Reviewing pharmaceuticals in the EU
On 11 December 2017, the Commission released a roadmap for jointly evaluating the Regulation on orphan medicinal products and the Regulation on medicinal products for paediatric use. The purpose of the evaluation is to review the functioning and effectiveness of the incentives provided for in the regulations to develop such medicinal products and to identify areas with room for improvement. The public consultation is scheduled for Q3 2018.
In October 2017, the Commission presented a report on the experiences gained over the ten years that the Paediatric Regulation has been in place. In the report, the Commission emphasises that the legislation has indeed led to positive developments in paediatric medicinal products. However, not enough progress has been made, as is also the case for orphan medicines. The challenges for both areas are similar: both have comparatively small target groups and research is relatively complex. Further complicating matters is the fact that a significant number of childhood diseases are also rare diseases.
The evaluation also supplements the consultation on the Paediatric Regulation from the end of 2016/start of 2017. Comments submitted to the consultation by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) can be read here.
In addition, the Commission launched a public consultation on supplementary protection certificates and patent research exemptions on 12 October 2017. The Commission has also had various studies conducted on incentives for researching, developing and authorising medicines, and their economic impact.
By the end of 2019, the evaluation of the two regulations will have been completed and new strategic approaches developed. In view of the European elections in May/June 2019 new approaches to pharmaceutical supply in the EU are expected from the new Commission in 2020.