FDA and Healthcare

Jackie Mulryne is an associate in the firm's London office and a member of the Healthcare group. Jackie advises clients in the biotechnology, pharmaceutical, and medical device sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law relating to medicinal products, medical devices, cosmetics, and foods, and has experience with a range of regulatory issues, in particular borderline products, clinical research, authorisation, advertising and labeling, and pricing and reimbursement.

Jackie advises on public and administrative law cases brought before the UK and European courts, including actions arising from the decisions of regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and the National Institute for Health and Care Excellence (NICE).

Jackie 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.

Jackie 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. She is a member of the firm’s pro bono committee.

Jackie trained at Arnold & Porter (UK) LLP, and also spent time in the firm’s Brussels office. She gained a Natural Sciences degree from Christ’s College, Cambridge University, and completed her Graduate Diploma in Law and Legal Practice Course at Nottingham Law School.

FDA and Healthcare Representative Matters

• Defending regulatory actions, such as claims against the grant of extensions to supplementary protection certificates under the Pediatric Regulation 1901/2006/EC.
• Administrative law challenges to the decisions of regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and the National Institute for Health and Care Excellence (NICE).
• Regulatory advice to medicinal product, medical device, food and cosmetics manufacturers concerning classification of products, regulatory requirements and product claims.
• Multiple Claimants v. Sanofi-Synthelabo Ltd (the Fetal Anticonvulsant Litigation) (multiparty product liability litigation brought on behalf of children of mothers with epilepsy alleging congenital abnormalities as a result of exposure to anti-epileptic medication during pregnancy).
• Product liability unitary claims for a number of pharmaceutical companies.