Home > News > High Court gives the NHS the green light to use off-label drugs in preference to on-label prescribing

On Friday 21 September Whipple J dismissed an application for Judicial Review by pharmaceutical companies Bayer and Novartis which had attempted to challenge a policy adopted by 12 NHS clinical commissioning groups which recommended that NHS clinicians should offer patients a choice between 2 licensed medicines for the treatment of wet age-related macular degeneration (marketed by Bayer and Novartis) and a much cheaper drug, Avastin, which had an EU marketing authorisation as a cancer drug.

The CCGs wanted to adopt the policy because, according to NICE, all 3 drugs had equal clinical effectiveness but their assessment was that if significant numbers of patients agreed to be treated with Avastin, millions of pounds would become available for the CCGs to fund NHS treatment for other patients.  Accordingly, giving wet AMD patients the choice between drugs would be of considerable overall benefit to the NHS.

The pharmaceutical companies which marketed the licenced drugs mounted a wide-ranging challenge to the CCG policy, based on a variety of both European and domestic law arguments.  However, in a 102 page judgment, all of the arguments raised by the pharmaceutical companies were comprehensively dismissed by the Judge.

The breadth of the issues that the Judge was required to address in order to reach a decision of this Judicial Review means the judgment will have far-reaching implications for the NHS.  In summary, the Judge found as follows:

  • The Judge comprehensively rejected the Claimants’ submission that the European Medicines Agency has exclusive competence to decide whether a drug or other medicinal product is safe, clinically effective or cost-effective.  The Judge found that both CCGs and NICE were legally competent to make their own decisions about whether drugs were safe, clinically effective or cost-effective:  see §140 to §147;
  • The Judge rejected the Claimants’ argument that a clinician is not permitted to take account of the cost of the drug at the point of prescribing.  The Judge found that doctors had a professional duty to make the most appropriate use of NHS resources: see §148 to §153;
  • The Judge decided that she did not need to consider whether Avastin was safe for ophthalmic use because that was a decision which the CCGs were entitled to make for themselves.  She noted that there was no proper basis to challenge the CCGs decision that using Avastin for wet AMD patients was safe and clinically effective.  In any event the Judge placed considerable weight on the fact that a 500 page report by NICE which had been published subsequent to the CCG decisions concluded that “Avastin is as safe as the licensed alternatives” (see §160).  She therefore rejected the application by the Claimants to rely on the expert evidence which called into question the safety of using Avastin for ophthalmic use [§154 to §162];
  • The Judge decided that there was a well-established mature market in compounded Avastin (referred to in the judgment is compounded bevacizumab (“CB”)) both in the UK and in parts of Europe for intravitreal use [see §163 to §177].  That finding has some relevance for the later parts of her judgment;
  • The Judge noted that the Medicine and Healthcare Regulatory Products Authority (“MHRA”) had described CB is an “unlicensed medicine”.  The Judge describes the present position as “highly unsatisfactory” on this point and expressly invited the MHRA to review their position.  Whilst the Judge states that she accepts the MHRA’s view as expressed in 2011 to the effect that CB is an unlicensed medicine, she decided that this conclusion was not relevant to determining whether the CCG policies were lawful or unlawful;
  • The next issue was the test that the Judge should apply to decide whether a policy is lawful.  The Judge decides that a policy would be unlawful if the only lawful method or methods of implementation are unrealistic or would constitute only a tiny part of the anticipated supply:  see §196;
  • The Judge then considered the four potential modes of supply which the CCGs had identified.  She decided at §220 that original vial use would be lawful because it does not require a fresh marketing authorisation and would not be prohibited under EU law;
  • She next concluded that an NHS Trust which compounded bevacizumab in its own pharmacy would be acting lawfully and not require marketing authorisation to supply the resultant CB to the hospital his own clinicians [§221 to §235];
  • The Judge then considered whether it would be lawful for a commercial entity to compound Avastin.  The Judge set out a number of ways in which this could be lawful but she refused to decide whether any such supply would be unlawful because, having decided that the established market exists for this supply, she was concerned that the commercial compounders were not before the court and thus she did not know what arguments they might wish to advance to persuade the court that their established practices were lawful.  However in a crucial passage she said, at §232, that “In any event, even if that market is built on repeated breaches of EU law as the Claimants assert, I am not persuaded that an NHS trust would necessarily be in breach of EU law and taking advantage of it to purchase CB for ophthalmic use”;
  • Finally, the Judge considered intra-NHS supply.  She did not directly consider whether such a supply was outside EU law because of article 168(7) of the Treaty for the Functioning of the European Union, as the CCGs had argued.  She decided instead that there were a number of potential ways in which this supply could be lawfully provided and, in any event, explained that whether any particular supply would be lawful would be a fact-specific decision depending on the precise circumstances of the supply.
  • The Judge dismissed the Claimants’ argument that the CCGs’ policy undermined the NICE Technology Appraisal Guidance.  That argument was summarily dismissed on the basis that NICE requires NHS patients to have options, and that the policy does not breach that duty  [§247 to §250];
  • Finally the Judge dismissed the Claimants’ complaints about the proposed Patient Information Leaflet.  The Judge decided at §256 that “none of the points made by the Claimants about this document has any substance”.

Hence, in summary, the Judge decided that all four modes of implementation of the policy are potentially lawful for the NHS Trusts and that the NHS Trusts would be acting entirely lawfully in implementing the choice policy.

It remains unclear at this point whether the pharmaceutical companies will be seeking permission to appeal this judgment to the Court of Appeal.

The judgment can be found here.

A BBC press report can be found here.

The CCGs were represented by David Lock QC and David Blundell, instructed by Dawn Brathwaite of Mills & Reeve. Charles Banner advised the Secretary of State for Health throughout, instructed by the Government Legal Department.

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