MEDICAL DEVICES INCORPORATING HUMAN BLOOD
OR PLASMA
(20706)
12656/99
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Draft Directive on medical devices containing stable derivatives of human blood or human plasma.
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| Legal base: |
Article 95 EC; co-decision; qualified majority voting
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| Department: |
Health |
| Basis of consideration:
| EM and Minister's letter of 29 November 1999
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| Previous Committee Report:
| None; but see (20058):
HC 34-xvii (1998-99), paragraph 8 (28 April 1999); and (16205) 7007/95, (17848) 5349/97 and (18550):
HC 155-xii (1997-98), paragraph 8 (14 January 1998)
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| To be discussed in Council:
| For adoption on 2 December 1999
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| Committee's assessment:
| Politically important |
| Committee's decision:
| Cleared |
Background
21.1 Between 1995 and 1998, protracted negotiations
took place in the Council on a Commission proposal to extend Community
legislation on the harmonisation of rules for marketing in
vitro medical diagnostic devices[61].
Because of concerns which arose during the discussions over suggestions
that this might include devices incorporating human tissues, it
was eventually decided to adopt a twin track approach. As a result,
a measure dealing only with in vitro devices as narrowly
defined was adopted by the Council on 12 April 1999.
21.2 Discussion since then has focussed
on the question of substances derived from human tissue being
used in medical devices, and, as we noted in our Report of 28
April, the then Parliamentary Under-Secretary of State at the
Department of Health (Baroness Hayman) had written to us to say
that an approach generally acceptable to Member States appeared
to emerging. This would have restricted the scope of the remaining
measure to devices which use human blood or plasma where the blood
component acted in an ancillary manner to the functioning of the
device, and where the blood/plasma had undergone the verification
procedure set out in the Blood Products Directive (89/831/EC)[62].
The Minister added that a proposal to this effect had been submitted
as a working text by the German Presidency, and that the Government
had asked the Commission to advise on the next steps and to let
it know when it intended to publish the draft Directive formally.
She said that she would at that stage provide us with an Explanatory
Memorandum, but that, against a background where the Presidency
was aiming to reach political agreement in June, the UK would
continue to negotiate on the basis she had set out, which she
felt would represent an acceptable conclusion. In noting the position,
we said that we would consider the matter further when we had
received the promised Explanatory Memorandum, but that in the
meantime, we were not clearing the document.
Minister's letter and Explanatory Memorandum of
29 November 1999
21.3 We have now received from the current
Parliamentary Under-Secretary of State at the Department of Health
(Lord Hunt of Kings Heath) a letter of 29 November, together
with a copy of the text which has emerged from discussions in
Council working groups under the Finnish Presidency, a covering
Explanatory Memorandum, and a Regulatory Impact Assessment.
21.4 The Minister has explained that hopes
of progress under the German Presidency turned out to be over-optimistic,
not least due to differences between the Presidency itself and
certain other Member States (including the UK). In particular,
Germany wanted to require manufacturers of medical devices to
comply not only with the Blood Products Directive, but also with
all the various national requirements imposed by Member States.
He goes on to say that the UK does not impose additional national
requirements, and believes it would be inconsistent to have more
stringent regulatory controls for blood derivatives in the medical
device sector than in the area of medicinal products. Consequently,
although the Government had some concerns that approval under
the Blood Products Directive would involve extending the competence
of the European Medicines Evaluation Agency (EMEA), it decided
to support such an approach. According to the Minister, the scope
of the measure will be limited to a small number of products falling
within the highest risk category, which will be subjected to the
"most rigorous conformity assessment procedures". He
believes this will ensure "appropriate safety and quality
standards for the devices concerned", and also meet the UK's
ethical concerns.
21.5 In commenting on the Regulatory Impact
Assessment, the Minister says that the estimated non-recurring
costs of complying with the new provisions are likely to be in
the range of £7,500 to £30,000 per product, depending
on whether the blood component is already a licensed medicinal
product. Annual recurring costs would be approximately £2,000.
Conclusion
21.6 We are grateful to the Minister
for this further information, which confirms that the measure
now emerging from discussions in the Council is likely to be similar
to that we considered in April, and to be acceptable to the UK
in terms of its scope and content. We also understand that broad
political agreement on the text before us has now been reached,
subject to our scrutiny reserve and that of Denmark. We now clear
the proposal.
61 Defined in this context as "reagents, instruments
or equipment for examining tissues or substances from the human
body for medical purposes". Back
62 OJ
No. L 181, 28.6.89, p.44. Back
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