More transparency and precise time limits for decision-making on pricing and reimbursement of medicines are needed to improve patients' access to affordable treatments and prevent barriers to getting medicines to market, said Environment and Public Health Committee MEPs voting on draft legislation on Tuesday.
"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 Union, not only to avoid unfair practices and market barriers but also to ensure an effective access to affordable medicines for millions of patients", said rapporteur Antonyia Parvanova (ALDE, BG).
Quicker decisions on generic medicines
Health committee MEPs recommended 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. The decisions concerning new medicines will have to respect the current timeline of 180 days. These deadlines include all the procedural steps and any applicable health technology assessment.
MEPs say member states’ legislation must provide for the applicant to seek mediation or remedial measures in cases where there are unjustified delays in including medicines in public health insurance systems.
Competent authorities in member states must in future disclose the names and the declarations of interests of their experts and members, in order to ensure the transparency and the integrity of their decision-making process, says the committee. They should also be required to publish the list of the medicinal products covered by their public health insurance system and their prices, at least once a year.
Authorisation issues not to interfere with pricing
Member states must ensure that the essential elements assessed for the marketing authorisation, such as quality, safety, efficacy, bioequivalence and biosimilarity, are not reassessed during the pricing and reimbursement process, say MEPs.