English: Diolch, Lywydd. Good afternoon, Cabinet Secretary. Thank you very much for bringing forward this statement today. I would also like to put on record my thanks to the review panel for conducting this and my thanks to you for involving all the opposition parties so comprehensively in this entire process. I'd also like to thank the great many members of the public. Particularly, I know that a lot of my constituents put forward their cases and they were very brave to do so. I'm grateful to all of them, because I think this is a very well-balanced report and I'm delighted that you've accepted all the recommendations and intend to move forward on it. I do want to ask you just a couple of questions that come from it, though. A lot of this is predicated on the word 'significant'. I'm sure all of us around this Chamber will be delighted that we no longer have to use the exceptionality clauses, but it says here quite clearly, 'By "significant," we mean that the nature of the benefit to be expected, and the consideration of cost-effectiveness of the intervention, should be comparable to the criteria normally applied to patients whose conditions have the benefit of HTA guidelines'. So, 'significance' is obviously an accepted word for the main cohort when you are passing a medicine and saying that it is all right to be used on a general level, and now, of course, you're looking to use that word, or the review recommends using the word 'significant' for rare and ultra-orphan diseases, for those who do not have an HTA, and for new interventions. So, I'd be very grateful if you could just give a little bit of clarity on how we define 'significance' - how that's defined and how we can remove any lack of clarity around that so people are very clear that it's a very, sort of, logical assessment, because, of course, we're trying to take the heat out of what is a very emotional subject. I'd be very grateful as well if you could just give us a quick update on where you see the new national IPFR quality function sitting. Would it be part of one of the existing areas such as - I don't know - Healthcare Inspectorate Wales, or will you be looking to set up something within your own portfolio, or an independent arm's-length body? Just two more questions: there was one area I didn't think the review dealt with, particularly, and that was the question of putting timings onto decision-making processes. I haven't been able to spot it when going through the review, and I just wondered if you might comment on that. By timings, that's timings for a decision to be made, because, of course, most of the people who are applying for these through the IPFR treatment are people who are grievously sick - time is not their friend - and I know that there have been examples put forward to the review panel about how long it's taken for a decision to be made, and how, in the end, that person has passed a point where what they were applying for would help them. So, if you could make some comment on that. And finally - again, it's timing, but this time the timing of the reports. I understand now that the health boards have between now and September to implement the recommendations, with a first report back to us in June 2018, and then ongoing reports every June after that. One of the criticisms of a previous method for the IPFR was that it wasn't transparent enough, and that public and clinicians have lost confidence in it. I'm concerned that if we don't get a full report back until June 2019, with a full 12 months of data, this may be too long to tweak it, pick up any issues, and correct any problems. So, I wonder if you might consider bringing forward, perhaps, for the short term, maybe three-monthly reports. I think it would help to increase public confidence, and it would allow problems to be identified and course corrections to be made much earlier, although I do accept that in the long term you'd want to lengthen that reporting process back out again. Thank you.
Welsh: Diolch, Lywydd. Prynhawn da, Ysgrifennydd y Cabinet. Diolch yn fawr iawn am gyflwyno'r datganiad hwn heddiw. Hoffwn hefyd gofnodi fy niolch i'r panel adolygu am gynnal hyn a'm diolch i chi am gynnwys yr holl wrthbleidiau mewn modd mor gynhwysfawr yn y broses gyfan hon. Hoffwn hefyd ddiolch i'r nifer fawr o aelodau'r cyhoedd. Yn arbennig, rwy'n gwybod bod llawer o fy etholwyr wedi cyflwyno eu hachosion ac roeddent yn ddewr iawn i wneud hynny. Rwy'n ddiolchgar i bob un ohonynt, oherwydd rwy'n meddwl bod hwn yn adroddiad cytbwys iawn ac rwyf wrth fy modd eich bod wedi derbyn yr holl argymhellion ac yn bwriadu gweithredu arno. Serch hynny, hoffwn ofyn un neu ddau o gwestiynau ichi amdano. Mae llawer o hyn yn ymwneud â'r gair 'arwyddocaol'. Rwy'n siŵr y bydd pawb ohonom o amgylch y Siambr hon yn falch iawn na fydd yn rhaid inni ddefnyddio'r cymalau eithriadoldeb mwyach, ond mae'n dweud yma yn eithaf clir, 'Drwy "arwyddocaol", rydym yn golygu y dylai natur y budd sydd i'w ddisgwyl, ac ystyriaeth o gost-effeithiolrwydd yr ymyrraeth, fod yn gymaradwy â'r meini prawf a ddefnyddir fel arfer ar gyfer cleifion y mae eu cyflyrau yn elwa ar ganllawiau HTA'. Felly, mae 'arwyddocâd' yn amlwg yn air a dderbynnir gan y brif garfan wrth ichi basio meddyginiaeth a dweud ei bod yn iawn i gael ei defnyddio ar lefel gyffredinol, ac nawr, wrth gwrs, rydych yn bwriadu defnyddio'r gair hwnnw, neu mae'r adolygiad yn argymell defnyddio'r gair 'arwyddocaol' ar gyfer clefydau prin a thra amddifad, ar gyfer rhai heb HTA, ac ar gyfer ymyraethau newydd. Felly, byddwn yn ddiolchgar iawn pe gallech roi ychydig o eglurder ynghylch sut yr ydym yn diffinio 'arwyddocâd' - sut mae hynny wedi'i ddiffinio a sut y gallwn gael gwared ar unrhyw ddiffyg eglurder ynghylch hynny fel bod pobl yn glir iawn ei fod yn asesiad, wel, rhesymegol iawn, oherwydd, wrth gwrs, rydym yn ceisio tynnu'r gwres allan o bwnc sy'n emosiynol iawn. Byddwn yn ddiolchgar iawn hefyd pe gallech roi diweddariad cyflym inni am ble yr ydych yn gweld swyddogaeth ansawdd cenedlaethol newydd yr IPFR. A fyddai'n rhan o un o'r meysydd sydd eisoes yn bodoli, fel - wn i ddim - Arolygiaeth Gofal Iechyd Cymru, ynteu a fyddwch chi'n sefydlu rhywbeth o fewn eich portffolio eich hun, neu gorff hyd braich annibynnol? Dim ond dau gwestiwn arall: roedd un maes nad oeddwn i'n meddwl bod yr adolygiad yn ymdrin ag ef, yn benodol, sef y mater o roi amseriadau ar brosesau gwneud penderfyniadau. Nid wyf wedi gallu ei weld wrth fynd drwy'r adolygiad, ac roeddwn yn meddwl tybed a allech chi roi sylwadau am hynny. Gydag amseriadau, rwy'n sôn am amseriadau ar gyfer gwneud penderfyniad, oherwydd, wrth gwrs, mae'r rhan fwyaf o'r bobl sy'n gwneud cais am y rhain drwy'r driniaeth IPFR yn bobl sy'n ddifrifol wael - nid yw amser yn ffrind iddynt - ac rwy'n gwybod y cyflwynwyd enghreifftiau i'r panel adolygu ynghylch pa mor hir y mae wedi'i gymryd i wneud penderfyniad, a sut, yn y diwedd, mae'r unigolyn hwnnw wedi mynd heibio i'r pwynt lle y byddai'r hyn y maent yn gwneud cais amdano wedi eu helpu. Felly, pe gallech wneud rhai sylwadau am hynny. Ac yn olaf - eto, ynglŷn ag amseru, ond y tro hwn amseru'r adroddiadau. Rwy'n deall nawr bod gan y byrddau iechyd rhwng nawr a mis Medi i roi'r argymhellion ar waith, ac y byddant yn cyflwyno eu hadroddiadau cyntaf inni ym mis Mehefin 2018 ac yna'n cyflwyno adroddiadau parhaus bob mis Mehefin ar ôl hynny. Un o'r beirniadaethau o un o ddulliau blaenorol yr IPFR oedd nad oedd yn ddigon tryloyw, a bod y cyhoedd a chlinigwyr wedi colli hyder ynddo. Rwy'n poeni, os na chawn adroddiad llawn yn ôl tan fis Mehefin 2019, â 12 mis cyfan o ddata, y gallai hyn fod yn rhy hir i'w addasu, ymateb i unrhyw faterion, a chywiro unrhyw broblemau. Felly, tybed a allech chi ystyried cyflwyno, efallai, ar gyfer y tymor byr, adroddiadau efallai bob tri mis. Rwy'n meddwl y byddai'n helpu i gynyddu hyder y cyhoedd, ac yn ein galluogi i ganfod problemau a chywiro'r cwrs yn llawer cynharach, er fy mod yn derbyn y byddech, yn y tymor hir, yn awyddus i ymestyn y broses adrodd yn ôl allan eto. Diolch.