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In this issue Pharmaceutical regulation Advanced therapeutics Medical devices Data protection and life sciences Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Life Sciences Highlights 2025/2026 Pharmaceutical regulation Council and Parliament reach political agreement on pharmaceutical legislation reform package The Council of the EU and the European Parliament have struck a provisional political deal on the EU’s extensive overhaul of medicines legislation, the ‘pharma reform package’. It prioritises patient access, regulatory streamlining, industry competitiveness and secure medicinal supplies, while adding incentives to tackle antimicrobial resistance. The accord preserves the familiar baseline exclusivity of nine years: eight years of regulatory data protection followed by one year of market protection. A new Article 56a would permit Member States to require companies to keep adequate stocks to satisfy national demand, signalling the EU’s sharpened focus on uninterrupted supply. The measures also recalibrate the environment for generics and biosimilars, broadening...
In this issue: Pension Protection Fund (PPF) Investment Retirement options Daily and weekly news alerts Dates for your diary Trackers Pension Protection Fund (PPF) PPF publishes consultation on the 2025/26 levy In a consultation document dated 12 September 2024, the PPF sets out: a levy forecast for 2025/26 of £100m (unchanged from 2024/25, the lowest to date and aligned with last year’s consulted approach) methodology adjustments to continue spreading the levy’s cost across a broad pool of risk-based payers, rather than allowing the burden to become concentrated on a smaller cohort. Specifically, the PPF would (i) cut the levy scaling factor so it does not collect more than the planned £100 million, (ii) raise the scheme-based levy multiplier to maximise utilisation of the scheme-based levy, and (iii) increase the asset and liability stresses applied to two standard deviations simpler processes for schemes to obtain levy credit for deficit reduction contributions (DRCs) ...
R (on the application of Mott) v Environment Agency [2018] UKSC 10, [2018] All ER (D) 77 (Feb) What are the practical implications of the decision? This case illustrates how the courts address the concept of a ‘fair balance’ in a human rights setting. Striking that balance requires weighing the general interests of the community against the protection of an individual’s fundamental rights; the balance is not achieved where the person affected is made to carry an individual and excessive burden. What was the background to the appeal? The respondent held a leasehold interest in a salmon fishery in the Severn Estuary, which he had run as his full-time occupation for almost four decades. After the Salmon Freshwater Fisheries Act 1975 was amended with effect from 2011, the appellant was able to issue fishing licences with conditions that capped the number of fish taken. To protect salmon stocks in the area, the appellant set conditions on the respondent’s licence, restricting his catch to 30 fish in...
Cases tracker This tracker showcases notable rulings and opinions from the General Court of the EU and the Court of Justice of the EU issued since 1 January 2023, of particular relevance to energy lawyers... The tracker is divided into: the General Court of the European Union the Court of Justice of the European Union General Court of the European Union What’s happening? When? Find out more Aquind and Others v ACER Case: T-492/21 Judgment: 15 February 2023 Energy – scope of ACER’s competence – the United Kingdom’s withdrawal from the European Union – error of law – Article 2(1) of Regulation (EU) 2019/943 – Article 92 of the Withdrawal Agreement – ad hoc exemption scheme under Article 308 of, and Annex 28 to, the Trade and Cooperation Agreement The applicants, Aquind Ltd, Aquind Energy Sàrl and Aquind SAS, sought annulment of the decision of ACER’s Board of Appeal dated 4 June 2021 concerning a...
FORTHCOMING CHANGE : In the Autumn Budget 2024 on 30 October 2024, the government revealed plans to include unspent pension pots and pension death benefits within an individual’s estate for IHT from 6 April 2027. This measure will cover both defined contribution and defined benefit arrangements, and will extend to UK-registered schemes as well as qualifying non-UK pension schemes. These rules apply across the entire pensions landscape. A technical consultation on how to deliver these reforms ran between 30 October 2024 and 22 January 2025. The reforms are legislated by the Finance Act 2026 and alter how personal representatives must declare the value of pension death benefits from 6 April 2027. For further details, see: Autumn Budget 2024—Private Client analysis — Inheritance tax. Effect of the grant A grant of probate, or a grant of letters of administration (sometimes with Will annexed), are the most frequently used forms of grant of representation in a deceased person’s estate. A grant of representation is a court order. Its function...
This Practice Note provides step-by-step guidance for personal representatives (PRs) on completing Form IHT35 when claiming relief on estate shares or securities sold at a loss against their value at the date of death, where that value was included in the IHT400 and inheritance tax has been paid. It should be read alongside: Claim for relief loss on sale of Shares Listed stocks and shares IHT411 The Note assumes an understanding of the background and the mechanics of submitting an IHT400 account, together with the ability of PRs to claim loss relief on a sale of shares. It is intended to assist with preparing the following document: Claim for relief loss on sale of Shares This form is also available through Lexis®Smart (subscription sensitive): Claim for relief loss on sale of Shares. The basic conditions for claiming relief under section 179 of the Inheritance Tax Act 1984 are: Preparing to complete Form IHT35...