Maria Isabel (Marie) Manley
Marie Manley is Head of our Life Sciences Regulatory practice, based in London. She is a leading adviser and recognised thought leader on EU and UK life sciences regulatory and competition law.
Marie advises life sciences companies on the regulatory issues that determine whether a product reaches, remains on or succeeds in the market. She is a leading UK and European life sciences regulatory lawyer, advising global pharmaceutical, biotech and medical device companies on some of the most complex and commercially significant issues across the product life cycle. Ranked Band 1 in Chambers for Life Sciences Regulatory and recognised in the Legal 500 Hall of Fame for Life Sciences and Healthcare, she combines deep regulatory expertise with a strong understanding of the commercial and strategic issues facing life sciences businesses.
Marie advises development-stage, specialty and established global life sciences companies across the full spectrum of contentious and non-contentious regulatory and competition matters. Her practice spans regulatory exclusivity and incentives, optimisation of regulatory and IP rights, market access and pricing and reimbursement strategy, including representation before the NICE Appeal Panel and the English courts. She also advises on product liability, clinical trials, marketing and advertising, digital health and AI technologies, commercial regulatory matters and antitrust issues, particularly at the intersection of competition law, IP and regulatory rights, as well as parallel trade. She has significant experience in engaging with the EU institutions and bodies, including the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) and the European Commission, as well as UK authorities including the Medicines and Healthcare products Regulatory Agency (MHRA) the Home Office and NICE.
A substantial part of Marie’s practice is contentious. She has a successful track record in litigation and judicial review before national and European courts and in proceedings before healthcare regulatory bodies, helping clients navigate high-stakes regulatory disputes and protect the commercial value of their products and rights across the UK and the EU.
Accolades
- “Thought Leader – Global Elite” for Healthcare and Life Sciences - Regulatory in Lexology: Thought Leaders 2026
- Recognized in the “Hall of Fame” for Life Sciences and Healthcare. (Legal 500 UK 2026)
- 2022 LMG Life Sciences “Impact Case of the Year”
- 2022 Managing IP awards “UK Impact Case of the Year.”
- Band 1 ranking in Chambers UK (since 2011) and Chambers Europe 2020 for Life Sciences: Regulatory
- Recommendations in Who’s Who Legal and Best Lawyers (since 2009).
- “Maria Manley heads a team with broad expertise covering all areas of pharma - biotech, medtech and companion diagnostics, including AI and digital applications. She is the ‘go-to’ person for bet-the-company pricing and reimbursement issues vis-a-vis national reimbursement authorities.” (Legal 500 UK 2026)
- “Maria Manley is the go-to person for all things regulatory in the life sciences setting and beyond. Tenacious, flexible, but always client-focused. Always ready to jump in at short notice and address clients’ key concerns. Can deal with contentions, non-contentious and due diligence queries effortlessly. (Legal 500 UK 2026)
- “Maria is the guru of life sciences and the go-to person for unprecedented matters,” “Maria is not only an extremely experienced lawyer but also a very savvy businessperson and charismatic leader” and “Maria is an acknowledged leader and has a strong track record in both high-value litigation and providing creative, problem-solving approaches against a continuously evolving regulatory landscape.” (Chambers UK 2025)
Experience & capabilities
Selected matters
- Experience representing a multinational pharmaceutical company before the EU General Court in proceedings challenging a European Commission decision alleging a breach of EU competition law, including appeals before the CJEU and the referral proceedings before the General Court.*
- Experience representing a multinational pharmaceutical company in UK parallel damages proceedings brought by public healthcare authorities alleging losses arising from an alleged breach of competition law, before the English courts and the CAT.*
- Successfully represented a biotechnology company before NICE Appeal Panel, securing a successful outcome on all points of law for a treatment addressing a life-threatening condition.*
- Represented a multinational pharmaceutical company before the CJEU concerning the interpretation of precedent case law relating to pharmaceutical regulatory exclusivities.*
- Les Laboratoires CTRS successfully in proceedings before the EU General Court against the European Commission for its refusal to grant a marketing authorization for CTRS’ orphan medicinal product (T-301/12). This case is of great importance for the industry as the Court ruled on fundamental issues at stake regarding the pharmaceutical legal framework. Further represented CTRS in another case challenging the grant of the marketing authorization to a competitor in breach of the orphan market exclusivity (T-452/14)
- Seattle Genetics Inc. successfully before the CJEU in a landmark SPC case (C-471/14)*
- Shire successfully before the European Commission and EU General Court on a pediatric extension (T 583/13)*
- AstraZeneca before the CJEU on an SPC matter (C-617/12)*
- EFPIA and PhRMA, the EU and U.S. pharma industry associations, on the AbbVie cases (T-29/13 and T-44/13)*
- Novartis before the CJEU on an SPC matter (C-207/03)*
- Clinuvel Pharmaceuticals successfully before the European Medicines Agency on a breakthrough drug*
*Experience prior to joining the firm
Sectors
Background
Marie studied law in Switzerland and holds an LL.M. in European Law from the University of Lausanne and an LL.M. in International Law from Columbia University in New York. She also completed postgraduate studies in EU competition law at King’s College London. Her international education, career and language skills underpin a distinctly cross-border practice, advising companies on regulatory and competition matters across the UK and EU.
She is fluent in English, French and Spanish and has a working knowledge of German, Italian and Catalan.
Marie is co-author and editor of “Navigating European Pharmaceutical Law”, Oxford University Press, 2015.
