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Roland Gilmore made this Rhyddid Gwybodaeth request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Medicines and Healthcare Products Regulatory Agency Nid oedd gan y wybodaeth y gofynnwyd amdani.

Dear Medicines and Healthcare products Regulatory Agency,

Why has Ivermectin treatment not been approved by MHRA and included as the preferred protocol for prophylaxis, early, post exposure and severe case treatment for Covid-19?

[Extraneous material removed]

Yours faithfully,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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Medicines and Healthcare products Regulatory Agency
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London
E14 4PU
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 20/565

Dear Mr Roland Gilmore,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 10 December 2020.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 20/565
 
Dear Mr Gilmore,
 
Thank you for your email.
 
In our role as the medicines regulator, MHRA is not in a position to hold
product licences itself or to solicit for new product licence applications
(or the adaptation of current product licences for new indications). Once
an application is made, then supporting data will be assessed with regard
to its quality, safety and efficacy for the conditions it is intended to
treat, and to confirm that it has an acceptable balance of risk and
benefit.
 
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: [1][MHRA request email]
 
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 Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
 

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

I am asking you to take responsibility for assessing safe and effective life saving treatments during the current public health emergency i.e. the Covid-19 pandemic. Currently, there is no prophylaxis approved for the treatment of Covid-19 or effective, low cost treatments for early, medium or late term Covid-19. Ivermectin is out of patent and therefore no application can be expected from a pharmaceutical company.

Since the MHRA is refusing or incapable of carrying out an approval process for the adaptation of the current product licence for the uses of Ivermectin (as described and referenced in my enquiry) and doctors are prevented from prescribing these successful protocols, please confirm who or which organisation that responsibility lays with?

Yours sincerely,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 20/565
Dear Mr Gilmore
 
Many thanks for your email.
 
Regarding your specific statements:
Currently, there is no prophylaxis approved for the treatment of Covid-19
or effective, low cost treatments for early, medium or late term
Covid-19. 
Currently, there are a number of treatments being used and/or trialled for
Covid patients.  For example, dexamethasone is being used in the treatment
of Covid patients, following data submitted from clinical trials. 
 
Ivermectin is out of patent and therefore no application can be expected
from a pharmaceutical company.
If ivermectin is out of patent, this should not be a barrier to any
company submitting a marketing authorisation (or variation to a current
marketing authorisation they hold) to include treatment of Covid-19
patients. As we previously advised, once an application is made then
supporting data will be assessed by the MHRA with regard to its quality,
safety and efficacy for the conditions it is intended to  treat, and to
confirm that it has an acceptable balance of risk and  benefit.
 
Please confirm who or which organisation that responsibility lays with?
As we stated in our response of December 2020, MHRA is not in a position
to hold product licences itself or to solicit for new product licence
applications  (or the adaptation of current product licences for new
indications). Once  an application is made, then supporting data will be
assessed with regard  to its quality, safety and efficacy for the
conditions it is intended to  treat, and to confirm that it has an
acceptable balance of risk and  benefit. Further information about how we
regulate and our responsibilities are provided below:
[1]https://www.gov.uk/government/organisati...
 
We suggest that you contact individual pharmaceutical companies to enquire
why no applications have been submitted for the use of ivermectin for use
in patients with Covid-19. Further, information concerning the use of
ivermectin is in the public domain, one link to this information is
provided below:
[2]https://www.independent.co.uk/news/world...
 
Yours sincerely
 
 
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU  Telephone 0203 080 6000
 
 

dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Gilmore,

Thank you for your email.

Regarding your specific statements:
Currently, there is no prophylaxis approved for the treatment of Covid-19 or effective, low cost treatments for early, medium or late term Covid-19.
Currently, there are a number of treatments being used and/or trialled for Covid patients. For example, dexamethasone is being used in the treatment of Covid patients, following data submitted from clinical trials.

Ivermectin is out of patent and therefore no application can be expected from a pharmaceutical company.
If ivermectin is out of patent, this should not be a barrier to any company submitting a marketing authorisation (or variation to a current marketing authorisation they hold) to include treatment of Covid-19 patients. As we previously advised, once an application is made then supporting data will be assessed by the MHRA with regard to its quality, safety and efficacy for the conditions it is intended to treat, and to confirm that it has an acceptable balance of risk and benefit.

Please confirm who or which organisation that responsibility lays with?
As we stated in our response of December 2020, MHRA is not in a position to hold product licences itself or to solicit for new product licence applications (or the adaptation of current product licences for new indications). Once an application is made, then supporting data will be assessed with regard to its quality, safety and efficacy for the conditions it is intended to treat, and to confirm that it has an acceptable balance of risk and benefit. Further information about how we regulate and our responsibilities are provided below:
https://www.gov.uk/government/organisati...

We suggest that you contact individual pharmaceutical companies to enquire why no applications have been submitted for the use of ivermectin for use in patients with Covid-19. Further, information concerning the use of ivermectin is in the public domain, one link to this information is provided below:
https://www.independent.co.uk/news/world...

Kind Regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

My query is "Please confirm who or which organisation that responsibility lays with?"

As a tax payer who contributes to your salary, I find your repetitive response not only insulting and unhelpful but dismissive. I therefore presume that MHRA has no knowledge of any organisation responsible for reviewing published medical/ scientific information for cheap, effective treatment of Covid-19 that (unlike the expensive and highly questionable efficacy of Remdesivir, that you did approve) would save lives.

I find MHRA negativity appalling.

Yours sincerely,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

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1. https://www.gov.uk/government/collection...