DR. CHRIS BOYLE is a life sciences lawyer and qualified veterinarian who advises and litigates in the highly regulated fields of human and veterinary medicinal products, medical devices, biocides, chemicals, food and feed. In addition to his advisory and litigation work, Chris coordinates multi-jurisdictional compliance projects, and supports complex life sciences corporate transactions and private equity deals by providing valuable legal and industry insights, and specialist due diligence.
For animal health clients, Chris advises across a broad range of regulatory issues, including advertising and promotional campaigns, commercial agreements, telemedicine, IP regulatory exclusivities, routes to regulatory approval, marketing authorisation, manufacturer and wholesaler licensing, off-label prescribing and compounding. He also advises clients adapting to the new EU Veterinary Medicines Regulations and EU Animal Health Regulations. Chris founded and chairs the Sidley Animal Health Legal Forum (AHLF), a network for animal health professionals and regulatory affairs colleagues who meet regularly to share best practices and to discuss legal and regulatory issues the animal health industry is facing.
For biopharma and pharma clients, Chris advises and litigates across a broad spectrum of regulatory frameworks. This includes advising on valuable IP regulatory rights such as orphan-drug market exclusivity, paediatric rewards, SPCs and regulatory data protection rights. On market access issues, Chris assists clients from pre-marketing authorisation through to commercialization phases. For instance, Chris helps guide clients through the legal and regulatory requirements in Health Technology Assessments, to present the best value to payors, including the utilization of Real World Evidence (RWE) to address gaps in clinical trial data. Chris has successfully supported clients to challenge unfavorable decisions of regulatory bodies such as the EMA and health technology authorities, such as NICE, and to enforce regulatory exclusivities in the courts. Chris is also actively involved in the development of the new EU Pharmaceutical Law Package, and advises clients on the potential impact of the proposals on the availability of medicines and the consequent impact on patients and the industry.
In the MedTech sector, Chris helps clients to adapt to the evolving regulatory frameworks under the new medical device regulations (MDR and IVDR) and he advises on the many classification and borderline issues that arise as the legal frameworks try to keep pace with technology, including companion diagnostics, wearables, RWE and AI.
Chris advises companies on novel food authorisations, human and animal supplements, food and feed claims, food incidents, product withdrawals and recalls.
Chris is solicitor-advocate, experienced in representing clients before the UK and EU courts. He is acting for a pharmaceutical company in high-value, follow-on damages proceedings in the UK concerning the intersection of competition, regulatory and patent law. Chris acted in two appeals before the UK Supreme Court and a month-long trial before the High Court, winning the 2022 LMG Life Sciences “Impact Case of the Year” and the 2022 Managing IP awards “UK Impact Case of the Year.” Chris has also helped to successfully enforce orphan-drug market exclusivity before the General Court in Luxembourg.
As in the previous years (2023) Chris was named a “Rising Star” in the 2024 edition of Legal 500 UK for Life Sciences and Healthcare, where clients comment: “Chris Boyle has a very reassuring presence, and is calm and reflective, and always appreciates the priority of the client. His advice is concise and always provided with the realities of the business environment in mind.” Sources from the 2023 edition commented: “Chris Boyle is an absolute superstar as a Senior Managing Associate. He is tremendously clever, prodigiously hard working and would be at the top of my list of people to have on any team. He also has a strong scientific background in life sciences, which is invaluable.” “Chris Boyle is a qualified veterinarian and life-sciences lawyer who uses his scientific background to great effect when advising his clients. Great practical advice.”
Chris speaks regularly on hot topics in regulatory life-sciences at international conferences.