12.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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| Department: | Health
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| Basis of consideration: | Minister's letter of 12 March 2003
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| Previous Committee Report: | HC 63-iv (2002-03), paragraph 19 (11 December 2002)
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| 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 (decision reported on 11 December 2002), but further information requested
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Background
12.1 Although a number of Community legislative measures
are applicable to blood and medicinal products derived from it,
the Commission believes that these do not address comprehensively
the necessary quality, safety and efficacy requirements. In clearing
the document on 14 November 2001, we reported on the changes made
following discussions in the Council and the European Parliament's
first reading, and we subsequently reported on 26 June 2002[20]
on an Explanatory Memorandum from the Parliamentary Under-Secretary
of State at the Department of Health (Ms Hazel Blears), drawing
our attention to the fact that two of the eight amendments proposed
by the European Parliament at its second reading on 12 June could
potentially cause considerable problems. The first appeared to
require a doctor to be present at the medical examination needed
before any blood is donated, whilst the second required blood
products to be tested in conformity with the latest scientific
and technical procedures, but did not make clear the extent of
the scientific certainty needed, or how much weight should be
put on cost-benefit analysis. Further complications arose over
the Commission's decision to base the proposal on Article 152(4)(a)
of the Treaty, and the fact that the proposed amendment also contravened
Article 152(5), which leaves national provisions on blood donation
to Member States.
12.2 In drawing these developments to the attention of
the House, we asked the Government to keep us informed of any
significant developments. We subsequently received an Explanatory
Memorandum of 6 December 2002 from the Minister saying that a
joint text had been agreed between the Council and the European
Parliament, which did not materially change the Common Position
text, and was fully supported by the Government. In noting the
latest position in our Report of 11 December 2002, we said that
we would have found it helpful to have received a copy of the
joint text, but that we inferred from the Minister's comments
that the two European Parliament amendments opposed by the UK
did not appear in the final version of the Directive. However,
we asked the Minister to confirm this, and also to let us know
the position on the legal base, where it appeared that, notwithstanding
the UK's reservations, Article 152(4)(a) had been retained.
Minister's letter of 12 March 2003
12.3 In her letter of 12 March 2003, the Minister says
that, on the first point of concern, the text adopted by the Council
and European Parliament no longer requires a doctor to be present
when blood is donated, and refers instead to the presence of a
qualified health professional, thus allowing the UK to continue
to use nurses. On the second point, she says that the wording
proposed by the European Parliament has been removed from the
body of the Directive, and that a modified form has been included
in one of the recitals.
12.4 On the legal base, she says that the Government
is satisfied that the text of the adopted Directive is within
the scope of Article 152(4)(a) of the Treaty, though she does
not state what has caused it to take this view. She adds that
the Commission has now started the process of determining through
a Regulatory Committee a number of detailed technical requirements,
and that it will be necessary to ensure that these also stay within
the scope of Article 152(4)(a).
Conclusion
12.5 Whilst we are grateful to the Minister for this
further information, it is not immediately clear from her letter
why the Government is now satisfied with Article 152(4)(a) as
the legal base for this measure. Consequently, although we have
already cleared the proposal, we would be glad if she could elaborate
on this, and explain what changes to the draft have enabled the
UK's earlier concerns to be met.
20
(23578) -; see HC 152-xxxiv (2001-02), paragraph 12 (26 June 2002). Back
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