The law on disclosing clinical trial data looks set to change following a recent announcement by the UK government. The rationale behind the proposed changes, which are due to be introduced into UK law by the end of this year, is that pharmaceutical companies should be in no doubt as to their responsibility to disclose any information they have that would have a bearing on the protection of health.
This announcement follows the completion of a four-year investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) into GlaxoSmithKline (GSK) and its anti-depressant drug Seroxat. The investigation was carried out to determine whether GSK had failed to inform the MHRA in a timely manner of information it had on the safety of Seroxat in children. The MHRA report concluded that the legislation in force at the time regarding companies' obligations to disclose safety-related information was not sufficiently clear where a drug was being used, or tested, outside its licensed indications.
The clinical trials in question were conducted between April 1994 and September 2002. Since then, numerous changes have been made to the law in this area, including the introduction of a criminal offence for failure to report adverse reactions occurring in clinical trials, and imposing obligations to report relevant safety information arising from clinical trials using products outside their normal conditions of use. However, the MHRA report suggests that the law in this area requires further attention.
The MHRA report calls for greater clarity in pharmacovigilance legislation such that pharmaceutical companies are aware of their responsibility to provide any information altering the benefit to risk profile of their products to the regulator, regardless of source, including data generated from studies conducted outside the EU. The report further calls for clarity regarding the time scales within which such information must be supplied to the regulator, and the resulting sanctions for non-compliance.
Professor Kent Woods, Chief Executive of the MHRA, has written to the Association of the British Pharmaceutical Industry, the British Generics Manufacturers Association, the BioIndustry Association and the Proprietary Association of Great Britain warning them that proposals will shortly be put out for consultation to amend UK law in this area, and furthermore, that the UK will propose that the necessary amendments be included in the forthcoming EU pharmacovigilance regulation. It seems inevitable therefore that the law in this area will be further constrained, translating any remaining moral obligation imposed on those performing clinical trials to disclose adverse data into a legislative requirement.
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| Shauna Garvey and Rob Burrows |
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