APPENDIX 2: QUALITY AND SAFETY OF ORGANS
INTENDED FOR TRANSPLANTATION REGULATIONS 2012 (SI 2012/1501):
ADDITIONAL INFORMATION |
Further information from the Department for Health
In the UK, we have a national blood and organ donation
organisation which is NHS Blood and Transplant (NHSBT). They have
responsibility for the procurement and allocation of deceased
donor organs across the UK. Transplantation of donated organs
is carried out by the 40 transplant centres, 10 of which are in
the private sector, the remainder being in the NHS. In relation
to living donation and transplantation, this is carried out in
the transplantation centres with NHSBT having little involvement
in this area. However, all living donations must be approved by
the Human Tissue Authority (HTA) before the transplantation can
There is currently no regulator in the UK that specifically
authorises transplantation centres and procurement organisations.
Currently, hospitals in England are registered by the Care Quality
Commission (CQC) for the provision of health services across the
board and similar arrangements are in place in the other three
countries. The National Commissioning Group (NCG) and Specialised
Commissioning Teams commission transplants from the transplantation
centres and do carry out audits, but these are broadly in relation
to clinical practice and not organisational governance and operational
procedures to ensure quality and safety of organs, which the Organ
Directive is concerned with.
The Organ Directive requires us to set up a Competent
Authority that will specifically license procurement and transplantation.
As this currently is not the case in the UK (see above), we are
setting up a new licensing regime and appointing the HTA as the
Competent Authority for the Organ Directive. Transplantation centres
and NHSBT will need to be licensed by the HTA should they wish
to continue to carry out procurement and/or transplantation activities
after 27 August 2012.
Schedule 1 of the Quality and Safety of Organs Intended
for Transplantation Regulations 2012 ('the Regulations') sets
out the procurement and transplantation activities that must be
licensed by the HTA. A procurement activity is an activity carried
out for the purposes of procurement and includes donor and organ
characterisation, preservation, retrieval and transport of an
organ. A transplantation activity is an activity carried out for
the purposes of transplantation and includes organ characterisation,
transport, preservation and implantation of an organ.
Schedule 1 transposes the requirements that the Directive
places on procurement organisations and transplantation centres,
requiring that the above mentioned activities must be licensed
if carried out after 27 August 2012. The Directive also requires
that full traceability of donors and organs is met across the
donation - transplantation - pathway including disposal. The Regulations
therefore require the HTA to ensure this and place requirements
on licensed organisations. Similarly, the Directive requires that
robust serious adverse events and reactions (SAE/R) reporting
arrangements are in place and the Regulations therefore implement
this requirement by placing requirements on the HTA and licensed
Department of Health officials have provided the
following responses to the questions put by the Committee:
"Q1. Will this facilitate the import/export
of organs for transplantation within the EU?
A. The Directive will establish common quality and
safety standards for organ transplantation across the EU. This
may lead to an increase in the availability of organs on an EU-wide
basis and may therefore lead to more organs being available for
transplant across Member State boundaries. However, as the Member
States closest to the UK already have advanced transplantation
programmes, the Department of Health does not anticipate that
the Organ Directive will significantly increase the import/export
of organs as far as the UK is concerned.
Q2. Will this affect the import/export of organs
from outside the EU which may not meet these standards?
A. In theory yes. Organs that are coming from outside
the EU will have to meet similar quality and safety standards
as those that are exchanged within the EU. In practice, this would
happen now. We would need to be certain of the quality of the
organ before accepting it for transplant.
Q3. Will the new regulatory system cover organs
privately purchased overseas?
A. The Organ Directive requires that organ donation
must be voluntary and unpaid, thus rendering it illegal to purchase
an organ. However, the UK has existing legislation in place, the
Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006,
that ban the sale of organs for profit. Organ purchasing and trafficking
is therefore already illegal in the UK and the new Regulations
do not need to address these issues.
Q4. Will implementation of these Regulations impact
on the Welsh Government proposal to introduce soft opt-out for
A. No. Member States have both opt-in and opt-out
systems of consent and the Directive recognises both.
Q5. In the new scenario, who will check on the
continued suitability of an organ that is dropped in transit?
A. The Organ Directive will not change existing arrangements
in relation to who will check on the continued suitability of
an organ that is dropped in transit. It will be a clinical decision
by the transplanting surgeon whether or not the organ is still
suitable for transplant
Much of the work that transplantation centres and
NHS Blood and Transplant will carry on as now, though with some
modifications to comply with the Directive's requirements. The
main change brought about the Directive is the setting up of a
licensing regime and appointment of a Competent Authority to oversee
procurement and transplantation activities that are being carried
Department of Health
19 June 2012