Question
To ask the Secretary of State for Health what steps the Government has (a) taken and (b) plans to take to amend legislation following the Medicines and Healthcare Products Regulatory Agency's report of its investigation into GlaxoSmithKline and the anti-depressant drug Seroxat.
Answer
On 23 May 2008 the Medicines and Healthcare products Regulatory Agency (MHRA) published a consultation on proposals to amend the Medicines for Human Use (Marketing Authorisations, Etc.) Regulations 1994 to ensure the United Kingdom's legislation is fully in line with existing European Union (EU) law covering the circumstances when marketing authorisation holders should report new information which might influence the evaluation of the benefits and risks for a medicine to the MHRA. The proposed changes state explicitly that marketing authorisation holders should; report information from clinical trials outside the licensed indication, report information arising from third countries and provide a timescale for the reporting of such information.Copies of consultation (MLX 350) have been placed in the Library or and are also available on MHRA's website at:"www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON017761."The consultation closes on 15 August 2008. Subject to the outcome of consultation, the Government plans to amend legislation before the end of the year.In addition, the European Commission is currently formulating proposals to strengthen the EU system for monitoring the safety of medicines. The MHRA has proposed that the EC take this opportunity to introduce a number of additional changes in the light of the investigation into GlaxoSmithKline. We expect European proposals to be published later this year.