Parliamentary activity

Answering body: Department of Health and Social Care

My Hon. Friend the Minister of State (Minister for Patient Safety, Suicide Prevention and Mental Health) (Nadine Dorries) has made the following written statement:

It is now 12 months since the Independent Inquiry into the issues raised by the convicted breast surgeon, Ian Paterson, published its report. The report made for difficult reading and describes the terrible harms that can occur when the malpractice of an individual, rogue surgeon goes unchecked.

In my statement to Parliament on 28 April 2020 I reluctantly announced a delay in our work to respond to the report. The Covid-19 pandemic has continued to exert unprecedented pressures on the health system, and this has necessitated a pragmatic response to the recommendations of the Paterson Inquiry.

The independent sector has stepped up and supplied much needed additional capacity for the NHS in its treatment of NHS patients during the response to the pandemic.

We have taken stock of all the recommendations and engaged with stakeholders across the system to gather views on the best way forwards. As part of this we have listened carefully to former patients of Ian Paterson through regular conversations with representatives of the three main patient groups and a bespoke event to ensure their voices are heard.

The immediate safety of patients has been our top priority and we have sought and received reassurance that the recalls of patients by University Hospitals Birmingham NHS Foundation Trust and Spire Healthcare have proceeded as quickly as possible.

When the recommendations have provided a clear way forward, we have worked with our system partners to put in place, or require, effective action. We will continue to consider all the recommendations and produce a full response to the inquiry’s 15 recommendations during 2021.

Today I am able to update the House on the Government’s initial response to the following five recommendations of the Independent Inquiry into the Issues raised by Paterson, and update on three other developments.

Recommendation 2 - Information to Patients: We recommend that it should be standard practice that consultants in both the NHS and the independent sector should write to patients, outlining their condition and treatment, in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient.

NHS England and NHS Improvement will examine how current guidance published by the Academy of Medical Royal Colleges (AoMRC) in 2018 on writing outpatient clinical letters addressed to patients (and copied to their GP) using simple, appropriate language can be incorporated into the requirements of the NHS standard contract.

Recommendation 4 – Consent: We recommend that there should be a short period introduced into the process of patients giving consent for surgical procedures, to allow them time to reflect on their diagnosis and treatment options. We recommend that the GMC monitors this as part of ‘Good Medical Practice’.

The General Medical Council (GMC) published its revised good practice guidance on consent on 30 September 2020. This came into effect on 9 November 2020 and sets out seven principles of decision making and consent, including giving patients the information they need to make a decision and the time and support they need to understand it. The GMC will work with organisations across the UK’s health services to support doctors to embed this into their everyday practice.

Recommendation 5 - Multidisciplinary Team (MDT): We recommend that CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area.

Specific questions relating to MDT are already included in appropriate CQC service frameworks. As part of a longer-term strategy (based upon a short- and medium-term action plan that includes this recommendation) the CQC will work to ensure these become mandatory elements of its assessment and inspection approaches and communicate its expectations to service providers.

Recommendation 7 – Patient Recall and Ongoing Care: We recommend that the University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen.

University Hospitals Birmingham NHS Foundation Trust (UHB) contacted 4,394 patients between May and August 2020. This has given rise to 355 enquiries. Following receipt of each enquiry, the patient /relative was contacted directly by a member of a dedicated team to ensure that the Trust was responding in a way that was respectful and responsive to individual patient preferences. For patients who underwent a breast procedure, care was reviewed by a Consultant Breast Surgeon who was independent from the Trust. For patients who had a general procedure e.g. hernia repair or a varicose veins/other vascular procedure, care was reviewed by a consultant from UHB.

Recommendation 8 – Patient Recall and Ongoing Care: We recommend that Spire should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS.

By December 2020 Spire Healthcare had contacted all known living patients of Ian Paterson for whom they had addresses (approximately 5,500). Spire Healthcare is currently ensuring that those patients’ care has been fully reviewed, that the outcome of the reviews has been fully communicated to them and that, if required, they are getting the support and care that they needed. Additionally, several hundred people have contacted Spire as a result of the letters sent out last year. A proportion of these are having their care reviewed by an independent consultant surgeon and some have been referred for counselling, follow up support or, where clinically appropriate, treatment. Spire Healthcare will continue their review of patients’ care during 2021.

In addition, we are taking three legislative actions to drive up patient safety and ensure care provided by the independent sector is closely scrutinised.

First, prior to the publication of the recommendations of the Independent Medicines and Medical Devices Safety Review the Government acted in June last year to amend the then Medicines and Medical Devices Bill to create the power to establish a UK-wide medical device information system. This system will mean that in future, subject to regulations, we can routinely collect medical device, procedure and outcome data from both NHS and private provider organisations across the UK, ensuring that no patient in the UK falls through the gaps. The Government is also considering how best to supply patients with the details of any device that has been implanted, to ensure they can continue to access that information in the future.

Secondly, following the Independent Medicines and Medical Devices Safety Review the Government is establishing a Patient Safety Commissioner (PSC) for England with responsibility for medicines and medical devices. The main duties and powers of the PSC are detailed in the Medicines and Medical Devices Act which achieved Royal Assent on 11 February 2021 and establishes the Commissioner role. The PSC for England will be able to exercise their powers in both the independent sector and the NHS.

Thirdly the White Paper, published in February 2021 setting out legislative proposals for the Health and Care Bill, announced our intention to extend the remit of the Health Service Safety Investigation Branch to private providers.

The report of the Paterson Inquiry shone a light on a set of harrowing events over many years and recommended a way forward to improve safety and quality in both the NHS and the independent sector. I believe it is right that we have taken urgent action where we can, and we will respond in full to the inquiry during 2021.

Answering body: Department of Health and Social Care

My Hon. Friend, the Minister of State (Minister for Patient Safety, Suicide Prevention and Mental Health) (Nadine Dorries), has made the following statement:

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 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 using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

The Government has no current plans to establish a redress agency as set out in recommendation three. The Government and industry have previously established redress schemes without the need for an additional agency.

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 four on redress schemes for sodium valproate, mesh, and HPTs remains under consideration.

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.

Good progress is being made on establishing specialist mesh services, which are the fifth recommendation in the Report. NHS England is working with NHS hospitals to establish specialist mesh services which are currently planned to go live from the Spring this year.

These services will bring together leading experts to provide multi-disciplinary care and treatment for all women who have experienced complications due to vaginal or abdominal mesh procedures.

With a centre in every NHS region, these new services will ensure nationwide provision, and centres will work together to hone their expertise and share best practice.

We continue to consider the second part of recommendation five, which is for specialist centres for those adversely affected by medicines in 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.

Patient safety is the MHRA’s top priority. The MHRA recognises that the major changes highlighted by the Report, particularly recommendation six, are very important.

The MHRA has already begun a substantial programme of work to improve how it involves patients in all aspects of its work, to reform systems for reporting adverse incidents with medicines and medical devices, and to strengthen the evidence base for its regulatory decisions.

Within the MHRA’s work to strengthen the evidence base, the safety of medicines in pregnancy is of utmost importance.

In the UK, three quarters of a million babies are born each year, and more than half of expectant mothers will need to take medicines when pregnant. We must ensure that women have high-quality, accessible information to be able to make informed decisions about their healthcare.

To that end, I would like to highlight two important developments of MHRA reform.

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 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.

Sodium Valproate

On sodium valproate, in response to concerns raised during the previous debate on the IMMDS Review, I am pleased to announce that the National Director of Patient Safety has recently established a Valproate Safety Implementation Group.

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.

In addition, last week the MHRA published the conclusions of a safety review into antiepileptic drugs conducted by the Commission on Human Medicines. This will help clinicians identify safer alternatives to valproate for the treatment of epilepsy in women who may become pregnant.

I am also pleased to announce that the first data from the new Valproate Registry will become available later this month. The registry is being developed by the MHRA and NHS Digital, and will support work to monitor adherence to the Valproate Pregnancy Prevention Programme, and allow for long-term individual patient follow up.

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 seventh recommendation in Baroness Cumberlege’s Report rightly reflects on the importance of collecting the right data for monitoring the safety of medical devices. We recognise the need for improved data collection and analysis for medical devices.

That is why the Government acted in June last year to amend the Medicines and Medical Devices Bill to create the power to establish a UK-wide medical device information system prior to the review report being published, as we recognised the need to deliver such an information system. This system will mean that in future, subject to regulations, we can routinely collect medical device, procedure and outcome data from all NHS and private provider organisations across the UK, ensuring that no patient in the UK falls through the gaps.

The Government is grateful to Members in both Houses, including Baroness Cumberlege, for their support for establishing a medical device information system.

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 is considering recommendation eight, which is that doctors’ financial and non-pecuniary interests should be declared and publicly available.

Any publication of declarations of interest should cover all clinical decision-making staff, not just doctors: it would also need to be held where patients could most easily access and interpret the information, with appropriate governance arrangements. We will consider these issues in discussion with the GMC, other stakeholders and the patient reference group to ensure the views of patients are listened to and incorporated.

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.

The Government has no plans to establish an independent taskforce to implement the Report’s recommendations. A cross-system working group has already been set up, meeting regularly, to develop the Government’s detailed response to the Report.

However, the Government recognises the need for effective patient engagement both to build trust, and ensure effective implementation. I am pleased to announce today that we are establishing a Patient Reference Group, which is part of Baroness Cumberlege’s ninth recommendation. The Patient Reference Group will ensure that patient voices are heard as we move forward towards a full response to the Report.

Conclusion

The Report of the IMMDS Review powerfully demonstrates the importance of hearing the patient voice in patient safety matters. The actions outlined here demonstrate the Government’s commitment to learning from this report, and will support vital work already underway to hear the voice of the patient as part of the NHS Patient Safety Strategy. We currently plan to respond further to the Report of the IMMDS Review during 2021.

Answering body: Department of Health and Social Care

My Hon Friend the Parliamentary Under Secretary of State (Minister for Patient Safety, Suicide Prevention and Mental Health) (Nadine Dorries) has made the following written statement:

The report of the Independent Inquiry into the issues raised by the former breast surgeon Ian Paterson was published on 4 February 2020. It describes significant failures in the ability of the healthcare system to detect and protect patients from the consequences of Paterson’s malpractice.

The report contains fifteen recommendations, some of which go to the heart of our regulatory system and the performance management of healthcare professionals. Government Ministers undertook to study these recommendations in detail and provide Parliament with a full response within a few months of the report’s publication or indeed within three months if that was appropriate.

Our action to tackle the COVID-19 crisis has unfortunately diverted resources from this work which has had to be put on hold for the present time. This will inevitably lead to a delay in the Government’s formal, written response.

I would like to assure Parliament and the public that we will resume our focus on the Government’s response as soon as these unprecedented circumstances are behind us. Also, that we remain committed to implementing considered and effective improvements in the areas set out in the Inquiry’s recommendations.

In the meantime, we will continue to talk to NHS England and NHS Improvement and Spire Healthcare about the current and ongoing care of patients treated by Paterson.