Business transactions

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The life sciences sector

The life sciences sector is made up of a broad set of industries, such as pharmaceuticals, medical technology (devices and diagnostics), biotechnology, plant protection and cosmetics. Within each of these industries are many subdivisions or specialisms. For example, within pharmaceuticals there are chemical compounds, active pharmaceutical ingredients, or chemical entities (which are more commonly known as small molecules). There are also biologically derived products used in pharmaceuticals, such as monoclonal antibodies and cell therapies. In addition, there are products at the borderline of pharmaceuticals, eg foodstuffs, which may be processed to have particular designed health benefits.

The highly regulated and highly technical nature of the life sciences industry can give rise to particular issues/challenges when advising on business transactions involving organisations operating in this space. Consequently, lawyers advising on such business transactions need to be alive to and understand the facets of the sector.

Mergers and acquisitions

In recent years, the life sciences sector has experienced significant merger and acquisition (M&A) activity. A number of factors have driven deal flow in the industry, including: progress in developing efficacious therapies, the need for mid-size and larger

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Latest Life Sciences News

EU outlines three-year implementation timeline for EU AI Act

The European Union's Artificial Intelligence (AI) Act, published in July 2024, will take at least three years to fully implement. The Act establishes a regulatory framework that categorises AI systems according to their risk levels and general-purpose AI (GPAI) models based on their capabilities. Additional regulatory instruments, including guidelines, standards and codes, are expected to complement the Act's implementation. The full regulatory framework is anticipated to be operational by mid-2027.

European Commission pushes on with AI models Code of Practice despite possible law delay

MLex: The European Commission is pressing ahead with finalising a Code of Practice for general-purpose AI (GPAI) model developers, intended as a key compliance tool for the likes of OpenAI, Anthropic and Microsoft, for application in August 2025, even though discussions on pausing the EU AI Act that underpins it are now formally on the table. The Code, GPAI guidelines, the template to disclose training datasets and related guidelines are expected by the first week of July 2025. Leading AI companies are being engaged to secure their support for the Code, though they are still in the dark on the critical copyright-related parts.

Directorate-General for Health and Food Safety launches pilot to streamline approvals

The Directorate-General for Health and Food Safety, together with the European Medicines Agency and participating Member States, has launched a pilot coordinated assessment procedure for multinational combined studies under the COMBINE programme. Initiated on 13 June 2025 as part of Project 1, the pilot allows sponsors to submit a single application for the simultaneous assessment of clinical trials involving medicinal products and performance studies of in vitro diagnostic medical devices. This ‘all-in-one’ process seeks to reduce administrative burdens, shorten authorisation timelines, and expedite patient access to innovative treatments. The pilot follows the May 2024 publication of the COMBINE analysis report, which identified regulatory challenges and proposed solutions. Expressions of interest for participation in the pilot must be submitted by 31 August 2025, with selection confirmations due by 31 October 2025.

UK government increases payment rate for branded medicines under the statutory scheme

The Department of Health and Social Care has confirmed that, following consultation, the statutory payment rate pharmaceutical companies must pay on NHS sales of newer branded medicines will rise from 15.5% to 31.3% from 1 July 2025. The adjustment raises the statutory scheme’s average annual payment rate to 23.4% in 2025, with headline rates of 24.3% and 26.0% set for 2026 and 2027 respectively. This move positions the UK’s repayment rates well above those in comparable markets, with Germany and France requiring repayments of 7% and 5.7% respectively.

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