Responses to the Consultation on the future regulation of medical devices in the UK

Dear Medicines and Healthcare Products Regulatory Agency,

I am making this request on behalf of TranspariMED:
www.TranspariMED.org

Please provide a copy of all responses received to the questions set out in Chapter 7 (Clinical Investigation / Performance Studies) of the "Consultation on the future regulation of medical devices in the United Kingdom" up to the closing time of the consultation (midnight on 25 November 2021), including the identity of the party submitting each response.

If MHRA plans to make all consultation responses public in full on its website (as it should) before the end of January 2022, please let me know and I will withdraw this FOI request.

Yours faithfully,

Till Bruckner

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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We will respond to you as soon as possible. 
 
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• 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. Ourguidance and information can be accessed here.

________________________________________ From: Till Bruckner
<[FOI #810590 email]> Sent: Thursday, November 25,
2021 11:40:39 AM To: MHRA Customer Services Subject: Freedom of
Information request - Responses to the Consultation on the future
regulation of medical devices in the UK Dear Medicines and Healthcare
Products Regulatory Agency, I am making this request on behalf of
TranspariMED:
https://eur01.safelinks.protection.outlo...
Please provide a copy of all responses received to the questions set out
in Chapter 7 (Clinical Investigation / Performance Studies) of the
"Consultation on the future regulation of medical devices in the United
Kingdom" up to the closing time of the consultation (midnight on 25
November 2021), including the identity of the party submitting each
response. If MHRA plans to make all consultation responses public in full
on its website (as it should) before the end of January 2022, please let
me know and I will withdraw this FOI request. Yours faithfully, Till
Bruckner
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #810590 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/1263

Dear Till Bruckner,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 25th November 2021.

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.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Service Centre

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

FOI 21/1263

 

Dear Till Bruckner,

 

Thank you for your information request, dated 25 November 2021, where you
asked for a copy of all responses received to the questions set out in
Chapter 7 (Clinical Investigation / Performance Studies) of the
"Consultation on the future regulation of medical devices in the United
Kingdom" up to the closing time of the consultation (midnight on 25
November 2021), including the identity of the party submitting each
response.

 

Unfortunately, the information relating to the first element of your
request, a copy of all responses received to the questions set out in
Chapter 7, is exempt from release under section:

 

Section 35 – Formulation of Government policy: the information you have
requested is being withheld under section 35 of the FOI Act. Section 35
protects the internal deliberative process as it relates to Government
policy making. In other words, the exemption is intended to ensure that
the possibility of public exposure does not deter from full, candid and
proper deliberation of policy formulation and development, including the
exploration of all options, the keeping of detailed records and the taking
of difficult decisions. Section 35 is a qualified exemption, which means
that we have considered whether the public interest in releasing the
information is outweighed by the public interest in not giving the
information.

 

In favour of disclosure, we consider that there is a general public
benefit from releasing the information on the grounds of transparency in
the making of government policy. However, we consider that the public
interest will be better served by not releasing the information as the
premature disclosure of the information requested could be taken out of
context or misinterpreted and be detrimental to the policy making process.
Disclosure of the information provided during the consultation would
inhibit free and frank discussions with essential external stakeholders in
the future, leading to damage to the quality of advice and lead to poorer
decision making in the future.

 

The proposals included in the public consultation do not constitute agreed
policies. The MHRA has held the public consultation to obtain evidence to
be used to develop policies, prior to these being agreed by the Secretary
of State. There are no plans to publish the responses received to Chapter
7 of the public consultation, though a Government report of the
consultation responses will be published in early 2022 and will include a
section on Chapter 7.

 

In relation to the second part of your request, that information be
provided on the identity of the party submitting each response, I can
confirm that we do not hold the information that you have requested as it
was not requested as part of the consultation submission process.

 

If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review will be carried out by a senior member of the Agency
who was not involved with the original decision.

 

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

 

Yours sincerely,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

[1]gov.uk/mhra

[2]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [3]MHRA,
[4]CPRD and [5]NIBSC.

 

 

 

 

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Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'Responses to the Consultation on the future regulation of medical devices in the UK'.

MHRA refused to disclose the requested argumentation with reference to section 35, arguing that:
"the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions."

The information in question was provided to MHRA during a consultation process that was publicly announced and that was open to input from any and all interested stakeholders.

The ICO's section 35 guidance explicitly states that:
"Safe space arguments can still apply where external contributors have been involved, as long as those discussions have not been opened up for general external comment." (para 198)
https://ico.org.uk/media/for-organisatio...

In this case, the discussions had clearly been "opened up for general external comment" in the form of a broad consultation. Therefore, the section 35 exemption does not apply here.

Furthermore, it is not plausible that releasing "general external comment" on potential policy options under consideration by the MHRA could "deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions."

The request did not cover MHRA internal deliberations or policy formulation. Rather, it covered only information provided by external actors that MHRA is likely to take into consideration, among other factors, while internally deliberating policy options.

Furthermore, MHRA's application of the public interest test is not persuasive. According to MHRA:
"premature disclosure of the information requested could be taken out of context or misinterpreted and be detrimental to the policy making process." Any information, including any information released under FOIA, "could be taken out of context or misinterpreted," making the first part of the argument void. Regarding the second part, MHRA did not explain how the release of input received during a consultation process could "be detrimental to the policy making process".

In contrast, there is an overwhelming public interest in understanding the benefits and drawbacks of various policy options for medical device regulation, and the difficult trade-offs between policy choices. Medical devices can literally save lives, or cause premature deaths, are used by millions of UK citizens, and are typically paid for with public money. Informed parliamentary, expert, patient and public discussions on how to strike the right balance in medical device regulation depends on access to detailed information on the benefits and drawbacks of various policy options for medical device regulation. The responses received by MHRA in the course of its consultation are likely to provide the best and most detailed overview of such benefits and drawbacks available in the UK regulatory context. Informed democratic and scientific debates on UK medical device regulations depend on this information being publicly available.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/r...

Yours faithfully,

Till Bruckner

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. Ourguidance and information can be accessed here.

________________________________________ From: Till Bruckner
<[FOI #810590 email]> Sent: Monday, January 10,
2022 12:52:21 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Responses to the Consultation on the
future regulation of medical devices in the UK Dear Medicines and
Healthcare Products Regulatory Agency, Please pass this on to the person
who conducts Freedom of Information reviews. I am writing to request an
internal review of Medicines and Healthcare Products Regulatory Agency's
handling of my FOI request 'Responses to the Consultation on the future
regulation of medical devices in the UK'. MHRA refused to disclose the
requested argumentation with reference to section 35, arguing that: "the
exemption is intended to ensure that the possibility of public exposure
does not deter from full, candid and proper deliberation of policy
formulation and development, including the exploration of all options, the
keeping of detailed records and the taking of difficult decisions." The
information in question was provided to MHRA during a consultation process
that was publicly announced and that was open to input from any and all
interested stakeholders. The ICO's section 35 guidance explicitly states
that: "Safe space arguments can still apply where external contributors
have been involved, as long as those discussions have not been opened up
for general external comment." (para 198)
https://eur01.safelinks.protection.outlo...
In this case, the discussions had clearly been "opened up for general
external comment" in the form of a broad consultation. Therefore, the
section 35 exemption does not apply here. Furthermore, it is not plausible
that releasing "general external comment" on potential policy options
under consideration by the MHRA could "deter from full, candid and proper
deliberation of policy formulation and development, including the
exploration of all options, the keeping of detailed records and the taking
of difficult decisions." The request did not cover MHRA internal
deliberations or policy formulation. Rather, it covered only information
provided by external actors that MHRA is likely to take into
consideration, among other factors, while internally deliberating policy
options. Furthermore, MHRA's application of the public interest test is
not persuasive. According to MHRA: "premature disclosure of the
information requested could be taken out of context or misinterpreted and
be detrimental to the policy making process." Any information, including
any information released under FOIA, "could be taken out of context or
misinterpreted," making the first part of the argument void. Regarding the
second part, MHRA did not explain how the release of input received during
a consultation process could "be detrimental to the policy making
process". In contrast, there is an overwhelming public interest in
understanding the benefits and drawbacks of various policy options for
medical device regulation, and the difficult trade-offs between policy
choices. Medical devices can literally save lives, or cause premature
deaths, are used by millions of UK citizens, and are typically paid for
with public money. Informed parliamentary, expert, patient and public
discussions on how to strike the right balance in medical device
regulation depends on access to detailed information on the benefits and
drawbacks of various policy options for medical device regulation. The
responses received by MHRA in the course of its consultation are likely to
provide the best and most detailed overview of such benefits and drawbacks
available in the UK regulatory context. Informed democratic and scientific
debates on UK medical device regulations depend on this information being
publicly available. A full history of my FOI request and all
correspondence is available on the Internet at this address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, Till Bruckner
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #810590 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/1263

Dear Till Bruckner,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/1263. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Service Centre

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Till Bruckner

Thank you for your email.

Please find attached the response to your Internal Review Request.

Yours sincerely

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

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