Capabilities
Life Sciences and Healthcare Regulatory

Administrative and EU Regulatory Litigation

Life Sciences is one of the most heavily regulated industries, in which decisions by regulating authorities on marketing approval and compliance with conditions, or on pricing and reimbursement of products, may give rise to procedural or substantive law challenges. We have extensive experience in bringing proceedings against UK and EU government agencies and in co-ordinating actions across the EU seeking the judicial review of regulatory decisions affecting our clients. We have dealt with many cases in the English courts that have been sent to the European Court of Justice on preliminary references and of bringing direct actions against EU bodies and institutions. In addition, we advise and represent clients challenging decisions of various tribunals performing administrative and quasi-judicial functions in the UK, including the National Institute for Health and Care Excellence (NICE), similar bodies in the devolved administrations and the Dispute Resolution Panel of the Pharmaceutical Price Regulation Scheme. We frequently advise clients in relation to issues surrounding freedom of information requests governed by EU or UK law and exemptions from disclosure, based on commercially confidential information or other grounds for exemption; NHS governance issues; public inquiries and coroner’s inquests.

Related Experience:

  • Application for judicial review and injunction in the General Court of the EU for annulment of a decision of the European Medicines Agency to disclose confidential information from an application for marketing authorization. The matter was ultimately concluded on terms favourable to the client.
  • Advising a major healthcare company on its rights under UK appeal procedures and its judicial review remedies relating to a proposal by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) to switch a significant product from pharmacy sale to a requirement for doctor prescription.
  • Providing continuing advice to a multinational pharmaceutical company on judicial review proceedings against the Licensing Authority, acting through the MHRA, in respect of its decisions to approve generic versions of one of its products.
  • Preparing an application for judicial review against the Secretary of State for Health and Public Health England on the exclusion of a new vaccine from the UK's immunisation programme.
  • Representing a leading global pharmaceutical manufacturer in relation to the judicial review of a decision by the Department of Health, in a matter which raised a large number of competition-related public procurement issues in addition to pharmaceutical regulatory issues. The case settled in our client's favour, and as a consequence the Department of Health wrote to all affected companies rescinding its previous decision.
  • Representing and advising various leading pharmaceutical clients on challenges to public procurement processes (award criteria, timing and design of tenders and exclusion of products) undertaken by the Commercial Medicines Unit of the Department of Health and National Procurement Scotland.
Overview

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