Select Committee on European Scrutiny Second Report


MEDICAL DEVICES INCORPORATING HUMAN BLOOD OR PLASMA


(20706)
12656/99

Draft Directive on medical devices containing stable derivatives of human blood or human plasma.
Legal base: Article 95 EC; co-decision; qualified majority voting
Department: Health
Basis of consideration: EM and Minister's letter of 29 November 1999
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)
To be discussed in Council: For adoption on 2 December 1999
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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Prepared 16 December 1999