6 Organ donation and transplantation
| (28686)
9834/07
ADDs 1-2
COM(07) 275
| Commission Communication: Organ donation and transplantation: policy actions at EU level
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| Legal base | — |
| Document originated | 30 May 2007
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| Deposited in Parliament | 11 June 2007
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| Department | Health |
| Basis of consideration | EM of 20 June 2007
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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The European Community's responsibilities for public health
6.1 Article 152 of the EC Treaty requires the Community to encourage
cooperation between Member States to improve public health and
prevent human illness and disease. It also requires Member States,
in liaison with the Commission, to coordinate their public health
policies and authorises the Commission to "take any useful
initiative to promote such coordination". Moreover, it expressly
requires the Council to adopt measures setting high standards
for the safety and quality of human organs. However, Article 152(5)
requires Community action to respect fully the responsibility
of Member States for the organisation and delivery of health services
and medical care; in particular, it provides that Community measures
on organs must "not affect national provisions on the donation
or medical use of organs".
6.2 In 2003, the Council adopted a Directive on standards
of quality and safety for human blood; and, in 2004, it adopted
a Directive on the safety and quality of tissues and cells.
The Commission's Communication
6.3 The Communication sets out the action the Commission
intends to take to ensure the quality and safety of organs donated
for transplantation; to increase donations; and to deter trafficking
in human organs.
6.4 The Commission believes that action by the Community
is needed because:
- donated organs can transmit
disease or illness to their recipients;
- there is a shortage of organs throughout the
Community — every day, ten people die while waiting for
a transplant and there are 40,000 people on waiting lists for
a transplant;
- donation and transplantation rates are much higher
in some Member States than in others;
- there is some legal transfer of donated organs
between Member States and some people are travelling from their
home Member States to others to get transplants; and
- the shortage of organs is an incentive to organised
criminal groups to traffick in human organs.
6.5 The Communication is based on views the Commission
invited from Member States, health organisations, scientific institutions
and associations representing patients and donors. It also takes
account of meetings the Commission arranged with a wide range
of experts and of the findings of research funded from the EC's
R&D programme.
6.6 The Commission proposes to prepare an Action
Plan for strengthening cooperation between Member States. It will
also draft EC legislation on quality and safety standards for
organ donation and transplantation.
6.7 The Commission notes that:
"Analysis of the organ transplantation situation
in the EU has revealed large differences in the deceased and living
organ donor rate within the EU and also considerable differences
in transplantation activity. These differences cannot be easily
explained and it is clear that some models are performing better
than others. There is scope for sharing expertise among EU Member
States and for cooperation between countries to help maximise
organ donation and equalise access to transplantation. The Community
will identify the best of the best models and support its application
throughout the EU while respecting cultural and organisational
diversity."[22]
6.8 The Commission says that the Action Plan should
apply the "open method of coordination"[23]
to organ donation and transplantation in order to help Member
States agree common objectives and performance indicators, monitor
outcomes and share best practice. The Action Plan could cover
such matters as:
- ways to increase donation rates
through, for example, donor cards, public education and awareness
raising campaigns;
- training for doctors and other staff who deal
with potential donors and their families;
- guidelines on offering any surplus organs to
other countries;
- arrangements for assessing, allocating and transporting
organs; and
- systems to record and trace transplanted organs.
6.9 The Communication stresses the importance of
the international agreements which ban trafficking in human organs.
For example, it refers to the UN Treaty against international
organised crime which requires the parties to the Treaty to criminalise
trafficking and penalise traffickers. The Commission says that
"it will closely monitor any developments in the organ trafficking
field both inside the EU and worldwide".[24]
6.10 The Commission also plans to propose EC legislation
on organ donation and transplantation. The legislation might include
:
- quality and safety standards
for the authorisation of organ donation and for the preservation
and transport of donated organs;
- requirements for the establishment and maintenance
of donor records and systems for tracing organs and reporting
adverse reactions; and
- provision on inspection and control of donations
and transplants.
6.11 The Commission staff working document (ADD 1)
enlarges on the proposals in the Communication, provides supporting
information and discusses the impact of the Commission's preferred
course of action and alternatives to it.
The Government's view
6.12 The Minister of State for Health Services at
the Department of Health (Ms Rosie Winterton) tells us that the
Commission's proposals "are broadly in line with policy across
the UK to increase the number of high quality and safe organs
available for transplantation". She adds, however, that:
"We will need to ensure that the principle
of subsidiarity continues to be respected — in a couple
of places the document talks about the best models for organising
services to increase donation. Although we support the sharing
of good practice, final decisions on the organisation of health
services must rest with Member States."
6.13 The Minister also tells us that officials from
her Department and from NHS Blood and Transplants (which is responsible
for the matching and allocation of organs for transplantation)
will be meeting the Commission and experts from other Member States
to discuss such matters as common objectives, indicators and how
to identify best practice. They will also discuss what provision
might be included in a new Directive on organ donation and transplantation.
Conclusion
6.14 We are satisfied that Article 152 of the
EC Treaty provides an appropriate legal base for Community action
on organ donation and transplantation. We also recognise the potential
benefits of cooperation between Member States to disseminate best
practice and agree common minimum standards for the safety and
quality of donated organs. But we endorse the Minister's cautionary
words about the need for vigilance to ensure that Community action
is consistent with the principle of subsidiarity. It will also
be necessary to ensure that the proposed Directive is compatible
with the requirement of Article 152(5) that the measure should
not "affect national provisions on the donation or medical
use of organs".
6.15 We regard the Communication as a useful contribution
on an important aspect of public health. Accordingly, we draw
the document to the attention of the House. We shall reserve further
comment until the Commission presents its proposals for the Action
Plan and a new Directive. Meanwhile, we clear the Communication
from scrutiny.
22 Commission Communication, page 10, first paragraph. Back
23
In March 2000, the European Council defined the open method of
coordination. Its purpose is to help Member States develop their
own policies by agreeing European guidelines and timetables for
short, medium and long-term goals, quantitative and qualitative
indicators and benchmarks. Member States then translate the guidelines
into national and regional policies. Outcomes are subjected to
periodic monitoring, evaluation and peer review. Back
24
Ibid, page 8, last paragraph. Back
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