Jackie Mulryne is a member of the Life Sciences practice group, and provides regulatory, policy and compliance advice to clients in the pharmaceutical, medical devices, cosmetics and foods sectors. She advises on complex UK and EU 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 also helps companies develop and implement cross-border regulatory compliance programmes, audits and investigations.

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 specialises in contentious disputes in the sector, and has extensive experience in public and administrative law litigation before the national and EU Courts, in defending enforcement actions by the competent authorities at EU and national level, and in coordinating such matters across the EU. She advises on actions arising from the decisions of regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), the European Commission and the European Medicines Agency (EMA), 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 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.
  • 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.
  • 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 (Cases T-611/18 and T-703/20).
  • 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.
  • A number of life sciences and technology companies on mHealth and related issues, including classification of digital technologies and launch of such technologies within the healthcare system.
  • Advising several personalised medicine companies on regulatory and compliance strategies for gene, cell therapy and tissue engineered products, including research, manufacturing and market access.
  • Advising 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.
  • 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.

Perspectives

European Commission Proposal to Delay Application of In Vitro Diagnostics Regulation
BioSlice Blog
Consultation on Framework for Medical Devices in UK
BioSlice Blog
Industry’s Response to the Commission’s Proposed Amendments to the EU Orphan and Paediatric Legislation
BioSlice Blog
Pharmaceutical Advertising 2021: England & Wales Chapter (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising Laws and Regulations 2021, 18th Edition (London: Global Legal Group, Ltd.)
Real-World Evidence and Its Use in Advertising of Medicinal Products in the EU and US (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising Laws and Regulations 2021, 18th Edition (London: Global Legal Group, Ltd.)
More

Recognition

Chambers UK
Life Sciences: Regulatory (UK-wide) (2021-2022)
The Legal 500 UK
"Next Generation Partner"–Life Sciences and Healthcare (2022)
Life Sciences and Healthcare (2021-2022)
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)

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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