Arnold & Porter Kaye Scholer LLP (LexBlog United Kingdom)

78 results for Arnold & Porter Kaye Scholer LLP (LexBlog United Kingdom)

  • Virtual and Digital Health Digest, March 2024

    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...

  • Virtual and Digital Health Digest: February

    This digest covers key virtual and digital health regulatory and public policy developments during January 2024. Regulatory Updates Publication of a Roadmap for the Future Regulation of Medical Devices in the UK. On January 9, the Medicines and Healthcare products Regulatory Agency (MHRA) published its roadmap for the future regulation of medical devices, which includes the...

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

    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...

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

    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...

  • Virtual and Digital Health Digest and webinar

    Spurred, in part, by the COVID-19 pandemic and the need for new ways to reach patients at home, 2023 saw a boom in digital technologies and healthcare solutions: one-stop-shop telemedicine platforms, app-based remote patient monitoring, direct-to-consumer online pharmacies, software-based medical devices, and artificial intelligence/machine learning to bolster delivery of telehealth services....

  • UK clinical trials – new notification scheme for lowest-risk clinical trials

    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...

  • New UK International Recognition Framework for Medicines

    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...

  • UK Government launches Innovative Devices Access Pathway (IDAP)

    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...

  • Legislative change is afoot for clinical trials conducted in the UK

    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...

  • New UK International Recognition Routes for Medicines

    On 26 May 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced plans to introduce new international recognition routes for medicines, whereby the MHRA can recognise decisions to authorise medicinal products taken in other countries so the MHRA can fast track approval in the UK. Further, on 4 July 2023, the MHRA published...

  • UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

    Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK. Stakeholders will no doubt be pleased to hear of...

  • MHRA consultation on medicines manufactured at the point of care

    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...

  • UK PMCPA publishes long-awaited guidance on use of social media

    On 26 January 2023, the Prescription Medicines Code of Practice Authority (the PMCPA) published long-awaited Guidance on Social Media 2023 (the Guidance). While a Digital Guidance note, which covered certain issues arising from use of social media, was published by PMCPA in 2016, the large number of complaints since that time is evidence of continued...

  • The Retained EU Law (Revocation and Reform) Bill 2022 – key facts and issues

    Synopsis On 22 September 2022, the UK government introduced the Retained EU Law (Revocation and Reform) Bill 2022 (the ‘Bill’) to Parliament. The Bill provides a mechanism to remove EU law currently on the national statute book and transition towards only domestically enacted legislation. A revised Bill was published on 29 November 2022 following its...

  • Adoption of New Procurement Regulations in the UK

    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...

  • Latest on software and AI devices from the MHRA

    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...

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

    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,...

  • Concern over high Scheme Payments under the UK VPAS

    The VPAS Payment Percentage for 2023, including the adjustments for accumulated Under Payments, is expected to be in excess of 26%.  As such, a number of VPAS Members have indicated that they are considering moving from VPAS to the Statutory Scheme. We explore how the situation arose and the implications below. Background: What is VPAS?...

  • UK Policy Paper on regulation of AI

    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...

  • MHRA response to consultation on the regulation of medical devices

    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 UK National Security and Investment Act 2021 (NSIA) – Implications for Life Sciences

    On 4 January 2022, after approximately four years from the UK government’s first attempt to reform the UK national security screening regime, the National Security and Investment Act 2021 (NSIA) became operational. The NSIA represents a radical overhaul to investment screening in the UK as it introduces for the first time a mandatory and suspensory...

  • The EU IVDR is here!

    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,...

  • Use of Real-World Evidence in the UK

    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...

  • Ten International Guiding Principles on Good Machine Learning in Medical Devices

    The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP).  The purpose of these principles is to “help promote safe, effective, and high quality medical...

  • Consultation on framework for medical devices in UK

    On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support...

  • AI and IP: Implications for digital health from possible reforms to UK IP law

    The use of artificial intelligence (AI) and machine learning is growing at a significant pace and  spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind”...

  • New 2021 Code of Practice for the British Pharmaceutical Industry

    The UK’s Association of the British Pharmaceutical Industry (ABPI) has, together with the Prescription Medicines Code of Practice Authority (PMCPA), published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code).  Publication of the 2021 Code follows a consultation conducted in 2020, with subsequent revisions prior to approval on 12 January 2021. The...

  • The EU-UK Agreement and the implications for life sciences companies

    On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences...

  • End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU

    As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer...

  • UK MHRA consultation on real-world evidence

    The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that is used to support regulatory decisions. It is intended to be the first in a series of guidance documents addressing RWE. The guidance is part of the MHRA’s push to reinforce the view of the MHRA as a pro-innovative...

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