English: Thank you very much, Deputy Presiding Officer. The LCM on the Medicines and Medical Devices Bill was referred to the health committee in July of last year. The committee ran an open call for written evidence and we heard back from BMA Cymru, the Welsh NHS Confederation and the Royal College of Nursing Wales. We also wrote to the Minister for Health and Social Services for further information on a number of outstanding concerns identified in the memorandum itself, and we held a scrutiny session with the Minister on 30 September. At the time of producing our report, the Minister had been able to secure an agreement from the UK ministerial lead on the Bill to table an amendment that would require consultation with Welsh Ministers and other devolved administrations when making regulations for the introduction of a medical device information system. However, the Minister said that he was seeking more than this. His officials were working on a set of broad principles that would shape the regulations in a way that would be acceptable to the devolved administrations collectively. If everyone could agree on these principles and if they were reflected in the regulations, the Minister said that it would largely address his concerns, as he has repeated again today. When we published our report, discussions on these principles were at an early stage, with much of the detail still to be resolved. As we did not have all the information needed to come to a view on the merits of the LCM, we did not make a recommendation to the Senedd about whether we should support the LCM or otherwise. Since that report, the Welsh Government has laid the supplementary LCM before us today. In addition, last week, the Minister wrote to me to provide an update on his discussions with the UK Government and to share a draft memorandum of understanding that includes a number of assurances relating to the operation and governance of the medical device information system. In the time available, the committee has not been able to consider formally either the supplementary LCM or the Minister's letter. Therefore, we have not updated our earlier report and we are not able to offer any further view, other than to note the position of the Welsh Government, as set out in the supplementary LCM, that it supports the policy underpinning the Bill, and the position of the Minister, which is set out in his letter to me, that the draft memorandum of understanding represents a positive compromise approach that provides him with sufficient assurance to enable him to recommend that the Senedd approves the supplementary LCM, although the governance arrangements for medical advice systems do not go as far as he would wish in terms of joint ministerial governance. Thank you very much.
Welsh: Diolch, Dirprwy Lywydd. Cafodd y memorandwm cydsyniad deddfwriaethol ar y Bil Meddyginiaethau a Dyfeisiau Meddygol ei gyfeirio at y pwyllgor iechyd ym mis Gorffennaf y llynedd. Cynhaliodd y pwyllgor alwad agored am dystiolaeth ysgrifenedig, ac fe glywon ni yn ôl gan Gymdeithas Feddygol Prydain yng Nghymru, Conffederasiwn GIG Cymru a Choleg Nyrsio Brenhinol Cymru. Hefyd, fe ysgrifennon ni at y Gweinidog Iechyd a Gwasanaethau Cymdeithasol i gael rhagor o wybodaeth am sawl pryder gafodd eu nodi yn y memorandwm ei hun, ac fe gawson ni sesiwn graffu gyda'r Gweinidog ar 30 Medi. Ar adeg llunio'n hadroddiad, roedd y Gweinidog wedi gallu sicrhau cytundeb gan Weinidog y Deyrnas Unedig oedd yn arwain ar y Bil i gyflwyno gwelliant a fyddai'n galw am ymgynghori gyda Gweinidogion Cymru a'r gweinyddiaethau datganoledig eraill wrth wneud rheoliadau ar gyfer cyflwyno system wybodaeth am ddyfeisiau meddygol. Fodd bynnag, dywedodd y Gweinidog ei fod yn awyddus am rywbeth mwy na hyn. Roedd ei swyddogion wrthi'n gweithio ar set o egwyddorion eang a fyddai'n siapio'r rheoliadau mewn ffordd a fyddai'n dderbyniol i'r gweinyddiaethau datganoledig gyda'i gilydd. Pe bai pawb yn gallu cytuno ar yr egwyddorion hyn a'u hadlewyrchu yn y rheoliadau, dywedodd y Gweinidog y byddai hyn yn datrys ei bryderon i raddau helaeth, fel mae o wedi dweud eto heddiw. Pan wnaethom ni gyhoeddi ein hadroddiad, roedd y trafodaethau ar yr egwyddorion hyn yn y camau cynnar, gyda llawer o'r manylion i'w datrys o hyd. Gan nad oedd yr holl wybodaeth angenrheidiol gennym ni i ffurfio barn ar rinweddau'r memorandwm, ni wnaethom argymhelliad i'r Senedd ynglŷn ag a ddylem gefnogi'r memorandwm ai peidio. Ers yr adroddiad hwnnw, mae Llywodraeth Cymru wedi cyflwyno'r memorandwm atodol sydd ger ein bron ni heddiw. Yn ogystal â hynny, yr wythnos diwethaf, fel rydym ni wedi clywed, ysgrifennodd y Gweinidog ataf i roi'r wybodaeth ddiweddaraf am ei drafodaethau gyda Llywodraeth y DU ac i rannu memorandwm cyd-ddealltwriaeth drafft sy'n cynnwys sicrwydd yn ymwneud â gweithrediad a llywodraethiant y system wybodaeth am ddyfeisiau meddygol. Yn yr amser a oedd ar gael, nid yw'r pwyllgor wedi gallu trafod y memorandwm cydsyniad deddfwriaethol atodol na llythyr y Gweinidog yn ffurfiol. Felly, nid ydym wedi diweddaru ein hadroddiad cynharach ac nid ydym yn gallu cynnig unrhyw farn bellach, heblaw nodi safbwynt Llywodraeth Cymru, fel sydd wedi'i nodi yn y memorandwm atodol, ei bod yn cefnogi'r polisi y tu ôl i'r Bil, a safbwynt y Gweinidog, sydd wedi'i nodi yn ei lythyr ataf i, fod y memorandwm cyd-ddealltwriaeth drafft yn cynrychioli dull cyfaddawdu cadarnhaol sy'n rhoi sicrwydd digonol iddo allu argymell bod y Senedd yn cymeradwyo'r memorandwm cydsyniad deddfwriaethol atodol, er nad yw'r trefniadau o ran llywodraethu'r system wybodaeth arfaethedig am ddyfeisiau meddygol yn mynd cyn belled ag y byddai'n dymuno o ran llywodraethu gweinidogol ar y cyd. Diolch yn fawr.