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On 21 May 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent (the Statement) setting out its proposals for international recognition of regulatory “approvals” of medical devices. Under the proposed scheme, medical devices will be subject to limited pre-market requirements where they are already “approved” in a trusted jurisdiction. This will replace the current provisions, which permit recognition of EU CE marks, and will expand recognition to a wider set of trusted regulators, including the US in certain cases. This has long been an intention of the MHRA, and follows a similar procedure for medicines announced last year, although the practicalities of how this will work for devices and the role of the relevant stakeholders has been difficult to resolve.

The proposals are intended to avoid duplication of assessments for medical devices and it is hoped this will lead to quicker access to new devices in Great Britain. It will also allow the MHRA to meet its stated aim of focusing resources on innovative devices, particularly artificial intelligence medical devices (AIMD) that are excluded from the scheme.  However, the Statement is silent on who will undertake the reviews required under the access routes. This is subject to ongoing consultation, though it seems likely that any reviews would be conducted by UK Approved Bodies. This will require coordination between Approved Bodies and the MHRA, which will be an important step in ensuring this scheme operates as intended.

The MHRA intends that the new recognition scheme will come into force at the same time as the future core changes to the medical devices regulatory framework in Great Britain, discussed in a previous post. It is expected the draft regulations implementing that scheme will be published later this year, with the regulations coming into force in 2025.Continue Reading MHRA outlines proposals for international recognition of medical devices

On 5 April 2024, the MHRA updated various guidance documents on the impact of the Windsor Agreement (the Agreement) on parallel imports into and within the UK. Since the end of the Brexit transition period, EMA-issued parallel distribution notices (PDNs) ceased to be valid in Great Britain (GB). A PDN must be obtained by a parallel distributor prior to engaging in parallel distribution in the EU. In GB, PDNs were replaced by Parallel Import Licences (PLPIs), which allowed distribution of products in GB only; while PDNs continued to be valid in Northern Ireland (NI).

As of 1 January 2025, when the Agreement is due to take effect, PDNs will no longer be valid in NI. All parallel imports into GB and NI will require a PLPI from the MHRA that will apply across the whole UK, and any PLPIs that were previously limited to GB will automatically convert into UK-wide PLPIs from this date.Continue Reading Brexit update: Changes to parallel imports in the UK

The Retained EU Law Bill is now an Act of Parliament, having received Royal Assent on 29 June 2023. In our blog, published at the end of last year, we explained the draft Bill’s key features. Since then, the Bill has undergone significant amendment. In this blog we consider key differences between the original Bill and the Act.Continue Reading The Retained EU Law (Revocation and Reform) Act 2023 – Update

On 27 February 2023, an agreement in principle was reached by the UK and EU, known as the Windsor Agreement, relating to post-Brexit trade issues in Northern Ireland (NI). The principles are expected to be approved shortly by the EU-UK Joint Committee. The UK Government and the EU institutions will then enact legislative measures to make the necessary amendments to their laws. 

Following Brexit, from 31 January 2020, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement’s Protocol on Ireland and Northern Ireland, NI continues to follow EU rules. This is to avoid customs checks between NI and the Republic of Ireland. In practice, this means that medicinal products on the market in NI must be authorised in line with the EU regime, which no longer applies in Great Britain. This causes difficulties for companies marketing their products in the UK, as different authorisations, following different rules, apply in different parts of the UK. It also means that patients have access to different products in GB or NI.

The current agreement covers a number of sectors, and in relation to medicines, the aim is to simplify supply between GB and NI, and ensure that only one authorisation is needed and one set of rules needs to be followed within the UK. However, much detail still needs to be published so that companies can fully understand the impact of the changes on their medicines supply chains.Continue Reading The Windsor Agreement and supply of medicinal products in Northern Ireland

Synopsis

On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards only domestically enacted legislation. A revised Bill was published on 29 November 2022 following its first debate in parliament and scrutiny by the Public Bar Committee. If current timelines are maintained, it is anticipated that the Bill would be passed in April or May 2023.
Continue Reading The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues

As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).

In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.

After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.

In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland

On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences companies have been concerned, and there are areas that will likely be the subject of further discussion during the implementation of the Agreement. However, many view the Agreement as being an important first step in the UK’s continuing relationship with the EU. We set out below a summary of the key aspects of the Agreement relevant to life sciences companies.
Continue Reading The EU-UK Agreement and the implications for life sciences companies

As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU

The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that is used to support regulatory decisions. It is intended to be the first in a series of guidance documents addressing RWE. The guidance is part of the MHRA’s push to reinforce the view of the MHRA as a pro-innovative regulatory authority, and that the UK is a leading country in which to conduct clinical research, post-Brexit.
Continue Reading UK MHRA consultation on real-world evidence

On 20 October 2020, “The Human Medicines (Amendment etc) (EU Exit) Regulations 2020” Bill was laid before the UK Parliament (the 2020 Bill). The Bill proposes amendments to various Statutory Instruments that were drafted in 2019 (the 2019 SIs) in anticipation of a “no-deal” Brexit. The 2019 SIs sought to enable the pharmaceutical regime in the UK to function independently of the EU, and for the MHRA to act as a stand-alone regulator of medicinal products placed on the UK market. The 2019 SIs have now been revived so that they are effective beyond the end of the transition period, which expires on 31 December 2020, subject to any agreement that may be reached with the EU about the ongoing relationship between the UK and EU.

The 2020 Bill includes a number of changes to the 2019 SIs, which themselves changed the current Human Medicines Regulations of 2012. However, one area that is of particular interest to the industry is the regulatory data protection (RDP), marketing protection and orphan exclusivity periods that apply to medicinal products authorised in the UK after the transition period. The 2020 Bill changes the position that had previously been set out in the 2019 SIs.
Continue Reading RDP periods in the UK after Brexit