Jackie Mulryne is a member of the Life Sciences practice group, and provides regulatory, policy and compliance advice to clients in the pharmaceutical, medical technology, cosmetics and foods sectors. She advises on complex regulatory issues that arise throughout the product life cycle, including maximising regulatory protections and the overlap with IP rights, borderline classification, clinical research, authorisation, advertising and promotion, and market access strategy. She regularly develops strategies to help bring innovative products to market, and helps companies develop and implement cross-border regulatory compliance programmes.
Ms. Mulryne also assists life sciences and technology companies navigate the medical devices and in vitro diagnostic regulatory frameworks, and in particular advises companies on launching digital health and AI technologies.
Ms. Mulryne specialises in contentious disputes in the sector, and has extensive experience in public and administrative law litigation, in assisting clients with sensitive internal investigations and regulatory inspections, and in defending enforcement actions by the competent authorities. She also coordinates such matters across Europe. She advises on a wide range of actions arising from the decisions of regulatory bodies, and represents clients challenging public procurement tenders.
Ms. Mulryne also works on product liability matters on behalf of pharmaceutical and medical device companies, and has assisted on large multiparty actions, and in defending individual personal injury and product liability claims.
Ms. Mulryne is committed to pro bono work, and has acted for a number of organisations and individuals before the UK and international courts.
Experience
- 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 and in the General Court and Court of Justice (Cases T-611/18, T-268-9/22, C-439/21).
- Orion Corp. on its pan-EU strategy to protect the regulatory data protection for its product, including in the General Court (Case T-223/20), preliminary reference in the Court of Justice (Case C-165/21), acting in the English administrative law action, and managing coordinating similar actions across the EU.
- A number of life sciences and technology companies on virtual and digital health, including classification of AI and digital technologies and launch of such technologies within the healthcare system.
- A number of life sciences and technology companies on the implications of the MDR and IVDR, including changes necessary to product systems and conformity assessments to ensure compliance with the new requirements, and reviewing and updating agreements with economic operators.
- A companion diagnostic manufacturer regarding its next generation sequencing technology on CE marking issues, including regulatory, market access and advertising issues.
- A number of pharmaceutical clients on issues arising from supply of devices with their medicinal products, including co-development of a novel companion diagnostic, and co-packaged devices.
- Several personalised medicine companies on regulatory and compliance strategies for gene, cell therapy and tissue engineered products, including research, manufacturing and market access.
- Several companies on strategic investments in and acquisitions of life sciences and technology companies, including targeted regulatory due diligence and advice on regulatory contractual matters.
- A number of life sciences companies on challenges to public procurement tenders in the UK.
- An international pharmaceutical company on the regulatory issues relating to launch of generic versions of its blockbuster product, including developing and coordinating strategy across the EU.
- InterMune Inc. (Case T-73/13), Amicus Therapeutics, Inc. (Case T-33/17) and Intercept Pharma (Case T-377/18) in their European General Court cases in relation to transparency of clinical trial data and access to documents held by the EMA.
- Pfizer Ltd. in successfully defending a claim against the grant of an extension to its supplementary protection certificates under the Pediatric Regulation 1901/2006/EC.
- ViiV Healthcare UK Ltd. (Case T-547/12) in its intervention before the European General Court in support of the European Medicines Agency (EMA), who refused to validate an application for a generic marketing authorisation.
- Pfizer Ltd. (Case T-48/14) in challenging the decision of the European Commission and EMA in relation to the grant of a compliance statement under the Pediatric Regulation 1901/2006/EC.
- Global pharmaceutical company in its judicial review challenges to amendments of the legislation on the pricing of medicinal products and to procurement procedures.
Perspectives
Recognition
Life Sciences and Healthcare (2021-2023)
Product Liability: Defendant (2020-2022)
"Next Generation Partner" Pharmaceuticals and Biotechnology (2020-2021)
"Next Generation Lawyer" Pharmaceuticals and Biotechnology (2017-2019)
Pharmaceuticals and Biotechnology (2020)
Life Sciences: Regulatory (2022)
Credentials
Education
- M.A., Natural Sciences, Cambridge University, 2006
- Legal Practice Course, Nottingham Law School, 2005
- Graduate Diploma in Law, Nottingham Law School, 2004
- B.A., Natural Sciences, Cambridge University, 2002
- Solicitor Advocate, The University of Law, 2016
Admissions
- England and Wales
- Ireland