Orphan Drugs: EC Law

Mark Simmonds
To ask the Secretary of State for Health how Regulation (EC) 141/2000 on orphan medicinal products is being implemented; and if he will make a statement.

Dawn Primarolo
Regulation (EC) number 141/2000 of the European Parliament on orphan medicinal products has been fully implemented. The Orphan Drug Register is managed by the European Medicines Evaluation Agency (EMEA). Information regarding Orphan Drugs is available on the website of the EMEA

www.emea.eu.int

The findings from research 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 European Commission in Relation to Article 10 of Regulation 141/2000 in Orphan Medicinal Products. This report is published on the website of the EMEA at:

www.emea.eu.int/htms/human/comp/compgen.htm

It includes an assessment of access to these medicines for patients in the different member states, including the United Kingdom.

A copy of the “COMP Report to the Commission in Relation to Article 10 of Regulation 141/2000 in Orphan Medicinal Products” has been placed in the Library.