Report on the Medicines and Medical Devices Bill: Further Legislative Consent Motion
Session: Session currently unavailable
Date: 19 November 2020
Reference: NIA 60/17-20
This report is the property of the Committee for Health.
Ordered by the Committee for Health to be published 19 November 2020
Report: NIA 60/17-20 Committee for Health
- Consideration by Committee for Health
- Consideration by Committee for Agriculture, Environment & Rural Affairs
- Links to relevant documents
- Appendix 1 Correspondence from Department of Health
- Appendix 2 Legislative Consent Memorandum
- Appendix 3 Memo from Committee for AERA
1. The Medicines and Medical Devices Bill 2019-20, was introduced in the House of Commons on 13 February 2020. It is currently at Committee stage in the House of Lords, which commenced on 19 October 2020.
2. The Bill derives from the UK decision in 2016 to withdraw from the EU; matters covered by the Bill have been within EU competence for the duration of the UK’s membership.
3. Section 2(2) of the European Communities Act 1972 has provided for the exercise of delegated powers to make regulations to transpose, amend and update relevant legislation.
4. Human medicines and veterinary medicines are transferred matters. The main regulations transposing the EU legislative framework on human medicines were enacted on a UK-wide basis, however, and a single UK-wide regulator is in place – the Medicines and Healthcare Regulatory Authority (MHRA) – but the regulations are amended or updated regularly by statutory rules made at devolved level. The main (UK-wide) regulations are:
- The Human Medicines Regulations 2012; and
- The Medicines for Human Use (Clinical Trials) Regulations 2004.
5. Once section 2(2) of the European Communities Act 1972 is repealed at the end of the transition period, currently 31 December 2020, a new power in primary legislation would be required to continue updating or amending these regulations.
6. The Medicines and Medical Devices Bill therefore provides replacement delegated powers to the Department of Health (the Department) in respect of human medicines (Part 1 of the Bill, Clauses 1 – 7) and to the Department of Agriculture, Environment and Rural Affairs in respect of veterinary medicines (Part 2 of the Bill, Clauses 8 – 11). As such, the Bill was described to the Committee as an ‘enabling bill’. In both cases, powers may be exercised by the Minister, acting along, or jointly by the Minister and the Secretary of State.
7. A Legislative Consent Motion (LCM) was brought in respect of this Bill in April 2020. The Committee reported on this on 15 June 2020, and declined to come to a position, due to the limited time the Committee had to consider the LCM and the importance of the issues connected to it.
8. The Minister of Health wrote to the Committee on 15 July, advising that a further legislative consent motion would be required in respect of an amendment made at the report stage of the Bill in the House of Commons. The Minister wrote again to the Committee on 5 October and 20 October, advising the Committee of amendments tabled in the House of Lords that would also require legislative consent.
9. The Legislative Consent Memorandum was laid in the Assembly on 5 November 2020. The Department cited the following as its rationale for utilising the Bill rather than an Act of the Assembly:
- the need for a legislative vehicle to provide a consistent approach across GB and NI to enable the existing regulatory framework for human and veterinary medicines to be updated following the UK’s departure from the EU;
- UK-wide legislation for a medical devices information system (MDIS) will provide a consistent legal framework, providing for improvements in both product safety and patient health outcomes and ensures an effective use of data; and
- it would not have been possible to progress legislation through the Assembly in a similar timeframe.
Consideration by Committee for Health
10. The memorandum was laid on 5 November and Departmental officials briefed the Committee on 12 November 2020.
11. On 12 November, the Committee invited the Committee on Agriculture, Environment and Rural Affairs to submit its views in relation to Part 2 of the Bill – Veterinary Medicines.Details of the AERA Committee’s consideration of the LCM are at paragraphs 22-24 below.
12. Officials briefed the Committee for Health on the amendments for which legislative consent is now required. These are:
- a new Clause 16, which provides a power by regulation to establish a Medical Devices Information System (MDIS) under the operation of NHS Digital. This amendment was made in response to the Cumberlege Review into the safety of medicines and medical devices. Although medical devices are a reserved matter, the Department advised that an MDIS will require information that relates to devolved matters, and domestic healthcare, and that, in time, the information system could also be used for devolved purposes;
- an amendment under Clause 41 to require the Secretary of State to consult the devolved administrations on regulations made under the new Clause 16, to ensure that the governance arrangements around medical devices and patient safety are taken into account. The Department advised the Committee of a separate, non-legislative commitment from the Department of Health and Social Care (DHSC), to ensure that the Department of Health is engaged in MDIS policy and operational discussions, and the development of draft regulations; and
- provision for a statutory information-sharing gateway to ensure vital information can be shared with bodies outside the UK, such as overseas regulators.
13. The Department advised that a number of amendments have been tabled in the House of Lords in response to concerns raised by the Delegated Powers and Regulatory Reform Committee, in relation to the scrutiny and the oversight of the use of delegated powers contained in the Bill. These are:
- to provide an overarching duty to have regard to the importance of promoting the health and safety of the public; the Secretary of State or Minister of Health must be satisfied that regulations made under Clause 1(relating to human medicines), and Clause 8 (relating to veterinary medicines) would promote the health and safety of the public or health and welfare of animals, whilst having regard to three principles: safety, availability and attractiveness. In addition, the principle of attractiveness is clarified to mean the likelihood of the relevant part of the UK being seen as an attractive or favourable place to conduct trials, or develop or supply medicines;
- to amend the requirement in Clause 41 on the Secretary of State or Minister of Health to consult with those they consider most appropriate, to a requirement for public consultation;
- to amend clause 42 of the Bill to apply draft affirmative procedure in Westminster and in the Northern Ireland Assembly, to all regulations made under Clause 1 and 8, except for those relating solely to fees, and to apply made affirmative (or confirmatory procedure in the Northern Ireland Assembly) to urgent regulations made under Clause 6;
- changes to the criminal sanctions powers in Clauses 1-8, to clarify that regulations cannot provide for prison sentences over two years; and
- to provide for a reporting obligation on the Secretary of State in respect of the operation of regulations regarding human and veterinary medicines once every two years, and a separate obligation on NI Ministers to report to the NI Assembly in respect of regulations made by NI Departments.
14. The Committee enquired if the Department had any concerns around the collection and sharing of patient information with NHS Digital, in terms of data security and ownership of the data, and how patients would be protected by the MDIS. In its response, the Department advised that the purposes for which data can be shared and the types of organisations that can receive this information, will be specified in the regulations made under the powers contained in the Bill and that the Department will be fully consulted in the making of these regulations, which will determine the scope and limitations on data-sharing. The Department is content that patients’ data shall be held securely, controlled and processed in compliance with data protection laws and General Data Protection Regulation (GDPR) that will ensure patient information will be protected.
15. The Department further advised that the aim of the 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 posed by specific devices much earlier.
16. The Committee enquired about the governance and patient safety arrangements for medical devices, and if the Minister was content with assurances received that that the devolved regions will be consulted on these regulations. In response, the Department referred to the statutory duty to consult Ministers in Scotland, Wales and Northern Ireland which will be written into the Bill, and to the non-legislative commitment from DHSC 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 relevant policy and operational discussions and the development of draft regulations. The Department advised that it is content with these assurances.
17. Members raised a number of issues relating to Brexit and the Protocol on Ireland/ Northern Ireland (the Protocol) in relation to the MDIS, whether any of the amendments to the Bill had implications for the Protocol, and the contingency planning around this. The Department advised that there were no such implications for the amendments for which legislative consent was being sought. The Department confirmed that medical devices appear in the list of subject areas in Annex 2 to the Protocol, and that consideration had been given to whether the amendment to provide for a MDIS may be subject to a different “regime” in Northern Ireland, but stated that this will not be the case.
18. The Department also confirmed that the Bill’s powers will be exercised in compliance with the Protocol and advised that the MDIS does not deal with the placement of medical devices on the market and that its purpose is to record the post-market use of the medical device by healthcare providers, enabling track and trace of patients who have medical devices implanted. The Department emphasised that the system is about improving patient safety, and not the supply of goods.
19. The potential impact of any future divergence in standards between the EU and GB was raised. The Department advised that NI’s involvement in the MDIS will not be affected; the MHRA, as regulator for the whole of the UK, will continue to regulate devices on the marketplace which should mitigate any potential divergence in standards between GB and NI, particularly as NI will remain part of the EU acquis for medicines. The Department referred to a number of actions that, in its view, will mitigate against any risk of divergence in regulations for patient data: the inclusion in the Bill of a statutory duty to consult, and the non-legislative commitment by the DHSC to engage with the Minister of Health on relevant policy and operational discussions and the development of draft regulations.
20. Members asked if NI could potentially be subject to two information-sharing systems within the EU and UK in the future. In its response, the Department advised that NI will be part of the UK information-sharing system, provided through the MDIS, which relates to the sharing of patient data on implanted devices within a central UK system only, for the provision of direct care to a patient and subsequent care if needed in the future. The EU does not require the storage of patient data at a central level and its forthcoming regulations only require that service providers record (preferably by electronic means) where, and on whom, implantable devices have been used; the Department advised that the MDIS will assist service providers in meeting this requirement in NI. Individual EU member states are responsible for their own healthcare systems, including the use of any devices on the EU market. Each member state’s regulator for devices monitors compliance with the EU regulations. The MHRA will remain the regulator for NI (and GB) after the end of the Transition Period.
21. The issue of the supply of medicines and medical devices, and the attractiveness of NI as a favourable location for clinical trials after the UK’s exit from the EU was raised. The Department advised that there are long-term implications for both the supply and regulation of medicines in NI, where the large majority of medicines supplies are drawn from the UK market via GB, but that NI is part of a UK-wide medical supplies contingency programme for EU Exit which is led by the DHSC, with the involvement of the Devolved Administrations. The Department further advised that the UK and the EU have agreed to allow the pharmaceutical industry twelve months from 1 January 2021 to comply with new regulatory requirements which apply only to NI and are a consequence of the Protocol. This will allow industry time to adapt to the new arrangements and to mitigate risks to barriers to trade. The Department further advised that the DHSC and the MHRA will work with the Department of Health in relation to compliance with the Protocol and future relations with the EU. This will include consideration of the optimal supply and logistics models for medical supplies for Northern Ireland, the attractiveness of Northern Ireland for clinical trials and opportunities that may arise for the life science industry.
Consideration by Committee for Agriculture, Environment & Rural Affairs
22. On 12 November, the AERA Committee considered oral and written evidence on the LCM from the Department of Agriculture, Environment and Rural Affairs and decided that it was content to support the motion in relation to veterinary medicines. Members raised a query in relation to the amendments proposed in respect of information-sharing in order for information to be shared with bodies outside the UK in pursuance of international agreements and arrangements, asking how this would comply with the Data Protection Act. Departmental officials advised that Bill would be fully compliant with all aspects of the Data Protection Act in the sharing of information.
23. Members also raised a query in relation to the lengthy list of matters on which regulations might be made and sought reassurance that any procedures in relation to this are put in place by the end of the transition period. Officials confirmed that this would this would be the case.
24. The response from the AERA Committee can be found in Appendix 3 to this report.
25. The Health Committee acknowledges that, in recent months, the Department of Health has been under enormous pressure to deal with COVID-19, and this has had an impact on the opportunity for scrutiny. However, in view of the importance of the issues addressed by the amendments to the Bill, including the significance of an MDIS in assisting with patient safety in the event of a recall of a medical device, the inclusion of the statutory duty to consult the Minister of Health on any regulations made in connection with this, and the improved scrutiny of regulations, the Committee decided that it was content to support the motion in relation to human medicines and medical devices.
26. The Committee for Health agreed this report to be published on 19 November 2020.
Links to relevant documents
Appendix 1 – Correspondence from the Minister of Health to the Health Committee
- Correspondence from the Chief Pharmaceutical Officer, Mrs Cathy Harrison, with answers to follow-up questions asked by the Committee
- Correspondence from the Minister of Health, Robin Swann – 20th October 2020
- Correspondence from the Minister of Health, Robin Swann – 5th October 2020
- Correspondence from the Minister of Health, Robin Swann – 15th July 2020
Appendix 2 – Legislative Consent Memorandum
Appendix 3 – AERA Committee
- Memo from Committee for Agriculture, Environment and Rural Affairs regarding Medicines and Medical Devices Bill – Further LCM
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