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“Healthy” collaboration on the health

care market

A comparative law analysis of the regulation and enforcement

of the cartel prohibition in the health care sectors of the

Netherlands and England

Sophia Wittkämper

11082585

University of Amsterdam Dissertation

Master: International and European Law: European Competition Law and Regulation Supervisors: O. Brook, LL.M. and Dr. J.M. Mendes

Words: 14.257

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Abstract

The enforcement of the cartel prohibition to collaborations on the health care market is a challenging field of law. As health care mechanisms and the competitive environments on health care markets vary across the EU, the extent to which the cartel prohibition applies, and the manner in which it is being applied in the health care sector likewise differ. It is questionable whether the manner in which collaboration in the health care sector is regulated and enforced in member states under the cartel prohibition is in line with the effectiveness of EU competition law, as this is a politically sensitive area of public interest. In this piece very different health care systems, and the enforcement of the cartel prohibition in these health care systems, of two states have been analysed in the form of a comparative law analysis. It has been concluded that the Netherlands does regulate and enforce collaboration under the cartel prohibition in line with the effectiveness of EU competition law, and that England does not. This piece therefore suggests that all operators on the English health care market should be obliged to comply with the cartel prohibition and that the CMA should be solely responsible for the enforcement of the cartel prohibition in the health care sector.

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Table of contents

List of abbreviations 5

1. Introduction 6

1.1. Preface 6

1.2. Research question and method 6

1.3. Structure of the analysis 7

2. Health care in the European Union 8

2.1. Introduction 8

2.2. Regulating public health in the EU legal order 8

2.3. Types of health care systems in the EU 9

2.4. Privatising health care 10

3. The EU cartel prohibition in the health care sector 11

3.1. Introduction 11

3.2. The EU competition law framework 11

3.3. Article 101(1) TFEU in the health care sector 12

3.3.1. ‘Undertakings’ in the health care sector 12

3.3.2. Effect on trade between Member States 15

3.3.3. Agreements, decisions or concerted practices 15 3.3.4. As object or effect the prevention, restriction or distortion of competition 15 3.4. Exceptions/exemptions applicable to the health care sector 16

3.4.1. Article 101(3) TFEU 16

3.4.2. Block Exemption Regulations 17

3.5. EU Guidelines 18

3.6. Clear-cut infringements of article 101(1) TFEU in the health care sector 18

4. The cartel prohibition in the health care sector in The Netherlands 20

4.1. Introduction 20

4.2. Framework of the Netherlands’ health care system 20 4.3. The Netherlands’ competition authorities and cartel prohibition 21

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4.4. Applying the cartel prohibition to the Netherlands’ health care sector 21 4.4.1. Undertakings in the health care sector in the Netherlands 21

4.4.2. Analysis of decisions and judgments 23

4.4.3. Analysis of informal opinions 24

4.5. On the agenda of the Netherlands’ competition authority 25

4.6. Dilemmas 26

5. The cartel prohibition in the health care sector in England 27

5.1. Introduction 27

5.2. Framework of the English health care system 27

5.3. The English competition authorities and cartel prohibition 28 5.4. Applying the cartel prohibition to the English health care sector 30 5.4.1. Undertakings in the health care sector in England 30

5.4.2. Analysis of decisions and judgments 32

5.4.3. Analysis of informal opinions 34

5.5. Dilemmas 34

6. Comparative analysis 36

6.1. Introduction 36

6.2. The Netherlands v. England 36

6.2.1. Health care systems 36

6.2.2. Responsible competition authorities and applicable cartel prohibition 36 6.2.3. Application of the cartel prohibition to the health care sectors 37

6.2.3.1. Undertakings 37

6.2.3.2. Decisions, judgments, informal opinions 38

6.3. The effectiveness of competition law 39

6.4. Recommendations 39

7. Conclusion 41

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List of abbreviations

ACM - Autoriteit Consument en Markt

CCAT - Competition Commission Appeal Tribunal CCG - Clinical Commissioning Group

CJEU - Court of Justice of the European Union CMA - Competition and Markets Authority EGC - European General Court

EU - European Union

GP - General Practitioner

LHV - Landelijke Huisartsen Vereniging NCA - National Competition Authority NHS - National Health Service

NMa - Nederlandse Mededingingsautoriteit NZa - Nederlandse Zorgautoriteit

OFT - Office of Trade

PCCR - Principles and Rules for Cooperation and Competition PPCCR - Procurement, Patient Choice and Competition Regulations TEU - Treaty of the European Union

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1. Introduction

1.1. Preface

Competition is considered to be ‘rivalry between undertakings’, an essential driver of economic efficiency, which includes dynamic efficiencies in the form of innovations.1 The process of the privatisation of previously publicly regulated and operated health care sectors, has to a certain extent brought competition law into play in many Member States of the European Union (‘EU’). Considering the fact that the health care sector represents about 9% of the gross domestic product within the EU,2 it is of great importance that the health care market is not distorted by anti-competitive behaviour. Certain forms of collaboration on the health care market are capable of restricting competition and distorting the market, and are therefore prohibited under the cartel prohibition. However, collaboration between health care providers can also lead to high quality care which fits the specific needs of patients. The dividing line between lawful and unlawful collaboration on the health care market is very thin, and needs to be scrutinized for every individual case. Consequently, it is important to read the cartel prohibition “in the context of the wider ambitions of the European Union”.3

1.2. Research question and method

In this research, the application of the cartel prohibition to collaboration in the health care sectors of two states will be examined. Since the scope of the cartel prohibition is determined by the specific way in which health care is organised by a state, two very different and typical types of health care systems have been chosen for the analysis: the market-based, private health care system of the Netherlands and the partly publicly managed and financed, and partly private system of England.4 The main research question for this dissertation will be:

1 Communication from the Commission, Guidance on the Commission’s enforcement priorities in applying Article

82 of the EC Treaty to abusive exclusionary conduct by dominant undertakings (2009) para.30

2 Commission Staff Working Paper, accompanying the report of the Commission on Competition Policy 2010, 2 Commission Staff Working Paper, accompanying the report of the Commission on Competition Policy 2010,

SEC(2011) 690 final, part I, point 269

3 Case 14/68 Walt Wilhelm v. Bundeskartellamt (1969) para.14; Case 6/72 Europemballage Corporation and Continental Can Company Inc v. Commission (1973) para.244–245

4 There has been chosen for England instead of the whole UK, because it would not be doable to set out the

slightly different health care systems of Northern-Ireland, Scotland, Wales and England within the maximum allowed amount of words.

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Is the manner in which collaboration in the health care sector is regulated and enforced in the Netherlands and England under the cartel prohibition in line with the effectiveness of EU competition law?

In this study of comparative law, the functional method will be applied, for which the functional-institutional approach will be used. Therefore, the examination of the relevant European, Netherlands’ and English institutions, legal frameworks and case law will be the starting point of this research, followed by a comparative analysis and a normative reasoning on whether these domestic regulatory and enforcement systems are in line with the effectiveness of competition law, including recommendations.

1.3. Order of analysis

This research will be structured as follows. The second chapter will outline the division of competences regarding the regulation and organisation of health care in Member States, followed by an explanation of the main types of health care systems and a section on the privatisation of these systems. The third chapter will give an overview of what the EU competition law regime roughly represents. It furthermore analyses the EU framework on the application of the EU cartel prohibition to the health care sector, including examples of clear-cut infringements. The fourth and fifth chapter entail the research on the regulation and enforcement of collaboration under the cartel prohibition in the health care sectors in the Netherlands and England. Chapter six compares the elements mentioned in chapters four and five, argues whether the effectiveness of EU competition law is ensured in these frameworks and closes with recommendations. The last chapter will answer the research question and conclude.

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2. Health care in the European Union

2.1. Introduction

The scope of the application of the cartel prohibition in the area of health care depends to full extent on how health care is organised in Member States. In this chapter the division of competences between the EU and its Member States regarding the regulation of health care will be outlined, and the main types of health care systems will be illustrated. Furthermore, the privatisation of health care systems will briefly be discussed.

2.2. Regulating public health in the EU legal order

The division of competences between the EU and Member States is laid down in the Treaties. Under article 5(2) of the Treaty of the European Union (‘TEU’), the EU can only act within the competences conferred upon it in the Treaties by the Member States. The area of health care does not belong to the Union’s exclusive competences, which are listed in article 3 of the Treaty on the Functioning of the European Union (‘TFEU’). Given that the health care sector is a politically and socially sensitive area, Member States have not been willing to give the Union any extensive competences in this field. It appears from the treaty provisions that neither the EU, nor the Member States hold an exclusive competence when it comes to the area of health care; it is a shared competence. This means that both the EU and Member States may legislate and adopt legally binding acts in that area.5 The EU legislators can adopt three types of measures through the ordinary legislative procedure to meet common safety concerns under article 168(4) TFEU, and measures of secondary law under article 168(5), under which several public health programmes have been established.6 It has been argued, though, that these programmes will come to influence the scope of EU law on health care over time.7 Article 168(7) TFEU is the legal basis for the Member

5 Article 2(2) TFEU; Van de Gronden J.W. et al., ‘Legal Issues of Services of General Interest: Health Care and EU Law’ (2011) p.23

6 The Public Health programme 2003-2008, of which the evaluation report is available at:

http://ec.europa.eu/health/archive/ph_programme/documents/evaluation/php_evaluation_en.pdf, The Public Health Programme 2008-2013, of which the last annual report is available at:

http://ec.europa.eu/health/programme/docs/implementation_2013_en.pdf, and The Public Health Programme 2014-2020, of which the ‘nutshell’ of the programme is available at:

http://ec.europa.eu/health/programme/docs/factsheet_healthprogramme2014_2020_en.pdf

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States’ competence to organise health care in their own state on the one hand, and the exclusion of EU involvement in that organization on the other:

“Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them.”

Despite the barrier that this provision forms for the EU to harmonize in the area of healthcare, the Union has recently enacted the ‘Patient’s Rights Directive’ based on article 114 TFEU8 in conjunction with article 168 TFEU. The creation of that Directive has been argued to underscore the ability of the Union to act outside its competences in the field of healthcare,9 however, this is a topic that will not be further discussed here. Healthcare policy primarily remains at the jurisdiction of the Member States.

2.3. Types of health care systems in the EU

All Member States of the EU have different health care mechanisms because of the unique historical economic and political development of each individual Member State,10 and their consequent cultural and institutional differences. These varying systems can be clustered into two types. One type is the insurance-based Bismarck-system, where insurers are often called ‘sickness-funds’, and cover every citizen of the state. Such a system can either be based on restitution, benefits in kind, or on a combination of both, and is predominantly private.11 This health care model can, amongst others, be found in the Netherlands and Germany.12 The other type of system

is the publicly financed (tax-based) Beveridge system, also called National Health System (‘NHS’), which for instance exists in Spain and the United Kingdom.13 The provision of health care in this system is mostly public, however in practice parallel systems of private provision also appear, for example to serve consumers that whish

8 Article 114 TFEU is the legal basis for the Union to adopt measures to achieve the objective of the internal

market, by way of approximating national rules of Member States

9 Hancher, supra note 7, p.15

10 Lear J. et al., ‘EU competition law and health policy’, chapter 8 of ‘Health Systems Governance in Europe, The

Role of European Law and Policy’ (2010) [online]

11 Hancher, supra note 7, p. 2

12 Lapre R. et al., ‘Algemene economie van de gezondheidszorg’ (1999) p. 299 13 Ibid

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to purchase health care services that fall outside the NHS.14 Thus, the main difference between the two systems exists in relation to the provision of health care and in the way that they are financed.15 As a consequence of the different health care regulations, the competitive environment may vary across Member States.16 However, EU law does apply uniformly across the Union, regardless of the domestic health care systems.17

2.4. Privatising health care

There are no provisions in the EU treaties that require Member States that deliver public services through the public sector to open these sectors up. However, more and more Member States do decide to outsource public services to private independent undertakings. Many states have moved, and some are still moving, towards market-based systems of health care.18 This transformation and modernization of national

health care systems brings EU internal market and competition law into play in an area of public interest.19 Economic objectives are not in conflict with public interest

objectives, but rather can go hand in hand. Privatisation of the health care market brings competition between operators into play, and pressures them to control their costs, perform more efficiently and deliver high quality products and services. This can eventually benefit the overall affordability and quality in the health care market. The accessibility to, and minimum standards of health care can be guaranteed through regulation.

14 Hancher, supra note 7, p.2 15 Ibid

16 Commission Staff Working Paper, supra note 2, part I, point 277

17 Lear, supra note 10, p.339, see Case C-385/99 Müller-Fauré v. Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen (2003)

18 Sauter W., ‘The impact of EU competition law on national health care systems’ (2013) European Law Review 19 Van de Gronden J.W., Szyszczak E., ‘Introducing competition principles into health care through EU law and policy: A case study of The Netherlands’ (2014) Medical Law Review, vol.22 no.2

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3. The EU cartel prohibition in the health care sector

3.1. Introduction

This chapter will first give a brief overview of what the EU competition law regime represents. Afterwards, the EU framework on the application of the EU cartel prohibition to the health care sector will be analysed. Lastly, examples of clear-cut anti-competitive collaboration on health care markets will be given.

3.2. The EU competition law framework

According to the Court of Justice of the EU (‘CJEU’), the EU competition law regime consists of a set of rules that intents to protect the interests of competitors and consumers, the structure of the market and competition as such.20 Thus, the competition rules, including the cartel prohibition, primarily exist to ensure that competition between firms, in areas where it is supposed to exist, is undistorted. This way the markets work well for businesses and the economy, and intended benefits for consumers can be delivered in their entirety.21 The EU has got exclusive competence when it comes to the establishment of the competition rules that are necessary for the functioning of the internal market.22 These provisions have direct effect in the national legal orders of the Member States,23 and take precedence over all national laws that could possibly undermine the effectiveness of these laws.24 The European Commission (‘Commission’) is the EU’s responsible authority for the enforcement of the cartel prohibition.25 Regulation 1/2003, establishing the ‘European Competition Network’, empowers both national competition authorities (‘NCA’s’) and national courts of the Member States to also apply and enforce the EU cartel prohibition in full. It obliges them to apply their national cartel prohibition in the same manner as article 101 TFEU,26 to avoid conflicting decisions, without precluding them from adopting stricter provisions prohibiting cartels. As a reaction, Member States have adopted similar national cartel prohibitions. The Regulation also allows Member

20 Joined Cases C-501/06 P, C-513/06 P, C-515/06 P and C-519/06 P GlaxoSmithKline Services Unlimited v. Commission (2009) ECR I-09291 para.63

21 Ben Collins, ‘Procurement and Competition rules, Can the NHS be exempted?’ (2015) The Kings Fund 22 Article 3(1)(b) TFEU

23 Case C-26/62 Van Gend en Loos (1963) ECR I-0001

24 Case C-399/11 Stafano Melloni v. Ministerio Fiscal (2013) ECLI:EU:C:2013:107 25 Chalmers D. et al., ‘European Union Law’, (2014) third edition, p.957

26 Council Regulation No. 1/2003 on the implementation of the rules on competition laid down in Articles 81 and

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States to implement national legislation protecting other legitimate interests, provided that such legislation is compatible with the general principles and provisions of EU law.27 The current legal framework also provides for a certain leeway for NCAs to take non-competition interests like public health and the environment into account, in interpreting the competition law provisions.28 In this regard, both the English and the Netherlands’ NCA seem to give some scope to non-competition interests when making competition law assessments.29

3.3. Article 101(1) TFEU in the health care sector

The cartel prohibition laid down in the TFEU is substantial for the examination of the competition law boundaries for collaboration in the health care sector. Article 101 TFEU, being the legal basis for the cartel prohibition,30 is the starting point for that analysis. The Commission stresses that the main objective of article 101 TFEU is to protect competition as a means of enhancing consumer welfare.31 The CJEU,

however, has broader perspective on that point.32 Article 101(1) considers the

following to be incompatible with the internal market and therefore prohibited:

‘(…) all agreements between undertakings, decisions by associations of undertakings and concerted practices which may affect trade between Member States and which have as their object or effect the prevention, restriction or distortion of competition within the internal market (…)’33

Thus all undertakings and associations of undertakings in the health care sector are obliged to comply with the prohibition on anti-competitive concerted practices, agreements and decisions.34 The different conditions that have to be fulfilled for the prohibition to apply will be analysed separately.

3.3.1. ‘Undertakings’ in the health care sector

Since only undertakings are subject to the cartel prohibition, the condition of ‘undertakings’ is the first element to define the scope of the prohibition. There is no

27 Ibid, recital 9

28 Lavrijssen S., ‘What role for national competition authorities in protecting non-competition interests after Lisbon?’ (2010) European Law Review, 35(5)

29 Ibid

30 Whenever the term ‘the cartel prohibition’ is being used in this paper, a reference is made to article 101(1)

TFEU and national competition laws of Member States that contain the same prohibition

31 Communication of the Commission, Guidelines on the application of article 81(3) of the Treaty (2004) para.13 32 Case Glaxo, supra note 19, para.63

33 Article 101(1) TFEU

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definition of undertaking in the Treaties, however, a definition has been set and further developed by the CJEU. Generally speaking, an undertaking is an entity that is engaged in economic activity, which consists of offering goods or services on a market,35 regardless of the legal status of that entity and the way that it is financed.36 Undertakings (at least potentially) face competition,37 are usually motivated to make a certain kind of profit,38 are independent in their choice making abilities and bear their own financial risks.39 The fact that the entity is formed by public institutions and financed by means of state resources does not affect the assessment.40 It is not the type of entity, but the very nature of the activity that matters for the concept of undertaking, which has been referred to as the ‘functional criterion’ for determining whether a body is an undertaking.41 An activity is not economic when it is connected to the exercise of the powers of a public authority.42 In that context, there are entities, for example public bodies, which are only considered undertakings when performing certain activities.43

The CJEU has in some cases discussed the concept of undertakings, and especially the concept of economic activity in the health care sector. It generally assumes that health care providers are engaged in economic activities,44 since patients are recipients of a service.45 The CJEU has held that independent medical specialists are self-employed economic operators, which offer services on the market of specialist medical services, get paid by their patients for their service and assume financial risk.46 Therefore, these independent medical specialists are individual undertakings, despite the complexity and technical nature of the services they provide and the fact that the practice of their profession is regulated.47 The latter principle also applies to

35 Case 118/85 Commission v. Italy (1987) ECR 2599 para.7 36 Case C-41/90 Hofner (1991) ECR I-1979, para.21

37 Ibid, para.22; and Opinion of AG Jacobs in Joined cases C-264/01, C-306/01, C-354/01 and C-355/01 AOK Bundesverband (2003) ECR I-2495, para.27

38 Odudu O., ‘Are state owned healthcare providers that are funded by general taxation undertakings subject to competition law?’ (2011) European Competition Law Review, 32(55); Although non-profit organisations can also

offer goods and services on the market, see to that extent: Joined Cases 209/78 to 215/78 and 218/78 Van

Landewyck (1980) ECR 3125, para.88

39 Joined Cases C-180/98 to C-184/98 Pavel Pavlov (2000) ECR I-6451, para.74 40 Case C-237/04 Enirisorse SpA v. Sotacarbo SpA (2006) ECR I-02843, para.32-33 41 Case T-319/99 FENIN v. Commission (2004) ECR II-00357, para.17

42 Case C-309/99 Wouters (2002) ECR 01577, para.57; referring to Case C-364/92 Eurocontrol (1994) ECR

I-43, para.30

43 Opinion AG Jacobs in Case C-475/99 Firma Ambulanz Glockner (2001) ECR I-8089, para.72 44 Hancher, supra note 7, p.225

45 Odudu, supra note 38

46 Joined Cases Pavlov, supra note 39, para.77

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independent pharmacies.48 Considering potential competition, the CJEU has held that the provision of emergency transport services constitutes an economic activity since it had not always been, and does not necessarily have to be, carried out by public authorities or mutual aid organisations.49 From this actual or potential ‘offering of services in competition’ approach can be concluded that private bodies active in the provision of health care, operating either in Bismarck or Beveridge systems, are likely to be regarded as undertakings.50

A different approach has been adopted by the CJEU towards organisations for which social objectives and the principle of solidarity play an important role. According to the CJEU, funds and organisations fulfilling an exclusively social function cannot be considered undertakings when their activity is based on the principle of national solidarity and is non-profit making; such an activity cannot be considered as an economic activity.51 To draw such conclusion the CJEU takes into account the degree

of public involvement, the objective and nature of the system, the way in which patient contributions are calculated and privileges are awarded.52 Even the purchase

of goods by a public entity discharged with social functions is not considered to be an economic activity.53 This principle can be applied to health care operators in general, thus to, for example, health care providers, purchasers of health care and providers of health insurance. However, providers of health insurance that manage schemes which are clearly based on a mix of competition and solidarity, are undertakings, and are subject to the cartel prohibition.54 A detailed analysis of the specific health programs and the circumstances of the operations of an entity is required to be able to determine whether its activity is social or economic, and whether it is an undertaking within the meaning of article 101(1) TFEU.55

48 Communication from the Commission: Draft Commission Notice on the notion of State Aid pursuant to Article

107(1) TFEU (2014), point 28

49 Case C-475/99 Ambulanz Glockner (2001) ECR I-8089, para.20 50 Hancher, supra note 7, p. 226-227

51 Joined Cases C-159-91 and C-160/91 Christian Poucet (1993) ECR I-637, para.18-19

52 Hancher, supra note 7, p. 228, referring to Case Poucet, supra note 51; and Case C-205/03 P FENIN v. Commission (2006) ECR I-6295

53 Alison Jones and Brenda Sufrin, ‘EU Competition Law, Text, Cases and Materials’ (2014) fifth edition, p. 134,

referring to: Case FENIN, supra note 52, para.26

54 For example: Case C-244/94 FFSA v. Ministere de l’Agriculture et de la Peche (1995) ECR I-4015, para. 17-18;

Joined Cases C-115/97, C-116/97 and C-117/97 Brentjens Handelsonderneming BV (1999) ECR I-6029, para.81-87; Case C-67/96 Albany International (1999) ECR I-05751, para.81-87

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3.3.2. Effect on trade between Member States

The ‘effect on trade’ condition defines “the boundary between the areas respectively

covered by EU law and the law of the Member States”.56 The effect on trade needs to

be appreciable for article 101 TFEU to apply.57 Health care services are mainly provided on a national or even local scale, and providers are mostly small or medium-sized.58 Apart from the cartel cases where pharmaceutical undertakings are involved, many anti-competitive forms of cooperation in the health care sector do not affect trade between Member States. In a purely internal situation the national cartel prohibition will apply.

3.3.3. Agreements, decisions or concerted practices

Article 101(1) prohibits all forms of cooperation, horizontal and vertical, between two or more undertakings that might lead to the prevention, restriction or distortion of competition. An ‘agreement’ is the most obvious form of cooperation, and has been defined by the CJEU as a ‘concurrence of wills between at least two parties, the form in which it is manifested being unimportant’.59 The term ‘concerted practices’, had

been defined by the CJEU as ‘a form of coordination between undertakings which, without having reached the stage where an agreement properly so-called has been concluded, knowingly substitutes practical cooperation between them for the risks of competition’.60 However, it has been stressed by the Commission that the importance of the concept of a concerted practice does not result from its distinction from an ‘agreement’,61 since that distinction does not legally affect the analysis. ‘A decision by associations of undertakings’ particularly prohibits anti-competitive coordination through an association of undertakings, in which the latter can play an important role.

3.3.4. As object or effect the prevention, restriction or distortion of competition

An agreement between undertakings is only prohibited if it genuinely has as its object or effect the distortion of competition. A restriction of competition by object has the potential to restrict competition by its very nature,62 for which it is not necessary to

56 Case C 22/78 Hugin Kassaregister AB v. Commission (1979) ECR I-01869, para.17

57 Commission Notice: Guidelines on the effect on trade concept contained in articles 81 and 82 of the Treaty

(2004) para.44

58 Commission Staff Working Paper, supra note 2, part I, point 277

59 Case C-2/01 P and C-3/01 P Bayer AG (2004) ECR I-23, para.97, referring to the judment under appeal: Case

T-41/96 Bayer AG (2000) ECR II-03383, para.69

60 Case 48/69 Imperial Chemical Industries Ltd. v. Commission (1972) ECR 619, para.64

61 Commission Decision IV/31/149 Polypropylene (1986), para.87, which had been confirmed by the CJEU in

T-305/94 Limburgse Vinyl Maatschappij (1999) ECR II-945, para.696-698, stating that the Commission is entitled to classify a complex infringement as an agreement ‘and/or’ concerted practice

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examine the actual or potential effects on the market once it has been established.63 The parties’ intention is not a necessary factor in determining whether an agreement has an anti-competitive object, however, the Commission may take that aspect into account.64 When cooperation does not restrict competition by object, it must be examined whether there are appreciable restrictive effects on competition.65 Collaboration that hardly influences competition, or leaves a sufficient amount of options on the market, is from a competition law perspective seldom problematic. Such a principle applies to, for example, agreements that are not vertical, nor horizontal, that is between two operators that are active in completely different areas of the health care market and are in no way competing with each other, such as physiotherapists and psychologists.

3.4. Exceptions/exemptions applicable to the health care sector

Not all agreements that could affect the internal market anti-competitively are considered to be unlawful under competition law. For example, there are circumstances in which efficiency gains or public interest objectives can outweigh restrictions of competition.

3.4.1. Article 101(3) TFEU

Article 101(3) TFEU can be considered the ‘legal exception’ of article 101(1) TFEU.66 When paragraph one applies to a certain type of anti-competitive cooperation between undertakings, it can be declared inapplicable when the four cumulative conditions of paragraph three are met: the agreement, decision or concerted practice must lead to efficiency gains; the restriction of competition must be indispensible to the attainment of the efficiency gains, i.e. must be necessary and proportionate; consumers must receive a fair share of the benefits that the efficiency gains bring; and the agreement must not eliminate competition.67 Collaboration between two health care providers that would, for example, distort competition, but improves the quality of certain care significantly, could be exempted under article 101(3), when such quality increase could not be realized through other means. The burden of proof to demonstrate that all four conditions are met rests on the

63 For example Case C-226/11 Expedia Inc. v. Autorite de la Concurrence (2012) ECLI:EU:C:2012:795, para.35 64 For example Case Cartes Bancaires, supra note 62, para.54

65 Case C-56/65 Société Technique Minière v. Maschinenbau (1966) ECR I-00235, para.240 (under section B) 66 Wish R. and Bailey D., ‘Competition Law’ (2012) seventh edition, p.151

67 Communication of the Commission, Guidelines on the applicability of Article 101 of the Treaty on the

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undertaking(s) invoking the benefit of the provision.68 The Commission must adequately examine the presented arguments to determine whether the conditions are satisfied.69 The CJEU has also settled the importance of other objectives both in relation to article 101(1),70 and to 101(3),71 with its reference to ‘achieving legitimate objectives’.72 This goes hand in hand with the considering that the protection of consumer welfare is not the exclusive aim of article 101 TFEU.73

3.4.2. Block Exemption Regulations

Block Exemption Regulations declare article 101(1) inapplicable to certain categories of agreements that meet predetermined criteria. These categories of agreements can be regarded as the type of agreements that the Commission normally regards as satisfying the conditions laid down in article 101(3).74 The Block Exemption Regulations are created by the Commission, which has received its power to create such regulations from the EU Council, and the provisions of the regulations are directly applicable in all Member States.75 The Commission does, however, have the

power to withdraw the benefit of a block exemption where it discovers that an agreement covered by the block exemption has certain effects that are incompatible with article 101(3).76 In some cases, undertakings operating in the health care sector could benefit from these regulations. For example, the Research and Development Block Exemption could be applicable to certain cooperation in research,77 and the Specialisation Block Exemption to various specialisation agreements.78 There are circumstances in which agreements between health care operators, active on different levels of the market chain, can benefit from the Vertical Block Exemption Regulation.79 Agreements concluded by health insurance companies can possibly be

68 Ibid, para.48, established in Joined Cases 43/82 & 63/82 VBVB and VBBB v. Commission (1984) ECR 00019,

para.52

69 Joined Cases 56/64 and 58/64 Consten and Grundig (1966) ECR 299, para.347

70 Case Wouters, supra note 42, para.97; Case C-519/04 P David Meca-Medina (2004) ECR I-06991, para.45

71 Cases T-528/93, T-543/93 and T-546/93 Metropole and Others v. Commission (1996) ECR II-649, para.118;

Case T-193/02 Laurent Piau v. Commission (2005) ECR II-00209, para.100-102 and 106

72 Case David Meca-Medina, supra note 70, para. 45 73 Joined Cases Glaxo, supra note 20, para. 63

74 Commission Regulation No. 1217/2010 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) recital 3

75 Frenz W. ‘Handbook of EU Competition Law’ (2016) p. 420 76 Council Regulation No. 1/2003, supra note 26, article 29(1)

77 Commission’s Regulation 1217/2010 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)

78 Commission’s Regulation 1218/2010 on the application of Article 101(3) of the Treaty on the Functioning of the

European Union to certain categories of specialisation agreements (2010)

79 Commission’s Regulation 330/2010 on the application of Article 101(3) of the Treaty on the Functioning of the

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exempted by the Block Exemption Regulation for the insurance sector, applicable to agreements meeting certain technical criteria.80

3.5. EU Guidelines

To date, the Commission has not set out any general principles on how article 101 TFEU should by applied to the health care sector.81 Therefore, the boundaries for lawful collaboration in this exceptional sector are unclear for both health care operators and NCA’s. Although many NCA’s do provide guidance on to which extent collaboration is allowed in their own Member State, the lack of guidance at EU level does not benefit the legal certainty in this area. One difficulty might exist at the point where the competences lie. Despite the fact that it has issued harmonising policy documents in the area of health care in the past,82 the EU does not legally have competences to harmonise in that area. It can be questioned to which extent the Commission and other EU institutions can provide desired guidance. Another problem is the difference between the current health care systems in the EU. Issuing guidance in a field that is regulated differently throughout the whole Union seems almost impossible.

3.6. Clear-cut infringements of article 101(1) TFEU in the health care sector

To provide an idea of what types of collusion are prohibited in the health care sector, two clear-cut infringements of the cartel prohibition that were fined by the Commission will be given.

In 2001, the Commission had decided to prohibit the dual pricing system that pharmaceutical GlaxoWellcome (now GlaxoSmithKline) had introduced, under which its Spanish wholesalers were required to pay a higher price for products they exported to other Member States, than the price they pay to resell the same products for consumption on the national market, aiming at reducing parallel trade within the single market.83 In appeal in 2006, the European General Court (‘EGC’) had held that, the Commission was wrong to decide that the agreement had the object of restricting

80 Commission’s Regulation 267/2010 on the application of Article 101(3) of the Treaty on the Functioning of the

European Union to certain categories of agreements, decisions and concerted practices in the insurance sector

81 Van de Gronden, supra note 5, p. 275

82 The EU has issued a directive, approximating national rules relating to the advertising and sponsoring of tobacco

products under article 114 TFEU, aimed at improving public health instead of improving internal market policy, discussed in Case C-376/98 Germany v. European Parliament and Council (2000) ECR I-08419

83 European Commission, Press Release of 8 May 2001, entitled: ‘Commission prohibits Glaxo Wellcome's dual

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competition,84 but it did have such an effect.85 In its analysis, the Commission did not adequately address the arguments that the parties had brought forward on article 101(3).86 In 2009, the CJEU upheld the EGC’s judgment,87 but unfortunately did not further clarify how agreements in the health care sector should be assessed under article 101(3).

Another fine that the Commission had imposed in 2001 was on eight distinct secret market-sharing and price fixing cartels in vitamin products, which aimed at eliminating their competition in twelve vitamin markets. The Commission called it

“the most damaging series of cartels the Commission has ever investigated due to the

sheer range of vitamins covered (…)” at that time.88 In appeal the EGC only

constituted an error in calculating the fines.89

84 Case T-168/01 GlaxoSmithKline Services Unlimited v. Commission (2006) ECR II-02969, para.171 85 Ibid, para.148-192

86 Ibid, para.304-317; and Van de Gronden, supra note 5, p.280

87 Court of Justice, Press Release of 6 October 2009 no. 85/09, on Joined Cases Glaxo, supra note 20, available at:

europa.eu/rapid/press-release_CJE-09-85_en.pdf

88 European Commission, Press Release of 21 November 2001, entiled: ‘Commission imposes fines on vitamin

cartels’, available at: http://europa.eu/rapid/press-release_IP-01-1625_en.htm?locale=en

89 European Commission, Press Release of 15 March 2006 No. 22/06, on Case T-15/02 BASF AG v. Commission

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4. The cartel prohibition in the health care sector in the Netherlands

4.1. Introduction

In this chapter the regulation and enforcement of collaboration under the cartel prohibition in the health care sector in the Netherlands will be analysed. To be able to scrutinize to what extent the cartel prohibition applies to the Netherlands’ health care sector, an overview of the framework of the health care system will be provided. Afterwards, the responsible competition authorities and the national cartel prohibition will be analysed, followed by a section on the application of that prohibition in the health care sector. The last section will set out the dilemmas of the current system.

4.2. Framework of the Netherlands’ health care system

The Netherlands has got an essentially market-driven health care system. Both providers of health insurance and health service providers are exclusively private, operating in a regulatory framework.90 The system is based on a compulsory health insurance scheme for the whole population, which is carried out by insurance companies that aim to make a profit.91 The so-called ‘Zorgverzekeringenwet’, which entered into force in 2006,92 had introduced a legal framework that requires all Dutch citizens to be medically insured, and compromises people with low incomes with a subsidy. The government does not manage the health care system, nor controls volumes, prices or productive capacity.93 It only safeguards the proper functioning of the system.94 Health insurers negotiate on prices and quality with health service providers, and patients are able to choose a health insurance and a health care ‘package’ that fits their needs. The supervising authority of the health care sector in the Netherlands is the ‘Nederlandse Zorgautoriteit’ (‘NZa’). It protects the interests of citizens with regards to affordability and quality of health care, sets maximum tariffs and treatment descriptions in the health care market and checks whether health insurers and health care providers comply with the rules and regulations.95

90 Van de Gronden, supra note 5, p.338

91 Den Exter A.P. and Guy M.J. ‘Market competition in health care markets in The Netherlands: Some lessons for England?’ (2014) Medical Law Review, Volume 22 No.2

92 This legal act could be translated into the ‘Health insurances act’

93 Daley C. and Gubb J., Healthcare systems: The Netherlands (updated in 2013) available at:

http://www.digitalezorg.nl/digitale/uploads/2015/03/netherlands.pdf

94 Schäfer W. et. al ‘The Netherlands, Health system Review’ (2010) Health Systems in Transition, Volume 12 no.

1, abstract

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4.3. The Netherlands competition authorities and cartel prohibition

When the Netherlands’ competition law ‘Mededingingswet’ took effect in 1998, the ‘Nederlandse Medediningsautoriteit’ (‘NMa’) was responsible for the enforcement of the competition law provisions. After a merge with other authorities, the NMa became the Autoriteit Consument en Markt (‘ACM’) in 2003.96 The ACM is linked to the Ministry of Economic Affairs,97 but operates independently. It is the Netherlands’ NCA within the meaning of Regulation 1/2003, and is responsible for the enforcement of the EU and national competition law provisions.98 Besides taking official decisions, the ACM regularly gives so-called non-binding ‘informal opinions’ on certain planned collaborations of undertakings. The ACM shares its competence in the area of supervising competition on the health care market with the NZa,99 but the NZa does not have particular competences in the enforcement of the cartel prohibition.

The Netherlands’ cartel prohibition, laid down in article 6 of the Mededingingswet, and article 101 TFEU are very similar. Apart from the ‘effect on trade between Member States’-condition, article 6(1) constitutes the same prohibition as article 101(1) TFEU, and article 6(3) provides for a similar exemption as article 101(3).100 In addition to 6(3), article 7 of the Mededingingswet provides for a general exception on the cartel prohibition for agreements between a limited number of undertakings with a low turnover.101

4.4. Applying the cartel prohibition to the Netherlands’ health care sector 4.4.1. Undertakings in the health care sector in the Netherlands

In 2010, the NMa had published guidelines for competition in the health care sector.102 This document tends to illustrate how and to which extent the cartel prohibition103 of the Mededingingswet and TFEU should be applied to the health care

96 Website ACM, available at: https://www.acm.nl/nl/organisatie/organisatie/de-autoriteit-consument-en-markt/ 97 Website Netherlands’ government (‘Rijksoverheid’), available at:

https://www.rijksoverheid.nl/ministeries/ministerie-van-economische-zaken/inhoud/diensten-en-instellingen-ez

98 Article 88 Mededingingswet

99 Under the ‘Wet marktordening gezondheidszorg’ and the ‘Samenwerkingsprotocol tussen de Autoriteit

Consument en Markt en de Nederlandse Zorgautoriteit’

100 Article 6 Mededingingswet

101 Article 7 Mededingingswet states that the cartel prohibition does not apply to agreements between a maximum

of eight undertakings, of which the joint turnover is no higher than 5.500.000 euros when the undertakings are trading in goods, and 1.00.000 euros when at least one of them provides services (the article includes some further specifications)

102 NMa, Richtsnoeren voor de zorgsector (2010)

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sector in the Netherlands, including a section on which entities in the health care sector are considered to be undertakings within the meaning of competition law. Health care providers within the Netherlands can generally be regarded as undertakings.104 For example hospitals provide services and receive a form of payment in return. They are engaged in economic activity and are thus undertakings.105 In this regard, the mere fact that hospitals and other health care providers are subject to a specific regulatory framework, does not change that finding.106 This principle also applies to, for example, home care providers, which offer home care services on the market,107 and general practitioners (‘GPs’), which offer general practices on a sustainable basis.108 The ACM has recently published a document in which it explains under which circumstances a health care specialist that works in a hospital is considered to be an undertaking of his own, and it falls under the responsibility of the hospital (board).109 Netherlands’ providers of health

insurance are also considered to be undertakings,110 since they engage in economic

activity by offering health care insurances and by purchasing care from health care providers.111 However, the so-called ‘health offices’, responsible for patients that are in need of long-term ‘AWBZ’ care,112 were not engaged in economic activity, but merely in dutiful application of the law, and were thus not undertakings.113 The institutional situation has changed since the 1st of January 2015, when the AWBZ had been modified. The tasks deriving from that act are now assigned to municipalities and providers of health insurance.114 Yet the performance of these particular tasks can probably still not be seen as an economic activity, so that these entities are not considered to be undertakings in the performance of these by law stipulated tasks. Thus, all entities that are currently active on the Netherlands’ health care market are undertakings engaged in economic activity, and are obliged to comply with the cartel prohibition.

104 ACM, supra note 102, point 62

105 Decision NMa, Case 165 Sophia Ziekenhuis (1998) para.16-27 106 Ibid

107 Decision NMa, Case 5851/211 Thuiszorg ’t Gooi (2008); and Case 6108/258 Thuiszorg Kennemerland (2008) 108 Decision NMa, Case 513 Landelijke Huisartsenvereniging (2001) para.71

109 ACM, Aanpassing: ACM-lijn maatschappen en ziekenhuizen niet altijd meer van toepassing (2015) available

via: https://www.acm.nl/nl/publicaties/publicatie/14730/Aanpassing-ACM-lijn-maatschappen-en-ziekenhuizen/

110 Article 122 Zorgverzekeringswet

111 Decision NMa, Case 5154 VGZ-IZA-Trias-Univé (2006)

112 AWBZ is the Algemene Wet Bijzondere Ziektekosten, which could be translated to ‘exceptional medical

expenses act’, which covered all serious medical risks that are not covered by a regular health insurance.

113 NMa, Visiedocument AWBZ-zorgmarkten (2004)

114 Website Zorgwijzer, which compares health insurance providers, available at:

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4.4.2. Analysis of decisions and judgments

To get an idea of how the cartel prohibition in the health care sector is being enforced in the Netherlands, an oversight of all final decisions and judgments of the past four years and the decisions that precede those, is given in this paragraph.

After an investigation that had started in 2008, the NMa decided in 2010 that the home care institutions Carinova and Carint-Reggeland Groep had concluded an anti-competitive non-competition clause prohibited under article 6(1) Mededingingswet.115 In its decision on appeal, the ‘Raad van Bestuur’116 upheld all parts of the decision, except those regarding the end date of the breach, for which reason the fines had been lowered.117 The court however supported Carinova and Carint’s reasoning in the second appeal, and decided that the documents referred to in this case, on the basis of which the NMa had concluded that there was a non-competition clause between the two undertakings, did not sufficiently prove that there was any concurrence of wills.118 The court of last instance upheld that judgment.119

In 2010, the NMa had taken a decision, in which two home care providers, Stichting Thuiszorg Zuidwest Friesland and Stichting Zorgverlening De Friese Wouden, had agreed on how and with which prices they were going to participate in a tendering procedure. It held that this agreement had restricted competition in the tendering procedure, and was therefore prohibited under article 6.120 When the two home care providers appealed the decision, the Raad van Bestuur121 and the court upheld the decision of the NMa.122

The national association of general practitioners ‘Landelijke Huisartsen Vereniging’ (‘LHV’) has made commitments, which have been officially validated by the NMa in 2012, to refrain from advising members on whether or not to sign general practice contracts with providers of health insurance and from negotiating for its members on the conditions of competition parameters in contracts with providers of health insurance, to prevent infringement of the cartel prohibition in the future.123 The NMa had fined the LHV and its two responsible officials earlier, in 2011, because it had

115 Decision NMa, Case 6274/569 Carinova en Carint-Reggeland Groep (2010) 116 ‘Board of Directors’ of the ACM, which takes decisions in appeal

117 Decision Raad van Bestuur NMa, Case 6274/635 Carinova en Carint-Reggeland Groep (2011) 118 Court of Rotterdam, Case ROT 12/203 and 12/258 (2013) ECLI:NLRBROT:2013:BZ4169 119 Court ‘College van Beroep voor het bedrijfsleven’, Case AWB 13/289 and 13/295 120 Decision NMa, Case 6642/516 Aanbesteding WMO thuiszorg Friesland (2010)

121 Decision Raad van Bestuur NMa, Case 6442/574 Aanbesteding WMO thuiszorg Friesland (2012) 122 Court of Rotterdam, Case ROT 12/3830 (2015) ECLI:NL:RBROT:2015:2912

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restricted the freedom of establishment by recommending its members to only permit the establishment of new GPs when all settled GPs had agreed that there would be a sufficient need for a new GP. The implementation of such advice would disadvantage new GPs and harm patients and providers of health insurance by giving them fewer options, which constitutes a restriction competition and is prohibited under article 6(1) Mededingingswet.124 The Raad van Bestuur upheld most parts of this decision in appeal, however, it did waive the individual fines and reduced the amount of the general fine.125 The court then ruled against both ACM decisions, by stating that because the recommendation did not specify any indications or norms with regards to a maximum amount of patients per GP, nor a maximum amount of GPs per region, it does not constitute an appropriate instrument to restrict competition. Therefore, it decided that the LHV had not infringed article 6(1) with its decision.126

The ACM has recently replied to a request of the so-called ‘Santeon’ partnership, for which it analysed an aimed collaboration in the area of breast cancer care between six Santeon hospitals.127 The ACM had announced that it allows this form of

collaboration, since the parties concerned are not direct competitors and the aim of the collaboration is to constitute a transparent nationwide offer of efficient, high quality breast cancer care.

4.4.3. Analysis of informal opinions

The ACM occasionally publishes non-binding informal opinions on health care operators who whish to collaborate on the health care market. Of these, all that were published in the last four years will be set out here.

The ACM clarified in one of its opinions in 2013 that independent pharmacies that are not competing with each other, are allowed to collectively bargain with providers of health insurance.128

In another letter in 2014, the ACM warned providers of health insurance that their proposed plans to concentrate complex emergency hospital care, in order to provide

124 Decision NMa, Case 6888/435 Vestigingsadviezen Landelijke Huisartsen Vereniging (2011)

125 Decision Raad van Bestuur NMa, Case 6888/510 Vestigingsadviezen Landelijke Huisartsen Vereniging (2014) 126 Court of Rotterdam, Case ROT 14/1977 (2015) ECLI:NL:RBROT:2015:9352

127 ACM, Letter ‘Borstkankerzorg Santeon-ziekenhuizen’ (2015) and Press Release of 19 May 2015, available at:

https://www.acm.nl/nl/publicaties/publicatie/14248/Zes-ziekenhuizen-mogen-samenwerken-voor-betere-borstkankerzorg/

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an improved and more efficient form of emergency care, could possibly reduce the amount of options for patients, and could lead to a restriction of competition.129 The ACM had also published its opinion in a reply to a request of providers of health insurance on a proposed collaboration in the purchase of proton therapy, a form of radiation therapy, at one specific centre in the Netherlands and at centres abroad. According to the providers of health insurance, the amount of patients who would actually qualify for the specific therapy is smaller than the amount for which the Minister had authorized. However, studies of the care institute (Zorginstituut) have proven that this is not the case, and that such joint purchase of the therapy at one centre in the Netherlands could lead to a qualitative and quantitative restriction of supply of the therapy, and to a restriction of competition under article 6(1) Mededingingswet, in a way that cannot be exempted under article 6(3). Joint purchase of the proton therapy abroad, will, however, not restrict article 6 or 101 TFEU appreciably according to the ACM.130

4.5. On the agenda of the Netherlands’ competition authority

Cooperation in the health care sector is currently on the agenda of the ACM (2016-2017) as one of the six chosen themes on which it will focus in the upcoming two years.131 This means that it will publish several market studies, best practices and frameworks in that period of time, which will further clarify to what extent collaboration in the health care sector is allowed in the Netherlands under the cartel prohibition. In this context, it has already published several documents, amongst which a concept version of a guidance on joint purchasing of drugs by specialist care providers132 and an interim report of a study on competition on the health insurance market,133 for which a research company has done a study on the business model of health insurance companies.134 The ACM has also recently confirmed that there is quite some space for primary health care providers, like GPs, speech therapists,

129 ACM, Press release of 16 July 2014, entitled: ‘ACM wijst zorgverzekeraars op mededingingsrisico bij

uitvoering gezamenlijke plannen spoedeisende zorg’, available at:

https://www.acm.nl/nl/publicaties/publicatie/13132/ACM-wijst-zorgverzekeraars-op-mededingingsrisico-bij-uitvoering-gezamenlijke-plannen-spoedeisende-zorg/

130 ACM, Letter ‘Informele zienswijze Gezamenlijke Inkopen door zorgverzekeraars van protonentherapie’ (2015) 131 Website ACM, available at:

https://www.acm.nl/en/about-acm/mission-vision-strategy/our-agendas/2016-2017-acm-agenda-/healthy-collaborations-in-health-care/

132 ACM, ‘Leidraad gezamenlijke inkoop geneesmiddelen voor de medisch-specialistische zorg’ (2016) 133 ACM, ‘Tussenrapportage concurrentie op markt voor zorgverzekeringen’ (2016)

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physiotherapists and psychotherapists, to collaborate, as long as it is in the interest of the patients and the benefits for patients weigh out the possible cons on the market.135

4.6. Dilemmas

Within the Netherlands’ market-based health care system, all operators on the health care market are subject to the cartel prohibition in almost all of their activities. The cartel prohibition ‘only’ prohibits collaborations that possibly restrict competition on the market, in such a way that benefits for patients and consumers flowing from that collaboration cannot counterbalance against the negative effects on the market. This standard is not so straightforward for, nor easily assessable by, health care operators. Many operators in the Netherlands have no idea with whom and to what extent they are still allowed to co-operate.136 The ACM, for example, noticed that providers of primary care are reluctant to collaborate,137 and that hospitals, providers of health

insurance and other parties are reserved in jointly purchasing medicines.138 It is

undesirable if operators on the health care markets would refrain from collaborating, only because there is a lack of clarity on the scope of the cartel prohibition and its exemptions on this market. It is obvious from the effort that the ACM puts in clarifying the extent of the prohibition in policy documents, guidelines, and informal opinions that it does recognise this dilemma.

135 ACM, Press Release of 19 August 2015, entitled: ‘ACM bevestigt ruimte voor samenwerking in

eerstelijnszorg’, available at: https://www.acm.nl/nl/publicaties/publicatie/14733/ACM-bevestigt-ruimte-voor-samenwerking-in-eerstelijnszorg/, which has been further explained in ‘Uitgangspunten toezicht ACM op zorgaanbieders in de eerste lijn’ (2015)

136 ACM, Annual report page 2013-2016 (2016) availabe at: https://jaarverslag.acm.nl/zorg 137 ACM, supra note 135

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5. The cartel prohibition in the health care sector in England

5.1. Introduction

In this chapter, the regulation and enforcement of collaboration under the cartel prohibition in the health care sector in England will be set out. To be able to appropriately compare the different regulatory frameworks and the enforcement of the cartel prohibition in the health care systems of the two states in the next chapter, the same components of the previous chapter on the Netherlands’ framework will be dealt with.

5.2. Framework of the English health care system

As already mentioned in paragraph 2.2., the health care system of England is very different from that of the Netherlands’. The majority of health care is publicly funded in England.139 The Beveridge-based NHS system, is open to everyone that lives permanently in the U.K. and is free of charge for all participants. The NHS is being managed fully by the state and is being funded publicly through taxes. Health care services are being supplied by over 250 publicly owned health care providers and, increasingly, independent providers including private companies and charities.140 Regional so-called Clinical Commissioning Groups (‘CCGs’), which are overseen by NHS England, purchase health care services at different health care providers and ensure the delivery of the services in local areas.141 Since the Health and Social Care Act 2012 (‘the 2012 Act’) came into force, the responsibility for pricing of NHS services has moved from the Department of Health, to a shared responsibility for NHS England and Monitor.142

The scope of NHS services is not defined in legislation, but in practice the NHS provides most types of health care services.143 Hospital care is predominantly offered by public hospitals that are operating through NHS hospital trusts or foundation trusts. The latter are independent public entities that are being controlled locally. The future intention is for hospitals to become more independent

139 Crawford R. and Emmerson C., ‘NHS and social care funding: The outlook to 2021/22’ (2012) Institute for

Fiscal Studies research report, p.6

140 Harvey J. ‘A healthy debate: competition policy in publicly funded health care, economic insight’ (2012)

European Competition Law Review 33(12)

141 Beckert W. et. al., ’Toepassing van de mededingingswet in the zorgsector’ (2011) KPMG and Van Doorne

working paper, p.4

142 Website of NHS England, available at:

https://www.england.nhs.uk/resources/pay-syst/tariff-consultation-notice/

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from NHS.144 In order to do so, all hospitals need to be operating through foundation trusts. Apart from the NHS, a form of private medical insurance is offered, which is being held by a rough 11% of the UK’s population.145 This private insurance offers more rapid and convenient access to care, especially for elective procedures, but most policies exclude certain health services.146 The operators active on the private health care market set their own prices.147 Both public and private entities are engaged in the provision of private, non-NHS care. The Secretary of State for Health and the Department of Health are the public bodies that are responsible for health policy and legislation and the health system as a whole in England, under the Health Act 2006.148 The aim of the establishment of the 2012 Act had been to provide a sufficient competition regime in the health care sector, by creating a framework in which choice and competition (on quality, not on price) can operate with appropriate safeguards.149

5.3. The English competition authorities and cartel prohibition

In April 2014, many of the functions of the Competition Commission and the Office For Trade (‘OFT’) had been taken over by the Competition and Markets Authority (‘CMA’), which is the present competition authority responsible for enforcing the EU and UK competition rules in the UK, and thus in England.150 The 2012 Act has established the health care sector regulator Monitor as the co-competent competition supervisor for the health care sector.151 Unlike other English sector regulators, it does not have the duty to promote competition in the interest of consumers,152 but to protect and promote the interests of the users of health care services,153 for which the prevention of anti-competitive behaviour can be seen as a tool. Both the CMA and Monitor are competent to enforce the national and EU cartel prohibition prohibition in the health care sector,154 in which they have to co-operate to a certain extent.155

144 Ibid

145 Commission on the Future of Health and Social Care in England, ‘The UK Private Health Market’ (2014) The

Kings Fund (in cases where data for England are unavailable, U.K. data are used instead)

146 Mossialis, supra note 143, p. 49, like mental health, maternity services, emergency care and general practices 147 See website of private health England, available at: http://www.privatehealth.co.uk/costs/

148 Mossialis, supra note 143, p. 49

149 UK government, Health and Social Care Act 2012: factsheets, Factsheet C4: Choice and Competition, point 4 150 CMA, Towards the CMA, CMA Guidance (2013) CMA1

151 Sanchez Graells A. ‘Monitor and the Competition and Markets Authority’ (2014) University of Leicester

School of Law Research Paper no.14-32, p.2

152 CMA, Regulated Industries: Guidance on concurrent application of competition law to regulated industries

(2014) p.63

153 Ibid. See also: Factsheet, supra note 149, point 6; and Monitor, Guidance on the Procurement, Patient Choice

and Competition Regulations: consultation response (2013)

154 CMA, supra note 152, para.2.2

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