EU Parliament votes for quicker access to generic drugs

Voting on a draft law Wednesday (6 February 2013), the European Parliament said patients should have quicker access to cheaper generic medicines. The draft rules will require national authorities to meet new deadlines and transparency standards on pricing and reimbursement.

MEPs backed a 60-day time limit for national authorities to decide on the pricing and reimbursement of generic medicines, in order to speed up their availability and save money for patients and social security systems.
Decisions concerning new medicines will have to respect the current deadline of 180 days.According to the European Commission, generic products are on average 40% cheaper than the original branded medicines, once they have been available for two years.An enquiry has shown that companies use various means to extend the period when they can market their medicines exclusively, without competition from generics. 

Rapporteur Antonyia Parvanova from the Alliance of Liberals and Democrats for Europe (ALDE) said the Parliament was sending a clear signal, stressing that updated EU rules for more transparency in the pricing and reimbursement of medicines would have a concrete added value for all stakeholders. "We need fair, transparent and evidence-based decisions for our healthcare systems in Europe and I hope that all institutions will be willing to engage in this direction. Citizens and patients can count on the European Parliament for maintaining these principles in our future discussions," Parvanova said. EU countries are fully responsible in defining the prices and reimbursement of medicines, but the proposed directive would improve the setting of transparent and fair rules on how these decisions are being taken, she said. More transparency in member states Parvanova stressed that It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days. "I'm convinced that fair practices in our pharmaceutical market would also benefit patients and national healthcare systems," Parvanova added. Her report was adopted with 559 votes in favour, 54 against and 72 abstentions. She will now negotiate an agreement with EU ministers.

The Parliament also says in the voting that authorities in member states should disclose their experts' and members' names and declarations of interests in order to ensure the transparency and the integrity of their decision-making process. The authorities 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.

• 2013: Parliament and Council to agree final version of updated transparency directive


The Transparency Directive was adopted at the end of the 1980s out of concerns over potential distortions of intra-community trade in medicinal products which may be caused by national measures controlling public health expenditure. It is peculiar because it lies at the interface between European Union responsibilities (Internal Market) and national competences in the area of Public Health (freedom of member states to organise their social
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