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Parliamentary questions
30 January 2018
Question for written answer
to the Commission
Rule 130
Joëlle Mélin (ENF)

 Subject:  The future of supplementary protection certificates

On 5 September 2017, the French judicial authorities ruled that the supplementary protection certificate (SPC) issued by the Gilead laboratory was not valid. The Netherlands, Sweden and Greece have already rejected the manufacturer’s SPC request and generics are already available. In France, a box can now be bought for less than EUR 200, while the laboratory was selling it for more than EUR 400. However, in other Member States, the SPC is a barrier to access to generics, thus hindering access to preventative HIV treatment.

A British judge opted to request legal clarification on a technical point from the European Court of Justice (ECJ). At the same time as this procedure, the arrangements for the SPCs are being discussed at the Commission, insofar as they are based on a 2009 regulation which seems outdated and vague, leading to differences of interpretation within the European Union.

In this connection, what is the Commission’s timetable for its draft revision of the regulation on the supplementary protection certificate and what stages of the consultations have been opened so far?

Original language of question: FR 
Last updated: 13 February 2018Legal notice