Bayer Plc v NHS Darlington Clinical Commissioning Groups (CCG) & Ors [2018] EWHC 2465 (Admin) (21 September 2018)

Bayer and Novartis challenge the lawfulness of a policy adopted by the twelve Clinical Commissioning Groups… The policy is headed “Treatment for Age-related Macular Degeneration” and it refers to three different drugs for treating patients with the neovascular form of that condition, which is known as “wet AMD”. The three medicines named are (1) Eylea which is specific to ophthalmic use; (2) Lucentis which is specific to ophthalmic use; and (3) Avastin for various uses not including ophthalmic use. All three of these drugs are anti-vascular endothelial growth factor (“anti-VEGF”) agents. (paragraph 1)

The policy states that Avastin will be offered to certain patients with wet AMD “as the preferred treatment option”. (paragraph 2)

…this policy because of the significant difference in price between Avastin and the other two medicines. (paragraph 3)

The Claimants challenge the policy on four grounds:

i) it is premised on an error of law, namely that there is a lawful basis for the supply of Avastin to treat wet AMD patients;

ii) it fundamentally undermines the objective of Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “Directive”) and constitutes a breach of the duty of sincere cooperation in Article 4(3) of the Treaty of the European Union (“TEU”);

iii) it undermines patients’ rights of access to NICE recommended treatments;

iv) it introduces information for the patients (by means of a Q&A document and a Patient Information Leaflet which accompany the policy) which are misleading and inaccurate in material respects. (paragraph 5)

…the Claimants seek to argue, that the national healthcare authorities are prohibited from considering the efficacy or safety of Avastin to treat wet AMD. That seems to me to be an absurd proposition. It would give unbounded power to the pharmaceutical companies to decide which medicines to make available for which purposes… (paragraph 144iii)

I reject all four grounds of challenge. In consequence, this application for judicial review is dismissed. (paragraph 260)