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New laws will oblige pharma to release data

Published on 07/03/08 at 02:12pm

The UK government has pledged to introduce new legislation that will require pharmaceutical companies to disclose all data from clinical trials or face prosecution.

The move comes after medicines regulator the MHRA concluded a long-running investigation into allegations that GlaxoSmithKline withheld important safety data on its antidepressant Seroxat.

After four years of investigation, government prosecutors say there is no realistic prospect of a conviction in this case, and that there should be no criminal prosecution, since laws in place at the time did not compel companies to make information available.

But MHRA chief executive Professor Kent Woods has made very clear that he believes GSK's conduct was far from satisfactory.

He said: "I remain concerned that GSK could and should have reported this information earlier than they did.

"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them. This investigation has revealed important weaknesses in the drug safety legislation in force at the time. Subsequent legislation has partially addressed the problem, but we will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies' obligations to report safety issues."

Health minister Dawn Primarolo responded to the MHRA's investigation by pledging to strengthen the law in the UK and Europe.

She added that all pharmaceutical companies "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".

Dr Alastair Benbow, medical director for GSK Europe, said: "We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18.

"GSK is committed to working with the government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area."

UK pharmaceutical industry association the ABPI said it looked forward to taking part in the consultation process for the new legislation, and welcomed the introduction of any new laws that would provide more "genuine protection for the patient, without simply adding unnecessary bureaucracy".

The international pharmaceutical industry currently runs a voluntary system of publication of clinical trial data, but allegations of data still being hidden or hard to access continue to be made.

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