Documents considered by the Committee on 11 March 2015 - European Scrutiny Contents


7 Regulation of medical devices

Committee's assessment Politically important
Committee's decisionNot cleared from scrutiny; further information requested; scrutiny waiver granted; drawn to the attention of the Health Committee and the Science and Technology Committee
Document details(a) Draft Regulation on medical devices

(b) Draft Regulation on in vitro diagnostic medical devices

Legal base(Both) Articles 114 and 168(4)(c) TFEU; co-decision; QMV
DepartmentHealth
Document numbers(a) (34294), 14493/12 + ADDs 1-5, COM(12) 542

(b) (34295), 14499/12, COM(12) 541

Summary and Committee's conclusions

7.1 These draft Regulations would repeal and replace three existing Directives which establish the EU regulatory framework for medical devices. The first — document (a) — applies to all types of medical devices, including implants. The second — document (b) — applies to in vitro diagnostic medical devices used to test samples derived from the human body. Both seek to introduce a more rigorous system for Member State supervision of "notified bodies" — bodies responsible for certifying that medical devices are safe for use — and to ensure greater transparency and accountability in relation to devices and their manufacturers.

7.2 The Government broadly welcomes the draft Regulations, subject to two principal concerns. First, it considers that the Commission's proposals to introduce additional pre-market scrutiny of higher risk devices by a central Committee of Member State experts would be ineffective, overly bureaucratic and delay patient access to life-changing medical technologies. Second, it questions the proposed removal of an existing exemption for "in house" devices manufactured and used within the same health institution which would substantially increase costs within the NHS.

7.3 Our earlier Reports, listed at the end of this chapter, provide a detailed overview of these important and complex draft Regulations, the Government's position, the outcome of a public consultation undertaken by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and the First Reading amendments agreed by the European Parliament in April 2014.

7.4 Last November, we agreed to grant a scrutiny waiver to enable the Government to support a possible general approach at the December 2014 Health Council. In doing so, we noted that there was broad agreement in Council on the need for an exemption for "in house" in vitro diagnostic medical devices, with discussions focussing on ensuring that such devices meet minimum safety standards. We considered that the Government had set out clearly the terms on which it would be willing to support a compromise on pre-market scrutiny for higher risk medical devices and expressed support for its efforts to secure an outcome which was "clinically focussed", applicable to a narrowly defined range of products, and did not undermine the wider objective of improving the quality of all notified bodies.

7.5 In the event, the December Health Council was unable to agree a general approach. In his latest letter, the Minister for Life Sciences (George Freeman) explains how the Latvian Presidency intends to approach the negotiations. He anticipates that the Health Council will be invited to reach either a political agreement or a general approach in June and asks us to grant a waiver on the terms previously agreed last November in order to enable the UK to support an acceptable Presidency compromise text.

7.6 As the Minister indicates, there is every prospect that the Council will agree a general approach, or reach a wider political agreement with the European Parliament, in June, before our successor Committee has been established. When we granted a scrutiny waiver last November, ahead of the December Health Council, we noted that the Minister had set out clearly the terms on which the Government would be willing to support a compromise Presidency text. The Minister reiterates those terms in his latest letter. Given the circumstances, and the Minister's foresight in requesting a scrutiny waiver to obviate the risk of an override, we agree to renew the scrutiny waiver.

7.7 We ask the Minister to report back to our successor Committee on the outcome of the Health Council and to make available the text of the general approach (or any wider political agreement) reached at the Council. Meanwhile, the draft Regulations remain under scrutiny. We draw the latest developments to the attention of the Health Committee and the Science and Technology Committee.

Full details of the documents: (a) Draft Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No. 1223/2009: (34294), 14493/12 + ADDs 1-5, COM(12) 542; and (b) Draft Regulation on in vitro diagnostic medical devices: (34295), 14499/12, COM(12) 541.

Background

7.8 In our earlier Reports, we indicated that we were content with the way in which the Government intended to approach negotiations. We shared the Government's concern that the introduction of additional pre-market scrutiny of higher risk medical devices might delay patient access to new technologies and increase costs for manufacturers without delivering any significant benefits for patient safety. We noted that the Government's consultation of stakeholders revealed mixed views on the need to maintain an existing exemption for high risk in vitro diagnostic devices developed and used within a single health institution (so-called 'in-house' tests). We asked the Government to inform us of any significant developments in the negotiations, particularly on these two issues, and to indicate what type of compromise the Government would be willing to accept to address shortcomings in the current regulatory system without introducing a further layer of pre-market scrutiny. We also welcomed the Government's efforts to increase transparency — a key concern raised by the Science and Technology Committee in its Report, Regulation of medical implants in the EU and the UK[14] — and the Minister's confirmation that the UK's efforts in this area would be reflected in the final agreed text.

7.9 The European Parliament (EP) formally agreed its First Reading position on both draft Regulations in April 2014. The EP proposed that certain high risk medical devices should be assessed by "special notified bodies" designated by the European Medicines Agency and that there should be a further tier of scrutiny, applicable on a case-by-case basis, to be carried out by an expert Assessment Committee for Medical Devices. The Government opposes these changes on the grounds that they may dilute responsibility for pre-market approval, create a longer and more uncertain approval process, and increase costs. It also opposes the EP's proposal to include new provisions on genetic testing, counselling and informed consent in the draft Regulation on in vitro diagnostic medical devices.[15]

The Minister's letter of 5 March 2015

7.10 The Minister (George Freeman) notes that the Latvian Presidency's draft agenda for the Health Council on 19 June envisages two possible outcomes: a political agreement or a general approach. He anticipates that a general approach is the most likely outcome and explains how this differs from a political agreement:

    "To clarify, when adopting such a 'general approach' after the European Parliament has adopted its position at first reading, the Council is not acting within the meaning of paragraphs 4 and 5 of Article 294 of the Treaty on the Functioning of the EU. This means that the Council is not adopting a formal first reading position.

    "The Latvian Presidency would choose this approach because it means that the Presidency can use the 'general approach' as a mandate to start trilogues with the European Parliament in an effort to reach an early second reading deal. This is where informal trilogues between the Council, European Parliament and European Commission take place, with Ministers then adopting a first reading position in a subsequent Council meeting, which the European Parliament is then able to accept without any amendments in their second reading position."

7.11 The Minister considers there to be "a slim chance" that the Latvian Presidency will make sufficient progress to complete informal trilogues with the European Parliament and the Commission and to seek political agreement at the Health Council to a formal first reading position. He continues:

    "Either way, with our Parliament expected to prorogue in late March, it is highly unlikely we will be able to return to this Committee to set out the near-final Presidency compromise text before Health Council on 19 June."

7.12 The Minister acknowledges our hesitancy to clear the draft Regulations from scrutiny until we have a better understanding of the content of any Presidency compromise text on pre-market scrutiny, also one of the Government's key negotiating objectives. He adds:

    "Therefore I am not requesting formal scrutiny clearance at this stage. However, I would like to reassure the Committee that my officials have been working closely with our coalition of like-minded Member States and the European Parliament to ensure that a compromise involving any additional pre-market scrutiny is clinically focussed and applicable only to a narrowly defined range of products. As I set out in my letter of 24 October, key points we want to avoid are substantial duplication of a notified body's own pre-market assessment and any shift of decision making away from notified bodies to Member States. If necessary, the UK would be prepared to vote against an unacceptable compromise on pre-market scrutiny, though I note that if we were to be opposed by a qualified majority then the proposal would be accepted regardless."

7.13 The Minister reiterates his request for a scrutiny waiver "on the basis that the Government will only support a 'general approach' or formal first reading position in Council that falls within the parameters I outlined in my earlier letter regarding our key negotiating objectives". He undertakes to provide a formal update to our successor Committee on the outcome of the Health Council and on the next steps in the negotiating process. Meanwhile, he offers to provide further details on the substance or progress of negotiations at official level.

Previous Committee Reports

Thirty-second Report HC 219-xxxi (2014-15), chapter 4 (4 February 2015); Twenty-second Report HC 219-xxi (2014-15), chapter 4 (26 November 2014); Sixteenth Report HC 219-xvi (2014-15), chapter 2 (29 October 2014); First Report HC 219-i (2014-15), chapter 7 (4 June 2014); Twenty-eighth Report HC 83-xxv (2013-14), chapter 7 (18 December 2013); Thirty-ninth Report HC 86-xxxviii (2012-13), chapter 4 (17 April 2013); Thirty-fifth Report HC 86-xxxv (2012-13), chapter 8 (13 March 2013); Thirty-second Report HC 86-xxxii (2012-13), chapter 2 (13 February 2013); Twentieth Report HC 86-xx (2012-13), chapter 10 (21 November 2012).


14   Fifth Report of Session 2012-13, HC 163. Back

15   The main changes proposed by the EP are described in our Twenty-eighth Report of Session 2013-14. Back


 
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