Departmental Correspondence related to Medicines and Medical Devices Bill: Further Legislative Consent Motion
Correspondence from the Minister of Health, Robin Swann - 20th October 2020
Department of Health
Date: 20 October 2020
Colm Gildernew MLA
Chairperson Health Committee
I wrote to you on 15th July and again on the 5th October to outline the need for a further Legislative Consent Motion (LCM) in relation of 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 relating to Human Medicines and Veterinary Medicines. 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 (MDIS), in advance of the Bill completing its amending stage in the House of Lords. The MDIS would be operated by NHS Digital and the amendment is 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 Medicines and Medical Devices Bill has now reached the Committee Stage in House of Lords, which commenced on Monday 19th October.
In my correspondence to you on the 5th October, I explained, in addition to the need to have an LCM on the MDIS, there had been discussions between officials on other possible amendments that may require legislative consent from the NI Executive and NI Assembly. Lord Bethell has now written to me to provide further details on these amendments and ask that I seek legislative consent from the NI Assembly. I plan to table an Executive Paper on 22nd October to ask the Executive for their agreement in principle in order to commence the legislative consent process, which needs to be completed by Lord's Report Stage, which is anticipated to be at the end of November 2020.
The new proposed amendments requiring legislative consent are summarised below.
Essential amendment related to information sharing
In order that the UK, and in particular the regulators, Medicines Healthcare products and Regulatory Agency (MHRA) and the Veterinary Medicines Directorate, can continue to work with international partners to ensure the safety of medicines in the UK, there is a need to strengthen the legal basis for sharing information internationally. This would be in the form of a statutory information-gateway inserted into the Bill to ensure that vital information can be shared with bodies outside the UK, such as overseas regulators, in pursuance of international agreements and arrangements.
Regulation Making Powers
The Bill has three tests or considerations which need to be taken into account when making regulations in respect of Human Medicines, Veterinary Medicines and Medical Devices - focussing on safety, availability of medicines / devices and the attractiveness of the relevant part of the UK. It is intended the appropriate authority must be satisfied that the regulations would promote the health and safety of the public, and in relation to veterinary medicines, the health and welfare of animals, and have regard to the considerations currently in clauses 1(2) (Human Medicines) and 8(2) (Veterinary Medicines) when determining whether they would.
Furthermore, in order to respond specifically to concern about the absence of a definition of 'attractiveness' of the UK, this will be clarified as a consideration of the likelihood of the relevant part of the UK being seen as an attractive or favourable place in which to supply and conduct clinical trials for human medicines and develop and supply veterinary medicines.
The appropriate authority will also be required to include in its consultation document an initial assessment as to how the considerations have been taken into account. This would include the consideration that the regulations will promote the health and safety of the public/animals. The consultation duty in clause 41 will be amended from a requirement to only consult those the appropriate authority considers it appropriate to consult, to a requirement for public consultation. This will allow for an unlimited scope of consultation responses. These amendments will apply to the NI Departments when making regulations under clause 1 for Human Medicines and clause 8 for Veterinary Medicines.
Concerns have been raised about the use of the negative procedure in relation to regulations made under clauses 1 (Human Medicines) and 8 (Veterinary Medicines), and in particular those relying on clauses 2(1)(n) and 9(1)(f) (persons who may supply medicines and related prohibitions).
It is intended to amend clause 42 of the Bill to apply the draft affirmative procedure in Westminster, and in the Northern Ireland Assembly, to all regulations made under clauses 1 and 8, except for those solely relating to fees and any urgent regulations made relying on clause 6.
It is also intended to amend clause 42 of the Bill so that urgent regulations relying on clause 6 are subject to the made affirmative procedure. This is similar to the confirmatory procedure in the Northern Ireland Assembly, whereby regulations are laid after being made and cease to have effect unless they are approved within a 40-day period.
A particular criticism of the UK Delegated Powers and Regulatory Reform Committee (DPRRC) was the ability to create new criminal offences through the regulation-making powers, with an additional concern expressed by the DPRRC was that the powers may be used to amend the penalties for existing offences with no restriction on the maximum that can be set. Amendments are to be tabled to make it clear that the powers in clauses 1 and 8 cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years. This maximum will then apply equally to penalties for new and existing offences. Again, as these amendments relate to the exercise of the powers under clause 1 (Human Medicines) and clause 8 (Veterinary Medicines) will require legislative consent. Officials have consulted with officials in DoJ, as they had previously considered the Bill for the first LCM, and they remain content with the current offences and penalties contained in the Bill.
Other considerations - Reporting Obligation
It is intended to provide for a reporting obligation on the Secretary of State, that would consider the operation of regulations made under clauses 1 (Human Medicines), 8 (Veterinary Medicines) and 12 (Medical Devices) within the (once in two years) reporting period, setting out the views of those who have been consulted, and whether change has been made as a result of consultation, including a look ahead at further proposed regulatory change known at the time within the forthcoming reporting period.
At the moment this obligation on the Secretary of State would be only in relation to regulations that the Secretary of State has made and those jointly made with NI Departments. The obligation would not extend to the Secretary of State reporting on the operation of regulations made under the Bill by the NI Departments acting alone. Lord Bethell has asked if we would like a similar reporting obligation to be placed on Northern Ireland Ministers in respect of regulations made by the NI Departments, and I have asked him this to include this in the Bill in order to ensure the NI Assembly has the same level of scrutiny as Parliament. This provision will also require legislative consent.
The amendments in relation to Human Medicines fall under the remit of the Department of Health (DoH) and the amendments in relation to Veterinary Medicines fall to the Department of Agriculture, Environment and Rural Affairs (DAERA) respectively. In terms of the handling arrangements, the DoH is content to take the lead with input from DAERA colleagues on any of the provisions that relate to veterinary medicines.
I understand that Minister Poots will be also writing to the Chair of the Committee for Agriculture, Environment and Rural Affairs to advise the Committee about the Bill.
Robin Swann MLA
Minister of Health