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.

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), the National Institute for Health and Care Excellence (NICE) and the Cancer Drugs Fund (CDF). She 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 advised a variety of clients on the protection of human rights and the right to a fair trial. She has also spent time working for the Cambodian Center for Human Rights in Cambodia.

Experience

  • InterMune Inc. (Case T-73/13) and Amicus Therapeutics, Inc. (Case T-33/17) 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 number of pharmaceutical companies in administrative law challenges to the decisions of the Cancer Drugs Fund and the National Institute for health and Care Excellence.
  • A number of life sciences and technology companies on mHealth and related issues.

Perspectives

Drafting and Negotiating Clinical Trial Agreements Seminar
WP29 Reviews the European Draft Code of Conduct on Privacy for Mobile Health Apps
Digital Health Download
The Developing Regulatory Framework for Biosimilars
10th Biosimilars & Follow-On Biologics Congregation 2017, London, UK
Recent Developments in Off-Label Use
Advisory
eHealth Standards for Europe
Digital Health Download
More

Recognition

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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