Legislative Consent Memorandum
Medicines and Medical Devices Bill
Draft legislative Consent Motion
1. The draft motion, which will be tabled by the Minister of Health, is:
"That this Assembly endorses the principle of the extension to Northem Ireland of the provisions within the Medicines and Medical Devices Bill dealing with human medicines, veterinary medicines and information systems as amended at Committee Stage in the House of Lords"
Background
2. This memorandum has been laid before the Assembl y by the 1\1.inister of Health under Standing Order 42A(2). The Medicines and Medical Devices Bill was introduced in the House of Commons on 131h F ebruar y 2020. At its meeting of 22 April 2020, the Northern Ireland Executive gave its agreement in principle to the need for a Legislative Consent Motion for transferred matters within the Bill in respect of human medicines and veterinar y medicines. The Assembly subsequently debated the Legislative Consent Motion on 16 June and agreed the Motion. A UK government amendment to the Medicines and Medical Devices Bill was made and passed during the Commons Report stage on the 23rd June 2020 dealing with a Medical Device Information System (MDIS) and as this system will require information that relates to devolved matters, domestic healthcare and, in time, may also be used for devolved purposes, legislative consent is required from Northern Ireland.
3. There are further amendments to the Medicines and Medical Devices Bill that have been proposed by the UK government in relation to human medicines and veterinary medicines and are being tabled at Lord's Committee Stage which commenced on 19th October 2020. These amendments relate to transferred matters and will also require legislative consent from Northern Ireland.
4. The latest version of the Bill can be found on the UK Parliamentary website at: https: //bills.parliamcnt.uk/bills/2700
Summary of the Bill and its policy objectives
5. The UK's regulatory provision governing human medicines and veterinary medicines which are transferred matters, and medical devices which are reserved, is largely provided for in subordinate / secondary legislation. This legislation has been made under powers within section 2 (2) of the European Communities Act 1972. Primary legislation is needed to ensure that the UK can continue to update and amend regulations.
6. The Bill comprises 5 parts. Part 1 deals with human medicines and contains a power to make regulations relating to human medicines. It sets out an exhaustive list of the matters on which regulations might be made, including making provision for dealing with falsified medicines and clinical trials.
Part 2 of the Bill deals with veterinary medicines and, again, sets out an exhaustive list of the matters on which regulations might be made including the manufacturing, marketing and supply, and field trials.
8. Part 3 of the Bill covers medical devices and contains a power to make regulations with regard to medical devices. It sets an exhaustive list of the matters on which regulations might be made and consolidates and makes clear the powers available to the relevant authorities to enforce the regulatory devices regime. Part 4 of the Bill provides for consequential provision, consultation and procedural requirements. Part 5 deals with commencement and includes a power for the relevant Northern Ireland department to make transitional provision in connection with commencement.
9. A UK government amendment passed on 23rd June at Commons Report Stage provides a power by regulations to establish an MDIS operated by NHS Digital. Regulations under clause 16 (information systems) enable the Secretary of State to instruct NHS Digital to create and operate an MDIS.
10. The amendment is in response to the report from the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege. 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 if a safety concern arises there will be an improved ability to track and trace medical devices.
Provisions which deal with a Devolution Matter
11. The subject matter of human and veterinary medicines (including clinical trials of human medicines) is reserved in relation to Scotland and Wales but transferred in relation to Northern Ireland. The Bill reflects this by conferring delegated powers on the "appropriate authority". In relation to England, Scotland and Wales the "appropriate authority" is the Secretary of State. In Northern Ireland the "appropriate authority" is the relevant Northern Ireland Department acting alone, or the Secretary of State and the relevant Northern Ireland Department acting jointly. For human medicines the relevant Northern Ireland Department is the Department of Health and for veterinary medicines is the Department of Agriculture, Environment and Rural Affairs.
12. The subject matter of medical devices is reserved in relation to Scotland, Wales and Northern Ireland. The Bill reflects this by conferring the delegated powers relating to medical devices on the Secretary of State in relation to the whole of the UK. The UK government amendment on 23rd June 2020, however that provides a power by regulations to establish an MDIS will require information that relates to devolved matters, domestic healthcare and, in time, the information system could also be used for devolved purposes.
Reasons for making the Provisions
13. The aim of an MDIS is to improve the safety and standards of medical devices, by ensuring better information can be captured and shared on implanted devices, in order to identify risks of specific devices early. By improving the data available on medical devices as part of post-market surveillance, the MHRA will be better able to take action earlier and more effectively as part of their regulation of devices on the UK market. It would mean in the event of a recall, it would be possible to identify which specific device has been implanted into a patient.
14. However in designing the information system, consideration needs to be given to ensure it reflects the needs of UK patients and the interests of Northern Ireland and the other Devolved Administrations. It is important to ensure that the regulations to be developed to implement the information system take account of the governance arrangements around medical devices and patient safety in Northern Ireland, and in response to concerns raised by the Devolved Administrations on this point, an amendment is being tabled at Lord's Report Stage. When making regulations under clause 16, under this amendment (made under clause 41 - consultation), the Secretary of State is required to consult Scottish Ministers, Welsh Ministers and the Department of Health in Northern Ireland.
15. In addition to the amendment made under clause 41 that has been listed to be tabled by the UK government [to require that the Secretary of State consults Scottish Ministers, Welsh Ministers and the Department of Health in Northern Ireland when making regulations under clause 16], there is also a separate non-legislative commitment from the Department of Health and Social Care to ongoing discussions on the MDIS governance arrangements and other operational details that will ensure that the Department of Health in NI is engaged in MDIS policy and operational discussions and the development of draft regulations.
16. In order that the UK, and in particular the regulators [namely the 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. An essential amendment on information sharing will therefore be tabled by the UK government during Lord's Committee Stage.
17. The Delegated Powers and Regulatory Reform Committee (DPRRP) in the House of Lords has raised concerns in relation to the scrutiny and oversight of the use of the delegated powers contained in the Bill. In response to this the government has listed a number of amendments to be tabled during Lord's Committee Stage to address these concerns and they will change the way in which the regulation making powers at clauses 1 (human medicines) and 8 (veterinary medicines) can be exercised.
18. In order to address a concern that the Bill provided Ministers with too much discretion in how the powers are exercised, an amendment will be tabled to provide for a reporting obligation on the Secretary of State, that would consider the operation of regulations made under clauses 1, 8 and 12 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. It is proposed a separate report will be taken forward by the NI Departments in respect of regulations made only by NI Departments and this will be laid before the NI Assembly.
19. Concerns have also been raised about the use of the negative procedure in relation to regulations made under clauses 1 and 8, 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 specified time period. It is proposed this time period will be 40 days.
20. Another matter on which there has been considerable debate prior to the Lord's Committee Stage has been the application of the three considerations that the appropriate authority must have regard to and how these considerations are weighted when making regulations under clauses 1 and 8 (and 12). In order to respond specifically to concern about the absence of a definition of 'attractiveness' of the UK it is intended to clarify that this is a consideration of the likelihood of the relevant part of the United Kingdom 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 amendment to be tabled seeks to clarify the intent in this regard.
21. It is also intended to provide for an overarching duty to have regard to the importance of promoting the health and safety of the public, and in relation to veterinary medicines, the health and welfare of animals. The considerations currently in clauses 1(2) and 8(2) will then form part of satisfying that duty. It is intended to provide that 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) and 8(2) when determining whether they would. This will strengthen provision around the exercise of these regulation-making powers and provide reassurance that it is only intended to make regulations to amend the current regulatory regimes where those changes promote health and safety.
22. A further concern was the ability to create new criminal offences through the regulation-making powers, and more specifically 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. The Department of Justice in Northern Ireland has previously considered the Medicines and Medical Devices Bill and now more recently the amendments being proposed and is content that the current offences and penalties are necessary and commensurate with the current offences and penalties framework in Northern Ireland.
23. The statutory consultation requirements are set out in clause 41 of the Bill, but there has been some concern with the language at clause 41, which states that the appropriate authority must consult such persons as the appropriate authority considers appropriate. An amendment is being tabled by the UK government that requires the relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, as well as requiring the relevant authority to set out the authority's assessment of the matters to which the authority must have regard in making the regulations. This would include the consideration that the regulations will promote the health and safety of the public/ animals. The amendment also provides for the Secretary of State to consult the Devolved Administrations in relation to regulations for information systems under clause 16(1).
Reasons for utilizing the Bill rather than an Act of the Assembly
24. It is appropriate on this occasion for the Department of Health and Social Care (England) to progress legislation on transferred matters as it would not have been possible to legislate for Northern Ireland separately within a similar timescale.
25. Having UK-wide legislation for a medical devices information system will be in the best interests of UK patients, as it will ensure a consistent legal framework for the information system, providing for improvements in both product safety and patient health outcomes in a way that ensures effective use of data.
26. With regards human and veterinary medicines, it is important to have a consistent approach across Great Britain and Northern Ireland in terms of having a legislative vehicle to enable the existing regulatory frameworks relating to human medicines and veterinary medicines to be updated following the UK's departure from the EU. The Medicines and Medical Devices Bill provides for such a consistent approach across the UK.
Consultation
27. As the purpose of the Bill is to provide delegated powers to amend the regulatory frameworks, the Department of Health and Social Care (England) did not consult on the Bill. However, before exercising any of these delegated powers, there is a statutory requirement to consult, as set out in clause 41 of the Bill. The amendments proposed to be tabled by the government to the Medicines and Medical Devices Bill strengthen the duty to consult on regulations that will be made for human medicines, veterinary medicines and information systems. The Secretary of State must consult with the Devolved Administrations on the information systems regulations. The majority of regulations will be subject to the affirmative resolution procedure allowing for appropriate Parliamentary and NI Assembly scrutiny.
Human Rights and Equality
28. The provisions of the Bill are compatible with the European Convention of Human Rights. No adverse impact on any of the groups listed under section 75 has been identified.
Financial Implications
29. These are enabling amendments, and there are no known financial implications. There may be financial implications in the development and implementation of any secondary legislation in relation to Information Systems. These costs have not yet been assessed
Summary of Regulatory Impact
30. The Department of Health and Social Care (England) published an Impact Assessment which is available at:
https://publications.parliament.uk/pa/bills/lbill/58-01/116/5801116-IA.pdf
31. No specific impact in Northern Ireland is anticipated on employment, charities, social economy enterprises and the voluntary sector.
32. The Department of Health and Social Care (England) has indicated that the provisions relating to human medicines, veterinary medicines and information systems are not intended or expected to bring about substantive changes to UK businesses in the medicines or life sciences sector. Any changes would be implemented by subordinate legislation which will be accompanied but its own bespoke economic appraisal.
Engagement to date with the Committee for Health
33. The Health Committee was informed on 15th July 2020 of the Minister of Health's intention to seek Executive agreement to a Legislative Consent Motion in relation to the government amendment to the Medicines and Medical Devices Bill to provide for a Medical Devices Information System. Further correspondence was then forwarded on 5rh October and 20th October to provide the Health Committee with an update. In the correspondence of 20th October details were provided on additional amendments proposed to be made at Lord's Committee Stage in relation to human medicines, veterinary medicines and information systems that will require legislative consent from the NI Assembly.
Conclusion
34. The view of the Minister of Health is that, in the interests of good government and consistency across the UK, in so far as the provisions of the Bill that deal with a devolution matter they should be considered by the UK Parliament.
