Bayer Plc v NHS Darlington CCG

JurisdictionEngland & Wales
JudgeMrs Justice Whipple
Judgment Date21 September 2018
Neutral Citation[2018] EWHC 2465 (Admin)
CourtQueen's Bench Division (Administrative Court)
Docket NumberCase No: CO/5288/2017
Date21 September 2018

[2018] EWHC 2465 (Admin)

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

ADMINISTRATIVE COURT

Royal Courts of Justice

Strand, London, WC2A 2LL

Before:

Mrs Justice Whipple DBE

Case No: CO/5288/2017

Case No: CO/5357/2017

Between:
Bayer Plc
First Claimant
and
(1) NHS Darlington CCG
(2) NHS Durham Dales, Easington & Sedgefield CCG
(3) NHS Hambleton, Richmondshire & Whitby CCG
(4) NHS Hartlepool & Stockton CCG
(5) NHS Newcastle Gateshead CCG
(6) NHS North Cumbria CCG
(7) NHS Durham CCG
(8) NHS Northumberland CCG
(9) NHS North Tyneside CCG
(10) NHS South Tees CCG
(11) NHS South Tyneside CCG
(12) NHS Sunderland CCG
Defendants

and

(1) Novartis Pharmaceuticals UK Limited
(2) Roche Products Limited
(3) The Secretary of State for Health
(4) NHS England
First Interested Parties
Between:
Novartis Pharmaceuticals UK Limited
Second Claimant
(1) NHS Darlington CCG
(2) NHS Durham Dales, Easington & Sedgefield CCG
(3) NHS Hambleton, Richmondshire & Whitby CCG
(4) NHS Hartlepool & Stockton CCG
(5) NHS Newcastle Gateshead CCG
(6) NHS North Cumbria CCG
(7) NHS Durham CCG
(8) NHS Northumberland CCG
(9) NHS North Tyneside CCG
(10) NHS South Tees CCG
(11) NHS South Tyneside CCG
(12) NHS Sunderland CCG
Defendants
and
(1) The Secretary of State for Health (Acting by his Executive Agency the Medicines and Healthcare Products Regulatory Agency)
(2) NHS England
(3) The General Pharmaceutical Council
(4) Bayer Plc
(5) Roche Products Limited
Second Interested Parties

Jemima Stratford QC and Emily MacKenzie (instructed by Arnold and Porter) for the First Claimant

Tom de la Mere QC and Eesvan Krishnan (instructed by Covington & Burling LLP) for the Second Claimant

David Lock QC and David Blundell (instructed by Mills and Reeve) for the Defendants

Martin Chamberlain QC (instructed by Fieldfisher) for Roche Products Limited

Hearing dates: 10, 11, 13 and 16 July 2018

Approved Judgment

Mrs Justice Whipple

A. INTRODUCTION

1

By this action, Bayer Plc (“Bayer”) and Novartis Pharmaceuticals UK Ltd (“Novartis”) challenge the lawfulness of a policy adopted by the twelve Clinical Commissioning Groups (“CCGs”) who are Defendants to this action. 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 (whose INN, or international non-proprietary name, is aflibercept) for which Bayer holds a marketing authorisation which is specific to ophthalmic use; (2) Lucentis (INN ranibizumab) for which Novartis holds a marketing authorisation which is specific to ophthalmic use; and (3) Avastin (INN bevacumizab) for which Roche holds a marketing authorisation for various uses not including ophthalmic use. All three of these drugs are anti-vascular endothelial growth factor (“anti-VEGF”) agents.

2

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

3

The CCGs have adopted this policy because of the significant difference in price between Avastin and the other two medicines. When compounded (a term I shall explain below), Avastin costs around £28 per injection; Eylea costs around £816 per injection; Lucentis costs around £551 per injection. The actual prices will vary depending on a number of factors, including whether any confidential discount on price has been negotiated with the relevant pharmaceutical company.

4

The Defendant CCGs are from the North of England. Together they form the Northern Clinical Commissioning Group Joint Forum, which is an association without separate legal status; it is for that reason that each CCG within the Joint Forum has taken a decision, independently and separately, to adopt the policy.

5

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.

6

There is extensive material to set out by way of background. But in the end, the challenge pivots on a handful of key issues which I shall resolve, before coming to my conclusion on the four grounds advanced. Regrettably, this will be a long judgment. I hope that this index will assist in its navigation:

B. BACKGROUND Wet AMD

Introduction

[1] – [6]

Background

[7] – [66]

Wet AMD

[7] – [9]

Use of Avastin to treat wet AMD

[10] – [26]

The Policy

[27] – [30]

NICE Guideline NG 82

[31] – [36]

Clinical Commissioning Groups

[37] – [47]

Other Domestic Healthcare Supervisory or Regulatory Bodies

[48] – [66]

Law

[67] – [138]

EU Law – the Treaties

[67] – [73]

EU law – Directive 2001/83/EC (the “Directive”)

[74] – [91]

Domestic Law

[92] – [98]

The boundary between EU law and domestic law

[99] – [109]

Cases before CJEU concerning intravitreal use of Avastin

[110] – [138]

Key issues

[139] – [198]

i) Exclusive Competence of EMA

[140] – [147]

ii) Taking cost into account at the point of prescribing an unlicensed medicine

[148] – [153]

iii) Is Avastin safe for ophthalmic use?

[154] – [162]

iv) Is there a mature and established market for Avastin compounded for ophthalmic use?

[163] – [177]

v) Is CB an unlicensed medicine or off-label use of a licensed medicine?

[178] – [192]

vi) The relevant test in domestic law

[193] – [198]

The four modes

[199] – [238]

Preliminaries

[199] – [210]

Mode 1: Original Vial Use

[211] – [220]

Mode 2: Compounded Bevacizumab supplied by a hospital's own pharmacy

[221] – [231]

Mode 4: CB supplied by a commercial entity

[232] – [235]

Mode 3: CB supplied by another NHS pharmacy

[236] – [237]

Summary on Modes

[238]

Response to the Grounds of Challenge

[239] – [257]

Ground 1

[239]

Ground 2

[240] – [246]

Ground 3

[247] – [250]

Ground 4

[251] – [257]

Conclusion

[258] – [261]

7

Age-related Macular Degeneration is known as “AMD”. AMD has traditionally been classified as early, intermediate or late according to the stage of disease progression. Late AMD can be further classified as either ‘wet’ AMD (neovascular) or ‘dry’ AMD (advanced geographic atrophy). Wet AMD can rapidly lead to severe loss of central vision but can be treated if people at risk are identified early; in people with untreated wet AMD, over half will become visually impaired or blind within 3 years.

8

Currently, the exact cause of AMD is not known but factors such as age, family origin (prevalence is higher in people of white and Chinese family origin), diet and nutrition, genetics and smoking are thought to affect the risk of developing the disease. Socioeconomic factors also may result in later presentation and poorer outcomes.

9

So far as wet AMD is concerned, the loss of vision is caused by the abnormal growth of new blood vessels beneath the macula of the retina. That growth is stimulated by a protein known as vascular endothelial growth factor (“VEGF”). Wet AMD can be treated by products which inhibit VEGF, which are in consequence known as “anti-VEGF” agents or “VEGF inhibitors”. The most common primary treatment procedure for wet AMD is injection into the eye (intravitreal injection) of anti-VEGF agents.

Use of Avastin to treat wet AMD

10

The following paragraphs are adapted from the chronology prepared and agreed by the parties. They provide an overview of events leading to this judicial review.

11

Avastin is a VEGF inhibitor. The intellectual property rights to Avastin are held by a company within the Roche group. On 12 January 2005, the European Medicines Agency (“EMA”) granted Avastin a marketing authorisation for treatment of colorectal cancer under the “centralised procedure” under the Directive. That approval has since been extended to other oncology uses. The Summary of Product Characteristics (“SmPC”, a document required by Article 11 of the Directive which accompanies any medicine which has a marketing authorisation) was amended in 2012 to emphasise that Avastin is “not formulated for intravitreal use”. Roche has never applied for Avastin to be given a marketing authorisation for ophthalmic use.

12

Lucentis is also a VEGF inhibitor. The intellectual property rights to Lucentis are also held by a company within the Roche group. On 22 January 2007, Lucentis was granted a marketing authorisation for the treatment of wet AMD. Thus, Lucentis was the first VEGF inhibitor to be placed on the market specifically authorised for ophthalmic use. Permission to market Lucentis in Europe has been granted by Roche to Novartis.

13

On 27 August 2008, NICE issued technology appraisal guidance (a “TAG”, as to which see further below) for Lucentis (this was re-issued in May 2012). The TAG number is TA155.

14

In 2011/12, a group of Southern PCTs adopted a policy favouring the use of Avastin for ophthalmic use. This prompted a judicial review by Novartis against these various PCTs (this is known as the “SHIP JR” to reflect the names of the various PCTs then involved: Southampton, Hampshire, Isle of Wight, and Portsmouth). Permission for judicial review was granted (Thirlwall J), following which the JR was compromised by the PCTs agreeing to alter their policy.

15

The Medicines and...

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