21 Sep 2018 [2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD (Whipple J)
25 Mar 2020 [2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA (Underhill, Floyd, Rose LJJ)
05 Nov 2020 Permission to appeal to Supreme Court refused [2021] PTSR 297, SC(E) (Lord Hodge DPSC, Lady Arden, Lord Sales JJSC)
NATIONAL HEALTH SERVICE — Medicinal products — Commissioning policy — Clinical commissioning groups adopting policy on treatment of eye condition — Policy recommending use of particular product as preferred option for certain patients — Market authorisation for product only covering use for cancer treatment whereas claimants’ rival products having market authorisation specific to opthalmic use — Product recommended in policy used “off-label” by dividing original vials into smaller doses for injection into eye — Whether policy lawful — Whether contrary to European Union law — EU Treaty, art 4(3)EU — Parliament and Council Directive 2001/83/EC (as amended by Parliament and Council Directive 2004/27/EC, art 1), arts 2(1), 3, 5, 6(1)
[2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD
[2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA
R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD
Decision of Wipple J affirmed on partly different grounds
R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA
EU Enactments
EU Treaty, art 4(3)EU
Directive 2001/83/EC (Parliament and Council), arts 2(1), 3, 5, 6(1) (as amended)
Cases considered in: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA
Novartis Pharma GmbH v Apozyt GmbH (Case C- 535/11); (Case C-535/11); EU:C:2013:226; [2013] CN 517, ECJ Applied
Cases considered in: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD
Hecht-Pharma GmbH v Hohenzollern Apotheke (Case C-276/15); EU:C:2016:801, ECJ Considered
Novartis Pharma GmbH v Apozyt GmbH (Case C- 535/11); (Case C-535/11); EU:C:2013:226; [2013] CN 517, ECJ Considered
European Commission v Poland (Case C-185/10); EU:C:2012:181, ECJ Applied
R (Association of the British Pharmaceutical Industry) v Medicines and Healthcare Products Regulatory Agency (Case C-62/09); EU:C:2010:219; [2011] PTSR 391; [2011] All ER (EC) 102, ECJ Applied
A. Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-352/07), Sanofi Aventis SpA v Agenzia Italiana del Farmaco (AIFA) (C-353/07), IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (C-354/07), Schering Plough SpA v Agenzia Italiana del Farmaco (AIFA) (C-355/07), Bayer SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-356/07), Simesa SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-365/07), Abbott SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-366/07), Baxter SpA v Agenzia Italiana del Farmaco (AIFA) (C-367/07) and SALF SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-400/07). (Case C-400/07); (Case C-367/07); (Case C-366/07); (Case C-365/07); (Case C-356/07); (Case C-355/07); (Case C-354/07); (Case C-353/07); (Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); (Joined cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); EU:C:2007:627; EU:C:2009:217; [2009] ECR I-2495, ECJ Applied
Duphar BV v The Netherlands (Case C-238/82); (Case C-238/82); EU:C:1984:45; [1984] ECR 523, ECJ Applied
Cases cited in: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD
A. Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-352/07), Sanofi Aventis SpA v Agenzia Italiana del Farmaco (AIFA) (C-353/07), IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (C-354/07), Schering Plough SpA v Agenzia Italiana del Farmaco (AIFA) (C-355/07), Bayer SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-356/07), Simesa SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-365/07), Abbott SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-366/07), Baxter SpA v Agenzia Italiana del Farmaco (AIFA) (C-367/07) and SALF SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-400/07). (Case C-400/07); (Case C-367/07); (Case C-366/07); (Case C-365/07); (Case C-356/07); (Case C-355/07); (Case C-354/07); (Case C-353/07); (Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); (Joined cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); EU:C:2007:627; EU:C:2009:217; [2009] ECR I-2495, ECJ
Abcur AB v Apoteket Farmaci AB (Joined Cases C-544/13 and C-545/13); EU:C:2015:481; EU:C:2015:481 [2015] CN 1236, ECJ
Boddington v British Transport Police [1998] UKHL 13; [1999] 2 AC 143; [1998] 2 WLR 639; [1998] 2 All ER 203, HL(E)
Duphar BV v The Netherlands (Case C-238/82); (Case C-238/82); EU:C:1984:45; [1984] ECR 523, ECJ
European Commission v Kingdom of Sweden. (Case C-246/07); EU:C:2010:203, ECJ
European Commission v Poland (Case C-185/10); EU:C:2012:181, ECJ
F Hoffmann-La Roche Ltd v Autorità Garante della Concorrenza e del Mercato (Associazione Italiana delle Unità Dedicate Autonome Private di Day Surgery e dei Centri di Chirurgia Ambulatoriale (Aiudapds) intervening) (Case C-179/16); EU:C:2018:25; [2018] 4 CMLR 13, ECJ
Gillick v West Norfolk and Wisbech Area Health Authority [1985] UKHL 7; [1986] AC 112; [1985] 3 WLR 830; [1985] 3 All ER 402; [1986] 1 FLR 224, HL(E)
Hecht-Pharma GmbH v Hohenzollern Apotheke (Case C-276/15); EU:C:2016:801, ECJ
Laboratoires CTRS v European Commission (Case T-452/14) EU:T:2015:373, ECJ
Lynch v General Dental Council [2003] EWHC 2987 (Admin), QBD
Marleasing SA v La Comercial Internacional de Alimentación SA (Case C-106/89); EU:C:1990:395; [1990] ECR I-4135, ECJ
Montgomery v Lanarkshire Health Board [2015] UKSC 11; [2015] AC 1430; [2015] 2 WLR 768; 2013 SC 245; 2015 SC (UKSC) 63; [2015] 2 All ER 1031; 2015 SLT 189; 143 BMLR 47; [2015] Med LR 149; [2015] PIQR P13; [2015] WLR (D) 123; Case details, SC
Mossell (Jamaica) Ltd (T/A Digicel) v The Office of Utilities Regulation, Cable and Wireless J A Ltd and Centennial JA Ltd [2010] UKPC 1; Case details, PC
Novartis Pharma GmbH v Apozyt GmbH (Case C- 535/11); (Case C-535/11); EU:C:2013:226; [2013] CN 517, ECJ
Pfizer Ltd (R on the application of) v Secretary of State for Health [2002] EWCA Civ 1566, CA
R (A) v Secretary of State for Health (Alliance for Choice intervening) [2017] UKSC 41; [2017] 1 WLR 2492; [2017] 4 All ER 353; Case details, SC(E)
R (Association of the British Pharmaceutical Industry) v Medicines and Healthcare Products Regulatory Agency (Case C-62/09); EU:C:2010:219; [2011] PTSR 391; [2011] All ER (EC) 102, ECJ
R (Bristol-Myers Squibb Pharmaceuticals Ltd) v National Institute for Health and Clinical Excellence [2009] EWHC 2722 (Admin); [2009] WLR (D) 318, CA
R (C) v Berkshire West Primary Care Trust (Equality and Human Rights Commission intervening) [2011] EWCA Civ 247; [2011] PTSR D35, CA
R (Children’s Rights Alliance for England) v Secretary of State for Justice [2013] EWCA Civ 34; [2013] 1 WLR 3667; [2013] HRLR 17; [2013] WLR (D) 57, CA
R (Condliff) v North Staffordshire Primary Care Trust [2011] EWCA Civ 910; [2012] PTSR 460; [2012] 1 All ER 689; [2011] WLR (D) 256, CA
R (Eisai Ltd) v National Institute for Health and Clinical Excellence [2008] EWCA Civ 438; 11 CCLR 385, CA
R (Fisher) v North Derbyshire Health Authority (1997) 1 CCLR 150
R (Letts) v Lord Chancellor (Equality and Human Rights Commission intervening) [2015] EWHC 402 (Admin); [2015] 1 WLR 4497; [2016] 2 All ER 968; [2015] WLR (D) 90, QBD
R (Lounes) v Secretary of State for the Home Department (Case C-165/16); EU:C:2017:862; [2018] QB 1060; [2018] 3 WLR 375; [2017] WLR(D) 762, ECJ
R (Refugee Legal Centre) v Secretary of State for the Home Department [2004] EWCA Civ 1481; [2005] 1 WLR 2219; [2004] Imm AR 142, CA
R (Rogers) v Swindon NHS Primary Care Trust [2006] EWCA Civ 392; [2006] 1 WLR 2649, CA
R (S (A Child)) v NHS England [2016] Med LR 329
R (S) v Director of Legal Aid Casework [2016] EWCA Civ 464; [2016] 1 WLR 4733; [2017] 2 All ER 642; [2016] 2 FLR 392; [2016] WLR (D) 277, CA
R (SB) v NHS England [2017] EWHC 2000 (Admin); [2018] PTSR 576; [2017] WLR (D) 567, QBD
R (Shoesmith) v Ofsted [2011] EWCA Civ 642; [2011] ICR 1195; [2011] PTSR 1459; [2011] LGR 649; [2011] WLR (D) 184, CA
R (Tabbakh) v Staffordshire and West Midlands Probation Trust [2014] EWCA Civ 827; [2014] 1 WLR 4620; [2014] WLR (D) 278, CA
R (West Berkshire District Council) v Secretary of State for Communities and Local Government [2016] EWCA Civ 441; [2016] 1 WLR 3923; [2016] PTSR 982; [2016] WLR (D) 260, CA
R v North West Lancashire Health Authority, Ex parte A [2000] 1 WLR 977, CA
R v Secretary of State for Health, Ex p Pfizer Ltd (1999) 2 CCLR 270
Cases cited in: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA
A. Menarini Industrie Farmaceutiche Riunite Srl and Others v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-352/07), Sanofi Aventis SpA v Agenzia Italiana del Farmaco (AIFA) (C-353/07), IFB Stroder Srl v Agenzia Italiana del Farmaco (AIFA) (C-354/07), Schering Plough SpA v Agenzia Italiana del Farmaco (AIFA) (C-355/07), Bayer SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-356/07), Simesa SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-365/07), Abbott SpA v Ministero della Salute and Agenzia Italiana del Farmaco (AIFA) (C-366/07), Baxter SpA v Agenzia Italiana del Farmaco (AIFA) (C-367/07) and SALF SpA v Agenzia Italiana del Farmaco (AIFA) and Ministero della Salute (C-400/07). (Case C-400/07); (Case C-367/07); (Case C-366/07); (Case C-365/07); (Case C-356/07); (Case C-355/07); (Case C-354/07); (Case C-353/07); (Joined Cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); (Joined cases C-352/07 to C-356/07, C-365/07 to C-367/07 and C-400/07); EU:C:2007:627; EU:C:2009:217; [2009] ECR I-2495, ECJ
Abcur AB v Apoteket Farmaci AB (Joined Cases C-544/13 and C-545/13); EU:C:2015:481; EU:C:2015:481 [2015] CN 1236, ECJ
Aventis Pharma Deutschland GmbH v Kohlpharma GmbH and MTK Pharma Vertriebs-GmbH. (Case C-433/00); EU:C:2002:510, ECJ
Cranage Parish Council (2) Bennion (James) (3) Oakley (John) (4) Worthington (Lillian) v (1) First Secretary of State (2) Secretary of State for Trade & Industry(3) Scottish Power UK plc (4) Scottish Power Gas Ltd [2004] EWHC 2949 (Admin), QBD
Duphar BV v The Netherlands (Case C-238/82); (Case C-238/82); EU:C:1984:45; [1984] ECR 523, ECJ
European Commission v Poland (Case C-185/10); EU:C:2012:181, ECJ
F Hoffmann-La Roche Ltd v Autorità Garante della Concorrenza e del Mercato (Associazione Italiana delle Unità Dedicate Autonome Private di Day Surgery e dei Centri di Chirurgia Ambulatoriale (Aiudapds) intervening) (Case C-179/16); EU:C:2018:25; [2018] 4 CMLR 13, ECJ
Fabio Caronna (Case C-7/11); EU:C:2012:396, ECJ
Gillick v West Norfolk and Wisbech Area Health Authority [1985] UKHL 7; [1986] AC 112; [1985] 3 WLR 830; [1985] 3 All ER 402; [1986] 1 FLR 224, HL(E)
Hecht-Pharma GmbH v Hohenzollern Apotheke (Case C-276/15); EU:C:2016:801, ECJ
ITV Broadcasting Ltd v TVCATCHUP Ltd [2011] EWHC 1874 (Pat), Ch D
Laboratoires CTRS v European Commission (Case T-452/14) EU:T:2015:373, ECJ
Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) (Case C-29/17); EU:C:2018:931, ECJ
Novartis Pharma GmbH v Apozyt GmbH (Case C- 535/11); (Case C-535/11); EU:C:2013:226; [2013] CN 517, ECJ
Oakley Inc v Animal Ltd (Secretary of State for Trade and Industry intervening) [2005] EWCA Civ 1191; [2006] Ch 337; [2006] 2 WLR 294, CA
R (A) v Secretary of State for Health [2009] EWCA Civ 225; [2010] 1 WLR 279; [2009] PTSR 1680; [2010] 1 All ER 87; The Times, April 2, 2009, CA
R (Association of the British Pharmaceutical Industry) v Medicines and Healthcare Products Regulatory Agency (Case C-62/09); EU:C:2010:219; [2011] PTSR 391; [2011] All ER (EC) 102, ECJ
R (C) v Berkshire West Primary Care Trust (Equality and Human Rights Commission intervening) [2011] EWCA Civ 247; [2011] PTSR D35, CA
R (Daly) v Secretary of State for the Home Department [2001] UKHL 26; [2001] 2 AC 532; [2001] 2 WLR 1622; [2001] 3 All ER 433, HL(E)
R (Detention Action) v First-tier Tribunal (Immigration and Asylum Chamber) [2015] EWCA Civ 840; [2015] 1 WLR 5341; [2016] 3 All ER 626; [2015] WLR (D) 352, CA
R (Letts) v Lord Chancellor (Equality and Human Rights Commission intervening) [2015] EWHC 402 (Admin); [2015] 1 WLR 4497; [2016] 2 All ER 968; [2015] WLR (D) 90, QBD
R (Raissi) v Secretary of State for the Home Department [2007] EWHC 243 (Admin); [2007] 4 All ER 225, DC
R (Refugee Legal Centre) v Secretary of State for the Home Department [2004] EWCA Civ 1481; [2005] 1 WLR 2219; [2004] Imm AR 142, CA
R (Rogers) v Swindon NHS Primary Care Trust [2006] EWCA Civ 392; [2006] 1 WLR 2649, CA
R (Tabbakh) v Staffordshire and West Midlands Probation Trust [2014] EWCA Civ 827; [2014] 1 WLR 4620; [2014] WLR (D) 278, CA
R (West Berkshire District Council) v Secretary of State for Communities and Local Government [2016] EWCA Civ 441; [2016] 1 WLR 3923; [2016] PTSR 982; [2016] WLR (D) 260, CA
R v North West Lancashire Health Authority, Ex parte A [2000] 1 WLR 977, CA
United States of America v Nolan [2015] UKSC 63; [2016] AC 463; [2015] 3 WLR 1105; [2015] ICR 1347; [2016] 1 All ER 857; [2015] WLR (D) 441; Case details, SC(E)
Cases citing: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2018] EWHC 2465 (Admin); [2019] PTSR 922; [2018] WLR (D) 589, QBD
R (D) v Hackney London Borough Council [2019] EWHC 943 (Admin); [2019] PTSR 1947; [2019] WLR(D) 228, QBD
R (FDJ) v Secretary of State for Justice (Lamble intervening) [2021] EWHC 1746 (Admin); [2021] 1 WLR 5265; [2021] WLR(D) 367, DC
R (ZK) v Redbridge London Borough Council [2020] EWCA Civ 1597; [2021] ELR 238, CA
R (ZK) v Redbridge London Borough Council [2019] EWHC 1450 (Admin); [2019] ELR 482, QBD
Cases citing: R (Bayer PLC) v NHS Darlington Clinical Commissioning Group [2020] EWCA Civ 449; [2020] PTSR 1153; [2020] WLR (D) 199, CA
Hussain v Secretary of State for the Home Department [2022] EWCA Civ 145; [2022] PTSR 1164; [2022] WLR(D) 82, CA
L, R (On the Application Of) v Hampshire County Council [2022] EWHC 49 (Admin), QBD
Newron Pharmaceutical SpA v Comptroller General of Patents, Trademarks and Designs [2023] EWHC 1471 (Ch), Ch D
R (A) v Secretary of State for the Home Department [2021] UKSC 37; [2021] 1 WLR 3931; [2022] 1 All ER 177, SC(E)
R (Advinia Health Care Ltd) v Care Quality Commission [2022] EWHC 965 (Admin); [2022] PTSR 1411; [2022] WLR(D) 189, QBD
R (BF (Eritrea)) v Secretary of State for the Home Department (Equality and Human Rights Commission intervening) [2021] UKSC 38; [2021] 1 WLR 3967; [2022] 1 All ER 213, SC(E)
R (Bell) v Tavistock and Portman NHS Foundation Trust [2021] EWCA Civ 1363; [2022] PTSR 544; [2022] 1 All ER 416; [2022] 1 FLR 69; [2021] WLR(D) 490, CA
R (Cardona) v Secretary of State for the Home Department [2021] EWHC 2656 (Admin); [2022] 1 WLR 1855; [2021] WLR(D) 505, QBD
R (Safe Passage International) v Secretary of State for the Home Department [2021] EWHC 1821 (Admin); [2022] 1 WLR 165; [2021] WLR(D) 372, DC
R (Timson) v Secretary of State for Work and Pensions [2022] EWHC 2392 (Admin); [2023] PTSR 85; [2022] WLR(D) 380, KBD
R (TransActual CIC) v Secretary of State for Health and Social Care [2024] EWHC 1936 (Admin); [2024] WLR(D) 361, KBD
R (United Trade Action Group Ltd) v Transport for London [2021] EWCA Civ 1197; [2022] RTR 2, CA
R (W) v Secretary of State for the Home Department (Project 17 intervening) [2020] EWHC 1299 (Admin); [2020] 1 WLR 4420; [2020] WLR(D) 310, DC
R (ZK) v Redbridge London Borough Council [2020] EWCA Civ 1597; [2021] ELR 238, CA
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