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.