Supplementary memorandum by the Department
of Health
Thank you for your recent emails following up
the evidence given to the EU Sub-Committee G Members on 13 December
on the Government's thinking on the nature of a European directive
on organ donation and transplantation safety that would be appropriate
and would add value to national provisions across the EU.
As Baroness Howarth and the other Members of
the Committee will know, on 31 May 2007 the EU Commission adopted
a Communication on organ donation and transplantation. This Communication
proposes future activities across the EU in the field of organ
transplantation. The Communication concludes that an appropriate
and flexible European legal framework could be an adequate community
response to meet the mandate provided in Article 152 (4) (a) of
the Treaty.
On 6 December 2007, the European Council adopted
conclusions on organ donation and transplantation. The Council
recognised the importance of having high standards with respect
to the quality and safety of organs for transplantation, in order
to ensure a high level of protection for patients throughout Europe.
It invited the Commission to continue its work under the proposed
action plan aimed at increasing the availability of donor organs
and, in consultation with the Member States, to continue its examination
of the need for an EU framework on quality and safety for human
organs. It also invited the Commission to coordinate, promote
and strengthen the cooperation between the Member States on organ
donation and transplantation, on the basis of agreed objectives
and priorities. The Community has already adopted Parliament and
Council Directives on quality and safety standards for blood and
for tissues and cells.
At the time of writing, the Commission has not
published proposals for an Organ Directive. It is likely however,
that in light of the extensive therapeutic use of human organs
for transplantation, quality and safety standards will be identified
in order to prevent the transmission of diseases. For example,
a Community framework could set quality and safety criteria with
respect to the procurement and traceability of human organs across
the Community. These standards would help ensure that human organs
are of comparable quality and safety across the EU and could facilitate
exchanges of organs across borders. Like the Blood and Tissue
and Cells Directives, the establishment of standards would help
reassure the public that human organs procured in another Member
State carried identical basic guarantees as those obtained in
their own country.
It is recognised that the severe shortage of
organs donated for transplant remains the main challenge that
EU Member States face. Waiting lists are increasing faster than
organ donor rates. Clinicians recognise that the risk-benefit
ratio is different for organ transplantation than for tissue and
cells procured for human application. The overall benefits of
an organ transplantation are high and broadly more risks can be
accepted than with blood or most tissues and cells based treatments.
In this context the clinician has an important role in deciding
whether to accept organs for transplantation.
We must therefore ensure that requirements contained
within a legislative framework do not impose a disincentive to
donation. However, experience obtained through the negotiation,
transposition and implementation of the tissues and cells Directive
indicates that there are a number of measures that could be considered
by Member States to improve the quality and safety of organs.
These include:
Competent Authorities—National Competent
Authorities have played a key role in ensuring the quality and
safety of blood, tissues and cells. For example, in the UK, the
Human Tissue Authority has been instrumental in establishing systems
for the licensing of tissue procurement, testing, storage and
distribution. based on common quality and safety criteria. Any
introduction of a similar system for organs would need to be discussed
with stakeholders to ensure an appropriate level of regulation.
Procurement—pre-transplant evaluation of
potential donors is an essential part of solid organ transplantation.
This evaluation must provide enough information to undertake a
proper risk-benefit analysis by the transplant team. Risks and
characteristics of the organ must be identified and documented
to allow allocation to a suitable recipient. In the UK we need
to be clear about the level of detail that should be included
with a framework document and how compliance would be monitored.
Traceability—It is recognised that any
transplant system must ensure traceability from donor to recipient(s).
The system must also have the capacity to detect and investigate
serious or unexpected adverse events. As organ donors are often
tissue donors, it will be vital that the introduction of quality
and safety requirements for organs complements existing systems
for tissues and cells.
UK Ministers have considered the Commission's
Communication and summary of the impact assessment. They believe
that the proposals are broadly in line with policy across the
UK to increase the number of high quality and safe organs available
for transplantation. However, concerns remain about the level
of detail that will be included within any Directive and compatibility
with current arrangements and operating principles. Ministers
recognise that implementation of a Directive would incur additional
costs of regulation, such as inspection and licensing with the
majority of the costs falling on the public sector. Many member
states, including the UK, already have high quality systems for
the identification, testing, procurement, allocation and distribution
of organs procured for transplant. In the UK, we will seek to
negotiate quality standards that add value but not unnecessary
cost, to enable appropriate investment in initiatives to increase
the number of organs donated for transplant.
The Committee will be aware that on 16 January
2008, Health Ministers across the UK accepted the Organ Donation
Taskforce's 14 recommendations to increase organ donor rates.
Copies of the Report have been placed in the Library of the House.
Alternatively it is available on the Department of Health's website
www.dh.gov,uk
The recommendations include: the establishment of a A UK Wide
organ donor organisation as part of NHS Blood and Transplant;
a strengthened network of dedicated Organ Retrieval Teams available
24 hours a day; and a doubling of the number of front line donor
coordinators (about an extra 100 donor transplant coordinators)
working with donor hospitals and families to facilitate donation.
All parts of the NHS will be encouraged to embrace organ donation
as a usual, not an unusual event and donation activity in all
Trusts will be monitored. Electronic on-line organ offering systems
will be developed to improve the allocation of organs and all
clinical and nursing staff likely to be involved in the treatment
of potential organ donors will receive mandatory training in donation
and regular update training.
Taken together, the Taskforce recommendations
draw heavily on the successful Spanish system—the country
with the world's highest organ donation rates. The Taskforce believe
that their recommendations, if implemented, could increase organ
donation rates by at least 50% over five years—a potential
1,200 extra transplants each year. Hundreds of additional people
will see their lives saved or dramatically improved. This significant
investment in the infrastructure of donation in the UK will see
UK rates rise to match some of the more successful countries in
Europe and elsewhere.
May I reassure the Committee that the UK will
continue to work with key stakeholders in the UK to ensure an
appropriate input into the development of Community guidance or
legislation. This will include representatives from NHS Blood
and Transplant—responsible for matching and allocating organs
in the UK and for auditing outcomes; the Human Tissue Authority—the
Competent Authority for the licensing of tissues and cells procured
and stored for human application and clinicians from the Transplant
community. We are also making arrangements to meet with UK MEPs
to discuss organ donation in the UK and the preferred content
of the Directive and Action Plan.
6 February 2008
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