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EU LAW OF COMPETITION AND TRADE IN THE PHARMACEUTICAL SECTOR

PABLO FIGUEROA, ALEJANDRO GUERRERO

This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector.     Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry.  The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
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TABLE OF LEGISLATION

EUROPEAN UNION

Charters

Charter of Fundamental Rights of the European Union [2012] OJ C326/391

Art 35 9.3

Decisions

Council Decision 2011/167/EU of 10 March 2011 authorising enhanced cooperation in the area of the creation of unitary patent protection [2011] OJ l76/53 12.17

Directives

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products [1965] OJ 369/65 11.17, 12.92, 12.96, 12.117, 13.2, 13.3, 13.7

Commission Directive 70/50/EEC of 22 December 1969 based on the provisions of Article 33(7), on the abolition of measures which have an effect equivalent to quantitative restrictions on imports and are not covered by other provisions adopted in pursuance of the EEC Treaty [1970] OJ L13/29 10.27

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products [1975] OJ L147/1 11.17, 13.7

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products [1975] OJ L147/13 11.17, 13.7

Art 5 11.19

Arts 8–13 11.19

First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (Trade Marks Directive) 11.38

Art 7 11.38

Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems [1988] OJ L40/8 (Transparency Directive) 10.27, 10.35, 11.23, 11.43, 13.169, 13.170, 13.171, 13.174, 13.175

Recital 6 13.170

Art 1(1) 11.46

Art 2(1) 13.171

Art 2(2) 13.172

Art 5 13.174

Art 6 13.176

Art 7 13.182

Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens [1989] OJ L142/14 13.7

Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals [1989] OJ L142/16 13.7

Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma [1989] OJ L181/44 13.7

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use [1992] OJ L113/1 13.7

Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets [1992] OJ L113/8 13.7

Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use [1992] OJ L113/13 13.7

Council Directive 92/73/EEC of 22 September 1992 widening the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to medicinal products and laying down additional provisions on homeopathic medicinal products [1992] OJ L297/8 13.7

Council Directive 93/42/EC of 14 June 1993 concerning medical devices [1993] OJ L169/1

Art 1(2)(a) 7.1. 7.60

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the law, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Clinical Trials Directive) [2001] OJ L121/34 12.116, 13.57, 13.122, 13.123, 13.132, 13.134, 13.135, 13.148, 13.158, 13.159, 13.160, 13.161

Art 2(b) 13.124

Art 2(k) 13.123

Art 2(m) 13.148

Art 2(n) 13.148

Art 2(o) 13.149

Art 3(e) 13.124

Art 3(f) 13.125

Art 4 13.127

Art 4(e) 13.127

Art 5 13.127

Art 6(2) 13.129

Art 6(5)–(7) 13.130

Art 7 13.132, 13.133

Art 9 13.128, 13.138

Art 10(a) 13.142

Art 10(b) 13.144, 13.146

Art 13(3) 13.135

Art 14 13.136

Arts 16–18 13.149

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [2001] OJ L311/1 11.17, 12.92, 12.95, 12.100, 12.108, 12.117

Title III 12.110

Art 8 12.110

Art 26.3 12.110

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, as amended by Directive 2004/27/EC [2001] OJ L311/67 3.75, 10.93, 11.17, 11.19, 12.84, 12.92, 12.95, 12.100, 12.108, 12.116, 12.117, 12.118, 13.3, 13.7, 13.32, 13.57, 13.102, 13.186

Art 1.2 12.91

Art 10.1 12.84

Art 10.6 12.82, 12.88

Art 54(a) 17.11

Community Code relating to medicinal products for human use 13.21, 13.22, 13.43, 13.45, 13.48, 13.51, 13.64, 13.94, 13.186, 13.191, 13.193, 13.196, 13.201, 13.203

Title IX Ch 4 13.206

Art 1(2) 13.18

Art 1(4) 13.25

Art 1(5) 13.46

Art 1(6) 13.43

Art 1(7) 13.45

Art 1(8) 13.45

Art 1(9) 13.45

Art 1(10) 13.28

Art 1(30) 13.50

Art 1(31) 13.50

Art 1(32) 13.50

Art 2(2) 13.21

Art 4(5) 13.36, 13.37

Art 6 13.55

Art 6(1) 13.94

Art 6(2) 13.94

Art 7 13.45

Art 10 13.108, 13.109, 13.116

Art 10a 13.202

Art 10(4) 13.111

Art 14 13.48

Art 16(a)(1) 13.52, 13.53

Art 16(a)(2) 13.54

Art 16(2) 13.49

Art 24(4) 13.89

Art 101 13.187

Art 102 13.187

Art 103 13.191

Art 104(1) 13.193

Art 104(3) 13.194

Art 107b(1) 13.200

Art 107c(2) 13.201

Arts 107i to 107k 13.203

Annex I 13.67, 13.158

Annex I Pt IV 13.32, 13.33

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [2003] OJ L33/30 13.30

Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts [2004] OJ L134/114 8.1, 8.220

Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use [2004] OJ L136/34 12.84, 12.100, 13.111

Art 8 12.82

Art 10(6) 3.75

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market [2007] OJ L247/21 7.1

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products [2009] OJ L168/33 11.17

Directive 2009/120/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products [2009] OJ L242/3 13.32

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use [2010] OJ L348/74 13.186

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2001 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products [2011] OJ L174/74 (Falsified Medicines Directive) 10.93

Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC [2014] OJ L94/65 8.1, 8.98, 8.219

Recital 59 8.220

Art 1 8.1

Art 2.1(11) 8.91

Art 2.1(12) 8.91

Art 5(4)(d) 8.219

Art 12 8.200

Art 19 8.91

Art 32.2(a) 8.58

Art 35(2) 8.148

Art 42.4 8.135

Art 47 8.132

Art 49 8.132, 8.141

Art 51 8.132

Art 63 8.91

Art 71 8.91, 8.109

Art 71.2 8.60

Art 91 8.1

Annex V, Pt BI, para.7 8.141

Notices

Commission Notice on the Definition of the Relevant Market for the purposes of Community competition law [1997] OJ C372/5 3.19, 3.84, 7.6, 8.128

Regulations

EEC Council Regulation No 17/62: First Regulation implementing Articles 85 and 86 of the Treaty [1962] OJ 13/204 16.1

Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community [1971] OJ L149/2 11.23, 11.50

Art 22 11.50

Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85(3) of the Treaty to categories of agreements, decisions and concerted practices [1971] OJ L285/46 3.27

Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products [1992] OJ L182/1 1.34, 2.159, 3.220, 12.94, 12.116, 12.117, 13.57, 17.70, 18.64

Art 1 3.81, 3.82

Art 3 12.117

Art 3(b) 12.117

Art 8(1)(a)(iv) 12.117

Art 8(1)(c) 12.117

Art 19 12.117

Art 19(1) 12.117

Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human veterinary use and establishing a European Agency for the Evaluation of Medicinal Products [1993] OJ L214/1 13.13, 13.69

Regulation (EC) No 3295/94 of 22 December 1994 laying down measures to prohibit the release for free circulation, export, re-export or entry for a suspensive procedure of counterfeit and pirated goods [1994] OJ L341/8 9.22

Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products [1996] OJ L198/30 12.94

Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [2000] OJ L18/1 13.60, 15.47

Art 8(2) 13.63

Art 8(3) 13.63

Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty [2003] OJ L1/1 3.8, 3.27, 3.40

Art 3 17.3

Art 11(6) 17.78

Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines [2003] OJ L135/5 9.43, 9.44, 9.45, 9.46, 9.47, 9.48, 9.49, 9.50

Recital 9 9.45

Art 1(2)(a) 9.47

Art 2 9.46

Art 3 9.46

Art 4(2) 9.46

Art 7 9.46

Art 8 9.45

Annex II 9.47

Annex III 9.46

Annex IV 9.47

Annex V 9.46

Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights [2003] OJ L196/7 9.22, 9.23, 9.25, 9.30, 9.41

Recital 8 9.28, 9.30

Art 1(1)(b) 9.22

Art 2(b) 9.22

Art 2(c)(i) 9.22

Art 2(c)(ii) 9.22

Art 2(c)(iii) 9.22

Art 2(c)(iv) 9.22

Art 2(c)(v) 9.22

Art 11(1) 9.22

Art 17(b) 9.22

Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings [2004] OJ L24/1 (EC Merger Regulation) 6.65, 7.4, 7.100, 8.147, 17.81, 20.45

Art 2 7.90

Art 2(2) 7.4

Art 2(3) 7.4

Art 4(5) 20.45

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [2004] OJ L136/1 11.17, 12.116, 13.32, 13.40, 13.69, 13.71, 13.72, 13.102

Art 3(2) 13.72

Art 6 13.79

Art 10 13.78

Art 14 13.78

Art 14(7) 13.78

Art 14(8) 13.78

Art 19 13.78

Art 20 13.78

Art 57 13.96

Annex 13.71, 13.72

Commission Regulation (EC) No 802/2004 of 7 April 2004 implementing Council Regulation (EC) No 139/2004 on the control of concentrations between undertakings [2004] OJ L133/1 6.65

Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems [2006] OJ L157/1 9.43, 9.51, 9.52, 9.53, 12.89, 12.90, 12.91

Art 1 12.91

Art 2(1) 12.91

Art 4 12.91

Art 5 9.52

Art 6(3)(a) 9.52

Art 6(3)(c) 9.52

Art 6(3)(f) 9.52

Art 7 9.52

Art 8(1)(b)(ii) 9.52

Art 10(2) 9.52

Art 10(3)(b) 9.52

Art 10(3)(d) 9.52

Art 10(4) 9.52

Art 13 12.91

Art 14 12.91

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 [2006] OJ L378/1

Title V 13.59

Recital 4 12.116

Art 36 12.116, 13.57, 13.59

Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 [2007] OJ L324/121 13.32, 13.33, 13.35, 13.36, 13.38, 13.39, 13.40, 13.42

Art 2(1) 13.35

Art 2(1)(b) 13.33

Art 2(1)(d) 13.35

Art 6 13.35

Art 9 13.35

Annex I 13.34

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [2008] OJ L334/7 13.91

Art 10 13.92

Annex I 13.91

Council Regulation (EC) No 207/2009 of 26 February 2009 on the Community trade mark [2009] OJ L78/1 9.31

Art 9(4) 9.31

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1) 4.3, 12.6, 12.96, 12.102, 12.112, 12.117, 12.127, 18.64

Preamble 12.93

Recital 4 12.94

Recital 6 12.94

Art 1 12.95

Art 1(b) 12.114

Art 1(c) 12.95, 12.114

Art 2 12.95, 12.110

Art 3 12.100, 12.117, 12.122

Art 3(a) 12.101, 12.103, 12.104, 12.105, 12.106, 12.107, 12.114

Art 3(b) 12.108, 12.109, 12.110, 12.118

Art 3(c) 12.111, 12.113

Art 3(d) 12.97, 12.110

Art 4 12.99

Art 5 12.99

Art 7 12.121

Art 8 12.121

Art 13 12.115, 12.117, 12.118, 12.120

Art 13.1 12.119

Art 15 12.122

Commission Regulation (EU) No 330/2010 of 20 April 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of vertical agreements and concerted practices [2010] OJ L102/1 4.28, 4.77, 4.85, 20.27

Art 3.1 20.27

Commission Regulation (EU) No 1217/2010 of 14 December 2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements [2010] OJ L335/36 3.27, 3.35, 3.252

Art 1(1) 3.35

Art 1(1)(i) 3.249

Art 1(1)(p) 3.35

Art 3(2) 3.35

Art 3(3) 3.35

Art 3(4) 3.36

Art 3(5) 3.36

Art 4 3.37

Art 4(2) 3.32

Art 4(3) 3.32

Art 5(a) 3.252

Art 5(b)(iv) 3.252

Art 6 3.28

Commission Regulation (EU) No 1218/2010 of 14 December 2010 on the application of Article 101(3) of the Treaty to categories of specialisation agreements [2010] OJ L335/43 3.27, 3.28

Art 1(1) 3.41

Art 2(2) 3.41

Art 2(3) 3.41

Art 3 3.32

Commission implementing regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council [2012] OJ L159/5 13.103

Art 25 13.102

Art 26 13.102

Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection [2012] OJ L361/1 11.10, 12.16, 12.17

Art 18 12.17

Council Regulation (EU) No 1260/2012 of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection with regard to the applicable translation arrangements [2012] OJ L361/89 11.10, 12.16, 12.17

Art 7 12.17

Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 [2013] OJ L181/15 9.30, 9.41

Recital 10 9.30

Recital 11 9.30

Art 2(1) 9.30

Commission Regulation (EU) No 316/2014 of 21 March 2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements [2014] OJ L93/17 3.27, 4.1, 4.5, 4.19, 4.20, 4.21, 4.22, 4.23, 4.24, 4.25, 4.26, 4.28, 4.30, 4.31, 4.35, 4.40, 4.42, 4.55, 4.72, 4.73, 4.85, 4.88, 4.90, 4.99, 4.111

Recital 6 4.24

Art 1(1)(b) 4.21

Art 1(1)(c) 4.20, 4.25

Art 1(1)(i) 3.249

Art 2(2) 3.249

Art 3 3.32

Art 4(1)(c) 3.226

Art 4(1)(d) 3.226, 3.249

Art 5 3.28

Art 5(2) 3.249

Art 8(e) 4.38

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (Clinical Trials Regulation) [2014] OJ L158/1 13.122, 13.160, 13.161, 13.162, 13.163, 13.164, 13.167

Regulation (EU) No 2015/2424 of the European Parliament and of the Council of 16 December 2015 amending Council Regulation (EC) No 207/2009 on the Community trade mark, and repealing Commission Regulation (EC) No 2869/95 on the fees payable to the Office for Harmonization in the Internal Market (Trade Marks and Designs) [2015] OJ L341/21 9.31

Treaties and conventions

Community Patent Convention (Luxembourg 15 December 1975)

Art 31(b) 12.80

European Patent Convention (EPC) 12.5, 12.14, 12.18, 12.19, 12.22, 12.24, 12.47, 12.50

Art 52.1 12.10, 12.43

Art 54 12.38

Art 54.1 12.25

Art 54.2 12.26

Art 54.3 12.26

Art 54.5 12.48, 12.49

Art 56 12.35, 12.36, 12.37, 12.38

Art 57 12.44

Art 63 2.158

Art 69 12.66, 12.69, 12.71, 12.101, 12.103, 12.105

Art 69.1 12.65

Art 83 12.56, 12.57, 12.59

Art 87 12.31

Art 138 12.61

Art 138.2 12.62

Art 138.3 12.63

Art 164 12.66

European Patent Convention 2000 12.47, 12.48, 12.66

Art 53 12.47

Art 54.5 12.50

Treaty of Lisbon amending the Treaty on European Union and the Treaty establishing the European Community, signed at Lisbon, 13 December 2007 (Lisbon Treaty) [2007] OJ C306/1 9.3

Art 3 9.3

Art 3(1) 9.3

Art 3(5) 9.3

Treaty Establishing the European Community (EC Treaty) 10.60

Art 81 3.10, 17.43

Art 82 1.51, 5.69, 20.37, 20.42

Art 152 9.3

Treaty on the Functioning of the European Union [2012] OJ C326/47) (TFEU) 20.27

Art 34 11.27

Art 36 11.27, 11.29

Art 101 1.45, 1.57, 2.69, 2.77, 2.78, 2.94, 2.128, 3.1, 3.2, 3.5, 3.8, 3.10, 3.14, 3.16, 3.26, 3.27, 3.30, 3.44, 3.53, 3.71, 3.84, 3.102, 3.103, 3.138, 3.149, 3.161, 3.172, 3.176, 3.181, 3.182, 3.218, 3.221, 3.229, 3.232, 3.233, 3.246, 3.247, 3.262, 3.263, 4.1, 4.6, 4.9, 4.13, 4.15, 4.19, 4.37, 4.49, 4.75, 4.77, 4.107, 5.25, 7.100, 8.15, 8.16, 8.43, 8.45, 8.82, 8.93, 8.184, 10.47, 10.48, 10.49, 10.52, 10.55, 10.58, 10.61, 15.1, 15.2, 15.77, 15.87, 15.93, 15.125, 15.146, 16.15, 16.22, 17.3, 17.4, 17.21, 17.24, 17.41, 17.43, 17.44, 17.49, 17.50, 17.71, 18.46, 18.56, 20.28, 20.30, 20.35

Art 101(1) 3.9, 3.11, 3.13, 3.14, 3.15, 3.16, 3.17, 3.21, 3.23, 3.24, 3.27, 3.28, 3.29, 3.33, 3.69, 3.78, 3.92, 3.93, 3.104, 3.107, 3.108, 3.123, 3.124, 3.137, 3.143, 3.145, 3.155, 3.162, 3.179, 3.183, 3.187, 3.203, 3.205, 3.256, 4.13, 4.14, 4.26, 4.44, 4.45, 4.59, 4.67, 4.73, 4.75, 4.78, 4.79, 4.82, 4.83, 4.86, 4.87, 4.89, 4.91, 4.92, 4.97, 4.101, 4.107, 4.108, 4.109, 8.204, 18.48

Art 101(1)(a) 8.102

Art 101(2) 3.23

Art 101(3) 1.57, 3.9, 3.16, 3.24, 3.27, 3.29, 3.46, 3.47, 3.48, 3.50, 3.99, 3.104, 3.163, 3.164, 3.166, 3.170, 3.171, 3.182, 3.2013.218, 3.235, 3.251, 4.11, 4.14, 4.26, 4.27, 4.42, 4.44, 4.66, 4.69, 4.75, 4.77, 4.79, 4.82, 4.83, 4.86, 4.92, 4.101, 4.111, 4.115, 15.100, 17.43, 17.45, 17.49, 17.51, 20.27

Art 102 1.99, 2.94, 3.53, 3.123, 3.145, 3.229, 4.19, 4.54, 4.107, 5.8, 5.11, 5.12, 5.14, 5.18, 5.19, 5.23, 5.25, 5.40, 5.41, 5.42, 5.43, 5.46, 5.62, 5.68, 5.69, 5.72, 5.73, 5.74, 5.75, 5.94, 5.95, 8.93, 8.184, 10.47, 10.63, 15.1, 15.2, 15.61, 15.76, 15.104, 15.113, 15.125, 15.147, 17.3, 17.4, 17.21, 17.23, 17.24, 17.55, 17.62, 17.70, 17.71, 17.79, 18.46, 18.56, 18.64, 20.16, 20.33, 20.35, 20.40, 20.42

Art 106(2) 8.211, 8.212

Art 168 3.75

Art 168(1) 9.3

Art 168(3) 9.3

Art 168(7) 11.5

Art 267 10.69, 15.95

FOREIGN LEGISLATION

Brazil

Law No 12529 of 30 November 2011 18.10

Decree No.7723/2012 of 7 May 2012 18.23

China

Law of the People’s Republic of China Against Unfair Competition (promulgated 2 September 1993, effective 1 December 1993) 16.4, 16.6, 16.77, 16.129

Art 10 16.126

Law of the People’s Republic of China on Lawyers (promulgated 15 May 1996, effective 1 January 1997, amended 28 October 2007)

Art 38 16.12

Pricing Law of the People’s Republic of China, adopted at the 29th Meeting of the Standing Committee of the Eighth National People’s Congress on 29 December 1997 and promulgated by Order No 92 of the President of the People’s Republic of China on 29 December 1997 16.4, 16.6, 16.25, 16.77

Art 2 16.6

Art 40 16.25

Law of the People’s Republic of China on Bid Invitation and Bidding (promulgated 30 August 1999, effective 1 January 2000) 16.4

Drug Administration Law 2001 16.14, 16.74, 16.78

Art 55 16.14

Anti-Monopoly Law of the People’s Republic of China, adopted at the 29th Meeting of the Standing Committee of the National People’s Congress on 30 August 2007 16.1, 16.4, 16.5, 16.6, 16.7, 16.9, 16.13, 16.15, 16.18, 16.24, 16.25, 16.30, 16.37, 16.38, 16.46, 16.48, 16.52, 16.54, 16.59, 16.63, 16.65, 16.71, 16.77, 16.83, 16.95, 16.102, 16.106, 16.115, 16.120, 16.129, 18.13

Chapter V 16.102

Art 1 16.5

Art 2 16.6

Art 7 16.5, 16.65

Art 8 16.5

Art 10 16.7

Art 11 16.5

Art 12 16.5, 16.52

Art 13 16.15, 16.16, 16.17, 16.18, 16.20, 16.21, 16.22, 16.23, 16.24

Art 14 16.30, 16.31, 16.32, 16.33, 16.34, 16.35, 16.38, 16.40, 16.44, 16.45

Art 14(1) 16.42

Art 14(2) 16.42

Art 14(3) 16.30

Art 15 16.20, 16.21, 16.33, 16.34

Art 17 16.48, 16.49, 16.57

Art 17(1) 16.61

Art 17(3) 16.67

Art 18 16.55, 16.56

Art 19 16.48, 16.54

Art 20 16.110, 16.111

Art 21 16.110

Art 22 16.115

Art 24 16.123

Art 25 16.123

Art 26 16.123

Art 27 16.116

Art 27(5) 16.117

Art 28 16.110, 16.116

Art 38 16.9

Art 39 16.9, 16.10

Art 39(1) 16.9

Art 39(5) 16.10

Art 40 16.11

Art 41 16.12

Art 42 16.12, 16.13

Art 46 16.24, 16.35, 16.36

Art 47 16.62

Art 49 16.37

Art 50 16.23, 16.38, 16.45

Art 52 16.13

Art 54 16.126

Regulation of the State Council on the Notification Thresholds for Concentrations of Undertakings 2008

Art 4 16.112

Arts 4–5 16.113

Germany

Patent Act

Section 11 No.2 12.88

Section 11 No.2b 12.88

India

Competition Act of 2002 18.12

Monopolies and Restrictive Trade Practices Act of 1969 18.12

Poland

Industrial Property Act of 30 June 2000

Art 69(1)(4) 12.88

Romania

Competition Act

Art 9 8.122

Russian Federation

Federal Law No. 45–FZ of 8 March 2015 18.11

Criminal Code

Art 178 18.11

Federal Law on Circulation of Medicines dated 12 April 2010, No. 61-FZ 18.28

Slovenia

Competition Protection Act

Art 6 8.82

Spain

Constitution

Art 38 10.62

Patent Act 11/1986, 20 March 12.90

Art 87.2 12.90

Law 25/1990

Art 100 10.23

Medicines Act 1990 17.10

Art 2(1) 17.62

Art 68(1) 17.62

Art 70 17.62

Art 100 17.43

Royal Decree 271/1990 17.11

Royal Decree 1416/1994 17.16

Royal Decree 725/2003 10.60

Competition Defence Act 15/2007 17.2, 17.3, 17.5, 17.7, 20.30

Art 1 17.3, 17.4, 17.21, 17.35, 17.37, 17.38, 17.41, 17.49, 17.52, 17.59, 17.71, 17.75, 20.30, 20.35

Art 1(1) 17.52

Art 1(1)(a) 8.102

Art 1(1)(c) 8.102

Art 1(3) 17.52

Art 2 17.3, 17.4, 17.21, 17.54, 17.55, 17.59, 17.62, 17.70, 17.71, 17.75, 17.79

Art 3 17.5, 17.32, 17.65

Royal Decree 1345/2007 17.10

Royal Decree 823/2008 17.13

Act on Guarantees and Rational Use of Medicinal Products and Medical Devices 2006 17.10, 17.11, 17.14, 17.17, 17.43, 17.47

Art 3(1) 17.62

Art 67 17.13

Art 67(1) 17.62

Art 69 17.62

Art 90 17.38, 17.47, 17.59

Art 94 17.11

Act 3/2013 17.2

Royal Decree 870/2013 17.16

Royal Decree 782/2013 17.13

Royal Decree 177/2014 17.12

Royal Legislative Decree 1/2015 17.10

Patent Act 24/2015 12.90

Law 48/2015 17.11

South Africa

Medicines and Related Substances Control Amendment Act 1997, Republic of South Africa Government Gazette No 18505, Act No 90, 1997 (12 December 1997) 9.13

Competition Act, 1998 (Act No 89 of 1998) 18.14

United States

Sherman Antitrust Act of 1890 2.8, 14.1, 14.52, 14.54, 14.55, 16.22, 19.50

Section 1 2.69, 14.1, 14.14, 14.44, 14.54

Sections 1 to 7 14.1

Section 2 5.20, 5.21, 14.1, 14.32, 14.34, 14.35, 14.44, 14.51, 14.54, 14.55, 19.33

Clayton Antitrust Act of 1914 14.54

s 7 14.1

Federal Trade Commission Act of 1914 14.1

s 5 14.1, 14.54, 14.55, 14.56

Multidistrict Litigation Statute (28 U.S.C. 1407) 2.8

Drug Price Competition and Patent Restoration Act of 1984 Pub. L. No. 98–417, 98 Stat. 1585 (codified as amended at 21 U.S.C. 355) (Hatch-Waxman Act) 2.13, 2.20, 2.47, 2.61, 2.140, 2.141, 2.149, 2.156, 2.162, 2.163, 2.164, 2.165, 2.166, 2.168, 2.169, 2.170, 2.172, 14.3, 14.9, 14.10, 14.11, 14.16, 14.20, 14.28, 14.30, 19.2, 19.9, 19.10, 19.11, 19.12, 19.13, 19.14, 19.21, 19.39, 19.50, 19.55

s 21 U.S.C. 355(j)(5)(B)(iii) 2.28

s 21 U.S.C. 355(j)(5)(B)(iv) 2.47

s 35 U.S.C. 156(c)(1) (2012) 2.163

s 35 U.S.C. 156(c)(2) (2011) 2.163

s 35 U.S.C. 156(c)(3) (2012) 2.163

s 35 U.S.C. 156(g)(4)(A) (2011) 2.163

s 21 U.S.C. 355(c)(3)(E)(ii) (2011) 2.164

s 21 U.S.C. 355(c)(3)(E)(iii) (2011) 2.164

s 21 U.S.C. 355(j)(5)(B)(iii) (2011) 2.164

s 21 U.S.C. 355(j)(2) (2011) 2.165

s 35 U.S.C. 271(e)(2) (2011) 2.165

s 21 U.S.C. 355(j)(2)(A)(vii)(I)–(IV) (2011) 2.166

s 21 U.S.C. 355(j)(5)(B)(iv) (2011) 2.166

s 42 U.S.C. 262(i)(2) (2011) 2.168

s 42 U.S.C. 262(i)(3) (2011) 2.168

s 42 U.S.C. 262(k)(7) (2011) 2.169

s 271(e)(1)(2004) 19.12

s 355(j)(5)(B)(iv) 19.13

s 355(j)(2)(A)(vii) 19.13

Medicare Prescription Drug, Improvement, and Modernization Act of 2003 2.140

Biologics Price Competition and Innovation Act of 2009 2.162, 2.168, 2.169, 2.170, 2.171, 2.172

Patient Protection and American Affordable Care Act of 2010 2.162, 14.58

INTERNATIONAL CONVENTIONS

 

Paris Convention for the Protection of Industrial Property (20 March 1883) 12.31

UK LEGISLATION

Statutes

Monopolies and Restrictive Practices (Inquiry and Control) Act 1948 15.5

Fair Trading Act 1973 15.1

Restrictive Trade Practices Act 1976 15.1, 15.2

Resale Prices Act 1976 15.1, 15.2

Competition Act 1980 15.1, 15.19

Competition Act 1998 15.2, 15.5, 15.6, 15.16, 15.17, 15.19, 15.44, 15.59, 15.60, 15.78, 15.122, 15.151

Ch I 15.2, 15.77, 15.78, 15.87, 15.146

Ch II 15.2, 15.16, 15.37, 15.60, 15.61, 15.77, 15.78, 15.113, 15.146, 18.64

s 2 15.2

s 2(1) 8.80

s 9 15.100

s 18 15.2

s 18(2)(a) 15.104

s 40A 15.104

s 46 15.95, 15.115

Enterprise Act 2002 15.3, 15.6

s 5 15.136

National Health Service Act 2006 15.13, 15.14

Enterprise and Regulatory Reform Act 2013 15.4

Health Service Medical Supplies (Costs) Act 2017 15.14, 15.120

Statutory instruments

Competition Act 1998 (Land and Vertical Agreements Exclusion) Order 2000 (SI 2000/310) 15.93

National Health Service (Procurement, Patient Choice and Competition) (No 2) Regulations 2013 (SI 2013/500) 8.209

reg 10 8.209, 8.211, 8.212

UNITED NATIONS

 

UN Resolution 53/202, 17 December 1998, A/RES/53/202 9.1

UN Millennium Declaration, UN Resolution 55/2, A/RES/55/2 9.1

WORLD TRADE ORGANIZATION

 

Marrakesh Agreement Establishing the World Trade Organization (WTO) (Morocco 15 April 1994)

Annex 1C 12.4

WTO Agreement on Trade Related Aspects of Intellectual Property Rights 1995 (TRIPS) 9.4, 9.7, 9.8, 9.9, 9.10, 9.11, 9.12, 9.13, 9.14, 9.15, 9.16, 9.17, 9.18, 9.19, 9.22, 9.24, 9.30, 9.33, 9.34, 9.36, 9.38, 9.40, 9.41, 9.42, 12.4, 12.10, 12.11, 12.73, 12.91, 18.15, 18.23, 18.34

Art 4 9.35

Art 7 9.12

Art 8 9.12, 18.5

Art 27 9.11, 12.10, 12.23, 12.43

Art 28 12.73

Art 28.2 12.89

Art 30 12.79

Art 31 9.12, 9.13, 9.52, 12.89, 18.5

Art 31(b) 9.13

Art 31(f) 9.13, 9.15, 9.16

Art 31bis 9.18

Art 33 9.11, 12.4

Art 40 18.5

Art 46 9.22

Art 51 9.22

Art 59 9.22

Art 65 12.10

Art 66 12.10