Welsh Government criticised for failing to appoint a Patient Safety Commissioner

Martin Shipton

The Welsh Government is facing criticism after refusing to appoint an independent Patient Safety Commissioner – a role established in England last year and currently being legislated for in Scotland.

The moves in England and Scotland follow publication of the Independent Medicines and Medical Devices Safety Review in 2020, which investigated a series of scandals where patients suffered because of negligence and inaction.

Chaired by Baroness Cumberlege, a former Tory Health Minister, the review looked at three medical treatments: hormone pregnancy tests, mainly the drug Primodos, alleged to cause serious birth defects; the anti-epileptic sodium valproate, which can cause birth defects and developmental delays; and pelvic mesh, a surgical material – technically a medical device – implanted in thousands of women to treat organ prolapse and urinary incontinence.

Mesh is now the subject of intense global scrutiny after reports of serious long-term effects from material that is twisted, moved, disintegrated or caused severe allergic reactions.

Disjointed

The review concluded: “We have found that the healthcare system, in which I include the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers and policymakers, is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre.”

The review went on to recommend the establishment of a Patient Safety Commissioner in England, and last September Dr Henrietta Hughes became the first such commissioner.

The Scottish Parliament is currently legislating to introduce a Patient Safety Commissioner.

Proposing the Bill, Public Health Minister Jenni Minto told MSPs in May: “We know from the testimony of countless patients, gathered by Baroness Cumberlege in the Independent Medicines and Medical Devices Safety Review, that, too often, patients, their families and members of the public do not feel listened to when they raise concerns about the safety of healthcare.

“As a result, they doubt that their feedback will lead to change and their relationship with healthcare providers may break down, causing them to lose trust in the healthcare system. At worst, as the cases highlighted by Baroness Cumberlege starkly demonstrate, that can lead to patients suffering serious avoidable harm.

“We need to address this. Good healthcare is a fundamental right for everyone. It is essential that patients have confidence that every time they access part of the healthcare system, not only will they receive the best available treatment without fear of harm, but also that any concerns they raise will be listened to. A culture of openness and learning enables everyone to feel able to share what has gone well, but also what has gone wrong or could have gone better. We must ensure that learning and improvement does happen when things go wrong, to continue to make healthcare better.

“In her report, Baroness Cumberlege recommended ‘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 and the use of medicines and medical devices.

“This Bill will create a Patient Safety Commissioner who will be directly accessible to patients, their families and members of the public to hear their concerns, bringing their stories together with quantitative safety data across the healthcare system, to spot trends and make healthcare safer for us all.

“They will be independent of the Scottish Government and NHS Scotland, allowing them to challenge the healthcare system, and they will be free to consider any issue pertaining to the safety of patients in healthcare settings across Scotland.”

Commercial interests

As well as being a Labour member of Penarth Town Council, Richard Cox is a trustee of Mesh (UK) Charitable Trust and took part in several of the Cumberlege Review’s hearings. He said: “Wales needs an independent Patient Safety Commissioner for the same reasons as England and Scotland, and because the situation in Wales is no different from in those countries.

“It’s essential that patients are protected from the risks caused by various devices and procedures, and that in particular commercial interests are not allowed to take priority over safety.”

A Welsh Government spokesman said: “The situation here is different to the other devolved nations. We’ve recently introduced our own legislation and other measures to improve patient safety.

“We strengthened the powers of the Public Service Ombudsman for Wales to undertake their own investigations and introduced new duties of quality, including safety, and candour for NHS bodies. We have created [the body] Llais to give a stronger voice to people in all parts of Wales on their health and social care services. It has a specific remit to consider patient safety and has the power to make representations to NHS bodies and local authorities and undertake work on a nationwide basis.

“Our view is that introducing a Patient Safety Commissioner in Wales at this time would create considerable complexity and confusion. Also one of the main roles of the proposed commissioner is in relation to medicines and medical devices, which are not devolved to Wales.”

The spokesman added: “The Health and Social Care (Quality and Engagement) (Wales) Act 2020 with its duties of quality and candour for NHS bodies requires them to exercise their functions with a view to securing improvement in the quality of health services, including patient safety and to build trust between the NHS and service users.”

Mr Cox is critical of Llais because, unlike the community health councils it replaced, it has no democratic accountability.