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In this issue: Medical devices Commercialisation Pharmaceuticals—regulatory framework Research and development Advertising of medicines Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Digital Omnibus on AI Regulation—considerations for life sciences companies The European Commission has unveiled its Digital Omnibus on AI Regulation Proposal, a draft law with targeted measures aimed at smoothing the practical roll-out of the EU AI Act. Hélène Boland and Fabien Roy of Hogan Lovells set out key points for life sciences companies. See News Analysis: Digital Omnibus on AI Regulation—considerations for life sciences companies. EU countries question proposed approach for delaying AI Act’s key duties MLex reports that plans to postpone core EU AI Act obligations face scrutiny from Member States, who caution that the Commission’s method lacks clear benchmarks, predictability and adequate participation of national regulators. Even backers of a pause voiced reservations, and others queried what ensues if compliance tools...
In this issue: Air emissions and climate change Energy efficiency and buildings Energy for environmental lawyers Environmental enforcement and prosecutions Environmental taxes, reliefs and incentives ESG and sustainability Hazardous substances and chemicals Key developments and materials Marine Nature, biodiversity and habitat conservation Waste Water, flooding and drainage Daily and weekly news alerts New and updated content Trackers Useful information Air emissions and climate change Defra updates UK and England's carbon footprint publication with 2021 figures Defra — the Department for Environment, Food and Rural Affairs — has refreshed its England and UK carbon footprint release to incorporate 2021 data. The analysis indicates an estimated 15% uplift in the UK’s carbon footprint between 2020 and 2021, driven by higher emissions across all activity types, with the sharpest rise linked to imported goods. The term ‘carbon footprint’ captures emissions associated with consumption expenditure by UK/England residents on goods and...
ESG has emerged as a priority for companies worldwide. In many countries, ESG disclosure is already compulsory or under active review. The climate emergency, the pandemic, geopolitical turbulence and the energy shock have shown how deeply businesses influence societies and the natural environment. This Practice Note sets out ESG fundamentals. It outlines the concept and the hurdles for in-house counsel, alongside suggested focus areas to help you manage ESG matters within your organisation... What is ESG? At its simplest, ESG is a catch-all for environmental, social and governance considerations that shape: the obligations organisations must satisfy the way they should run the benchmarks by which they are assessed ESG factors ESG factors are applied to embed responsibility within business practice. ‘E’ is for environmental. The E in ESG examines the effects on, and from, the natural world and will consider an organisation’s carbon footprint, the pollution and waste it produces, and its implications for biodiversity. ‘S’ is for social...
This Practice Note reviews current and forthcoming rules shaping TMT and examines leading organisations influencing sector benchmarks. It identifies the organisations most influential on evolving industry norms and compliance expectations. It then considers technology’s environmental effects and sets out actions and openings the TMT industries will probably need to adopt to progress towards a sustainable future. The discussion frames both risks and opportunities for TMT as it charts a path towards sustainability. It outlines the part played by the telecoms and media sectors in assessing their environmental footprint and how they might promote sustainable practices. It also reflects on how these sectors can promote greener practices across operations. It concludes by signposting ways companies can tackle sustainability across internal policies and practices, supply chains and the use of technology. For sustainable business guidance, see: ESG and sustainability collection. Many TMT businesses are still expanding, driven by technological progress and wider access, the digital transformation of business, and the cross‑sector dominance of major tech firms. Although unchecked growth can endanger the...
First developed in collaboration with Dr Justin Macinante of Edinburgh Law School, The University of Edinburgh. Revised by Dalia Majumder‑Russell, Alex Ibrahim and Shinae Lee of CMS Cameron McKenna Nabarro Olswang LLP. Conceptual context Emissions trading prices negative externalities—assigning costs to impacts that would not otherwise appear in the price of an activity, for example the release of greenhouse gases (GHGs). Such trading schemes may take the following forms: Cap‑and‑trade—participants face a limit on their emissions and are either issued allowances or buy them to cover those emissions. If they exceed the cap, they must acquire additional allowances from entities with a surplus or pay a penalty at the end of the relevant compliance period. Accordingly, cap‑and‑trade arrangements are compliance schemes. Baseline‑and‑credit—participants implement projects that reduce emissions below a defined baseline through avoidance, reduction, or removal (i.e., drawing pollutants from the atmosphere), thereby generating credits. These credits can be sold to other entities wishing to offset their carbon footprint...