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 June 14, 2023, an overwhelming majority of the European Parliament (Parliament) recently voted to pass the Artificial Intelligence Act (AI Act), marking another major step toward the legislation becoming law. As we previously reported, the AI Act regulates artificial intelligence (AI) systems according to risk level and imposes highly prescriptive requirements on systems considered to be high-risk. The AI Act has a broad extraterritorial scope, sweeping into its purview providers and deployers of AI systems regardless of whether they are established in the EU. Businesses serving the EU market and selling AI-derived products or deploying AI systems in their operations should continue preparing for compliance.

Now, the Parliament, Council, and Commission have embarked on the trilogue, a negotiation among the three bodies to arrive at a final version for ratification by the Parliament and Council. They aim for ratification before the end of 2023 with the AI Act to come into force two (or possibly three) years later.

In our recent advisory, we summarize the major changes introduced by the Parliament and guide businesses on preparing for compliance with the substantial new mandates the legislation will impose.

Continue Reading European Parliament Adopts Its Version of AI Act

On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA can fast track approval in the UK. Further, on 4 July 2023, the MHRA published its Corporate Plan, 2023 to 2026 (Corporate Plan) outlining its four strategic priorities over the next three years, including to “deliver scientific and regulatory excellence through strategic partnerships” through, for example, collaboration with international regulatory partners.

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.

The aim is for these routes to be in place by the first quarter of 2024.

Continue Reading New UK International Recognition Routes for Medicines   

Answers to Some Common Questions

After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.

Continue Reading Demystifying the UPC and the Unitary Patent

In a judgment handed down today, 10 July 2023, Mr Justice Turner refused permission for an application by the British Generic Manufacturers Association (BGMA) for judicial review of the refusal of the Secretary of State for Health and Social Care (SoS) to appoint it as a second “industry body” (in addition to the Association of the British Pharmaceutical Industry (ABPI)) for the purposes of negotiation of the next voluntary scheme controlling the prices of branded health service medicines. The result of this decision is that negotiation will involve only the SoS and the ABPI, albeit taking into account submissions from other industry bodies (including the BGMA) and other stakeholders.

Continue Reading BGMA refused permission for judicial review in relation to negotiation of the voluntary scheme

We have finalised the latest installment of our Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during May 2023 from the United States, United Kingdom, and European Union.

For the EU and UK, this provides an update of the progress of the EU AI Act, new MHRA guidance on reporting of adverse incidents involving Software as a Medical Device (SaMD) as well as the latest discussions on the potential adequacy decision by the European Commission on the EU-U.S. Data Privacy Framework.

Next month is coming soon!

Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.

Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

Today, 26 April 2023, the European Commission (the Commission) published its long-awaited proposed amendments to the EU regulatory framework for medicinal products (the Proposals). We set out the key takeaways from these Proposals in our Advisory.

This is the culmination of a number of years’ work by the Commission, starting with the new pharmaceutical strategy for Europe (the Strategy) announced on 25 November 2020. We set out a summary of and reasons behind the Strategy in a previous Advisory, noting that the Strategy sought to ensure a high level of public health by increasing the availability, accessibility, and affordability of medicinal products throughout the EU and harmonize the internal market.

To meet these goals, the Commission has proposed substantial changes to the EU regulatory system, via a new Directive that will replace Directive 2001/83 (medicinal products for human use), and a new Regulation that will replace Regulation (EC) No 726/2004 (authorization and supervision of medicinal products), Regulation (EC) No 141/2000 (orphan medicinal products), and Regulation (EC) No 1901/2006 (pediatric medicines). The Proposals include changes to the regulatory protections available for medicinal products and orphan medicinal products and a new procedure relating to shortages of medicinal products.

Continue Reading Proposed Amendments to the EU Regulatory Framework for Medicinal Products

With much fanfare, in January 2023, the European Commission released its proposal to extend the MDR transition periods and abolish the ‘sell-off’ deadline, after which medical devices and in vitro diagnostics (IVDs) would have to be withdrawn from the EU and EEA market. Today, the proposal has been adopted via Regulation 2023/607 (the Regulation), and will come into force today, 20 March 2023. This date is now important, as CE certificates that expired before today may be able to be considered as valid if certain conditions are met. Certificates that expire from today until the new transition periods will be considered as valid if the conditions set out below are met. This provides important breathing space for companies and should ensure that a large number of devices are not withdrawn from the market over the next year.

Continue Reading Extension to EU MDR transition periods finalised

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