English: I must confess that I'm regularly frustrated at the manner in which the discussion around Orkambi has taken place. At the centre of all this, we should remember, are people, families, who want to have the best possible treatment available on our national health service. Every single company that manufactures a medicine available for the NHS understands the process they must go through, and that process is to make sure that medicines are safe and effective and that there is an appropriate value for that treatment. This treatment - Orkambi - is not readily available on the national health service in any other UK nation. That is simply not the case. It is potentially - . It is not available in other nations within the United Kingdom, nor is it available in Wales. It is available on individual patient funding requests, and it has been made available on a trial basis by the manufacturer on a limited basis for people in each of the different UK nations. So, it is simply wrong to suggest that NHS Wales has taken a different view. That is part of my frustration, because I accept that Members in every party have had correspondence from the company, and I believe I've had correspondence from Members in each and every party in this Chamber who have written to me about the issue. And I am frustrated about the lack of clarity in the process. Because I do not believe that Members are recounting matters - they have not been told, and accepted in good faith. The benefits are not proven - that is one of our biggest problems in this area. Orkambi did not simply fail a NICE appraisal on cost grounds, but NICE, on the information available to it on clinical data provided by Vertex, put it onto the 'do not use' list. Now, that is highly unusual, and that is because of the state of the clinical data available at the time. I have said, more than once, directly in correspondence to Orkambi, and, indeed, when I got doorstepped above this place by the company and their representative, that they need to engage in the process that they understand. And that is part of my frustration. I do not believe that you are having the full story painted to you. In the Petitions Committee, when they considered this matter - [ Interruption.] In the Petitions Committee, when this matter was raised, it was stated that, since the NICE appraisal, there are now 96 weeks of additional clinical data available. NICE and the All Wales Medicines Strategy Group cannot assess that information, because it has not been provided to them. Once that information is provided to NICE, then a decision will be made. But it is the company's responsibility, and nobody else's, to provide that data and information, because they have access to it and no appraisal body does. I'm more than happy to talk to Members outside here, but my frustration is that I do not believe that the full picture is being provided to you about the manner in which this drug is and is not available and responsibility for that.
Welsh: Mae'n rhaid i mi gyfaddef fy mod yn teimlo'n rhwystredig yn aml ynglŷn â'r ffordd y mae'r drafodaeth wedi digwydd mewn perthynas ag Orkambi. Yn ganolog i hyn oll, dylem gofio bod yna bobl, teuluoedd, sydd eisiau sicrhau bod y driniaeth orau bosibl ar gael yn ein gwasanaeth iechyd gwladol. Mae pob cwmni sy'n cynhyrchu meddyginiaeth ar gyfer y GIG yn deall y broses y mae'n rhaid iddynt ei dilyn, a'r broses honno yw sicrhau bod meddyginiaethau'n ddiogel ac yn effeithiol a bod gwerth priodol i'r driniaeth honno. Nid yw'r driniaeth hon - Orkambi - ar gael yn rhwydd yn y gwasanaeth iechyd gwladol mewn unrhyw wlad arall yn y DU. Nid yw hynny'n wir. Mae'n bosibl - . Nid yw ar gael mewn gwledydd eraill yn y Deyrnas Unedig ac nid yw ar gael yng Nghymru. Mae ar gael i geisiadau cyllido cleifion unigol, ac mae ar gael ar sail treialon gan y gwneuthurwr, ar sail gyfyngedig i bobl ym mhob un o wahanol wledydd y DU. Felly, mae'n anghywir awgrymu bod GIG Cymru wedi mabwysiadu safbwynt gwahanol. Mae hynny'n rhan o fy rhwystredigaeth, oherwydd rwy'n derbyn bod Aelodau ym mhob plaid wedi cael gohebiaeth gan y cwmni, ac rwy'n credu fy mod wedi cael gohebiaeth gan Aelodau o bob plaid yn y Siambr hon, sydd wedi ysgrifennu ataf ynglŷn â'r mater. Ac rwy'n teimlo'n rhwystredig ynglŷn â'r diffyg eglurder yn y broses. Oherwydd nid wyf yn credu bod yr Aelodau'n adrodd materion - nid ydynt wedi cael gwybod, ac maent wedi'u derbyn yn ddidwyll. Nid yw'r manteision wedi'u profi - dyna yw un o'n problemau mwyaf yn hyn o beth. Nid yn unig fod Orkambi wedi methu arfarniad NICE ar sail costau, ond mae NICE, yn ôl y wybodaeth sydd ar gael iddo ar ddata clinigol gan Vertex, wedi'i roi ar y rhestr o feddyginiaethau na ddylid eu defnyddio. Nawr, mae hynny'n hynod anarferol, a'r rheswm am hynny yw oherwydd cyflwr y data clinigol a oedd ar gael ar y pryd. Rwyf wedi dweud fwy nag unwaith, mewn gohebiaeth uniongyrchol ag Orkambi, ac yn wir, pan ddaeth y cwmni a'u cynrychiolydd i fy ngweld uwchben y lle hwn, fod angen iddynt ymwneud â'r broses y maent yn ei deall. Ac mae hynny'n rhan o fy rhwystredigaeth. Nid wyf yn credu eich bod wedi cael y stori'n llawn. Yn y Pwyllgor Deisebau, pan oeddent yn ystyried y mater - [ Torri ar draws. ] Yn y Pwyllgor Deisebau, pan godwyd y mater, dywedwyd bod yna 96 wythnos o ddata clinigol ychwanegol ar gael erbyn hyn ers yr arfarniad gan NICE. Ni all NICE na Grŵp Strategaeth Meddyginiaethau Cymru Gyfan asesu'r wybodaeth honno am nad yw wedi'i darparu ar eu cyfer. Pan gaiff y wybodaeth ei darparu ar gyfer NICE, bydd penderfyniad yn cael ei wneud. Ond cyfrifoldeb y cwmni, a neb arall, yw darparu'r wybodaeth a'r data hwnnw, am mai hwy sydd â mynediad ato, nid unrhyw gorff arfarnu. Rwy'n fwy na bodlon siarad â'r Aelodau y tu allan i'r lle hwn, ond rwy'n teimlo'n rhwystredig nad wyf yn credu eich bod wedi cael y darlun llawn ynglŷn â sut y mae'r cyffur ar gael ac nad yw ar gael a'r cyfrifoldeb am hynny.