FOI 21/103 – Enquiry Into GcMaf Data and David Noakes Prosecution
Published 24 March 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-22-february-2021/foi-21103-enquiry-into-gcmaf-data-and-david-noakes-prosecution
Thank you for your communication to the MHRA in relation to a Freedom of Information request for:
• Please provide all the evidence that the MHRA have on GcMaf, including but not limited to its effect on cancer?
• Please provide all the information relating to the prosecution of David Noakes?
• Would the MHRA license GcMaf as a cancer treatment given the wealth of evidence , of its benefits , including individuals overcoming terminal pancreatic cancer and other cancers?
• Would a license for GcMaf be something that is considered in the future given the wealth of evidence on cancer treatment etc?
The MHRA brought a criminal prosecution against David Noakes as Gc Macrophage Activating Factor (GcMAF) does not hold a Marketing Authorisation (licence) in the UK and has not been tested appropriately for quality, safety or efficacy. Consequently, its manufacture and distribution without appropriate licences is unlawful.
Mr Noakes pleaded guilty to the charges and did not contest the determination that GcMAF is a medicinal product. The Court did not raise any questions about the product’s status as a medicine.
MHRA holds no clinical data on the use of GcMAF.
Any marketing authorisation application submitted would be considered by MHRA and the data submitted assessed to evaluate whether a marketing authorisation can be granted based on the benefit/risk of this product.
MHRA cannot comment on the grant of a marketing authorisation for any product until the marketing authorisation application has been assessed by our assessors.
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Yours sincerely
IE&S FOI Team MHRA Inspection, Enforcement and Standards cc FOI_Policy