The draft Human Transplantation (Wales) Bill is one of the more controversial measures proposed by the Welsh Government under its newly devolved competences, and an earlier post reviewed the prior consultation, draft Bill and resulting spat between Westminster and Cardiff regarding the exact nature of these competences. The Bill was introduced on 3 December 2012, and since then has been progressing through its various stages. The detailed consideration of amendments under Stage 3 commenced on 23 May 2013 and the Plenary session on which the marshalled list of amendments was debated on 2 July.
To facilitate discussion, these were grouped together under generic headings in the order in which they and any relevant procedural information would be debated: promotion of transplantation; resources for Local Health Boards; review of system of consent; consent to donation: excluded material; consent to donation: deemed consent; appointed representatives; technical and consequential; consent to donation: express consent; consent: excepted adults; appointed representatives: children; living donation involving adults who lack capacity to consent; preservation for transplantation; and guidance.
The outcome of the voting on the amendments is reported here. None of the amendments relating to either deemed- or express consent was carried. As a consequence of the debate, all sections and schedules of the Bill were deemed agreed, thereby concluding the Stage 3 proceedings. This two-hour consideration of the Bill was immediately followed by the shorter five-minute Stage 4 to approve the Human Transplantation (Wales) Bill. The Bill was passed: For, 43; Against, 2: and Abstentions, 8.
Wales thus becomes the first UK nation to introduce a “soft opt-out system of organ donation”, i.e. unless a person states a wish to be a donor (opts-in) or not to be a donor (opts-out), their consent to donation will be deemed to have been given. The Bill now awaits Royal Assent and is expected to come into force in 2015.
The controversial part of the Bill is Clause 4(2) which concerns the consent necessary for adults, and this is “deemed” to have been given unless “express consent” is required, Table 1. The express consent of a person is applicable when: that person is alive; or has died and a decision of the person to consent, or not to consent, to the activity was in force immediately before his or her death. Where the person has died without giving formal consent, express consent rests with the person or persons appointed to deal with the issue of consent in relation to organ donation. However, where such a person or persons have been appointed but no one is able to give consent under the appointment, express consent falls to the person who stood in a qualifying relationship, as defined in Clause 17(2)&(3), to the person immediately before death.
Thus under the Act, grieving relatives cannot determine whether organs are donated where: an express consent has been given during the person’s lifetime; a decision to consent was in force immediately before his or her death; they have not been appointed to so act; or if no decision can be made by any appointee, they are not in a qualifying relationship. However, Health Minister Mark Drakeford is reported to have said that any organs will not be taken unless a family member is present, and although the family may have no legal veto, clinicians have a duty not to add distress to families of someone who has died.
Other aspects of consent are dealt with elsewhere in the Bill: excepted adults, (Clause 5); children, (Clause 6); material excluded by Regulation, (Clause 7); material from adults who lack capacity to consent, (Clause 9).
The Archbishop of Wales, Dr Barry Morgan has provided a focus for the objections of faith leaders and senior health professionals in Wales, here, and elsewhere, who urged ministers to honour their commitment to respect families.
Kelvin Holdsworth considers presumed consent and the associated pastoral issues in his blog, and the BBC has produced a useful set of Q&As on the implications of the Bill, here. The latter reveals two interesting practical points. Firstly, on the basis of evidence from opt-out regimes in other countries, the estimated impact of the legislation is small in numerical terms, (though significant for the organ recipients) – it will provide about 15 additional donors and 45 extra organs per year, where at any one time, there are 250 people on a waiting list for a transplant. In Wales, 33 people died in 2012/13 whilst waiting for a transplant.
Secondly, organs obtained in Wales under the “opt-out” regime may go anywhere in the UK, and those freely donated under “opt-in” schemes elsewhere may go to Wales, as at present.
Despite the wide ambit and controversial “opt-in” provisions of the Bill, it does not go as far as the proposals outlined in the NHS Blood and Transplant, (NHSBT), which drew strong criticism from the Archbishops’ Council. Watch this space.