Inevitably in a sector as dynamic and heavily regulated as life sciences, the law struggles to keep abreast of changes, and so do regulators. We have long experience in representing clients in judicial review proceedings (or preliminary matters) related to decisions from virtually all regulatory bodies relevant to the life sciences sector in domestic and European contexts.

Regulatory decisions by governmental and European agencies on a range of issues have an immense impact upon life science companies, for example in relation to marketing authorisations, clinical trial authorisations, access to data, licences, suspension notices for medical devices and reimbursement. However, regulatory complexity and uncertainty mean that these decisions are prone to error. It is therefore important for clients to be able to challenge decisions effectively by means of judicial review; first in preliminary proceedings, and (if necessary) at a full hearing, and to be alert to the possibility of a referral to the Court of Justice of the European Union.

Judicial review disputes commonly have a multi-jurisdictional perspective. Bristows’ very strong and longstanding relationships with professionals across Europe, the United States and Australia enable us to respond to such multi-jurisdictional matters effectively, whether as the lead coordinator or simply as part of a larger team.

We have represented clients in relation to disputes arising from decisions of each of the following:

  • Medicines: European Medicines Agency (EMA) (including the Committee for Advanced Therapies and the Committee for Medicinal Products for Human Use) and the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Medical Devices: MHRA Notified Bodies and the EMA (class III devices with ancillary medicinal ingredients)
  • Research and Medical Practice: MHRA Human Tissue Authority; Human Fertilisation and Embryology Authority and Care Quality Commission
  • Market Access and Tenders: National Institute for Health and Care Excellence (NICE); NHS England; NHS Wales and various CCGs and NHS Trusts.

Key contact

Alex Denoon

Contact

Experience

We represented the Interested Party in judicial review proceedings commenced by our client’s competitor against the MHRA. The court upheld the Marketing Authorisation granted to our client under the decentralised procedure, and refused the competitor’s application for a preliminary reference to the CJEU.

We commenced judicial review proceedings on behalf of a pharmaceutical client against NHS England, which had limited access to our client’s novel lung cancer medicinal product, despite a positive Technology Appraisal by NICE. NHS England had adopted an interpretation that was narrower than the terms of the marketing authorisation granted by the EMA.

Our client had a fusion protein with two distinct moieties: one primary and the other secondary. This novel product posed challenges for all of the regulators involved. We were able to ensure that the product was reviewed by the CHMP, but only after threatening or initiating proceedings against three different regulators. This matter also involved extensive Freedom of Information applications.

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What others say

“They are excellent, they have really good work and nice people there.”

Chambers and Partners 2023

“Their reputation is well deserved.”

Chambers and Partners 2023

“The Bristows team members are not only exceptionally good at a professional level, but, at the same time, very easy to talk to and discuss with. They always have an open ear for the client’s needs and are happy to brainstorm.”

Legal 500 2023

“The team has exceptional knowledge of the life sciences space. It acts for a broad range of industry players and has a deep understanding of market practice.”

Legal 500 2023

“Justified reputation as one of, if not the, leading firms for IP life sciences. Excellent reputation in the UK and beyond – widely respected throughout Europe for coordinating multi-jurisdictional disputes.”

Legal 500 2023

Recent rankings and awards

Life Sciences and Healthcare - Tier 1

Life Sciences - Band 1

Life Sciences Chambers and Partners 2017