Legal problems with organ donation

The Welsh Government published its ‘white paper’ about organ donations on Tuesday.  The Welsh Government proposes to introduce a ‘soft opt-out’ regime for organ donation, rather than the present ‘opt-in’ regime involving an organ donation register or cards.  Those resident in Wales and dying in Wales would be presumed to have consented to their organs being donated and used for transplant unless they indicated otherwise.  The Welsh Government’s document is here, and there’s coverage from BBC News here and the Western Mail here.

This is neither a new proposal nor an uncontroversial one.  The Welsh Assembly Government (as it then was) proposed a legislative competence order on the subject in January 2011 (the draft order and Assembly Government’s memorandum are available here).  This was considered by the National Assembly’s Legislation Committee No. 1, whose report of February 2011 is here.  The proposal was withdrawn following the March referendum.  Both the Assembly’s Legislation Committee and the Commons Welsh Affairs Committee (which took evidence but never published a substantive report, thanks to the referendum result) found a good deal of concern on ethical grounds about what was proposed.  This white paper forms part of a further consultation exercise, which closes on 31 January 2012.  (It’s also misnamed, as this is a consultation document not an outline of a policy or legislative scheme, so it should be a green paper not a white one.)

The Government’s white paper is problematic, for a number of legal and policy reasons, quite apart from the moral issues involved.  There are potential issues of compliance with the European Convention on Human Rights, particularly Article 9 (Freedom of thought, conscience and religion).  Article 8 (Respect for private and family life) might also be an issue. However, similar ‘soft opt-out’ schemes operate in many other European countries, so these problems are not insuperable but depend on exactly how the scheme safeguards the interests of those who object to organ donation.

The principal legal problems – which aren’t even hinted at in the white paper – are:

1. It’s not clear that this is within the Assembly’s legislative competence. Subject 9 in Schedule 7 to the Government of Wales Act 2006 gives the Assembly competence to legislate ‘health and health services’, meaning (among other things)

‘Prevention, treatment and alleviation of disease, illness, injury, disability and mental disorder. … Provision of health services, including medical, dental, ophthalmic, pharmaceutical and ancillary services and facilities.’

The Welsh Government has consistently asserted that this matter is within the Assembly’s legislative competence, but it has not explained its reasoning for this.  One particular concern is that while transplanting an organ into a patient may help treat or alleviate disease or illness in the patient, the same can’t be said of the act of removing an organ from a donor – and it’s hard to see how that act of removal forms part of the ‘provision of health services’ either.  Whether the collection of organs is within Schedule 7 needs a good deal of careful thought and argument, and is unlikely to be resolved without a judgment of the UK Supreme Court.  This would not be an interference with devolved powers, but simply clarification of them.

2. The proposal will need the consent of the Secretary of State. This is not simply a devolved matter.  The 2006 Act is clear that the functions of a ‘Minister of the Crown’ can only be altered when the Secretary of State gives her/his consent.  As much of the working of the present ‘opt in’ system in England and Wales depends on powers of the Secretary of State, this is not a negligible issue – and how the Secretary of State responds will depend on how the proposed Welsh system will affect the organ donation system as it continues to operate in England.  The white paper is silent about that.

3. There needs to be much greater clarity about the future role of NHS Blood & Transplant, and the Human Tissue Authority. NHSBT runs the UK’s organ donation system; the HTA may be abolished under the Public Bodies bill, but at present is responsible for regulating the system of tissue retention and organ donation.  It appears that the National Assembly has power to make laws affecting the functions of such bodies, though the 2006 Act doesn’t create a direct power for it do this so its power depends on the general provisions of the legislation being within the Assembly’s legislative competence.  (The Assembly doesn’t have power to pass legislation affecting such bodies for non-devolved functions.)   The evidence – see the evidence given to the Legislation Committee No. 1 by NHSBT, here – suggests that the Welsh Government had not consulted these bodies in any detail over its proposals when it tabled the draft LCO, and the white paper does not say what further consultation might have taken place since then.

These issues seem to have been overlooked by the Welsh Government.  It’s certainly not set out its position regarding them in the white paper.  They need to be considered before any firm proposal for legislation is introduced.  They should also form part of any pre-legislative scrutiny carried out by the National Assembly.