Bayer Plc v NHS Darlington CCG
| Jurisdiction | England & Wales |
| Judge | Lord Justice Underhill,Lord Justice Floyd,Lady Justice Rose |
| Judgment Date | 25 March 2020 |
| Neutral Citation | [2020] EWCA Civ 449 |
| Date | 25 March 2020 |
| Docket Number | Case No: C1/2018/2744 C1/2018/2746 |
| Court | Court of Appeal (Civil Division) |
and
[2020] EWCA Civ 449
Lord Justice Underhill
(Vice-President of the Court of Appeal, Civil Division)
Lord Justice Floyd
and
Lady Justice Rose
Case No: C1/2018/2744 C1/2018/2746
IN THE COURT OF APPEAL (CIVIL DIVISION)
On appeal from
THE HIGH COURT OF JUSTICE, QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Mrs Justice Whipple
Royal Courts of Justice
Strand, London, WC2A 2LL
Ms Jemima Stratford QC and Ms Emily MacKenzie (instructed by Arnold & Porter Kaye Scholer LLP) for the First Appellant
Mr Thomas de la Mare QC and Mr Eesvan Krishnan (instructed by Covington & Burling LLP) for the Second Appellant
Mr David Lock QC and Mr David Blundell (instructed by Mills & Reeve LLP) for the Respondents
Ms Victoria Wakefield QC (instructed by Fieldfisher LLP) for the First Interested Party
Mr George Peretz QC (instructed by the Treasury Solicitor) for the Second Interested Party
Ms Monica Carss-Frisk QC (instructed by CMS Cameron McKenna Nabarro Olswang LLP) for the Third Interested Party
The other Interested Parties were not represented and did not appear
Hearing dates: 19 th–22 nd November 2019
Written submissions: 25 th and 27 th November 2019
Approved Judgment
| Introduction | [1] – [17] |
| The legislation | [18] – [49] |
| The EU Legislation: | [18] – [39] |
| Introduction | [18] – [20] |
| The Medicines Directive | [21] – [38] |
| The EMA Regulation | [39] |
| The Domestic Legislation: | [40] – [49] |
| Marketing Authorisation | [41] – [42] |
| Manufacturing Authorisation | [43] – [45] |
| Wholesale Dealer's Licence | [46] – [47] |
| Scope | [48] – [49] |
| The CJEU cases about compounded Avastin | [50] – [89] |
| Introduction | [50] – [51] |
| Apozyt | [52] – [71] |
| Introduction | [52] – [57] |
| Marketing Authorisation | [58] – [64] |
| Manufacturing Authorisation | [65] – [69] |
| The Subsequent Proceedings in Germany | [70] – [71] |
| AGCM | [72] – [75] |
| AIFA | [76] – [89] |
| Analysis of the Apozyt exemption | [90] – [118] |
| The Requirements | [90] – [93] |
| (1) Marketing Authorisation | [94] – [107] |
| (a) “Modification” | [94] – [101] |
| (b) Individual Prescriptions | [102] – [107] |
| (2) Manufacturing Authorisation | [108] – [117] |
| Overview | [118] |
| Judgment of Whipple J | [119] – [135] |
| Issues on the appeal | [136] – [140] |
| Mode 2: CB compounded “in-house” | [141] – [148] |
| Lawfulness | [141] – [143] |
| Reality | [144] – [148] |
| Mode 3: CB compounded by another NHS hospital pharmacy | [149] – [164] |
| Lawfulness | [150] – [162] |
| Section 10 of the Medicines Act | [152] – [156] |
| Wholesale Dealer's Licence | [157] – [162] |
| Reality | [163] – [164] |
| Mode 4: CB supplied by a commercial entity | [165] – [169] |
| Mode 1: Single vial use | [170] – [172] |
| Grounds of Appeal | [173] – [207] |
| Grounds 2 and 3 | [174] – [193] |
| Unlawful Undermining of the Regulatory Scheme | [177] – [185] |
| GMC Guidance | [186] – [192] |
| Conclusion on grounds 2 and 3 | [193] |
| Ground 4 | [194] – [195] |
| Ground 1 | [196] – [207] |
| Conclusion | [208] – [210] |
INTRODUCTION
This is an appeal against a judgment of Whipple J, handed down on 21 September 2018, dismissing an application for judicial review brought by the two Appellant pharmaceutical companies. The Appellants' challenge was to a policy (“the Policy”) adopted by the Respondent Clinical Commissioning Groups (“CCGs”) 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 will start by setting out a bare outline of the facts which give rise to the claim. In doing so I will refer to aspects of the EU drug licensing regime, and some other factual matters, that I will need to explain more fully at a later stage; but more detail generally can be found in Whipple J's comprehensive judgment.
CCGs and NHS Trusts. The relevant constitutional arrangements within the NHS are clearly set out by Whipple J at paras. 37–47 of her judgment. For present purposes I need only note the following. CCGs are statutory corporations established under Chapter A2 of Part 2 of the National Health Services Act 2006. They have a statutory responsibility to commission medical and healthcare services: see section 3 (1). Typically they do so from NHS Trusts, which are separate legal entities. The relationship between CCGs and NHS Trusts in commissioning services is contractual. There are standard conditions of service governing such contracts. One (service condition 4) requires the parties to co-operate with one another to facilitate the delivery of services. It is common ground that as a result of that duty NHS Trusts from whom the Respondents commission treatment of patients with WAMD will have to take the Policy into account in making their decisions about which drug to use. The Policy is thus not as such binding on the Trusts, but the CCGs' intention and no doubt expectation is that it will be followed.
Treatment of WAMD. WAMD is a very common disease worldwide, mainly (as the name indicates) among older people. It is now generally treated by the injection into the eye (“intravitreal injection”) of so-called “anti-VEGF agents”, which inhibit the over-production of the protein which causes the condition.
Avastin and its licensing. The first anti-VEGF agent to be used in this way was a drug produced by Roche 1 (the First Interested Party) marketed as Avastin, of which the active ingredient is bevacizumab. Avastin was originally developed for the treatment of colorectal cancer. It was approved for that purpose by the US Food and Drug Administration in 2004, and subsequently for treatments of other cancers, and it is now widely licensed for such purposes internationally. It was licensed by the European Commission on the recommendation of the European Medicines Agency (“the EMA”) for such use in the EU in January 2005. The use of Avastin for the wholly different purpose of treating WAMD was initially experimental but soon became widespread, principally in the US and in developing countries but also to some extent in Europe, including the UK. At the root of the issues in this case is the fact that Roche has never applied, whether to the FDA or by way of an EU marketing authorisation, to vary the
licence for Avastin to cover its use for the treatment of WAMD; indeed its formal “Summary of Product Characteristics” (“SMPC”) says in terms that it is “not formulated for intravitreal use”. Use of a medicine otherwise than for the purposes, or under the conditions, specified in its licence is generally described as “off-label”. Off-label use of a drug is not necessarily unsafe or otherwise inappropriate, provided that the clinician takes full responsibility for the decision to use itCompounding. Avastin is supplied in glass vials containing 4 ml of fluid. For the oncological uses for which it is licensed the contents of the vial are diluted before administration. The amount required for intravitreal use is no more than 0.1 ml per injection (undiluted). Typically, therefore, the contents of each 4ml vial are divided for such use between a large number of syringes. That process was referred to before Whipple J as “compounding” 2, and Avastin which has been divided in that way as “compounded bevacizumab” (“CB”); likewise, businesses or institutions which compound Avastin have been referred to as “compounders”. Whipple J herself also used the term “aliquoting”, which refers to the division of a larger quantity of a drug into equal (typically dose- or sample-size) quantities. As we shall see, in some of the EU case-law compounding is described as “repackaging”: that too is rather odd language, because it seems awkward to describe a syringe as a “package”, but, as we will see, the terminology appears to have been chosen in order to reflect the language of the applicable legislation.
Lucentis and Eylea. Meanwhile other anti-VEGF agents have been developed and, unlike Avastin, have received EU marketing authorisations specifically for intra-ocular use to treat WAMD. The two which are in widespread use in this country are:
– Lucentis (active ingredient ranibizumab), which was developed by Roche but which is licensed in Europe to Novartis. Lucentis received its EU marketing authorisation in 2007. It was originally supplied in glass vials containing 0.23 ml, together with a syringe into which the clinician would draw off the contents of the vial: thus both vial and syringe would be for single use only. Latterly, after (we were told) considerable regulatory effort, its marketing authorisation was extended to cover the supply of Lucentis in a pre-filled single-use syringe.
– Eylea (active ingredient aflibercept), which was developed by Bayer and which received its EU marketing authorisation in 2012. It is supplied in a single-use glass vial, from which the clinician will need to draw the requisite dose into a syringe.
Cost differential. The circumstance which has led to these proceedings is that the cost of treating WAMD using Lucentis or Eylea is enormously greater than that...
To continue reading
Request your trial
-
The King (on the application of) Ms Helen Timson v Secretary of State for Work and Pensions
...can be derived from Gillick, as it was interpreted by Underhill LJ in R (Bayer plc) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153 (“ Bayer”), at paragraph 200: (1) it was not the role of policy guidance to eliminate all uncertainty regarding its appli......
-
The Queen (on the application of Allan Leonardo Contreras Cardona) v Secretary of State for the Home Department
...the gloss that “permit” in this context means something like “sanction”) in R (Bayer plc) v NHS Darlington Clinical Commissioning Group [2020] PTSR 1153, paras 196–208 (Underhill LJ); see also para 214 (Rose LJ).” 43 Mr Malik submitted, at the hearing, that the test is the “real risk” test ......
- R (on the application of A) v Secretary of State for the Home Department
-
Safe Passage International v Secretary of State for the Home Department
...59 Different considerations may apply depending on the purposes for which and the bodies to whom the guidance was issued, see R (Bayer plc) v NHS Darlington CCG [2020] EWCA Civ 449 at paragraph 214. The test has been expressed in slightly different ways in later cases, see R (Tabbakh) v St......
-
A v. SSHD: Supreme Court Decides The Standards For Judicial Review Of Public Policies
...meaning 'sanction' or 'positively approve' (as observed by Underhill LJ in R (Bayer plc) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153 Applying Gillick, the Supreme Court identified (in ex parte A, at [46]) three types of cases in which the content of a......
-
A v. SSHD: Supreme Court Decides The Standards For Judicial Review Of Public Policies
...meaning 'sanction' or 'positively approve' (as observed by Underhill LJ in R (Bayer plc) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153 Applying Gillick, the Supreme Court identified (in ex parte A, at [46]) three types of cases in which the content of a......