European Parliament - Discussions on Transparency Directive take off
On 1 March, the Commission adopted a draft Directive on the transparency of the prices of medicinal products, revising the existing text dating back to 1989. Under EU legislation, member states are free to take measures to manage the consumption of medicines, regulate their prices and set conditions for their financing by public health insurance systems. However, since these national measures can create barriers to trade, the EU put in place legislation imposing basic conditions for procedural transparency so that decisions on pricing and reimbursement of medicines do not discriminate against imported products.
However, the existing Directive is no longer adapted to today’s market, largely due to the emergence of generic drugs. The March proposal therefore aims to address this: it establishes shorter time limits for medicinal pricing and reimbursement decisions in order to guarantee that patients have faster access to medicines, to strengthen the industry’s competitiveness, and to facilitate budget savings through faster introduction of generic drugs on the market. For originator medicines, deadlines would be cut from 90 to 60 days for pricing decisions and 60 days for reimbursement decisions. For generic drugs, deadlines would be reduced to 15 days
On 10 October Rapporteur Antonyia Parvanova MEP (ALDE, Bulgaria) presented her draft report on this proposal to members of the Committee on the Environment and Public Health, which was generally well received. Her proposed changes mainly relate to increasing transparency on pricing and reimbursement systems and leaving more time (25 as opposed to 15 days) for generic drugs to be granted market authorisation.
However, concerns are being expressed about the proposal not being adopted in Council (similar to the proposal on medicine information to patients, which is still being blocked). Apparently, there is agreement in Council that the topic is a difficult one, particularly in view of the subsidiarity principle and the changes it entails with respect to national price-setting systems
