6 Rare diseases
- (30171) 15775/08 COM(08) 679 + ADDs 1-2
(b)(30172) 15776/08COM (08) 726
+ ADDs 1-2
| Commission Communication — Rare Diseases: Europe's challenges
Commission staff working documents: impact assessment and summary of assessment
Draft Council Recommendation on European action in the field of rare diseases
Commission staff working documents: impact assessment and summary of assessment
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| Legal base | (a) —
(b) Article 152(4) EC; co-decision; QMV
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| Department | Health |
| Basis of consideration | Minister's letters of 19 January and 3 March 2009
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| Previous Committee Report | HC 19-i (2008-09), chapter 9 (10 December 2008)
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| To be discussed in Council | June 2009
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| Committee's assessment | (Both) Legally and politically important
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| Committee's decision | (Both) Cleared; but further information awaited
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Previous scrutiny of the documents
6.1 When we considered these documents in December, we noted that
the Commission's Communication argued for a new Community strategy
on rare diseases (such as some diseases of the auto-immune system)
because of the difficulties of providing patients with quick and
easy access to medical services with the necessary knowledge,
expertise and equipment. Document (a) also pointed to the difficulties
of organising and financing top-quality research. So the Commission
proposed a strategy based on improving the classification of rare
diseases and the dissemination of information about them; a common
approach by Member States to work on rare diseases; and European
cooperation to improve access to high quality care.
6.2 The Commission also proposed a draft Recommendation
(document (b)) with the aim of helping and inspiring Member States
to adopt the common approach the Commission advocates in the Communication.
6.3 In her Explanatory Memorandum of 25 November
2008, the Minister of State at the Department of Health (Dawn
Primarolo) told us that decisions on health priorities and funding
must remain with Member States because countries' needs and health
systems differ. The Government would support some parts of the
proposed Recommendation but resist others. Moreover, the Minister
questioned whether all the provisions of the draft Recommendation
complied with the requirement in Article 152(5) of the EC Treaty
that Community action on public health must fully respect the
responsibilities of the Member States for the organisation and
delivery of health services and medical care.
6.4 We shared the Minister's doubts about compliance
with Article 152(5) and questioned whether it was necessary or
desirable to make such detailed recommendations on some of the
matters covered in document (b). We asked the Minister to tell
us whether other Member States and the Council's Legal Service
shared the Government's doubts; and for progress reports on the
negotiations.
The Minister's letter of 19 January 2009
6.5 In her letter of 19 January in response to our
request for further information, the Minister said that the Government's
concerns were shared by some other Member States and were discussed
in December in both the Health Council and the Working Group of
officials. The Commission offered to amend the original proposal
to take account of Member States' concerns. The revised draft
of the Recommendation was expected shortly.
The Minister's letter of 3 March 2009
6.6 On 3 March, the Minister wrote to us again. She
enclosed with her letter a copy of the Presidency's revised draft
of the Recommendation. In her view, the Presidency's draft addresses
the Government's concerns. For example, it omits wording which
in the original draft was over-prescriptive and excessively detailed.
The Presidency is expected to circulate a further draft —
which is unlikely to differ in substance from the Presidency's
current text — and to ask the Health Council to approve
it at its meeting in June. The Minister would be happy to send
us the new draft when it is circulated.
Conclusion
6.7 We are grateful to the Minister for sending
us the Presidency's revised draft of the Recommendation and her
assessment of it. The revised draft supersedes documents (a) and
(b) and so we clear them from scrutiny.
6.8 We agree with the Minister that the revised
draft removes the objectionable features of the original draft.
Crucially, whereas the original contained frequent statements
about what Member States "should" do, the revised draft
does not tell Member States what to do but, rather, invites them
to consider action or to aim to achieve certain outcomes. In our
view, the revised draft complies with the terms of Article 152(5)
of the EC Treaty.
6.9 We note that the Presidency is expected to
circulate a further draft. We ask the Minister to deposit it for
scrutiny as soon as it is circulated and to provide an Explanatory
Memorandum on it in the usual way.
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