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

“The ‘highly responsive, commercial’ Marek Petecki is a ‘standout partner’ who ‘finds and communicates practicable solutions to issues, and tailors his work carefully’; he is noted for his strength in M&A involving IP and technology. Petecki’s highlights included advising AstraZeneca on the £135m sale of its pharmaceutical manufacturing facility in Avonmouth to Avara, and assisted Diageo with its acquisition of a stake in a joint venture established by Piers Adam to develop a new whisky brand.”

Legal 500 2017

“The ‘partner-led’ practice group at Bristows LLP has ‘good expertise in the area of partnership’, acting for investment partnerships and professional partnerships. Joint department head Iain Redford specialises in investment partnerships and also has particular expertise in refinancing partnerships. In 2016, he acted for multiple individual members in relation to the sale of their LLP.”

Legal 500 2017

“Commended for its ‘excellent service’ and ‘good value for money’, Bristows LLP’s department is strong in the TMT and life sciences sectors; it also has notable experience in the consumer goods space.”

Legal 500 2017

“Life sciences expert Mark Hawes, who heads the group, acted for Albireo on its NASDAQ listing and its $200m reverse merger with Biodel.”

Legal 500 2017

“Corporate partners Mark Hawes and Marek Petecki…are recommended” in the Pharmaceuticals and biotechnology sector.”

Legal 500 2017

Recent rankings and awards

Life Sciences - Top tier
Chambers and Partners UK 2017

Pharmaceuticals and Biotechnology - Top tier
Legal 500 2017

Life Sciences Chambers and Partners 2017
Chambers and Partners Europe 2017