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Developing Countries: Clinical Trials

Volume 472: debated on Tuesday 26 February 2008

To ask the Secretary of State for International Development (1) what discussions he has had with (a) governments of developing countries and (b) international organisations on cases where UK-based pharmaceutical companies’ clinical trials on medicinal products in developing countries have caused death, injury or blindness; and if he will make a statement; (188827)

(2) if his Department will provide support to people in developing countries who have been adversely affected, or have had close relatives killed, in pharmaceutical trials of medicinal products of UK-based pharmaceutical companies.

The UK Government regulates clinical trials run by the pharmaceutical industry through the Medicines and Healthcare products Regulatory Agency. DFID has had no reason to have discussions with developing countries’ governments or international organisations about cases where clinical trials run by UK-based pharmaceutical companies have caused death, injury or blindness.

All clinical trials that receive DFID funding are run according to good clinical practice and are also listed on the international clinical trials register. To protect people taking part in clinical trials funded by DFID, each trial has its own Independent Data Monitoring Committee, which looks at the data collected as the trial progresses, and a separate independent Trial Steering Committee (which oversees and monitors the trial). These committees have the power to stop the trial at any time and at the earliest indication of harm.

Clinical trials run by pharmaceutical companies have insurance, to make provision for anyone harmed in research, and no-fault compensation schemes. DFID is not involved in any UK-based pharmaceutical company trials and therefore can not make provision for anyone claiming to have been harmed by participation.