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

Appendix 1 – Letter from the Minister of Health to the Health Committee

FROM THE MINISTER OF HEALTH

Castle Buildings
Stormont Estate
BELFAST, BT4 3SQ

Colm Gildemew MLA
Chair of the Health Committee
Room 416
Parliament Buildings
Ballymiscaw
Stormont
Belfast,
BT4 3XX

Date: 1 April 2020

Dear Colm

WESTMINSTER HEALTH MEDICINES AND MEDICAL DEVfCES BILL - LEGISLATIVE CONSENT MOTION

I wish to advise you about a Legislative Consent Motion asking the Assembly to agree a number of provisions that deal with transferred matters within the Medicines and Medical Devices Bill which was introduced in Parliament on 13 February 2020. A copy of the Bill as introduced in Parliament is available from:

https://publications.parliament.uk/pa/bills/cbill/58-01/0090/20090.pdf

The aspects of the Bill that will require a Legislative Consent Motion relate to the clauses that fall under Parts 1, 2, 4 and 5.

Background

A large proportion of the legal framework for medicines and medical devices in the UK derives from EU Directives and has been implemented into domestic legislation through section 2(2) of the European Communities Act 1972 ('the 1972 Act'). This enables EU Directives to be transposed into UK Law through secondary legislation and has been used to create a body of regulations that include the:

• Human Medicines Regulations 2012;
• Medicines for Human Use (Clinical Trials) Regulations 2004:
• Veterinary Medicines Regulations 2013; and,
• Medical Devices Regulations 2002.

At the end of the Transition Period, the European Union (Withdrawal) Act 2018 will have preserved these frameworks as "retained EU Law". The 1972 Act. however, will no longer be available to the UK to amend the regulations. There is no other 'general power' for updating these regulations. except through the introduction of primary legislation.

The Bill does three things;

i. introduces targeted delegated powers in the fields of human medicines, veterinary medicines and medical devices to enable the existing regulatory frameworks to be updated rollowing the UK's exit from the EU;

ii. consolidates the enforcement provisions for medical devices and introduces sanctions; and,

iii. provides an information gateway to enable the sharing of information held by the Secretary of State about medical devces, for example to warn members of the public about safety concerns.

The regulatory gap is addressed by proving delegated powers to replace section 2(2) of the 1972 Act, supported by an exhaustlve list of purposes for which those powers can be used. These powers will enable updates to be made to the Human Medicines Regulations 2012, Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and Veterinary Medicines Regulations 2013. These powers are necessary to prevent stasis and enable the UK to remain at the forefront of the global life
sciences industry.

The Bill will also enable government to support its regulators (i.e. the Medicines and Healthcare Products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD)) to go even further in developing innovative regulation. The effective regulation of human and veterinary medicines and medical devices is necessary to benefit industry and people in all regions and nations of the UK and help to ensure that the right balance is achieved between having robust safeguards to protect patient safety and encouraging innovation in the health system. In particular, the Bill consolidates the enforcement regime for medical devices and provides the Secretary of State with the ability to impose civil sanctions - as an alternative to criminal prosecution - for breaches of the medical device regime.

The Department of Health and Social Care (DHSC) has advised that the majority of the Bill 's provisions will commence two months after it receives Royal Assent. The only exception to this will be those measures relating to events that could pose serious harm to human health which will be commenced immediately, and certain medical devices enforcement measures which will be by oommencement order.

The Bill deals with policies that fall under the remit of the Department of Health (DoH) and the Department of Agriculture, Environment and Rural Affairs {DAERA) respectively. In terms of the handling arrangements, the DoH is content to lake the lead with input from DAERA colleagues on any of the provisions that relate to veterinary medicines.

A copy of the Bill has been shared with the Departmental Solicitor's Office (DSC) with a request for a legal perspective on those provisions dealing with human medicines. I am aware, however, that they are under oonsiderable pressures providing advice in response to the Covid-19 pandemic.

I will, of course, continue to keep you apprised of all developments with the Bill and I look forward to working with the Health Committee on this issue.

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.

Yours sincerely

Robin Swann MLA
Minister of Health