23 January 2015
Organ Donation Legislation Team
Directorate for Public Health
Welsh Government
Cathays Park
Cardiff
CF10 3NQ
Dear Sir/Madam
Consultation on draft regulations under the Human Transplantation
(Wales) Act 2013
Thank you for the opportunity to provide our views on the consultation relating to
draft regulations under the Human Transplantation (Wales) Act 2013.
The General Medical Council helps to protect patients and improve medical
education and practice in the UK by setting standards for students and doctors. We
support them in achieving (and exceeding) those standards, and take action when
they are not met.
We welcome the opportunity to comment, as implementation of the Act clearly has
significant implications for professional practice.
In offering feedback our concern is to help ensure that the regulations (and any
accompanying guidance) do not place obligations on doctors which are inconsistent
with the obligations set out in Good Medical Practice and, in particular, our
guidance on Consent. We have also considered whether there are any provisions in
the regulations where GMC guidance may be complementary.
Our response
We welcome the development of regulations which provide additional clarity about
the operation of the Organ Donation Act.
We have no comments on the Human Transplantation (Excluded Relevant Material)
(Wales) Regulations 2015 or the Human Transplantation (Appointed
Representatives) (Wales) Regulations 2015.
We have only one observation to make, on the Human Transplantation (Persons
who Lack Capacity to Consent) (Wales) Regulations 2015. The meaning of the text
is ambiguous given the stated intention to maintain the current position in relation
to adults who lack capacity to understand the concept of ‘deemed consent’ and/or
to make a decision to opt out.
As we understand the current position, donation from a living adult who lacks
capacity (and falls into the ‘excepted persons’ category) is not possible under
deemed consent. In such cases the Mental Capacity Act would apply and any
decision would have to be based on whether donation could be said to be in that
person’s ‘best interests’. The draft Code of Practice seems to support this position
(at paragraphs 62, 69 and the summary table at paragraph 74 of the Code).
It is not clear from the wording of the draft Regulation whether it applies solely to
deceased patients. It could be read as permitting donation from either living or
deceased adults who lacked capacity to understand (in the period prior to a
decision being made) the concept of deemed consent and/or to make an ‘opt out’
decision. We understand the aim as being to allow ‘best interests’ decisions about
donation to be made by a relative or other person in a ‘qualifying relationship’ with
a deceased adult who knows whether or not the deceased had a clearly expressed
wish to donate?
We appreciate that your aim overall is to avoid any lack of clarity in relation to
vulnerable adults which would be unhelpful to patients and healthcare
professionals alike and make it difficult to achieve the aims of the new legislation in
relation to incapacitated adults.
We wonder whether it is possible, on the face of the Regulation, to make clear
which category of incapacitated adult is involved including reference to the MCA
best interests principle. Alternatively we wonder whether the draft Code of Practice
could be amended to make this clearer.
Yours sincerely
Rachel Podolak
Head of Welsh Affairs
Email: [email protected]
Telephone: 02920 494948
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