Jurisdictional guides

This subtopic provides a range of international guidance.

The Lexology Panoramic guides, curated by leading lawyers and law firms, provide a view of laws and regulations in multiple jurisdictions

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

TAKE A FREE TRIAL

Latest Life Sciences News

Medical device maker can’t revive stoma bag patent case

Law360, London: An ostomy care company failed on 19 February 2026 to revive a patent infringement case, after an appellate court held that a rival's drainable pouch for collecting waste in colostomy patients was missing some crucial patented elements.

MHRA publishes guidance on new integrated scientific advice service with NICE

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have jointly delivered the Integrated Scientific Advice (ISA) service, which provides pharmaceutical companies with coordinated regulatory and health technology assessment (HTA) advice through a single application process, meeting and integrated report. Intended primarily for medicines in clinical development aligned to MHRA and NICE pathway timelines, the service replaces the previous joint advice model and aims to support earlier patient access by clarifying evidence requirements for market authorisation and HTA at an early stage, including advice on pivotal study design, real-world evidence generation and strategic planning, although it does not cover medical devices. Applicants must confirm eligibility, submit a request form, agree a contract and fee, and provide a briefing book and presentation before attending an advice meeting, after which a single report is issued within 80 working days of acceptance, subject to complete and timely submissions; limited factual clarifications may be requested. A single fee, payable in two instalments, covers the service, with a waiver available for the MHRA component for eligible UK-based SMEs, and the advice provided is not legally binding and reflects the information and regulatory context at the time.

General Court issues procedural orders in pharmaceutical industry challenges to wastewater directive

The EU General Court has issued three orders in response to 16 actions brought in March 2025 challenging the revised Urban Wastewater Treatment Directive, Directive (EU) 2024/3019 (UWWTD). The actions were filed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and 15 pharmaceutical and cosmetics companies and associations contesting the Directive’s Extended Producer Responsibility (EPR) regime. The actions were lodged on 7 March 2025. EFPIA lodged its own action, while the lead case among the related proceedings is Accord Healthcare France v Parliament and Council (C/2025/2672, Case T-156/25). The applicants challenge the Directive’s allocation of principal financial responsibility to the pharmaceutical and cosmetics sectors for quaternary wastewater treatment, including the removal of micropollutants, arguing that this infringes the EU law principles of polluter pays principle, proportionality and non-discrimination.

EFPIA publishes report on economic impact of clinical trials and benefits of increasing EU activity

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report assessing the economic and societal contribution of industry-sponsored clinical trials in Europe, estimating that 35,000 additional Europeans could gain access to clinical trials if new EU targets aimed at attracting research are met. According to the report, achieving the 11% increase in trial activity target set by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) would generate an additional €4bn annually for EU healthcare systems and the wider economy, create 18,000 jobs and prevent three million sick days each year, equating to around 500 additional multinational trials over five years and increasing annual trial numbers from 900 to 1,000. The report estimates that industry-sponsored clinical trials currently generate €35.7bn per year across the European Economic Area (EEA), comprising €21.7bn from clinical trial activity, €3.6bn in research and development spillovers and €10.4bn in productivity gains linked to the prevention of 26.9 million sick days annually. The analysis also examines two more ambitious scenarios, finding that a 25% increase in trial activity would deliver an additional €8.9bn in gross value added (GVA) and 79,000 more trial places, while a 50% increase would unlock up to €17.9bn in additional GVA and 158,000 additional places. The report notes that Europe’s share of global industry-sponsored clinical trials declined from 22% in 2013 to 12% in 2023, despite an overall rise in global trial numbers during the same period. The Association of the British Pharmaceutical Industry (ABPI) states that the findings align with its previous UK analysis, which found that industry clinical trials contributed £7.4bn to the UK economy in 2022, including £1.2bn in revenue for the NHS and that restoring activity to 2017 levels would generate an additional £3bn and support 26,000 jobs.