More Cracks Appear In EU Pharma Reform As Ministers Debate RDP Proposals

As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

Plenary room in the European Council building
The Council of the EU has a key role in negotiating the pharma reform package • Source: Shutterstock

The stage is set for lengthy and complex negotiations among the EU institutions on the pharmaceutical reform package after member states expressed very different views on the future structure of the regulatory data protection (RDP) system at the Health Council meeting on 21 June.

Most of the 27 member states support the European Commission’s proposal for a “modulated” system – which includes a cut in baseline RDP – provided it is “clear and predictable” and “respects the need for

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