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European Commission opens public consultation on Orphan and Paediatric Regulations

The European Commission has embarked on the latest round of evidence gathering to support its review of pharmaceutical incentives, launched in response to the Council Conclusions of June 2016.

The Health and Food Safety Directorate opened a public consultation on the Orphan and Paediatric Regulations on 18 October 2018. This joint evaluation will assess whether “the EU legislation is efficient and effective” and “whether it is fit for purpose”. The consultation will look in particular at the “impact of the incentives introduced for research, development and marketing” of medicines for special populations.

Interested parties, especially health professionals treating patients with rare diseases and private citizens, are invited to share their views by completing an on line questionnaire which is open until 4 January 2019. Organisations and businesses who wish to take part must first ensure that they have registered in the EC Transparency Register.

In parallel, the European Commission has asked the consultancies, Technopolis Group and Ecorys BV, to survey organisations involved in the development and marketing of medicines for rare diseases and their representatives organisations. The purpose of the survey is  to better understand the perspectives of stakeholders on the “efficiency, effectiveness, relevance and EU added value of the EU Orphan Regulation as well as its coherence with other regulations.”. The views of both originators and generic and biosimilar marketing authorisation holders are sought.  The study is expected to be completed by the middle of 2019 and the report will be publically available.