Bayer v NHS Darlington Appeal

Darlington Memorial Hospital

Steven Fruitsmaak / CC BY (https://creativecommons.org/licenses/by/3.0)

Jane Lambert

Court of Appeal (Lords Justice Underhill and Floyd and Lady Justice Rose) Bayer Plc and Another v NHS Darlington Clinical Commissioning Group and others [2020] EWCA Civ 449 (25 March 2020)

This was an appeal by Bayer Plc and Novartis Pharmaceuticals UK Limited against Mrs Justice Whipple's judgment in Bayer Plc v NHS Darlington Clinical Commissioning Groups and others : [2019] PTSR 922, [2018] WLR(D) 589, [2018] EWHC 2465 (Admin) which I blogged in Bayer Plc v NHS Darlington CCG and Others 2 Oct 2018. In her judgment, Mrs Justice Whipple dismissed applications for judicial review by Bayer and Novartis of a decision by NHS Darlington and other Clinical Commissioning Groups in Northeast England that the NHS Trusts from which they commission services should use a drug called Avastin as the preferred treatment option for an eye disease generally referred to as wet age-related macular degeneration ("WAMD").

I set out the reason for the CCGs' decision in my case note:

"Avastin costs £28 per injection compared to £816 for Bayer's EYLEA and £551 for Novartis's Lucentis.  The CCGs had made their decision to save money."

There was, however, a problem in that Avastin had been developed for the treatment of cancer and not ophthalmology whereas the other two drugs had been authorized by the European Medicines Agency for treating WAMD. The learned judge decided that Avastin could safely and lawfully be used to treat WAMD in the UK even though the EMA had not authorized such use and the reason for choosing Avastin was to save money.

Bayer and Novartis appealed on a number of grounds which were condensed into the following issues by their counsel:

"Ground 1: Did the Judge get the test for reviewing the lawfulness of the Policy wrong or wrongly apply the test?
Ground 2: Was the Judge wrong to find that prior prescriptions were not part of the ratio in Apozyt?
Ground 3: Was the Judge wrong to find Modes 2 (own-hospital), 3 (intra-NHS) and 4 (commercial) supply were potentially lawful?
Issues:
3A – Is CB a modification of Avastin such that, when it is supplied under any of modes 2-4, that is necessarily a new placing on the market?
3B – Is there in any event a placing on the market in relation to modes 2-4 because there is a release into the distribution chain for each of those modes?
3C – …
3D – Does the Policy unlawfully undermine the Directive (including if all supply is done under the Art. 3 compounding exemption?)
3E – Is the Policy contrary to GMC guidance and, if so, does that make it unlawful?
Ground 4: Was the Judge wrong to find that Mode 1 (original-vial use) was potentially lawful?"

The appeal came on before Lord Justices Underhill and Floyd and Lady Justice Rose between 19 and 22 and from 25 to 27 Nov 2019.   The hearing was videoed and anyone who wishes to hear the arguments will find them on the Bayer PLC & others –v- NHS Darlington CCG & others page of the Court of Appeal's website. The Court of Appeal delivered its judgment on 25 March 2020.

To understand those issues, it is necessary to know that Apozyt refers to Case C-535/11Novartis Pharma GmbH v Apozyt GmbH   EU:C:2013:226, ECLI:EU:C:2013:226, [2013] EUECJ C-535/11_J. That was a reference to the Court of Justice of the European Union from the Hamburg Landgericht in proceedings brought against Apozyt by Novartis for breach of art 6 of The Medicines Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p. 67–128).  Apozyt loaded syringes for use in ophthalmology with small doses of Avastin which had been supplied in 4-millilitre vials for administration to cancer patients and distributed those syringes to doctors treating patients for WAMD.  This process of loading Avastin into vials is known as "compounding" and "CB" is short for "compounded bevacizumab" - bevacizumab being the active ingredient of Avastin.  The question for the Court was whether such compounding needed marketing and manufacturing authorization,

The lead judgment of the Court of Appeal was delivered by Lord Justice Underhill.  His lordship mentioned Guideline NG82 on "The Diagnosis and Management of Age-Related Macular Degeneration" from the National Institute for Health and Care Excellence which found that "no clinically significant differences in effectiveness and safety between the different anti-VEGF treatments have been seen in the trials considered by the guideline committee",   He discussed in detail the CCGs' policy to recommend the use of Avastin.  He reviewed the EU and national legislation and the case law on CG including Apozyt.   Finally, the Court analysed Mrs Justice Whipple's judgment before addressing the above-mentioned issues.

The Court of Appeal upheld Mrs Justice Whipple's judgment that it is legally open to NHS Trusts to use compounded Avastin off-label to treat WAMD patients in line with the CCGs' policy. The preparation and supply of Avastin in that form does not require marketing or manufacturing authorisation provided that the Court of Justice's requirements in Apozyt are observed.  The Court also decided that it was not contrary to General Medical Council guidance for clinicians to recommend it to patients in preference to Lucentis or Eylea even though that the preference may be based on cost considerations.  However, Lord Underhill and indeed the rest of the Court differed from the judge below on the following points:

"(1) I do not believe that the Court is able to rule either way on the lawfulness of Trusts obtaining CB from commercial suppliers as opposed to from a hospital pharmacy. That is regrettable but it is the result of the way in which the issues have come before the Court. I hope that my analysis of the legislation will at least assist Trusts in reaching a decision on this question if it is a course which they are interested in pursuing.
(2) If Trusts wish to obtain CB from a hospital pharmacy, whether within their own Trust or from elsewhere in the NHS, that will only be lawful if an individual (prior) prescription system is in place."

Counsel for the claimants and the Association of the British Pharmaceutical Industry had warned that upholding the lower court's decision would open the door to widespread evasion of the requirements of the licensing system, which are essential for patient safety, in the interests of saving costs. The Court regarded those concerns as unfounded.  Their decision rested on the very narrow exception allowed by the Court of Justice in the particular circumstances of the Apozyt case and there was no question of its being widened.

Although this is not an intellectual property case I have discussed it because some of the issues are the same.   For instance, the ophthalmic use of Avastin was a second medical use and the need for marketing authorization is the reason why supplementary protection certificates were created.  Also, one of the Lord Justice who heard the appeal was Lord Justice Floyd who had been a Patents Court judge and had spent his career at the intellectual property bar.   

Anyone wishing to discuss this case note or any of the issues arising in it is invited to contact me through my message form rather than our main telephone number as everybody is working from home during the coronavirus emergency.