Medical Law Review, Vol. 22, No. 2, pp. 238–254 doi: 10.1093/medlaw/fwu008

JOHAN VAN DE GRONDEN1 and ERIKA SZYSZCZAK2* 1

Faculty of Law, Radboud University, Nijmegen, The Netherlands 2 Sussex Law School, University of Sussex, Brighton, UK *Correspondence: School of Law, Politics and Sociology, Friston Building 121, University of Sussex, Brighton BN1 9RH, UK, Email: [email protected]

A B S T R AC T A national health care service is one of the central pillars of the welfare state in Europe. Recent moves to modernise health care, alongside introducing efficiencies through competition have resulted in experimentation and a re-organisation of national health care systems. The experimental nature of the reforms has brought health care into the focus, but uncertain territory, of EU economic law, especially competition law. Added to these pressures, the new EU fiscal measures oblige Member States to avoid excessive budgets and macro-economic imbalances. One constraint on an EU-based system of competition in health care is the effect of decentralisation, resulting in variations at the national level. Thus a case study is taken of the experience in The Netherlands. From this case study, we argue that a new form of Euro-national competition law is emerging for the health care sector with national authorities taking the lead in shaping the contours of this law. KEYWORDS: EU law, Healthcare, Competition, Public policy

I . I N T RO D U C T I O N Traditionally, the economic and social spheres of the EU have been separated. This has allowed the Member States to develop their own culturally distinct social and welfare policies and continue with redistributive policies in tune with national preferences and mediated through national democratic processes. In this regard, the health care systems of the Member States of the EU are protected from EU legislative intervention with Article 168(7) TFEU setting a subsidiary principle. © The Author 2014. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals. [email protected]

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INTRODUCING COMPETITION PRINCIPLES INTO HEALTH CARE THROUGH EU LAW AND POLICY: A CASE STUDY OF THE NETHERLANDS

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Regulation 1175/2011 of the European Parliament and the Council amending Council Regulation 1466/ 97 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies, OJ 2011 L306/12; Regulation 1174/2011 of the European Parliament and of the Council on enforcement measures to correct excessive macroeconomic imbalances in the euro area, OJ 2011 L306/8; Regulation 1175/2011 of the European Parliament and of the Council amending Council Regulation 1466/97 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies, OJ 2011 L306/12; Regulation 1176/2011 of the European Parliament and of the Council on the prevention and correction of macroeconomic imbalances, OJ 2011 L306/ 25; Regulation 1177/2011 of the Council amending Regulation on speeding up and clarifying the implementation of the excessive deficit procedure, OJ 2011 L306/33 and Directive 2011/85 of the Council on requirements for budgetary frameworks of the Member States, OJ 2011 L306/41. On 30 May 2013, an additional ‘two pack’ was adopted to increase monitoring and surveillance: Council Regulations 472/2013 and 473/2013, OJ 2013 L140/1. The Treaty on Stability, Coordination and Governance was signed on 2 March 2012 by the leaders of all euro area members and eight other EU member states, and entered into force on 1 January 2013. The signatories to the treaty agreed to implement a balanced budget rule in their national legislation through permanent, binding provisions, preferably of a constitutional character, by the end of 2013. For a discussion of the institutional and constitutional implications of these measures see: P Athanassiou, ‘Of Past Measures and Future Plans for Europe’s Exit From the Sovereign Debt Crisis: What Is Legally Possible (and What Is Not)’ (2011) 36 ELRev 558; P Craig, ‘The Stability, Co-ordination and Governance Treaty: principles, Politics and Pragmatism’ (2012) 37 ELRev 23; M Dawson and F de Witte, ‘Constitutional Balance in the EU after the Euro-Crisis’ (2013) 76.5 MLR 817; also available on SSRN: accessed 2 April 2014. See eg Recommendation 2 of Council Recommendation of 10 July 2012 on the National Reform Programme 2012 of Austria and delivering a Council opinion on the Stability Programme of Austria, 2011– 2016, OJ 2012 C219/1, para 14 of the Council Recommendation of 10 July 201 on the National Reform Programme 2012 of Cyprus and delivering a Council opinion on the Stability Programme of Cyprus 2012–2014, OJ 2012 C219/13 and para 12 of the Recommendation of 10 July 201 on the National Reform Programme 2012 of Germany and delivering a Council opinion on the Stability Programme of Germany, 2012–2016, OJ 2012 C219/35. The Country Specific Recommendations can be found at: accessed 2 April 2014. For a general critique, see F Scharpf, ‘Monetary Union, Fiscal Crisis and the Preemption of Democracy’ (2011) LEQS Paper No 36 22. See European Economy The Quality of Public Expenditures in the EU, Occasional Papers 125, December 2012, Staff of the Directorate for Economic and Financial Affairs of the European Commission, p 26.

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However, national health care systems have been exposed to EU economic law as new providers of health care and new markets have emerged. First, through the use of the internal market provisions to widen patient choice in health care provision, then through the application of competition law, free movement, and procurement law, and more recently, through the application of the new platform of fiscal measures implemented in response to the economic crisis in the EU. The EU has adopted a set of economic measures,1 in the form of, inter alia, Regulations, that oblige Member States to avoid excessive budgets, and macro-economic imbalances. The Council, on the basis of Recommendations of the Commission, has adopted country-specific Recommendations. These Recommendations concern health care2 by addressing issues of efficiency and competition as important values. The European Commission has suggested that health-care-related country-specific Recommendations may feature more prominently in the future.3 Thus there may be incentives for the State to tender out the provision of health care services and to create new markets. In the absence of EU legislative competence and the political will on the part of the Member States to regulate health care at the EU level, EU competition law now

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II . EU COM P ET IT IO N LAW There is much debate as to the aims of EU competition law. One aim is that EU competition law is based on considerations of efficiency and consumer welfare.8 Initial analyses of the impact of EU competition law on health care attempted to maintain a distinction between public undertakings financed through state resources, for example, taxation, and obviously private health care practice which was not funded

4 5 6 7 8

W Sauter, ‘The Impact of EU Competition Law on National Healthcare Systems’ Tilburg Law School Legal Studies Research Paper Series No 12/2012, 1. Case C-70/95 Sodemare [1997] ECR I-3395; Case C-8/02 Leichtle [2004] ECR I-2641. See: Case C-158/96 Kohll [1998] ECR I-1931. Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patient’s rights in cross-border healthcare, OJ 2011 L 88/45. Eg A Jones and B Sufrin, EU Competition Law/ Text, Cases and Materials (4th edn OUP, Oxford 2011) 4–18; R Whish and D Bailey, Competition Law (7th edn Oxford University Press, Oxford 2012) 19 and 20 and S Marco Colino, Competition Law of the EU and UK (7th edn Oxford University Press, Oxford 2011) 28–31.

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‘forms a default regulatory framework for the sector’.4 But the EU competition tools are not particularly flexible in addressing the marketisation of sectors previously protected from competition, particularly social services that ought not to be subject to market rules. A crucial limitation of the rules is that initially they were designed to address un-competitive behaviour of non-state ( private) undertakings and thus contain limited justifications and exemptions. Initially, EU law wrapped a blanket of protection around state intervention in the market, providing a huge comfort zone for the state to continue to supply and trade in goods and services with a public or social aim. The nature of liberalisation in the EU has been to transfer the provision of many State activities either completely, or partially, to the private sphere, or to create new forms of hybrid undertakings, especially through a mix of public–private initiatives. However, the monopsony role of the state in buying many forms of social services continues. The current EU competition legal tools are ill-equipped to handle these transformations of the state and the market, especially in allowing for public interest justifications to temper the full application of the market rules. Initially, the European Court was sensitive to the Member States’ competence to organise their own health care systems, as part of a wider national social security system.5 Equally limiting is the issue of what form of anti-competitive behaviour occurs on health care markets and what are the consequences? The increasing marketisation of social services has led the EU Institutions to re-appraise the application of economic law to such services, adopting novel and nuanced approaches to protecting social services from the full application of the market rules. Dissatisfaction with the lack of competition or consumer choice in national health care systems first manifested in EU law through the use of the free movement and Citizenship provisions to facilitate patient choice.6 The Member States’ reluctance to allow EU regulation of health care services is seen in the removal of health care from the Services Directive and the tortuous negotiation of the Patients’ Rights Directive in 2011.7

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JT Lang, ‘Privatisation of Social Welfare: European Union Competition Rules’ in M Dougan and E Spaventa (eds) Social Welfare and EU Law: Essays in European Law (Hart Pub., Oxford 2005) 65. See the discussion by O Odudu, ‘Are State-owned health-care Providers Undertakings Subject to Competition Law?’ [2011] ECLR 231. See JW van de Gronden, ‘The Treaty Provisions on Competition and Health Care’ in JW van de Gronden, E Szyszczak, U Neergaard, and M Krajewski (eds) Health Care and EU Law (TMC Asser PressSpringer, The Hague 2011) 271–4. See Case C-475/99 Firma Ambulanz Glöckner v Landkreis Südwestpfalz [2001] ECR I-8089. Joined Cases C-180/98 to C-184/98 Pavel Pavlov et al. v Stichting Pensioenfonds Medische Specialisten [2000] ECR I-6451. See para 76 of Pavlov Ibid. Joined Cases C-264/01, C-306/01, C-354/01, and C-355/01 AOK Bundesverband et al. v IchthyolGesellschaft Cordes, Hermani & Co. et al. [2004] ECR I-2493. Case C-437/09, AG2R Prévoyance v Beaudout Père et Fils SARL [2011] ECR I-973. See for eg Joined Cases C-159/91 and C-160/91 Christian Poucet v Assurances Générales de France and Caisse Mutuelle Régionale du Languedoc-Roussillon [1993] ECR I-637.

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through state resources.9 Such a simple binary divide is not so easy to apply in health care where the responsibility of the state to provide a health care system has led to experimentation particularly in the procurement of health care services from publicly funded and privately owned bodies, as well as using a mix of public and private suppliers of health care services.10 In health care cases, the CJEU has created a sharp distinction between health care providers and bodies managing health care schemes, such as NHS bodies and health insurance companies.11 When examining health care providers, the CJEU is clear: they provide services or supply goods for remuneration and therefore, they are undertakings.12 In Pavlov, 13 the CJEU found that the medical specialists were engaged in economic activities, as they offer services on the market in specialist medical services and they are reimbursed for these activities.14 The outcome of this case law is striking: consideration of EU competition law should be regarded to be an important value in every national health care system. In contrast, the reasoning of the CJEU is more sophisticated for bodies managing health care schemes. From case law, such as AOK 15 and AG2R,16 it is apparent that the CJEU carries out a different test.17 It examines, with great care, whether the design of the scheme managed by a particular body justifies the application of the competition rules. If a particular scheme is predominantly based on solidarity and the managing bodies concerned are subject to substantial state control, EU competition law does not apply. Therefore, the German sickness funds in AOK escaped the application of EU competition law. In contrast, in AG2R a French insurer administrating a supplementary health care scheme did fall within the scope of competition law, since no substantial State control was carried out. It should be pointed out that the scheme concerned was predominately based on solidarity, but the CJEU was of the opinion that the role of the State in supervising the management of this scheme was limited. Consequently, the conditions on solidarity and State control are cumulative for finding immunity from the competition rules. Thus, it may be assumed that the State bodies ensuring that every citizen is entitled to basic health care are not undertakings. If a managing body is assigned its primary task of, organising the delivery of health care, is not an undertaking and it is not engaged in economic activities, if it purchases goods and services on a particular

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A. The Role of Article 106(2) TFEU: SGEI in Health Care Health care lends itself to being categorised as a SGEI, bringing into play the derogation of Article 106(2) TFEU. The performance of a SGEI is capable of justifying restrictions of competition, provided that the principle of proportionality is met.21 The CJEU held that competition restrictions resulting from the implementation of SGEI are permitted, if this is necessary in order to provide SGEI under economically acceptable circumstances.22 An operator entrusted with a SGEI mission should have the possibility to offset the less profitable sector against profitable sectors,23 and commercially oriented firms should be prevented from deploying the most profitable activities.24 The CJEU has applied Article 106(2) TFEU to restraints in the health care sector.25 The tensions arising from the need to finance the provision of SGEI and the competition objectives pursued by the TFEU provisions on state aid were addressed by the CJEU in the Altmark judgment.26 The European Commission seized control over

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Case C-205/03P FENIN [2006] ECR I-6295.See J Lear, E Mossialos, and B Karl, ‘EU Competition Law and Policy’ in E Mossialos, G Permanand, R Baeten, and TK Hervey (eds) Health Systems Governance in Europe. The Role of European Union Law and Policy (CUP, Cambridge 2010) 342. M Fererra, The Boundaries of Welfare: European Integration and the New Spatial Politics of Social Protection (OUP, Oxford 2005). The CJEU has held that agreements in local markets do not appreciably affect inter-state trade: Case C-234/89 Stergios Delimitis v Henninger Brau AG [1991] ECR I-935. See also Guidelines on the effect on trade concept contained in Articles 81 and 82 of the Treaty, OJ 2004 C 101/81; The De Minimis Notice, OJ 2001 C 368/13. Case C-320/91, Criminal Proceedings against Paul Corbeau [1993] ECR I-2533. See para 16 of Corbeau, Ibid. See also para 52 of Case C-159/94, Commission v France [1997] I-5817. See para 17 of Corbeau, above, n 21. See para 18 of Corbeau, above, n 21. See, for eg: Case C-475/99 Ambulanz Glockner [2001] ECR I-8089. Case C-437/09 AG2R Prévoyance v Beaudout Père et Fils SARL [2011] ECR 973. Case C-280/00 Altmark [2003] ECR I-7747.

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market.18 This leads to an unequal relationship between providers and managing bodies in health care. Whereas health care providers when entertaining commercial relations with managing bodies are under the ‘constant obligation’ to observe the EU competition rules, these bodies are not bound by the EU competition rules. Until the recent liberalisation agenda health care systems were national; a bounded space19 where the impact of private and public health care provision across borders was minimal and therefore unlikely to trigger EU competition law. The national approach to health care provision creates a natural barrier to entry through foreclosure.20 But in the view of the European Court, the objectives of public interest should be pursued by the competent authorities of the Member States; health care operators should confine themselves to protecting their own interests. Thus the EU competition rules force health care operators to base their policies on considerations of efficiency. This approach leads to an incentive for health care operators to seek profits. In many national health care systems, operators are not allowed to make a profit, but EU competition law, by emphasising the importance of protecting business interests, compels operators to adopt commercially oriented policies. Other objectives, which are not based on competition values, do not seem to play an important role in the general EU approach.

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27

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See the Commission Decision of 2005 on the application of Art 86(2) of the EC Treaty to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest, OJ 2005 L312/67 and the Community framework for State aid in the form of public service compensation, OJ 2005 C297/4. Also of relevance was Commission Directive 2006/111 on the transparency of financial relations between Member States and public undertakings as well as on financial transparency within certain undertakings, OJ L 318/17. This Directive was not amended in the 2011 update. See the Communication from the Commission on the application of the European Union State aid rules to compensation granted for the provision of services of general economic interest, OJ 2012 C8/4; the Commission Decision of 20 December 2011 on the application of Art 106(2) of the Treaty on the Functioning of the European Union to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest, OJ 2012 L7/3; the Communication from the Commission on a European Union framework for State aid in the form of public service compensation, OJ 2012 C8/15 and Commission Regulation 360/2012, on the application of Arts 107 and 108 of the Treaty on the Functioning of the European Union to de minimis aid granted to undertakings providing services of general economic interest, OJ 2012 L114/8. Eg the 2011 Commission Communication on a Quality Framework for Services of General Interest, p 3 and para 48 of the Communication from the Commission on the application of the European Union State aid rules to compensation granted for the provision of services of general economic interest, OJ 2012 C8/4. See W Sauter, ‘Services of General Economic Interest and Universal Service in EU Law’ (2008) 33 ELR 179, 180. Commission Decision of 20 December 2011 on the application of Art 106(2) of the Treaty on the Functioning of the European Union to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest, OJ 2012 L7/3.

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the application of the Altmark conditions through a package of soft law measures in 2005/2007,27 which was updated in 2011/12.28 A statement made by the European Commission in its update package is that an important feature of SGEI is that without public intervention these services would not be provided, or at least not under circumstances that meet requirements such as quality, safety, affordability, equal treatment, and universal access.29 It is clear that the European Commission relates the provision of SGEI to the existence of market failure: intervention by the Member States is only justified, in so far as a particular market failure prevents an essential service from being provided on the market. In legal doctrine, market failure is a logical starting point for the designation of SGEI missions, as only if the market fails to provide an essential service government action is necessary.30 It is open to debate which problems should be regarded as a market failure. In many cases, it will be difficult to determine whether the level of provision of a particular service is adequate. Furthermore, it could be argued that the circumstance that a service is not (adequately) provided on the market should not be mixed with the question whether it constitutes a SGEI mission. Theoretically, it could be put forward that the first step is to determine whether the provision of a particular service amounts to a SGEI task and the next step is then to establish whether State intervention is needed given the inadequate level of service provision. The update of the Altmark package is an attempt of the European Commission to curtail the SGEI competence of the Member States. One measure is of great importance for health care: the Commission Decision of 2011.31 This Decision applies, if one of the Altmark conditions is not satisfied.

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See European Commission, Staff Working Document, Guide to the application of the European Union rules on state aid, public procurement, and the internal market to services of general economic interest, and in particular to social services of general interest, Brussels, 29 April 2013, SWD(2013) 53 final/2. Available at: accessed 2 April 2014. Decision of the Commission of 22 December 2005 on the introduction of a risk equalisation system in the Dutch Health Insurance, N541/2004 and N542/2004- C (2005) 1329 fin. Case T-137/10, Coördinatie van Brussels instellingen voor welzijnswerk en gezondheidszorg (CBI), 7 November 2012, n.y. r. Commission Decision of 28 October 2009 in case NN 54/2009, Financing the public hospitals of the IRIS network of Brussels, C(2009)8120 final.

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However, the Commission Decision exempts state aid measures financing particular SGEI from the obligation to notify creating a safe harbour for these measures.32 Hospitals and social services (as regards health and long-term care) are covered by the 2011 Commission Decision but are constrained by a set of conditions. Article 4 requires a transparent act of entrustment that includes specific elements, such as a description of the applicable compensation mechanisms. Article 5 sets out in great detail how the amount of compensation should be calculated. At the heart of this provision is efficiency: overcompensation should be avoided at all cost. To date, the CJEU has not had the opportunity to rule on a significant case on health care and state aid. However, in BUPA the General Court has shown a willingness to apply the Altmark conditions in a flexible way to health care cases. It has accepted that the SGEI mission could be derived from the general wording of some obligations laid down in national legislation. Similarly, in the Zorgverzekeringswet case,33 which concerned the financing of the risk equalisation scheme of the Dutch health care system, the European Commission applied the EU rules on SGEI and state aid in a flexible way. In contrast, after the European Commission’s update of the Altmark Package, the GC appears to have taken a stricter approach in the CBI case.34 The issue concerned aid given to public hospitals in Brussels. In Belgium, hospitals are funded by the State in order to provide particular medical services. The state aid measures were notified to the European Commission, which approved these measures.35 The European Commission was of the opinion that the task to provide medical services constitutes a PSO/SGEI, as this was laid down in a piece of Belgian legislation. The approval of the Belgian scheme was challenged by Belgian private hospitals before the General Court. They only targeted the aid given in order to finance the provision of the social services and did not question the funding of the medical services. The GC assessed first whether the public hospitals were entrusted with a SGEI mission and secondly, whether the risk of overcompensation was avoided. As for the task to provide assistance to social patients, the GC pointed to the general duty of Belgian law, according to which every hospital is obliged to treat persons in need: it is a matter of law that a hospital must help persons needing health care, even if the patient cannot pay for the costs incurred. Consequently, it was questionable whether giving assistance to social patients belonged to the sole responsibilities of the public hospitals. Concerning the issue of overcompensation, the GC put forward that the conditions for giving subsidies to the public hospitals were unclear and left a wide margin of appreciation to the public authorities involved. The concern of the GC was

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I I I. A NAT I O N A L CA S E S T U DY The Netherlands aligned its competition laws with EU rules and in 1998 the Mededingingswet (Competition Act) (Mw) entered into force. The authority responsible for the enforcement of this Act was the ‘Nederlandse Mededingingsautoriteit’ (The Netherlands Competition Authority) (NMa). This authority merged with the Dutch authorities for telecommunications and consumer affairs on 1 April 2013 becoming the Autoriteit Consument en Markt (Consumer & Markets Authority) (ACM). The ACM operates independently from the Dutch Minister of Economic Affairs and is trusted with the task to enforce both the Dutch and EU competition rules in The Netherlands.36 Pursuant to Article 6 (1) Mw agreements, concerted practices and decisions of associations of undertakings restricting competition are prohibited. In line with EU competition law, such practices could be permitted according to Article 6 (3) Mw, if they aim to contribute to the production, distribution, or innovation of particular products or services. Article 24 Mw precludes dominant undertakings from being engaged in abusive practices. This provision is also modelled on after EU competition law. Pursuant to Article 56 Mw, the ACM has the power to impose penalties, such as fines, upon undertakings that have infringed Article 6 or Article 24 Mw. A similar competence is assigned by Article 89 Mw to the ACM in relation to infringements of the EU competition rules committed in The Netherlands. The maximum amount of the fine imposed may not succeed ten per cent of the turnover of the undertakings concerned.37 Articles 27 – 48 Mw entrust the ACM with the task to review mergers that meet particular thresholds, which are below the thresholds of the EU merger control rules. As a result, many Dutch mergers that are not subject to review by the European Commission must be notified to the ACM. It should be noted that the thresholds for notifying mergers of health care operators to the ACM are even (temporarily) lowered a special Decree.38 As a result, many health care mergers are subject to scrutiny by the ACM. The Dutch merger control rules are derived from the EU experience with merger control. Companies considering merging should notify their plans to the

36 37 38

See Art 88 Mw. See Art 57 Mw. See the ‘Besluit houdende tijdelijke verruiming van het toepassingsbereik van het concentratietoezicht op ondernemingen die zorg verlenen’, Stb 2007, 518, as amended by Stb 2012, 515. (Decree on the temporary extension of the scope of merger control on undertakings providing health care.)

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that overcompensation was not excluded from the outset, as no mechanisms for preventing overcompensation were in place. Accordingly, the GC contended that the European Commission had failed to examine properly whether problems of overcompensation existed. Therefore, it annulled the European Commission Decision approving the social aid given to the public hospitals in Brussels with an admonishment to examine with great care whether the aid given to these hospitals is compatible with the EU rules for state aid. It is apparent from this case and the 2011 update of the Altmark package that the European Commission cannot create automatic exemptions for the health care sector. Transparency and efficiency are prerequisites for the application of any special rules.

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39 40 41 42 43

44

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See Art 34 Mw. See Art 37 (2) Mw and Art 41 (2) Mw. See Art 2 (2) of Regulation 139/2004 on the control of concentrations between undertakings, OJ 2004 L24/22. See the Jaarverslag of the NMa (Annual report of the Dutch competition authority) of 1998, The Hague 1999, 25. This system was introduced by the Zorgverzekeringswet (Health Insurance Act). See for a brief discussion of this Act: GJ Hamilton, ‘A new Private Universal Health Insurance in the Netherlands’ in A den Exter (ed.) Competitive Social Health Insurance Yearbook 2004 (Erasmus University Press, Rotterdam 2005) 8 et seq. On this authority, see W Sauter, ‘Experiences from The Netherlands; the Application of Competition Rules in Health Care’ in JW van de Gronden, E Szyszczak, U Neergaard, and M Krajewski (eds) Health Care and EU Law (TMC Asser, The Hague 2011) 349ff. Wiggers notes that the NZa has made use of its competition powers (related to significant market powers) only in a limited number of cases. See M Wiggers, De NMa en de NZa in de curatieve zorgsector. Een toetsing aan het Europees mededingingsrecht (The NMa and the NZa in the health care sector. An assessment in the light of European competition law) (Kluwer Deventer 2013) 391, 392. Note: the NZa has also the authority to adopt tariff regulations for the Dutch health care sector. As these regulations do not concern competition issues, they fall outside the scope of this article.

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ACM in advance (ex ante control).39 The ACM bases its assessment on the criterion of the significant impediment of competition:40 if chances are high that a particular merger will significantly impede competition, it will be blocked by the ACM; the creation or strengthening of a dominant position is supposed to give raise to such an impediment. This is the same test that is carried out in EU merger control.41 All in all, it is clear that the set-up of the legal framework of Dutch competition law is largely inspired by the EU competition rules. As a result, the ACM and the Dutch judicial bodies, when interpreting and applying the provisions of the Mw, have paid due consideration to the case law of the EU courts and the decisional practice of the Commission dealing with competition law. The ACM has played an important role in cases dealing with competition and health care. As self-regulation is an important feature of the Dutch health care sector, many health insurers and providers decided to notify their contracts to the Dutch competition authority at the moment the Mw entered into force. In the first years of operation, a number of the agreements notified under the transitional rules of the Mw concerned the health care sector.42 As a result, the ACM was offered the opportunity to develop a competition policy for health care, which it has done over the years. In 2006, The Netherlands introduced a market-oriented health care system, in which private insurance companies are the managing bodies.43 At the same time, a new regulatory health care authority was established: the Nederlandse Zorgautoriteit (The Netherlands Health authority) (hereafter: NZa).44 However, to date, the NZa has not been able to take the lead in matters concerning competition and health care.45 This finding should be explained by the role of the ACM, which was at that time already established in the Dutch health care sector. As a result, the discussion of the Dutch experience with health care and competition is limited to analysing the decisions adopted by the ACM.46 The ACM was called upon to decide on the status on the question whether sickness funds are undertakings for the purposes of competition law. Until 2006, the basic health care schemes were managed by sickness funds, which were governed by public

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47 48 49 50 51

52 53 54 55

See eg the Decision of the NMa in case 1165, ANOZ-ANOVA/ZAO of 29 December 1998 and the Decision of the NMa in case 882/44, Amicon and case 407/49, Texincare and Tevic t. Amicon of 18 June 1999. The Dutch competition authority referred to case law of the CJEU, such as Joined Cases C-159/91 and C-160/91, Poucet et Pistre [1993] ECR I-637 and Case C-224/94, FFSA [1995] ECR I-4013. Joined Cases C-264/01, C-306/01, C-351/01, and C-355/01, AOK et al. [2004] ECR I-2493. See the ACM Decision in case 3473 e.a., Klachten van zorgaanbieders m.b.t. misbruik inkoopmacht zorgverzekeraars of 26 May 2005. In AOK, above, n 49, the CJEU based its finding that German sickness funds were not engaged in economic activities, inter alia, on the circumstances that the benefits were fixed in national law and these were not allowed to be for profit. See Case C-437/09, AG2R [2011] ECR I-973. See the Decision of the Commission of 22 December 2005 on the introduction of a risk equalisation system in the Dutch Health Insurance, N541/2004 and N542/2004—C (2005) 1329 fin. See Art 122 of the Zorgverzekeringswet (Health Insurance Bill). In Dutch: Richtsnoeren voor de zorgsector. In 2010, a third version of these Guidelines was published, available at: accessed 2 April 2014.

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law and subjected to government control. In cases that emerged at the end of 1990s, the ACM assigned great value to the freedom of the sickness funds to set the level of premiums and to the room of manoeuvre they had on markets for purchasing services and products from health care providers.47 It pointed out that the Dutch competition law concept of undertaking must be interpreted in the light of the Treaty provisions on competition. It derived from the case law of the CJEU48 that the Dutch sickness funds were undertakings. However, in 2004, the CJEU handed down its judgment in the AOK case49 making it clear that German sickness funds were not undertakings within the meaning of Article 101 TFEU. The ACM was forced to reconsider its point of view on the status of the Dutch sickness funds, since the German and Dutch sickness funds had a lot in common. A striking similarity was, for example, that the level of benefits was fixed in both German and Dutch law. Therefore, in 2005, the ACM decided that the Dutch sickness funds were not undertakings for the purposes of competition law.50 Since 2006 in The Netherlands, a market-oriented system is in place and the basics health care schemes are not managed by sickness funds anymore but by private insurance companies. It may be assumed that these companies are undertakings for the purposes of competition law, as they have the freedom to influence the level of benefits the affiliated persons are entitled to, and they are for profit.51 Another argument is that they are not subject to substantial state control.52 Furthermore, in the Zorgverzekeringswet state aid case, the European Commission put forward the argument that the Dutch private health insurance companies were undertakings.53 In order to ensure that these insurance companies were bound by competition law, the Dutch government added a provision to the Health Insurance Act stating that irrespective of the fact of whether private health insurers qualify as undertakings under EU competition law, they must be regarded as undertakings within the meaning of Dutch competition law.54 In sum, finally the Dutch legislature stepped in in order to solve a long drawn-out conflict with regard to the status of managing bodies in Dutch health care by creating a special rule for health care and competition. In this regard, it should be noted that the ACM has adopted Guidelines for the health care sector55 in order to clarify a wide variety of specific issues. In its Guidelines, the ACM contends that on the one hand competition leads to incentives and

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56 57 58 59 60 61

See paras 21 and 22 of the Guidelines for the health care sector. See points 116 and 120 of the NMa Guidelines on health care. See para 97 of the ACM Decision in case 3309/NIP, LVE, NVP, and NVVP of 26 April 2004. See para 98, Ibid. See para 2.5.3 of Rb. Rotterdam, 17 July 2006 NIP, NVVP, and LVE v NMa, LJN: AY4928. See para 5.5 of CBb 6 October 2008, NIP, NVVP, and LVE v NMa, LJN: BF8820.

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efficiencies in health care but that on the other hand many agreements and partnerships are not incompatible with the competition rules.56 Furthermore, it is apparent from the Guidelines that the ACM wishes to take into account the public interests that are at play in health care. Despite this ambition, the ACM is reluctant with acknowledging that justifications may play a significant role in cases concerning health care and competition. Striking are the observations made by the ACM about SGEI. In its Guidelines, the ACM stresses that this exception, which is capable of justifying competition restrictions should be interpreted narrowly.57 Some of the ACM decisions have been challenged. In Dutch competition law, the Rechtbank Rotterdam (District Court of Rotterdam) (Rb. Rotterdam) and het College voor Beroep voor het bedrijfsleven (Trade and Industry Appeals Tribunal) (CBb) have the sole authority to review ACM decisions in first instance, respectively, in higher appeal. In two important cases, these courts have dealt with decisions taken by the ACM in the health care sector. In the first case, the Rb. Rotterdam was called upon to review the decision taken by the ACM with regard to associations representing psychologists. At issue was the question whether price recommendations issued by these associations amounted to a violation of the cartel prohibition. In the view of the ACM, these recommendation had the object of restricting competition, as they were directed at approximately sixty per cent of the practising psychologists.58 As the psychologists affiliated with the associations under review had a common interest in aligning their commercial policies with the recommendations issued, the ACM was of the opinion that prices were coordinated.59 The Rb. Rotterdam decided, however, that the ACM had not provided conclusive evidence as to whether the context of the recommendations concerned allowed for price competition.60 It pointed out that the ACM had not assessed the role of the general practitioners who usually refer patients to psychologists. It was unclear to what extent the level of tariffs was decisive for a general practitioner for selecting a particular psychologist. Furthermore, the ACM had not taken into account the role of the health insurers, which reimburse the costs of treatment in many cases. Consequently, in this judgment, the absence of a sound analysis of the context of the health care market made the Rb. Rotterdam annul the ACM decision concerned. On appeal, the CBb confirmed the ruling of the Rb. Rotterdam. Before the CBb, the ACM had drawn attention to a report published by the consultancy group of KPMG. The CBb derived from this report that the competition conditions on the market for psychologists were not transparent and that the length of the waiting lists constituted the most significant reason for general practitioners to base their decision of referring on, whereas in the report no information on the importance of the level of tariffs was available.61 As a result, the CBb was also of the opinion that the ACM had not proven that the price recommendations issued by the associations of psychologist had the object of restricting competition. From the

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62 63 64

65 66

See Wiggers, above, n 45, p. 218. See the ACM Decision in case 6108, Thuiszorg Kennemerland of 19 September 2008 and the ACM decision in case 5851, Thuiszorg ‘t Gooi of 19 September 2008. See paras 2.5.4 and 2.5.5 of Rb Rotterdam, 12 April 2012, Zorgbalans and Viva! v NMa, LJN: BW1327 and paras 2.5.1–2.5.3 of Rb. Rotterdam, 12 April 2012, Thuiszorg Gooi, Hilverzorg and Vivium Zorggroep v NMa, LJN: BW1335. See also the case comment of W Sauter in (2012) SEW Tijdschrift voor Europees en economisch recht (Dutch Journal of European and economic law), 485. Eg the ACM decision in case 165, Sophia Ziekenhuis – Ziekenhuis/Verpleeghuis De Weezenlanden of van 5 June 1998.

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judgments analysed, it is apparent that the ACM had failed to analyse the health care specific context of the market for psychologists and in future the ACM should analyse with great care how health care markets work.62 In the second case, the ACM had imposed penalties upon two home care organisations.63 The organisations concerned provided care services to patients at home, such as nursing, medical, and housekeeping services. On the basis of its investigations, the ACM found that the agreements concluded by these providers amounted to market sharing: they had agreed not to provide services to patients from other regions, where the other party operated. On appeal the Rb. Rotterdam examined whether the parties to the agreements concerned were able to compete with each other. It found that policy measures taken by the Dutch government, especially those regarding the financing of the provision of home care, prevented home care providers from entering new regions.64 At that time, the body managing the home care subsidy schemes was not prepared to finance services outside the region of a particular provider and, therefore, it was not possible for home care organisations to set up new business activities in other regions. As a result, the ACM lost the case, because it had failed to analyse accurately the context of the agreements under investigation. In particular, the consequences of some policy measures of the competent health authorities were not considered sufficiently. Eventually, the ACM decided not to appeal against the judgments of the Rb. Rotterdam and to drop the home care cases. These cases show that the analysis of the health care-specific context should not only include the market conditions but also the specific regulations adopted by the competent authorities. These regulations could prevent health care providers from competing on the market and, as a consequence, lead to limits for applying the antitrust rules. A sound and comprehensive analysis of the factual and legal context in cases concerning health care and competition law is required.65 Additionally, the ACM has made decisions on a number of merger plans of hospitals but, to date, no significant judgments have been delivered by Dutch courts on merger control and health care. Therefore, this article only focuses on the approach adopted by the ACM. In the last decade, many hospitals have merged in The Netherlands. From the early years of its establishment, the ACM has contended that hospitals are engaged in economic activities and are, therefore, undertakings within the meaning of competition law. This finding made hospitals subject to the obligation to notify their merger plans to the ACM.66 The first merger control applications of hospitals did not lead to any in-depth analyses, as the ACM found that the legal

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67 68 69 70

71 72

See JW van de Gronden, Mededingingsrecht en gezondheidszorg (Competition law and heath care), Markt en Mededinging (Market and Competition), 2001, 275. See the ACM decision in case 3897, Ziekenhuis Hilversum-Ziekenhuis Gooi-Noord of 15 July 2004. See the ACM decision in case 3897, Ziekenhuis Hilversum-Ziekenhuis Gooi-Noord of 8 June 2005. See JW van de Gronden and HM Stergiou, Fusietoets in de zorg: Hoe past een dergelijke toets in het Europese en nationale economische recht? (Health care specific merger review: How does such a review fit in European and national economic law?), in: Raad voor de Volksgezondheid (Dutch Council for Public Health and Health Care), Schaal en zorg. Achtergrondstudies (Scale and health care. Background studies), The Hague 2008, 185. Ibid. See the ACM decision in case 5196, Ziekenhuis Walcheren–Stichting Oosterscheldeziekenhuizen of 18 November 2005.

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framework that was then in place in health care left virtually no room for hospitals to compete.67 As a result, the mergers notified to the ACM were not capable of causing serious competition problems and were, therefore, cleared. However, the market conditions of the hospital sector have been changed considerably, since the Dutch government is increasingly introducing competition elements in this sector. Consequently, the ACM was forced to assess with great care the effects of hospital mergers that are notified in the last 10 years. For example, in the merger case of the hospitals in the Gooi area (a region in the neighbourhood of Amsterdam), the ACM raised competition concerns for the first time.68 It feared that the proposed merger would lead to the creation of a dominant position. The ACM had based its decision on a relatively narrow definition of the relevant geographic market by finding that this market would only compromise the Gooi region and not the urban regions of Amsterdam and Utrecht, although these cities were very near to the hospitals concerned. Finally, the ACM decided to clear the merger not for reasons related to health care objectives but for reasons of market definition. It found that patients were prepared to travel to the neighbouring hospitals of Amsterdam and Utrecht, if the quality of the treatment of the merged hospitals would decrease, which implied that the geographic market was not as narrow as it was first believed to be.69 Consequently, the merger plans of the hospitals from the Gooi area were not considered to be anti-competitive. The merger case of the hospitals from the Gooi region was representative for the ACM approach: the focus was mainly on competition issues such as the definition of the relevant market, whereas general objectives such as the continuity, affordability, and quality of health care services were only taken into consideration incidentally.70 What mattered most in the ACM’s view was whether neighbouring hospitals are good alternatives for the merging hospitals in the perception of the patients.71 Accordingly, the ACM merger decisions were in line with its view on the application of the antitrust rules to health care: a context-based approach that does not pay attention to health care objectives. In 2008 and 2009, the ACM changed its approach considerably. In 2008, it was confronted with the merger plans of two hospitals located in the province of Zealand. It was not the first time that these two hospitals had notified their plans to the ACM. In 2005, this authority had already assessed these plans and pointed out that the merger under review could lead to serious competition concerns and that, therefore, further examination was needed.72 Further, it had explicitly rejected the efficiency defence of the parties to the merger. The parties had pointed to the positive effects

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1) consumers must benefit from the improvement of efficiencies 2) the improvement must be merger specific 3) the improvement must be verifiable.75 Apparently, the ACM is of the opinion that the doctrine of efficiency defence covers health care objectives. Hence, it could be argued that the 2009 ACM decision on the Zealand hospital merger is a turning point in the way the merger control rules are applied to health care in The Netherlands. Nevertheless, it is not clear from the outset to what extent the approach taken by the ACM is in line with the Commission’s point of view laid down in its Guidelines on horizontal mergers. It is apparent from these guidelines that in the Commission’s view mainly improvements of an economic nature may benefit from the efficiency defence.76 In contrast with its previous decisions, in 2009 the ACM found that consumers will benefit from the proposed merger and, moreover, it was of the opinion that the efficiencies claimed could only be achieved by the merger plans of the parties. Consequently, the first two conditions of the efficiency defence doctrine are fulfilled. However, the ACM found that the condition of verifiability was not met: the parties had not managed to provide objective evidence that the improvements claimed would be realised. The parties had stated only in general wording that the accessibility, quality, and affordability of hospital care would be improved in Zealand, without providing the ACM with concrete evidence as to how these improvements would materialise. 73

74 75 76

See the ‘Mededeling van intrekking van een aanvraag om vergunning voor een voorgenomen concentratie in zaak 5196’ of 16 August 2006 (official announcement of the Dutch competition authority stating that the merger notification of case 5196 is withdrawn, available at the following website: accessed 2 April 2014. See the ACM decision in case 6424, Ziekenhuis Walcheren-Oosterscheldeziekenhuizen of 25 March 2009. See paras 76–88 of the Commission Guidelines on the assessment of horizontal mergers under the Council Regulation on the control of concentrations between undertakings, OJ 2004 C31/5. Ibid, paras 76 and 77, 88.

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that in their view the merger would have with regard to the realisation of health care objectives such as the continuity and the quality of health care services. In 2005, the ACM was of the opinion that the parties had not sufficiently substantiated the claim that these efficiencies would be realised by the proposed merger. Therefore, the parties concerned decided to withdraw their notification.73 In 2009, the Zealand hospitals notified their merger plans to the ACM for the second time. Again, the ACM found serious competition problems, as the parties to the merger were the only hospitals that were capable of providing a full range of hospital services in the (remote) province of Zealand.74 It was clear from the outset that patients would not have any freedom of choice once the two hospitals of Zealand were merged. The ACM took a different position as to whether the parties concerned could rely upon an efficiency defence. The parties had claimed that the merger was necessary in order to ensure the accessibility, quality, and affordability of hospital care in Zealand. The ACM assessed this claim in the light of the conditions formulated by the European Commission in its horizontal merger guidelines:

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77 78 79

80 81

A summary of this criticism is found in Wiggers, above, n 45, 265–81. Cf Wiggers, above, n 45, 274–7. See the ACM decision in case 7236, Orbis-Atrium of 2 November 2012; the ACM decision in case 7295, TweeSteden ziekenhuis–St. Elisabeth Ziekenhuis of 2 November 2012 and the ACM Decision in case 7332, Spaarne Ziekenhuis–Kennemer Gasthuis of 2 November 2012. See case 7236, Orbis-Atrium, at para 25; case 7295, TweeSteden ziekenhuis–St. Elisabeth Ziekenhuis, at para 24 and Spaarne Ziekenhuis–Kennemer Gasthuis, at para 21. See Ibid.

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Nevertheless, the ACM cleared the merger, as it assigned great value to the report that the Dutch Health Care Inspectorate had issued on the ACM’s request. This report urged the ACM not to block the merger in order to ensure the access of affordable health care of high quality for all in Zealand. However, the ACM needed to address the problem of the lack of verifiability. Therefore, it decided to attach conditions to its decision approving the merger. These conditions were not of a structural but rather of a behavioural nature. What is more, they concerned regulatory-type of obligations, such as compliance with a price cap determined on the basis of the average development in hospital care costs in The Netherlands, and the duty to facilitate the entry of new health care providers in the province of Zealand. The ACM decision on the hospital merger in Zealand is a considerable change of policy, as the main reason for clearing this merger lies in the need of achieving health care objectives. Although the decision concerned has been subject to much criticism,77 it was not appealed. A very important observation that should be made in this respect is that the ACM decided to take into account arguments related to the public interest by giving an interesting twist to the efficiency defence.78 It is striking that it did not take any other avenues that are commonly accepted in competition law, such as relying upon the concept of SGEI. Pursuant to Article 41 (3) of the Mw, the ACM has the authority to approve mergers, if this is necessary with a view to the provision of SGEI. In the Zealand hospital case for the first time, the ACM approved anti-competitive behaviour on the basis of a line of reasoning that is mainly inspired by health care objectives. In 2012, the ACM was again confronted with hospital mergers leading to concentrations of hospitals with large market shares. Remarkably, this time the ACM did not apply the efficiency defence but embarked from an economic line of reasoning. It held that hospitals holding large market shares would be disciplined by insurance companies; in the ACM’s view, health insurers exercise purchasing power over hospitals, which, inter alia, will prevent hospitals from rising price above anticompetitive level.79 An important argument was that recent changes of Dutch health care have improved the possibilities for health insurers to negotiate on price with hospitals. The reason for this is that recently the government has abolished price controls for seventy per cent of the hospital services.80 This change of policy has enabled the health insurers to negotiate on the tariffs. On top of that, health insurers will increasingly bear the financial consequences for their purchase activities, as compensations given by the government in order to supplement deficits will be reduced considerably.81 The incentive to purchase care at low prices will, accordingly, increase for the health insurance companies. As the ACM, nevertheless, cannot rule out that in the

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future health insurance companies will not be able to exercise sufficient countervailing power, it has imposed price caps on the merging hospitals.82 In other words, in recent cases, the ACM has opted to derogate from its approach towards public health interests as adopted in the Zealand hospital case, but preferred to continue to impose regulatory type of obligation upon the merging parties. Concerns related to public interests are now accommodated in an economic reasoning based on the existence of countervailing power. In the ACM’s latest view, a high level of quality will be achieved by health insurers exercising purchasing powers and as a safety mechanism price caps must be imposed on hospital.

82 83

See case 7236, Orbis-Atrium , paras 152–157; case 7295, TweeSteden ziekenhuis–St. Elisabeth Ziekenhuis, paras 135–140 and case 7332, Spaarne Ziekenhuis–Kennemer Gasthuis , paras 143–148. See A Sanchez Graells and E Szyszczak, ‘Modernising Social Services in the Single Market: Putting the Market into the Social’ Paper presented at the Fostering Growth: Reinforcing the Internal Market Conference, Universidad CEU San Pablo, Madrid October 2013. Available at: accessed 2 April 2014.

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I V. CO NC L US IO N S Health care is undergoing radical changes in the EU. It is no longer viewed as a special case in EU law. The broad interpretation of the concept of undertaking and the introduction of competition into health care schemes has increased the role of EU competition law in the organisation of national health care and many practices that are common in health care are subject to EU competition law and national competition and merger control rules. However, the major players at EU level, the European Commission and the Union Courts, have failed to respond with a coherent competition law approach towards health care. This allows some scope for national competition authorities to cloak their preferences in how health care cases should be addressed by using national provisions seen in tandem with EU law. However, there are uncertainties, arising partly from the evolution of an experimental approach to introducing competition principles into a core aspect of the welfare state and partly from the lack of centralising guidance from the EU. From the case study of The Netherlands, reinforced by a similar case study approach analysing the UK reforms to health care,83 we argue that many questions remain open, especially how to integrate competition goals with health care objectives. Furthermore, due to the lack of clear precedents at EU level, national authorities called upon to apply competition law to concrete cases are guided by only a limited number of principles and rules of EU competition law. Consequently, national competition authorities have taken the lead over the EU Institutions and elaborated the general principles and rules. In The Netherlands, the ACM had no other option than to fine-tune the open norms of EU competition law. A NCA such as the ACM can present these rules as originating from the EU, which implies that other national actors and even the national legislature do not have any power to contradict these rules. In reality, the shaping of the exact contours of the rules takes place at the national level. Consequently, the application of EU competition law gives rise to a new model of competition law: Euro-national competition rules for health care. This new architecture is a mix of a top-down and a bottom up model: national competition authorities are building a second storey of health care

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84

85 86

C Townley, ‘Co-ordinated diversity: revolutionary suggestions for EU competition law (and for the EU too)’ SSRN Paper 26 July 2013, available at: accessed 2 April 2014. See JW van de Gronden and W Sauter, ‘Taking the Temperature: EU Competition Law and Health Care’ (2011) 38 LIEI 213, 239–41. Cf E Szyszczak, ‘Modernising Healthcare: Pilgrimage for the Holy Grail?’ in M Krajewski et al. (eds) The Changing Legal Framework for Services of General Interest in Europe (TMC Asser Press, The Hague 2009).

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competition rules and principles on the first storey that is of EU origin. It may be argued that this is a special way of respecting national competences. Townley has offered a more ambitious perspective by suggesting that in the application of competition law at the national level NCA should be able to diverge considerably.84 This latitude, he argues, is consistent with the architectural structure of the EU which allows for procedural and substantive diversity. This diversity would allow for greater respect of national policy concerns. To avoid fragmentation of the EU, Townley suggest that an iterative process could emerge if the diversity of Member State experimentation is harnessed by NCA and the European Commission share exchanges of policy and solutions through the ECN. This proposal is far more revolutionary that what is seen in practice in the case study of the Netherlands. If this pattern in health care cases is followed in other Member States, the emergence of a Euro-national competition law for health care creates problems. The analysis of the decisional practice of the ACM shows that this particular national authority encounters problems with accommodating considerations of public interest in its competition policies. It has expressed the ambition to pay due consideration to the public interests at play in health care but to date, it has failed to develop a coherent approach to this effect. Illustrative are the decisions it took with regard to hospital merger cases. At first, it refused to examine the public interest issues at stake, later it gave an interesting twist to the efficiency defence to take these interests into account and recently, it integrated quality concerns in its reasoning about the countervailing power which possibly health insurers can exercise over merged hospitals. It is inevitable that a clear and transparent approach should be developed at EU level because it is at this level the main principles governing the Euro-national competition rules should be set.85 The European Commission could develop a coherent set of nonbinding guidelines for competition law and health care in close co-operation with the competent authorities.86 The framework of the ECN appears to be a suitable arena to discuss the Euro-national competition rules for health care. The conclusions of these discussions may be set out in soft law documents such as guidelines and communications. Health care is an emerging market, which is increasingly becoming subject to market forces. But social and demographic issues are at the core of the provision of health care services. In Europe, these issues are characterised in an ageing population. The scientific progress made in health care issues, not only to increase longevity, but also to cure and prevent serious diseases and illness, and the fragmentation of the traditional family unit reducing the availability of care in the community, create new pressures for the welfare state in Europe. As a result, EU competition policy can only maintain the key role that it now plays in the European integration process, if it is able to develop a coherent approach towards health care and to strike an adequate balance between ( public policy) health care concerns and competition goals.

Introducing competition principles into health care through EU law and policy: a case study of the Netherlands.

A national health care service is one of the central pillars of the welfare state in Europe. Recent moves to modernise health care, alongside introduc...
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