On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines (i.e., the unavailability of which may cause patients serious harm, and whose supply must be ensured even in crisis periods) and to diversify international supply chains. On the same date, the European Medicines Agency (EMA) published details on the Solidarity Mechanism, recently created by the EMA Medicines Shortages Steering Group (MSSG) to facilitate redistribution of medicines between Member States (MS) in cases of critical shortages (i.e., medicine shortages where no alternative is available).

These EU-level actions are in addition to the mechanisms to tackle shortages already included in the European Commission’s proposal for a reform of the EU Pharmaceutical Legislation (read our advisory).

Continue Reading New EU-level actions addressing shortages

In a previous blog post, we discussed the UK government’s proposed changes to the regulatory framework governing clinical trials. Marking the start of this legislative change is a new notification scheme for the lowest-risk clinical trials (the scheme), published on 12 October 2023. The scheme is based on the proposal set out in the Medicines and Healthcare Regulatory Agency’s (MHRA) consultation earlier this year, which was supported by 74% of respondents.

The scheme allows for the processing of eligible clinical trials by the MHRA in less than 14 days, instead of the statutory 30 days. The scheme currently only applies to clinical trial authorisation (CTA) applications for Phase 4 and certain Phase 3 clinical trials deemed as low risk, and provided they meet the MHRA’s eligibility criteria, set out below. Initial “first in human” Phase 1 or Phase 2 trials and clinical trial amendment applications will not be eligible.

The scheme aims to reduce the time taken to get lowest-risk clinical trials up and running, to give UK patients quicker access to potentially life-saving medicines, without undermining patient safety. The MHRA encourages clinical trial sponsors to use the scheme for all eligible trials and estimates that this will include 20% of UK initial clinical trial applications.

Continue Reading UK clinical trials – new notification scheme for lowest-risk clinical trials

In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public health initiatives focused on promoting the transparency of both EMA decision-making and clinical data, sharing of knowledge and use in future research.

While the Policy was adopted by the EMA back in 2014, it has been suspended since 2018 due to the EMA’s relocation to Amsterdam and COVID-19. During the COVID-19 pandemic, the EMA adopted exceptional transparency measures for centrally approved COVID-19 vaccines and treatments. This was deemed a success further showing the need for clinical data sharing and, thus, the need  for relaunching the Policy.

Continue Reading EMA relaunches Policy 0070 on publication of clinical data for medicinal products for human use

We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the MHRA to fast-track approval in the UK.

On 30 August 2023, the MHRA published detailed guidance on how it will use the IRP for medicinal products. The IRP will be open to applicants who have already received an authorisation for the same product from one of the MHRA’s specified Reference Regulators (RRs) in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. However, the MHRA retains the right to reject the IRP and conduct a full assessment if considered necessary.

This procedure will operate in parallel to the MHRA’s current national procedures, including the shortened 150-day timetable, offering applicants a range of authorisation routes depending on the status in other countries and type of application. The hope is that this will allow the MHRA to be able to use the decisions in other countries, while still being able to conduct its own assessment where necessary for the UK market.

The IRP will be available from 1 January 2024. However, until the Windsor framework is in place on 1 January 2025, discussed here, products falling within the scope of the EU Centralised Procedure can only be authorised in Great Britain (England, Scotland and Wales).

Continue Reading New UK International Recognition Framework for Medicines

On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.

Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.

Applications for the pilot phase are open and will close after 29 October 2023; they can be made via an online application form and associated guidance.

Continue Reading UK Government launches Innovative Devices Access Pathway (IDAP)

The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted, the rules will apply to all companies involved in the packaging life cycle that place packaging and packaging waste in the EU internal market regardless of whether these companies are based in the EU.  While there are various exceptions for manufacturers of medicinal products and medical devices sectors, if adopted, the Proposed Regulation will require life sciences companies to make significant amendments to their current and future product packaging, with resulting cost impacts. We set out the key requirements and takeaways from the Proposed Regulation in our Advisory, and will continue monitoring and reporting on new developments as the legislative process evolves.

We have also prepared this helpful summary for your reference.

Continue Reading Proposal for Revision of EU Legislation on Packaging and Packaging Waste

On 19 July 2023, the European Medicines Agency (EMA) published a draft Reflection paper on the use of artificial intelligence (AI) in the lifecycle of medicines (the Paper). The Paper recognises the value of this technology as part of the digital transformation within healthcare, and acknowledges its increasing use and potential to “support the acquisition, transformation, analysis, and interpretation of data within the medicinal product lifecycle”, provided of course it is “used correctly”.

The Paper reflects EMA’s early experience with and considerations on the use of AI, and gives a sense of how EMA expects applicants and holders of marketing authorisations to use AI and machine learning (ML) tools. The EMA has made clear that the use of AI should comply with existing rules on data requirements as applicable to the particular function that the AI is undertaking. It is clear that any data generated by AI/ML will be closely scrutinised by the EMA, and a risk-based approach should be taken depending on the AI functionality and the use for which the data is generated.

The Paper is open for consultation until 31 December 2023. EMA also plans to hold a workshop on 20-21 November 2023 to further discuss the draft Paper. EMA’s plan is to use the feedback from the public consultation to finalise the Paper and produce future detailed guidance. Our summary below sets out the key takeaways and the key issues that arise in the Paper.

Continue Reading EMA publishes first draft of reflection paper on the use of AI in the medicinal product lifecycle

At the beginning of July, the MHRA published its 2023 – 2026 Corporate Plan, which highlights, amongst many other topics, the importance of introducing new legislation and guidance on clinical trials in the UK to help provide the “stable and predictable regulatory environment that companies require”. The intention is that by 31 March 2026, the MHRA will implement a revised regulatory framework for clinical trials.

Work on a new clinical trial framework is already underway. On 21 March 2023, the MHRA published its response to the UK consultation (which ran from 17 January to 14 March 2022) on legislative proposals for changes to the law governing clinical trials, namely the Medicines for Human Use (Clinical Trials) Regulations 2004.

Responses demonstrated strong support to update and improve the legislation governing clinical trials, with most respondents agreeing that patient safety should remain the focus of the legislation, but with a more flexible and risk proportionate approach to decision-making. In line with responses to other recent consultations, the MHRA is looking to align with international standards rather than be limited by alignment with the EU. It is hoped 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 retaining the UK as an attractive place for trials.

In terms of next steps, the drafting of the statutory instrument to update the clinical trials legislation is expected to be laid before parliament in the Autumn of 2023. Comprehensive guidance will also accompany the legislation.

Continue Reading Legislative change is afoot for clinical trials conducted 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 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