My Lords, I start by profoundly thanking my noble friend Lady Cumberlege. It has not escaped the notice of anyone in this Grand Committee that her amendment has the support of a very large number of noble Lords, including the noble Lords, Lord Patel and Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Thornton. Many Members spoke in favour of her report’s recommendation at Second Reading, and I expected that we would spend time on these matters now.
Let me say at the outset that the Government take very seriously the report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege. We are absolutely determined to learn from it. We are taking time to carefully consider the report and all its recommendations before we respond, which is reasonable. Given the important issues it raises, it is only right that the report gets due consideration. It is right that, on a report of this length and breadth, we take the time to do this properly.
At the heart of the review are harrowing stories of hundreds of people and their families. It is right that the Government have made an unqualified apology on behalf of the health system to all the individuals affected by this report.
I shall say a word about the pause in the use of vaginal mesh in the treatment of prolapse and incontinence which was introduced in mid-2018. As my noble friend Lady Cumberlege rightly observed, the pause introduced a period of high vigilance, restricted practice to ensure that NICE guidance was followed. A blanket ban on the relevant procedures was not recommended as there needed to be some exceptions within the pause. I am aware of the six conditions that must be met before the pause can be lifted. The majority of the six measures are in hand. NHSE is working closely with providers to set up specialist mesh removal centres and is working in partnership with the British Association of Urological Surgeons and the British Society of Urogynaecology to ensure that there is a consistent approach to informed consent and shared decision-making in these centres with clear and accessible information available for patients. I am aware that a data solution is yet to be fully implemented, but I reassure noble Lords that I understand that NHS Digital, working with NHSX, has put together a programme of work to establish an information system to collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures, and that this work is in the pilot stage with a view to establishing a medical device information system.
We recognise that Amendment 117 stems from the centrepiece recommendation of that bold and far-reaching report to establish an independent patient safety commissioner. He or she would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. We recognise that the role would be to help patients navigate the healthcare system architecture and to troubleshoot problems and that, as my noble friend put it in her report, the commissioner could be a golden thread tying our complex health system together in the interests of patients and the public. We recognise the significance of the intention of this amendment. We wholeheartedly accept that listening to patients is a key step to preventing the sort of issues that the report by my noble friend Lady Cumberlege has highlighted.
We accept that policymakers, the NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers need to do more to engage patients and families, and to recognise and use their insights as a vital source of learning. It is only by listening to patients, their families and staff that we can learn from mistakes and continually improve. On this point, it has been imperative that we listen, and I am listening very carefully today to the points made by colleagues about the arguments for a commissioner and how this might sit within the wider system. I will continue to listen.
However, before I turn to Amendment 117, allow me to explain why patient safety is an unwavering commitment for the Government and the measures we are taking to embed patient safety throughout the NHS. These include putting a positive learning culture at the heart of the NHS and ensuring that providers are listening to those who raise concerns at the time they are raised, whether by patients, their families or staff, and that they show empathy and sensitivity when they respond. This is a culture where patients are listened to in the first place and not one where they feel they must resort to a third party in order to be heard.
Following the tragedy of Mid-Staffs, which the noble Baroness, Lady Thornton, referred to, and some other very concerning cases, we have overhauled the infrastructure underpinning safety and quality in the past decade. That includes taking steps to help staff speak up when they see things going wrong. A culture that listens and responds to concerns in the first place is crucial if the right lessons are to be learned and errors are to be minimised. Our measures include establishing: the Healthcare Safety Investigation Branch to examine the most serious patient safety incidents and promote system-wide learning; medical examiners to provide much-needed support for bereaved families and to improve patient safety; a duty of candour so that hospitals tell patients if their safety has been compromised and apologise; and protections for whistleblowers and freedom to speak up guardians across all trusts, supported by a national guardian.
In addition, the NHS people plan for 2020-21 sets out our vision for a health service that is compassionate and inclusive, that is not hierarchical and where people are listened to. We know that implementing change can be a slow and complex process for many organisations
and individuals. Healthcare will always involve risks, but they can be reduced by analysing and tackling the root causes of patient safety incidents.
However robust our regulatory and oversight system is, ultimately, improving patient safety requires those at the executive level of our health service to act just as much as individuals involved in patient care. It is why in 2019 we commissioned the NHS national director of patient safety, Dr Aidan Fowler, to publish a new NHS patient safety strategy. Substantial programmes are planned which include: a framework to support patients to contribute to their own safety by having patients or their advocates on all safety-related clinical governance committees in NHS organisations; a requirement for all NHS organisations to identify a specialist to lead on patient safety; the first ever system-wide patient safety syllabus and training for all staff so that they have the knowledge to make care safer themselves; a new patient safety incident response framework to improve the handling of patient safety investigations in the NHS; a successor to the national reporting and learning system to support safety improvement and help the NHS when things go wrong; and a national patient safety improvement programme to prioritise the most important safety issues in the NHS, including medicines safety.
Implementation of the 10-year NHS patient safety strategy is being led by a team that is more than 50 strong. At its core, the strategy seeks to significantly improve the way the NHS learns, treats its staff and involves patients. The strategy seeks to ensure that all healthcare organisations in England adopt a different focus for patient safety that is based on culture and systems. NHS England and NHS Improvement have assessed that getting patient safety right could save 1,000 lives and £100 million in care costs each year from 2023, with the potential to reduce claims provision by around £750 million a year by 2025. The NHS patient safety strategy will be refreshed each year to support our ambition of cementing patient safety into the everyday fabric of the NHS and encouraging a safety and learning culture. NHS safety bodies are doing more to involve patients to better understand issues that give rise to patient safety concerns. Let me give a couple of examples.
The Healthcare Safety Investigation Branch has established a citizen partnership panel to bring in patient insights and ideas for referrals or improvements in HSIB’s investigations. The experiences of patients and their families are central to the regulatory approach of the CQC and its future direction. The MHRA has begun a substantial programme of work to drive forward change in its culture, where a key priority is listening and responding to patients.
Lest we forget, the healthcare system architecture is complex. This means that patient safety regulation is prone to overlaps of remit and gaps between oversight bodies. It is why our consideration of the recommendations by my noble friend Lady Cumberlege includes how a patient safety commissioner would interact with other bodies across the healthcare landscape, ensuring that they could make a difference without creating duplication or confusion.
With this in mind, although Amendment 117 from my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt, and the noble Baroness, Lady Jolly, would give the patient safety commissioner considerable latitude about how he or she would operate, it is without detail about how the commissioner would interact with other bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among many others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants whatever the cause of the complaint may be. These bodies also have their own routes for reporting. For example, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme. Proposed new subsection (5)(e) does not address how a new route for patients to report safety concerns would mitigate the risk of drawing patients away from reporting these incidents to the MHRA or of causing a delay in the MHRA receiving this vital information or receiving it at all.
Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety. Although this power does not, as we might expect, extend to requiring information for the purposes of fulfilling the commissioner’s other functions, it is otherwise broad, because it would apply to both public and private bodies, and individuals, and could involve requests for sensitive personal data and confidential commercial information that these bodies may not agree are reasonable for the purposes of the commissioner’s public reports.
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The Government want to ensure that patients in England are not let down by our most loved institution, which was set up to protect each and every one of us. There is no doubt that the report by my noble friend Lady Cumberlege gives the Government and everyone in healthcare a lot to think about. My noble friend has done a great service by highlighting the importance of listening to patients and we are considering carefully her recommendation to establish a patient safety commissioner.
Whatever structures we put in place, the reality is that patient safety is a combination of culture, behaviours and underlying conditions. Patients should be able to trust that their concerns will be listened to without feeling that they must resort to a third party to be heard. It is ultimately about the way we work with, and behave towards, each other, and towards patients and their families. Any approach to add a further layer to an already complex health system architecture should aim to mitigate the potential for issues to get lost, confused or duplicated. It definitely should not hamper the effectiveness of existing patient safety bodies. It is absolutely right that we put the patient at the heart of the system and improve the system around them.
I am very grateful to my noble friend Lady Cumberlege, to the noble Lords, Lord Patel and Lord Hunt, and to the noble Baroness, Lady Jolly, for tabling their amendment. However, with the utmost respect to them,
the Government are unable to accept it for the reasons I have outlined. I therefore hope the noble Baroness feels able to withdraw her amendment.