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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

On 25 January 2023, the UK government published its response to the consultation on Point of Care (POC) manufacturing, described as personalised medicines made for the patient either within or very close to the healthcare setting. The joint consultation between the MHRA and the Northern Ireland Department of Health sought views on legislative proposals to introduce a new regulatory framework for the manufacture and supply of POC products. Those proposals were warmly received by stakeholders and steps will now be taken to introduce amendments to the legislative framework for POC manufacture and supply.…

Continue Reading MHRA consultation on medicines manufactured at the point of care

The procurement landscape in the UK is due to change next year. A draft procurement bill (Bill) seeks to consolidate a number of different procurement regulations that originate from EU legislation, including the Public Contracts Regulations 2015 (PCR), into a single revised regime. The aim is to modernise and unify procurement systems and processes into a single piece of legislation and to develop the regime specifically for England, Wales and Northern Ireland.

In addition to the Bill, a proposed Provider Selection Regime, introduced by regulations made under the Health and Care Act 2022, will create a new set of rules for arranging healthcare services in England, and take NHS healthcare services outside the scope of the Bill. That said, some services of relevance to the NHS may still fall under the Bill, in particular, the procurement of goods and medicines.

The aim of both the proposed Bill and the Provider Selection Regime is to give more flexibility to procurers to adapt the procurement process to the services and goods being procured, and to make it easier for the most suitable bidders to win the bid, while at the same time maintaining transparency. Neither the Bill nor the Provider Selection Regime apply in Scotland given that these are devolved matters and the pre-existing regime will remain in place there. Since the existing procurement regime originated in European law, there is currently little, if any, divergence between Scotland and the rest of the UK. The new changes will bring about the potential for divergence.

In this post, we have set out some key takeaways about the new procurement regime under the Bill and the proposed Provider Selection Regime. …
Continue Reading Adoption of New Procurement Regulations in the UK

The MHRA is continuing to publish details on how software and AI medical devices will be regulated in the UK post Brexit, with the aim of making the UK an attractive place to launch such products. The MHRA’s recent updates to its ‘Software and AI as a Medical Device Change Programme’ (the Change Programme) intend to “deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market.”

The MHRA has also recently announced it will extend the period during which EU CE marks on medical devices (including for software) will be accepted on the UK market, until July 2024.

We set out an overview of these updates below.…

Continue Reading Latest on software and AI devices from the MHRA

On 14 July 2022, the European Commission published a proposal for a Regulation on the safety and quality of substances of human origin (SoHO) intended for human application. When adopted, the proposed Regulation will repeal and replace the currently applicable Directive 2002/98/EC on blood (the Blood Directive) and Directive 2004/23/EC on tissues and cells (the Tissue and Cells Directive), with the aim of reforming and modernising the existing EU legislation. The proposal sets out requirements and standards for the safety and quality of blood, tissues, and cells (BTC), as well as other SoHOs, through a single instrument that will apply in all EU Member States in a (hopefully) harmonised manner.

This will be a major development for life sciences companies operating in the EU, including companies developing advanced therapy medicinal products (ATMPs, such as cell and gene therapies) manufactured from or using SoHOs. The Regulation will apply from donation to human application, unless the SoHOs are used in the manufacture of medicinal products or medical devices, in which case the Regulation will apply to donation, collection and testing of the substances only. A public consultation is open until 8 September 2022, and the proposal will also be discussed by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force, with the proposal setting out a 2-year or 3-year transition period depending on the provision.…

Continue Reading EU Commission adopts Proposal for a Regulation on substances of human origin

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. They sometimes overlap, which can cause confusion for businesses trying to identify the relevant requirements that have to be met, or to reconcile potentially conflicting provisions.

As a step towards a clearer, more coherent approach, on 18 July, the UK government published a policy paper on regulating AI in the UK. The government proposes to establish a pro-innovation framework of principles for regulating AI, while leaving regulatory authorities discretion over how the principles apply in their respective sectors. The government intends the framework to be “proportionate, light-touch and forward-looking” to ensure that it can keep pace with developments in these technologies, and so that it can “support responsible innovation in AI – unleashing the full potential of new technologies, while keeping people safe and secure”. This balance is aimed at ensuring that the UK is at the forefront of such developments.

The government’s proposal is broadly in line with the MHRA’s current approach to the regulation of AI. In the MHRA’s response to the consultation on the medical devices regime in the UK post-Brexit, it announced similarly broad-brush plans for regulating AI-enabled medical devices. In particular, no definition of AI as a medical device (AIaMD) will be included in the new UK legislation, and the regime is unlikely to set out specific legal requirements beyond those being considered for software as a medical device. Instead, the MHRA intends to publish guidance that clinical performance evaluation methods should be used for assessing safety and meeting essential requirements of AIaMD, and has also published the Software and AI as a medical device change programme to provide a regulatory framework with s a high degree of protection for patients and public.…

Continue Reading UK Policy Paper on regulation of AI

On 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), and following analysis of the nearly 900 responses received, its intentions for the future UK regulatory regime for medical devices (the UK Regulations).

In September 2021, we posted about the MHRA’s consultation, with a summary of the proposals set out across 15 technical chapters.  The consultation ran between September and November 2021, and focused on patient safety and innovation, whilst recognising that gaining and maintaining competitiveness in a global market will be best supported by aligning with internationally recognised best practice and standards.

We have considered the Response and set out some of the key factors we consider to be of particular interest below. We have not precisely follow the order in the Response and have not covered every aspect or changes; this is necessarily a high level summary.

While the approach the MHRA intends to take in the UK Regulations is clarified and set out in more detail in the Response, no draft statutory text has yet been published. A lot of detail will also be left to guidance that will accompany the UK Regulations. It will therefore be important to see how closely aligned the new UK framework is to the proposals described in the Response and with international rules and standards.…

Continue Reading MHRA response to consultation on the regulation of medical devices

In September 2021, we posted about the European Commission’s implementation of its new pharmaceutical strategy (which was also discussed in more detail in our posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response). Readers will be aware that the focus of the Strategy is on the availability, accessibility and affordability of medicinal products, based on the view that current incentive models do not provide an adequate solution for unmet medical needs or appropriately incentivise investment in innovation. As part of its work on the revision of the EU pharmaceutical legislation, the European Commission launched a public consultation to seek views on the current framework and on some of the proposals for changes in order to support the European Commission’s impact assessment for the revision of the legislation.

Following this consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published an article entitled “Back Innovation, Boost Access” with its response to the EU pharmaceutical strategy consultations and some of the concerns raised by the Commission. This expresses EFPIA’s position that innovation is only meaningful if patients have access to it, but highlights that access is not always in the control of the pharmaceutical companies. It also describes the current status of access to medicines in the EU Member States, some of the reasons for the delays to access and EFPIA’s proposals to improve patient access to innovative medicines.…

Continue Reading EFPIA’s Response to EU Pharmaceutical Strategy Consultations

Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provisions for certain products. The Commission noted that the COVID-19 pandemic has hampered the capacity of Member States, health institutions and companies to comply with the new requirements in time for the current deadline of May 2022, and that the “serious shortage of notified body capacity, mak[es] it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”. As such, the proposal provides industry and patients some much needed relief, and aims to avoid a large number of products that are already on the market being discontinued in May due to non-compliance.

While the proposal still needs to go through the EU legislative procedure, it seems likely that the amendment will be adopted before the current date of application of May 2022. It is also important to note that the delay does not apply uniformly to all IVDs, as set out below.…

Continue Reading European Commission proposal to delay application of In Vitro Diagnostics Regulation

On 28 September 2021, the European Commission took another step in the implementation of its  new pharmaceutical strategy (discussed in more detail in our previous blog posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response).

As part of its work on the revision of the EU pharmaceutical legislation, the Commission launched a dedicated public consultation. The purpose of this consultation is to gather views and information to support the Commission’s impact assessment for the revision of the EU pharmaceutical legislation. This is, therefore, a good opportunity for all stakeholders to share their views and concerns, as well as their vision for the future EU pharmaceutical legislation.

The consultation is open until 21 December 2021 and seeks the views of all stakeholders on key issues such as:…

Continue Reading European Commission launches consultation on reform of EU pharmaceutical legislation