On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.

The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.

In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain.  For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines).  The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).

The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations.  It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.

Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

In this episode of Covington’s Life Sciences Audiocast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.

Parliament’s position comes less than a year since the Commission published its proposal, and constitutes a significant step in the legislative process. Although many of the Parliament’s amendments to the Commission proposal can be seen as improvements by the innovative industry, many challenges and some unresolved questions remain, especially in relation to the incentive regime.

During this audiocast, we therefore discuss improvements, challenges and unresolved questions of the EU Pharma law review, with a particular focus on incentives.

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. 

Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence

On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here).  In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process. 

Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series).  Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.

We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.

Continue Reading European Parliament adopts its Position on EU Pharma Law Review: 8 Key Takeaways for Industry

Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners.  The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.

Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement

Tune into this episode of Covington’s Life Sciences Audiocast, where Sibel Yilmaz, Majken Lagerbielke, and Leire Garagorri Eguidazu discuss the new market definition notice published by DG COMP, specifically the latest on the new guidance concerning pharmaceutical innovation markets and possible implications for analysing M&A and licensing deals.

Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also discuss some of the key legal considerations that are coming into increasing focus for Life Sciences Transactions, such as competition/antitrust considerations and the Inflation Reduction Act. This is the first Life Sciences Transactions audiocast for 2024, and we plan to release further audiocasts over the course of this year that dive deeper into some of the above topics.

The European Union has adopted various new rules for emergency situations relating to public health.  These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States. 

The new rules create a complex public health crisis management system.  Measures that may be adopted under this system can be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of critical products.  The primary aim of the new rules is to ensure availability and supply of these critical products in times of crises.

This blog briefly discusses the impact of the health emergency measures on medical devices.

Background

Based on the experience with the past pandemic, the EU has adopted several regulations aimed at tackling future public health emergencies, namely:

  • Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices (“Regulation 2022/123”).
  • Regulation (EU) 2022/2371 on serious cross-border threats to health (“Regulation 2022/2371”).
  • Council Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (“Regulation 2022/2372”).

The Commission has also published a proposal for a Regulation on compulsory licensing for crisis management, which is currently going through the EU legislative procedure.  The Commission proposal for a Single Market Emergency Instrument, which does not relate specifically to health but indirectly impacts medical devices, is also going through the EU legislative process (see our blog on this topic here).

Impact of each Regulation on Medical Devices

a. Regulation on Reinforced Role for EMA

Regulation 2022/123 provides a framework for managing the impact of public health emergencies and major events, and assigns new tasks to the EMA, including monitoring, preventing and reporting shortages of medicines and medical devices.  The Regulation became applicable on 1 March 2022 for medicines and on 2 February 2023 for shortages of critical medical devices.  In respect of the latter, the Regulation established within the EMA the Executive Steering Group on Shortages of Medical Devices (“MDSSG”) to coordinate urgent actions within the Union in relation to the management of supply of critical medical devices and in vitro diagnostic medical devices in the case of a public health emergency. 

Following the recognition of a public health emergency, Regulation 2022/123 sets out certain measures that will impact medical devices:

  • The MDSSG must adopt and publish a list of categories of medical devices which it considers to be critical during the public health emergency.  MDSSG will gather information on those medical devices through EUDAMED, but also directly from importers, distributors, and national databases.
  • The MDSSG must then monitor supply and demand with a view to identifying shortages of critical medical devices. 
  • The MDSSG must also regularly report the information it gathers under the previous two points to the Commission and to Member States and make recommendations on approach to manage (potential) shortages of critical devices.
  • To facilitate the information collection detailed above, the EMA may request information from manufacturers of critical medical devices, authorised representatives, importers, distributors, and notified bodies.  Relevant economic operators will also have an obligation to proactively report information on shortages to the EMA.
  • The Commission, taking into account the MDSSG’s recommendations, must take all necessary action with a view to mitigating actual or potential shortages of medical devices included on the public health emergency critical devices list.  The Commission will be empowered to do this in a number of ways, including through adopting guidelines for Member States and liaising with third countries and international organizations.

b. Regulation on Serious Cross-Border Threats to Health

Regulation 2022/2371 entered into force on 26 December 2022.  It lays down rules for the surveillance, preparedness, response planning, and emergency research related to cross-border threats to health.  This Regulation repeals and replaces the previous Decision 1082/2013/EU.  In this framework, it addresses EU-Member States joint procurement for medical countermeasures (including medical devices) and provides that the Commission and Member States may engage, as contracting parties, in a joint procurement procedure. 

The Commission will take a central role in this process and will ensure coordination and exchange of information between parties, compliance with procurement procedures (including in particular the EU Financial Regulation (EU) 2018/1046), and execution of the procurement.  This could include development, stockpiling, distribution, and donation of medical countermeasures.  Importantly, Regulation 2022/2371 also permits the advance purchase of medical countermeasures in anticipation of a potential serious cross-border threat to health.  

c. Regulation on Supply of Crisis-relevant Medical Countermeasures

Regulation 2022/2372 establishes a framework of measures for ensuring the supply of crisis-relevant medical countermeasures (including medical devices) in the event that a public health emergency at Union level has been established.  It creates the Health Crisis Board to coordinate the implementation of measures adopted under the Regulation.

In the event of a public health emergency, Regulation 2022/2372 grants power to the Council to adopt, upon proposal of the Commission, a regulation activating the emergency framework and setting out appropriate measures to handle the situation.  There are five measures that could impact medical devices:

  • Monitoring: the Commission will monitor the supply and demand of crisis-relevant medical countermeasures, including medical devices: their production capacity, stockpiles, possible supply chain disruptions and purchasing agreements.
  • Procurement and manufacturing: the Health Crisis Board will advise the Commission on appropriate ways to procure crisis-relevant countermeasures, including medical devices (e.g., through existing contracts, or through Regulation 2022/2371).  In case of shortage, the Commission has power to help increase the availability of crisis-relevant medical countermeasures. 
  • Inventory of production and production facilities: the Commission may request manufacturers of crisis-relevant countermeasures, including medical devices, to inform on their production capacity and existing stocks, in the EU or in third countries.  The requested information may also include a schedule of production plans for the next three months.
  • Inventory of crisis-relevant medical devices: where it considered that there is a risk of shortage of medical devices, the Commission may request that manufacturers share an inventory of those medical devices.
  • Measures to ensure availability and supply: where it considers that there is a risk of shortage for medical countermeasures, including medical devices, the Commission may adopt measures to increase their availability (i.e., reorganize supply chains and utilise existing stocks).  In doing so, the Commission will have to act in coordination with concerned Member States and economic operators.  Potential measures include: (i) Facilitating the creation, expansion or repurposing of production capacities; (ii) Implementing procurement initiatives, reserving stockpiles; (iii) Facilitating the licensing of intellectual property and know-how.

d. Commission Proposal for a Regulation on Compulsory Licensing for Crisis-management

On 27 April 2023, the Commission proposed to establish a Union compulsory licensing of certain intellectual property rights in force in one or more Member States: patents (including published patent applications), utility models, or supplementary protection certificates. 

According to the proposal, the Commission may grant a Union compulsory license if an emergency or crisis instrument has been activated (e.g., if a public health emergency is recognized under Regulation 2022/2371, or where the emergency framework under Regulation 2022/2372 is activated).  If granted, the Union compulsory license would be limited to “crisis-relevant products” which could include medical devices.

The proposal is going through the legislative procedure.  On 13 March 2024, the European Parliament adopted a series of amendments (accessible here).  The Council has not yet adopted its position.

Conclusion

Regulations adopted in the wake of the COVID-19 pandemic create a complex public health crisis management system.  For medical devices, the primary aim of these Regulations is to ensure their availability and supply in times of crises.  To that end, new powers have been granted to the Commission, and new bodies have been created to monitor and oversee issues that could impact the supply of medical devices and in vitro diagnostic medical devices to the EU market. 

Measures that may be adopted under this new coordinated system could potentially be far-reaching.  They include supply chain monitoring, information requests, and sometimes direct intervention of authorities in production and distribution of medical devices.  It is difficult to predict how it will work in practice because its implementation has not yet been tested. 

Nevertheless, a possible future activation of this public health crisis management system is very likely to impact medical devices.  To anticipate measures under these Regulations, it will be important for companies to pay attention to the work of the Commission and newly created bodies as they monitor the market and report on its situation.

It is in any event reassuring to know that European institutions and regulatory agencies are committed to implementing a coordinated approach to manage shortages of critical products in the event of future pandemics or health emergencies. 

If you have any queries concerning the material discussed in this blog or medical devices more broadly, please contact members of our Food, Drug, and Device practice.

The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. 

Continue Reading Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules