Parliamentary activity

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