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Parliamentary questions
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28 February 2020
E-004090/2019(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-004090/2019

The Commission is currently evaluating the functioning of the EU Orphan and Paediatric Regulations, including an assessment of the impact of incentives introduced for research, development and marketing of medicines for rare diseases and for children and on accessibility of orphan medicines in Member States(1). This evaluation will be finalised with a Staff Working Document to be published in spring 2020.

Once the evaluation is finalised, the Commission will consider whether further steps may be needed.

An orientation paper(2) on Horizon Europe, the next research and innovation framework programme, was released in June 2019 and subject to public consultation(3).

The document aimed to stimulate a co-design process by setting the foundations to prepare the first four years of the Horizon Europe Strategic Plan (2021-2024). T

he document(4) following public consultation refers to research on rare diseases and a future possible Rare diseases partnership building on the lessons learnt from the European Joint Programme on Rare Diseases(5), and to implement the objectives of International Rare Diseases Research Consortium(6).

(1)https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6059807_en
(2)https://ec.europa.eu/info/files/orientations-towards-first-strategic-plan-horizon-europe_en
(3)https://ec.europa.eu/info/files/co-design-towards-first-strategic-plan-horizon-europe_en
(4)https://ec.europa.eu/info/sites/info/files/research_and_innovation/strategy_on_research_and_innovation/documents/ec_rtd_he-orientations-towards-strategic-plan_102019.pdf
(5)https://www.ejprarediseases.org/
(6)http://www.irdirc.org/
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