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Revision of the EU Regulation on orphan and paediatric medicines - Public consultation

The European Commission published on 25th November 2020 its roadmap for the revision of Regulation 141/2000 on orphan drugs and Regulation 1901/2006 on paediatric drugs.

A recent evaluation of these regulations in August 2020 showed that they had stimulated research and development of medicines to treat rare diseases and other conditions affecting children. However, the evaluation also revealed shortcomings in the current system. The legislation has failed to stimulate the development of medicines in areas of unmet need (e.g. 95% of rare diseases still have no treatment option) and it has not ensured that medicines are accessible to all European patients in all Member States.

A public consultation is now open until 30th July 2021 and will be followed by a legislative proposal in early 2022. The public consultation is open to all and aims to explore several options to address the shortcomings identified in the evaluation, with a view to revising the existing legislation. 


Link to the public consultation

Link to more information

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