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Parliamentary questions
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11 January 2018
E-000157-18
Question for written answer E-000157-18
to the Commission
Rule 130
Tadeusz Zwiefka (PPE)

 Subject:  Introduction of the Supplementary Protection Certificate Manufacturing Waiver (SPC MW)
 Answer in writing 

The introduction of the Supplementary Protection Certificate Manufacturing Waiver (SPC MW) for exports would allow the producers of generic and biosimilar medicines to manufacture medicines in the EU at an earlier stage, which means they can not only be introduced into the internal market as soon as their patent protection has expired, but can also be sold to third countries in which the patent has ceased to apply. This solution will make it possible for European producers of generic and biosimilar medicines to operate in markets outside the EU under exactly the same conditions as companies from other parts of the world. The SPC MW does not in any way violate the protection guaranteed by patents in the EU.

On 5 October 2017, the Commission published a report indicating that introducing the SPC MW into EC law would result in faster access to generic and biosimilar medicines for European patients and increase the value of sales from European pharmaceutical companies from EUR 7.3 billion to EUR 9.5 billion by 2025, thereby creating between 20 000 and 25 000 highly specialised new jobs. This in turn would increase the innovative potential of European companies, which is crucial for the development of small and medium-sized businesses across the whole EU.

In light of these points and given that the Commission has now finished public consultations:

1. Is the Commission working on a legislative proposal on this issue?
2. If so, when is this proposal scheduled to be submitted to the Council and to Parliament?

Original language of question: PL 
Last updated: 25 January 2018Legal notice