Written question asked by Mike Hancock (Liberal Democrat) on Thursday, 13 November 2008, in the House of Commons. It was due for an answer on Monday, 17 November 2008. It was answered by Baroness Primarolo (Labour) on Wednesday, 26 November 2008 on behalf of the Department of Health.

Myodil

Question: To ask the Secretary of State for Health if he will hold discussions with the World Health Organisation and the European Union on the continued use of Myodil overseas following its withdrawal from UK markets.

Answer: The withdrawal of Myodil from the United Kingdom market for commercial reasons in 1987 predated the start of the current European Union system of drug regulation. As the decision to withdraw was a commercial one made by the manufacturer there would have been no reason to hold discussions with EU member states or the World Health Organisation.There is currently an EU network of drug safety monitoring and close interactions with all EU member states on matters of medicines safety. The forum for discussions on issues of drug safety is the monthly meeting of the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal products for Human Use (CHMP) held at the European Medicines Agency. The PhVWP has representation from all EU member states and any delegate can add issues to the agenda for discussion. The PhVWP also has links with the World Health Organisation. Any proposed withdrawal of a medicine for safety reasons is discussed at the PhVWP or the CHMP to ensure a consistent EU-wide approach.

Secondary information