We have two short debates this afternoon, and the first is to be introduced by David Melding. 

Thank you very much, Presiding Officer. I have agreed to give some of my time to Hefin David and to Angela Burns.

The subject of my short debate is the Cumberlege review—lessons for informed consent in the NHS. I want to start by commending the authority and insight of the review undertaken by Baroness Cumberlege, aptly entitled 'First Do No Harm'. That is the oldest principle of ethical medicine, and I think it's appropriate that we bear that in mind when we consider the issues before us in this debate. Although commissioned by the Secretary of State for Health in the UK Government and focused predominantly on the NHS in England, evidence was taken in Wales and Scotland, and, indeed, many of us have probably had some casework from witnesses who did give evidence in Wales; I certainly have. 

The review investigated what had happened in respect of two medications and one medical device, namely hormone pregnancy tests, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages; sodium valproate, an effective antiepileptic drug, which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and pelvic mesh implants, used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence, the use of which has been linked to crippling, life-changing complications. However, it has been widely acknowledged that the review has general relevance and application to the safety of medicines and medical devices. 

One of the things the review was asked to consider was how to strengthen the patient's voice, which simply wasn't being heard and was leading to poor choices and outcomes. A central recommendation of the report is the establishment of a patient safety commissioner. As the report states, and I quote,

'The patients’ stories were harrowing.... They told their stories with dignity and eloquence, but also with sadness and anger, to highlight common and compelling themes'.

And the theme—arguably the strongest theme—that I want to examine today is the lack of information to make informed choices and therefore give informed consent. 

Innovation in medical care has brought great relief to millions and saved many lives, however without, as the report states, comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes, innovation can be dangerous. The lack of basic information is astonishing. The NHS does not know how many women have undergone mesh procedures, it does not know how many pregnant women took the antiepileptic drug sodium valproate. As the report concludes, 

'In the absence of such information, it is impossible to know how many women would have chosen a different form of treatment...if only they had been given the information they needed to make a fully-informed choice'.

And I do think that is a damning conclusion. 

The Deputy Presiding Officer took the Chair.

Indeed, the health system cannot be relied upon to identify promptly adverse outcomes arising from a particular medication or device. The yellow card scheme in which doctors can report adverse reactions to treatments is not fit for purpose. As Cumberlege notes, there is gross underreporting and our complaint systems are both too complex and too diffuse to allow early signal detection, and I do think that is very, very worrying. And it led to recommendation 7, which calls for databases on all devices, allowing for patient identification and audit of outcomes. Lack of information and databases makes the system opaque.

A further flaw is the opportunity for conflicts of interest to arise in the medical profession. This is particularly so, the report notes,

'where doctors have financial and other links with the pharmaceutical and medical device companies. Currently there is no central register of clinicians’ financial and non-financial interests.'

This led to recommendation 8, which calls for the register of the General Medical Council to include a list of financial and non-pecuniary interests. And I'm pleased the GMC has noted that the current arrangements to record and manage interests falls short of delivering adequate transparency and assurance for patients. Indeed, I should note that the GMC has taken an interest in this short debate and I believe they've made a very helpful briefing note available to Members and I do welcome that.

Let us return to the voice of patients. Here are a few patient voices quoted in the report:

'I have had a constant battle to get the help and treatment I needed with my mesh complications. "Gaslighting" and a "fobbing off" culture appears to be rife'.

And I would remember that this is probably from an older patient, but the term 'gaslighting' is used for when someone in a position of power implies the person is losing their mind. What an experience that patient must have gone through. Another patient:

'the person I once was, she has gone and no-one seems able to help me. No-one is listening.'

Another patient:

'They would tell you there is nothing wrong with you and that you are just a hysterical woman'.

What a thing to have implied to a patient who is suffering complications from a particular procedure. And finally:

'Had I realised the full implications of this medication, I would never have taken it.'

In the UK Supreme Court's landmark case Montgomery v Lanarkshire Health Board, it was held that obtaining consent needs to be framed by the information an individual patient requires. It is the patient's right to be told whatever information they need to know and in a manner that they can understand so they can make decisions on whether or not to proceed with a particular procedure or medication. In other words, there needs to be a true equality, a true partnership in the decision-making process between patients and their treating physicians. But this requires not a plethora of information by a confetti of patient information leaflets that lead to confusion and give little support in their interpretation, but rather effective patient decision aids. Patient decision aids encourage active participation by patients and healthcare professionals to make decisions. They make it easier for patients and those professions to discuss treatment options, and this is done through information and clinical evidence, the discussion of benefits, risks and uncertainties, the acknowledgement of patient preferences, which can be quite profound in many areas of medical practice, support for patients, so that they are taken through the decision-making process and given a chance to fully understand it, and recording and implementing these joint decision-making decisions. And it is not to be a one-off consultation but a process that allows patients time for reflection and understanding, hence the need for recording, and that done by various technologies now—audio and video.

I now want to conclude by asking the Minister if, in his response, he could cover the following: whether the patient safety commissioner that has now been established by the UK Government for England will have a role in Wales, and possibly be an England-and-Wales appointment, or will a similar office be established for Wales, and if not, why not, and how will the Cumberlege review in this respect be carried forward in Wales; if he would review the provision of informed consent in the Welsh NHS, and in particular the use of patient decision aids, their improvement and their application across the board as a matter of common practice; and finally, whether databases are going to be held on devices, so that we can have proper audit and evaluation of outcomes.

I finish by once again commending the work of Baroness Cumberlege and also paying tribute to the many witnesses from Wales who gave evidence. It's time for us to act on this excellent review. It has many, many lessons for us to learn in Wales. Thank you very much, Deputy Presiding Officer.

Thank you to David Melding. One of the reasons that I asked to contribute today was to pay tribute to the work of my constituent Jo Cozens, who is chair of the Organisation for Anti-Convulsant Syndrome charity, or OACS. For several years, Jo has campaigned tirelessly on behalf of families across the UK touched by foetal anti-convulsant syndromes. Jo does this out of first-hand experience, having been given sodium valproate to treat epilepsy, with which she was diagnosed as a  teenager. Later on, on the advice of a doctor at the time, she continued to take this medication while pregnant with her son Tomas. Tomas is now a teenager and he's faced multiple health challenges all his life, having been diagnosed with foetal valproate neurodevelopmental effects, and it's through her work with OACS that Jo's discovered that many other families have been affected like her, due to mothers taking sodium valproate when pregnant.

Jo's made it her mission to ensure that Governments across the UK legislate so that experiences like hers, and of other families affected, never happen again, and that's why she wants to see the implementation of the Cumberlege review's recommendations. I would be grateful to the Minister if he, as David Melding said, could provide us with an update today as to where we are with this in Wales. He will be aware that I've written to him about this, and that Jo has met with his officials, although not since last September. We're really keen to see progress on this, for the benefit of Jo, Tomas and all those who have been affected like them.

I'd like to thank David Melding for bringing this forward, because the Cumberlege report is such a crucial piece of evidence in trying to move medicine for women forward. I have two points I really want to make. One of the things that Cumberlege said very clearly was that the system, the big system, is not good at spotting trends in practice and outcome that give rise to safety concerns. We can look at this, we can look at maternity services at Cwm Taf—it doesn't matter, whatever it is. Now, if you had an aeroplane that fell out of the sky, they're not going to send the next plane up until they absolutely not only know what went wrong, but can ensure that it never happens again—safety record is par excellence in something like the aircraft industry. But we don't apply the same kind of principles to what we do here on the ground in the NHS, whether it's in Wales or the UK. It's that sort of drive that we must have to ensure that we follow innovation, that we give it good pre-market testing, that we follow the outcomes and we ensure it does no harm.

The first thing I'd like to ask, Minister, is: can we start looking at really developing a robust system to ensure that we learn from our mistakes? We're always going to make mistakes—it happens—but we must learn from each and every one. And my last comment is—and I have to say it again: gender bias. There is such strong gender bias in the development of medicines, the trialling of medicines. You've only got to look at all the reports that are written about it, and how gender bias is shown in cardiovascular and the management of irritable bowel syndrome, even just risk bias for saying, 'We'll let this device go forward'. And we need to look at how we alter that paradigm within research. I think it's probably a question for all Governments—I'm not aiming this at the Welsh Government—but there is gender bias in the delivery and research of medicine, and we need to work our way slowly towards balancing that out. Women and children tend not to have quite the same attention to some of the details. I'm not saying it; report after report that I've read say that, and I think we need to consider that. 

Thank you. Can I now call the Minister for Health and Social Services to reply to this debate, Vaughan Gething? 

Thank you, Deputy Presiding Officer, and I'd like to thank David Melding, Angela Burns and Hefin David for their contributions today, for the thoughtful nature of those contributions, and the manner in which they were put on a subject matter that is difficult, upsetting and life-changing. And I recognise what Angela Burns has said about the bias and the challenges over women's health, and I've said this before on other subjects. I do think that we have a particular challenge with the history of our NHS that is still with us; that was part of the reason why I set up the women's health group, with a particular focus on taking forward issues where there is a need to deliver improvement.

And the independent medicines and medical devices safety review, commonly known now as the Cumberlege report, that was, as David Melding said, published in July last year, 'First Do No Harm', was commissioned by the previous Secretary of State for Health in the UK Government, but that review did take evidence from across the UK, and much of what it has to say is relevant here in Wales. 

In terms of the three issues, the pregnancy tests such as Primodos, the impact of sodium valproate especially, as has been said, on an unborn child during pregnancy, and medical devices were the particular issues that led to the report, but there is much broader learning here, and I think it's entirely appropriate that David Melding has focused on informed consent.

The review's focus did look more generally at patient safety in order to build a system that listens, hears and acts with speed, compassion and proportionality. That is much of what we say about our NHS at its finest—the speed with which new treatments are brought on board, the compassion of our staff and the challenge of a risk-based approach to delivering care and treatment, much of which we are living through now. But we also know that when you get that wrong, the impact can be significant for the person receiving treatment. 

The report identified consent as an overarching theme, and it identified the missed opportunities where avoidable harm could have been prevented, and which should be addressed. And it specifies that patients should receive information they require in a form that they can understand to make decisions, including on procedures, treatments, the options available, including no treatment, the risks both long and short term of adverse outcomes, and the alternative available remedial treatments. It recognises, as David Melding highlighted, the need for clear, consistent and meaningful information leaflets to avoid confusion, and the need for a single patient decision aid for each surgical procedure or medical intervention. It also advocated more use of non-paper information sources.

The requirement, though, for clinicians to seek, at pace, to give informed or meaningful consent does not come from the Cumberlege report. It has a longstanding history in our NHS, including here in Wales. The previous Welsh Government incarnation issued guidance to clinicians in 2008 on this subject. The chief medical officer wrote to clinicians again on the subject in 2014, when the first signs of complications experienced by those who had received mesh implants became evident.

Welsh Government guidance was reinforced to reflect the ruling of the Montgomery v Lanarkshire case in 2015 that David Melding referenced, and that again shifted the focus of consent towards the specific need of the patient. Now, that went through the points about examination and treatment becoming shared between clinicians and patients, and embraced the principle of patient-centred care and co-production—exactly the sorts of things we find in our prudent healthcare approach and in the centre of our plan, 'A Healthier Wales'. We've had a model of informed consent policy since 2017, backed by a Welsh health circular, and guidance, which incorporated the Montgomery ruling and was supported by clinicians from all of our health boards.

The NHS Wales shared services risk pool co-ordinates an all-Wales consent group to support the development of a unified approach across all health boards on consent matters. That group has produced refreshed training and education packages for clinicians across Wales, including an e-learning system, a series of webinars, and presentations. These are all designed to ensure that clinicians receive up-to-date training on legal matters and good consent practice. The Cumberlege review called the wide range and number of patient information leaflets 'bewildering' and a 'major source of confusion'. Again, David Melding highlighted this in his contribution. To avoid this, the Welsh risk pool has adopted a more standardised approach and commissioned an all-Wales basis, professionally authorised, clinically reviewed, plain English campaign that should support patient information leaflets, and the Welsh risk pool has recently commissioned a pilot programme of digital consent platforms within a number of NHS Wales organisations. If successful, and I expect it will be, this will result in an all-Wales procurement exercise to be rolled out to all of Wales's health boards, and that will not be a matter of choice. There will be a decision, and that will be a national platform that everyone must use.

The new platform should provide patients who experience different comorbidities with access to information to cover their individual treatment requirements, to move away from those generic information sources that the Cumberlege report identified and criticised. The new platform should support a move from an informed consent to a shared decision-making approach, where patients are active participants and not simply recipients: active participants with clinicians in determining their future treatment, based on access to relevant advice and information, and possibly contact with those who have experienced similar clinical procedures. And this is what Cumberlege calls that true equality of partnership. Finally, the risk pool intends to undertake a national review of the arrangements for informed consent, to establish their effectiveness, identify areas for development, and determine future direction. The review has been delayed by the pandemic, but it will commence in April this year and is expected to report to the new Government.

I want to finish by dealing with some of the questions and points that were raised, and on improving patient safety and improving patient outcomes, on devices, as Members will know, we've given consent for a UK-wide system to introduce a device register. That should allow tracking back to understand more clearly the safety of devices, and I think will be a significant step forward for patient safety, and understanding patient outcomes for different devices. There is, of course, more to do, and you can expect a fuller response within this term before the Senedd ends, to take forward how equivalent improvement is made here in Wales as envisaged by the recommended patient safety commissioner in England. Our system is set up in a different way, and so our answer will be slightly different but the aim is the same: how do we practically improve patient safety and have a more visible way for that safety being assured?

My final comment is to reflect the sadness and the anger for people who have been let down: those people who were not listened to, those people who were harmed, and the length of time it has taken to respond. That response is not complete yet, but I confirm we'll do more within this term, and whoever is in the next Government will still have more to do with the changes that we intend to make to make sure they deliver the improvement in not just consent but in patient outcomes and patient safety.

Thank you very much.