English: 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.
Welsh: Diolch, Ddirprwy Lywydd, a hoffwn ddiolch i David Melding, Angela Burns a Hefin David am eu cyfraniadau heddiw, am natur feddylgar y cyfraniadau hynny, a'r modd y cawsant eu rhoi ar bwnc sy'n anodd, yn peri gofid ac yn newid bywydau. Ac rwy'n cydnabod yr hyn y mae Angela Burns wedi'i ddweud am y gogwydd a'r heriau sy'n ymwneud ag iechyd menywod, ac rwyf wedi dweud hyn o'r blaen ar bynciau eraill. Credaf fod gennym her arbennig gyda hanes ein GIG sy'n dal gyda ni; roedd hynny'n rhan o'r rheswm pam y sefydlais y grŵp iechyd menywod, gan ganolbwyntio'n benodol ar ddatblygu materion lle mae angen gwelliant. A chomisiynwyd yr adolygiad annibynnol o ddiogelwch meddyginiaethau a dyfeisiau meddygol, a adwaenir yn awr yn gyffredinol fel adroddiad Cumberlege, ac a gyhoeddwyd, fel y dywedodd David Melding, ym mis Gorffennaf y llynedd, sef 'First Do No Harm', gan yr Ysgrifennydd Gwladol blaenorol dros Iechyd yn Llywodraeth y DU, ond cymerodd yr adolygiad hwnnw dystiolaeth o bob rhan o'r DU, ac mae llawer o'r hyn sydd ganddo i'w ddweud yn berthnasol yma yng Nghymru. O ran y tri mater, y profion beichiogrwydd megis Primodos, effaith sodiwm falproat yn enwedig, fel y dywedwyd, ar blentyn cyn ei eni yn ystod beichiogrwydd, a dyfeisiau meddygol oedd y materion penodol a arweiniodd at yr adroddiad, ond mae llawer i'w ddysgu'n fwy eang yma, a chredaf ei bod yn gwbl briodol fod David Melding wedi canolbwyntio ar gydsyniad ar sail gwybodaeth. Roedd ffocws yr adolygiad yn edrych yn fwy cyffredinol ar ddiogelwch cleifion er mwyn adeiladu system sy'n gwrando, yn clywed ac yn gweithredu gyda chyflymder, tosturi a chymesuredd. Dyna lawer o'r hyn a ddywedwn am ein GIG ar ei orau - pa mor gyflym y caiff triniaethau newydd eu cyflwyno, tosturi ein staff a her dull sy'n seiliedig ar risg o ddarparu gofal a thriniaeth, ac rydym yn byw drwy lawer o hynny yn awr. Ond pan fyddwch yn cael hynny'n anghywir, rydym hefyd yn gwybod y gall yr effaith fod yn sylweddol i'r sawl sy'n cael triniaeth. Nododd yr adroddiad gydsyniad fel thema gyffredinol, a nododd y cyfleoedd a gollwyd lle gellid bod wedi atal niwed y gellid ei osgoi, ac y dylid mynd i'r afael ag ef. Ac mae'n nodi y dylai cleifion gael y wybodaeth sydd ei hangen arnynt ar ffurf y gallant ei deall i wneud penderfyniadau, gan gynnwys ar lawdriniaethau, triniaethau, yr opsiynau sydd ar gael, yn cynnwys dim triniaeth, y risgiau yn y tymor hir a'r tymor byr o ganlyniadau andwyol, a'r triniaethau adferol amgen sydd ar gael. Fel y nododd David Melding, mae'n cydnabod yr angen am daflenni gwybodaeth clir, cyson ac ystyrlon er mwyn osgoi dryswch, a'r angen am un cymorth penderfynu i gleifion ar gyfer pob llawdriniaeth lawfeddygol neu ymyrraeth feddygol. Roedd hefyd yn argymell mwy o ddefnydd o ffynonellau gwybodaeth nad ydynt yn rhai ysgrifenedig. Er hynny, nid yw'r gofyniad i glinigwyr ofyn am gydsyniad ar sail gwybodaeth neu gydsyniad ystyrlon yn gyflym yn deillio o adroddiad Cumberlege. Mae iddo hanes hirsefydlog yn ein GIG, gan gynnwys yma yng Nghymru. Cyhoeddodd llywodraeth flaenorol Cymru ganllawiau i glinigwyr yn 2008 ar y pwnc hwn. Ysgrifennodd y prif swyddog meddygol at glinigwyr eto ar y mater yn 2014, pan gafwyd yr arwyddion cyntaf fod rhai a oedd wedi cael mewnblaniadau rhwyll yn profi cymhlethdodau. Atgyfnerthwyd canllawiau Llywodraeth Cymru i adlewyrchu dyfarniad achos Montgomery v Swydd Lanarkshire yn 2015, achos y cyfeiriodd David Melding ato, ac unwaith eto symudodd hynny ffocws cydsyniad tuag at angen penodol y claf. Nawr, aeth hwnnw drwy'r pwyntiau fod archwiliadau a thriniaeth yn cael eu rhannu rhwng clinigwyr a chleifion, a chroesawodd yr egwyddor o ofal sy'n canolbwyntio ar y claf a chydgynhyrchu - yr un math o bethau a welwn yn ein dull gofal iechyd darbodus ac yn ganolog yn ein cynllun, 'Cymru Iachach'. Rydym wedi bod â model o bolisi cydsyniad ar sail gwybodaeth ers 2017, wedi'i gefnogi gan gylchlythyr iechyd yng Nghymru, a chanllawiau, a oedd yn ymgorffori dyfarniad Montgomery, ac a gâi eu cefnogi gan glinigwyr ym mhob un o'n byrddau iechyd. Mae cydwasanaethau cronfa risg GIG Cymru yn cydlynu grŵp cydsyniad Cymru gyfan i gefnogi'r gwaith o ddatblygu dull unedig ar draws yr holl fyrddau iechyd ar faterion cydsynio. Mae'r grŵp hwnnw wedi cynhyrchu pecynnau hyfforddiant ac addysg wedi'u hadnewyddu ar gyfer clinigwyr ledled Cymru, gan gynnwys system e-ddysgu, cyfres o weminarau, a chyflwyniadau. Mae'r rhain i gyd wedi'u cynllunio i sicrhau bod clinigwyr yn cael yr hyfforddiant diweddaraf ar faterion cyfreithiol ac arferion cydsyniad da. Galwodd adolygiad Cumberlege yr ystod eang a nifer y taflenni gwybodaeth i gleifion yn 'ddryslyd' ac yn 'ffynhonnell dryswch mawr'. Unwaith eto, tynnodd David Melding sylw at hyn yn ei gyfraniad. Er mwyn osgoi hyn, mae cronfa risg Cymru wedi mabwysiadu dull mwy safonol ac wedi comisiynu ymgyrch glir ar gyfer Cymru gyfan, wedi'i hawdurdodi'n broffesiynol, a'i hadolygu'n glinigol, a ddylai gefnogi taflenni gwybodaeth i gleifion, ac mae cronfa risg Cymru wedi comisiynu rhaglen beilot o blatfformau cydsyniad digidol yn ddiweddar o fewn nifer o sefydliadau GIG Cymru. Os bydd yn llwyddiannus, ac rwy'n disgwyl y bydd, fe fydd yn arwain at gyflwyno ymarfer caffael i Gymru gyfan i'w gyflwyno i holl fyrddau iechyd Cymru, ac nid mater o ddewis fydd hynny. Gwneir penderfyniad, a bydd hwnnw'n blatfform cenedlaethol y bydd yn rhaid i bawb ei ddefnyddio. Dylai'r platfform newydd roi mynediad at wybodaeth i gleifion sy'n dioddef gwahanol fathau o gydafiachedd a fydd yn cwmpasu eu gofynion triniaeth unigol, er mwyn symud oddi wrth y ffynonellau gwybodaeth generig a nodwyd ac a feirniadwyd gan adroddiad Cumberlege. Dylai'r platfform newydd gefnogi newid o gydsyniad ar sail gwybodaeth i ddull o wneud penderfyniadau ar y cyd, lle mae cleifion yn gyfranogwyr gweithredol ac nid yn dderbynwyr yn unig: cyfranogwyr gweithredol gyda chlinigwyr yn y broses o benderfynu ar eu triniaeth yn y dyfodol, yn seiliedig ar fynediad at gyngor a gwybodaeth berthnasol, a chyswllt â phobl sydd wedi profi llawdriniaethau clinigol tebyg o bosibl. A dyma'r hyn y mae Cumberlege yn ei alw'n bartneriaeth wirioneddol gydradd. Yn olaf, mae'r gronfa risg yn bwriadu cynnal adolygiad cenedlaethol o'r trefniadau ar gyfer cydsyniad ar sail gwybodaeth, i sefydlu eu heffeithiolrwydd, nodi meysydd i'w datblygu, a phennu cyfeiriad yn y dyfodol. Mae'r adolygiad wedi'i ohirio gan y pandemig, ond bydd yn dechrau ym mis Ebrill eleni a disgwylir iddo adrodd i'r Llywodraeth newydd. Rwyf am orffen drwy ymdrin â rhai o'r cwestiynau a'r pwyntiau a godwyd, ac ar wella diogelwch cleifion a gwella canlyniadau cleifion, ar ddyfeisiau, fel y gŵyr yr Aelodau, rydym wedi cydsynio i system ledled y DU i gyflwyno cofrestr dyfeisiau. Dylai hynny ganiatáu ar gyfer olrhain yn ôl i ddeall diogelwch dyfeisiau'n gliriach, a chredaf y bydd yn gam sylweddol ymlaen o ran diogelwch cleifion, a deall canlyniadau cleifion ar gyfer gwahanol ddyfeisiau. Wrth gwrs, mae mwy i'w wneud, a gallwch ddisgwyl ymateb llawnach yn y tymor hwn cyn i'r Senedd ddod i ben, i ddatblygu sut y mae modd i welliant cyfatebol i'r hyn a ragwelwyd gan y comisiynydd diogelwch cleifion a argymhellwyd yn Lloegr gael ei wneud yma yng Nghymru. Mae ein system wedi'i sefydlu mewn ffordd wahanol, ac felly bydd ein hateb ychydig yn wahanol ond mae'r nod yr un fath: sut y mae gwella diogelwch cleifion yn ymarferol a chael ffordd fwy gweladwy o sicrhau'r diogelwch hwnnw? Mae fy sylw olaf yn adlewyrchu'r tristwch a'r dicter i bobl sydd wedi cael eu siomi: y bobl na wrandawyd arnynt, y bobl a gafodd eu niweidio, a'r amser y mae wedi'i gymryd i ymateb. Nid yw'r ymateb hwnnw wedi'i gwblhau eto, ond rwy'n cadarnhau y byddwn yn gwneud mwy yn y tymor hwn, a bydd gan bwy bynnag a fydd yn y Llywodraeth nesaf fwy i'w wneud eto â'r newidiadau y bwriadwn eu gwneud i sicrhau eu bod yn cyflawni'r gwelliant nid yn unig o ran cydsyniad ond o ran canlyniadau cleifion a diogelwch cleifion.