Coronavirus (COVID-19)

This subtopic brings together news and other resources regarding the implications of the coronavirus (COVID-19) pandemic for the UK and European life sciences industry.

Regulatory implications for the UK and European life sciences industry

Coronavirus (COVID-19) presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators have provided guidance in response to the crisis, as well as to support research and development (R&D) designed to contain the impact of the pandemic.

For a discussion of the key regulatory implications

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Latest Life Sciences News

MHRA launches major clinical trials overhaul, real-world data consultation and Inclusion and Diversity Plan pilot

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the most significant update to the UK’s clinical trials regulatory framework in over two decades, aligning with International Clinical Trials Day. The reforms aim to create a more efficient, inclusive, and adaptable environment for clinical research in the UK, placing participants at the centre of the process and expediting the approval and delivery of innovative treatments to patients and the NHS. These changes are part of a broader strategy to secure the UK’s global leadership in life sciences and clinical research.

NICE updates health technology evaluation manual with new inequality assessment methods

The National Institute for Health and Care Excellence (NICE) has published a modular update to its health technology evaluations manual, introducing new methodological requirements for assessing health inequalities. The update implements 'distributional cost-effectiveness analysis' approaches and provides updated guidance for pharmaceutical companies and assessment groups on producing evidence of health inequality impacts. The changes aim to enable NICE committees to evaluate health inequalities more systematically when making NHS technology recommendations. This represents the first implementation under NICE's 2024 modular updates framework.

EFPIA warns against proposed EU medicine supply obligations for all Member States

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has responded to proposed EU legislation that would require pharmaceutical companies to launch and continuously supply products in all Member States. EFPIA's analysis, based on data from 94 medicines approved between January 2021 and June 2024, argues that such mandatory launch requirements would not address underlying causes of market access delays, which their research indicates are primarily due to national regulatory processes.

Life Sciences weekly highlights—15 May 2025

This week's edition of Life Sciences weekly highlights includes two analyses by Gill Jennings & Every LLP: one regarding the EU landscape of patent-eligible subject matter in AI healthcare and another on a judgment (Generics, Teva & Glenmark v AstraZeneca) that again demonstrates how UK patent law is diverging from the European Patent Office’s approach. Also included, are Law360 news reports on the call for the UK-US trade deal to address better pharma and IP and analysis of the Court of Appeal’s unanimous decision upholding the CMA’s initial fine against Advanz for breaking competition law through excessive pricing of liothyronine tablets to the NHS overruling the CAT’s reduction of the fines. Further stories included are news that international draft guidance establishing regulatory principles for AI’s use in pharmacovigilance was published, the ABPI warned in its response to the DHSC’s March 2025 consultation on increasing the statutory scheme payment rates for branded medicines that these rates along with VPAG payments could undermine UK pharmaceutical investment, the EMA and the HMA published a joint workplan on data and AI in medicines regulation through 2028, the EMA launched a consultation on revised ATMP manufacturing guidelines, and the European Commission opened a consultation on its EU Biotech Act proposal, among other stories.