Hannah Kerr-Peterson is an associate in Ropes & Gray’s life sciences regulatory and compliance team, based in London.
Hannah’s practice concentrates on the regulation of pharmaceutical, medical device and digital health technologies in the UK and EU. She regularly advises clients who are active in these industries on advisory, transactional, commercial and contentious matters, which often relate to product classification, clinical research, early access, product approval, CE marking, pricing and reimbursement, market access, manufacturing, advertising and promotion, distribution, and safety vigilance.
Having obtained a first-class degree in Pharmacology and Molecular Genetics, conducted scientific research at a leading London-based research institute, and undertaken a secondment at a market-leading pharmaceutical company, Hannah is quick to grasp complex technical issues and provide clients with practical advice tailored to the needs of their businesses.
- Advising numerous clients on how to comply with the EU Medical Device Regulation (MDR) and In Vitro Medical Device Regulation, including advising on the implications of the broadened scope and developing strategies for product launch
- Advising several pharmaceutical companies on the restrictions on the engagement of healthcare professionals and organisations, disclosure obligations and transfers of value with respect to national self-regulatory codes and legislation
- Advising a major biopharmaceutical manufacturer on matters related to the new EU Health Technology Assessment Regulation
- Assisting numerous clients with their navigation of the obstacles and opportunities posed by the COVID-19 pandemic, including the advertisement and promotion of vaccines, the deployment of health monitoring technology and various classification issues concerning various testing techniques, medical devices and personal protective equipment
- Assisting numerous clients with preparations for Brexit including, for example, the impact on pan-European clinical trials, supply chains and the Northern Ireland protocol
- Advised an internet-based consumer goods retailer on the rules around remote sales of pharmaceutical products, medical devices, optical appliances and veterinary medicines*
- Assisted Bain Capital in its acquisition of a majority stake in Classys, Inc., a medical aesthetic devices company based in South Korea
- Assisted the Singaporean wealth fund GIC on its acquisition of a 40% interest in The Oxford Science Park from Magdalen College, as well as on the strategic joint venture between GIC and Magdalen College aimed at accommodating the strong demand for life sciences and technology space in Oxford
- Assisted Humble Group AB on its acquisition of Solent Global Limited, a leading international supplier of healthy food and personal care products
- Assisted Partners Group on its €1.6 billion acquisition of Pharmathen, a European pharmaceutical company, from international investment firm BC Partners on behalf of its clients
- Assisted AmerisourceBergen Corporation on its $6.47 billion acquisition of Walgreens Boots Alliance, Inc’s wholesale distribution business in Europe, together with specified pre-wholesale services, as well as certain pharmacy operations in Lithuania, the Netherlands and Norway*
- Drafting and negotiating an NHS supply agreement which comprises an entirely novel drug pricing mechanism
- Drafting and negotiating MDR-compliant importation and distribution agreements
- Drafting and negotiating a range of commercial contracts including a product supply and apheresis services agreement for a novel CAR-T therapy, distribution agreements and manufacturing agreements*
- Assisting a pioneering pharmaceutical company to secure the reclassification of its female contraceptive pill from prescription-only to pharmacy
- Assisting a global pharmaceutical company in its challenge of the Medicines and Healthcare products Regulatory Agency’s decision to include certain information in the authorisation documentation of a generic version of our client’s medicinal product
- Assisted a multinational pharmaceutical company with its provision of information to, and cooperation with, the Infected Blood Inquiry*
- Assisted a multinational pharmaceutical company in an advanced-stage Prescription Medicines Code of Practice Authority complaint, which concerned an allegation that the company had offered inducements to healthcare professionals in return for their prescription of its medicinal products*
- Assisted numerous clients with proceedings before the European Courts: T-33/17 Amicus Therapeutics UK Ltd; Amicus Therapeutics v European Medicines Agency; T-733/17 GMP-Orphan SA v European Commission and Appeal Case C-575/19P; T-337/18 Intercept Pharma Ltd, Intercept Pharmaceuticals Inc v European Medicines Agency*
*Experience prior to joining Ropes & Gray