EU lawmakers made little headway in the latest round of negotiations on the bloc’s sweeping pharmaceutical package, clearing several issues already settled at the technical level but leaving the more contentious points unresolved.
“No real progress was really expected. The next trilogue, potentially the last one, will obviously be the most difficult,” one parliamentary source said after Tuesday evening’s meeting between the co-legislators, the Council – represented by Denmark’s rotating presidency – the European Parliament and the European Commission.
Copenhagen’s push for greater flexibility from member states appeared to bear fruit, with the Council presidency signalling openness to revisit several contested elements of the package, including the concept of “unmet medical need.”
Parliament has championed the idea, which grants extra incentives for medicines targeting diseases with few or no treatment options. The Council had previously struck it out, calling it too vague and difficult to define, but Denmark now appears to have persuaded capitals to reconsider.
“Saying ‘we are open’ is not enough – it has to be meaningful,” another parliamentary source said, warning that governments could still walk away from the concept.
The most difficult issue – how long drug developers should enjoy market incentives and at what levels – will be tackled at the final trilogue on 10 December, when negotiators hope to close both the regulation and directive.
According to the Danish Council presidency, this week’s talks nonetheless helped identify “potential political landing zones” on multiple points, including the Bolar clause – which allows generic companies to prepare for market entry before patent expiry – data protection periods, and Article 56a on medicine accessibility.
Lawmakers also explored possible trade-offs between the institutions’ positions. A provisional deal was struck on priority antimicrobials, merging the Council’s transferable-voucher idea for new antibiotics with Parliament’s preference for fixed payments to guarantee supply.
Copenhagen still hopes to wrap up the file by December, though one parliamentary negotiator stuck a cautious note:
“There’s still a chance for a deal in December, but we have to stay realistic: everything needs to be wrapped up at the technical level within the next two weeks so that we can finalise the package during a jumbo trilogue covering both the regulation and the directive.”
(cz)
