“A lot of the work that I do is historic-the maximum sentences change at different points of time. It's really complicated and people get it wrong all the time. That's when having a timeline is really useful.”
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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...
What is the impact of Brexit on the UK nuclear sector? As of 31 January 2020 (exit day), the UK ceased to be an EU Member State. From that date, a transition/implementation phase applied, during which the EU continued, for many purposes, to treat the UK as if it remained a Member State. Leaving the EU also entailed withdrawal from the Euratom Community. The transition ended at 11 pm (GMT) on 31 December 2020—known in UK law as ‘IP completion day’. At that point, key transitional measures expired and notable shifts started to apply across the UK’s legal framework. The UK’s exit from the EU likewise meant departure from Euratom. Any changes pertinent to this content are outlined below. Following IP completion day, the European Union (Withdrawal) Act 2018 (EU(W)A 2018) introduced a new category of domestic law—‘retained EU law’ (REUL)—comprising EU-derived rights and legislation preserved in the UK after Brexit. On 29 June 2023, the Retained EU Law (Revocation and Reform) Act 2023 (REUL(RR)A 2023) received Royal Assent...
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;...
Health and safety Please supply, where relevant, records covering: Health and safety policy; certifications (ISO 45001/45004, contractor accreditation); contents/index of the management system. Risk-based documentation: sample risk assessments (incl. explosion); COSHH inventory and assessments (SI 2002/2677); COMAH notifications, Major Accident Prevention Policy and, where relevant, Site Safety Report (SI 2015/483). Asbestos: surveys, register, management plans, clearance certificates, periodic checks, or basis confirming no asbestos. Fire safety: risk assessment and actions; inspection/maintenance of alarms, emergency lighting, extinguishers/sprinklers, smoke vents, dry/wet risers. Electrical and gas: most recent fixed‑wiring inspection and actions; latest gas plant service records. Water hygiene: legionella risk assessment/audit and management records (treatment, tank cleans, temperature checks); cooling tower/evaporative condenser notifications to the local authority. Lifting and machinery: inspection/test records, machinery safety assessments and example periodic/pre‑shift checks. Occupational exposure: noise surveys and airborne monitoring for any specified chemicals; ionising radiation records (personal dosimetry, authorised users, local rules, safety audit, risk assessment). Incidents and claims: accident/incident/near‑miss records for six...