Meeting of the EU Joint Task Force on Orphan Medicinal Products in Brussels

At the end of May, the members of the EU Joint Task Force on Orphan Medicinal Products and Rare Diseases, including BIO Deutschland, met in Brussels to discuss recent developments. The first item on the agenda was a discussion with a representative of the European Commission who is responsible forthe topic of rare cancers and diseases at the Directorate General Health and Food Safety. The meeting provided an opportunity to discuss the Commission’s viewpoint on the revision of the Regulation on Orphan Medicinal Products. At present, the Commission does not see a need to revise this Regulation. Instead, it wants the EMA guidelines to be adapted. It is highly likely that the guideline on added benefit will be the first to be adapted. The Commission is also currently exploring whether it can make improvements in the field of rare cancers. Among other things, it is planning to publish a recommendation on the conditions under which cancers can be defined as rare. To this end, the Commission has compared the National Cancer Plans with the National Strategies for Rare Diseases.

The meeting participants also discussed the endeavours by Belgium, the Netherlands and Luxembourg to establish joint pricing and reimbursement in the field of rare diseases. This approach was welcomed as a means of giving patients faster access to treatment. Future progress will depend on how this approach is developed.  Other countries, such as Italian, Portugal, Austria and the Czech Republic, could follow this lead. Expert opinion is that Germany will not participate.

The agenda also included discussion on how awareness of rare diseases can be raised in Turkey. The participants agreed to wait until the elections have been held and new ministers have been appointed in the Ministry of Health and the Ministry of Economy, as is expected. The first talks with these two ministries should take place in the autumn in order to draw attention to the topic.

The Joint Task Force will conduct a study with IMI Health in order to obtain data and facts for the budget impact. This study will be presented at Rare Connect Day in late November, an annual event organised by the Joint Task Force. The next meeting is also scheduled for November.