This week very silently and on the day Parliament left for Summer recess, the Government finally announced the long awaited response to The Cumberlege Review recommendations. For the families affected by Sodium Valproate harm in Pregnancy, this was a cruel, shallow and bitter blow. Despite the high level of evidence of regulatory and Government failures, suppression of evidence , continued ongoing harm to babies, the response provided NO Redress or any Care to the disabled children and their families.
This response was not the response we expected and really blindsided us, following a meeting we had with Health Minister Nadine Dorries on Wednesday 7th July (week before). This meeting was very constructive, engaging, with a firm acceptence from the Minister as to why we campaign so very hard for those harmed by Valproate with her stating
“If I was in your position, I would be alongside you”
” with you guys are on the
outside, campaigning the way you are to make a difference… I’m totally with you.
To then receive the response we did, were these words just platitudes?
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
Government response – accept. On 9 July 2020, the day after publication of the Review,
the government issued an unreserved apology on behalf of the healthcare system to the
Government response to the report of the Independent Medicines and Medical Devices Safety Review women affected, as well as their children and their families, for the time the system took to listen and respond.
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.’
Government response – accept. We have legislated for a Patient Safety Commissioner
through the Medicines and Medical Devices Act 2021. The Patient Safety Commissioner
will act as a champion for patients in relation to medicines and medical devices, adding to
and enhancing the existing work described above. We are now consulting on the proposed
legislative details that will govern the Commissioner’s appointment and operation.
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
Government response – do not accept. We have no plans to establish an independent
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.’
Government response – We do not accept this recommendation. Our priority is to make
medicines and devices safer and the government is pursuing a wide range of activity to
further this aim.
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.’
Government response – accept in part. NHS England and Improvement has led work to
establish specialist mesh services. There are now 8 specialist centres in operation.
Regarding specialist centres for those adversely affected by medicines taken during
pregnancy, the government’s view is that a network of new specialist centres is not the
most effective way forward. We will in instead take forward work to improve the care
pathways for children and families adversely affected by other medicines in pregnancy. On
valproate specifically, we are taking forward significant work to ensure that valproate is
only prescribed where clinically appropriate.
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.’
Government response – accept. The MHRA, reflecting its corporate Delivery Plan for
2021-2023 “Putting patients first – A new era for our Agency”, has initiated a substantial
programme of work to improve how it listens and responds to patients and the public, to
develop a more responsive system for reporting adverse incidents, and to strengthen the
evidence to support timely and robust decisions that protect patient safety.
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 be linked to specifically created registers to research and audit the outcomes both in
terms of the device safety and patient reported outcomes measures.’
Government response – accept. We have legislated to create a power for the Secretary
of State to regulate for the establishment of a UK-wide Medical Device Information System
(MDIS) through the Medicines and Medical Devices Act 2021, which creates. Alongside
developing regulations, a package of work is underway to build, test and cost options for
how an MDIS could be embedded into the UK healthcare system, as well as complete a
business case for a 5-year programme of work.
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.’
Government response – accept in principle. We agree that lists of doctors’ interests
should be publicly available, but we do not think that the GMC register is the best place to
hold this information. Our approach is to ensure it is a regulatory requirement that all
registered healthcare professionals declare their relevant interests, and that this
information is published locally at employer. Regarding industry reporting, we agree with
the need for greater transparency and we are exploring options to expand and reinforce
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
Government response to the report of the Independent Medicines and Medical Devices Safety Review
Government response – accept in part. We have no current plans to establish an
independent task force to implement the government response. We established a Patient
Reference Group to work with the government to develop this response.
For us here at INFACT, although it is a disappointing response , the Campaign continues. The response given by Government particularly on Redress is not credible nor acceptable. For the Valproate intervention of the Review we have proved
Suppression of Evidence by Successive Governments
Continued Regulatory Failures
Data of children harmed
Answered the Remit (2018 Pre cumberlege) as to why children harmed by Sodium Valproate should be awarded Compensation
Acceptance by the Regulators and Government of the harm Valproate poses
Baroness Julia Cumberlege We are deeply disappointed the government has rejected calls for an independent redress agency or any redress for families whose lives have been devastated by medicines or medical devices. For those families justice has not been done today
Summer may have rested for Parliament however it is business as usual and we will continue to work through doing our normal work. We have already had meetings with MPs, Legal Team, Campaigners, Organisation and we want to reassure all our members and families that as always we have great support.
This campaign is not over until our children receive the Redress and support that is rightly deserved
Managing Director Emma Murphy – “The Government response to the Cumberlege Review is a cruel bitter blow to the thousands of children and families harmed by Sodium Valproate in Pregnancy. Despite Government accepting the Science and the damage it causes in Utero to a baby, and the lifelong damaging effects to the children. The INFACT campaign has proved Government had knowledge of the risks at licensing (1973) yet suppressed this information to the patient, and continued to allow Valproate to be prescribed without adequate warnings despite among other things the proven 40% risk of Autism to the unborn child. The very systems that were set up to protect and safeguard our children, ultimately disabled them.”