4 September 2015 - The European Medicines Agency (EMA) is organising a workshop on 7 December 2015 to discuss the approach that should be followed by medicine developers to demonstrate the significant benefit of an orphan medicine over existing treatments. Demonstrating a significant benefit is one of the criteria medicines that treat rare diseases must fulfil to benefit from 10 years of market exclusivity once they have been authorised.

The workshop will bring together medicine developers, regulators, healthcare professionals, academia, patients, health-technology-assessment bodies and healthcare payers who need to register by 31 October 2015 if they wish to participate. The workshop will also be broadcast live.

In the European Union (EU), medicines that treat rare diseases, so-called orphan medicines, can benefit from a number of incentives. These incentives are provided for by the European Regulation on orphan medicinal products to stimulate research and development as well as the actual marketing of medicines for patients with rare diseases. They include fee reductions for scientific advice and 10-year market exclusivity once the medicine is authorised in the EU.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/09/news_detail_002390.jsp&mid=WC0b01ac058004d5c1