Employment, Social Policy, Health and Consumer Affairs Council

Jane Ellison Excerpts

Thursday 11th June 2015 Written Statements

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

The Employment, Social Policy, Health and Consumer Affairs Council will meet on 18-19 June in Luxembourg. The Health and Consumer Affairs part of the Council will take place in the morning of 19 June.

The main agenda item is the following:

Regulations on medical devices and in vitro diagnostic medical devices: the presidency plans a general approach on medical devices. The regulations seek to address weaknesses in the current regulatory system, ensure a more consistent level of implementation across the EU, and ensure that the EU will continue to be viewed by business as an innovation-friendly regulatory environment.

The UK has broadly supported the Commission’s proposals in order to ensure high standards of patient safety. At the outset of negotiations the UK identified three areas as priorities:

avoiding an ineffective and bureaucratic process proposed by the Commission involving additional pre-market scrutiny of higher risk devices by a central committee of member state experts;

ensuring sufficient flexibility is in place to allow health institutions to manufacture and use diagnostic tests developed ‘in-house’; and

resisting proposals to introduce additional regulatory burdens.

Under ‘any other business’ there will also be presentations on three other issues by the following delegations:

Slovenia—follow-up to the informal meeting of EU Health Ministers on a new framework for the EU alcohol policy;

Cyprus, Greece, Italy and Malta—importance of the health dimension in the European agenda on migration;

Luxembourg—priorities for their forthcoming presidency, which will run from July until December 2015.

It is also available online at: http://www.parliament.uk/writtenstatements.

[HCWS24]