On 11 March, the European Commission adopted the proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use: Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024. The amendments will apply from 1 January 2025.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.

Continue Reading European Commission proposal to amend the Variation Regulation for Medicines

This digest covers key virtual and digital health regulatory and public policy developments during February 2024.

Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating AI, while leaving regulatory authorities, like the Medicines and Healthcare products Regulatory Agency (MHRA), discretion over how the principles apply in their respective sectors. A central governmental function will coordinate regulation across sectors and encourage collaboration. The government’s aim with this approach is to enable the UK to remain flexible to address the changing AI landscape, while being robust enough to address key concerns. This is in sharp contrast to the position in the EU, where the EU AI Act is reaching the conclusion of the legislative process.

Continue Reading Virtual and Digital Health Digest, March 2024

On 15 March 2024, the European Parliament and the Council of the European Union (EU legislators) reached a provisional agreement on the text of the Regulation creating a European Health Data Space (EHDS).

Please note that the text of the agreement has not yet been officially published. This blog is solely based on the press releases that have been published by each of the institutions on their websites (available here, here and here) and has been updated considering some additional indications as to the content of the agreed text.

Continue Reading EU legislators reach provisional agreement on the European Health Data Space

A version of this article was first published in Life Sciences IP Review

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 that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government recently published its response to its consultation on regulating AI in the UK.  This maintains the government’s “pro-innovation” framework of principles, to be set out in guidance rather than legislation, which will then be implemented by regulatory authorities in their respective sectors, such as by the MHRA for medicines.  The MHRA has already started this process and signalled itself as an early-adopter of the UK government’s approach. The hope is that this will lead to investment in the UK by life science companies as the UK is seen as a first-launch country for innovative technologies.

Continue Reading The UK’s pro-innovation approach to AI: What does this mean for life science companies?

On 1 February 2024, the Danish Data Protection Agency announced that it reported the private hospital HP Gildhøj Privathospital ApS’s (Capio A/S) to the Danish police and recommended imposing a fine of not less than DKK 1,500,000 (over 200.000 euros). In their investigation, the Danish Data Protection Agency found that the hospital had failed to effectively supervise the data processors they used for the processing of large amounts of patients’ sensitive  personal data.

Continue Reading Proposed fine against Danish hospital for failure to supervise data processors

On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices — Quality Management System Requirements for Regulatory Purposes. The ISO standard is the version used in much of the world and provides a good framework for meeting the requirements in the EU Medical Devices Regulation (MDR).

The FDA’s decision to align the US QMS requirements to international standards is one of many efforts undertaken by the Agency to promote global regulatory harmonization. Ex-US device and tech developers will hopefully receive some of the efficiency and alignment they were hoping for when it comes to quality system compliance requirements in the US.

You can read more in our advisory.

On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
  • include a notification obligation in case of interruption of supply

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.

Continue Reading Commission proposes extension to IVDR transition periods and accelerated launch of Eudamed

The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the UK, leading to prompt changes in patent examination practices by the UKIPO. The Thaler decision was unsurprising and consistent with decisions in other jurisdictions. Consequently, this article focuses on the second of these judgments, especially as Emotional Perception could have ramifications for life sciences companies utilising artificial neural networks (ANN); inventions using ANNs will no longer be excluded from patentability on the basis that it engages the computer program exclusion to patentability in the UK.

Continue Reading Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs