Current Status of Life Sciences Regulation in the UK Post-Brexit
The UK left the EU on January 31, 2020, and this began the complex process of de-coupling the UK regulatory regime from that of the EU. This has not been straightforward, particularly where goods move into and out of Northern Ireland (NI), where the EU rules continue to apply, from Great Britain (England, Wales, and Scotland (GB)), where they do not. Given all of the changes that have arisen due to Brexit, we set out below a summary of the current position in the UK for medicinal products and medical devices, and of recent consultations and initiatives from the UK government as the UK develops its post-Brexit regulatory regime. You can subscribe to our updates here.
Supply of Medicinal Products and Medical Devices in the UK
When the UK left the EU, the UK continued to apply EU law and procedure for an 11-month transition period until December 31, 2020. On December 24, 2020, the EU and the UK agreed to the EU-UK Trade and Cooperation Agreement, discussed in a previous Advisory, setting out the terms of their future relationship. Under this agreement, from January 1, 2021, the UK was no longer subject to EU single-market rules or the EU legislative framework. However, NI continues to follow EU rules in order to protect, among other things, peace and stability on the island of Ireland.
For medicinal products, the current position is that a medicinal product can only be placed on the market in the UK pursuant to a UK national marketing authorization (MA) granted by the UK regulator, the MHRA. However, on account of NI continuing to follow EU rules, UK MAs are now split into various types, depending on the parts of the UK to which they apply. In particular, the EU “centralized authorization” granted by the European Commission, which allows a medicinal product to be placed on the market in all EU Member States, no longer applies in GB, but does, for now, apply in NI.
In relation to devices, on January 1, 2021, a new route was introduced to place a medical device on the GB market, with an accompanying mark based on the requirements derived from the previous EU legislation: the UKCA. However, the UK government has agreed that CE marking and certificates issued by EU-recognized Notified Bodies will continue to be valid for the GB market until the new UK regime is established. EU CE marking continues to be required in NI.
In practice, this means that products on the market in NI must be authorized in line with the EU regime, which no longer applies in GB. This causes difficulties for companies marketing their products in the UK, as different authorizations or approvals, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.
Trade Issues — The Windsor Agreement
The EU-UK Trade and Cooperation Agreement, by which the UK’s terms of withdrawal from the EU was decided in December 2020, was accompanied by a Protocol on Ireland and Northern Ireland. This was required to prevent a hard customs border between the Republic of Ireland (an EU Member State) and NI (part of the UK and no longer within the EU). However, the protocol has not worked perfectly and trade has been disrupted.
On February 27, 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in NI.
“Red” and “green” customs lanes will be introduced that distinguish between goods coming from GB for the NI market and those for the EU market: a green lane will be used for goods moving from GB to NI, with reduced requirements and checks. A red lane will apply where goods are intended for onward supply from NI to the Republic of Ireland, with additional checks as goods enter the EU market.
In relation to medicines, and to overcome the current practical difficulties for the supply of these products, the European Commission will suspend the application of certain EU provisions applicable to medicinal products intended to be placed on the market in NI. In particular:
- MHRA will regulate and authorize all medicines in NI under a UK-wide marketing authorization granted in line with UK law.
- Medicines can be imported from GB into NI without the need for a manufacturing import authorization.
- The EU Falsified Medicines Directive regarding safety and tracking features will no longer apply in NI.
- UK medicines will need to carry a “UK-only” marking.
- Products that are already on the market when the arrangements come into force can remain on the market.
- These amendments shall apply from January 1, 2025.
The agreement does not address the supply of medical devices, although such products may be able to benefit from the customs procedures that have been put in place, which will reduce requirements on companies to meet both EU and UK rules. Further information about the Windsor Agreement can be found here.
In the EU, Regulation (EU) 2023/1182 was published on June 14, 2023 to implement this agreement. The UK amendments are still being debated. A subcommittee of the UK House of Lords has concluded that the Windsor Agreement is a distinct improvement on the Protocol on Ireland/Northern Ireland as originally negotiated. However, industry representatives are calling for clarity over labelling requirements and safety features for medicinal products, the supply of medical devices, and concerns that Northern Ireland may get slower access to cutting-edge products than Ireland.
As part of its status as an independent regulator that is no longer bound to follow the regulatory regime of the EU, the MHRA has been consulting on future regulations and how to retain the UK’s position as an attractive place to launch products.
In 2017, the EU substantially revised its legislative framework for the regulation of medical devices. However, on account of Brexit, although the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) apply in NI, they do not apply in GB. GB continues to follow its 2002 legislation that is based on the previous EU regime.
As such, in November 2021, the MHRA consulted on proposed changes to the regulatory framework for medical devices and on June 26, 2022, the MHRA published its response to the various comments received during the consultation. The aim is to better align with international best practices where this is to the benefit of UK patients and diverge only where advantageous to do so. On the whole, the proposals bring the UK regime into line with the requirements in the EU MDR and IVDR, and refer to international definitions and guidance. The proposals are not yet confirmed in legislation. However, the government is aiming for “core aspects” of the future regime to apply from July 1, 2025. Further information on the proposals can be found here.
The UK government has also amended legislation to extend the period during which valid EU CE marked medical devices can continue to be placed on the market in GB in line with the extended MDR transitional periods. The extended periods align with the expected transitional periods under the new UK Regulations. Further information on the extension periods can be found here.
The new EU Clinical Trial Regulation came into effect in the EU on January 31, 2022. The UK’s clinical trial legislation dates back to 2004 and is based on the previous EU regime, amended to reflect the UK’s departure from the EU.
On March 21, 2023, the MHRA published the response to the consultation on legislative proposals for changes to the law governing clinical trials. The MHRA is again looking to align with international standards rather than be limited to alignment with the EU. Patient safety remains the focus of the legislation, but with a more flexible and risk proportionate approach to decision-making. The hope is that the implementation of the proposals will make it easier and more efficient to run trials in the UK, enabling greater patient access to new, safe, and life-changing treatments, while making the UK a more attractive place for trials. The intention is that the MHRA will implement the revised regulatory framework by March 31, 2026. Further information on these proposals can be found here.
New Recognition Routes
Post-Brexit, a number of new routes were introduced in the UK to allow for the quick authorization of products that have been approved in the EU (via recognition of the EU assessment) and greater flexibility in UK MA procedures (such as a “rolling review” that permits the submission of an application in modules).
On May 26, 2023, the MHRA announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognize decisions to authorize medicinal products taken in other countries so the MHRA can fast track approval in the UK. The new international recognition routes will enable recognition of medicinal product approvals in Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. Further information on these proposals can be found here.
The UK government has also stated that it will consult on how a similar regime would operate for medical devices.
Artificial Intelligence (AI)
There is currently no specific legislation in the UK that governs AI or its use in healthcare. Instead, a number of general-purpose laws apply. These laws, such as the rules on data protection and medical devices, have to be adapted to specific AI technologies and uses.
The EU Commission has published proposals for specific legislation on the regulation of AI; see our Advisory for a summary of the current position. In contrast, on July 18, 2022, the UK government published a policy paper on regulating AI in the UK, which states that the EU Regulation on AI is not the right approach for the UK. Instead, the government plans to focus on the specific context in which AI is being used, and to take a proportionate, risk-based response. The contextual focus is intended to foster “a targeted and nuanced response to” AI-related risk at the application level, by allowing flexibility to treat different uses of AI differently, rather than dictating “one-size-fits-all” rules. This approach was confirmed in the UK government white paper regarding AI, published in March 2023. Further information on the proposals can be found here.
In relation to medicinal products, the MHRA’s position set out in its Change Programme is in line with the pro-innovation approach and makes clear that it is unlikely that the MHRA AI regime will entail specific legal requirements beyond those being considered for software as a medical device, although there will be various factors that need to be taken into account as the technology is developed and in line with its intended purpose. Further information can be found here.
© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.