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Parliamentary questions
28 September 2017
Question for written answer
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

 Subject:  Incentives to develop medicinal products

In the light of the call made to it at the June 2016 Health Council meeting to assess the system of incentives in the pharmaceutical sector (such as patent exclusivity, supplementary protection certificates and legislation on orphan medicinal products), the March 2017 European Parliament report on options for improving access to medicines and the report on the impact of pharmaceutical incentives which it is due to publish in late 2017, does the Commission intend to put forward specific legislative proposals to revise the laws on orphan medicinal products?

In the recent European Action Plan on resistance to antimicrobial agents, the Commission referred to the need to offer pharmaceutical companies incentives. Is the Commission thinking of introducing incentives similar to those in force for orphan medicinal products in the area of resistance to antimicrobial agents, taking account of the misgivings which this system is prompting as regards access to medicines, prices and the quality of innovations?

Could it provide more information on the supplementary protection certificate, the manufacturing waiver in connection with the export of generics and biosimilars and the broadening of the scope of the restrictions on patent rights and supplementary protection certificates, all of which are options under consideration?

Original language of question: ES 
Last updated: 12 October 2017Legal notice