Legal problems with organ donation

Alan Trench analyses legal aspects of the Welsh Government’s ‘soft op-out’ plan for presumed consent

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  The proposal was withdrawn following the March referendum.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.

Alan Trench is a non-practicing solicitor and an academic, associated with the University of Edinburgh and the Constitution Unit at University College London. This article first appeared on his blog Devolution Matters.

3 thoughts on “Legal problems with organ donation

  1. Thank you for this piece Alan. My concern lies not particularly around the issue of competence but rather the removal of the family veto. Surely this no longer makes it a ‘soft-opt out’ scheme but rather a hard scheme which my well alienate the general public in backing this scheme further. While the Minister has made her views known on this issue, as it stands, it is purely supposition. Unless that element is built into the legislation itself, then I cannot see this Bill progressing.

  2. Leading Counsel Tim Otty QC has provided an Opinion which has confirmed to the Kidney Wales Foundation that the Welsh Government is competent to legislate. The views of Timothy Otty QC of Blackstone Chambers may be summarised as follows:

    (a) The proposed legislation is within the legislative competence envisaged by the 2006 Act;
    (b) There is nothing to preclude the introduction of an opt out system in relation to organ transplantation in Wales;
    (c) It would be possible for a law introducing such an opt out to be drafted in such a way as to make it compatible both with the European Convention on Human Rights, and with European Community law.

    We wish to see a soft opt out system as in Belgium. Families will be consulted.

    On 17 November 2008 an “Organ Donation Taskforce” established by the previous Government of the United Kingdom published an independent report entitled “The Potential Impact of An Opt Out System for Organ Donation in the UK”. It then stated that the timing was not right to put in place an Opt Out system for the whole of the UK. It did not rule it out neither did a Health Committee of the Assembly in the orevious Assembly term(often misquoted).Annex C to theODT report contained a careful analysis of the potential Convention issues arising in respect of any opt out system adopted focusing, in particular, on the concept of presumed consent. The analysis was prepared by the Legal Working Group to the Taskforce. 11.The Working Group correctly identified the core Convention provisions falling for consideration as being Articles 8 (right to respect for private life) and 9 (freedom of religion). It focused on the principles that would need to underpin any opt out system rather than any detailed proposals. It summarised its views in the following way: “a system that was based on a presumption of consent or authorisation that allowed adequate provisions for a person to opt out would be compatible with the ECHR. Such a system would need to allow a person to indicate their wishes (such as on a register) during their lifetime and also to allow for evidence from family members about the person’s wishes and beliefs after their death. Particular consideration would be needed for some groups of people, in particular children, people who lack the mental capacity to make a decision to opt out and those whose identity was unknown at the time of their death.’

    For present purpose and to comment on the above, the Working Group’s most important conclusion was that there was no necessary incompatibility problem with an opt out system such as to make any assertion of legislative competence illegitimate. We agree with this view and believe it is further justified by the following considerations: Opt out systems operate in a substantial number of European Union and Council of Europe countries and they have never, so far as we are aware, led to any challenge before the European Court of Human Rights -The Additional Protocol to the Council of Europe’s European Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186) provides at least some insight into the core standards which the European Court might expect to be respected in this field. It includes the following key provisions, none of which preclude the existence of an opt out system:

    Signatory States must have a clear legally recognised system specifying the conditions under which removal of organs or tissues is authorised (Article 17);The only absolute bar to organ and tissue removal concerning a deceased person is presented if that person had objected to it (Article 17);The human body must be treated with respect and all reasonable measures must be taken to preserve the appearance of the donor corpse (Article 18);

    Signatory States are obliged to take “all appropriate measures to promote the donation of organs and tissue” (Article 19);The Convention requires adequate measures for the protection of the confidentiality of any donor (Article 23).

    There is no indication in the approach of the European Commission of the European Community to the issue of transplantation that it considers that such a system would be incompatible with fundamental rights. This is of at least some significance, even having regard to limitations on European Union competence in this area.

    A helpful summary of recent developments in European Union governance over organ donation and transplantation, focusing on the Commission’s action plan and the (then proposed) Organs Directive (subsequently Directive 2010/45/EU 7 July 2010) is set out in the article “Adding Value? EU Governance of Organ Donation and Transplantation” Ann Maree Farell, EJHL 17 (2010) 51-79. This article makes the following important points each of which support my view that an opt out system would be compatible with European Community law:The Commission and the Directive allow for flexibility on the part of Member States in relation to the meeting of obligations with respect to e.g. donor consent (see paragraph 4.3 & Directive Article 14);As Farell explains “in relation to regulatory requirements covering consent to organ donation, the EU’s competence to act on this issue is circumscribed by Article 168(7) TFEU which states that national provisions regarding the donation or medical use of organs shall not be affected by the adoption of minimum harmonisation measures under Article 168(4)(a) TFEU” (p. 73);The Commission has expressly acknowledged that there is a “degree of variation as between Member States in relation to the consent regimes that have been adopted in relation to deceased organ donation, reflecting the national specificities of historical, socio cultural protection and political flexibility” (p. 73 citing Commission Impact Assessment accompanying Communication 30.5.02007 SEC (207) 704 at 24-27).For the purposes of this I have assumed that it is to the issue of “geographical restriction” that the Some refer to when they speak of the “need to ensure that there is no ambiguity with regard to jurisdiction” (see paragraph 2 above). Spain, Austria and Belgium are the most prominent examples but they are not alone: see e.g. S Gevers, A Janssen and R Friele “Consent Systems for Post Mortem Organ Donation in Europe” European Journal of Health Law 11 (2004) 176-177; New York Times 23 April 2010; Impact of presumed consent for organ donation on donation rates: a systematic review BMJ 2009 338: a3162; The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study (December 2005) – Alberto Abadie & Sebastian ”
    Although the United Kingdom has not signed or ratified this Convention it has been ratified by 12 member States of the Council of Europe.The Convention has only been referred to in the case law of the European Court of Human Rights in an unrelated context (see e.g. SH & Others v Austria Application No. 57813/00 1 April 2010 relating to the availability of fertility treatment.

    Some European Union countries operate opt-out systems and some do not.Indded patients lives in Wales have been saved by organs donated from those who resided in so called euro zone countries.

    As one person dies every week waiting for a transplant this change in the law will save lives.Three people die every day in the UK every day where 10,000 sadly wait for a transplant.This is progressive legislation as introduced by other progressive European countries,

  3. Thank you for your most useful contribution to this debate. The argument of the Welsh Government that we should move towards presumptive attitude because almost everybody is in favour of organ donation is specious and dangerous. There is no hard evidence to back-up this conclusion. Indeed, because only 29 per cent of ‘almost everybody’ registers for voluntary organ donation, we may deduce that the majority of ‘almost everybody’ whilst willing to receive an organ donation are, nevertheless, unwilling to voluntarily donate their own organs or have them harvested by the state. This is human nature, so we should not be surprised. And so much for a presumptive attitude of altruism. Despite the opinion of learned counsel quoted, I doubt that either the UK Supreme Court or the European Court of Human Rights would acknowledge a small provincial assembly of the United Kingdom to be a sovereign state with full powers and prerogatives to enact this type of legislation. Please do not contact me.

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