Daisy Bray’s practice focuses on the regulation of pharmaceutical products and medical devices. Daisy advises on the boundaries of the ABPI and EFPIA Codes of Practice and UK and EU legislation in relation to numerous issues throughout a product life cycle including clinical research, advertising and promotion, market access, authorisation, safety vigilance, pricing and reimbursement, use of social media and marketing materials, CE marking, manufacturing and distribution.
Daisy also provides regulatory compliance advice, assisting with product-related investigations, public inquiries and resolving disputes arising from the decisions of regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). In addition, Daisy assists clients in assessing regulatory risks associated with potential acquisitions and investments in UK and EU regulated entities.
Experience
Advisory and Commercial
- Advising several pharmaceutical companies on the restrictions on the engagement of healthcare professionals and organizations, disclosure obligations and transfers of value with respect to national self-regulatory codes and legislation in various key geographical jurisdictions.
- Advising a clinical stage pharmaceutical company on how cannabis-derived substances are regulated in the UK and the implications of such.
- Advising a charity on the regulatory and requirements on the supply of surplus medicines, including advising on commercial and contractual aspects.
- 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.
- Providing regulatory advice on internal policies, SOPs and the boundaries of the ABPI and EFPIA codes of conduct.
- Assisted multinational pharmaceutical company on submission of documents to the European Commission during the coronavirus pandemic.*
- Seconded to global pharmaceutical companies to assist with product-related commercial and regulatory matters.*
- Drafted and negotiated a range of commercial contracts including investigator driven study agreements, collaborative research agreements, master services agreements, clinical trial agreements, supply and distribution agreements and pharmacovigilance agreements.*
Transactional
- Assisted Partners Group on its acquisition of Pharmathen, a European pharmaceutical company, from international investment firm BC Partners on behalf of its clients. The transaction values Pharmathen at an enterprise value of around EUR1.6 billion.
- Representing a leading private equity firm in its acquisition of a supplier of medical equipment.
- Advising a leading multinational pharmaceutical manufacturer on the acquisition of a biotechnology company committed to transforming the treatment of patients living with haematological and solid cancers.
- 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.
Contentious
- Advising a global developer of therapies for rare and orphan diseases on the maintenance of its drug’s orphan designation upon obtaining market authorisation, including strategy before the European Medicine Agency’s Committee for Orphan Medicinal Products.
- Advising a global pharmaceutical company on its response to a pharmacovigilance audit with respect to their provision of homecare services to patients in the UK.
- Assisted multinational pharmaceutical companies with product-related investigations regarding GCP and the conduct of worldwide clinical trials.*
- Assisted multinational pharmaceutical companies with public inquiries and reviews including the Infected Blood Inquiry and the Independent Medicines and Medical Devices Review.*
- Assisted clients on administrative law matters such as Orion Corporation v Secretary of State for Health & Social Care.*
- Assisting clients in cross-border litigation matters.*
- Assisted families of the deceased with several Inquests on a pro bono basis.*
*Experience prior to joining Ropes & Gray
Credentials
Publications
Disclaimer
Ropes & Gray International LLP is a limited liability partnership registered in Delaware, United States of America and is a recognised body regulated by the Solicitors Regulation Authority (with registered number 521000).