English: 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.
Welsh: Yn wir, ni ellir dibynnu ar y system iechyd i nodi canlyniadau andwyol sy'n deillio o feddyginiaeth neu ddyfais benodol yn gyflym. Nid yw'r cynllun cerdyn melyn lle gall meddygon roi gwybod am adweithiau andwyol i driniaethau yn addas i'r diben. Fel y noda Cumberlege, ceir tangofnodi dybryd ac mae ein systemau cwyno yn rhy gymhleth ac yn rhy wasgaredig i ganiatáu ar gyfer canfod arwyddion yn gynnar, ac rwy'n credu bod hynny'n destun pryder mawr. Ac arweiniodd at argymhelliad 7, sy'n galw am gronfeydd data ar bob dyfais, i ganiatáu ar gyfer adnabod cleifion ac archwilio canlyniadau. Mae diffyg gwybodaeth a chronfeydd data yn gwneud y system yn anhryloyw. Gwendid arall yw'r cyfle i wrthdaro buddiannau godi yn y proffesiwn meddygol. Mae hyn yn arbennig o bwysig, fel y noda'r adroddiad, lle mae gan feddygon gysylltiadau ariannol a chysylltiadau eraill â'r cwmnïau fferylliaeth a dyfeisiau meddygol. Ar hyn o bryd nid oes cofrestr ganolog o fuddiannau ariannol ac anariannol clinigwyr. Arweiniodd hyn at argymhelliad 8, sy'n galw ar gofrestr y Cyngor Meddygol Cyffredinol i gynnwys rhestr o fuddiannau ariannol ac anariannol. Ac rwy'n falch bod y Cyngor Meddygol Cyffredinol wedi nodi nad yw'r trefniadau presennol i gofnodi a rheoli buddiannau yn darparu digon o dryloywder a sicrwydd i gleifion. Yn wir, dylwn nodi bod y Cyngor Meddygol Cyffredinol wedi dangos diddordeb yn y ddadl fer hon a chredaf eu bod wedi sicrhau bod nodyn briffio defnyddiol iawn ar gael i'r Aelodau ac rwy'n croesawu hynny. Gadewch inni ddychwelyd at lais cleifion. Dyma ychydig o leisiau cleifion a ddyfynnir yn yr adroddiad: Rwyf wedi gorfod brwydro'n gyson i gael y cymorth a'r driniaeth roeddwn eu hangen gyda'r cymhlethdodau gyda fy rhwyll. Ymddengys bod diwylliant "dibwyllo" a "gwneud esgusodion" yn rhemp. Ac rwy'n cofio mai claf hŷn a ddywedodd hyn, mae'n debyg, ond defnyddir y term 'dibwyllo' pan fydd rhywun sydd â phŵer yn awgrymu bod y person yn colli ei gof. Rhaid bod y claf wedi mynd drwy brofiad ofnadwy. Claf arall: mae'r person yr arferwn fod ar un adeg wedi mynd ac nid yw'n ymddangos bod neb yn gallu fy helpu. Nid oes neb yn gwrando. Claf arall: Byddent yn dweud wrthych nad oes dim o'i le arnoch chi ac mai dim ond menyw hysterig ydych chi. Am beth i fod wedi'i awgrymu wrth glaf sy'n dioddef cymhlethdodau yn sgil llawdriniaeth benodol. Ac yn olaf: Pe bawn i wedi sylweddoli goblygiadau llawn y feddyginiaeth hon, ni fyddwn byth wedi'i chymryd. Yn achos nodedig Montgomery v Bwrdd Iechyd Lanarkshire, a gynhaliwyd yng Ngoruchaf Lys y DU, barnwyd bod angen i gydsyniad gael ei fframio gan y wybodaeth sydd ei hangen ar glaf unigol. Hawl y claf yw cael gwybod pa wybodaeth bynnag sydd angen iddynt ei gwybod ac mewn modd y gallant ei ddeall fel y gallant wneud penderfyniadau ynglŷn ag a ddylid bwrw ymlaen â llawdriniaeth neu feddyginiaeth benodol ai peidio. Mewn geiriau eraill, mae angen cydraddoldeb gwirioneddol, partneriaeth wirioneddol yn y broses o wneud penderfyniadau rhwng cleifion a'r meddygon sy'n eu trin. Ond nid yw hyn yn golygu toreth o wybodaeth ar lu o daflenni gwybodaeth i gleifion gan arwain at ddryswch heb fawr o gefnogaeth i'w dehongli, ond yn hytrach, cymhorthion penderfynu effeithiol i gleifion. Mae cymhorthion penderfynu i gleifion yn annog cleifion a gweithwyr gofal iechyd proffesiynol i gymryd rhan weithredol yn y broses o wneud penderfyniadau. Maent yn ei gwneud yn haws i gleifion a'r proffesiynau drafod opsiynau triniaeth, a gwneir hyn drwy wybodaeth a thystiolaeth glinigol, trafod manteision, risgiau ac ansicrwydd, cydnabod dewisiadau cleifion, a all fod yn eithaf dwys mewn nifer o feysydd ymarfer meddygol, cymorth i gleifion, fel y cânt eu tywys drwy'r broses o wneud penderfyniadau a chael cyfle i'w deall yn llawn, a chofnodi a gweithredu'r penderfyniadau hyn a wneir ar y cyd. Ac nid ymgynghoriad untro mohono ond yn hytrach, proses sy'n caniatáu amser i gleifion ystyried a deall, a dyna pam y mae angen cofnodi, a gwneud hynny bellach drwy ddefnyddio gwahanol dechnolegau - sain a fideo. Hoffwn gloi yn awr drwy ofyn i'r Gweinidog yn ei ymateb i ymdrin â'r canlynol: a fydd gan y comisiynydd diogelwch cleifion sydd bellach wedi'i sefydlu gan Lywodraeth y DU ar gyfer Lloegr rôl yng Nghymru, ac a fydd o bosibl yn benodiad ar gyfer Cymru a Lloegr, neu a fydd swydd debyg yn cael ei sefydlu ar gyfer Cymru, ac os na, pam ddim, a sut y caiff adolygiad Cumberlege yn hyn o beth ei weithredu yng Nghymru; a wnaiff adolygu'r ddarpariaeth ar gyfer cydsyniad ar sail gwybodaeth yn GIG Cymru, ac yn enwedig y defnydd o gymhorthion penderfynu i gleifion, a'u gwella a'u cymhwyso'n gyffredinol fel mater o ymarfer cyffredin; ac yn olaf, a fydd cronfeydd data'n cael eu cadw ar ddyfeisiau, fel y gallwn gael archwiliad priodol a gwerthuso canlyniadau. Rwy'n gorffen drwy ganmol gwaith y Farwnes Cumberlege unwaith eto a hefyd drwy dalu teyrnged i'r tystion niferus o Gymru a roddodd dystiolaeth. Mae'n bryd inni weithredu ar yr adolygiad rhagorol hwn. Mae ynddo lawer o wersi inni eu dysgu yng Nghymru. Diolch yn fawr iawn, Ddirprwy Lywydd.