Jane Summerfield
Jane Summerfield is Co-Head of our Life Sciences and Health Care sector and leads the Hogan Lovells life sciences regulatory and commercial practice in London. She advises life sciences companies on a wide range of regulatory matters, including clinical trials, early access, marketing authorisations, manufacturing and distribution licences, CE/UKCA marking, digital health, advertising and marketing activities, HCP compliance, and pricing and reimbursement.
Jane also advises on commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements.
Jane works with clients to resolve issues with UK enforcement authorities and regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA) and Advertising Standards Authority (ASA).
Jane combines a scientific background with deep regulatory knowledge and a commercial approach, providing "clear responses with business impact".
Practice Area
Panel
- Contributing Author
3 Contributions by Jane Summerfield
PRACTICE NOTES
EU and UK regulatory data protection for medicinal products: 8+2+1 rule, global marketing authorisation, orphan exclusivity, OTC/indication extensions, and post‑Brexit (GB/NI) regime and reforms
Directive 2001/83/EC (the Pharmaceutical Code) introduces a period of data exclusivity starting from the first authorisation of innovative medicinal products, during which the pre-clinical and clinical trial evidence produced to support that approval cannot be relied upon by any applicant seeking a marketing authorisation (MA) for a generic medicine. During this time, such data may not be cited or cross‑referred to by others at all.
Accordingly, data exclusivity provides innovative companies with assurance that the scientific material prepared for the MA of the innovative product is safeguarded and will not be used to evaluate dossiers submitted by makers of generic or biosimilar medicines until the exclusivity enjoyed by the innovative product has expired. This protection is also termed regulatory data protection (RDP).
This Practice Note sets out an overview of the relevant EU rules that govern RDP for MAs covering innovative medicinal products and considers how those rules affect the timing of market entry for generic and biosimilar medicines. It further outlines how RDP is addressed in the UK.
Introduction to the concept of regulatory data protection
An ‘innovative medicinal product’, also known as a ‘reference medicinal product’ owing to its role in the authorisation of later generic or biosimilar...
Life Sciences
PRACTICE NOTES
EU medical devices: legacy Directives regime—classification, conformity and CE marking, post-market surveillance and advertising, and transitional provisions for legacy devices to MDR/IVDR
Practice Note
Within the EU, medical devices are strictly overseen by legislation that manages safety and performance throughout the whole lifecycle and across the full product lifetime, spanning pre- to post-market stages. This Practice Note outlines the regime established by Directive 93/42/EEC on medical devices (MDD), Directive 90/385/EEC on active implantable medical devices (AIMDD), which applied until 25 May 2021, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which remained in force until 25 May 2022; collectively, the MD Directives. The MD Directives continue to matter for ‘legacy’ devices that were authorised under them for placement on the EEA market before the new rules started to apply. They will also persist as points of reference for several years for particular legacy devices, for differing durations, pursuant to transitional provisions. This Practice Note sets out how devices were categorised, subjected to conformity assessment, and affixed with the CE mark under the MD Directives. It further addresses advertising and promotion of medical devices, the issue of counterfeit medical devices, 3D printing, and mobile health...
Life Sciences
PRACTICE NOTES
Falsified medicinal products: EU FMD and UK post‑Brexit regimes (including the Windsor Framework), active substance controls, supply chain obligations, online sales logo, safety features and UK‑only labelling
Across both advanced and developing nations, the commerce in falsified medicinal products is a global problem. The labels ‘falsified medicines’ and ‘counterfeit medicines’ must not be conflated—falsified medicines are fake items crafted to imitate genuine treatments, while counterfeit medicines are those that breach trade marks or other intellectual property rights.
This Practice Note reviews the regulatory changes introduced by Directive 2011/62/EU on preventing the entry of falsified medicinal products into the legitimate supply chain (the Falsified Medicines Directive, FMD), aimed at addressing the growing incidence of falsified medicines. It first explains the meaning of ‘falsified medicinal product’, then outlines the FMD’s measures, including:
tighter oversight of active substances
duties placed on participants within the supply chain
safety features added to medicinal product packaging
a common logo for websites that sell medicinal products
This Practice Note also sets out an overview of the EU and UK frameworks on falsified medicines.
EU regulatory framework—Falsified Medicines Directive
The FMD recognises a troubling rise in medicinal products identified within the EU that are falsified and which reach patients through illegal routes and via the legal supply...
Life Sciences
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