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PRACTICE NOTES
Introduction The impact of climate change is introducing a new dimension of risk for property owners, occupiers, lenders and lawyers.  On 12 May 2025, the Law Society of England and Wales issued a Practice Note on Climate Change and Property (PN25), which considers how to address climate change risks in property transactions, whether they involve residential, commercial, or mixed-use properties, together with a Supplementary Technical Note on Physical Climate Risk. Climate risk is not just a concern for landowners and society at large. It has legal implications too, as the growing body of climate-related litigation demonstrates.  PN25 is the Law Society’s view of good practice and does not constitute legal advice. PN25 concludes that some topics, for example the physical impact of climate change, go beyond legal matters and that solicitors are not competent to advise on such topics. However, solicitors, subject to client instructions, should advise on the legal implications of any potential liabilities stemming from physical or transition risks specifically
NEWS
Law360: A quarter of pension scheme trustees want a new interpretation of their fiduciary duties to allow them to consider climate risk because doing so will help tackle the dangers posed by a changing environment, Lane Clark & Peacock LLP (LCP) said on 5 June 2024.
NEWS
The International Association of Insurance Supervisors (IAIS) is conducting a fourth public consultation on climate risk in the insurance sector, including proposed new supporting material to better reflect climate-related risk as part of effective supervisory practice. It covers issues related to supervisory reporting and public disclosure, as well as macroprudential considerations and supervisory co-operation. Responses are sought by 28 October 2024.
PRACTICE NOTES
ARCHIVED: This Practice Note has been archived and is no longer maintained. This Practice Note provides an introduction to the Bank of England (BoE)’s Climate Biennial Exploratory Scenario (CBES) exercise, launched in June 2021, examining the CBES’s structure, purpose, the scenarios covered and the areas of focus. It also considers the Prudential Regulation Authority (PRA)’s Climate Change Adaptation Report 2021, published in October 2021, BOE’s report on climate-related risks and the regulatory capital frameworks, published in March 2023. Background and introduction The BoE has noted that the financial risks posed by climate change are unprecedented, so building a toolkit to help manage and mitigate them is equally unprecedented. Climate scenario analysis and stress testing is a key part of such a toolkit, allowing for the exploration of impacts and exposures at the level of the financial system under a range of different potential climate pathways. For these reasons, the BoE decided to use its stress testing framework to assess the impact of climate-related risks on the UK financial
NEWS
The UK Parliament has progressed the Clinical Negligence Bill, a Private Members’ Bill introduced under the Ten-Minute Rule by Catherine McKinnell MP, to its second reading in the House of Commons. The Bill proposes the introduction of a fixed recoverable costs scheme for certain clinical negligence cases, requires regular review of cost limits, amends the Law Reform (Personal Injuries) Act 1948 (LR(PI)A 1948) and mandates a report on options for reform of clinical negligence compensation in obstetric cases and for connected purposes.
PRACTICE NOTES
Overview On 27 August 2024, a Clinical Negligence Claims Agreement (the Agreement) was signed by NHS Resolution, the Society of Clinical Injury Lawyers (SCIL) and the patient safety charity Action against Medical Accidents (AvMA). The Agreement came into effect on the day it was signed. It replaced the earlier Covid-19 Clinical Negligence Protocol 2020 (the Protocol), which enabled claims to be progressed efficiently during the coronavirus pandemic. The Agreement relates to civil claims under English domestic law (including claims under the Human Rights Act 1998) and to claims under the European Convention on Human Rights. It builds on the success of the earlier Protocol in improving working practices in clinical negligence litigation and intends to continue to encourage positive behaviours from claimant and defendant lawyers and to promote a consistent approach in practice across England. Key aspects of the Agreement include a change to the process that was in place under the earlier Protocol for suspension of limitation periods. It also outlines ways in which parties to clinical negligence litigation should work cooperatively,
PRACTICE NOTES
Introduction GPs who work within the NHS generally practice in partnerships or within NHS out-of-hours or walk-in centres. Private GPs may be self-employed or employed by larger organisations such as health insurance companies. Up until 1 April 2019 GPs needed to arrange their own professional indemnity insurance. The cover was historically provided by one of the three main Medical Defence Organisations (MDOs): the Medical Defence Union (MDU), the Medical Protection Society (MPS) and the Medical and Dental Defence Union of Scotland (MDDUS), all of which ensured that the legal requirement was met. However in 2019 and 2020 two new government schemes were introduced for the provision of state-backed indemnity for GPs and practice staff which removed the need for them to arrange and fund their own cover in respect of liability for clinical negligence in connection with the provision of NHS services. The National Health Service (Clinical Negligence Scheme for General Practice) Regulations 2019 (the 2019 Regulations), SI 2019/334 (CNSGP), effective from 1 April 2019, covers GP practice clinical negligence liabilities occurring
PRECEDENTS
This Agreement is made on [date] Parties 1 [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] and whose registered office at [insert address] (The Sponsor); and 2 [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] whose registered office is at [insert address] (The CRO) (each of the Sponsor and the CRO being a party and together the Sponsor and the CRO are the parties). Background (A) The Sponsor is sponsoring a series of clinical trials in support of marketing authorisation for the IMP and wishes to engage the CRO for certain services. (B) The CRO is knowledgeable and experienced in the design, management and conduct of clinical trials and wishes to provide such services to the Sponsor subject to the terms and conditions set out in this Agreement. The parties agree 1 Definitions and interpretation 1.1 Definitions In this Agreement: Applicable Laws • means: (a) any law, statute, regulation, by-law or subordinate legislation in force from time to time, and all subsequent amendments thereto, applicable to a party or the Study in any jurisdiction in which the parties
NEWS
The European Commission has further revised (version 6.9) its Q&A guidance document for compliance with Regulation (EU) 536/2014 (the Clinical Trials Regulation (CTR)). Key updates include several revisions in line with the revised CTIS transparency rules, new question 6.6 on intermediate data analysis, Summary of Product Characteristics are no longer required for authorised auxiliary medicinal products (Annex V), and revisions on the process for substantial modifications to a trial, such as changing the principal investigator or extending the validity of a decision.
NEWS
Private Client analysis: The case involved an application by the family of an incapacitated patient regarding the lawfulness of his clinicians’ decision to discontinue life-sustaining treatment. At first instance, the Court of Protection refused the family permission to bring proceedings on the basis that where a ’clinical decision’ has been taken not to offer a particular form of treatment, there was effectively no option for the Court of Protection to consider. The Court of Appeal overturned that decision, holding that any decision about the care and treatment of a mentally incapacitated adult, including the withdrawal of life-sustaining treatment, is subject to the best interests framework; there is no carve out for ’clinical decisions’. The decision has important implications for NHS bodies and their legal advisers who will need to consider whether to bring cases before the Court of Protection for determination where there is disagreement between the treating clinicians and family members, even if there appears to be only one course of action that is clinically appropriate. Written by David Rees KC, barrister, 5 Stone Buildings, Lincoln’s Inn.
PRACTICE NOTES
This Practice Note describes key changes to the requisite clinical evaluation and performance evaluation processes of medical devices under the EU regulatory regime introduced by Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), collectively referred to as the MD Regulations. The MD Regulations introduce a major transformation in the assessment of the health and safety of medical devices through a formalised and heavily evidenced clinical/performance evaluation process that begins with the conformity procedure (CE marking) and continues throughout the entire lifecycle of a device. This Practice Note considers the practical implications of the changes to the definitions and requirements for clinical data, clinical evidence and, in particular, clinical investigations. For further information on: • an introduction to the MD Regulations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation • scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical
PRACTICE NOTES
This Practice Note provides an overview of clinical negligence claims relating to treatment within a general practice setting. It explains the role of the GP and the primary care services provided by the practice. The Practice Note also looks at common types of claim, the complexities of claims relating to GP practice and what to look out for. Introduction to general practice A General Practitioner or GP is a doctor working in a primary care setting within the National Health Service (NHS) by promoting health, preventing disease, providing cure, care or palliation, and promoting patient empowerment and self-management. GP practices tend to be organised by way of geography or population area. This is achieved either by direct contact with their patients or by referring them on to other services where required. As such they are the first point of contact for almost all people with a new health concern and for many act as the gate keeper to other medical specialists. The breadth of knowledge required to perform this role means