19. QUALITY AND SAFETY OF BLOOD
(a)
(23901)
11392/02
COM(02) 479
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Opinion of the Commission on the European Parliament's amendments to the Council's Common Position on a draft Directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Council Directive 2001/83/EC.
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(b)
(24051)
—
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Draft Directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Council Directive 2001/83/EC.
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| Legal base: | Article 152(4)(a) EC; co-decision; qualified majority voting
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| Document originated: | (a) 23 August 2002
(b) —
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| Document deposited: | (a) 25 October 2002
(b) —
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| Department: | Health
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| Basis of consideration: | (Both) EM of 6 December 2002
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| Previous Committee Report: | None, but see footnotes below
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| To be discussed in Council: | 16-19 December 2002
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| Committee's assessment: | Legally and politically important
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| Committee's decision: | Cleared, but further information requested
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Background
19.1 Although the Community has enacted a number of legislative
measures applicable to blood and medicinal products derived from
it, the Commission has taken the view that these do not address
comprehensively the necessary quality, safety and efficacy requirements.
It therefore put forward in December 2000 a draft Directive[59]
which would set out the ways in which this aim might be achieved.
Together with the Government's reactions, these were described
at greater length in our predecessors' Report of 14 March 2001,
and, in clearing the document on 14 November 2001, we ourselves
reported on the changes made to the proposal following discussions
in the Council and the European Parliament's first reading.
19.2 We subsequently reported on 26 June 2002[60]
on an Explanatory Memorandum of 20 June 2002 we had received from
the Parliamentary Under-Secretary of State at the Department of
Health (Ms Hazel Blears), drawing our attention to the eight amendments
which the European Parliament had proposed at its second reading
on 12 June to the Council's Common Position. Although the Minister
said that the UK could accept six of these, she considered that
the remaining two could potentially cause considerable problems.
The first appeared to suggest that a doctor should be present
at the medical examination required before any blood is donated,
which the Minister said would create major problems in the UK,
where nurses are trained to conduct these sessions. The second
concern related to an amendment requiring blood products to be
tested in conformity with the latest scientific and technical
procedures, which did not make clear the extent of the scientific
certainty needed, or how much weight should be put on cost-benefit
analysis.
19.3 The Minister also pointed out that the Commission
proposal was based on Article 152(4)(a) of the Treaty, which ensures
a high standard of quality and safety of blood, whereas the health
of the donor is outside the scope of this Article, and that the
proposed amendment also contravened Article 152(5), which leaves
national provisions on blood donation to Member States. In view
of these concerns, she said that the Government felt justified
in rejecting the amendments, and that, if necessary, it would
be seeking support in the Council to push the proposal into conciliation
19.4 In our Report, we noted the Government's strong
reservations over two of the European Parliament's second reading
amendments, and said that we shared the Minister's concerns on
the question of the Treaty base. We added that, although we did
not think any useful purpose would be served at that late stage
in seeking to put in place a scrutiny reserve, we nevertheless
thought these two points were of sufficient importance to be drawn
to the attention of the House, and we asked the Government to
keep us informed of any significant developments.
Explanatory Memorandum of 6 December 2002
19.5 We have now received an Explanatory Memorandum of
6 December 2002 from the Minister saying that a joint text has
been agreed between the Council and the European Parliament, which
does not materially change the Common Position text, and is fully
supported by the Government. She adds that there are no additional
cost implications, and that the final Regulatory Impact Assessment
is little changed from an earlier partial Assessment. She also
points out that the joint text supersedes the opinion issued by
the Commission (document (a)) on the Parliament's second reading
amendments.
Conclusion
19.6 Whilst we have noted the latest position, and
again have no wish to maintain a scrutiny reserve, we would have
found it helpful to have received a copy of the joint text. As
it is, we can only infer from the Minister's comments that the
two European Parliament amendments opposed by the UK do not appear
in the final version of the Directive. We would, however, like
the Minister to confirm this, and also to let us know the outcome
on the question of the legal base, where it would appear from
her Explanatory Memorandum that, notwithstanding the UK's reservations,
Article 152(4)(a) has been retained. Meanwhile, we clear the document.
59
(22122) 5773/01; HC 28-viii (2000-01), paragraph 11 (14 March
2001), HC 152-iv (2001-02), paragraph 5 (7 November 2001), HC
152-vi (2001-02), paragraph 6 (14 November 2001) and HC 152-xii
(2001-02), paragraph 13 (16 January 2002). Back
60
(23578) -; see HC 152-xxxiv (2001-02), paragraph 12 (26 June 2002). Back
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