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

Correspondence from the Minister of Health, Robin Swann - 15th July 2020

Departmetn of Health
Castle Buildings
Stormont Estate

Date: 15th July 2020

Colm Gildernew MLA
Chair of the Health
Committee Room 416
Parliament Buildings
Belfast, BT4 3XX


Dear Colm


I wish to advise you about 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. 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.

I received formal correspondence from Lord Bethell (Parliamentary Under Secretary of State for Innovation (Lords) in DHSC) on the 18th June, following a telephone conversation on the 17th 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 amendment to the Medicines and Medical Devices Bill was made and passed during the Commons Report stage on the 23rd June 2020 and it has reached its 2nd Reading Stage in the House of Lords. A link to the Bill as amended in Parliament is available on the UK Parliamentary website:

By way of background to the amendment, in February 2018, the then Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, announced a review into how the health system responds to reports from patients about the harmful side effects from medicines and medical devices. The announcement in the House of Commons followed a number of patient-led campaigns on the use of the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and surgical mesh.

The Independent Medicines and Medical Devices Safety Review was chaired by Baroness Julia Cumberlege and its report was published on the 8th July 2020. The report highlights failure of the healthcare system in a number of areas including the need to listen and understand patients’ voices and their concerns raised around certain treatments.

The proposed Government amendment is in response to the report and seeks to provide a power to by regulations establish a “medical device information system” operated by NHS Digital. The information system would 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 regulations made under the power introduced by this amendment would provide the legal underpinning for a UK-wide system to capture the unique identifier of a specific medical device and relevant data from a patient’s information record, such that in future, we are better able to track and trace medical devices if a safety concern arises.

It will ensure that NHS Digital is able to obtain the information to populate the medical device information system from health providers across the UK, including private health providers. The Department of Health and Social Care (DHSC) sees this amendment as critical in order to mitigate the risk of harm to patients posed by unsafe medical devices.

Whilst the key function of the amendment is to support the effective monitoring of the safety of medical devices, and therefore relates to a reserved matter, DHSC recognises that the information system will require information that relates to devolved matters, domestic healthcare and, in time, the information system could also be used for devolved purposes. For example, to improve patient health outcomes more generally, such as through informing clinical practice as to what devices and clinical procedures are best for patients.

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. I have written to Lord Bethell on this point to ensure the necessary assurances are in place.

In terms of timings, DHSC would wish to secure legislative consent before the House of Lords stages of the Medicines and Medical Devices Bill. Whilst DHSC does not yet have any confirmed timings for subsequent stages of the Bill, it is very unlikely that the Bill will reach its Lords Report stage before the autumn.

I will, of course, continue to keep you apprised of all developments and I look forward to working with the Health Committee on this issue. My officials would also be happy to offer a briefing for the Committee on the proposed amendment if that would be of help.

Yours sincerely

Robin Swann MLA

Minister of Health

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