On 3 December 2020, the House of Lords is due to debate the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. Both instruments were laid under the draft affirmative procedure and must be approved by both Houses before they can be brought into force.
Both draft regulations are made in exercise of the powers detailed in sections 8(1) and 8C of the European Union (Withdrawal) Act 2018 to “address failures of retained EU law to operate effectively and other deficiencies” arising from the the UK’s withdrawal from the EU and to give effect to the Northern Ireland Protocol.
Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020
The draft regulations will amend how medicines and clinical trials will be regulated in Northern Ireland and in Great Britain at the end of the implementation period on 31 December 2020, taking into account the Northern Ireland Protocol. It will do this by amending several instruments, such as the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.
A brief description of some of the changes made by the draft regulations are as follows:
At present, there are four routes by which a company can gain marketing authorisation (regulatory approval) to place human medicine on the UK market. Three of these routes involve the EU regulatory network:
- a national UK route, that does not involve the EU regulatory network, which results in an authorisation for the UK only.
- a centralised authorisation granted by the European Commission, which is valid for the whole of the EU.
- a national UK authorisation granted following either:
- a mutual recognition of a national authorisation granted by another EU member state (the ‘mutual recognition procedure’); and
- a collective assessment procedure by several member states and led by one of them (the ‘decentralised procedure’).
According to the draft regulations’ explanatory memorandum—produced by the Department of Health and Social Care—once the UK leaves the EU, the UK will no longer be a part of the EU licensing system “in the way that it is now”. Instead, centralised authorisations granted by the European Commission (and valid for the whole EU) will continue to apply in Northern Ireland, while all medicines coming into Great Britain will be required to be authorised via a UK national route.
Therefore, to facilitate “continued patient access” to medicines as soon as they are available in the EU, the draft regulations will include a power enabling the Medicines and Healthcare products Regulatory Agency (MHRA) to “automatically recognise” licensing decisions made by the EU. In addition, the regulations provide for the MHRA, when making licensing decisions of its own, to take regard of decisions taken by EU member states on products approved by decentralised or mutual recognition procedures. The explanatory memorandum outlines that the MHRA will authorise products entering Great Britain “even when relying on EU scientific assessments and decisions”. According to the department, this is to ensure that the UK can take “effective regulatory and safety action” on these products.
Moving goods from Northern Ireland to Great Britain
The Government has previously committed to Northern Ireland businesses having “unfettered access” to the market in Great British once the implementation period ends. This would ensure that such businesses can trade “EU-compliant goods” in Britain without “facing new […] regulatory controls and checks”. Therefore, this instrument introduces transparency requirements and safety clauses for medicines to move via this route. These requirements will allow the MHRA to maintain oversight of a product when it enters the market in Great British and to take “pre-emptive” regulatory steps, should there be “early concerns” over a product.
Implementing the Northern Ireland Protocol
The draft regulations would implement the Northern Ireland Protocol by making several amendments to a number of regulations to ensure that applicable EU law will continue to be implemented in Northern Ireland. The amendments would also ensure that the MHRA can continue operating in Northern Ireland after the transition period ends. The explanatory memorandum details these changes, including the impact on testing medicinal products, advertising and packaging.
Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2020
The draft regulations would amend certain existing regulations to provide regulatory requirements on medical devices in Great Britain and Northern Ireland after the end of the implementation period. This includes amendments to the Medical Devices Regulations 2002 to clarify how medical devices will be regulated in Northern Ireland after 31 December 2020. The 2002 regulations placed obligations on manufacturers to ensure that medical devices, such as bandages and surgical equipment, and in vitro diagnostic medical devices, for example, blood glucose monitors, were “safe and fit for purpose”.
Similarly, the draft regulations would amend the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to provide a regulatory route to market in Great Britain once the implementation period has ended. As part of this, the Secretary of State for Health and Social Care will be able to designate UK approved bodies to conduct assessments against the relevant regulatory requirements and be able to award certificates, enabling medical devices to bear a UK Conformity Assessment (UKCA) mark.
The explanatory memorandum for the draft regulations—also produced by the Department of Health and Social Care—notes that any devices that are in conformity with EU legislation can continue to be placed on the British market until 30 June 2023. This is to provide manufacturers of such devices time to “adjust” to future regulations that will be consulted on and published at a later date.
What parliamentary scrutiny has there been?
In October 2020, the two draft regulations were laid before both Houses. The draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 comes into force immediately before the end of the implementation period.
In the same month, the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 were laid before both Houses but were later withdrawn due to drafting errors. On 10 November 2020, new draft regulations were laid before both Houses. Regulations 1 and 4 come into force on the day after the regulations are made, whilst regulations 2 and 3 come into force immediately before 31 December 2020.
In November 2020, the Secondary Legislation Scrutiny Committee and Joint Committee on Statutory Instruments considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, but raised no concerns. On 18 November 2020, the Joint Committee on Statutory Instruments considered the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2020. The Committee also raised no concerns.
On 26 November 2020, the House of Commons Delegated Legislation Committee debated the draft regulations. Introducing the draft regulations, the Minister for Health, Edward Argar, said that the instruments “broadly achieve” three things:
- Firstly, the draft regulations make minor amendments to existing regulations to take account of the implementation period agreed under the withdrawal agreement.
- Secondly, they implement the UK’s obligations under the Northern Ireland protocol.
- Lastly, the draft regulations “implement specific policy changes” to the regulatory regime in Great Britain, to ensure that the regulatory framework at the end of the transition period is “up-to-date and functioning correctly”.
Mr Argar also stated that both instruments “uphold the Prime Minister’s commitment” to “unfettered access” for Northern Ireland’s businesses to the whole of the UK market. The Minister contended that in doing so, the instruments provide for transparency requirements for medicines and medical devices moving from Northern Ireland to Great Britain, which will allow the MHRA to “maintain oversight of products” on the market in Great British and “thus protect patient safety”.
Responding to the Minister, the Shadow Minister for Health and Social Care, Alex Norris, stated that the draft regulations were a “necessary step” towards ensuring that people were kept safe when using medicines and medical devices, and that the UK met its obligations under the Protocol. However, he identified a number of areas where Labour wanted “greater clarity”, such as the impact of the MHRA’s workload when authorising products entering Great Britain, and whether there will be extra pre‑assessments or checks. In response, the Minister stated that the MHRA would receive additional funding of just under £13 million by the end of March 2021 to help it prepare for the end of the transition period and meet its obligations under the regulations. He argued that this would contribute towards investing in new and improved IT systems to enable “better regulation” of medicines and medical devices in Northern Ireland. It would also contribute towards additional staffing requirements.
- Cabinet Office, ‘Moving goods under the Northern Ireland Protocol: Introduction’, updated
17 November 2020
- Medicines and Healthcare products Regulatory Agency, ‘Guidance: Regulating medical devices from 1 January 2021’, updated 4 November 2020; and ‘Guidance: Supplying medicines to Northern Ireland from 1 January 2021’, updated 20 October 2020
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