The Human Transplantation (Wales) Act 2013: an Act of Encouragement, not Enforcement

DOIhttp://doi.org/10.1111/1468-2230.12117
Published date01 March 2015
Date01 March 2015
LEGISLATION
The Human Transplantation (Wales) Act 2013: an Act of
Encouragement, not Enforcement
James F. Douglas*and Antonia J. Cronin**
The Human Transplantation (Wales) Act became law in Wales in September 2013. The Act aims
to increase deceased donor organ and tissue donation in Wales by introducing a ‘soft opt-out’
system to replace the previous requirement of express ‘appropriate’ consent under the Human
Tissue Act 2004. Adults dying in Wales (with certain exceptions) will be ‘deemed’ to consent to
donation, unless evidence of their objection is produced, and a duty is imposed on Ministers
to promote transplantation and inform the public through awareness campaigns about how to
choose the deemed status or opt out. Although a welcome development, these campaigns may
obscure the effects of deemed consent, especially in the context of generally rising UK donation
rates. There may also be problems of legal interpretation and of integration with the ‘opt-in’ laws
in the rest of the UK. In the absence of any statutory duty to retrieve all lawfully donated organs,
the apparently restricted influence of donor relatives is likely to remain effectively dominant.
INTRODUCTION AND OVERVIEW
On 10 September 2013 the Human Transplantation (Wales) Act 2013 (HTWA)
became law in Wales. It will come fully into effect on 1 December 2015. First
Minister Carwyn Jones described the new Welsh Act as ‘. . . arguably the most
significant piece of legislation passed by the National Assembly for Wales since
it acquired full lawmaking powers in 2011’.1The aim of the HTWA is to
increase the number of organs and tissues available for transplantation by intro-
ducing a ‘soft opt-out’ system of organ and tissue donation in Wales.2The new
Act replaces the previous requirement of express (‘appropriate’) consent to
deceased organ donation under the Human Tissue Act 2004 (the 2004 Act).3It
provides that adults dying in Wales (with certain exceptions) are ‘deemed’ to
consent to donation unless evidence of their objection is produced.4The Act’s
rationale is based upon the claims that many countries with so-called ‘presumed
consent’ or ‘opt-out’ laws have high donation rates, and that public opinion
*School of Medicine, Dentistry and Biomedical Sciences, Queen’s University, Belfast.
**NIHR Biomedical Research Centre, Guy’s and St. Thomas’ NHS Foundation Trust and MRC
Centre for Transplantation, King’s College, London.
1 BBC News Wales 10 September 2013 at http://www.bbc.co.uk/news/uk-wales-24032031 (all
URLs last accessed 1 December 2014).
2 An ‘opt-in’ system of deceased organ donation requires individuals to register their willingness to
donate their organs in the event of their death. In contrast, an ‘opt-out’ system of deceased organ
donation requires individuals to register their unwillingness to donate their organs in the event of
their death.
3 Human Tissue Act 2004, s 3.
4 Human Transplantation (Wales) Act 2013, s 3(3).
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© 2015 The Authors. The Modern Law Review © 2015 The Modern Law Review Limited. (2015) 78(2) MLR 324–348
Published by John Wiley & Sons Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA
favours the change.5Since relatives are allowed to present evidence of the
deceased’s (although not of their own) objection, this is a ‘soft’, not a ‘hard’,
opt-out law (hard laws do not permit any family influence).6Much of the 2004
Act is retained, although regulatory changes will be necessary. Time for public
information and education will be required before implementation, because the
Act imposes a duty on Welsh ministers to promote transplantation, increase
public knowledge and awareness of it and inform the public of the circumstances
in which consent will be deemed to exist.7
Although designed to integrate with the ‘opt-in’ system of consent in the rest of
the UK (‘authorisation’ in Scotland)8the HTWA may raise legal problems, for
example regarding the status of ‘excepted adults’, for whom express consent will
5 See for example B. H. Willis and M. Quigley, ‘Opt-out Organ Donation: on Evidence and Public
Policy’ (2014) 107 J R Soc Medicine 56.
6 For a summary of different opt-out systems in use around the world see Table 1.
7 Human Transplantation (Wales) Act 2013, s 2.
8 Human Tissue (Scotland) Act 2006, s 6.
Table 1: Summary of Different Consent Systems in use Around the World
Option Details
1. A ‘hard’ opt-out system Doctors can remove organs from every adult who dies – unless a
person has registered to opt-out. This applies even if relatives know
the deceased would object to donation, but had failed to register
during life. Example: Austria.
2. A ‘hard’ opt-out system
which does not cover
some groups
Doctors can remove organs from every adult who dies – unless a
person has registered to opt-out OR the person belongs to a group
that is defined in law as being against an opt-out system. Example:
Singapore, where Muslims chose to opt out as a group.
3. A ‘soft’ opt-out system Option 3(a) No need to consult relatives
Doctors can remove organs from every adult who dies – unless a
person has registered to opt-out OR the person’s relatives tell
doctors not to take organs. It is up to the relatives to tell doctors
because the doctors may not ask them. Example: Belgium.
Option 3(b) Relatives should be consulted
Doctors can remove organs from every adult who dies – unless a
person has registered to opt-out. It is good practice for doctors to
ask the relatives for their agreement at the time of death. Example:
Spain.
4. A ‘soft’ opt-in system Doctors can remove organs from adults who have opted in. It is up to
each person to decide if they want to opt-in. It is normal practice to
let relatives know if the person has opted in and doctors can decide
not to proceed if faced with opposition from relatives. Example: the
current UK system.
5. A ‘hard’ opt-in system Doctors can remove organs from adults who have opted in. It is up to
each person to decide if they want to opt-in. Relatives are not able
to oppose the person’s wishes.
6. A choice to opt-in or
opt-out
Option 6 (a) People can register their choice to opt-in or opt-out.
Option 6 (b) People must register their choice to opt-in or opt-out.
Table 1 Source: Organ Donation Taskforce Independent Report: The Potential Impact of an Opt-Out
System for Organ Donation in the UK.
James F. Douglas and Antonia J. Cronin
© 2015 The Authors. The Modern Law Review © 2015 The Modern Law Review Limited. 325(2015) 78(2) MLR 324–348

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