Departmental Correspondence related to Medicines and Medical Devices Bill: Further Legislative Consent Motion

Correspondence from the Minister of Health, Robin Swann - 5th October 2020

Department of Health
Castle Buildings
Stormont Estate

Date: 5 October 2020

Colm Gildernew MLA
Chair of the Health Committee

Dear Colm

I am following up on my correspondence to you of 15th July that advised of the requirement for a further Legislative Consent Motion in relation to the Medicines and Medical Devices Bill which was introduced in Parliament on 13 February 2020.

You will recall at its meeting of 22 April 2020, the Executive gave its agreement in principle to the need for a Legislative Consent Motion for transferred matters within the Bill. The Assembly subsequently debated the Legislative Consent Motion on 16 June and agreed the Motion.

Following this I received correspondence from Lord Bethell (Parliamentary Under Secretary of State for Innovation (Lords) in DHSC) on the 18th June, with a request to bring forward a further Legislative Consent Motion in the Northern Ireland Assembly in respect of an amendment to the Bill to provide for a medical devices information system, in advance of the Bill completing its amending stage in the House of Lords.

The purpose of this letter to you is to give you and members of the Health Committee an update on the current position.

The UK Government amendment seeking to provide  a power by regulations  to establish a “medical device information system” operated by NHS Digital  was mainly in response to the report from the Independent Medicines and Medical Devices Safety  Review, chaired by Baroness Julia Cumberlege which was published on 8th July 2020. An information system is to be established  for purposes  relating  to the efficacy and safety of medical devices; the safety of individuals who have received or been treated with a medical device, or into whom a medical device has been implanted; and/or the improvement of medical devices through advances in technology.

The creation of a UK-wide Medical Device Information System (MDIS), is to be welcomed, however it is important to ensure that the regulations to be developed to implement this take account of the governance arrangements around medical devices and patient safety in Northern Ireland and in the other Devolved Administrations, and I wrote to Lord Bethell on this point on 15th July.  He responded on 14th  September  2020 to give these necessary assurances to me that the Bill will reflect a statutory duty to consult with all the Devolved Administrations in the development of regulations  to support the establishment of the MDIS operational model.

The Medicines and Medical Devices Bill has reached the Committee Stage in House of Lords – although the date regarding when the Committee Stage will commence has yet to be formally announced. There have been approximately 100 amendments to the Bill proposed for Lord’s Committee Stage and a link to these is available on the UK Parliamentary website:

There have been discussions between officials  on further  possible amendments  that may require legislative consent from the NI Executive and NI Assembly. It  is for this reason I have not yet tabled the Executive paper for agreement in principle on the Legislative Consent Motion to allow it to proceed, as Lord Bethell needs  to write formally to me on the content of these amendments. I have written to Lord Bethell to emphasise the need to have this information in a timely manner highlighting the number of Northern Ireland Assembly statutory procedures that need to be adhered to for any agreement by the legislative consent process.

I will, of course, continue to keep you apprised of developments.

Yours sincerely

Robin Swann MLA

Minister of Health