Libby Amos-Stone is a regulatory lawyer and litigator in the Life Sciences practice group. She specialises in contentious disputes in the sector and has broad experience in English and EU public and administrative litigation, as well as coordination of multi-party cross-border actions. Ms. Amos-Stone works on product liability matters, defending large multiparty actions, and individual personal injury and product liability claims. Additionally, she represents life sciences clients in public inquiries.
Ms. Amos-Stone provides regulatory and compliance advice to clients in the pharmaceutical, medical technology, food, cosmetic, and cannabis sectors. She assists companies on strategic issues arising during the life cycle of pharmaceutical products including, clinical trials, borderline classification, regulatory data protection, pediatric and orphan rewards, market access, and investigations. She also advises companies on the boundaries of the legislation and codes of practice regarding the promotion of medicinal products and medical devices and represents clients in response to PMCPA complaints.
Ms. Amos-Stone also assists life sciences and technology companies on mHealth and related issues, including classification of digital technologies, AI and navigation of the medical device, and IVD regulatory frameworks.
Experience
- Bayer, representation in Judicial Review before the High Court, Appeal Court and application to the UK Supreme Court regarding the regulatory framework for off-label use.
- Biogen, as an interested party in support of the MHRA and EMA, who refused to validate applications for generic marketing authorisations due to the data protection for Biogen’s product, in the English Court.
- Biogen, in multiple jurisdictions, on its pan-EU strategy to protect the regulatory data protection for its product.
- Orion Corp. on its pan-EU strategy to protect the regulatory data protection for its product, including in the General Court and preliminary reference in the Court of Justice.
- Orion Corp. in English administrative law action to protect the regulatory data protection and coordinating similar actions across the EU.
- Application for permission for judicial review on behalf of an authority regarding amendments to the process of pricing assessment.
- Multiple cases before the EU General Court cases in relation to transparency of clinical trial data and access to documents held by the EMA.
- Application to the EU General Court for annulment of a Commission Decision as to the eligibility of an orphan medicinal product to receive a pediatric extension on the basis of a pediatric investigation plan conducted voluntarily.
- Reference to the CJEU regarding the correct date for use in the calculation of duration of a supplementary protection certificate.
- Defending an action for declaratory relief that a marketing authorisation first authorised in East Germany prior to reunification constituted a valid reference medicinal product in accordance with Directive 2001/83/EC.
- Judicial review of the grant of marketing authorisations by the MHRA of a generic product authorised under Article 10(3) of Directive 2001/83/EC by reference to data contained in the dossier of a previously authorised Article 10(3) medicinal product where the Global MA concept does not apply.
- [Competition] Action for annulment of a Commission Decision condemning a large pharmaceutical company for breach of Articles 101 and 102 TFEU.
Perspectives
Recognition
"Recommended" Life Sciences: Product Liability (2023, 2025)
Regulatory — EMEA (2023)
Product Liability: Defendant (2023)
Credentials
Education
- Solicitor Advocate, BPP University Law School, 2016
- Post-Graduate Diploma in European Union Law, King's College London, 2015, with distinction
- LL.B., The College of Law, 2011, First Class Honours
- B.Sc., Physiological Sciences, University of Bristol, 2006, First Class Honours
Admissions
- England and Wales
- Ireland