Drug safety data is destroyed 15 years after licensing

All information on the safety of medicines is destroyed by the MHRA 15 years after products have been licensed in the UK, a letter in this week's BMJ revealed.

Professor Peter Gøtzsche from the Nordic Cochrane Centre in Denmark, explains that, under MHRA record management policy, all files and data for licences are held for 15 years.

Files are then destroyed unless there is a legal, regulatory or business need to keep them or they are considered to be of lasting historic interest.

Professor Gøtzsche argues this makes it impossible for treatments to continue to be assessed by the scientific community.

He said: ‘The action of the MHRA may mean that it is impossible for independent researchers to correct the seriously flawed publication record on fluoxetine, which, ironically, is the only drug approved for use in childhood depression.'

Professor Gøtzsche added: ‘I have asked the UK DoH and the EMA how we can obtain the data the MHRA has destroyed, and I suggest legislation be introduced to prevent the MHRA from destroying the evidence in future. Lack of space is no excuse because the documents can be scanned.’

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