Rare Connect Day and meeting of the EU Joint Task Force on Orphan Medicinal Products in Brussels

Rare Connect Day took place in Brussels on 18 November. With this event, the European associations EuropaBio and EFPIA wanted to draw attention to the care given to patients with rare diseases and to initiate a dialogue with national organisations and patient representatives for discussion of potential improvements to this particular type of care.
On the following day, the members of 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 Bruno Sepodes, chairman of the EMA’s Committee of Orphan Medicinal Products (COMP). The meeting provided an opportunity to discuss the Committee’s viewpoint on the revision of the Regulation on Orphan Medicinal Products. For some time now, the European Commission has been exploring whether there is a need to revise this Regulation. In mid-November it published a public consultation on the clarification of the definition of “significant benefit” in the Regulation (see http://ec.europa.eu/health/files/committee/75meeting/pharm689_2b_review_ 2003_comm_on_orphans.pdf). The Joint Task Force will submit a statement regarding this matter.

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. In addition, the “Budget Impact” study by IMS Health was presented and discussed.