Bayer Plc v NHS Darlington Clinical Commissioning Groups (CCG) & Ors

Bayer Plc v NHS Darlington Clinical Commissioning Groups (CCG) & Ors

The CCGs' policy is not unlawful because it is realistically capable of being implemented in a manner that does not lead to, permit, or encourage unlawful acts. The use of Avastin for ophthalmic purposes, whether compounded or not, does not necessarily require a new marketing authorisation under EU law, and the national authorities are competent to assess clinical effectiveness, safety, and cost. The policy does not undermine the EU regulatory regime, NICE recommendations, or provide unlawful patient information.

Parties
First Claimant: Bayer PLC; Second Claimant: Novartis Pharmaceuticals UK Limited; Defendants: NHS Darlington CCG and 11 other CCGs; First Interested Party: Roche Products Limited; Second Interested Party: The Secretary of State for Health; Third Interested Party: NHS England; Fourth Interested Party: The General Pharmaceutical Council
Jurisdiction
England and Wales
Judgment Date
21 September 2018
Procedural Posture
Judicial Review / Judgment After Full Hearing
Outcome
Application for judicial review dismissed
Legal Topics
Judicial Review, Pharmaceutical Regulation, Off Label Use of Medicines, Marketing Authorisation, Public Procurement, Patient Safety, NHS Policy, EU Directives
Administrative Law Health Law EU Law Judicial Review Pharmaceutical Regulation Off Label Use of Medicines Marketing Authorisation Public Procurement +3 more

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Parties

Bayer PLC

First Claimant

Novartis Pharmaceuticals UK Limited

Second Claimant

NHS Darlington CCG and 11 other CCGs

Defendants

Roche Products Limited

First Interested Party

The Secretary of State for Health

Second Interested Party

NHS England

Third Interested Party

The General Pharmaceutical Council

Fourth Interested Party

Procedural Posture

Judicial Review / Judgment After Full Hearing

Legal Issues

  1. 1 Whether the CCGs' policy to offer Avastin as preferred treatment for wet AMD is lawful under EU and domestic law
  2. 2 Whether the policy undermines the EU regulatory regime for medicines
  3. 3 Whether the policy unlawfully restricts access to NICE-recommended treatments

Ratio Decidendi

The CCGs' policy is not unlawful because it is realistically capable of being implemented in a manner that does not lead to, permit, or encourage unlawful acts. The use of Avastin for ophthalmic purposes, whether compounded or not, does not necessarily require a new marketing authorisation under EU law, and the national authorities are competent to assess clinical effectiveness, safety, and cost. The policy does not undermine the EU regulatory regime, NICE recommendations, or provide unlawful patient information.

Court Disposition

Application for judicial review dismissed

Orders

  • All four grounds of challenge are rejected.
  • Permission to rely on expert evidence is refused.