Memorandum by the Human Tissue Authority
INTRODUCTION
1. The Human Tissue Authority (HTA) welcomes
the opportunity to contribute to the Select Committee on the European
Union's Inquiry into the EU Commission's Communication on organ
donation and transplantation: policy actions at EU level.
2. The HTA's evidence covers topics raised
within the Commission's Communication and other relevant issues
which relate to the work and remit of the organisation.
3. We would of course be happy to provide
further oral or written evidence to the Inquiry.
THE HUMAN
TISSUE AUTHORITY
4. The Human Tissue Authority was established
in April 2005 to implement the Human Tissue Act 2004. The Authority's
remit covers the removal, storage, use and disposal of human bodies,
organs and tissue for a number of purposes including transplantation.
The Act and the Authority's remit apply to England, Wales and
Northern Ireland.
5. The Authority regulates the donation
by living people of solid organs, bone marrow and stem cells.
It is responsible for approving all organ transplants from living
donors; and this latter role is also extended to Scotland.
6. The Authority is also one of two UK Competent
Authorities for the implementation of the European Tissues and
Cells Directive.
CONSENT
7. Underpinning the provisions of the Human
Tissue Act 2004 is the need to obtain appropriate consent for
the removal, storage, use and disposal of human tissue, organs
or cells for transplantation—and for other purposes specified
in the Act. Consent is therefore a mandatory first step in removing,
storing and using human tissue for transplantation. The Human
Tissue Authority has taken the view that the giving of consent
is a positive act; that the absence of refusal is not evidence
of consent; and that consent should where appropriate be generic
and enduring. We have stated this in our published statutory guidance.
8. The Human Tissue Act 2004 specifies whose
consent is needed, but is generally silent on defining what form
appropriate consent should take, or how it should be sought or
recorded. The Human Tissue Authority is charged through its remit
to consider these ethical and practical matters, and has published
guidance on them in its code of practice on consent. The HTA has
also issued a code of practice on the donation of organs for transplantation,
which provides guidance on the donation process and sets the standards
practitioners are expected to meet.
LIVING DONORS
9. The Human Tissue Authority replaced and
extended the role of the erstwhile Unrelated Live Transplant Regulatory
Authority (ULTRA). Before the Authority was established, organ
donations from living people could only be made to genetic relatives
and to people with a close personal relationship. The Human Tissue
Act 2004 has now widened the scope of living donation to include
altruistic and paired cases (covered in more detail below).
10. Under the provisions of the Act, which
came into force on 1 September 2006, the Human Tissue Authority
is responsible for approving all organ transplants from living
donors. All donors and recipients have to be individually assessed
by a local independent assessor, who is trained and accredited
by the Authority to act on behalf of the donor. The independent
assessor ensures that the donor and recipient have an appropriate
relationship; that the donor fully understands the risks which
donation involves; that s/he is not under any pressure to donate;
and that consent has been given freely and voluntarily. The independent
assessor then submits an on-line report making a recommendation
on approval to the HTA.
11. The HTA will make a decision on each
individual transplant case based on the report provided by the
independent assessor, subject to the requirements of the Human
Tissue Act 2004 and the Authority's guidance. Most HTA decisions
are made by a dedicated transplant approvals team. Decisions on
complex cases including altruistic and paired donations are made
by a panel of Authority members. The average turn-round time for
approval by the HTA for straightforward genetically or emotionally
related living donor cases is two working days.
12. Since the Act came into force in September
2006, we have approved almost 900 living donor transplants, mainly
involving kidneys.
13. We note the EU Commission's Communication
states that "exploring the promotion of altruistic donations
from volunteer living donors, on the basis of appropriate safeguards
for the donors and the prevention of trafficking, could be important
in expanding the organ pool." The HTA has already introduced
systems to enable more flexibility in who can donate to whom,
by allowing both non-directed altruistic donation and paired donation.
Non-directed altruistic donation involves a donation by a person
who does not have a relationship with the recipient. In such cases
a psychiatric assessment of the donor is required. Paired donation
is where a related donor and recipient whose blood groups or tissue
types are mismatched (or incompatible) are paired with another
donor and recipient in the same situation.
14. These new means of finding suitable
organ donors are expected to increase transplant numbers. Two
altruistic and two paired donations have already taken place since
the Act came into force. Altruistic donations are probably never
likely to be numerous, but enthusiasm on the part of the transplant
community and the wide national publicity that accompanied the
first paired donation suggests that the number of paired donations
is likely to increase substantially, perhaps to as many as fifty
per year.
ORGAN DONATION
FROM THE
DECEASED
15. The Human Tissue Act 2004 makes it lawful
for organ donation from a deceased person to take place provided
that consent was given by the person prior to their death. In
the absence of the known wishes of the deceased, consent may be
obtained from the person nominated by the deceased person to act
on his or her behalf or, if there is no-one so nominated, from
a person in a qualifying relationship—such as a spouse,
partner or other relative or friend.
16. Under the Act the wishes of the deceased
person are paramount and take precedence over the views of the
family.
17. The Human Tissue Authority's code of
practice on donation of organs for transplantation advises that
if the family or those close to the deceased person object to
the donation, even though the deceased person (or his/her nominated
representative) has explicitly consented, clinicians should seek
to discuss the matter sensitively with them. The family should
be encouraged to accept the deceased person's wishes and it should
be made clear that they do not have the legal right to veto or
overrule the wishes of the deceased person.
18. Currently all deceased organ donation
in the UK is non-directed: organs are allocated according to clinical
need rather than according to any specific wishes of the donor
communicated while they were alive or of their family. In the
past year the Authority has been made aware of a number of cases
which might merit consideration as exceptions to that general
rule. We are examining these with other members of the transplant
community at the moment.
"PRESUMED CONSENT"
19. As we have explained, the underpinning
principle of the Human Tissue Act 2004 is that consent must be
obtained to use human organs and tissue for transplantation, whether
from the living or after death. The option of presumed consent
was debated extensively during the passage of the Act through
Parliament. It was decided then that the opt-in system should
remain.
20. Any move to a system of presumed consent
within the UK would thus require a change in the law. There would
need to be extensive consultation and debate before that happened.
The Human Tissue Authority would favour as much transparency as
possible in shaping and conducting that debate.
21. Provisions for appropriate consent have
only recently been established through the Act, and the Authority
would see an argument for giving the current legislation more
time to take effect before considering whether to change the nature
of what constitutes appropriate consent for deceased donation
of organs for transplantation.
22. Furthermore, the HTA would want to be
reassured about the impact that a system of presumed consent for
organ transplantation would have on the current provisions in
the Human Tissue Act 2004 for fully informed consent for other
purposes, such as body donation for medical science or removal
of tissue at autopsies.
ETHICAL ISSUES
RELATING TO
ORGAN DONATION
23. A number of ethical principles inform
the Human Tissue Act 2004 and its provisions for organ donation
and transplantation: these include the need for consent and for
freedom from coercion, for equity and justice in assessing individual
need, and for respect to be accorded to bonds of kinship in directing
donations.
24. These principles have been central to
our development of both the HTA codes of practice and the systems
for regulating living and deceased donation.
ILLEGAL TRAFFICKING
25. We share the view of the European Commission
Communication that organ trafficking is an issue of serious political
and ethical concern.
26. The Human Tissue Act 2004 makes it an
offence to give or receive a reward for the supply or offer of
human material for transplantation. The offences relating to the
prohibition of commercial dealings in human material came into
force on 20 October 2005.
27. The Act does not however prevent import
or export of organs for transplants. Numbers are small but there
is a regular exchange of organs between European countries that
meet similar quality and safety standards to ours. The UK Transplant
wing of the NHS Blood and Transplant Authority facilitates this
on the occasions that it occurs.
EUROPEAN ACTION
IN THE
FIELD
28. The European Commission Communication
examines the scope for a European directive setting standards
for the quality and safety for organs.
29. The Authority has experience of implementing
a European directive. We are one of the two Competent Authorities
for the implementation of the EU Tissues and Cells Directive in
the UK: that Directive is intended to create a common framework
for ensuring consistent standards across the EU community.
30. This has required the HTA to set up
and regulate two systems of licensing, one under the Human Tissue
Act 2004 and another under the regulations which transposed the
European Directive into UK law.
31. Implementing this dual approach has
created significant challenges for the Authority in keeping the
resulting regulatory burden within the confines of Better Regulation
expectations.
32. From our experience of implementing
the European Tissue and Cells Directive, we would strongly suggest
that any directive for the quality and safety of organ donation
should be flexible and practicable in approach: one way to encourage
this would be to involve stake-holders directly from the beginning
in the drafting of the proposals to ensure that unintended consequences
are minimised. We believe that this involvement should be in addition
to consulting stake-holders after the work is done. We would also
suggest that any directive should endorse the principle of subsidiarity
among member states: for example, different legislative models
for consent should be allowed to co-exist; and any wider system
should be organised in such a way to enable these different models
to work as intended.
CONCLUSION
33. The Human Tissue Authority's role under
the Human Tissue Act 2004 in regulating living and deceased donation
for transplantation has given it experience and insights into
a number of the issues under consideration by the Inquiry.
34. In implementing the provisions of the
Act, the Authority has had the opportunity to consider the practical
and ethical aspects of both living and deceased donation.
35. And our experiences of implementing
the European Directive on tissues and cells points to the benefits
of a flexible and practical approach to developing any European
directive on organ donation.
36. The Authority would be happy to provide
the Committee with further evidence on any of these points.
30 October 2007
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