European Commission Starts Public Consultation on Orphan Medicines
The European Commission opened a public consultation on the EU rules governing orphan medicines that treat rare diseases. It asks both private citizens and healthcare professionals to share their perspectives on access to orphan medicines and on the impact of applicable EU rules on the development of orphan medicines.
The consultation and the accompanying study will also dwell on the links between orphan and paediatric medicines, as a considerable number of paediatric diseases qualify as a rare disease. A report on the 10-year old EU paediatric rules concluded last year that EU law had bolstered the development of medicines to treat diseases in children, but that progress had not been sufficient, especially when it comes to rare diseases, including childhood cancers (see our article of 30 October 2017). This finding prompted the Commission to redouble its efforts on combining the orphan medicines and paediatric rules. The results of these efforts should be known by 2019.
The wider background to the Commission’s latest consultation is a decision to review the impact of a broad range of regulatory pharmaceutical incentives, such as intellectual property rights and data and market exclusivities, on the availability, affordability and accessibility of medicines and on the quality of medical innovation.
Comments on the orphan medicines consultation are due by 4 January 2019.