Pharmacology: Clinical Trials

Health written question – answered on 21st April 2008.

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Photo of Doug Naysmith Doug Naysmith Labour, Bristol North West

To ask the Secretary of State for Health if he will bring forward legislative proposals to require pharmaceutical companies to disclose the evidence from all their clinical trials.

Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

The conduct of clinical trials in the European Union (EU) is governed by EU law, implemented in the United Kingdom by means of regulations. These represent a comprehensive framework for the conduct of clinical trials, including requirements on reporting. However, following an investigation by the Medicines and Healthcare products Regulatory Agency into allegations that GlaxoSmithKline withheld relevant information gathered in clinical trials on the use of Seroxat in children and adolescents, some weaknesses in the law as it stood at the time of the alleged offences were identified. The Government have made a commitment to clarify and strengthen both EU and UK law in this area. We will seek to strengthen EU legislation on the obligations on pharmaceutical companies to report any information impacting on the risk and benefits of licensed medicines, including the results of clinical trials. In the meantime we will clarify the current law as it applies in the UK. Consultation on changes to UK law will take place in the summer.

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