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 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 ultimately approved, EU nations 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.
Government regulators would also in future disclose the names and interests of their experts and members to ensure the integrity of their decision-making process, the committee agreed.
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.
"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 (Bulgaria, Alliance of Liberals and Democrats for Europe).
Generic medicine providers welcome move
The European Generic Medicines Association (EGA) welcomed the result of the vote. In a statement the group said that the introduction of a shorter price and reimbursement approval time-limit for generic medicines “will help to maximise potential savings to patients and the healthcare sector, whilst increasing affordability, patient access and health budget control.”
“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 Beata Stepniewska, EGA’s acting director-general.