FOI release

Freedom of Information request on using Descovy or generic Descovy (TAF/FTC) as PrEP in the UK (FOI 22/769)

Published 21 December 2023

FOI 22/769

22nd June 2022

Dear

Thank you for your email of 07 June 2022 where you asked the following question:

I am a 48-year-old, based in Glasgow, who is currently prescribed generic Truvada (TDF/FTC) as PrEP.

https://www.aidsmap.com/news/may-2022/nhs-england-considering-use-descovy-prep

After reading the above linked article, I was wondering if you could tell me when the final decision by CPAG and/or the MHRA will be reached with regards to using Descovy or generic Descovy (TAF/FTC) as PrEP in the UK?

Even though I’ve been told my kidney function is still good for my age, if Descovy is less damaging to kidney function long term than Truvada, I’d obviously be interested in switching should it become a viable recommended option.

The Medicines and Healthcare Products Regulatory Agency is the agency responsible for licensing medicines and ensuring that medical devices work and are acceptably safe.

The MHRA is responsible for the regulation of medicines used in the UK. This includes the authorisation of clinical trials and the evaluation and granting of Marketing Authorisation -or licences- for medicinal products.  Please see link how we regulate https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Regarding whether any application has been received by MHRA for the use of Descovy as PrEP in preventing HIV infection, we refuse to  confirm or deny we hold any information under Section 41 (S41) and Section 43 (S43) of the FOI Act (FOIA). S41 is an absolute exemption and no consideration of the public interest is required, except to state that we would consider the release of this information to be an actionable breach of confidence. S43 is a conditional exemption and requires a consideration of the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors to whether a competitor is close to obtaining a marketing authorisation or not.

As the article you have referenced states, “the EMA and MHRA cannot pursue authorisation of a drug or new indication by themselves.” MHRA does not solicit applications for new medicines, or the addition of indications to current authorised medicines, and we do not conduct our own research and development. We recommend you contact the individual marketing authorisation holders for Descovy further information on whether they intend to market this product in the UK for this indication

There are also Clinical Trial databases available where records of clinical trials that are currently in progress as well as completed trials can be searched:

https://www.clinicaltrialsregister.eu/ctr-search/search

https://www.isrctn.com/

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre