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.