asked Her Majesty's Government:

Whether the Committee for Orphan Medicinal Products has undertaken research into the effectiveness of regulations on the development and licensing of orphan medicines; and whether there has been an assessment of access to these medicines for patients in the United Kingdom. [HL3444]

Research findings into the effectiveness of regulations on the development and licensing of orphan medicines are presented in the Committee for Orphan Medicinal Products (COMP) report to the Commission in relation to Article 10 of Regulation 141/2000 on orphan medicinal products. It includes an assessment of access to these medicines for patients in the different member states, including the United Kingdom.

The report concludes that while COMP considers that the current legislation framework for orphan medicinal products is suitable overall to achieve public health benefits for patients suffering from rare diseases, it has identified a number of policy areas that require strengthening. COMP makes six recommendations to stimulate and foster European Union policy and makes three suggestions for action to the European Commission.

This report is published on the website of the European Medicines Agency under document reference EMEA/35218/2005 available at www.emea.eu.int and is available in the Library.