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Drug Substitutability Case - Could This Be Another Option Following a No-Deal Brexit?

on Tuesday, 11 December 2018.

The recent NHS win against drug companies Bayer and Novartis could save the NHS hundreds of millions of pounds and will impact on the treatments available and chosen for NHS users in the future.

In 2017, 12 NHS clinical commissioning groups (CCGs) implemented a policy to offer a drug known as Avastin to people with a blindness-causing eye condition - wet age-related macular degeneration. Avastin was to be offered as a preferred treatment option instead of similar drugs Eylea and Lucentis, as it is approximately 95% cheaper and has been shown in clinical trials to be equally safe and effective.

The controversy around this policy stemmed from the fact that Avastin does not hold a marketing authorisation for use to treat the eyes ('ophthalmic' use) - it is licensed to treat cancer - although it is commonly used as such in other countries. Supply of Avastin in its usual form to treat the eyes is therefore off-license, and supply of Avastin in a form which has been compounded for ophthalmic use is unlicensed. Both Eylea and Lucentis do hold marketing authorisations for ophthalmic use. Bayer and Novartis, the respective holders of the Eylea and Lucentis marketing authorisations, made an application for judicial review to challenge the lawfulness of the CCGs' policy of preferring Avastin. Bayer and Novartis argued that supply of Avastin as an unlicensed or off-license product was unlawful.

The High Court determined that the relevant legal test to apply was whether the policy could be implemented in a way which did not lead to, permit or encourage unlawful acts. In applying this test, the Court found that each of the ways to supply Avastin for ophthalmic use (either the off-license usual product or the unlicensed compounded product) could be lawful.

Bayer and Novartis also argued that a clinician is not permitted to take account of cost at the point of prescribing. However, the High Court found that cost could and should be taken into account when deciding between various options which are of equivalent clinical effect and safety. The Court did not believe that marketing authorisations should protect the commercial interests of pharmaceutical companies in cases where "the jeopardy to the public purse is enormous". The licence holders' commercial interests should be balanced with the public benefit.


In this case, the court accepted that treating clinicians can lawfully choose an unlicensed or off-license treatment on grounds of cost. This was under the unusual circumstance that the treatment in question had been shown to be as safe and effective as the licensed treatments.

If concerns about the pharma supply chain post-Brexit are realised, the question is whether a similar approach could be adopted towards recommending and prescribing safe and effective unlicensed or off-license alternatives to drug treatments which are unavailable due to shortages?

We will be holding a PING (Pharmaceutical Industry Network Group) Conference, in association with EMIG, on 3 April 2019 just after Brexit date, on how Brexit is affecting the pharma supply chain. If you are interested in attending the event, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.