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GLOSSARY
Rule that allows an employer to recover from a scheme money due from an employee as a result of the employee’s criminal, fraudulent or negligent act or omission. These rules are restricted by the Pensions Act 1995, ss 91-94
GLOSSARY
For a life policy effected after 19 March 1968, but before 13 March 1984, provided the policy was a qualifying policy, its premiums were eligible for income tax relief.
NEWS
Law360: General counsel at life sciences venture capital firms say they're navigating increased regulation in healthcare and are now looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.
NEWS
The Subsidy Advice Unit (SAU) of the Competition and Markets Authority (CMA) has agreed to provide a report advising the Office for Life Sciences (OLS) concerning its proposed Life Sciences Innovative Manufacturing Fund 2025–2030 (LSIMF)’s scheme and whether it complies with the subsidy control requirements as a Subsidy Scheme of Particular Interest. LSIMF policy objective is to expand the UK’s life sciences manufacturing capabilities, by incentivising private investment through capital grants to businesses. The fund will be a grant competition targeted at projects that will manufacture human medicines, medical diagnostics, and MedTech products. The programme has a budget of £520m to be delivered between 2025–2030. It builds on previous capital grant competitions for the life sciences sector. The SAU report should be completed within 30 days.
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is not maintained. 11 pm (GMT) on 31 December 2020 marked the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. From this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements come to an end and significant changes begin to take effect across the UK’s legal regime. Below is a maintained list and summary of all News Analysis pieces published that provide insights into the impact of the UK’s withdrawal from the EU on the life sciences field. For more general information, see Practice Note: What does IP completion day mean for Life Sciences? [Archived]. Date News Analysis Brief description of News Analysis 22 September 2022 Brexit Bulletin—Retained EU Law (Revocation and Reform) Bill introduced, LNB News 22/09/2022 78 On 22 September 2022, the government introduced the Retained EU Law (Revocation and Reform) Bill 2022 to Parliament. Previously referred to as the ‘Brexit Freedoms Bill’, the legislation is intended to
NEWS
Life Sciences analysis: This News Analysis provides a round-up of key developments in the field of Life Sciences in UK in 2025 and looks ahead to what’s coming up in 2026. This edition focuses on clinical trials, medical devices, the pharmaceutical regulatory framework, AI and digital health, pricing and reimbursement, key life sciences litigation in IP issues and competition law, and data protection and life sciences, among other developments.
PRACTICE NOTES
This year’s annual round-up reviews some of the most significant developments of 2017 and previews what is on the horizon for 2018. This includes the decision on the relocation of the European Medicines Agency; the delay in the implementation of the new Clinical Trials Regulation; preparations for the new Medical Devices Regulations; the Life Sciences Sector Deal; as well as the forthcoming application of the General Data Protection Regulation and introduction of the Accelerated Access Pathway. Also included are updates on Lexis®+ UK’s content, including news of exciting developments from the past year and what is coming up in the next 12 months. Reviewing 2017 Brexit What happened? On 20 November 2017 Amsterdam was chosen as the new home of the European Medicines Agency (EMA) following Brexit. What are the practical implications? There are several practical implications of the relocation of the European medicines regulator from London to Amsterdam. Firstly, EMA’s operations will be affected as the EMA looks to free up staff to focus on preparing for the relocation
NEWS
This week's edition of Life Sciences weekly highlights includes news that the national EU Competent Authorities published a consensus statement on the state-of-play of transitioning to the medical devices regulatory framework (MDR and IVDR) and called for further urgent reform, the CMA launched a call for input on its proposal to review the purpose of the Assimilated Technology Transfer Block Exemption Regulation, Assimilated Regulation (EU) 316/2014 (Assimilated TTBER) and it published its decision to clear the acquisition by Thermo Fisher Scientific of Olink, the EMA released a draft addendum to a guideline on vaccine development for the inclusion of immunocompromised people in clinical trials and the ASA found several ads making unauthorised medicinal claims in relation to prostrate matters, among other news.
NEWS
This week's edition of Life Sciences weekly highlights features news analysis by Addington Chambers of a breach of research contract case (Innovate Pharmaceuticals v University of Portsmouth). Also included is news that the MHRA seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30m in 2023, the Competition and Markets Authority launched an investigation under Chapter II of the Competition Act 1998 to consider whether Vifor Pharma engaged in anti-competitive conduct in the supply of intravenous iron deficiency treatments, the European Commission released its report to the European Parliament and the Council of the EU on the final evaluation of Horizon 2020, the Health Research Authority released its key focus for 2024 to boost transparency in research and clinical trials, the EMA announced that all ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System by 31 January 2025, the Medical Device Coordination Group released three Device Specific Vigilance Guidance documents regarding the vigilance system for CE-marked devices and that the UK government will ban disposable vapes to tackle the rise in youth vaping and to protect children’s health and will bring forward legislation to ban proxy sales in line with the change in age of sale legislation, alongside other actions, among other news.
NEWS
This week's edition of Life Sciences weekly highlights includes two news analyses on the EU AI Act, its key developments and strategic implications for business as well as the challenges of the EU AI Act-GDPR interplay, and news that the European Commission opened a targeted consultation on guidelines to clarify rules for general-purpose artificial intelligence (GPAI) models under the EU AI Act, the Association of British HealthTech Industries (ABHI) published guidance to help UK policymakers considering international regulatory reform and recognition understand the US Food and Drug Administration (FDA) 510(k) process of pre-market submission for devices deemed substantially equivalent to those already legally marketed, the EFPIA released a research on assessment of the impact of the transferable exclusivity voucher (TEV) system proposed as part of the pharmaceutical legislation reform package, both the EFPIA and MedTech Europe have submitted responses to the Commission’s call for evidence on the EU Life Sciences Strategy. Also included is news that the MHRA issued new guidance on risk minimisation measures to reduce or prevent the risk of an adverse event, the HRA published updated model agreements for research as well as a report on clinical trial registration and a blog on the impact of its 2022–25 strategy, and the EMA and ICH released two new Step 2b guidelines on drug development, among other stories.
NEWS
This week's edition of Life Sciences weekly highlights includes a key Patents Court judgment in Aristo Pharma GmbH v Takeda Pharmaceuticals USA upholding the validity of Takeda’s supplementary protection certificate (SPC) and addressing the meaning of ‘active ingredient’ for lisdexamfetamine (LDX), while considering the Advocate General’s opinion in the pending Halozyme reference before the Court of Justice (Case C-456/24). Further developments include the Council of the EU’s adoption of the pharmaceutical reform package, ahead of the formal adoption by the European Parliament and publication in the Official Journal, and the sentencing of Kenneth Harrison following fraud convictions concerning medical devices supplied to UK hospitals with invalid CE marking.
NEWS
This week's edition of Life Sciences weekly highlights includes news analysis on the applicability of the EU’s AI rulebook, and news that the European Commission launched the AI Continent Action Plan, the MHRA announces closure of the UK Innovative Devices Access Pathway (IDAP) pilot phase and published guidance on exceptional use authorisation for non-UKCA/CE certified medical devices, the EMA reported on the Clinical Trials Information System (CTIS) being designated as a primary registry within the WHO’s Clinical Trials Registry Platform. Also included, is news that the EMA published roadmap and reflection paper on real-world evidence guidance and launched two consultations on ICH Guideline M13B and on reduced data requirements for biosimilars, the MHRA published new guidance on national medicine marketing authorisation process, the EFPIA and Medicines for Europe met with European Commission President to warn of US exodus risk and tariff impact, the HRA has detailed its regulatory oversight role for the new £600m Health Data Research Service announced by the government, among other stories.