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It is just over a year since the Human Transplantation (Wales) Act 2013 was given Royal Assent. Members will recall that the main provisions of the Act relating to consent will be brought into force on the 1 December 2015\. From that date, a new deemed consent system for organ donation will be in place in Wales.


Since the passing of the Act the Government with its many partners has been working hard to ensure Wales is ready for this change to the way in which consent is to be given to organ donation. We are taking two years to ensure that as many people as possible have the opportunity to learn about the new law and the choices they have under it.


I am therefore very pleased today to lay a report before the Assembly to fulfil my duty under Section 2(3\) of the Act to report annually for the first five years, on work undertaken to:


 


* Promote transplantation as a means of improving the health of people in Wales;
* Provide information and increase awareness about transplantation;
* Inform the public of the circumstances in which consent to transplantation activities is deemed to be given in the absence of express consent; and
* Ensure that the resources available to local health boards include the specialist skills and competences required for the purpose of this Act.


 


Today, under Standing Order 15(2\), the first of these annual reports has been laid outlining the work undertaken to inform the public and ensure the NHS is prepared for the new legislation. The report covers the period September 2013 to October 2014\. It is available here:


http://www.assemblywales.org/en/bus\-home/Pages/Plenary.aspx?category\=Laid Document


I would also like to take this opportunity to highlight the opening of the consultation on three sets of draft Regulations to be made under the Act.


The Act gives Welsh Ministers the power to regulate on three areas:


 


* To define excluded materials – organs and tissues to which deemed consent will not apply – so\-called “novel” forms of transplantation \[Section 7];
* To define who may or may not become an appointed representative \[Section 8]; and
* To set out when consent to transplant activities may be deemed for living adults lacking capacity \[Section 9].


 


During the passage of the Bill a commitment was given to a wide ranging consultation on these Regulations.  This Statement marks the opening of the consultation, which will run for 12 weeks, closing on 15 January 2015\. The draft Regulations and consultation document can be found online.


I very much hope that Members will take the time to consider the draft Regulations and to provide any comments.


I will return to the Assembly in the autumn of 2015 to seek formal approval of the Regulations together with the Human Tissue Authority’s draft Code of Practice.


Finally, I would advise Members that the social research company GfK NOP, working with Professor Roy Carr\-Hill of the University of York and Institute of Education have been appointed to carry out the impact evaluation of the new law. Following discussions with the researchers we have agreed an updated timetable for the completion of the report.


It was originally planned that the final impact evaluation report would be delivered to the Welsh Government by March 2017\. However, following a request made by the evaluation team, I have agreed that the delivery date will be changed to September 2017\. Any conclusions on impact are still likely to be tentative at this stage – and ongoing monitoring of NHSBT donor data will be needed – but this will provide a clearer early indication of the impact of the Act. This change does not incur any additional cost.







Translation:


 
Ychydig dros flwyddyn yn ôl cafodd Deddf Trawsblannu Dynol (Cymru) 2013 y Cydsyniad Brenhinol.  Bydd yr Aelodau’n cofio y daw prif ddarpariaethau’r Ddeddf sy’n ymwneud â chydsyniad i rym ar Ragfyr 2015\.  O’r dyddiad hwnnw, bydd system newydd sef system cydsyniad tybiedig ar gyfer rhoi organau yn bodoli yng Nghymru.  

Ers i’r Ddeddf gael ei phasio mae’r Llywodraeth wedi bod yn gweithio’n galed i sicrhau bod Cymru’n barod am y newid hwn i’r ffordd y rhoddir cydsyniad i roi organau.  Rydym yn cymryd dwy flynedd i sicrhau bod cynifer o bobl â phosibl yn cael y cyfle i ddysgu am y gyfraith newydd a’r dewisiadau sydd ganddynt o dan y gyfraith newydd.  

Rwyf, felly, yn falch iawn o gyflwyno adroddiad gerbron y Cynulliad er mwyn cyflawni fy nyletswydd o dan Adran 2(3\) o’r Ddeddf  i adrodd yn flynyddol am y pum mlynedd gyntaf, ar waith sydd wedi’i wneud:

* I hyrwyddo trawsblannu fel ffordd o wella iechyd pobl yng Nghymru;
* I ddarparu gwybodaeth a chodi ymwybyddiaeth am drawsblannu;
* I hysbysu’r cyhoedd am o dan ba amgylchiadau y bernir bod cydsyniad i weithgareddau trawsblannu wedi’i roi yn niffyg cydsyniad datganedig; ac
* I sicrhau bod yr adnoddau sydd ar gael i fyrddau iechyd lleol yn cynnwys y sgiliau a’r cymwyseddau arbenigol y mae eu hangen at ddibenion y Ddeddf hon.

Heddiw, o dan Reol Sefydlog 15(2\), mae’r cyntaf o’r adroddiadau blynyddol hyn wedi’i osod yn amlinellu’r gwaith sydd wedi’i wneud i hysbysu’r cyhoedd ac i sicrhau bod y GIG yn barod am y ddeddfwriaeth newydd. Mae’r adroddiad yn ymdrin â’r cyfnod rhwng Medi 2013 a Hydref 2014\. Mae ar gael yn electronig yma.

http://www.assemblywales.org/cy/bus\-home/Pages/Plenary.aspx?category\=Laid Document

Hoffwn achub y cyfle hwn hefyd i danlinellu dechrau’r ymgynghoriad ar dair set o reoliadau drafft i’w gwneud o dan y Ddeddf.  

Mae’r Ddeddf yn rhoi’r pŵer i Weinidogion Cymru reoleiddio mewn tri maes:

* Diffinio deunydd a eithrir \- organau a meinweoedd na fydd cydsyniad tybiedig yn gymwys iddynt \- dulliau trawsblannu “newydd” fel y’u gelwir \[Adran 7];
* Diffinio pwy gaiff neu bwy na chaiff fod yn gynrychiolydd penodedig \[Adran 8]; a
* Nodi pryd y gellir barnu bod cydsyniad tybiedig i weithgareddau trawsblannu  wedi’i roi yn achos oedolion byw nad oes ganddynt alluedd \[Adran 9]

Yn ystod hynt y Bil rhoddwyd ymrwymiad i ymgynghori’n eang ar y Rheoliadau.   Mae’r Datganiad hwn yn nodi dechrau’r ymgynghoriad, a fydd yn para am 12 wythnos, ac a ddaw i ben ar 15 Ionawr 2015\. Mae’r rheoliadau drafft a’r ddogfen ymgynghori i’w gweld ar lein.

Mawr obeithiaf y bydd yr Aelodau’n cymryd yr amser i ystyried y rheoliadau drafft ac i gyflwyno unrhyw sylwadau.  

Byddaf yn dychwelyd i’r Cynulliad yn yr hydref 2015 i geisio cymeradwyaeth ffurfiol i’r Rheoliadau ynghyd â Chod Ymarfer drafft yr Awdurdod Meinweoedd Dynol.

Yn olaf, hoffwn ddweud wrth yr Aelodau fod y cwmni ymchwil gymdeithasol GfK NOP wedi cael ei phenodi i gynnal gwerthusiad o effaith y gyfraith newydd. Bydd y cwmni’n gweithio gyda’r Athro Roy Carr\-Hill o Brifysgol Caerefrog a’r Sefydliad Addysg.  Yn dilyn trafodaethau â’r ymchwilwyr rydym wedi cytuno ar amserlen wedi’i diweddaru ar gyfer cwblhau’r adroddiad

Y bwriad gwreiddiol oedd y câi’r adroddiad gwerthuso terfynol o’r effaith ei gyflwyno i Lywodraeth Cymru erbyn Mawrth 2017\. Er hynny, yn sgil cais gan y tîm gwerthuso, rwyf wedi cytuno i newid y dyddiad ar gyfer cyflwyno’r adroddiad i fis Medi 2017\. Mae’n debygol y bydd unrhyw gasgliadau ynghylch yr effaith yn dal yn amhendant bryd hynny \- a bydd angen parhau i fonitro data am roddwyr NHSBT \- ond bydd hyn yn rhoi arwydd cynnar cliriach o effaith y Ddeddf. Nid oes unrhyw gost ychwanegol ynghlwm wrth y dewis hwn.