English: 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what had happened in respect of two medications and one medical device, namely hormone pregnancy tests, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages; sodium valproate, an effective antiepileptic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 treatmentif only they had been given the information they needed to make a fully-informed choice'. And I do think that is a damning conclusion.
Welsh: Diolch yn fawr iawn, Lywydd. Rwyf wedi cytuno i roi rhywfaint o fy amser i Hefin David ac i Angela Burns. Testun fy nadl fer yw adolygiad Cumberlege - gwersi ar gyfer cydsyniad ar sail gwybodaeth yn y GIG. Hoffwn ddechrau drwy ganmol yr awdurdod a threiddgarwch yr adolygiad a gynhaliwyd gan y Farwnes Cumberlege, o'r enw 'First Do No Harm'. Dyna egwyddor hynaf meddygaeth foesegol, a chredaf ei bod yn briodol inni gadw hynny mewn cof pan ystyriwn y materion sydd ger ein bron yn y ddadl hon. Er iddo gael ei gomisiynu gan yr Ysgrifennydd Gwladol dros Iechyd yn Llywodraeth y DU a'i fod yn canolbwyntio'n bennaf ar y GIG yn Lloegr, cymerwyd tystiolaeth yng Nghymru a'r Alban, ac yn wir, mae'n debyg fod llawer ohonom wedi bod â rhywfaint o waith achos gan dystion a roddodd dystiolaeth yng Nghymru; fe gefais i waith achos o'r fath yn sicr. Ymchwiliodd yr adolygiad i'r hyn a ddigwyddodd mewn perthynas â dwy feddyginiaeth ac un ddyfais feddygol, sef profion beichiogrwydd hormonaidd, a waharddwyd o'r farchnad ar ddiwedd y 1970au ac y credir eu bod yn gysylltiedig â namau geni a chamesgoriad; sodiwm falproat, cyffur gwrthepileptig effeithiol, sy'n achosi camffurfiadau corfforol, awtistiaeth ac oedi datblygiadol mewn llawer o blant pan gaiff ei gymryd gan eu mamau yn ystod beichiogrwydd; a mewnblaniadau rhwyll y pelfis a ddefnyddir mewn llawdriniaethau i atgyweirio prolaps organau'r pelfis ac i reoli anymataliaeth straen wrinol y cysylltwyd eu defnydd â chymhlethdodau andwyol sy'n newid bywydau. Fodd bynnag, cydnabuwyd yn eang fod yr adolygiad yn berthnasol a bod modd ei gymhwyso i ddiogelwch meddyginiaethau a dyfeisiau meddygol yn gyffredinol. Un o'r pethau y gofynnwyd i'r adolygiad ei ystyried oedd sut i gryfhau llais y claf, nad oedd yn cael ei glywed ac a oedd yn arwain at ddewisiadau a chanlyniadau gwael. Un o argymhellion canolog yr adroddiad yw sefydlu comisiynydd diogelwch cleifion. Fel y dywed yr adroddiad, ac rwy'n dyfynnu, Roedd straeon y cleifion yn ysgytwol Gwnaethant adrodd eu hanesion gydag urddas a huodledd, ond hefyd gyda thristwch a dicter, i dynnu sylw at themâu cyffredin a chymhellol. A'r thema - y thema gryfaf, gellid dadlau - rwyf am ei harchwilio heddiw yw'r diffyg gwybodaeth i allu gwneud dewisiadau ar sail gwybodaeth ac felly i roi cydsyniad ar sail gwybodaeth. Mae arloesi mewn gofal meddygol wedi dod â rhyddhad mawr i filiynau ac wedi achub llawer o fywydau, ond fel y dywed yr adroddiad, heb brofion cynhwysfawr cyn eu cyflwyno i'r farchnad a goruchwyliaeth ar ôl eu cyflwyno i'r farchnad a monitro canlyniadau yn hirdymor, gall arloesi fod yn beryglus. Mae'r diffyg gwybodaeth sylfaenol yn syfrdanol. Nid yw'r GIG yn gwybod faint o fenywod sydd wedi cael llawdriniaethau rhwyll, nid yw'n gwybod faint o fenywod beichiog a gymerodd y cyffur gwrthepileptig sodiwm falproat. Fel y casgla'r adroddiad, Yn niffyg gwybodaeth o'r fath, mae'n amhosibl gwybod faint o fenywod fyddai wedi dewis math gwahanol o driniaeth mae'n drueni na fyddent wedi cael y wybodaeth roeddent ei hangen i wneud dewis ar sail y wybodaeth lawn. Ac rwy'n credu bod hwnnw'n gasgliad damniol.