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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...
Save Greater Manchester Green Belt Ltd v Secretary of State for Housing, Communities and Local Government and others [2025] EWHC 2742 (Admin) What are the practical implications of this case? For plan-makers, the court emphasises that identifying ‘exceptional circumstances’ to amend Green Belt boundaries is a wide policy notion entrusted to planning judgment; it is not limited to a ‘fundamental change’ or to smoothing out ‘boundary anomalies’. Inspectors and LPAs may lawfully set criteria to structure that judgment, but those criteria cannot be treated as inflexible legal preconditions: decision-makers must still balance all pertinent Green Belt considerations and set out why the evidence ‘fully evidences and justifies’ alteration. In practice, authorities promoting Green Belt extensions or releases may draw on a combination of site-specific factors—provided the examination record demonstrates the broader policy balance has been undertaken and not unduly narrowed. Objectors and developers should recognise that submissions focused solely on the absence of a ‘fundamental change’ are unlikely to prosper unless they engage with the wider policy matrix...
This Practice Note offers a primer on the reinsurance market—what it is, how it operates, and the core ideas that underpin it. What is reinsurance? Reinsurance is cover for insurers. It is an insurance contract bought by an insurer—often via a specialist reinsurance broker—to protect that insurer’s liabilities. In practice, the reinsurance agreement can sometimes be set up before the underlying insurance contract to which it relates. Reinsurance can address a wide range of risks—life, property, third-party liabilities and cyber—in much the same way as insurance. Purpose of reinsurance The reinsurance sector is a vital global business and the backbone of the insurance market. It serves several key purposes, including: enabling insurers to spread the financial risk assumed when writing policies, reducing volatility and smoothing loss experience, and protecting against major catastrophes and events (such as hurricanes, wildfires and earthquakes) reducing the regulatory capital that insurers are required to hold allowing an insurer to move into new lines of business with...
Income sources for a storage scheme hinge on the relevant electricity market, the technology deployed, the size of the project and whether it runs behind the meter to meet a specific site’s needs or is connected to the grid. Storage can generally extract value through some or all of the following: supplying grid services (frequency response, Capacity Market income, demand-side response) market price arbitrage smoothing generation output and avoiding imbalance charges in a hybrid model where an underlying (typically intermittent) electricity generation plant is co-located with a storage unit These income streams are explained in more detail below. All such revenue forms are described in further detail below. More detail is provided below. Investors usually want the flexibility to stack (i.e. combine) revenues, perhaps relying on different sources at different times of day or year, whilst debt financiers will look for a longer-term contracted base revenue stream to underpin repayment of debt and/or assess the management experience and creditworthiness of the corporate...