13 Quality and safety of human organs
for transplantation
| (a)
(30265)
16521/08
COM(08) 818
+ ADDs 1-2
(b)
(30266)
16545/08
COM(08) 819
+ ADDs 1-2
|
Draft Directive on standards of quality and safety of human organs intended for transplantation
Commission staff working documents: impact assessment and summary of assessment
Commission Communication: Action Plan on Organ Transplantation (2009-15): Strengthened cooperation between Member States
Commission staff working documents: impact assessment and summary of assessment
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| Legal base | (a) Article 168(4)(a) TFEU; co-decision; QMV
(b) —
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| Department | Health |
| Basis of consideration | Minister's letter of 28 June 2010
|
| Previous Committee Report | HC 19-iii (2008-09), chapter 5 (14 January 2009); HC 19-viii (2008-09), chapter 6 (25 February 2009);
HC 19-xiv (2008-09), chapter 5 (22 April 2009); and HC5-xv (2009-10), chapter 2 (24 March 2010)
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| To be discussed in Council | 28 June 2010
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| Committee's assessment | Politically important
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| Committee's decision | (a) Cleared.
(b) Not cleared; further information requested
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Background
13.1 Article 168(1) of the Treaty on the Functioning of the European
Union (TFEU) provides that action by the EU on public health should
complement national policies and be directed to the improvement
of public health and the prevention of illness and disease. Article
168(2) requires the EU to encourage cooperation between Member
States to improve public health. Article 168(4)(a) authorises
the Council to adopt measures setting standards of quality and
safety for human organs, blood and other substances of human origin.
Article 168(7) requires EU action to pay full respect to the responsibilities
of the Member States for the organisation and delivery of health
services and medical care and says that measures adopted under
Article 168(4)(a) "shall not affect national provisions on
the donation or medical use of organs".
13.2 Similar provision was made in Article 152 of
the EC Treaty; in particular, Article 168(4)(a) and Article 168(7)
TFEU are word for word the same as Article 152(4)(a) and Article
152(5) of the EC Treaty.
13.3 In 2007, the Commission published a Communication
on organ donation and transplantation.[55]
It suggested ways in which the EC and Member States might increase
the supply of organs and improve the quality and safety of transplantation.
The Commission advocated the preparation of an Action Plan to
encourage cooperation between Member States and EC legislation
to establish basic principles of safety and quality.
Previous scrutiny of the documents (a) and (b)
13.4 The draft Directive (document (a)) and the proposed
Action Plan (document (b)) are the documents the Commission had
advocated in the Communication.
13.5 Document (a) specifies common quality and safety
standards for the donation, storage, transport and transplantation
of human organs. For example, it provides that Member States should
ensure that:
- there is a national framework
for quality and safety to ensure compliance with the requirements
of the Directive;
- the donation of organs takes place in a "procurement
organisation" (that is, in a hospital or other body authorised
by the national competent authority to procure organs in specialised
facilities which minimise risks of contamination);
- transplantation takes place in an authorised
"transplantation centre"; and
- all organs can be traced from donor to recipient
and vice versa and that the relevant data is kept for a minimum
of 30 years.
13.6 The Commission's Action Plan for 2009-15 (document
(b)) includes proposals for cooperation between Member States
and the Commission to increase the number of organs donated and
improve access to transplantation. The Plan would not be legally
binding and each Member State would be invited to draw up its
own programme and set its own priorities.
13.7 In December 2008, the then Minister of State
at the Department of Health (Dawn Primarolo) told the previous
Committee that the Government supported the proposed Directive
but would argue strongly that the common standards should be kept
to the minimum necessary to ensure safety and quality, should
not be excessively bureaucratic and should not impose requirements
beyond those which were clinically justified.
13.8 In the Conclusion to its report of 14 January
2009,[56] the previous
Committee noted that the Commission had cited Article 152(4)(a)
of the EC Treaty as the legal base for the draft Directive and
that Article 152(5) expressly said that the measures referred
to in Article 152(4)(a) "shall not affect national provisions
on the donation of or medical use of organs". The Human Tissue
Act 2004 and the Human Tissues (Scotland) Act 2006 make national
provision on those matters. It was not readily apparent to the
previous Committee, therefore, that the draft Directive complied
with Article 152(5).
13.9 In the course of the subsequent Council negotiations,
amendments were made to the draft Directive which satisfied the
previous Committee that the measure would be compliant with Article
152(5) EC (and now Article 168(7) TFEU).[57]
The Minister's letter of 28 June 2010
13.10 In her letter of 28 June, the Parliamentary
Under-Secretary of State for Public Health at the Department of
Health (Anne Milton) tells us that the Council and the European
Parliament have reached a First Reading deal on the Directive.
13.11 The Minister also tells us that the vast majority
of the UK's negotiating aims have been achieved. For example:
- the draft Directive has been
amended to permit national competent authorities to delegate their
functions or to be assisted by other bodies (this will permit
existing organisations in the UK — such as NHS Blood and
Transplant — to perform some of the competent authority's
key functions);
- the draft Directive has also been amended to
give Member States discretion to maintain protective requirements
which are more stringent than the minimum standards set out in
the Directive's Technical Annex;
- provision has been introduced to allow medical
teams, on the basis of a risk analysis, to proceed with transplants
even if not all the information required by the Directive has
been received; and
- the Commission's delegated powers to make subordinate
legislation have been reduced.
13.12 The Minister says that she hopes that the Committee
will understand that, because the UK has achieved most of its
negotiating aims, the Government intends to take part in the adoption
of the Directive even though it is still under scrutiny.[58]
Conclusion
13.13 In the circumstances the Minister describes,
we accept that it was reasonable for the Government to give its
agreement to the adoption of the Directive. Accordingly, we clear
the Directive from scrutiny. But we ask the Minister to send us
progress reports on the consideration of the Action Plan; meanwhile,
we shall keep document (b) under scrutiny.
55 (28686) 9834/07: see HC 41-xxvii (2006-07), chapter
6 (27 June 2007). Back
56
See HC 19-iii (2008-09), chapter 5 (14 January 2009). Back
57
See HC 5-xv (2009-10), chapter 2 (24 March 2010). Back
58
The Council adopted the Decision on 28 June with the Government's
agreement. Back
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