18/11/2015 (Agence Europe) - Public consultation on orphan medicines. The European Commission is looking at the best way of updating the 2003 communication on orphan medicines (2003/C 178/02). On 16 November, it opened a public consultation until 15 February, in an effort to develop ideas on this issue. Questions will focus on, for example, clarifying the definition of “sufficient benefit”, the development of orphan medicines for transmissible diseases and simplification of the procedure for reassessing criteria when two authorisation requests are launched at the same time for orphan medicines. The update of the communication will take the shape of a Commission note and will seek to take into account technical progress and consolidate the regulatory framework. Orphan medicines are described as such when they are used to treat a dangerous or debilitating disease that affect 5 out of 10,000 people at the very most in the European Union. Link: http://ec.europa.eu/health/files/orphanmp/2015_11_pc_orphanmp/2015_11_06_notice_orphan_medicinal_products_comments.pdf (SPj)