Members of the European Parliament (MEPs) have voted for more transparency and precise time limits to be set for pricing and reimbursement decisions on medicines.
Changes are needed to improve patients' access to affordable treatments and to prevent barriers to getting medicines to market, said members of the Parliament's Environment and Public Health Committee (ENVI), in a vote making significant amendments to the draft Transparency Directive 2012/0035 (COD), which covers the transparency of measures governing decisions on medicine pricing.
"EU member states have full competence to decide on pricing and reimbursement of medicines, but it is essential to guarantee minimum transparency requirements throughout the [European] Union, not only to avoid unfair practices and market barriers but also to ensure effective access to affordable medicines for millions of patients," said the rapporteur for the draft, Bulgarian MEP Antonyia Parvanova, vice chair of the Group of the Alliance of Liberals and Democrats for Europe (ALDE) in Parliament.
The ENVI vote also called for a 60-day time limit to decide on the pricing and reimbursement of generic drugs, but for such decisions concerning new medicines to respect the current timeline of 180 days - 90 days for pricing plus 90 for reimbursement decisions - rather than the 120 days - 60 plus 60 - proposed by the Commission. These deadlines should include all procedural steps and any Health Technology Assessments (HTA) that may apply, the MEPs added.
The vote also requires that measures should be included in the member states' legislation which provide for the applicant to seek mediation or remedial measures in cases where there are unjustified delays in including medicines in their public health instance systems.
In addition, the MEPs have said that the member states' competent authorities must in future disclose the names and declarations of interests of their experts and members, in order to ensure the transparency and integrity of their decision-making processes. They should also be required to publish the list of medicines covered by their public health insurance systems, with their prices, at least once a year.Finally, the MEPs emphasise that authorisation issues must not interfere with pricing. The member states must ensure that the essential elements assessed for marketing authorisation - quality, safety, efficacy, bioequivalence and biosimilarity - are not reassessed during the pricing and reimbursement process, they say.
The ENVI vote has been welcomed by the EU generic drugmakers group, the European Generics medicines Association (EGA), which comments that the adopted amendments are in line with the findings of the European Commission's 2007 pharmaceutical sector Inquiry, which were adopted on July 8 2009 and identified the key hurdles that block or delay the entry of generics to the market.
"It is very significant that the MEPs have responded to the sector inquiry recommendations and we trust that the member states will maintain the same position in the next legislative step," said EGA acting director general, Beata Stepniewska.