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The European Comission publishes the evaluation of EU regulations on orphan and paediatric medicines

The European Comission publishes the evaluation of EU regulations on orphan and paediatric medicines

2020-08-12
The European Comission publishes the evaluation of EU regulations on orphan and paediatric medicines

This is the first comprehensive evaluation since their adoption aiming to assess the strengths and weaknesses of the two regulations.

The last 11th of August the European Commission has published the evaluation of the legislation of rare diseases, representing the first comprehensive evaluation since their adoption in 2000.The rare disease legislation has been evaluated together with the children legislation given that the majority of rare diseases may appear already in children and many children's diseases are also rare.

The evaluation has been performed following the criteria of the Commission's Better Regulation Guidelines and has consisted of several steps in order to analyse the strengths and weaknesses of the two regulations.

The results of the report indicate that both regulations have fostered the development and availability of new drugs for patients for rare diseases and for children.

Nevertheless, the evaluation has also highlighted that the drug development has not been efficiently supported in those rare and pediatric areas where the need for new medicines is highest, while also indicated that European citizens do not have the same access to authorized  treatments.

The future solutions proposed by the European Commission will aim to address any identified shortcomings and foster patient-centred innovation as well as ensuring the availability and access to medicines for patients with rare diseases and for children.