4 Regulation of medical devices |
|Committee's decision||Not cleared from scrutiny; further information requested; 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
|Document numbers||(a) (34294), 14493/12 + ADDs 1-5, COM(12) 542
(b) (34295), 14499/12, COM(12) 541
Summary and Committee's conclusions
4.1 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.
4.2 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.
4.3 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.
4.4 When we last considered the draft Regulations,
at our meeting on 26 November 2014, we agreed to grant a scrutiny
waiver to enable the Government to support a possible general
approach at the December 2014 Health Council. If agreed, this
would provide a mandate for the Council to start informal "trilogue"
discussions with the European Parliament and the Commission.
In granting a waiver, 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.
4.5 In his latest letter, the Minister for Life Sciences
(George Freeman) explains that the Italian Presidency was unable
to secure a general approach at the December 2014 Health Council
and sets out the next steps in the negotiating process.
4.6 We are grateful for the Minister's update.
The draft Regulations remain under scrutiny and the Government
will need to request a further scrutiny waiver or clearance if
the Latvian Presidency seeks to achieve a general approach within
the Council, or a political agreement with the European Parliament,
before the end of its term in June. As negotiations appear to
be entering an important phase, we draw the latest developments
to the attention of the Health Committee and the Science and Technology
Committee. Meanwhile, we look forward to receiving regular progress
reports on negotiations within the Council and on any informal
trilogue discussions with the European Parliament.
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.
4.7 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
and the Minister's confirmation that the UK's efforts
in this area would be reflected in the final agreed text.
4.8 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.
The Minister's letter of 27 January 2015
4.9 The Minister (George Freeman) expresses his gratitude
for the specific scrutiny waiver we granted last November, ensuring
that "any last-minute negotiations on [
] a 'general
approach' at the Health Council would have been aligned with UK
negotiating priorities, which have previously been established
with your Committee".
4.10 He confirms that, in light of concerns expressed
by some Member States, the Italian Presidency decided not to seek
agreement to a general approach, but instead gave a short progress
report accompanied by a brief exchange of views on a few key issues.
He adds that there are "no relevant updates to report on
the UK's key negotiating objectives at this stage".
4.11 Turning to the timetable envisaged by the Latvian
Presidency, the Minister indicates that there is the prospect
either of a political agreement or a general approach on the draft
Regulations at the Health Council on 19 June. He continues:
"The Presidency's ideal goal would be to
achieve a political agreement following informal trilogues between
the European Commission, European Parliament and the Council.
This would constitute Council's formal first reading position
and assuming agreement with the Parliament was achieved
during trilogues would then allow this text to be adopted
by the Parliament in their second reading position.
"Achieving a 'general approach' at Health
Council is perhaps more realistic. In this outcome, the Council
would not be adopting a formal first reading position. Instead
the 'general approach' would form the basis for the Council's
position in informal trilogues to begin under the incoming Luxembourg
Presidency in the second half of 2015."
4.12 The Minister undertakes to inform us of any
informal trilogue negotiations and to provide any further details
we require on the substance or progress of negotiations. He adds:
"More generally, I would like to take this
opportunity to reassure you that I take the issue of ensuring
rapid access to innovative therapies very seriously, which is
why I have launched a major review of the pathways for the development,
assessment, and adoption of innovative medicines and medical technology.
This review will consider how to speed up access for NHS patients
to cost-effective new diagnostics, medicines and devices, including
cancer treatments and diagnostics. It will set out both short
and long-term options for action by Government and relevant bodies,
including the National Institute for Health and Care Excellence,
the Medicines and Healthcare products Regulatory Agency and NHS
England, and mark a major contribution to the policy debate."
4.13 During his visit to Brussels at the end of February,
the Minister reiterates his intention to "highlight the need
for Europe to embrace innovative medical technologies and to ensure
that regulations in this sphere are fit for purpose".
Previous Committee Reports
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).
19 Fifth Report of Session 2012-13, HC 163. Back
The main changes proposed by the EP are described in our Twenty-eighth
Report of Session 2013-14. Back