European Parliament adopts report on medicines pricing transparency

Members of the European Parliament have given their support for 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. The Parliament's report also indicates that national authorities should 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.

The current European legislative, subject file on medicines pricing transparency, is designed to be an update of an existing Directive from 1989. However, national governments have so far given a less than enthusiastic response to the proposals, with many countries considering that the requirements infringe the principles of subsidiarity and proportionality.

Negotiations between governments, the European Parliament and the Commission will continue on the issue.

Commission publish new information on pharmacovigilance black symbol

The European Commission has published further information about the operation of a new Pan-European black symbol to denote medicines subject to additional monitoring after authorisation.

The black symbol, in the form of an inverted equilateral triangle, is being introduced as part of the implementation of European pharmacovigilance legislation adopted by the European Union in 2010.

Under the new rules, medicinal products that are subject to additional monitoring after they have been placed on the market must be identified. Based on the recommendation of the European Medicines Agency (EMA), the Commission chose a black inverted triangle as the symbol to appear in product information, …