Hugo advises on a broad range of regulatory matters impacting the life sciences sector in the UK and the EU. In particular, he advises on issues affecting medicines and medical devices throughout the entire product-lifecycle, including clinical research, authorisations and certification, regulatory exclusivities, manufacturing, supply chain structures and market access.
Hugo also has experience advising life sciences clients on a variety of self-regulatory codes of conduct for the life sciences industry which govern advertising and industry interaction with the healthcare sector, such as the EFPIA, ABPI and ABHI Codes.
Hugo regularly provides specialist due diligence support in the context of corporate life sciences transactions.
Recent areas of particular activity have included:
- Navigating the complexity of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).
- Advising relation to the requirements of the ABPI Code, including assisting clients in relation to complaint administered by the PMCPA.
- Providing specialist regulatory due diligence support for a various corporate transactions in the life sciences sector.
Some of Hugo’s work highlights include:
- Advising several leading pharmaceutical companies on the implications of the new repayment mechanism introduced under VPAG, including in relation to product classification.
- Assisting an innovator pharmaceutical company in responding to several PMCPA complaints in relation to alleged breaches of the ABPI Code.
- Conducting specialist due diligence in relation to the corporate sale of a large company providing healthcare products and services with a portfolio including products classified as medicines, medical devices, cosmetics and food supplements.
- A project to implement global internal standard operating procedures in relation to the use of software as a medical device (SaMD) in a large pharmaceutical company.
Hugo joined Bristows as a trainee solicitor in 2019 and gained experience in a range of practice areas, including transactional intellectual property, patent litigation and data protection. During his training, Hugo spent three months on secondment at a leading clinical artificial intelligence company, where he gained valuable medical device regulatory and commercial contract experience.
After qualifying into the life sciences regulatory team, Hugo completed a full-time secondment at a leading global pharmaceutical company, assisting the company with an internal compliance audit.
Prior to joining Bristows, Hugo worked as a chemistry teacher in a secondary school in London.
Biotech Review of the Year
Read here