Go back to the Europarl portal

Choisissez la langue de votre document :

  • bg - български
  • es - español
  • cs - čeština
  • da - dansk
  • de - Deutsch
  • et - eesti keel
  • el - ελληνικά
  • en - English (Selected)
  • fr - français
  • ga - Gaeilge
  • hr - hrvatski
  • it - italiano
  • lv - latviešu valoda
  • lt - lietuvių kalba
  • hu - magyar
  • mt - Malti
  • nl - Nederlands
  • pl - polski
  • pt - português
  • ro - română
  • sk - slovenčina
  • sl - slovenščina
  • fi - suomi
  • sv - svenska
Parliamentary questions
12 December 2017
Answer given by Mr Andriukaitis on behalf of the Commission

1. The Paediatric Report published on 26 October 2017(1), informs that the Commission is planning a joint evaluation of the EU regulations on orphan and paediatric medicines(2)(3). The ongoing Commission study on the impact of pharmaceutical incentives, and a new study on orphan medicinal products will feed into this joint evaluation. The aim of the evaluation will be to assess whether the current EU paediatric and orphan legislations continue to deliver the expected results and innovative products for the benefit of patients in Europe.

2. Regarding the European One Health Action Plan against antimicrobial resistance (AMR), the Commission will analyse and benchmark regulatory tools and incentives(4). Information available through the ongoing study on incentives will feed into the analyses conducted under the action plan. In addition, a range of push incentives including research grants, loans and inducement prizes was already implemented in the context of the AMR Action Plan.

3.  The 2015 Commission Single Market Strategy undertook to explore the introduction of an SPC manufacturing waiver and update of the EU patent exemptions(5). The Commission published an ‘Inception Impact Assessment’(6) on these issues, contracted studies, and on 12 October 2017 launched an online public consultation. Therefore, the Commission is still in the phase of consultation and analysis.


Last updated: 2 February 2018Legal notice