that pricing and reimbursement decisions follow transparent procedures and do not discriminate between medicines produced nationally and those imported from other member states. It ultimately benefits patients by facilitating trade in medicines in the EU. (I.L./transl.rt)