Table 1.

The four claims and the reasons for their dismissal by the Court

Claim	Ground for judicial review advanced by Bayer and Novartis	The Court’s conclusion
1	The Policy is based on an error of law, namely that there is no lawful basis for the supply of Avastin to treat wet AMD patients [23]	Argument rejected. Each mode of potential delivery of Avastin for ophthalmic use might be lawfully implemented [24]
2	The Policy fundamentally undermines the object of Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “Directive”, which regulates the legal basis for marketing authorisations) and constitutes a breach of the duty of sincere cooperation in Article 4(3) of the Treaty of the European Union because patient safety will be jeopardised and protection afforded to pharmaceutical companies will be damaged [25]	Argument rejected: a) Avastin is safe for ophthalmic use [26] b) Bayer and Novartis “significantly overstate the protection afforded to pharmaceutical companies by the Directive”. Their most persuasive argument concerned an orphan drug which Avastin is not. This is discussed further below c) The claimants are also wrong to claim that pharmaceutical companies would be at liberty to make alterations to medicines at will should the judicial review claim be rejected, given that the Directive requires pharmaceutical companies to seek marketing authorisation or at least an amendment to the Summary of Product Characteristics if the alterations are modest. The Court held that authorities of Member States are not subject to this same regime and are acting within their national competence in choosing a licensed or non-licensed alternative. These two processes should not be conflated. In any event, the Directive should not be read to “extend to protecting the commercial interests of the pharmaceutical companies in a case such as this, where the facts are unusual and the jeopardy to the public purse is enormous.” [27] It is notable that the impact of permitted off-label or unlicensed use on intellectual property protection afforded to innovator drugs was not pleaded
3	The Policy undermines patients’ right of access to NICE recommended treatments [48].	Argument rejected: Each patient is free to still choose Lucentis or Eylea if the patients’ wet AMD is within the parameters specified in NICE’s technology appraisal guideline for those therapies [50]
4	The Policy 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 [49].	Argument rejected. The documents were in draft form so there is no decision to challenge. Further, as to the Patient Information Leaflet document, the NHS Trusts, not the CCGs, would be responsible for its final formulation. Whilst the CCGs were responsible for the Q&A, that document was not inaccurate or misleading on the facts, for example because the use of the term “off-label” was understandable given the recent decisions of the European Court of Justice and the "confusion" around the term. [51].