Which government department is responsible for decision making on using repurposed drugs for Covid 19

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Dear Medicines and Healthcare products Regulatory Agency,
Please can you inform me ;
1. Which government department/s are responsible for deciding which repurposed medication can be used for Covid 19?
2. Who is the individual ultimately responsible for the decision in 1. Above?
3. Which government department/s are responsible for granting 'temporary authorisation' for a medication for Covid 19?
4. Is the granting of 'temporary authorisation' conducted by the same department/s as the decision to repurpose a medication.
5. What process is used to make the decision to repurpose a medication for Covid 19 and to grant 'temporary authorisation'?
6. Is the Therapeutics Taskforce involved in the decision as to which repurposed medication to use for Covid 19? If so what is their remit and how does their decision making process interact with other government departments?

Yours faithfully,
Barbara Slaska

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/417

Dear Barbara Slaska,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/417
 
Dear Barbara Slaska,
 
Thank you for your email.
 
Please find below answers to the questions you raise below;
 
 

 1. Which  government department/s are responsible for deciding which
repurposed medication can be used for Covid 19?

 
MHRA authorises medicines for use in specific indications, including the
repurposing of current authorised medicines for use in treating Covid-19
infection.
 
2. Who is the individual ultimately responsible for the decision in 1.
Above?
 
The MHRA is advised by the Commission on Human Medicines (CHM), an
independent public body that advises ministers on the safety efficacy and
quality of medicinal products.  The membership of the CHM is published:
[1]https://www.gov.uk/government/organisati...
 
The Chair and Commissioners are appointed in accordance with the Code of
Practice for Ministerial Appointments to Public Bodies, issued by the
Commissioner for Public Appointments. The Chair and Commissioners follow a
code of practice, in which they are precluded from holding personal
interests. Their interests in the pharmaceutical industry are published in
the Commission’s annual report each year.
 
The CHM is advised by a COVID-19 Vaccines Benefit Risk Expert Working
Group and the membership of this Group is also published in the link
provided above.
 
3. Which government department/s are responsible for granting 'temporary
authorisation' for a medication for Covid 19?
 
MHRA is responsible for authorising medicines, including the vaccines that
have been authorised for use in preventing Covid-19 infection.
 
4. Is the granting of 'temporary authorisation' conducted by the same
department/s as the decision to repurpose a medication.
 
Yes the authorisation of the vaccines is conducted by MHRA, although some
decisions to authorise medicines are done following a European Commission
decision.
 
5. What process is used to make the decision to repurpose a medication for
Covid 19 and to grant 'temporary authorisation'?
 
The process for repurposing a medicine is described above.
 
The temporary authorisation of the vaccines was done through an expedited
rolling review. A ‘rolling review’ can be used to complete the assessment
of a promising medicine or vaccine during a public health emergency in the
shortest time possible. This is done as the packages of data become
available from ongoing studies on a staggered basis. The temporary
authorisation under Regulation 174 permits the supply of identified
vaccine batches, based on the safety, quality and efficacy data submitted
to MHRA. These authorisations do not constitute a marketing authorisation.
 
All vaccines are tested through three phases of clinical trials to ensure
they meet the gold standard. Phase 1 trials are with a small group of
people to make sure there are no safety concerns and determines the
appropriate dosage for the best immune response. Phase 2 trials are
conducted on a larger group of people to check the vaccine works
consistently and that the immune response is sufficient. Phase 3 trials
test the vaccines on thousands of people for scientists to assess if the
vaccine is producing immunity that will prevent disease. Usually, these
phases are run in sequence, but in an effort to find a safe and effective
Covid-19 vaccine as quickly as possible, once safety has been ascertained
through Phase 1, Phases 2 and 3 are being run in parallel. Extensive
checks and balances are required at every stage of the development of a
vaccine, and this is no different for a Covid-19 vaccine. No stages in the
vaccine development processes were bypassed.
 
Please note, the Pfizer/BioNTech vaccine (Comirnaty) was granted a
marketing authorisation following a European Commission (EC) decision on
21 December 2020 (PLGB 53632/0002). Further information is available on
the European Medicines Agency (EMA) website, a link to this is provided
below:
[2]https://www.ema.europa.eu/en/medicines/h...
 
The Moderna vaccine was granted a marketing authorisation on 31 March 2021
following an EC Reliance Procedure (PLGB 53720/0002). Further information
is available on the MHRA website and the EMA website, links to these are
provided below:
[3]https://www.gov.uk/government/publicatio...
[4]https://www.ema.europa.eu/en/medicines/h...
 
In addition, the European Commission, following recommendations from the
European Medicines Agency (EMA), have granted a marketing authorisation
for the Oxford/AstraZeneca vaccine. Further information is provided below:
[5]https://www.ema.europa.eu/en/medicines/h...
 
6. Is the Therapeutics Taskforce involved in the decision as to which
repurposed medication to use for Covid 19? If so what is their remit and
how does their decision making process interact with other government
departments?
 
We suggest you contact the Department of Health and Social Care (DHSC) for
information on the Therapeutics Taskforce, as per the link below.
 
[6]The COVID-19 Therapeutics Taskforce - GOV.UK (www.gov.uk)
 
[7]Web contact form - https://contactus.dh.gov.uk/?openform 
  
Please review the following links to MHRA ‘About us’: [8]About us -
Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk)
And MHRA guidance on coronavirus [9]MHRA guidance on coronavirus
(COVID-19) - GOV.UK (www.gov.uk)
 
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Yours sincerely
 
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
 
 

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