Report on the Medicines and Medical Devices Bill: Legislative Consent Motion

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This report is the property of the Committee for Health. Ordered by the Committee for Health to be published 15 June 2020

Contents

• Introduction

• Consideration by Committee for Health

• Consideration by Committee for Agriculture, Environment & Rural Affairs

• Conclusion

• Links to relevant documents 

• Appendix 1 – Letter from Minister of Health

• Appendix 2 – Legislative Consent Memorandum

• Appendix 3 – Report by Committee for Agriculture, Environment & Rural Affairs

Introduction

1. The Medicines and Medical Devices Bill 2019-20, comprising 45 Clauses and 2 Schedules, was introduced in the House of Commons on 13 February 2020. It had its second reading on 2 March 2020 before moving to Committee Stage; the Public Bill Committee reported on 11 June.  

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 Once section 2(2) of the European Communities Act 1972 is repealed at the end of the transition period, currently 31 December 2020, a new power in primary legislation would be required to continue updating or amending these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 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. Part 3 of the Bill deals with medical devices which is a reserved matter so consent is not requested in this area. Regulations made under powers in this Part will therefore be scrutinised in the UK Parliament.

8. The motion seeks the Assembly’s consent, in line with the Sewel Convention, for Clauses 1 to 11, dealing with human medicines and veterinary medicines, which are transferred matters, to extend to Northern Ireland.  

Consideration by Committee for Health

9. The Minister of Health wrote to the Committee on 1 April, advising that a legislative consent motion would be required.

10. The memorandum was laid on 27 May and Departmental officials briefed the Committee on 4 June 2020. A copy of the Hansard of the evidence session with the departmental officials will be available on the Official Report pages of the Assembly website.

11. On 2 June, 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. See paragraph 27 below for details of the AERA Committee’s consideration of the LCM.

12. Officials briefed the Committee for Health on the background to the Bill and on the nature of the powers to be provided to the Department, under Part 1, Human Medicines.

13. Clause 1 provides the Northern Ireland Department of Health acting alone, or jointly with the Secretary of State, with delegated powers to make regulations in relation to human medicines. Clauses 2 to 6 specify the purposes for which such powers may be used:  

• Clause 2 Manufacture, marketing and supply of medicines: regulations under Clause 1 may be used to issue authorisations to manufacture, import or distribute as well as to regulate advertising, labelling and packaging;
• Clause 3 Falsified medicines: regulations may be made to help prevent the supply of medicines that falsely represent their source, provenance or identity, e.g. by requiring unique identifiers on packaging;
• Clause 4 Clinical trials: powers may also be used for the purposes of authorisation, notification and reporting requirements of clinical trials similar to EU Clinical Trials Regulation  
• Clause 5  Fees, offences, powers of inspectors: this Clause allows such further administrative matters also to be dealt with by regulations under Clause 1. 
• Clause 6  Emergencies: the Department is also empowered to use the power in Clause 1 to make regulations providing for the disapplication of human medicines provisions in urgent situations, in order to prevent serious harm to public health.

14. Members were advised that Clause 1(2) requires the Department to consider three factors before making regulations:

a. the safety of human medicines;

b. the availability of human medicines; and  

c. the attractiveness of the relevant part of the UK as a place in which to conduct clinical trials or supply human medicines.

16. Members were assured that, since the Bill is essentially an enabling bill, the regulations to be made under the provisions requiring consent will come back to the Committee for consideration in the usual way and will be subject to the draft affirmative procedure.

17. The Committee discussed with officials:

• the scope of the delegated powers;
• the impact of EU Exit and the Protocol on Ireland/Northern Ireland¹ (‘the Protocol’) on the matters covered by the Bill, e.g. NI participation in EU-wide clinical trials;
• North-South and East-West co-operation and regulatory alignment; and
• the division of powers to be exercised at UK and Northern Ireland level.

18. Officials confirmed that human medicines regulations are updated regularly, usually twice-yearly, and that such updates directly affect prescribing practice.

19. In response to questions about the impact of EU Exit, officials confirmed that human medicines is among the areas of EU legislation covered by the Protocol, in respect of which Northern Ireland will continue to apply EU standards.  

20. Asked about potential divergence on a North-South basis, officials therefore stated that there was greater risk of divergence between Northern Ireland and Great Britain. They also advised that work was ongoing between the Department of Health (NI), the UK Department of Health and Social Care and the MHRA, to reduce that risk. By way of example, Northern Ireland will be required to comply with EU standards in relation to falsified medications, whereas GB would be free to diverge.

21. In relation to clinical trials, officials stated that the MHRA would continue to manage in this area and that it there is an aspiration to maintain a close link with the EU, though discussions are at an early stage.

22. Officials confirmed that issues around the supply of, and access to, medicines were being addressed as part of preparatory work ahead of implementing the Protocol.  

23. The Committee enquired if a detailed list could be provided setting out the limits of devolved authority to legislate, in terms of the Protocol and UK Government powers. Officials advised that this is a complicated field and that a comprehensive list could not yet be provided but that officials are working through the issues. Officials did confirm, however, that all areas of the Bill address matters that have been within the EU’s remit to date.  

24. The Committee put further questions to the Department at its meeting on 11 June, in response to which the official confirmed that the implementation of the Protocol would have implications for human medicines but that while that work is ongoing, it is separate from the Bill insofar as the Bill provides replacement delegated powers to continue amending human medicines regulations in line with current practice.  

25. Officials undertook to return to the Committee in due course to provide an update on the implementation of the Protocol.

26. The Committee did not take any further evidence on the Bill due to time constraints and its focus on COVID-19. Whereas its deadline to report under Standing Order 42A, would have been 17 June, the Committee was advised that the House of Commons may schedule Report Stage as early as 18 June and that therefore debate on the LCM in the Assembly would be scheduled for 16 June, requiring the Committee to produce its report as quickly as possible.  

Consideration by Committee for Agriculture, Environment & Rural Affairs

27. On 11 June, 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, though it emphasised that it had not had the opportunity to consult with stakeholders or consider in full the implications of the clauses, for Northern Ireland. The Committee reports, however, that it asked for, and received, assurances that after the enactment of the Bill, the existing regime would remain largely the  same.

28. Appendix 3 sets out the AERA Committee’s report on the LCM, providing detail on provisions relevant to veterinary medicines and the issues raised by the Committee.

Conclusion

29. The Health Committee acknowledges that, in recent months, the Department of Health has been under enormous pressure to deal with COVID-19, however, this has had an impact on the opportunity for scrutiny. In view of the lack of prior engagement on the content of the LCM, the short time available for consideration of the LCM once laid, and the importance of the issues connected to the Bill, the Committee decided it was not in a position to come to a decision on support for the motion.