Regulatory Work at Bristows


Mention to most people that you’re a regulatory lawyer working in London and they’ll think banking and (perhaps) start talking about MiFID II. However, it should come as no surprise that the regulatory team at Bristows is focused on life sciences and product liability rather than high finance.

So what is life sciences regulation?

To consumers it is the laws that ensure their food, cosmetics, medicines, and medical devices are safe and fit for purpose. This means that lawyers ensure that, for example, the regulations for clinical trials, labelling, and manufacturing are complied with, and then play a role in the ensuing litigation when they are not.

But the work at Bristows goes far beyond a simple tick-box exercise of meeting criteria. Technology is an ever growing part of the life sciences field, and where new ideas come up against legislation written in the 1990s, analytical insight is often required. Nowhere is this more apparent than in the development of software medical devices; for example, Natural Cycles, the app that offered a non-hormonal, non-barrier method of contraception based on the menstrual cycle and body temperature readings. How should such devices be tested and regulated and where should liability rest if things (as they have in the case of Natural Cycles) go wrong? The Bristows team provides advice to clients, ranging from start-ups to more established international players, on these exact issues.

In product liability Bristows has a growing practice, and one that can see a huge variety of work, from evaluating the rules on the transport of dangerous goods to defending proceedings brought by Trading Standards. As with the life sciences sector, new technologies are presenting challenges to the product liability regime, for example see our articles on driverless cars (Parts 1 and 2).

Given that regulatory issues are primarily covered by EU legislation, Brexit features heavily. The team advises on the implications, and steps required to retain market access in the United Kingdom and the EU27.

The team also works alongside other departments to help provide a full-service package. For example, we work with the corporate team (see Harry’s article for more on the corporate department) during an acquisition in the pharmaceutical sector to conduct regulatory due diligence to ensure that the target company holds the appropriate approvals for their medicines and is compliant with their obligations in relation to the manufacture, sale and monitoring of those products. That same approval regime also contains protections for companies that develop their own drugs in the form of data and market exclusivities. These exclusivities complement the protection afforded by patents, and so we work with the Patent Litigation department (see Emma and Marc’s article) to help protect clients’ products around the globe.

Software medical devices often rely on collecting and using highly sensitive data from patients, and so the team often works with Bristows’ data protection department (see here) to ensure that products and clinical studies comply with the GDPR. Finally, on the products side, the team involves lawyers from the brands department to help evaluate adverts and consider issues such as trade mark infringement.

What does the trainee do?

Of course some of the work is familiar to all departments, such as taking attendance notes of client calls. However, the department is one of the smaller ones in the firm, so there is greater scope to take on more responsibility whilst still being supported by the team. For example, the work may involve conducting initial research and producing a memo for the rest of the team, helping to prepare a fee estimate for a discrete piece of advice, or assisting in a due diligence exercise.

The regulatory regime is often legislation heavy and so the seat offers the ideal opportunity to get to grips with a raft of interlocking domestic and EU law, a skill that will prove invaluable wherever one qualifies. Given the range and nature of the work, I’d thoroughly recommend requesting a seat in the department.

Jonathan Ross