Jackie Mulryne advises clients in the life sciences, medical devices, cosmetics and foods sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product life cycle, including borderline classification, clinical research, authorisation, advertising and labeling, and pricing and reimbursement. She has assisted a number of life science and medical device companies in developing and implementing cross-border regulatory action and compliance programmes. In addition, Ms. Mulryne advises on privacy and data protection matters for life science and medical device companies, including the UK and EU framework under the General Data Protection Regulation (GDPR).

Ms. Mulryne also advises on contentious disputes in the sector, and she has extensive experience in public and administrative law litigation before the national and EU Courts. She advises on actions arising from the decisions of regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the National Institute for Health and Care Excellence (NICE), and represents clients challenging public procurement tenders under EU and UK rules. 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

  • Orion Corp. on its pan-EU strategy in relation to the regulatory data protection for its product, including acting in the UK administrative law action and coordinating similar actions across the EU.
  • An international pharmaceutical company on the regulatory issues relating to launch of generic versions of its products, including coordinating advice across the EU.
  • GMP-Orphan SA (Case T-733/17) in an application to the General Court to challenge a decision of the European Commission to grant a marketing authorisation without orphan designation
  • Biogen, as an interested party in support of the MHRA, who refused to validate an application for a generic marketing authorisation, and in the General Court (Case T-611/18).
  • 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.
  • A family in the inquest into the death of their seven-day-old son, conducted under Article 2 of the European Convention of Human Rights due to the systematic and structural failings at the Trust, and which amounted to neglect.
  • A number of life sciences and technology companies on mHealth and related issues.
  • A number of life sciences companies on challenges to public procurement tenders in the UK.

Perspectives

EU and US Orphan Drug Regimes: Benefits And Limitations of International Cooperation
Pink Sheet, Informa Pharma Intelligence
Pharma & Medical Device Regulation: European Union
Getting the Deal Through
Pharma & Medical Device Regulation: United Kingdom
Getting the Deal Through
Medical Device Product Liability and the Rise of Digital Health/Artificial Intelligence
Analyzing Key ATMP Talking Points Through IP and Regulatory Lenses (pdf)
Cell and Gene Therapy Insights, 2020 vision - Tools and Technologies of Tomorrow
More

Recognition

The Legal 500 UK
"Next Generation Partner" – Pharmaceuticals and Biotechnology (2018-2020)
"Next Generation Lawyer" – Pharmaceuticals and Biotechnology (2017-2019)
Pharmaceuticals and Biotechnology (2020)
Product Liability: Defendant (2020)
London Super Lawyers
"Rising Star" for Administrative and Public Law (2014-2015)
Legal Week
Shortlisted for British Legal Award "Associate Solicitor of the Year" (2012)

Credentials

Education
  • MA, Natural Sciences, Cambridge University, 2006
  • Legal Practice Course, Nottingham Law School, 2005
  • Graduate Diploma in Law, Nottingham Law School, 2004
  • BA, Natural Sciences, Cambridge University, 2002
  • Solicitor Advocate, The University of Law, 2016
Admissions
  • England and Wales
  • Ireland
Overview

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