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

Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers September and October highlights across the virtual and digital health space. This newsletter focuses on key virtual and digital health and telehealth-related developments in the United States, United Kingdom, and European Union in the healthcare, regulatory, privacy, and corporate transactions space.

Continue Reading Virtual and Digital Health Digest

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

The international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.

In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.

The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.

Continue Reading ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry

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

As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.

Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland.

Continue Reading The EU IVDR is here!

In December 2020, we posted about the MHRA’s draft guidance on randomised controlled trials generating real-world evidence (RWE) to support regulatory decisions. As we noted in our previous blog, although real-world data (RWD) are widely used to monitor the performance of medicines and devices in patients after regulatory approval, RWD have been utilised much less frequently to demonstrate the safety and efficacy of a product at the stage of initial authorisation. The MHRA aims to provide sponsors with points to consider when planning to conduct clinical trials using RWD sources, and to provide information on the design of studies seeking to generate evidence suitable for supporting regulatory decisions. It is hoped that a greater use of RWD, and more uniform collection and use, will accelerate the availability of cost-effective treatments and reduce the time and cost currently required to generate relevant data.

Following a public consultation on the draft guidance, the MHRA issued its guidance at the end of last year in the form of two papers:

  1. An introduction to the RWD guideline series; and
  2. The first guideline in the series, on planning a prospective randomised controlled trial using RWD sources with the intention of using the trial data to support regulatory decisions.

The intention is for the MHRA to publish further guidelines in the series in due course.

Continue Reading Use of Real-World Evidence in the UK

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