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By Sarah Barber,
Nikki Sutherland The Medicines and Medical
7 July 2021 Devices Safety Review
Summary
1 The Independent Medicines and Medical Devices Safety review
2 Primodos (Hormone pregnancy tests)
3 Sodium Valproate
4 Surgical mesh
5 Government response
6 Parliamentary material
7 Further reading
commonslibrary.parliament.ukNumber CBP 9274 The Medicines and Medical Devices Safety Review
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2 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review Contents 1 The Independent Medicines and Medical Devices Safety review 5 2 Primodos (Hormone pregnancy tests) 10 3 Sodium Valproate 13 4 Surgical mesh 16 5 Government response 21 5.1 Patient Safety Commissioner 23 5.2 Medical device registry 24 5.3 Specialist centres 25 5.4 Sodium Valproate 25 6 Parliamentary material 27 Written statements 27 PQs 33 7 Further reading 40 3 Commons Library Research Briefing, 7 July 2021
The Medicines and Medical Devices Safety Review Summary The Independent Medicines and Medical Devices Safety review was announced by the former Secretary of State for Health and Social Care, Jeremy Hunt, in February 2018 to look at three issues of concern: • the use of primodos (the hormone pregnancy test); • use of the anti-epileptic drug sodium valproate in pregnancy; and • the use of vaginal mesh. Following the consideration of written and oral evidence from patients and their families, campaigners, healthcare professionals and regulators over a two-year period, the review published the report of its findings and recommendations, First do no harm, in July 2020. There were eight main recommendations. These included the establishment of an independent Patient Safety Commissioner, the introduction of redress schemes for those affected by these products, and changes to the way the medicines regulator, the Medicines and Healthcare products Regulatory Agency, works with patients. The Government have responded to the review’s report. It has accepted a number of the recommendations and has taken measures in the Medicines and Medical Devices Act 2021 to make provision for the patient safety commissioner. Other recommendations were not accepted by the Government, and some remain under consideration. A debate on a Motion relating to the implementation of the recommendations of the Independent Medicines and Medical Devices Safety Review has been tabled by the Backbench Business Committee on 8 July 2021. The debate will be led by Emma Hardy and Alec Shelbrooke. This briefing provides an overview of the Independent Medicines and Medical Devices Review and its recommendations, and the Government’s response to this. Further press articles and parliamentary material are also included. 4 Commons Library Research Briefing, 7 July 2021
The Medicines and Medical Devices Safety Review
1 The Independent Medicines and Medical
Devices Safety review
Background
On 21 February 2018, the then Secretary of State for Health and Social Care,
Jeremy Hunt, announced an independent review on medicines and medical
device safety. He highlighted three issues of concern:
• the use of primodos (the hormone pregnancy test);
• use of the anti-epileptic drug sodium valproate in pregnancy; and
• the use of vaginal mesh.
These issues had been the subject of ongoing campaigning from patient
groups, and debates in Parliament. He said that the review, led by Baroness
Cumberlege, would look at what had happened in the three cases above, and
make recommendations on future action:
To do better in the future, we need to ensure that patient voices are
bought to the table as systematically and consistently as other
voices in the system, so today I have asked Baroness Julia
Cumberlege to conduct a review into what happened in each of these
three cases, including whether the processes pursued to date have
been sufficient and satisfactory, and to make recommendations on
what should happen in future. She will assess, first, the robustness
and speed the of processes followed by the relevant authorities and
clinical bodies to ensure that appropriate processes were followed
when safety concerns were raised; secondly, whether the regulators
and NHS bodies did enough to engage with those affected to ensure
their concerns were escalated and acted upon; thirdly, whether
there has been sufficient co-ordination between relevant bodies and
the groups raising concerns; and fourthly, whether we need an
independent system to decide what further action may be required
either in these cases or in the future. This is because one of the
judgments to be made is whether, when there has been widespread
harm, there needs to be a fuller, or even statutory, public inquiry.
Baroness Cumberlege will make recommendations on the right
process to make sure that justice is done and to maintain public
confidence that such decisions have been taken fairly. 1
1
HC Deb 21 February 2018, c166
5 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
The aims of the review were to “make recommendations for improving the
healthcare system’s ability to respond where concerns have been raised
about the safety of particular clinical interventions, be they medicines or
medical devices.” 2
It was set out in the terms of reference that the review would look at historical
evidence on the three issues, consent processes in relation to the treatments,
and the responses to safety concerns raised by patients and their families and
whether these responses were sufficient.
In each of the three areas of concern the review intended to investigate:
• the robustness, speed and appropriateness of those
processes and actions followed by the relevant
pharmaceutical/ medical device manufacturers and
applicants for and holders of licenses to manufacture and
sell pharmaceutical products and medical devices, the
regulatory authorities, healthcare providers, public and
clinical bodies and policy makers;
• whether problems could have been recognised by the
relevant bodies, authorities, manufacturers and license
holders and others sooner and more effectively;
• whether the same bodies could, and should, have acted upon
concerns sooner and if they did not, the reasons why. 3
More information about the terms of reference and aims of the review is
provided on the review website.
The review took written evidence from patients, regulators, campaign groups
and others and undertook evidence sessions around the UK for a period of two
years, taking evidence from over 700 women and their families. 4 The evidence
submitted to the review, and transcripts of evidence sessions are published
on the review website.
The report of the review, published in July 2020, explained that whilst it may
have appeared that the group were being asked to look at three disparate
issues, there were many similarities between them:
On the face of it we were being asked to investigate three disparate
interventions governed by two different product regulatory
frameworks in the one Review. It soon became apparent, however,
that far more binds these interventions than separates them:
2
The Independent Medicines and Medical Devices Safety Review, Terms of reference [accessed 6 July
2021]
3
The Independent Medicines and Medical Devices Safety Review, Terms of reference [accessed 6 July
2021]
4
The Independent Medicines and Medical Devices Review, Press Conference Speech 8 July 2020.
6 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
• they all are taken or used by women and, in the cases of
valproate and hormone pregnancy tests, usage is during
pregnancy;
• patients affected by each tell similar and compelling stories
of their battles to be listened to when things go wrong;
• patients turning to each other for help and mutual support;
• patients campaigning for years, if not decades, to achieve
acknowledgement, resorting to the media and politicians to
take up their cause because the healthcare system did not. 5
The report provides more information on what it describes as the
“overarching themes” that apply to all three issues of concern and also apply
more widely in healthcare. These included that patients felt that they were
not being listened to, the feelings of guilt parents experienced, a lack of
informed consent in treatment and no clear route for complaints.
Conclusions and recommendations
The Review’s report was published on 8 July 2020. In a press conference
speech on that day,the Chair, Baroness Cumberlege, highlighted the scale of
the impact of these medical interventions:
I and members of the Review team have conducted many reviews
and we all agree – we have never encountered anything like this, the
intensity of suffering, the fact that it has lasted for decades. And the
sheer scale. This is not a story of a few isolated incidents.
No one knows the exact numbers affected by mesh, Primodos and
sodium valproate but it is in the thousands. Tens of thousands. As if
the physical, developmental and emotional harm weren’t enough,
these families have had to fight to be listened to and to be taken
seriously. They organised themselves into groups and have battled
for years. I want to thank the patient groups. Their expertise,
courage and tenacity is truly remarkable and they have helped us
throughout. I want to stress our Review was set up because these
people refused to give up. 6
The report provides specific conclusions and recommendations for each of the
issues of concern, set out in more detail in the sections below, but the overall
recommendations are set out below:
5
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review, July
2020
6
The Independent Medicines and Medical devices review, Press Conference Speech 8 July 2020.
7 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
Recommendation 1: The Government should immediately issue a
fulsome apology on behalf of the healthcare system to the families
affected by Primodos, sodium valproate and pelvic mesh.
Recommendation 2: The appointment of a Patient Safety
Commissioner who would be an independent public leader with a
statutory responsibility. The Commissioner would champion the
value of listening to patients and promoting users’ perspectives in
seeking improvements to patient safety around the use of medicines
and medical devices
Recommendation 3: A new independent Redress Agency for those
harmed by medicines and medical devices should be created based
on models operating effectively in other countries. The Redress
Agency will administer decisions using a non-adversarial process
with determinations based on avoidable harm looking at systemic
failings, rather than blaming individuals.
Recommendation 4: Separate schemes should be set up for each
intervention – HPTs, valproate and pelvic mesh – to meet the cost of
providing additional care and support to those who have
experienced avoidable harm and are eligible to claim.
Recommendation 5: Networks of specialist centres should be set up
to provide comprehensive treatment, care and advice for those
affected by implanted mesh; and separately for those adversely
affected by medications taken during pregnancy.
Recommendation 6: The Medicines and Healthcare products
Regulatory Agency (MHRA) needs substantial revision particularly in
relation to adverse event reporting and medical device regulation. It
needs to ensure that it engages more with patients and their
outcomes. It needs to raise awareness of its public protection roles
and to ensure that patients have an integral role in its work.
Recommendation 7: A central patient-identifiable database should
be created by collecting key details of the implantation of all devices
at the time of the operation. This can then be linked to specifically
created registers to research and audit the outcomes both in terms
of the device safety and patient reported outcomes measures.
Recommendation 8: Transparency of payments made to clinicians
needs to improve. The register of the General Medical Council (GMC)
should be expanded to include a list of financial and non-pecuniary
interests for all doctors, as well as doctors’ particular clinical
interests and their recognised and accredited specialisms. In
addition, there should be mandatory reporting for the
pharmaceutical and medical device industries of payments made to
teaching hospitals, research institutions and individual clinicians.
8 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
Recommendation 9: The Government should immediately set up a
task force to implement this Review’s recommendations. Its first task
should be to set out a timeline for their implementation. 7
7
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review, July
2020, p187-88
9 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
2 Primodos (Hormone pregnancy tests)
Drugs containing synthetic versions of the hormones progesterone and
oestrogen were taken as a form of pregnancy test from the late 1950s until
1970s; the most commonly used of these in the UK was Primodos. Concerns
have been expressed for many years that these hormone pregnancy tests
(HPTs) may have caused congenital anomalies and miscarriage.
A 2015-17 review of the evidence on hormone pregnancy tests, undertaken by
an expert working group from the Commission on Human Medicines, 8
concluded that a the scientific evidence did not support a causal association
between the use of HPTs such as Primodos and birth defects or miscarriage.” 9
However, there have been a number of criticisms of this report, including that
it did not look at potential regulatory failures in the 1960s and 70s.
Background information on the use of these products, and concerns that have
been raised about their use, is provided in the following sources:
• Chapter 3 of the report of the Independent Medicines and medical
devices review, First do no Harm, July 2020
• Commons Library debate pack, Expert Working Group report on hormone
pregnancy tests, April 2019
The Medicines and Medical Devices Safety
review
The specific questions of interest for the review in relation to Primodos were:
• where the science is not broadly acknowledged or accepted, whether the
available historic and scientific evidence (and its assessment to date)
can reasonably preclude ‘a possible association’ between Hormone
Pregnancy Tests and their teratogenic effects, and/or needs to be
revisited, in the opinion of the Review;
• given the knowledge on Hormone Pregnancy Tests available to the
manufacturers, regulators and clinicians at the time, the consideration,
8
The Commission on Human Medicines advises ministers on the safety, efficacy and quality of
medicinal products, see Commission on Human Medicines - GOV.UK (www.gov.uk)
9
Commission on Human Medicines, Press release: Independent Expert Working Group finds totality of
scientific evidence does not support a causal association between the use of hormone pregnancy
tests and birth defects, 15 November 2017
10 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
advice and practice with regard to the use of alternative, non-invasive
pregnancy tests. 10
The 2020 report, First do no harm, concluded that hormone pregnancy tests
should not have been available from 1967 onwards, when an alternative was
available, and concerns had been raised about the risks associated with their
use. The review group also recommended the provision of specialist support
for those affected. In her press conference speech, Baroness Cumberlege
stated that in relation to this product and those affected by its use, the
system had failed:
In our view Primodos continued to be given as a pregnancy test for
years longer than it should. In the face of growing concerns it should
have ceased to be available from 1967. A non-invasive alternative
was available by then, and the concerns that were being expressed
should have led to action by the regulator. It continued to be given to
women for years longer. While there is disagreement between
experts about whether Primodos caused birth defects, the fact
remains that thousands of women and unborn children were exposed
to a risk that was acknowledged at the time. That should not have
happened. This is not a case of us judging the actions of the past by
the standards of today. This was discussed at the time, but not acted
upon. The system failed. 11
A summary of the conclusions and recommendations of the report in relation
to Primodos are set out below:
• In 1967 HPTs should have been withdrawn as pregnancy tests
given concerns about risk and the availability of non-invasive
alternatives. This was years earlier than they were
withdrawn.
• When the indication was removed in 1970 the system failed to
prevent HPTs being provided/prescribed, thus exposing more
women and their babies to HPTs during pregnancy.
• An apology is due, and support is required for those who have
suffered avoidable harm.
• Those affected are not receiving adequate support. We
recommend that specialist centres are established for all
families adversely affected by medications taken during
pregnancy, to provide integrated medical and social care
expertise to enable those affected to access the services they
need in one place.
10
The Independent Medicines and Medical devices Safety Review, Terms of Reference
11
The Independent Medicines and Medical devices review, Press Conference Speech 8 July 2020.
11 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
• The question of causality was outside our scope, but we note
that it has been addressed by others and it may be revisited
in the prospective legal action.
• We also make recommendations to reduce the risk of
exposure to suspected or known teratogens. 12
12
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review, July
2020, p187-88
12 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
3 Sodium Valproate
Sodium valproate, commonly known by brand names including Epilim,
Episenta, Epival, is licensed in the UK to treat epilepsy and bipolar disorder. 13
Valproate is described as highly teratogenic (a teratogen is any agent that
causes an abnormality following fetal exposure during pregnancy). The
Medicines and Healthcare products Regulatory Agency (MHRA) report that
whilst the general risk of a fetal abnormality is 2-3%, in women taking sodium
valproate the risk is around 10%. Birth defects can include spina bifida,
malformation of limbs and facial and skull malformations. It also states that
the use of sodium valproate in pregnancy can affect a child’s development,
about three to four children in ten may have developmental problems such as
delays in learning to walk and talk, lower intelligence than children of the
same age and poor speech and language skills. 14
There are regulatory measures in place to ensure that these medicines are
not prescribed to women and girls of childbearing potential unless certain
safeguards are in place. More information about the valproate pregnancy
prevention programme can be found in the Patient Guide: What women and
girls need to know about valproate, published by the MHRA and updated in
November 2020.
There has been long standing knowledge of the risks associated with anti-
epileptic drugs in pregnancy. Since the introduction of valproate medicines in
the 1970s the product information for doctors has included a warning about
the possible risk of birth defects.
However, epilepsy charities and patient groups report that women have not
been made aware of the potential risks when taking the drug in pregnancy. In
October 2016, a group of epilepsy charities reported that a survey of 2,788
women had shown that 20% of those who were taking sodium valproate for
their epilepsy were not aware of the risks in pregnancy. 15
For further background information on the use of sodium valproate in
pregnancy, and concerns about lack of awareness on this issue, see:
• Chapter 4 of the report of the Independent Medicines and medical
devices review, First do no Harm, July 2020
13
BNF, Sodium Valproate, not dated
14
MHRA, Valproate use by women and girls, March 2018
15
Epilepsy Today, Women with epilepsy should be better informed about the risks of taking sodium
valproate during pregnancy, survey shows, October 2016
13 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
• Commons Library debate pack, Valproate and Fetal Anti-Convulsant
Syndrome, October 2017
The Medicines and Medical Device Safety
Review
The following issues were identified as of interest to the review in relation to
sodium valproate:
• the circumstances of the pharmaceutical licensing of Sodium
Valproate and treatment to date for women and girls of child
bearing age based on the growing body of agreed scientific
evidence as to its teratogenicity;
• how that scientific knowledge was, or should have been,
communicated between the manufacturers, regulatory
authorities, clinicians and patients and subsequently acted
upon;
• whether a consensus has been reached on defining the
characteristics of the conditions referred to as Fetal
Valproate Spectrum Disorders and the implications of this for
proper diagnosis and assessment of the lifetime needs of
those affected. 16
Chapter 4 of the report examines sodium valproate use in pregnancy in detail.
In relation to sodium valproate, the review concluded:
We believe that it has taken far too long for serious action to be
taken to reduce the number of women who take sodium valproate
during pregnancy while unaware of the risk. Women were not given
the information they needed to make an informed choice, and
despite the efforts of the valproate toolkit and the PPP, too many
women still do not have this information. Access to a diagnosis of
FVSD, and to the care and support individuals and families need, is
not what it should be. In addition, we cannot be sure that today the
system is adequately regulating and monitoring new antiepileptic
drugs. In paragraphs 4.90 – 4.106 we set out the actions we believe
need to be taken to minimise harm and better support those already
affected, including:
• Continuing to improve communication of risks to ensure that
all women on sodium valproate are aware of the risks prior to
family planning decisions.
16
Independent Medicines and Medical Devices Safety Review, Terms of Reference, not dated
14 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
• Identifying all of those affected by exposure to sodium
valproate in utero to ensure access to support.
• Establishing specialist centres for families affected by
teratogenic medication.
• An ex gratia scheme to provide need-based payments to help
those affected by valproate exposure. In our view both the
government and Sanofi should contribute to this scheme.
• Long-term data collection of women on all antiepileptic
drugs (AEDs) and their children.
• Measures to reduce and monitor effects of other medications
which are regularly taken during pregnancy, and are
considered to have teratogenic potential, or known risk
above that of the general population. 17
17
First Do No Harm, The report of the Independent Medicines and Medical Devices Safety Review, para
4.9, p101
15 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
4 Surgical mesh
Mesh implants may be used in a number of surgical procedures to provide
additional support when repairing weakened or damaged tissue. Over recent
years attention has increased on complications that can occur with the use of
this mesh in urogynaecology procedures to treat pelvic organ prolapse (POP)
and stress urinary incontinence (SUI).
These complications can include persistent pain, sexual problems, mesh
exposure through vaginal tissues and occasionally injury to nearby organs,
such as the bladder or bowel. It is acknowledged by NHS England, NICE and
others that there has been limited evidence on the long-term adverse effects
following these procedures. 18
Concerns have also been raised about the regulatory process used to assess
mesh implants.
For further background information on complications caused by mesh
implants, and concerns about the regulatory process used to assess them,
see:
• Chapter 5 of the report of the Independent Medicines and medical
Devices Safety review, First do no Harm, July 2020
• Commons Library briefing paper, Surgical mesh implants, September
2019
The Medicines and Medical Devices Safety
review
The following questions were identified of interest for the review with regards
to mesh implants:
• whether the scientific evidence underpinning current
regulatory and clinical practice fully and properly reflects:
• the long term quality of life impact where there are adverse
complications following these pelvic mesh procedures;
18
NICE, Urinary incontinence and pelvic organ prolapse in women: management, June 2019
16 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
• the innate properties of the polymeric material currently in
use in the manufacture of pelvic mesh products and what is
known about how those properties change once the mesh has
been implanted in the human body and over time; and
• the risks associated with the procedures themselves in
comparison with the alternative available options.
• the circumstances of the synthetic pelvic mesh medical
device regulation, approval and adverse effects reporting to
date. 19
July 2018: Halt in the use of surgical mesh in stress
urinary incontinence procedures
In July 2018, the Independent Medicines and Medical Devices Safety Review
called for the immediate halt of the use of surgical mesh in stress urinary
incontinence procedures.
The Chair of the Review, Baroness Cumberlege, said that the decision had
been made following the evidence heard by the review about the experiences
of complications after these procedures:
“We strongly believe that mesh must not be used to treat women
with stress urinary incontinence until we can manage the risk of
complications much more effectively. We have not seen evidence on
the benefits of mesh that outweighs the severity of human suffering
caused by mesh complications.
I have been appalled at the seriousness and scale of the tragic
stories we have heard from women and their families. We have heard
from many women who are suffering terribly. Their bravery and
dignity in speaking out is deeply moving, and their sadness, anger,
pain and frustration at what has happened to them and others has
been compelling. We had to act now.
My team and I are in no doubt that this pause is necessary. We must
stop exposing women to the risk of life-changing and life-threatening
injuries. We must have measures in place to mitigate the risk, and
those are sadly lacking at the moment.
At this stage in our Review we are not recommending a ban, but a
halt to procedures until the conditions we have laid down are met. I
am pleased that both the Department of Health & Social Care and
NHS England support our recommendation, and I look forward to its
quick implementation”.
19
The Independent Medicines and Medical devices Safety review, Terms of Reference, 2018
17 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
This follows NICE’s 2017 guidance that mesh for vaginal wall
prolapse should only be used in the context of research. In 2014 the
Scottish government put in place a suspension in the use of mesh for
SUI 20
The Department of Health and Social Care accepted this recommendation.
On 17 July, it stated that the pause included all procedures where mesh is
inserted vaginally to treat stress urinary incontinence and pelvic organ
prolapse. 21
A letter from NHS England to all acute NHS trusts set out that a high vigilance
restriction period would apply to these procedures. For some patients, mesh
procedures would be the only viable treatment but this would only be used for
a “group of carefully selected patients who understand the risks.” 22
The letter sets out that the restrictions would remain in place until the
following conditions are met:
• a. Surgeons should only undertake operations for SUI if they
are appropriately trained, and only if they undertake
operations regularly.
• b. Surgeons report every procedure to a national database.
• c. A register of operations is maintained to ensure every
procedure is notified and the woman identified who has
undergone the surgery.
• d. Reporting of complications via MHRA is linked to the
register.
• e. Identification and accreditation of specialist centres for SUI
mesh procedures, for removal procedures and other aspects
of care for those adversely affected by surgical mesh.
• f. NICE guidelines on the use of mesh for SUI are published. 23
In her press conference speech on the review’s report in July 2020, Baroness
Cumberlege highlighted that these conditions had not yet been met, and that
the review group envisaged that mesh implants would only be used in a tiny
number of women in the future:
20
The Independent Medicines and Medical devices Safety review, News: Independent Review calls for
immediate halt of the use of surgical mesh for stress urinary incontinence, 10 July 2018
21
Department of Health and Social Care, Government announces strict rules for the use of vaginal
mesh, 11 July 2018
22
NHS England, Letter to Acute trusts: Vaginal mesh: High vigilance restriction period, 9 July 2018
23
ibid.
18 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
Twenty years after mesh started to be used in the pelvis we still don’t
know its long-term risks or complication rate. The same is true for
mesh removals. There is still no consensus on how to treat these
complications and what type of procedures are best.
We have said that if the conditions for lifting the pause are ever met
and the pause is lifted, then mesh should only be considered after all
the other surgical and non-surgical options have been considered.
And women must be able to make a fully informed decision about a
mesh implant in the full knowledge of all the risks.
On this basis, we expect that the number of pelvic mesh procedures
in the future will be tiny. Gone are the days when women in their tens
of thousands had mesh implanted and were told it was the gold
standard. 24
The report made the following specific conclusions and recommendations in
relation to the use of pelvic mesh:
• The current position:
– Mesh for the treatment of Stress Urinary Incontinence
is paused until the conditions recommended for the
lifting of the pause are met;
– Mesh cannot be used transvaginally for Pelvic Organ
Prolapse unless the operation is part of a research
trial (NICE Interventional procedures guidance
IPG599);
– Other abdominal pelvic organ prolapse mesh
procedures, including rectopexies for rectal prolapse,
can only be carried out under ‘high-vigilance’
regimes.
• In our opinion the current data does not reflect true
complication rates. Twenty years after mesh started to be
used in the pelvis we still do not know its long-term risk
profile. The same is true for mesh removals. Women were not
warned about the risks they faced (known and unknown)
leading to avoidable harm for a significant number.
• An apology is due, and support is required for those who have
suffered avoidable harm.
• We have not recommended a complete ban on the use of
mesh in the treatment of urinary incontinence or repair of
pelvic organ prolapse. Regulators should review this in the
24
The Independent Medicines and Medical devices review, Press Conference Speech 8 July 2020.
19 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
light of new and more accurate long-term, patient-focussed
outcome data.
• We have discussed with NHS Digital an audit and follow-up of
all pelvic mesh surgery carried out in 2010. If feasible, this
should provide more accurate complication data.
• One of the conditions for lifting the pause is the identification
and accreditation of specialist mesh complication centres.
The process of commissioning these has started. However,
there is still no consensus on how to treat those
complications and what type of removals/procedures are
best.
• If the conditions for lifting the pause are met and the pause is
lifted, then mesh implants should only be considered after all
the options for conservative and nonmesh surgery have been
explored. 25
25
First Do No Harm, The report of the Independent Medicines and Medical Devices Safety Review, July
2020
20 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
5 Government response
The Government published a Written Statement in response to the report of
the Independent Medicines and Medical Devices Safety Review on 8 July 2020.
The statement thanked Baroness Cumberlege, together with the “patients
and their families who have contributed their time and energy to the Review”.
It added that it was “imperative for the sake of patients” that the Government
gives “the recommendations from this independent review the full
consideration they deserve”. 26
An oral statement, made by the Minister for Patient Safety, Mental Health and
Suicide Prevention (Nadine Dorries), followed the next day in the House of
Commons. The Minister said that the report made for “harrowing reading”
and, on behalf of the health and care sector, the Minister stated that she
would “like to make an apology to those women, their children and their
families for the time the system took to listen and respond”. 27
Government response January 2021
The Government published an update to the government’s response to the
Independent Medicines and Medical Devices Safety Review in January 2021. 28
This set out that the Government had tabled amendments to the Medicines
and Medical Devices Bill to introduce a new independent Patient Safety
commissioner, and that good progress was being made on establishing
specialist centres for the treatment and support of people affected by
surgical mesh.
The statement went on to state that the MHRA had begun work to improve
how it involves patients in its work. It also noted the importance of MHRA
work to ensure the safety of medicines in pregnancy and highlighted two
developments in this area:
Firstly, the MHRA Expert Working Group on Optimising Data on
Medicines used During Pregnancy is today publishing its report which
recommends ways in which healthcare data can be better collected
and made available for analysis. This will enable the generation of
26
Written statement - HCWS347 [on Publication of the Independent Medicines and Medical Devices
Safety Review (Cumberlege Review)], 8 July 2020
27
HC Deb 9 July 2020, c1147
28
DHSC, Update on the government’s response to the Independent Medicines and Medical Devices
Safety Review, 11 January 2021
21 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
better evidence on medicines used in pregnancy and will be vitally
important when developing clear and consistent advice for women.
Secondly, the MHRA has established a Safer Medicines in Pregnancy
and Breastfeeding Consortium. This brings together 16 leading
organisations from across the NHS, regulators, and key third sector
and charitable organisations. Today, they are launching a strategy
setting out how they will work to improve information on medicines
for women who are thinking about becoming pregnant, are
pregnant, or are breastfeeding. 29
The MHRA published its new delivery plan in July 2021, Putting patients first: A
new era for our agency. Dr June Raines, Chief Executive of the MHRA said
that this new delivery plan highlighted the plan’s role in responding to the
Medicines and Medical Devices review:
Our response to the COVID-19 pandemic is proof positive that we can
rise to challenges with fresh thinking and innovative approaches –
fulfilling our responsibilities to patients first and foremost, as
outlined in the Independent Medicines and Medical Devices Safety
Review, and opening up the many opportunities now that the UK has
left the EU, with real benefit to the brilliant UK Life Sciences industry
and to healthcare.
This plan is our response to these challenges and more. We have
shown that we can not only excel under pressure and in exceptional
circumstances, but also where we can take direct action to support
and protect patients and improve health outcomes.
It marks a step-change in our efforts to build a world-leading
organisation, bringing together excellence in science and regulation
to serve patients and public health to the best of our ability. 30
In its response to the Medicines and Medical Devices Safety review, the
Government said it was still considering recommendations relating to redress
scheme to provide assistance with meeting the costs of additional care and
support to those who have experienced avoidable harm, and relating to the
transparency of financial and non-pecuniary interests of clinicians.
It also said that the Government had no plan to establish an independent
Redress Agency for those harmed by medicines and medical devices as
recommended in the review’s report. It said that these have been established
in the past without the need for an additional agency. It also set out that
there were no plans to establish a task force to implement the reviews
recommendations. Instead, it explained that the Government had set up a
cross-system working group to develop the Government’s detailed response
29
Update on the government’s response to the Independent Medicines and Medical Devices Safety
Review, 11 January 2021
30
MHRA, MHRA puts delivering for patients at the heart of its Delivery Plan 2021-2023, 4 July 2021
22 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
to the report, and it would establish a Patient Reference Group to “ensure
that patient voices are heard as we move forward towards a full response to
the report.”
5.1 Patient Safety Commissioner
One recommendation of the Review was the appointment of an independent
patient safety Commissioner who would “champion the patient voice and
from this unique perspective would support and encourage the efforts of the
healthcare system to improve patient safety around the use of medicines and
medical devices.” 31
The Government tabled amendments 1 and 54 to introduce a Patient Safety
Commissioner at Report Stage of the Medicines and Medical Devices Bill (now
Act). The Health Minister, Lord Bethell, said that patient safety was “the
golden thread that runs through this entire Bill” and that the Government had
heard the calls to establish a patient safety commissioner for the health
service in England:
Of course, this was the centrepiece recommendation of the Independent
Medicines and Medical Devices Safety Review helmed by my noble
friend Lady Cumberlege, to whom I pay profound tribute for her tireless
championing on behalf of patients. I am delighted that Amendment 1 in
my name—with which it is convenient to debate Amendments 54, 65, 70
to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation.
These amendments provide for an independent advocate to champion
the safety of patients. The patient safety commissioner will promote
their interests and those of other members of the public in relation to
the safety of medicines and medical devices. 32
Baroness Cumberlege had also tabled amendment 65 to introduce a Patient
Safety Commissioner at Report Stage of the Bill. She welcomed the
Government amendment and withdrew hers but asked for further reassurance
on three matters in relation to the Patient Safety Commissioner, that the role
be established quickly, that the Commissioner should be able to seek
information from any public body necessary, and that manufacturers of
medicines and medical devices should be required to cooperate and share
information with the Commissioner. 33
A Department of Health and Social Care factsheet provides further
information about the proposed Patient Safety Commissioner. 34
31
The report of the Independent Medicines and Medical Devices Safety Review, First Do No
Harm, July 2020,
32
HL Deb, 12 January 2021, c615
33
HL Deb, 12 January 2021, c620
34
Department of Health and Social Care, Factsheet: Patient Safety Commissioner, 25 January 2021
23 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
In the January 2021 Written Statement, an update was provided on the role of
the Commissioner:
The commissioner will act as an independent advocate for patients,
and strengthen the ability of our health services to listen to the voice
of patients. The commissioner will be established as a statutory
office holder, appointed by the Secretary of State for Health and
Social Care, and will act independently on behalf of patients.
The commissioner’s core duties will be to promote the safety of
patients and the importance of the views of patients in relation to
medicines and medical devices. To help in carrying out these duties,
the commissioner will have a number of powers and functions,
including the ability to make reports and recommendations to the
NHS and independent sector, and to request and share information
with these bodies.
The government looks forward to working with members of both
Houses to ensure this new post acts as a beacon for listening and
reflecting the safety concerns of patients, so that we can drive
positive culture change in our healthcare system. 35
On 10 June, the Minister for Patient Safety, Suicide Prevention and Mental
Health, Nadine Dorries, announced the launch of a public consultation on the
proposed legislative provisions setting out the appointment and operation of
the Patient Safety Commissioner. 36 She said that the “consultation will help to
ensure that the provisions governing the appointment and operation of the
Patient Safety Commissioner are as comprehensive as needed, so that the
Commissioner will be able to work for, with and in the best interests of
patients.” More detail about the consultation is available on the Department
of Health and Social Care website, it closes on 7 August 2021.
5.2 Medical device registry
Recommendation seven of the Cumberlege Review was the creation of a
central database for the details of implantation of all devices at the time of
the operation. The Government highlighted in its response in January 2021
that it had introduced powers for the Secretary of State to create one or more
“medical device information systems through regulations” in the Medicines
and Medical Devices Act 2021.
During the debate on this measure, the Minister, Jo Churchill stated that
medical devices were “not subject to the same comprehensive regulatory
system of pre-market assessment that medicines are” and that the
35
Update on the government’s response to the Independent Medicines and Medical Devices Safety
Review, 11 January 2021
36
HCWS80 [Announcement of the public consultation on the appointment and operation of the Patient
Safety Commissioner for England] 10 June 2021.
24 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
Government recognised “that the system could be made stronger in respect
of how devices are purchased, used and reviewed”. 37 The Minister went on to
describe the benefits of the new system as “broad”:
Such a system would monitor the performance of devices and ensure
that patient outcomes can be tracked. The longer-term aim is to
intervene earlier, through clinical analysis of the data in the
information system, to prevent patient harm before it happens by
enabling the healthcare system to flag concerns, drive clinical
system and regulatory action where appropriate, and use alternative
and better devices and procedures to mitigate risk to UK patients. It
would support the registries, both present and future, to take action
underpinned by the national data from all four corners of the United
Kingdom. 38
5.3 Specialist centres
The report of the Medicines and Medical Devices review recommended the
setting up of “networks of specialist centres […] to provide comprehensive
treatment, care and advice for those affected by implanted mesh; and
separately for those adversely affected by medications taken during
pregnancy.”
The British Society of Urogynaecology announced in February 2021, that
specialist centres for the treatment of women with mesh complications had
been announced in seven NHS Trusts. 39
A July Parliamentary Question response from Nadine Dorries confirms that
there are now eight specialist mesh centres in operation in England and a
provider in the South West will be announced shortly. However, she stated
that the recommendations for the establishment of specialist centres for
those impacted by medicines used in pregnancy remained under
consideration. 40
5.4 Sodium Valproate
The Government response to the Medicines and Medical devices Safety Review
highlighted the establishment of a Valproate Safety Implementation Group. It
said that this would drive forward work to reduce harm from valproate:
37
HC Deb 23 June 2020 c 1222
38
ibid
39
BAUS, England Mesh Complication Centres Announced, February 2021
40
Written Question 25044, 6 July 2021
25 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
This Valproate Safety Implementation Group will drive forward work
to reduce harm from valproate through taking action to reduce the
number of women prescribed valproate, and improving patient
safety for women for whom there is no alternative medication, for
example by increasing adherence to the Valproate Pregnancy
Prevention Programme. The Programme will ensure that every girl or
woman knows about the risks of valproate in pregnancy, that where
appropriate she is on effective contraception, and that she has a
review by her specialist prescriber at a minimum once a year, when a
risk acknowledgement form will be discussed and signed by both
prescriber and woman herself. Importantly, the Valproate Safety
Implementation group will work with patients to understand how
women can be supported to make informed decisions about their
health care.
NHS England provides more information about the group and sets out the
areas it will explore:
• stopping initiation and deprescribing valproate where safer
alternatives are available and making dispensing safer
• ensuring patients in this group who do take valproate have
access to highly effective contraception, sexual and
reproductive health advice
• ensuring shared decision making is in place wherever
valproate is prescribed to people who can get pregnant.
The groups actions have included sending a letter to all girls aged twelve and
over to provide information about the risk of valproate in pregnancy and
advice, developing guidance on prescribing and the monitoring of the use of
valproate medicines, and providing accessible information for patients on this
issue. 41
41
NHS England, Valproate Safety Implementation Group
26 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review
6 Parliamentary material
Written statements
Written statement 10 June 2021 | HCWS80
Announcement of the public consultation on the appointment and
operation of the Patient Safety Commissioner for England
I would like to inform the House of the launch of a public consultation on
proposed legislative provisions governing the appointment and operation of
the Patient Safety Commissioner for England.
As my colleagues will be aware, on 14 December 2020, the Government
tabled an amendment to the Medicine and Medical Devices Bill to establish
an independent Patient Safety Commissioner for England. The Medicines and
Medical Devices Act 2021 (MMD Act) achieved Royal Assent on 11 February
2021 and on 11 April established the Commissioner position and its main duties
and powers.
The introduction of a Patient Safety Commissioner also acts on the second
recommendation of the Independent Medicines and Medical Devices Safety
Review, First Do No Harm, published in July 2020 by Baroness Cumberlege.
The Patient Safety Commissioner will add to and enhance the existing work
that has been done to improve patient safety by acting as a champion for
patients. Listening to our patients is integral to our healthcare system and
the Commissioner will help to make sure patient voices are heard.
The core duties of the Commissioner are to promote the safety of patients in
the context of the use of medicines and medical devices and to promote the
importance of the views of patients and other members of the public in
relation to the safety of medicines and medical devices.
Under the MMD Act 2021, (paragraph 6 of Schedule 1) the Secretary of State is
able to make legislative provisions about the appointment and operation of
the Commissioner, for example the terms of office, finances and other support
for the Commissioner. As is required by the MMD Act 2021, the department
has launched a public consultation to gather views from interested persons
on the detail on the appointment and operation of the Commissioner.
Consultation responses will be carefully considered and will feed into the
required secondary legislation.
This consultation will help to ensure that the provisions governing the
appointment and operation of the Patient Safety Commissioner are as
27 Commons Library Research Briefing, 7 July 2021The Medicines and Medical Devices Safety Review comprehensive as needed, so that the Commissioner will be able to work for, with and in the best interests of patients. I would like to take this opportunity to reassure the House that the Government continues to prioritise work on this initiative. The launch of this consultation represents good progress in setting up of the Commissioner. The consultation can be accessed using the following link: https://www.gov.uk/government/consultations/the-appointment-and- operation-of-the-patient-safety-commissioner Written statement 11 January 2021 | HCWS692 Update on the Government’s response to the Independent Medicines and Medical Devices Safety Review The Report of the Independent Medicines and Medical Devices Safety Review (IMMDS Review) was published on 8 July last year. I would like first to sincerely thank Baroness Cumberlege and her team for their work on the Review. I also pay tribute to the women and their families who bravely shared their experiences and brought these issues to light. Without their tireless efforts to have their voices heard, this Review would not have been possible. The overriding question investigated by the Review is how the health and care system listens and responds to patient concerns raised by patients, and women in particular. We must not forget that the Cumberlege Review, alongside other independent inquiries including the Paterson Inquiry, was commissioned because women did not feel listened to or their concerns acknowledged – today is another step towards righting this. On the Paterson inquiry, I would also like to provide a very brief update. Work on the Government response was temporarily paused last Spring due to the first wave of the COVID-19 pandemic. Efforts have since resumed at pace, and I can confirm today that I will announce and publish the Government’s initial response in Parliament shortly. Returning to the IMMDS Review, many of the Report’s recommendations have already been discussed in detail during the Committee stage of the Medicines and Medical Devices Bill, and this has helped us to determine our future direction. We are very grateful to Members from both Houses who have worked with us on this. I am today updating the House on the Government’s response to the Report of the IMMDS Review, taking each recommendation in turn. Recommendation 1: The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh. In July, when I introduced this Report to the House, I made an unreserved apology on behalf of the health and care system to those women, their 28 Commons Library Research Briefing, 7 July 2021
The Medicines and Medical Devices Safety Review children and their families for the time the system took to listen and respond. I assure those affected that the Government has listened, and will continue to listen. Recommendation 2: The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices. The central recommendation in the Report is for the establishment of an independent Patient Safety Commissioner. This recommendation has rightly ignited much interest and debate in both Houses, and the Government has listened carefully to the arguments made for a Commissioner, and how this might sit within the wider patient safety landscape. Patient safety is a key priority for the healthcare system. In my role as Minister of State for patient safety, I often hear from and meet with people who have been affected by issues of patient safety. Their stories have common themes – of suffering avoidable harm, of not being listened to and of a system that is then difficult to navigate when things go wrong. We want to make the NHS as safe as anywhere in the world, and we must retain an absolute focus on achieving this goal. I can therefore confirm that the Government tabled an amendment to the Medicines and Medical Devices Bill before the Christmas Recess to establish the role of an independent Patient Safety Commissioner, in line with Baroness Cumberlege’s second recommendation. The Commissioner will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients. The Commissioner will be established as a statutory office holder, appointed by the Secretary of State for Health and Social Care, and will act independently on behalf of patients. The Commissioner’s core duties will be to promote the safety of patients and the importance of the views of patients in relation to medicines and medical devices. To help in carrying out these duties, the Commissioner will have a number of powers and functions, including the ability to make reports and recommendations to the NHS and independent sector, and to request and share information with these bodies. The Government looks forward to working with Members of both Houses to ensure this new post acts as a beacon for listening and reflecting the safety concerns of patients, so that we can drive positive culture change in our healthcare system. Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions 29 Commons Library Research Briefing, 7 July 2021
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