Examination of Witnesses (Questions 358
- 359)
THURSDAY 13 MARCH 2008
Mr Peter Lemmey
Q358 Chairman: Mr Lemmey,
it would be very helpful if you would for the record say who you
are and your title.
Mr Lemmey: I am Peter Lemmey and I am the Policy
Director of the Human Tissue Authority.
Q359 Baroness Neuberger: Before
I ask my question I need to declare an interest, which is that
my brother-in-law is deeply involved in transplant policy and
practice at Queen Elizabeth in Birmingham, James Neuberger. Mr
Lemmey, really it is a multiple question I have to ask you. The
first bit of it is asking you to explain how the 2004 Human Tissue
Act impacts on organ donation in England and Wales and how the
Scottish Act differs from it, if it does, and whether it leads
to different practices. If you could start with that, I have a
bit more to say.
Mr Lemmey: Let me start with the impact of the
2004 Act. The first point to make is that the Human Tissue Act
covers both donation from living people and donation from the
dead. The Act sets out provisions to ensure that appropriate consent
is obtained for donation for transplantation, and indeed other
activities involving organs and tissue and human bodies. The Act
set up the Human Tissue Authority, which came into being in 2005
with a role to issue guidance and advice to Ministers, to practitioners
and to the public—and in some cases to license and inspect,
but those provisions do not apply to transplantation or donation
for transplants. The Authority also implements the European Tissue
and Cells Directive, and I think we may get on to that in a bit
more detail in a minute. The Act outlaws trafficking in organs
and commercial dealings. It also covers Northern Ireland as well
as England and Wales. The impact of the Act is rather different
as between donation of organs from the deceased and from the living.
For donations in death the Human Tissue Act regulates through
its requirements on consent. The Authority regulates through the
Act's requirements on consent and on the guidance and the codes
of practice that the Authority issues. They are approved by Parliament,
they are statutory documents, and they set out good practice.
We also work with stakeholders in the field, particularly with
partner organisations like, for example, UK Transplant. For live
donations, donations from the living, the situation is different.
Each individual case of a donation for transplantation—we
are talking about live transplants—has to be approved by
the Human Tissue Authority according to the Human Tissue Act and
also according to the secondary legislation, the regulations that
came afterwards. Those require that the consent be properly informed,
and that it is clear, and that the risks have been explained to
both the donor of the organ—the donor of a kidney perhaps—and
the recipient, and that it is clear as far as we can be that there
has been no coercion of the donor and that there has been no payment.
That process of regulating donation for live transplantation is
particularly focused by the Act on the need for the Authority
to consider the interests of the donor in the transplant. The
process works like this. The Authority accredits independent assessors
in each of the hospitals where there is a transplant unit. There
are about 110 assessors, several to each unit, and they are almost
entirely senior medical staff, consultants, but, crucially, not
working in the area of transplantation. At an appropriate point
in the working up of a transplant those independent assessors
will interview both the donor and the recipient of the organ,
and the donor and recipient together, to ensure that the issues
that I mentioned earlier about consent, risk and coercion, and
indeed payment, are explored. The independent assessor will then
send a report electronically to the Human Tissue Authority, and
we then check that the provisions of the Act have been complied
with and deal with any unstraightforward points that the assessor
may have raised. In that way, we check through local assessment
and then centrally that the provisions of the Act in each case
have been met. As far as we can see, the whole process works smoothly.
It has been running since 2006. There is generally a two-day turn-round
in approvals from the Human Tissue Authority.
|
