Freedom of Information Team
Department of Health and Social Care
39 Victoria Street
London SW1H 0EU
www.gov.uk/dhsc
Ms Linda Birr-Pixton
By email to
: xxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx
23 October 2024
Dear Ms Birr-Pixton,
Freedom of Information Request Reference FOI-1534130
Thank you for your request dated 25 September to the Department of Health and Social
Care (DHSC), a copy of which can be found in the accompanying annex.
Your request has been handled under the Freedom of Information Act 2000 (FOIA).
DHSC does not hold any information relevant to your request.
With reference to your question about guidance to the Medicines and Healthcare products
Regulatory Agency (MHRA), DHSC has not issued any advice or guidance to the MHRA
on this issue. With reference to research generally, the DHSC (through its research arm,
the National Institute for Health Research (NIHR)) does not engage in any pre-human
research and development, so does not hold any information relating to research involving
animals or animal tissue.
You may be aware that the use of animals in experiments and testing is regulated under
the Animals (Scientific Procedures) Act 1986 (ASPA). A section of the Home Office (The
Animals in Science Regulation Unit) is responsible for administration and enforcement of
ASPA. More information about that unit is available at the following link:
Animals in Science Regulation Unit - GOV.UK. If you should wish to submit a request
under the FOIA to the Home Office, it can be contacted at:
xxxxxxxxxxx@xxxxxxxxxx.xxx.xx
You may also be interested in the following information, which we are providing on a
discretionary basis. This is outside of the scope of the FOIA, and not subject to internal
review.
The MHRA has advised us of the following. The relevant guidelines that the MHRA refers
to on medicinal product development are those of the International Conference on
Harmonisation (please see
https://www.ich.org/page/ich-guidelines), the World Health
Organisation (please s
ee https://www.who.int/publications/m/item/annex1-nonclinical.p31-
63) and other international regulatory bodies (e.g. the US Food and Drug Administration
and the EU European Medicines Agency) as well as a small number produced by the
MHRA itself.
If you have any follow up questions with reference to the above, we suggest that you may
wish to contact the MHRA. Requests under the FOIA can be submitted to the MHRA at
xxxx@xxxx.xxx.xx
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Guidance on contacting the ICO can be found at
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information about making a complaint can be found a
t https://ico.org.uk/make-a-complaint. Yours sincerely,
Freedom of Information Team
xxxxxxxxxxxxxxxxxxxx@xxxx.xxx.xx
Annex
From: Linda Birr-Pixton <xxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx>
Sent: Wednesday, September 25, 2024 10:43 AM
To: FreedomofInformation <xxxxxxxxxxxxxxxxxxxx@xxxx.xxx.xx>
Subject: Freedom of Information request - Performance assessments on 21st century
technology
Dear Department of Health and Social Care, I read with interest the recent UK government
press release announcing a £400 million public-private collaboration launched to kickstart
economic growth and build an NHS fit for the future.
Can you please refer me to the advice and guidance you have provided to the MHRA with
regard to the continuing use of unreliable animal tests as the back bone of pre-clinical
studies by pharmaceuticals?
According to the US Food and Drug Administration, out of ten drugs that successfully pass
animal tests, nine will fail during clinical trials, either as a result of adverse reactions not
seen in the animals or else due to lack of efficacy in humans.
What has the Department of Health and Social Care provided as advice and indeed
regulation to ensure that the the availability of modern technologies that far surpass
animal tests in terms of reliability and relevance to human health such as Liver on a chip is
now one of the key and expected tools in preclinical studes.
As one example, the human « liver on a chip » is far more reliable than animal tests at
detecting drug induced liver injury (DILI for short). This is hugely significant because the «
liver on a chip » will prevent dangerous drugs from ever reaching clinical trials, whereas
animal testing is notoriously unreliable at detecting and predicting DILI.
Not only is DILI the leading cause of prescription drug withdrawal from the market, but
such liver damage can even result in a patient requiring a liver transplant.
One single liver transplant costs the NHS around £ 121 000.
I attach these articles which have informed my request for information
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.nature.com%2
Farticles%2Fs43856-022-00209-
1&data=05%7C02%7Cdhmail%40dhsc.gov.uk%7Cb679c669f96c4bc9afc308dcdd6da4e1
%7C61278c3091a84c318c1fef4de8973a1c%7C1%7C0%7C638628710198621497%7CU
nknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWw
iLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=k03ZnJKQAoLAYz0MPjwTMLG%2Bq%2
BWnNtZr17S1aA2QErw%3D&reserved=0
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.nature.com%2
Farticles%2Fs41573-021-00323-
0&data=05%7C02%7Cdhmail%40dhsc.gov.uk%7Cb679c669f96c4bc9afc308dcdd6da4e1
%7C61278c3091a84c318c1fef4de8973a1c%7C1%7C0%7C638628710198637666%7CU
nknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWw
iLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=DZBAQVknQrmsnkxaepvxcZDmndcPK9
MHrlYrlaQxI3Y%3D&reserved=0
Adoption of organ-on-chip platforms by the pharmaceutical industry | Nature Reviews Drug
Discovery.
Can you point me to the information that is being used to not allow the implementation
of the use of the Liver on a chip as a part of the pre-clinical toolkit for researchers and
drug development and is this a general omission or a specific one with regard to the use of
non animal methods?
Yours faithfully,
Linda Birr-Pixton
