Independent Medicines and Medical Devices Safety Review Report: Government Response

Wednesday 21st July 2021 Written Statements

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

The report of the Independent Medicines and Medical Devices Safety Review (IMMDS review) was published on 8 July 2020.

On 11 January, I updated the House on the Government’s progress in responding to the recommendations of the IMMDS review.

I am pleased to today announce to the House the publication of the Government’s full response to the IMMDS review. We have accepted four of the nine strategic recommendations in full, one in principle and two in part. We have also accepted 46 of the 50 actions for improvement in full or in principle, one in part and one remains under consideration. We do not accept two of the actions for improvement.

This response sets out an ambitious programme of change, which at its core is about improving patient safety by:

improving how the system listens to and responds to concerns raised by patients by putting patient voice at the centre of patient safety:

strengthening the evidence base on which decisions are made, including through making sure the right data is collected and used; and

improving the safety of medicines and devices, and embracing the new opportunities following the UK’s departure from the European Union to reform regulatory frameworks.

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.

The Government accept recommendation 1.

In July 2020, the Government apologised in full on behalf of the healthcare system to all the families affected by the report for the time it has taken to listen and respond to their concerns. I salute their courage and persistence in coming forward to make these concerns heard; without their bravery, the review would not have been possible.

Listening to patients

The review was commissioned because the Government recognised and accepted that the system had taken too long to listen to patients. One of the key conclusions from the report was that “the system has not been listening as it should”. The Government recognised the need for effective patient engagement to rebuild trust and ensure that patient voice was embedded in work to develop the full Government response to the report. We were pleased to announce in January that we had accepted the second part of the report’s ninth recommendation, for the establishment of a patient reference group (“the group”).

The purpose of the group was to provide challenge, advice and scrutiny to the work to develop the Government’s response to the report’s recommendations. The group represented a diverse range of experiences, and members include individuals who have been affected by or have an interest in pelvic mesh, sodium valproate, and hormone pregnancy tests (HPTs), those who have been affected by or have an interest in other medicines or medical devices, and also those with a wider interest in patient safety. The group met regularly and worked closely with officials to discuss the report’s recommendations in great detail. I met with the group in June to listen to their feedback directly.

We are extremely grateful to the group for their insight and honesty. The Government response has undoubtedly been strengthened through listening to and learning from group members’ experiences, knowledge and expertise. I am very pleased that the final report of the patient reference group has been published alongside the Government response today.

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 Government accept recommendation 2.

Patient safety is a top priority for the healthcare system; we want to make the NHS the safest healthcare system in the world, and we must retain an absolute focus on achieving this goal.

As Members will know, the central recommendation in the report is for the establishment of an independent patient safety commissioner.

The Government have accepted this recommendation, and we have already legislated for a patient safety commissioner through the Medicines and Medical Devices Act 2021 (MMD Act).

It is integral that patients are listened to in our healthcare system and the commissioner will help to make sure patient voices are heard, as envisaged in the report of the IMMDS review.

The core role of the commissioner will be 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.

A public consultation is currently open seeking views on the proposed legislative details on the appointment and operation of the commissioner. The consultation closes on 5 August 2021. After the consultation has closed, responses will be carefully considered and reviewed, and will feed into the drafting of the regulations on the appointment and operation of the commissioner.

We plan to have the first patient safety commissioner in post in the first half of 2022.

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.

The Government do not accept recommendation 3.

As set out in the January statement, we have no current plans for a redress agency, as set out in recommendation 3.

We do not believe it is necessary to create a new agency for redress as it is already possible for the Government and others to provide redress for specific issues where that is considered necessary. Neither do we believe that creating an agency would succeed in making products safer as the report suggests, or that grouping existing redress schemes through a single front door would add value for harmed patients.

Recommendation 4: separate schemes should be set up for each intervention—hormone pregnancy tests (HPTs), valproate and pelvic mesh—to meet the cost of providing additional care support to those who have experienced avoidable harm and are eligible to claim.

The Government do not accept recommendation 4.

While the Government are sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices. This includes not just the products themselves but also ensuring they are used in line with the latest evidence of best practice—in ways that are both effective and safe for patients. This means we will continue to focus our work on direct support for future safety, improve how the system listens to patients, and support and monitor the safety of clinical practice where medicines and devices are concerned. The MMD Act delivers further on our commitments to patient safety, embedding reform through legislation and delivering an ambitious programme of improvements medicines and medical devices.

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.

The Government accept recommendation 5 in part.

The Government accept the first part of recommendation 5; specialist centres for those adversely affected by implanted mesh.

Much progress has been made to establish the specialist mesh services, led by NHS England and Improvement. These services became operational on 1 April 2021, and there are now eight specialist centres in operation across England. Good progress is being made towards the establishment of a ninth regional service with a south-west provider, to ensure patients across the country can access these vital services. It is important that women have choice over their surgeon where possible and I am happy to confirm that when patients request treatment for mesh complications, they can exercise patient choice and be referred to another centre if they wish.

The report of the IMMDS review highlights the importance of the specialist services working together and re-enforces the need for the commissioned mesh services to network across providers to ensure each service provides comprehensive treatment, care and advice services. I am pleased to confirm that the providers of specialised services for women with complications of mesh will meet annually from 2021 at a clinical summit to discuss data and outcomes.

Recognising the need for enhanced data collection on pelvic mesh, the Government in 2018 announced the provision of £1.1 million for the development of a comprehensive database of urogynaecological procedures, including vaginal mesh, to treat pelvic organ prolapse and stress urinary incontinence. I can update the House that the pelvic floor information system has started to receive live data, including historical data from July 2017 onwards, with an initial focus on supporting specialist services to report every pelvic floor and comparative procedure to this national database.

The report of the IMMDS review also recommends that the information system is accompanied by a retro-spective audit of mesh procedures, and by the development of a patient reported outcome measure (PROM) or patient reported experience measure (PREM). I am pleased to announce to the House today that the Government accept both these recommendations. NHS Digital has been commissioned to scope and deliver the retrospective audit. Subject to receiving high quality research bids, a new validated PROM for pelvic mesh procedures will be commissioned through the National Institute of Health Research in 2022. Additionally, earlier this year a £440,000 research study into “Experiences of Urogynaecological Services” was commissioned by the NIHR to feed into this vital work to develop a new PROM.

The Government do not accept the second part of recommendation 5, specialist centres for those adversely affected by medications taken during pregnancy.

We recognise the underlying issue that there is a need to improve the care and support for the individuals and families affected by a range of medicines used in pregnancy, including valproate exposure. However, our view is that a network of new specialist centres is not the most effective way forward. We will instead take forward work to improve the care pathways for children and families affected by medicines in pregnancy, within existing services. This will include strengthening care pathways and tackling the variation in access to services across NHS regions.

Currently, services for all children with neuro-developmental disorders are primarily managed by multidisciplinary teams within child development centres, which are commissioned locally. These are then supported by regional clinical networks, and specialised neuroscience centres. A limited number of specialist centres focused only on those affected by medications in pregnancy would not be able to provide the whole range of services that patients need, for example coordinating provision across local health, education and social care systems. It is important that patients who need ongoing care can access services as conveniently as possible, and many of these services are better delivered at a local level. Additionally, a new network of specialist centres could divert clinical expertise and potentially result in a reduced service for all the patient groups involved.

We will also continue work to improve the safety of medicines in pregnancy more widely, and to ensure that valproate is only prescribed where clinically appropriate.

Sodium Valproate

The report of the IMMDS review discusses sodium valproate (valproate) in much detail and contains a number of actions for improvement related to valproate. For this reason, we have dedicated a chapter in the Government response to valproate.

The January statement updated on the significant work underway to ensure valproate is only used where clinically appropriate, and to improve patient safety for women and girls for whom there is no alternative medicine. The Government do not however support calls to eliminate the use of valproate completely; for some women, it is the only drug which is able to control their epilepsy, and it is vital that women are able to access effective treatments.

I am pleased to update the House that much progress continues to be made. The first report from the valproate registry was published on 11 February 2021, and a second is planned for September 2021. The first report presents an important step to improving our ability to monitor implementation and compliance with the pregnancy prevention programme. There are plans to extend the registry to the whole of the UK and to expand it to include other anti-epileptic drugs later this year, as recommended by the report. As recommended by the report, NHS England and Improvement have recently sent a letter to all women of childbearing age who are prescribed valproate, including important safety reminders in relation to contraception, pregnancy and regular prescribing reviews.

I have also heard from patients that measures to reduce valproate prescribing and support women to make informed choices must be holistic and wide-ranging. I am pleased to announce that the MHRA is planning to consult on an amendment to the human medicines regulations which would require pharmacists to supply sodium valproate in the manufacturers original pack with a patient informational leaflet. This will ensure that prescriptions for valproate are dispensed with a patient information leaflet and information on risk minimisation measures.

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.

The Government accept recommendation 6.

In the January statement the Government announced that the MHRA 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.

This is set out in detail in the MHRA’s corporate delivery plan for 2021 to 2023, “Putting patients first—a new era for our Agency”, which was published on 4 July. This sets out the MHRA’s future plans, which centre on: putting patients first; becoming a truly world-leading, enabling regulator; and protecting public health through excellence in regulation and science.

A key strand of this work is improving how the MHRA engages with patients, and ensures patients have an integral role in its work. In May this year, the MHRA published its draft “Patient and Public Involvement Strategy” for public consultation. This sets out how the Agency will deliver a step change in its involvement and engagement with patients. Following the consultation, the MHRA will publish the final strategy later this year.

I am pleased to confirm to the House that the MHRA’s newly appointed chief safety officer will lead the MHRA’s ongoing implementation of the recommendations from the report. This will help to ensure that the MHRA continues delivering on their commitment to keep patients safe. The postholder will oversee the development of a revitalised approach to vigilance of both medicines and medical devices.

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.

The Government accept recommendation 7.

The Government have legislated for a patient identifiable database in the MMD Act, which creates a power for the Secretary of State to regulate for the establishment of a UK-wide medical device information system (MDIS).

The report of the IMMDS review rightly identifies the need for the healthcare system to centralise and standardise the collection, retention and analysis of data for monitoring the safety and effectiveness of implantable medical devices. In order to close the gap identified in the collection and analysis of this data, it is essential that the UK has a comprehensive system to ensure that implantable devices are effectively monitored and any issues affecting patient safety are responded to appropriately. As required by the MMD Act, the Government are planning to hold public consultation on the MDIS regulations. Formal public consultation on the MDIS regulations will begin later this year with the aim of laying the regulations in 2022.

Alongside developing regulations, I can announce that over £11 million has been set aside for a package of work in 2021-22, involving partners across the healthcare system to scope, test and cost options for MDIS and other medical devices patient safety workstreams.

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.

The Government accept recommendation 8 in principle.

The Government accept in principle the first part of recommendation 8, for greater transparency of doctors’ interests.

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. It is absolutely crucial that any published list of interests is meaningful and accessible to patients. Our approach is therefore for publications of interests to be held by healthcare providers at the local level, because patients know where healthcare professionals work, and are more likely to seek information from the organisation that provides their treatment and care. Additionally, at the local level healthcare providers can ensure patients have the necessary support to understand the relevant information

We also believe that it is not just doctors who must declare their interests, but rather all registered healthcare professionals. That is why we are going further than the recommendation, and we will make it a regulatory requirement that all registered healthcare professionals must declare their relevant interests. Registered healthcare professionals will be required to declare their relevant interests to their employer, contractor, or the organisation where they are providing services. All healthcare providers will be required to collect, monitor, and publish a list of their employees’ relevant interests. At the local level, healthcare providers must ensure that all declarations of interest are publicly available for patients to access, and providers can then ensure there is meaningful oversight of publications of interests.

These changes build on current NHS guidance, which states that all staff should declare interests and organisations should publish the interests of decision making on their website. These changes will also extend publication of declarations of interest to the private sector. We will continue to work with healthcare organisations across the NHS and independent sector, as well as regulators, to ensure there is appropriate implementation, governance, and enforcement of this approach.

The Government also accept in principle the second part of recommendation 8, for mandatory reporting of payments from the pharmaceutical and medical device industry.

The Government agree that transparency of medicine and medical device industry payments to clinicians and organisations is an important part of ensuring patient confidence. As with doctors’ interests, it is important that this information is published and easily accessible for patients.

Regarding medicines, the Government have listened to stakeholder concerns that the existing industry scheme is voluntary, and that more could be done to achieve consistent transparency in reporting of payments. We have listened to concerns from patient groups and others that a mandatory scheme is needed. We are exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation.

Regarding medical devices, we recognise that the sector does not have any formal scheme for reporting payments. We have listened to stakeholder concerns that the current situation means that that patients lack crucial information on a highly important area of clinical decision-making. We will work with the devices industry and other stakeholders on the options for introducing reporting of payments for the medical device sector, including making reporting mandatory through legislation.

Recommendation 9: the Government should immediately set up a taskforce to implement this review’s recommendations. Its first task should be to set out a timeline for their implementation.

The Government accept recommendation 9 in part.

As set out in the statement of 11 January, the Government have no plans to establish an independent taskforce to implement the report’s recommendations. As is convention with independent reports and inquiries, conclusions and recommendations are passed to Government for consideration.

The Government have considered the report’s recommendations carefully, and our response sets out an ambitious programme of change. We have accepted the majority of the report’s nine strategic recommendations and 50 actions for improvement.

The actions set out in this response are a combination of well-established programmes of work and new initiatives. The Government are committed to making rapid progress on all the areas set out in this response. To ensure that Parliament and patients can continue to hold the Government to account, we will publish an update on progress to implement the Government response in 12 months’ time.

Conclusion

The report of the IMMDS review is a powerful call to action, and we are determined to deliver meaningful change through the Government response.

I would like to once again thank my right hon. Friend the Member for South West Surrey (Jeremy Hunt) and my right hon. Friend the Member for Maidenhead (Mrs May) for commissioning this landmark review, and to thank Baroness Cumberlege and the review team for their diligence and dedication in conducting this review.

Above all, I would like to once again recognise and thank the women and their families, who fought to bring these issues to light and to have their stories heard.

The report highlights a stark inequality in the healthcare system. We cannot ignore the fact that the report of the IMMDS review is one of several independent reports and inquiries to have concluded that our healthcare system disproportionately fails to listen to women and keep them safe. This Government are determined to change this, not least through our work to develop the first ever women’s health strategy for England later this year.

I am depositing a copy of the Government response and the “Independent Report of the Patient Reference Group” in the Libraries of both Houses.

[HCWS225]