Parliamentary activity

Answering body: Department of Health and Social Care

My noble friend the Parliamentary Under-Secretary of State for Patient Safety, Women's Health and Mental Health (Baroness Merron) has made the following Written Statement

I am pleased to report that through the National Institute for Health and Care Research, my Department has commissioned an independent evaluation of the sector-led Voluntary Code of Practice (the Code) launched by medical defence organisations (MDOs) on 6th January this year.

The intention to develop a sector-led Code to address concerns highlighted by the Paterson Inquiry report was previously announced in March 2024. The Code has now been launched as planned by the Medical Defence Union, Medical Protection Society and Medical and Dental Defence Union of Scotland.

Clinical negligence cover is the system that enables patients to receive compensation if they are harmed during treatment through the cover held by regulated healthcare professionals such as doctors, nurses and dentists. The Code aims to improve the transparency and clarity of MDOs’ operations and the discretionary indemnity they provide healthcare professionals whose activities (e.g. private practice) are not covered by state schemes. With these improvements and healthcare professionals’ better understanding of the appropriate cover required for their scope of practice, there will be greater protection for patients’ access to compensation if harmed during treatment.

The full Code, which can be accessed on the MDOs’ websites, sets out seven core principles described under the following headings:

Corporate governance

Fair member treatment

Scope of benefit available to members

Decision making

Independent Complaints Review Service (ICRS)

Financial attestation

Statement of adherence

This short-term evaluation focuses on the implementation of the Code. We will be exploring a further commission to assess impact and whether further interventions are required.

We continue to consider further policy options to reform the clinical negligence cover system such as addressing cover for criminal acts to improve patients’ access to compensation, and I will provide an update in due course.

Answering body: Department of Health and Social Care

In December 2022, I reported on the steps we are taking to respond to the findings of the inquiry into the issues raised by disgraced surgeon, Ian Paterson. Today, I am reporting further progress on Recommendation 10 of the Inquiry Report which identified shortcomings in the clinical negligence cover system.

Clinical negligence cover is the system that enables patients to receive compensation if they are harmed during treatment through the cover held by regulated healthcare professionals such as doctors, nurses and dentists. The Inquiry highlighted that Paterson’s private patients were unable to access compensation for the harm caused by his actions due to gaps in clinical negligence cover in the independent sector. These gaps do not occur in the NHS where cover is via a state scheme.

The Government’s Implementation Update on the Inquiry’s recommendations included proposed policy options for Recommendation 10. One of the policy options was to make the system more transparent through safeguards, such as the introduction of a Code of Practice for medical defence organisations who provide a particular type of clinical negligence cover called discretionary indemnity that many healthcare professionals purchase. Unlike regulated insurance, where terms and conditions are set out contractually, discretionary indemnity allows for discretion to be applied to accept or refuse claims.

Following engagement with patients and the wider sector last year, I am pleased that medical defence organisations propose to implement a sector-led Code of Practice by end of 2024. The aim of this Code is to provide greater transparency around this system of discretionary indemnity.

For example, there will be more information on how decisions are made to assist healthcare professionals to pay patients compensation. The Code will include an escalation procedure with an independent review of disputed claims assistance decisions. Importantly, the Code will now offer healthcare professionals information on the basis of any decisions to decline claims.

We welcome the Code as a meaningful step forward. The Department of Health and Social Care will evaluate its implementation, including the long-term impact on patients and healthcare professionals, to determine whether further intervention is required. I will provide an update on further steps to reform the clinical negligence cover system, such as addressing cover for criminal acts or when a healthcare professional has otherwise worked outside the terms of their cover, in due course.

Alongside this update, the report on a survey that the Government commissioned IFF Research to carry out into healthcare professionals’ clinical indemnity arrangements will also be published. A copy of the report will be placed in the libraries of both Houses.

Answering body: Department of Health and Social Care

On 16 December 2021, the government published its response to the findings of the inquiry into the issues raised by disgraced surgeon, Ian Paterson. We reiterated the apologies of the government to the patients affected and those close to them and committed to ensuring we did more to protect patients in the future.

In line with this commitment, the government accepted the overwhelming majority of the recommendations made by the inquiry and set out an implementation plan of 40 actions to put those recommendations into effect. Finally, we committed to providing a further update on the progress of this implementation plan in 12-months’ time. I am happy to be able to publish this report fulfilling that commitment today.

All the relevant bodies within the health sector have been united in understanding that these changes are essential. We all agree that patients cannot be failed in the same way again. On behalf of the government, I want to thank every organisation which has engaged in this process for their commitment to making improvements. I would especially like to thank the representatives of patient groups impacted by Ian Paterson, who have campaigned tirelessly to ensure their experiences do not go unheeded. They have continued to be a source of inspiration and expertise throughout the implementation period.

I am pleased to report that good progress has been made across the implementation plan which we set out in December 2021. The report published today provides full details of this progress against the four themes of the government’s response as laid out in the implementation plan. In this statement, I will highlight some of the most important developments under each of these themes.

Patient-centred information

Patients now have more access to information relevant to their treatment than they did during Ian Paterson's time practising. This includes access to information about the performance of consultants working for independent sector healthcare providers, and specialties in the NHS. These continue to be added to, so patients will have more, and better, access to independent information before choosing a consultant. NHS England (NHSE) will work with the professions so that meaningful consultant-level information on the numbers and types of procedures performed should be made publicly available. If patients choose to be treated in the independent sector, there is now more information about what to expect, with further information to be made available over the coming year.

Patients now have the right to access their treatment records and clinicians are aware of the need to write to patients directly following a consultation or treatment, rather than only writing to their GP. This information gives patients a record of their condition, and test results to reflect on, or to seek a second opinion if required. This is reinforced by ensuring patients gets the time they need to consider treatment options and have access to a range of new resources to help them consider their options; options that patients will also be able to discuss with medical professionals who are equipped to handle these conversations.

Making challenge heard

Doctors across more specialties now have independent data on their practice available and will be required to use this as part of their appraisal and revalidation processes. This will help to identify issues and fix them. Staff in the health system also have more opportunities to make their voices heard about a patient's care, including through clarified guidance and assessment of multidisciplinary team use as a forum.

Care Quality Commission (CQC) updated its guidance on complaints processes in early 2022. It is now easier for patients to raise concerns about treatment they receive and access independent resolution of their complaint if they are unsatisfied with the provider's handling. As part of the implementation of the NHS patient safety strategy, NHSE has introduced measures to advance safety and the response to harm. The government has appointed the first ever Patient Safety Commissioner for England, Dr Henrietta Hughes OBE.

Ensuring accountability

CQC published the new single assessment framework in July 2022, which sets out what good care looks like, and National Quality Board published national guidance on System Quality Groups, setting out the requirements for quality governance in integrated care systems. Alongside this, we have seen significant culture change in the independent sector, now leaving no doubt that independent providers must take responsibility for maintaining high standards of care in their facilities, irrespective of how the medical professionals involved are engaged by them (through employment or practising privileges). This has been supported by Independent Healthcare Providers Network's refresh of the Medical Practitioners Assurance Framework in September 2022. NHS Resolution launched new exclusion guidance in April 2022.

Putting things right

Patients who are impacted by potential issues with their care will be reviewed through recall processes which are now better informed of how to put patients at the centre of their focus. The new national recall framework was published in June 2022 to facilitate this.

Patients will continue to receive apologies from healthcare professionals and providers for potential issues with their care when appropriate. Enhanced training and resources are now available to clinicians to ensure these apologies are delivered effectively and meaningfully.

The government is working to ensure that any future changes to indemnity and insurance arrangements will be made using the best evidence base available. This includes a thorough assessment of the impact on patients, healthcare professionals, providers, and the wider market; with the aim of improving the position for patients when receiving treatment from any regulated healthcare professional, regardless of the setting. The government’s ambition is that when this work concludes, patients have confidence that they can access appropriate compensation if harmed while receiving care, including when harm arises from criminal/intentional acts or omissions. The summary of responses to the consultation on appropriate clinical negligence cover for regulated healthcare professionals will be published alongside this implementation update on 15 December 2022.

The government will be continuing to ensure this work is built upon, as part of our wider commitment to ensuring patient safety and high standards of care across the health system. We understand that there is no room for complacency when it comes to patient safety and, together with the patient safety commissioner, will make sure this is one building block towards a health system which patients and those close to them can have the maximum possible confidence.

Copies of the government’s full implementation update will be available at: https://www.gov.uk.

Answering body: Department of Health and Social Care

In July 2021, the government published its response to the recommendations of the Independent Medicines and Medical Devices Safety Review (the review). In this, we accepted the overarching conclusion of the review that the system failed to listen to patients, or to put patients at the centre of their care. We accepted the majority of the review’s nine strategic recommendations and 50 Actions for Improvement.

We also committed to publishing an update on progress made in the following year to implement the accepted strategic recommendations and actions for improvement. I am happy to be able to publish that report today, which shows that we have made substantial progress and sets out the remaining next steps. The key points are set out below.

Putting patient voice at the centre of patient safety

Dr Henrietta Hughes was appointed as the first Patient Safety Commissioner in July 2022. Dr Henrietta Hughes is already championing the value of listening to patients to seek improvements to patient safety around the use of medicines and medical devices.

Pelvic mesh

In April 2022, the ninth specialist mesh centre opened in Bristol. Women from every region now have access to the specialist support services they need, including pain management, psychological support and surgical mesh removal. As of October 2022, over 1,900 patients had been referred for treatment.

The first annual clinical summit took place on 6 December 2022, where all 9 mesh centres came together to share best practice in setting up the centres, delivering patient-centred care, and ensuring robust data collection to support continued improvement. To ensure these centres are supporting women as intended, I have asked the Department to work with NHS England to review mesh centre outcomes and patient experience.

Sodium valproate

Government takes safety concerns associated with sodium valproate very seriously. Significant measures were introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018 to further reduce the use of valproate during pregnancy, including the introduction of the Pregnancy Prevention Programme and smaller pack sizes to encourage monthly prescribing with a pictogram/warning image on valproate packaging.

The MHRA and NHS Digital have developed the Medicines and Pregnancy Registry to improve our ability to monitor implementation and compliance with the Pregnancy Prevention Programme. This tracks all women in England who are taking NHS-prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. The latest data from the registry shows that the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. Last year the registry was also expanded to cover other anti-epileptic drugs in addition to sodium valproate.

Existing approaches to reduce the number of pregnant women exposed to sodium valproate are important and are making a difference, but there is no room for complacency, and we still need to do more. For that reason, the independent Commission on Human Medicines (CHM) has considered a comprehensive assessment by MHRA which included input from patients and other key stakeholders and a review of the available data.

The CHM has advised that there should be greater scrutiny of the way sodium valproate is prescribed and that further risk minimisation measures are required, in particular that two specialists should independently consider and document that there is no other effective or tolerated treatment. The CHM has established an implementation group to support the safe introduction of the new measures into clinical practice. The implementation group includes representation from across the healthcare system.

The proposed new measures will be implemented over the coming months according to patient priorities so that they can be introduced safely. In the meantime, health professionals are being reminded that sodium valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated, and the Pregnancy Prevention Plan should be closely adhered to. It is important to note that patients taking sodium valproate are strongly advised to continue to do so until reviewed by a healthcare professional.

I will also be hosting a roundtable on valproate prescribing with key stakeholders on 19 December 2022, to discuss how we can work together to further improve monitoring and compliance with the regulatory controls.

Last year we held a consultation on original pack dispensing and whole pack dispensing of medicines containing sodium valproate, which included a proposal that medicines containing sodium valproate are always dispensed in the original manufacturer’s packaging. This would ensure patients, and particularly women and girls of childbearing potential, always receive the patient information leaflet with warnings about taking the medicine while pregnant. The government has considered the responses received and will shortly publish a response to the consultation.

Medical device information system

Following extensive scoping work we have concluded that the best and fastest way to deliver a medical devices information system is by increasing the scope and coverage of outcome registries.

We aim to increase the scope and coverage of medical device outcome registries from 15% to 80% of high-risk procedures over the next three years. As well as device tracking the registries will include patient outcomes and patient experience, helping us deliver on wider objectives such as better information about individual consultants’ performance, which was highlighted in the Paterson inquiry.

Declaration of interests

The IMMDS review stated that transparency of payments made to clinicians needs to improve. We are in a piloting phase for the declaration of doctor’s interests in NHS and independent settings. Healthcare providers will publish this information to ensure it is more accessible to patients.

During the pilot, we will seek feedback from healthcare providers, doctors, and patients on the feasibility and cost of establishing and maintaining systems across different healthcare settings; the content of standardised templates and guidance; and the accessibility of information for patients. Full implementation will begin in 2023. Once we have a system in place for doctors, we will consider systems for other healthcare professionals.

Next steps

We know there is more work to do to improve women’s experiences of the healthcare system, and patient safety. The government is committed to continuing to work with partners across the health and care system to implement the accepted recommendations and actions for improvement.

The review also brought into sharp focus the importance of listening to women's voices and was a key driver behind the decision to develop the first ever Women's Health Strategy for England, which we published this summer. Through the Women’s Health Strategy, we will continue to improve the health and wellbeing of women and girls.

Answering body: Department of Health and Social Care

On 4th February 2020, the Independent Inquiry into the issues raised by the disgraced surgeon Ian Paterson published its report, which was welcomed by the government. On 28th April 2020, we reluctantly announced a delay in the government response due to the unprecedented pressures of the COVID-19 pandemic. On 23rd March 2021, we provided an update on the progress made and committed to publishing a full response during 2021. Today, the government has published that response.

We want to thank the Right Reverend Bishop Graham James and the inquiry team for their thorough report which provides a detailed analysis of the issues which allowed this malpractice to take place and recommends steps to better protect patients moving forward.

Our thanks also go to the patients who shared their experiences with the Inquiry and to their representatives who subsequently continued to engage with the government through the process of preparing this response. Patient voices have rightly been central to this entire process.

The government’s response

The Inquiry’s findings point to several important themes where action is needed to improve protections for patients being given hospital-based care – whether in the NHS or independent sector. These actions must improve the way our health system works for patients at every stage of their treatment journey.

The health system has to provide patient-centred information to enable patients, their families and carers to make informed decisions about their treatment and care. Medical practitioners should face regular challenge to improve the standard of care they provide as part of their overall learning and development, with concerns about their practice from any source heard and acted upon. There must be accountability across the healthcare system, ensuring quality of service from the frontline to the boardroom. Finally, when things do go wrong, patients must have the confidence that the entire system will work to put things right – meeting the needs of the patient and learning the lessons to prevent the same mistakes being repeated.

Working with patients and stakeholders, we have carefully considered all 15 recommendations the Inquiry made for improving the health system. We are accepting 12 of these recommendations either in full or in principle with a further 1 recommendation still pending. There is 1 recommendation we are not accepting but keeping under review and 1 recommendation that we do not accept. Whether we are accepting the recommendation or not, we are taking action to improve healthcare against every recommendation.

The response outlines actions which have been taken since Ian Paterson’s malpractice came to light, in addition to detailing 40 actions for our further implementation plan. The government will review the progress made in this implementation in a further publication after 12 months to ensure adequate action has been taken and update where additional action is planned.

Recommendation 1

Recommendation 1 calls for a single repository of the whole practice of consultants in England containing critical consultant performance data. This would be made accessible for use by both managers and healthcare professionals, and by members of the public. We accept this recommendation in principle. A significant amount of progress has been made on the collection of consultant performance data in both the NHS and independent sector. We commit to making more progress on the collection of data, use of the information it allows us to develop, and the publication of useful metrics. In 2018, the Acute Data Alignment Programme was launched to move towards a common set of standards for data collection and reporting across the NHS and independent sector. This brings together data collection through NHS Digital, with the use and processing of this data in parallel in the NHS and independent sector through the National Consultant Information Programme (NCIP) and the Private Healthcare Information Network (PHIN). This is currently in pilot, with the potential to be fully implemented, dependent on the results of that pilot, in 2022-23. This data will be made available for managers and healthcare professionals across the system to support learning and identify outliers. PHIN is already mandated to publish information on consultant practice in the independent sector and will be continuing to roll-out the publication of further metrics in the coming years. Over the next 12 months, we commit to reaching a decision with key stakeholders on what further information should be made publicly available and whether further government action will be needed to achieve this.

Recommendation 2

Recommendation 2 asks that it become standard practice for consultants to write directly to patients about their treatment and care in language they can understand. We are pleased to accept this recommendation. Guidance across the system makes clear that this is best practice and a range of key stakeholders have agreed to write to their members to encourage the uptake of this advice. We will continue to explore with providers how their systems can change to embed this process and to monitor that best practice is being followed.

Recommendation 3

Recommendation 3 requires the publication of information explaining the differences in how care is organised in the NHS and the independent sector, so that patients can make informed decisions. We have accepted this recommendation. We will be commissioning the production of this independent information, to be created in partnership with patients, families and carers. This will be published in 2022 and made widely accessible.

Recommendation 4

Recommendation 4 calls for the introduction of a short waiting period in the decision-making process for surgical procedures, to enable reflection on the diagnosis and treatment options. We are accepting this recommendation in principle. Whilst a specific period for general surgery is not being introduced, as the time required will depend on the patient and the procedure in question, the General Medical Council has updated its guidance to confirm that patients should be given sufficient time to consider their options before making decisions about treatments. During appraisals, doctors must demonstrate they are meeting the principles set out in GMC’s ‘Good Medical Practice’, and CQC takes all GMC guidance into account during its assessments across the NHS and independent sector.

Recommendation 5

Recommendation 5 relates to multi-disciplinary teams, asking CQC to assure that all hospital providers are complying effectively with national MDT guidance. We have accepted this recommendation. CQC has added more detailed prompts to its inspection framework on multi-disciplinary team working. When assessing providers across the NHS and independent sector, CQC will continue to seek assurance that patients are not at risk of harm due to non-compliance in this area.

Recommendation 6

We have considered recommendation 6, which relates to complaints processes, in two parts. The first part calls for more effective communication to patients of the means to escalate a complaint to an independent body. We have accepted this part of the recommendation. The Parliamentary and Health Service Ombudsman is piloting the NHS Complaints Standards which set out in one place the ways in which the NHS should handle complaints. This includes the need for organisations to ensure people know how to escalate a complaint to the ombudsman. These have been developed with the Independent Sector Complaints Adjudication Service, ISCAS, who have included it in their code of practice.

The second part of recommendation 6 proposes that all private patients are given the right to mandatory independent resolution of their complaints. We have accepted this part in principle. CQC will strengthen its guidance to make clearer that it expects to see arrangements in place for patients to access independent complaints resolution. We will review the impact of this guidance in the coming year and will explore whether legislative action is needed, if insufficient action is taken.

Recommendations 7 and 8

Recommendations 7 and 8 both relate to the recall of patients of Ian Paterson by providers – University Hospitals Birmingham NHS Foundation Trust and Spire Healthcare. These recommendations have already been accepted in full. UHB has contacted all known living patients of Ian Paterson and ensured that all cases had been reviewed by June 2021. Spire had proactively contacted all known living patients by December 2020 and have now reviewed the care of over two-thirds of the patients concerned. We have asked Spire to provide an update on progress in 12 months on reviewing the remaining patients.

Recommendation 9

Recommendation 9 calls for a national framework to be developed for the recall of patients. We have accepted this recommendation. This framework has been developed and outlines actions to be taken by organisations in the NHS and independent sector in the event that a patient recall is necessary. This framework will be published in 2022 and will be owned by the National Quality Board, who will ensure it is periodically updated.

Recommendation 10

Recommendation 10 relates to indemnity products for healthcare professionals and asks for the shortcomings in clinical negligence cover identified by the inquiry to be resolved. The outcome of this recommendation is pending. We recognise that a system needs to be in place to ensure that patients have confidence that they can access compensation if harmed while receiving care, and we will bring forward proposals in 2022. These proposals will build on the consultation at the end of 2018 on ‘Appropriate clinical negligence cover’ for regulated healthcare professionals. The summary of responses to this consultation will be published in early 2022. We have put forward an extended programme of actions in our response to work towards change in this area, and we will ensure any reforms are robust, meeting the needs of both patients and professionals, before implementing them.

Recommendation 11

Recommendation 11 calls for the government to ensure that the system of regulation in healthcare serves patient safety, that regulators collaborate effectively and that weaknesses identified by the inquiry are resolved. We are accepting this recommendation. The healthcare regulators referenced in the Paterson Inquiry (the GMC, Nursing and Midwifery Council, and CQC) exist to protect patient safety and this is reflected in their new corporate strategies. They have also taken a number of actions to encourage collaboration and information sharing between organisations. The government’s consultation on ‘Regulating Healthcare Professionals, Protecting the Public’ sets out proposals which address issues raised by the inquiry, including a proposed duty to cooperate for all regulators. We plan to bring forward legislation in relation to the GMC in 2022.

Recommendation 12

We have considered recommendation 12 in two parts. The first part required that any investigation of a healthcare professional’s behaviour should result in a suspension, if there is any perceived risk to patient safety. We have not accepted this recommendation. Exclusion and restriction of practice can be a necessary and appropriate response during an investigation in some instances. However, we do not believe it would be fair or appropriate to impose this step as a blanket rule in all cases. It is vital that investigations are robust and conducted in a timely manner. Guidance has been implemented in recent years to ensure concerns are taken seriously and appropriate action taken, including clear advice on when exclusion is the right step to take.

The second part of recommendation 12 proposes that any concerns about a healthcare professional at one provider should be shared with other providers they work with. We accept this recommendation in principle. Where patient safety is at risk, information should be shared. Providers must use their judgement, though, as they are taking on responsibility to ensure the information is appropriate and accurate when shared. Regulators have taken key steps to make it easier for people and organisations to share information regarding patient safety risks.

Recommendation 13

Recommendation 13 identifies a specific issue relating to the engagement of consultants through practising privileges in the independent sector. This is where the consultant is self-employed and allowed to work in the hospital’s facilities, rather than employed by the hospital. In the case of Ian Paterson, this led to a gap in responsibility and liability for the consultant’s actions. The Inquiry reported the impression that private providers were just renting consultants a room, and claims for compensation took significant time and effort from patients to resolve. We accept this recommendation in principle. Independent sector providers must take responsibility for the quality of care provided in their facilities, regardless of how the consultants are engaged. The Independent Healthcare Provider Network published the Medical Practitioners Assurance Framework in 2019 to improve consistency around effective clinical governance in the independent sector. We encourage all private providers to take up this framework, and CQC will continue to assess the strength of clinical governance in all providers as part of its inspection activity. We will be using the response to recommendation 10 on indemnity products and the programme of action laid out there as the initial response to the challenges faced by patients of Ian Paterson in accessing compensation. We will additionally keep the potential liability held by providers in the independent sector under review.

Recommendation 14

Recommendation 14 says that apologies should be given at the earliest stage of investigation when something goes wrong, and that potential liability should not hold anyone back from apologising. We accept this recommendation. Healthcare organisations have a statutory duty of candour – which sets out specific requirements providers must follow when things go wrong with care and treatment, including providing truthful information and an apology. This duty is regulated by CQC. NHS Resolution consistently advises members to apologise when things go wrong and that this has no impact on potential legal liability. We continue to ensure this guidance is promoted.

Recommendation 15

Finally, recommendation 15 says that private providers should not be eligible for NHS contracted work unless they have implemented all the other accepted recommendations from this response across the entirety of their workload. We are not accepting this recommendation, but will keep it under review. Across all the issues raised in this inquiry report, independent sector providers are fully committed to implementing changes alongside NHS providers. These providers must meet the same regulatory standards as NHS providers, as required by CQC. Independent providers must meet the conditions of the NHS Provider License and the NHS Standard Contract to be able to deliver NHS-funded treatment. Accepting this recommendation would create a duty on the NHS which would need to be carefully implemented to ensure it could be monitored effectively and would not reduce the capacity available to the NHS for providing care – particularly given the numbers of patients waiting for treatment as a result of the pandemic. We do, however, recognise the importance of ensuring change takes place. We will continue to work with the independent sector to implement the changes related to the Inquiry’s recommendations and will review progress in 12-months’ time. We commit to taking robust action should progress not meet our expectations.

This response forms part of the government’s broader commitment to patient safety, including our response to the Independent Medicines and Medical Devices Safety Review as previously published and the measures included in the Health and Care Bill.

Copies of the government’s full response will be laid before the House and will be available from the Vote Office and at: https://www.gov.uk

Answering body: Department of Health and Social Care

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

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

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.

Answering body: Department of Health and Social Care

Today the report of the Independent Inquiry into the issues raised by the former breast surgeon Ian Paterson has been published.

This report follows two years of work by the Inquiry, led by Bishop Graham James. The Bishop has adopted a strong commitment to a “patients and families first” approach to public disclosure, which means that the process of public disclosure began earlier this morning with the patients and families themselves.

The report contains an analysis of the circumstances surrounding Ian Paterson’s malpractice that has affected so many patients and considers other past and current practices. It also tells the stories of patients who came forward to provide evidence to the Inquiry, which bears testament to their courage. As such it makes for difficult reading and it is with deep regret that we have to acknowledge the failure of the NHS and the independent sector to protect patients from Paterson’s malpractice.

The public should be able to trust that a health professional will never again be allowed to place personal gain or advancement over the best interests of his or her patients whether care is funded by the NHS or privately. It is therefore essential that the whole of the health sector responds quickly and effectively to the lessons of this inquiry. The Government will give a thorough and detailed consideration of its findings over the coming weeks.

We expect now for all the relevant agencies and organisations both nationally and locally, and across the whole healthcare sector to give this report urgent and thorough attention.

Once that work is done, the relevant agencies will decide what steps to take next.

Copies of the report will be laid before the House and will be available from the Vote Office and at: https://www.gov.uk

An oral statement will be delivered to the House today.

Answering body: Department of Health and Social Care

It is normal practice, when a government department proposes to undertake a contingent liability in excess of £300,000 for which there is not statutory authority, for the Minister concerned to present a departmental Minute to Parliament giving particulars of the liability created and explaining the circumstances; and to refrain from incurring the liability until fourteen parliamentary sitting days after the issue of the statement, except in cases of special urgency.

I have today laid a departmental Minute proposing to provide an indemnity that is necessary in respect of a Department of Health and Social Care established non-statutory, independent inquiry into the issues raised by the malpractice of the former breast surgeon, Ian Paterson, in the independent sector and the NHS. The actions of Ian Paterson have affected a significant number of patients. The disclosures about the seriousness and extent of his malpractice are deeply and profoundly shocking. The Inquiry reflects the Government’s commitments to ensuring lessons are learnt in the interest of patient protection and safety, both in the independent sector and the NHS.

In 2017, the Minister of State for Health announced the establishment of the Inquiry (HCWS323, on 7 December 2017) to be chaired by The Right Reverend Graham James, Bishop of Norwich. This indemnity will cover the entire duration of the Inquiry’s work, from December 2017 until when the Inquiry submits its report, now expected at the end of 2019. The indemnity will cover the Chair and all independent advisers appointed to the Inquiry against any liability for any act done or omission made honestly and in good faith in the execution of his or her duty as such, or in the purported execution of his or her duty as such. The indemnity only applies to acts done or omissions made during the course of the Inquiry. If the liability is called, provision for any payment will be sought through the normal Supply procedure.

The Treasury has approved the proposal in principle. If, during the period of fourteen parliamentary sitting days beginning on the date on which this Minute was laid before Parliament, a member signifies an objection by giving notice of a Parliamentary Question or by otherwise raising the matter in Parliament, final approval to proceed with incurring the liability will be withheld pending an examination of the objection.

I attach a copy of the departmental Minute.

Answering body: Department of Health and Social Care

On 7 December 2017, Philip Dunne MP, Minister of State for Health, announced an independent, non-statutory Inquiry, under the Chairmanship of The Right Reverend Graham James, Lord Bishop of Norwich into the circumstances and practices surrounding the former breast surgeon Ian Paterson, who was convicted in April 2017 of wounding with intent and unlawful wounding.

Since then the Bishop has worked with affected families to ensure their views are taken into account in shaping the terms of reference.

Today, I can announce the terms of reference for the Inquiry, which will report in summer 2019.

The remit of the independent, non-statutory Paterson inquiry will be to:

Examine and seek to learn from what happened to former patients of Ian Paterson, both in the independent sector and in the NHS informed by their experiences and concerns; and

Review the circumstances and practices surrounding Ian Paterson as a case study, and consider other past and current practices, so as to draw conclusions in relation to the safety and quality of care provided nationally to all patients.

The Inquiry will consider issues raised in previous relevant reports about Ian Paterson, but does not intend to revisit the evidence that led to his conviction.

A central objective of the Inquiry is to afford former patients of Ian Paterson and their families an opportunity to tell of their experiences and to be heard.

The Inquiry will aim to report its conclusions and recommendations by summer 2019. The Inquiry will publish its report and the Secretary of State for Health and Social Care will make arrangements for its presentation to Parliament.

This announcement marks the beginning of the important work of the Inquiry in listening to the experiences of former patients and gathering other evidence to ensure that the independent healthcare sector and the NHS are able to learn the lessons from Ian Paterson’s appalling malpractice that has taken or damaged the lives of so many people who invested their trust in him.

I attach a copy of the Terms of Reference.

Answering body: Department of Health

Ian Paterson, a consultant breast surgeon who was employed by the Heart of England NHS Foundation Trust (HEFT), and had practising privileges in the independent sector at Spire Parkway and Spire Little Aston, was found guilty in April this year of 17 counts of wounding with intent. He was sentenced to jail for 20 years.

The Government is appalled by the actions of Ian Paterson and the harm that has affected a significant number of patients. The disclosures about the seriousness and extent of his malpractice are deeply and profoundly shocking.

The Government committed to ensuring lessons were learnt in the interest of patient protection and safety, both in the independent sector and the NHS.

Today, I am announcing the establishment of an independent, Non-Statutory Inquiry into the circumstances and practices surrounding Ian Paterson that have affected so many patients. I have asked The Right Revd Graham James, Bishop of Norwich to chair the Inquiry.

The Inquiry should be informed by the victims of Paterson and families’ concerns, and seek to learn from their experience. Therefore, the Inquiry will look at the local care and treatment for private patients in the Solihull area, and review current and past practices to establish if safeguards for patients treated at independent healthcare providers have fallen short of the standards the public has a right to expect. This will help to inform the broader lessons applicable to care provided by the independent healthcare sector across the country.

The Inquiry is likely to consider issues including, but not limited to:

the responsibility for the quality of care in the independent sector; appraisal, revalidation and multi-disciplinary working in the independent sector

information sharing, reporting of activity and raising concerns between the independent sector and the NHS;

and the role of insurers of independent sector providers (including sharing of data), and arrangements for medical indemnity cover for clinicians in the independent sector.

The Inquiry will also draw on issues raised in previous relevant reports about Paterson.

It is not intended to revisit the evidence that we already have about Paterson and that led to his conviction.

The terms of reference and other arrangements relating to the inquiry will be published in due course after a period of engagement.

The Inquiry will be formally established from January 2018 and will report in summer 2019.

I am confident that Bishop Graham will oversee a thorough and independent non-statutory inquiry and deliver his recommendations swiftly.