European Parliament Transparency Drive

The European Parliament’s Environment and Public Health (ENVI) Committee has voted on a report on the proposal for a revision of the Transparency Directive, addressing the pricing of medicines. This was presented by the Commission in March 2012 to modernise the 1989 text, which is no longer adapted to today’s market, if only due to the emergence of generic drugs. More transparency on the pricing and reimbursement of medicines should be the rule for the future to improve patient's access to affordable treatments, MEPs said after backing the draft legislation. They recommend a 60-day time limit to decide on the pricing and reimbursement of generic medicines, in order to speed up the availability of these cheaper products for patients. Decisions concerning new medicines will have to respect the current timeline of 180 days, but this will include all the procedural steps and applicable health technology assessments.

If the legislation is approved, EU member states would also be obliged to provide remedies for patients in cases where there are unjustified delays, including those where the medicines are provided as part of a public health insurance systems. In addition, medicinal products covered by public health insurance and their prices should be published once a year in a list under the proposals that were adopted by the committee on 18 December.  MEPs also agreed that member states should ensure that elements required to be assessed for marketing authorisation – including quality, safety, efficacy, bio-equivalence and biosimilarity – are not subject to reconsideration during the pricing and reimbursement process. In its report, the Committee states that EU member states have full competence to decide on pricing and reimbursement of medicines, but that it is essential to guarantee minimum transparency requirements throughout the EU not only to avoid unfair practices and market barriers but also to ensure an effective access to affordable medicines for millions of patients. The Council and Parliament twill agree a final version of the updated transparency directive this year. 

For more information:

http://www.europarl.europa.eu/meetdocs/2009_2014/organes/envi/envi_20121217_1500.htm