The EMA has announced it is organizing a workshop on December 7, 2015, to discuss the approach that should be followed by medicine developers to demonstrate the significant benefit of orphan medicines over existing treatments. In the EU, medicines that treat rare diseases are known as "orphan medicines," and developers of such products can benefit from a number of incentives. Demonstrating a significant benefit is one of the criteria that orphan medicines must fulfill to benefit from 10 years of market exclusivity once they have been authorized. The workshop, which will be broadcast live, will bring together medicine developers, regulators, health care professionals, academia, patients, health-technology-assessment bodies, and health care payers. Registration to attend is open until October 31, 2015.
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