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

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 Northern Ireland of the provisions within the Medicines and Medical Devices Bill as introduced to Parliament on 13 February 2020 dealing with human medicines and veterinary medicines.”

 

Background

2. This memorandum has been laid before the Assembly by the Minister of Health under Standing Order 42A(2). The Medicines and Medical Devices Bill was introduced in the House of Commons on 13 February 2020. The latest version of the Bill can be found at:

https://services.parliament.uk/Bills/2019-21/medicinesandmedicaldevices.html

 

Summary of the Bill and its policy objectives

3. 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 relating to human medicines and veterinary medicines.

4. The Medicines and Medical Devices Bill provides for the Secretary of State, in respect of England, Scotland and Wales, and for relevant Northern Ireland departments in respect of Northern Ireland, to make regulations relating to human medicines and veterinary medicines.

5. 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.

6. 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.

7. 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 and Part 5 deals with commencement and includes a power for the relevant Northern Ireland department to make transitional provision in connection with commencement.

 

Provisions which deal with a Devolution Matter

8. The subject matter of human and veterinary medicines (including clinical trials of human medicines) is reserved in relation to Scotland and Wales but is 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 relation to 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.

9. The subject matter of medical devices is reserved in relation to Scotland, Wales or 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.

Reasons for making the Provisions

10. The regulation of medicines, medical devices, clinical trials and veterinary medicines has been a matter of EU competence since the UK joined the EU. The legislative frameworks are in the Human Medicines Regulations 2012, the Veterinary Medicines Regulations 2013, the Medical Devices Regulations 2002 and the Medicines for Human Use (Clinical Trials) Regulations 2004.

11. At the end of the transition period, the EU Withdrawal Act 2018 will have preserved these frameworks as “retained EU law” and supporting legislation will ensure they can operate effectively after the UK leaves the EU. However, the EU Withdrawal Act 2018 will repeal the legislation allowing these frameworks to be amended. Without these delegated powers, the UK would have to rely on primary legislation to make changes to these regulatory frameworks.

 

Reasons for utilizing the Bill rather than an Act of the Assembly

12. 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.

13. 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.

14. New primary legislation is, therefore, needed to replace the broad regulation-making power currently available in section 2 (2) of the European Communities Act 1972. The Medicines and Medical Devices Bill will provide these powers to ensure that the UK can use subordinate/secondary legislation to bring forward any necessary amendments to the regulatory regime for human medicines and veterinary medicines.

Consultation

15. After the end of the transition period, section 2 (2) of the European Communities Act 1972 will no longer be available to update the regulatory schemes for human medicines, clinical trials of human medicines , or veterinary medicines through subordinate legislation.

The Medicines and Medical Devices Bill simply seeks to provide targeted delegated powers in the field of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated following the UK’s departure from the EU.

16. 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 40 in relation to the powers in clauses 1(1), 8(1) and 12(1) and paragraph 9 of Schedule 1. The only exception to this requirement is where regulations contain only provision made in reliance on clause 6(1) (disapplication of provisions relating to human medicines where there is a risk of serious harm to health), or clause 15(1) (disapplication of provisions relating to medical devices where there is a risk of serious harm to health) and if they contain a declaration that they need to be made urgently. This will enable the power to be exercised urgently to protect the public from an imminent threat of serious harm to health, when there may not be time for consultation.

 

Human Rights and Equality

17. 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

18. Existing regulations which govern human medicines, veterinary medicines and medical devices will become retained EU law at the end of the transition period by virtue of the European Withdrawal Act. The Bill introduces powers to enable changes domestic legislation to be made. There a no immediate financial implications arising from the delegated powers in the Bill.