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In this issue: Commercialisation Pharmaceuticals—regulatory framework Medical devices Data protection Research and development LexTalk® Life Sciences: a Lexis®Nexis community Daily and weekly news alerts Useful information Commercialisation DHSC publishes response to NICE cost-effectiveness threshold consultation The DHSC has issued its reply to the consultation on proposed changes to the National Institute for Health and Care Excellence (NICE) rules on cost-effectiveness thresholds. Released alongside the National Institute for Health and Care Excellence (Amendment) Regulations 2026 and the accompanying explanatory memorandum, the amendments give ministers a narrow power of direction to set the standard cost-effectiveness threshold applied by NICE when preparing guidance, including technology appraisals and evaluations of highly specialised technologies. The revisions also remove the need for NICE to consult on procedural changes arising from ministerial directions. These measures will take effect on 24 March 2026. See: LNB News 04/03/2026 49. Pharmaceuticals—regulatory framework DHSC publishes fifth England Rare Diseases Action Plan 2026 The...
In this issue: EU fundamentals Commercial Competition and state aid Banking and finance Corporate Data protection and cybersecurity Financial services Energy Environment Insurance and reinsurance IP Life sciences Regulatory TMT International trade Daily and weekly news alerts New and updated content Trackers and horizon scanners EU fundamentals The Commission has launched a four-week call for evidence to shape technical guidance on applying the ‘do no significant harm’ principle within the 2028–34 multiannual financial framework. Required by Article 5 of the proposed Regulation establishing a budget expenditure tracking and performance framework, the guidance will be applied where feasible and appropriate. The evidence window closes on 1 April 2026, with adoption scheduled for Q4 2026. See: LNB News 04/03/2026 56. Commercial: The Council of the EU has agreed conclusions to steer delivery of the 2030 Consumer Agenda, urging enhanced consumer protection—particularly online—greater encouragement of sustainable consumption, stronger...
Extension of EPA Part IIA to radioactive contamination At first, land affected by radioactivity was excluded from the ambit of Part IIA of the Environmental Protection Act 1990 (EPA 1990). Section 78YC of EPA 1990 makes clear that the Pt IIA regime does not apply to harm, or water pollution, attributable to radioactivity. However, that section grants the Secretary of State authority to make regulations and guidance concerning radioactive substances. These powers have been used to create, in effect, a parallel Part IIA scheme for radioactive contaminated land: Radioactive Contaminated Land (Enabling Powers) (England) Regulations 2005, SI 2005/3467 Radioactive Contaminated Land (Modification of Enactments) (England) Regulations 2006, SI 2006/1379 Radioactive Contaminated Land (Modification of Enactments) (Wales) Regulations 2006, SI 2006/2988 The government has published legally binding statutory guidance explaining how local authorities and the Environment Agency should implement the radioactive contaminated land regime (the RCL Statutory Guidance) in England, with equivalent guidance issued for Wales. The RCL Statutory Guidance is distinct...
ARCHIVED This Practice Note is archived and no longer maintained. This Energy legislation tracker presents key forthcoming legislation of interest to Energy lawyers from 1 January 2017. The tracker is divided into the following jurisdictions: England and Wales European Union Entries appear in reverse chronological order. Items applying solely to Wales are flagged on the tracker. England and Wales Ionising Radiations Regulations 2017 (SI 2017/1075) Key date: 1 January 2018 Status: Comes into force; In force Topics: Nuclear licensing and regulation These Regulations establish a framework to ensure occupational exposure to ionising radiation is kept as low as reasonably practicable. They transpose the occupational elements of Directive 2013/59/Euratom, which sets basic safety standards for protection against the dangers arising from ionising radiations. The Ionising Radiations Regulations 1999 are revoked. See: the occupational elements of Directive 2013/59/Euratom are transposed;...
Nuclear energy in the EU As at September 2023, 12 of the 27 EU Member States (Belgium, Bulgaria, Czechia, Finland, France, Hungary, Netherlands, Romania, Slovakia, Slovenia, Spain and Sweden) operate nuclear power stations on their soil, while Germany shut its last reactors in April 2023. Nuclear power usage fell by 16.7% between 2021 and 2022, yet it still supplied over a fifth (21.8%) of the EU’s total electricity generation in 2022. Nuclear safety is treated as a priority at EU level, due to the potential for cross-border consequences should a nuclear accident occur. This Practice Note introduces the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), which provides the foundation for EU-wide nuclear rules and standards, and sets out principal EU legislation pertinent to the nuclear industry. It addresses rules on nuclear safeguards, installation safety and licensing, protection of human health and the environment from radiation, impact assessments for proposed nuclear installations, the management of radioactive waste, and the decommissioning of sites. Euratom Treaty The...