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GLOSSARY
An application for life assurance can be made by a person who is not to be the life assured. In this case the application is referred to as one of life of another. The insurance company will need evidence that the applicant has an insurable interest in the life assured before accepting the application.
FLOWCHARTS
This Flowchart demonstrates how health and safety cases progress from investigation, to trial and to Fatal Accident Inquiries
NEWS
TMT analysis: The terms of service of Elon Musk’s Starlink, a satellite internet constellation currently being constructed by SpaceX, has recently sparked a debate over the nature and limitations of current space law and whether or not it would benefit from an update. Given that a clause in a Starlink service contract requires participants to acknowledge Mars as a ‘free planet’, and the recent successful landing of NASA’s Mars 2020 rover mission, we discuss with Professor Donald Rothwell of the Australian National University the possibility of an international legal framework for Mars.
GLOSSARY
This is a type of regulated investment as defined in the Regulated Activities Order 2001, art 3.
PRACTICE NOTES
This Practice Note is intended to be used to track the progress of EU cases relevant to the life sciences sector. For archived items on life sciences, see Practice Note: Life sciences tracker [Archived]. Judgments—Supplementary protection certificates For archived supplementary protection certificate (SPCs) judgments, see Practice Note: Life sciences tracker [Archived]—Judgments—Supplementary protection certificates. Court of Justice of the European Union What's happening? When? Find out more Halozyme, Inc. v Úřad průmyslového vlastnictví Case C-456/24 23 April 2026: Opinion of the Advocate General (AG).6 September 2024: Application (OJ).27 June 2024: Request for a preliminary reference. Reference for a preliminary ruling—SPC—Definition of ‘product’—Active ingredient—Excipient Background The Court of Justice of the European Union has been asked to clarify the interpretation of the definition of ‘product’ and in particular what constitutes an ‘active ingredient’ in the definition of a product as set out under Article 1(b) of the SPC Regulation. The issue arising in this case is whether a substance classified as an excipient in a MA can nonetheless be regarded as an ‘active ingredient’
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is no longer maintained. It tracked EU cases relevant to the life sciences sector between 2020–2022. To track the progress of EU cases relevant to the life sciences sector since 2023, including ongoing cases, see Practice Note: Life sciences cases tracker—EU. To track the progress of current EU legislative proposals, consultations and developments, relevant to the life sciences sector, see Practice Note: Life sciences tracker—EU. To track the progress of current UK legislative proposals, consultations and developments, as well as significant cases in the UK, which are relevant to the life sciences sector, see Practice Notes: Life sciences tracker—UK and Life sciences cases tracker—UK. Judgments—Supplementary protection certificates For archived supplementary protection certificate (SPCs) judgments, see Practice Note: Life sciences tracker [Archived]—Judgments—Supplementary protection certificates. Court of Justice of the European Union What's happening? When? Find out more Santen SAS v Directeur général de l’Institut national de la propriété industrielle Case C-673/18, ECLI:EU:C:2020:531 9 July 2020: Judgment delivered. SPCs The Court of Justice held that
PRACTICE NOTES
This Practice Note is intended to be used to track the progress of UK cases relevant to the life sciences sector. Jump to: • Judgments—Patents • Judgments—Supplementary protection certificates • Judgments—Medical devices and medicinal products • Judgments—Trade marks For archived items on life sciences, see Practice Note: Life sciences tracker [Archived] and for UK cases relevant to the life sciences sector between 2020 and 2022, see Practice Note: Life sciences cases tracker—UK 2020–2022 [Archived]. For a discussion on the extent to which UK courts and tribunals are bound by EU case law after the end of the transition period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? Judgments—Patents For archived patents judgments, see Practice Notes: Life sciences tracker [Archived]—Judgments—Patents and Life sciences cases tracker—UK 2020–2022 [Archived]. Supreme Court What's happening? When? Find out more UKSC 2021/0209Appeal from:FibroGen Inc v Akebia Therapeutics Inc; Astellas Pharma Inc v Akebia Therapeutics Inc [2021] EWCA Civ 1279 March 2024: Supreme Court hearing (scheduled)3 October 2022:
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is no longer maintained. It tracked UK cases relevant to the life sciences sector between 2020–2022. To track the progress of UK cases relevant to the life sciences sector since 2023, including ongoing cases, see Practice Note: Life sciences cases tracker—UK. To track the progress of current UK legislative proposals, consultations and developments, as well as significant cases in the UK, which are relevant to the life sciences sector, see Practice Note: Life sciences tracker—UK. To track the progress of current EU legislative proposals, consultations and developments, as well as significant cases in the EU, which are relevant to the life sciences sector, see Practice Notes: Life sciences cases tracker—EU and Life sciences tracker—EU. Judgments—Patents For archived patents judgments, see Practice Note: Life sciences tracker [Archived]—Judgments—Patents. Supreme Court What's happening? When? Find out more Secretary of State for Health and another (Appellants) v Servier Laboratories Ltd and others (Respondents) [2021] UKSC 24: UKSC 2019/0172 2 July 2021: Supreme Court judgment delivered14
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is not maintained. This Practice Note served as a reference guide to monitor relevant EU-UK divergence in the legislation and guidance of interest to the life sciences sector from the end of the Brexit implementation period (eg 31 December 2020) following the UK’s decision to withdraw from the EU through 2023. Where applicable, it also includes key points of divergence within the UK (between Great Britain (GB) and Northern Ireland (NI)). In this Practice Note, the term ‘divergence’ refers to differences in the legislation, guidance or required standards which arise following IP completion day (11 pm on 31 December 2020). A parallel but identical or substantially similar regime would not constitute ‘divergence’. See also related Practice Notes: • Post-Brexit transition period—the regulation of medicinal products • What does IP completion day mean for Life Sciences? [Archived] • Medicines and Medical Devices Act 2021 • What does IP completion day mean for medicinal products? [Archived] • What does IP completion day mean for clinical trials? [Archived] • What
PRACTICE NOTES
C–D | E–H | I–N | O–P | Q–V. Accelerated assessment Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products—EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) offers a 150-day assessment timeline for innovative medicines MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA aims to evaluate the application for a UK-wide MA and to reach its opinion on whether to approve the licensing of eligible innovative medicines within 150 days of submission of
PRACTICE NOTES
A–B | E–H | I–N | O–P | Q–V. CE marking The CE (Conformité Européene—meaning European Conformity) mark is a mandatory marking that certain products, including medical devices, must bear to indicate the device conforms with all relevant regulation of medical devices before it can be lawfully sold within the EEA. It: • shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements • is an indicator of a product’s compliance with EU legislation • allows the free movement of products within the EEA The equivalent of the CE mark within Great Britain (GB) following Brexit is the UKCA mark, which has been available for medical devices placed on the GB market since 1 January 2021, although the CE mark continues to be required under EU legislation in Northern Ireland. The CE mark will continue to be recognised for existing ‘legacy’ devices on the GB market for varying timelines beyond 30 June 2023, in accordance with transitional provisions, provided certain conditions are met. See related terms: conformity assessment, declaration of conformity, Notified
PRACTICE NOTES
A–B | C–D | I–N | O–P | Q–V. Early access to medicines scheme Under the early access to medicines scheme (EAMS), the Medicines and Healthcare products Regulatory Agency (MHRA) grants patients with life-threatening or seriously debilitating conditions access to medicines which do not yet have marketing authorisation (MA) (or are not licensed to treat that indication yet) but where there is a clear unmet medical need. For more information, see Practice Notes: UK marketing authorisations for medicinal products—Early access to medicines scheme (EAMS)—exemption and Unlicensed medicinal products and off-label use of medicinal products—Early access to medicines scheme (EAMS)—UK regime and MHRA guidance: Apply for the early access to medicines scheme (EAMS). EFPIA Code The EFPIA Code is a collection of industry, self-governance ethical rules of conduct that govern the promotion of prescription-only medicines (POMs) by all European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies when interacting with healthcare professionals (HCPs) healthcare organisations (HCOs), patients’ organisations (POs) and the general public. This includes pharmaceutical companies interactions in the context of research or contractual