The Relevance of Market Definition for Finding a Restriction of Competition by Object in Hoffmann-La Roche II Master’S Thesis in European Union Law
The relevance of market definition for finding a restriction of competition by object in Hoffmann-La Roche II Master’s thesis in European Union Law
Author: Tjaša Petročnik [SNR: 2017897] Supervisor: dr. Francisco Alves Da Costa-Cabral
International and European Law (LLM), Faculty of Law, Tilburg University, the Netherlands
Submitted: January 2019
Table of contents
1 Introduction ...... 2 2 Off-label use of medicinal products ...... 5 3 Restriction of competition by object: the notion and how to find it ...... 11 3.1 Conceptualizing ‘by object’ restrictions in case law ...... 20 4 Case study: Hoffmann-La Roche II ...... 23 4.1 Factual and legal background ...... 23 4.1.1 Proceedings before the Italian Competition Authority ...... 25 4.2 Issues of law ...... 29 4.2.1 The definition of the relevant product market ...... 30 4.2.2 The restriction of competition by object...... 37 5 Normative conclusions ...... 44 References ...... 50 Case law, opinions of Advocates General, and Commission decisions ...... 55
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1 Introduction
Competition law does not operate in a vacuum; in practice, it often interacts with other regulatory regimes, like the pharmaceutical legal framework and ensuing obligations. When it comes to marketing and prescribing medicinal products for human use, the so-called off-label use – a practice referring to the use of a medicine for an unapproved indication, or in an unapproved patient group, dosage, or method of administration1 – is relatively common, yet “poorly regulated”2 and raises concerns regarding potential risks. It poses challenges that also need to be dealt with in the framework of applying the competition rules:3 can a medicinal product used off label in medical practice exert competitive pressure on another authorized product? Moreover, can an arrangement between undertakings to distribute information on safety of the product used off label with a view to reduce such competitive pressure be prohibited under Article 101(1) of the Treaty on the Functioning of the European Union (TFEU)? These were some of the issues the Court of Justice of the EU (CJEU; the Court) addressed its judgment of 23 January 2018 F. Hoffmann-La Roche Ltd and Others v. Autorità Garante della Concorrenza e del Mercato (Hoffmann-La Roche II).4
Hoffmann-La Roche II is a preliminary ruling concerning the arrangement between the companies Roche and Novartis, which aimed to discourage the use of Avastin, authorized as a cancer treatment medicine, for the treatment of eye diseases, and to increase the use of Lucentis, authorized specifically to treat eye diseases. Italian Competition Authority found that Roche and Novartis had conspired to disseminate information to regulatory authorities, healthcare professionals, and the general public that Avastin was less safe when used off label than Lucentis. The conduct of Roche could have been viewed as implementation of regulatory obligations regarding adverse effects of medicines. However, the CJEU ruled that Avastin and Lucentis may be considered competing and that the agreement to disseminate misleading information on safety of Avastin to reduce the competitive pressure on Lucentis constitutes a restriction of competition by object, which is to say it by nature reveals a sufficient degree of harm to competition.5 The CJEU found that an arrangement with an aim to artificially differentiate between the two medicinal products (and thus share markets) “must be regarded as being sufficiently harmful to competition to render an examination of its effects superfluous”.6
1 Arnaudo, L. [2014] ‘The Strange Case of Dr. Lucentis and Mr. Avastin. The Italian Competition Authority Fines Roche and Novartis for Collusion’, European Competition Law Review, 35(7), footnote 6 2 Ibid. 3 Opinion of Advocate General Saugmandsgaard Øe in the case C‑179/16 [2017] ECLI:EU:C:2017:714, para. 5 4 Case C-179/16 F. Hoffmann-La Roche Ltd and Others v Autorità Garante della Concorrenza e del Mercato [2015] ECLI:EU:C:2018:25 5 Whish, R. and D. Bailey [2018] ‘Competition Law’, Oxford University Press, UK, p. 121-3 6 Hoffmann-La Roche II, supra note 4, para. 94
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The thesis therefore delves into the off-label use of medicinal products for the purposes of competition law. The focus is placed on the relevant product market, which is defined to identify actual competitors and competitive constraints they face,7 and on the notion and finding of restriction of competition by object. The research aims to explore the (demand) substitutability of medicinal products and how it ties with the regime governing medicinal products.8 The thesis aims to provide an insight into what is it about off-label use of medicines, in particular arrangements aiming to limit the such use, that subjects them to being considered a restriction of competition by object, and specifically, what misconduct was sought to be prevented in Hoffmann-La Roche II. By looking into Hoffmann-La Roche II, the thesis attempts to contribute to the understanding of the notion of restriction of competition by object, the role of the relevant product market definition for this notion, and more generally to the discussions on the complex and often tense interplay between competition law and the regulatory regime governing medicinal products. In doing so, the thesis does not deal with possible exemptions under the Article 101(3) TFEU, as well as the issues regarding the licensing agreement and ancillary restrictions of the agreement at hand that were also addressed in Hoffmann-La Roche II, and also not with the broader interplay of competition law with exclusivity regimes, namely the intellectual property rights.
As regards the methodological approach, this thesis examines the off-label use of medicines through the competition law framework. Descriptive method is first used to outline the economic and legal reality of off-label use of medicines, specifically the pharmaceutical regulatory framework and the medical practice, as it proved instrumental in the Court’s definition of the relevant product market and finding a restriction of competition. In this part, the research relies on the applicable legislation and policy and soft law documents, such as Commission guidelines and notices, to provide for the relevant definitions and concepts, as well as academic literature and the studies produced for the European Commission and the European Parliament to present the practice. Then, the thesis conceptualizes how the notion of restriction of competition by object and approaches to finding was constructed through the Court’s jurisprudence building towards Hoffmann-La Roche II. This is done by summarising the evolution of the case law, so as to identify the common elements of the past judgments and construct a case law framework. Apart from the Court’s case law and the opinions of Advocates General in cases dealing with restrictions of competition, the research also engages with relevant scholarly contributions. This is then relied upon in the case study, which presents and analyses the Court’s consideration of the questions at hand, in order to discuss and evaluate how Hoffmann-La Roche II advances the understanding of the notion of restriction of competition by object. This part draws from the Hoffmann-La Roche II ruling, the relevant case law and Commission decisions in merger control, and academic literature to understand
7 Commission notice on the definition of relevant market for the purposes of Community competition law [1997] OJ C 372, para. 2 8 Todino, M. and N. Colombo [2018] ‘Case C-179/16 Hoffmann-La Roche: By Object Restrictions Still Bitter Pills to Swallow? A Close Watch on the Pharmaceutical Sector’, Journal of European Competition Law & Practice, 9(6), p. 376-378
3 the Court’s reasoning in this judgment and the approach in similar cases or decisions and to conceptually fit Hoffmann-La Roche II in the settled case law. Lastly, the thesis addresses the importance of Hoffmann-La Roche II; the judgment is approached normatively, to discuss the relevant implications of the ruling, based on insights from the case analysis and supporting literature.
The remainder of this thesis is organized as follows: chapter two addresses the off-label use of medicinal products, both from the medical practice and regulatory perspective, pointing to potential competitive issues. Chapter three is devoted to the concept of the notion of restriction by object and approaches to finding it, as constructed in the jurisprudence of the CJEU. Chapter four is a case study of the Court’s ruling in Hoffmann-La Roche II, analysing the relevant issues of law. The concluding chapter addresses the importance and normative implications of the ruling.
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2 Off-label use of medicinal products
This chapter outlines the landscape of off-label use of medicines in the EU. It first presents the medical practice of off-label use and factors motivating it and then focuses on the regulation of medicinal products, namely placing medicines on the market use their subsequent use in medical practice. The features advanced in this chapter are of particular relevance for understanding the (economic and legal) reality of off-label use, which will be relied upon in the case study part of the thesis.
European Medicines Agency (EMA) defines off-label use as “situations where a medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorisation”,9 for example when it is used for a different indication in terms of medical condition, a different patient group, a different method of administration etc. The marketing authorization in the country where the product is used is the reference point for off-label use.10 It results from the therapeutic freedom of healthcare professionals and is a relatively common and widespread medical practice in both hospital and outpatient contexts; in some cases it can become the predominant treatment for a certain condition.11 12 It is present, to some extent, across all EU Member States, while it is explicitly regulated only in Italy, Denmark, and France.13 According to some studies, approximately 40% of medicines in adults and over 90% in children are said to be used off label,14 yet the data appears to differ across different medical fields and countries.15 16 Prescribing medicines off label is often necessary to fulfil individual patient’s (unmet) needs, due to the absence of other suitable, authorized alternatives.17 Concerning children, off-label use is prevalent due to limited investment in adapting medicines for paediatric population, resulting from high costs of development of medicines, small and very fragmented market, and specific requirements for paediatric clinical trials.18 In adults, off-label use of medicines is found in various therapeutic fields – the most commonly referred to being oncology, but rheumatology,
9 European Medicines Agency [2017] ‘Guideline on good pharmacovigilance practices (GVP). Annex I - Definitions (Rev 4)’, available at
5 neurology, and psychiatry are also among the most commonly mentioned – and is related to the fact that medicines are usually registered for a limited number of indications or are not fully studied in specific patient groups, like pregnant women or elderly with specific comorbidities.19 Medicines for off-label use can be prescribed with different levels of clinical evidence supporting their use. Wittich and others conclude off-label use might be more common with regards to population less likely to take part in clinical trials (children, pregnant women, or psychiatric patients).20
Off-label use of medicines is driven by several factors, including economic and therapeutic reasons; they can be related, for example, to (un)availability of a specific product in certain smaller markets or, more generally, due to manufacturing disruptions. Further, off-label prescribing could result from the fact that off-label products are cheaper than on-label ones and sometimes even reimbursed by the national healthcare system.21 Pharmaceutical industry has limited incentives to extend the labelling of their existing medicinal products, as legislation offers only one additional year of market protection for the product with a registered new indication subject to conditions, whereas off-label use will usually continue even with no such investment, which might take significant time and resources. Revenues coming from the additional indication might therefore not offset the efforts involved in obtaining approval, like preparing a dossier for submission or investigating a new indication. On the other hand, national competent authorities have no legal power to enforce such extension.22 23 On a more individual level, off-label use offers the prescriber more options for better treatment and comes into play if there is no appropriate authorized medicine, which is especially relevant in patients with rare diseases or severe medical situations or specific patient groups. In life-threatening or terminal situations, healthcare professionals might give any treatment available, whether approved or not. Sometimes, off-label use stems from treatment or healthcare professional guidelines that are not aligned with regulatory approvals or from favourable past experience with certain products, even if on-label product is available. Off-label use might also result from “irrational prescribing practice” or patient’s insistence or self-medication. As regards individual patient, authorized product might have unacceptable side effects for them, which could lead to off-label use. Here, certain methods of administration that might be off-label are also relevant, as they might lead to better adherence.24 25
Turning the attention to the applicable regulatory framework, it is important to make a distinction between the regulation of medicinal products – placing the products on the market, and the use of
19 European Commission, supra note 13, p. 43, 46 20 Wittich and others, supra note 12, p. 982-90 21 European Commission, supra note 13, p. 50-2 22 Ibid. 23 Wittich and others, supra note 12, p. 984 24 European Commission, supra note 13, p. 53-5 25 Wittich and others, supra note 12, p. 983
6 medicinal products in medical practice, as this distinction comes into play later in the case study part of the thesis. The EU has established common rules on market access and assuring medicinal products are fit for human use. EU legislation on medicinal products aims to ensure free movement of goods, as medicinal products are classified as such, and the protection of public health.26 27 Hancher and Sauter note pharmaceuticals markets in the EU remain fragmented along national lines concerning the market access, intellectual property rights, and also pricing and profit controls, even though medicinal products offered are “substantially identical”.28
Concerning the placing of the medicine on the market, applicable legislation regulates the authorization of medicinal products by setting common standards of safety, quality, and efficacy, focusing on preventive controls and discovering and averting adverse effects, rather than compensating damages in retrospect, as is the case with general product liability.29 For a product to be marketed in the EU, it must be authorized either by an EU Member State or the European Commission (Commission), through a centralized, decentralized, mutual recognition, or national procedure, as outlined in Directive 2001/83/EC and Regulation (EC) No 726/2004. The authorization is based on the assessment of quality, safety, and efficacy, as well as the (positive) benefit-risk ratio, based on the relevant data submitted to the competent authority.30 31 It is important to note that the marketing authorization contents are defined by the authorization holder.32 In principle, placing on the market a medicinal product without marketing authorization is prohibited. What this can entail was elaborated in Novartis v. Apozyt,33 which in fact dealt with medicinal products Lucentis and Avastin that feature in the case study part of the present thesis; in this case, the CJEU ruled that drawing a medicine from the original vial and transferring it into ready-to-use syringe, using one vial multiple times, cannot be equated with a new placing on the market. As such it does not require a new marketing authorization, provided that the medicinal product is not modified in the process and that such action is based on an individual prescription, as the same procedure is analogous to actions carried out by doctors or pharmacists.34 A limited number of exceptions, which must be interpreted strictly, are foreseen for the prohibition of placing on the market a medicinal product without authorization, so in authorized clinical trials or as exceptions as defined in either Directive
26 European Commission, supra note 13, p. 28 27 Hancher, L. and W. Sauter [2015] ‘A dose of competition: EU antitrust law in the pharmaceuticals sector’, TILEC Discussion Paper No. 2015-017, available at ssrn.com/abstract=2655691, p. 4-5 28 Ibid. 29 Lenk, C. and G. Duttge [2014] ‘Ethical and legal framework and regulation for off-label use: European perspective’, Therapeutics and Clinical Risk Management, 10, p. 541 30 European Parliament [2015] ‘Medicinal products in the European Union. The legal framework for medicines for human use’, available at
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2001/83 or Regulation 726/2004.35 The latter include magisterial and officinal formulae, medicinal products in authorised clinical trials, and medicinal products in medical need situations (named patient supply, emergency situations, and compassionate use programs). The scope of these exceptions was further delimited by the CJEU.36 In Commission v. Poland the CJEU considered the exemption for named patient supply and established that ‘special needs’ refer to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient, whereas a ‘bona fide unsolicited order’ means the medicinal product must have been prescribed by the doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations.37 This is only applicable in situations where the doctor considers the health status of the patient requires a medicinal product for which there is no authorized equivalent or it is unavailable on the market. Financial considerations by themselves cannot justify such an exception.38 39
Before a medicine is granted a marketing authorization, clinical trials results provide evidence on its safety and efficacy. Once the medicines are authorized and placed on the market, they are subject to pharmacovigilance, assuring the prevention, detection and assessment, as well as reporting of any adverse reactions, including from off-label use. Implementing pharmacovigilance activities, done by national competent authorities, the EMA, and the Commission, relies on exchange of information between patients, healthcare professionals, regulatory authorities, and pharmaceutical companies.40 As stated earlier, it is the marketing authorization holder that is responsible for providing all the relevant information regarding the medicinal product, which includes clinical trials information, as well as information on use outside the terms of product’s marketing authorization.41 Further, adding a new indication to the marketing authorization can only be requested by the marketing authorization holder.42 The EMA and the Commission have exclusive jurisdiction in examining the applications and adopt a decision to vary, suspend or revoke the marketing authorization of a medicinal product authorized under the centralized procedure, based on the new information on medicine’s adverse effects.43
35 Killick, J. and P. Berghe [2015] ‘Pharmaceutical Sector: Can Non-Authorized Products be Included in the Relevant Market for the Assessment of Alleged Anticompetitive Conduct? A Short Analysis of the Recent Italian Avastin-Lucentis Decision’, Journal of European Competition Law & Practice, 6(2), p. 103 36 European Commission, supra note 13, p. 29 37 Case C-185/10 European Commission v. Republic of Poland [2012] ECLI:EU:C:2012:181, paras. 34 and 35 38 Commission v. Poland, supra note 37, paras. 36 and 38 39 Killick and Berghe, supra note 35, p. 103-4 40 European Parliament, supra note 30, p. 12 41 European Commission, supra note 13, p. 31 42 European Parliament [2014] ‘Parliamentary questions: Collusion between Novartis and Roche in connection with the marketing of the drugs Lucentis and Avastin’, available at
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With regards to the use of the medicine once placed on the market, its properties and terms of use are described in the product information (the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet), which is a part of the marketing authorization process. The SmPC cannot be changed upon approval of the medicinal product, except when such change is approved by a competent authority. While SmPC is “an important tool for prescribing physicians”,44 in medical practice the products are not always used according to it; however, the EU does not regulate the use of medicines outside the indications in the SmPC. In relation to off-label use, it has to be noted market approval of medicines usually lags behind science and clinical practice, meaning that the SmPC might not reflect all available evidence.45 On the other hand, as evident from Laboratoires CTRS v. Commission,46 the SmPC itself can contain information on efficacy of medicinal product that extends beyond the authorised therapeutic indications and is therefore liable to facilitate off-label prescribing.
As indicated, the EU does not (directly) regulate off-label use; that is, it does not regulate how medicinal products are ultimately used in medical practice. Case law recognizes that off-label prescribing “is not prohibited, or even regulated, by EU law. There is no provision which prevents doctors from prescribing a medicinal product for therapeutic indications other than those for which a marketing authorisation has been granted”.47 Prescribing of a medicine is thus a decision that is taken in the context of the individual relationship between the patient and their treating healthcare professional and their professional assessment.48 49 Prescribing medicines outside existing regulatory boundaries as already mentioned does not mean such use is “against the law”; it does, however, invite special responsibility of the treating healthcare professional, as they are prescribing “something which the regulatory body has not stated is safe and effective” (for that particular use, author’s note),50 thus assuming all the risks to patient safety which would normally be ‘absolved’ by the regulatory process and medical malpractice law.51 Following the case law of CJEU, off-label prescribing is the sole responsibility of the prescribing physician.52 In this regard, Killick and Berghe note off-label uses that led to patient safety concerns and underline off- label use carries higher risk than authorized indications.53
Moreover, based on the division of EU competences in the area of health, as provided for the Article 168 TFEU, the organisation and delivery of health services and medical care is the responsibility of Member States, which would include the use and prescribing of medicinal products. Regulating off-
44 Case T‑452/14 Laboratoires CTRS v. Commission [2015] ECLI:EU:T:2015:373, para. 93 45 European Commission, supra note 13, p. 13, 15, 36, 51 46 Laboratoires CTRS v. Commission, supra note 44, paras. 94 and 95 47 Laboratoires CTRS v. Commission, supra note 44, para. 79 48 European Commission, supra note 13, p. 25 49 Killick and Berghe, supra note 35, p. 103 50 European Society for Medical Oncology in Lenk and Duttge, supra note 29, p. 540 51 Lenk and Duttge, supra note 29, p. 541 52 Laboratoires CTRS v. Commission, supra note 44, para. 82, and Novartis v. Apozyt, supra note 33, para. 48 53 Killick and Berghe, supra note 35, p. 107-8
9 label use of medicines, namely handling the risks to patient safety and (in)efficacy, thus differs significantly across the EU Member States, which are following diverse approaches, 54 55 and also includes other areas of law, such as tort or professional and product liability law, health insurance and reimbursement provisions, criminal law etc., as well as medical ethics.56 Specifically, as regards decisions on pricing and reimbursement, they are made on the Member State level, predominantly in negotiations between governments and marketing authorization holders.57 In this regard, Schweitzer highlights “distinct commercial dynamics” of the sector affecting the demand, as in this particular market those “who make decisions about drug use neither pay for them nor consume them”, with consumers frequently being insulated from the costs of the product by health insurance.58 In the EU, much attention concerning off-label use has been paid to children and adolescents and orphan drugs;59 off-label use has also been recognized in the ‘new’ EU pharmacovigilance legislation, namely Regulation (EU) No 1235/2010, Directive 2010/84/EU, and an Implementing Regulation.60 As in other regions, manufacturers are not allowed to marked off-label use of medicines in the EU and can be subject to fines up to 5% of the EU turnover, if they violate this prohibition.61 62
To conclude, off-label use is a practice that developed against marketing authorization holder’s wishes at the initiative “of those who create demand for it”, the prescribing healthcare professionals, as pointed out by the Advocate General Saugmandsgaard Øe.63 Lenk and Duttge note that, ideally, “important applications in medical practice should not fall into the area of off-label use”.64 As illustrated above, however, the day-to-day medical practice and use of medicinal products, in contrast to what was intended following marketing authorizations, is much more nuanced and complex, due to various reasons. This is to some degree reflected in the (settled case) law concerning off-label use of medicines. This feature is heavily drawn upon in the following chapters of the thesis.
54 Drenska and Getov, supra note 14, p. 20 55 See also Lenk and Duttge, supra note 29, p. 541-4 56 Ibid. 57 European Parliament, supra note 30, p. 9 58 Schweitzer in Arnaudo, supra note 1, footnote 16 59 Lenk and Duttge, supra note 29, p. 539 60 European Commission, supra note 13, p. 15 61 Lenk and Duttge, supra note 29, p. 538 62 Killick and Berghe, supra note 35, p. 103 63 Advocate General Saugmandsgaard Øe, supra note 3, paras. 45 and 46 64 Lenk and Duttge, supra note 29, p. 537
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3 Restriction of competition by object: the notion and how to find it
Hoffmann-La Roche II establishes that dissemination of misleading information concerning a medicinal product used off label constitutes a restriction of competition by object. Under the Article 101 TFEU, “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” are prohibited as incompatible with the internal market. While restrictions of competition by object are in itself to reveal a sufficient degree of harm to competition, having an effect of restricting competition means an agreement must be liable to “have an appreciable adverse impact on the parameters of competition,” like the price, quantity, and quality of goods and services.65 A broad scope of practices have been found to restrict competition by object;66 however, what actually adds up to the notion of a restriction of competition by object has been a contested point of debates.67 Similarly, regarding finding it, Advocate General Wahl for example remarked that the case law varies: certain Court’s judgments “seem to have made it difficult to draw the necessary distinction between the examination of the anticompetitive object and the analysis of the effects on competition of agreements between undertakings”.68 Against this backdrop, this chapter therefore aims to present an overview of the understanding of the notion of restriction of competition by object and ways to find it as constructed through the case law, firstly, by outlining in a chronological manner the selected judgments, with a focus on how the restriction of competition by object is defined and then found. This is performed to, secondly, identify and conceptualize the common elements of the case law on this notion and address the (in)consistencies, in particular as regards the object-effect distinction. The relevance of the relevant market for restriction of competition by object is also discussed. Later, in the case study part, this is relied upon to explore and assess how Hoffmann-La Roche II fits conceptually into the established case law framework, to advance the understanding of the notion of restriction of competition by object.
The case law as regards restrictions of competition by object has been evolving for more than six decades. Already in Société Technique Minière, the Court established that restriction of competition by object or effect are alternative requirements. First, there is a need to consider the precise purpose of an
65 MasterCard Inc. and Others v. European Commission in supra note 5, p. 132 66 Bruzzone, G. and S. Capozzi [2015] ‘Restrictions by Object in the Case Law of the Court of Justice: In Search of a Systematic Approach’, n 'L'applicazione delle regole di concorrenza in Italia e nell'Unione europea. Atti del V Convegno biennale Antitrust di Trento', G. Benacchio- M. Carpagnano (eds.), Editoriale scientifica, 2015, p. 4-5 67 Colomo, P. I. and Lamadrid, A. [2016] ‘On the notion of restriction of competition: what we know and what we don’t know we know’, in Gerard, D., M. Merola, and B. Meyring (eds.), The Notion of Restriction of Competition: Revisiting the Foundations of Antitrust Enforcement in Europe, Bruylant 2017, p. 4; see also supra note 5 68 Opinion of Advocate General Wahl in case C‑67/13 P [2014] ECLI:EU:C:2014:1958, para. 46
11 agreement in the economic context in which is to be applied; the interference with competition within the internal must result from the agreement itself. If the analysis of the agreement’s clauses “does not reveal the effect on competition to be sufficiently deleterious”, its consequences are to be considered. Further, the competition in question is to be understood “within the actual context in which it would occur in the absence of the agreement in dispute”; to determine if an agreement is to be considered prohibited “by reason of its object or effect”, in particular nature and quantity of the products concerned, nature or position of the disputed agreement, severity of the clauses or opportunities for competitors are to be taken into account.69 In Consten and Grundig, the CJEU further said that there is no need to take account of the concrete effects of an agreement once it appears that it has as its object the prevention, restriction or distortion of competition,70 which has been held since.71
Later, Asnef-Equifax concerned a credit information exchange system, which the Court recognised “inevitably entails a certain amount of cooperation between competitors”.72 As regards existence of a restriction of competition, the Court looked into the “essential object” of such a system and the nature of information it provides, acknowledging that it is capable of improving the functioning of the supply of credit. It concluded such a system “(does) not thus have, by (its) very nature, the object of restricting or distorting competition” and that it is for the national court to determine if it produces such effects.73 It further noted that assessing the effects of agreements in the light of now Article 101 TFEU “entails the need to take into consideration the actual context to which they belong, in particular the economic and legal context in which the undertakings concerned operate, the nature of the goods or services affected, as well as the real conditions of the functioning and the structure of the market or markets in question”.74 The case law cited, for example DLG, revolves around the object or effect of restricting competition. In DLG, the Court stated that compatibility of statutes of a cooperative purchasing association with then Community rules on competition “cannot be assessed in the abstract”, but depends on the particular clauses and economic conditions in the markets concerned.75 Provisions laid down in the statute were found not to necessarily violate the now Article 101(1) TFEU and may have beneficial effects, as well as adverse effects on competition; the Court ultimately found they are not prohibited as long as they are restricted to what is necessary.76 Returning to Asnef-Equifax, the Court said EU
69 Case C-56/65 Société Technique Minière (L.T.M.) v Maschinenbau Ulm GmbH (M.B.U.) [1966] ECLI:EU:C:1966:38, p. 250 70 Joined cases C-56/64 Établissements Consten S.à.R.L. and Grundig-Verkaufs-GmbH v Commission of the European Economic Community [1966] ECLI:EU:C:1966:41, p. 342 71 Bailey, D. [2012] ‘Restrictions of Competition by Object Under Article 101 TFEU’, Common Market Law Review, 49, p. 564 72 Case C-238/05 Asnef-Equifax, Servicios de Información sobre Solvencia y Crédito, SL and Administración del Estado v Asociación de Usuarios de Servicios Bancarios (Ausbanc) [2006] ECLI:EU:C:2006:734, para. 30 73 Asnef-Equifax, supra note 72, paras. 46-8 74 Asnef-Equifax upra note 72, para. 49 75 Case C-250/92 Gøttrup-Klim and Others Grovvareforeninger v. Dansk Landbrugs Grovvareselskab [1994] ECLI:EU:C:1994:413, para. 31 76 DLG, supra note 75, paras. 35-45
12 competition rules preclude contacts between undertakings if their object or effect is to “give rise to conditions of competition which do not correspond to the normal conditions of the market in question, taking into account the nature of the products or the services provided, the size and number of the undertakings and also the volume of the market”.77 Compatibility of the information exchange system with EU competition rules cannot be assessed in the abstract; a restriction of competition depends on the context in which such system exists, in particular the market conditions and the characteristics of the system in question.78 The Court concluded the exchange of information at hand does not in principle have as its effect a restriction of competition.
In Beef Industry Development Society, the CJEU differentiated between infringements by object and by effect in the case of coordinating the market outcomes. The distinction “arises from the fact that certain forms of collusion between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition”,79 which was endorsed in several judgments since.80 Relying on settled case law, as presented above, once the restrictive object is established, there is no need to consider the actual effects of an agreement; that examination is to be made in the light of the agreement’s content and economic context.81 In her opinion, Advocate General Trstenjak stated that if it is clear that an agreement has as its object the restriction of competition, it does not matter whether it actually has it as its effect. Therefore, it is sufficient for the purposes of the fundamental prohibition under Article 101(1) TFEU that an agreement has as its object the restriction of competition.82 This is reflected in the Commission’s Guidelines on the application of Article 101(3) TFEU, which state that infringements by object are based on the serious nature of the restriction; the Guidelines refer to a presumption, which is also based on the experience showing they are likely to produce negative effects on the market.83 84 Moreover, the Court also held that subjective intention is irrelevant for applying what is now Article 101(1) TFEU, as, in determining whether an agreement restricts competition, “close regard must be paid to the wording of its provisions and to the objectives which it is intended to attain”; agreement can have a restrictive object even if it pursues other legitimate objectives.85 As the Article 101(1) TFEU does not constitute an exhaustive list of prohibited collusion, the Court examined if the agreements at hand have as their object the restriction of competition, noting that the arrangements are intended to “enable several
77 Asnef-Equifax, supra note 72, para. 52 78 Asnef-Equifax, supra note 72, paras. 54, 57, and 72 79 Case C-209/07 Competition Authority v. Beef Industry Development Society Ltd, Barry Brothers (Carrigmore) Meats Ltd [2008] ECLI:EU:C:2008:643, paras. 15-17 80 Killick, J. and J. Jourdan [2014] ‘Cartes Bancaires: A Revolution Or A Reminder of Old Principles We Should Never Have Forgotten?’ Competition Policy International, p. 3 81 Beef Industry Development Society, supra note 79, para. 16 82 Opinion of Advocate General Trstenjak in the case C-209/07 [2008] ECLI:EU:C:2008:467, para. 37 83 Communication from the Commission. Notice: Guidelines in the application of Article 81(3) of the Treaty [2004] OJ C 101/08, para. 21 84 European Commission in Bailey, supra note 71, p. 562-3 85 Beef Industry Development Society, supra note 79, para. 21
13 undertakings to implement a common policy”, conflicting with “the concept inherent in the (…) Treaty provisions relating to competition”, ultimately finding a restriction of competition by object.86
Further, in T-Mobile, the Court reinstated competition rules protect not only competitors or consumers but also the structure of the market and competition as such, thus link between a practice and consumer prices need not be established (presumed) for finding a restriction of competition by object.87 Recalling Société Technique Minière, the alternative nature of the object-effect distinction means that first, the precise purpose of the practice at hand is to be considered in its economic context. If the practice is not found to be sufficiently deleterious, its consequences are to be considered; however, if such an object is found, effects need not be taken into account, as settled in previous judgments.88 Regarding the assessment, the Court said that “for a concerted practice to be regarded as having anti-competitive object, it is sufficient that it has the potential to have a negative impact on competition”;89 it must be capable in an individual case, considering specific legal and economic context, to result in a restriction of competition.90 This was criticised by some for interpreting restrictions by object too broadly.91
Parallel trading has been “a habitual bugbear of EU competition policy” ever since Consten and Grundig.92 In GlaxoSmithKline, the Court reminded anticompetitive object and effect of an agreement are alternative conditions to assess if Article 101(1) TFEU applies, as held in Société Technique Minière: precise purpose of an agreement must be considered in the economic context in which it is to be applied; if the analysis of the content does not reveal sufficient degree of harm, consequences of the agreement are to be considered, or, once an anticompetitive object is stablished, effects need not be examined.93 The Court relied on settled case law to formulate the now familiar diction: to assess the anticompetitive nature of an agreement “regard must be had inter alia to the content of its provisions, the objectives it seeks to attain and the economic and legal context of which it forms a part”94 and recalled that, “with respect to parallel trade /…/ in principle, agreements aimed at prohibiting or limiting parallel trade have as their object the prevention of competition”, which also applies to the pharmaceutical sector.95 However, the Court also established that finding an agreement has an anticompetitive object does not require final consumers are deprived of advantages of effective competition, as the Article 101 TFEU
86 Beef Industry Development Society, supra note 79, paras. 23, 24, 33, 34 87 Case C-8/08 T-Mobile Netherlands BV, KPN Mobile NV, Orange Nederland NV, Vodafone Libertel NV v. Raad van bestuur van de Nederlandse Mededingingsautoriteit [2009] ECLI:EU:C:2009:343, paras. 38 and 39 88 T-Mobile, supra note 87, paras. 28 and 29 89 T-Mobile, supra note 87, para. 31 90 T-Mobile, supra note 87, para. 43 91 Bailey, supra note 71, p. 589 92 Hancher and Sauter, supra note 27, p. 6 93 Case C-501/06 P GlaxoSmithKline Services and Others v. Commission and Others [2009] ECLI:EU:C:2009:610, para. 55 94 GlaxoSmithKline, supra note 93, para. 58 95 GlaxoSmithKline, supra note 93, paras. 59 and 60
14 aims to protect not only the interests of competitors or consumers, but the structure of the market and competition as such.96 With this, the Court underlined neither the Treaty nor case law support that agreement limiting parallel trade is to be considered having an anticompetitive object “in so far as it may be presumed to deprive final consumers of the advantages of effective competition in terms of supply or price”.97 98
In Pierre Fabre, dealing with selective distribution system, the Court was asked among others to ascertain if a contractual clause at issue amounts to a restriction of competition by object within the meaning of Article 101(1) TFEU. As noted by Killick and Jourdan, no reference is made for such a restriction to be limited to conduct that is injurious by its very nature;99 the Court remarks the purpose of the agreement is first to be considered in its economic context and then delves into finding a restriction by object by considering “content of the clause, the objectives it seeks to attain and the economic and legal context of which it forms a part”, as in GlaxoSmithKline.100 The Court stated that agreements constituting a selective distribution system necessarily affect competition in the common market and are to be considered, in the absence of objective justification as regards the products in question, restrictive of competition by object.101 Individual and specific examination of the content and objective of the contractual clause at hand is required to ascertain whether it amounts to a restriction of competition by object;102 even in existence of a precedent, finding a restriction by object in an earlier case “does not dispense with the need for an individual assessment of an agreement”.103 Bailey further contends that the requirement for objective justification might not correspond with previous case law stating an agreement may restrict competition by object even if it also pursues other legitimate objectives; however, the legitimate objective would need to rely on public regulation aiming to protect a public good and extend beyond how an undertaking wishes to market its products.104 105
Later on, Expedia dealt with agreements concerning the internet sale of tickets and travel and whether competition law precludes the application of Article 101(1) TFEU to agreements that may affect trade but not reaching the thresholds specified in Commission’s de minimis notice. In the ruling, it was recognized it is settled case law that agreements must have as their object or effect an appreciable
96 GlaxoSmithKline, supra note 93, paras. 62-4 97 GlaxoSmithKline, supra note 93, para. 62 98 See also Opinion of Advocate General Trstenjak in the case C-501/06 P [2009] ECLI:EU:C:2009:409, para. 92 99 Killick and Jourdan, supra note 80, p. 3 100 Case C-439/09 Pierre Fabre Dermo-Cosmétique SAS v. Président de l’Autorité de la concurrence, Ministre de l’Économie, de l’Industrie et de l’Emploi [2011] ECLI:EU:C:2011:649, paras. 34 and 35 101 Pierre Fabre, supra note 100, paras. 38-41 102 Pierre Fabre, supra note 100, para. 47 103 Advocate General Mazák in Bailey, supra note 71, p. 575 104 Bailey, supra note 71, p. 581 105 Opinion of Advocate General Mazák in the case C-439/09 [2011] ECLI:EU:C:2011:113, para. 35
15 restriction of competition. Prohibition of a cartel in national law can be applied to an agreement “only where that agreement perceptibly restricts competition within the common market”; existence of such a restriction is to be found by reference to the actual circumstances of an agreement with its provisions, objectives, and economic and legal context to be taken into account and the nature of the goods or services affected, as well as the real conditions of the functioning and the structure of the market or markets in question can be taken into consideration.106 Thresholds set in the said notice “are no more than factors” that may enable determining the appreciability of restriction by reference to the actual circumstances of the agreement.107 The Court recalled that certain forms of collusion can be by their very nature regarded as injurious to the proper functioning of normal competition, as held in Beef Industry Development Society and T-Mobile, and stated that “an agreement that may affect trade between Member States and that has an anti-competitive object constitutes, by its nature and independently of any concrete effect that it may have, an appreciable restriction on competition”.108
Then came Allianz Hungária, which blurred the distinction between restrictions by object and effect.109 The Court in the judgment recalls Beef Industry Society Development, Expedia, and T-Mobile in distinguishing restrictions by object from effect as certain forms of collusion can be regarded by their very nature injurious to normal competition. To find such a restriction, the Court restated the need to analyse the content, objectives, and context of the agreement to find a restriction of competition by object from GlaxoSmithKline, Football Association Premier League, and Pierre Fabre, with the nature of the goods or services affected, as well as the real conditions of the functioning and the structure of the market or markets in question to be taken into consideration, pursuant from Expedia.110 Quoting T- Mobile, the Court also said for an agreement to be regarded as having an anticompetitive object, having the potential to have a negative impact on competition is sufficient.111 The Court in this manner went on to examine the agreement, its object, and, “even if there is no agreement or concerted practice between those insurance companies, it will still be necessary to determine whether, taking account of the economic and legal context of which they form a part, the vertical agreements at issue in the main proceedings are sufficiently injurious to competition (…) so as to amount to a restriction of competition by object”.112 The Court, however, added that an agreement would also amount to restriction by object
106 Case C‑226/11 Expedia Inc. v. Autorité de la concurrence and Others [2012] ECLI:EU:C:2012:795, paras. 20 and 21 107 Expedia, supra note 106, para. 31 108 Expedia, supra note 106, para. 37 109 See, for example, Nagy, C. I. [2013] 'The Distinction between Anti-competitive Object and Effect after Allianz: The End of Coherence in Competition Analysis?', World Competition: Law and Economics Review, 36(4), 541-564 110 Case C-32/11 Allianz Hungária Biztosító Zrt, Generali-Providencia Biztosító Zrt, Gépjármű Márkakereskedők Országos Szövetsége, Magyar Peugeot Márkakereskedők Biztosítási Alkusz Kft, Paragon- Alkusz Zrt., the legal successor of the Magyar Opelkereskedők Bróker Kft v. Gazdasági Versenyhivatal [2013] ECLI:EU:C:2013:160, paras. 35 and 36 111 Allianz Hungária, supra note 110, para. 38 112 Allianz Hungária, supra note 110, paras. 39-46
16 if it is “likely that, having regard to the economic context, competition on that market would be eliminated or seriously weakened following the conclusion of those agreements. In order to determine the likelihood of such a result, that court should in particular take into consideration the structure of that market, the existence of alternative distribution channels and their respective importance and the market power of the companies concerned.”113 Nagy notes the Court went beyond settled case law quoting Expedia, regarding the nature of the goods affected and the functioning and structure of the market in question,114 as well as against the Advocate General’s opinion, as that particular paragraph in Expedia appeared to had referred to restrictions of competition at large and not specifically to restrictions of competition by object.115 This requirement for comprehensive analysis led several observers to conclude an effects analysis is apparently required to find a restriction of competition by object when looking at the agreement’s context.116 117
Attempting to address such criticisms, in Groupement des Cartes Bancaires, Advocate General Wahl reminded why Article 101 TFEU provides an alternative to find an agreement restricting competition by object,118 and called for a restrictive interpretation and cautious attitude towards the notion of restriction of competition by object.119 The Court set aside the judgment of the General Court; it recalled certain types of coordination reveal “a sufficient degree of harm that it may be found that there is no need to examine their effects”, as certain types of coordination have an object that can be regarded by their very nature to be harmful to normal competition.120 It pointed out that experience shows such behaviour results “in poor allocation of resources to the detriment, in particular, of consumers”.121 Killick and Jourdan observe that the element of experience was featured in a Court’s judgment for the first time.122 The CJEU underlined that the essential legal criterion to ascertain whether a coordination involves a restriction of competition by object is that “such coordination reveals in itself a sufficient degree of harm to competition”: the measures must display a sufficient degree of harm to competition in the light of their wording, objectives, and context to be regarded as having as their object a restriction of competition; it is thus not about finding the potential of the practice to have a negative impact on competition.123 124 The concept of restriction of competition by object must be interpreted restrictively, as otherwise competition authorities “would be exempted from the obligation to prove the actual effects
113 Allianz Hungária, supra note 110, para. 48 114 Expedia, supra note 106, para. 21 115 Nagy, supra note 109 116 Killick and Jourdan, supra note 80, p. 3 117 Nagy, supra note 109, p. 559 118 Killick and Jourdan, supra note 80, p. 5 119 Advocate General Wahl, supra note 68, para. 58 120 Case C-67/13 Groupment des Cartes Bancaires v. European Commission [2014] ECLI:EU:C:2014:2204, paras. 49 and 50 121 Groupment des Cartes Bancaires, supra note 120, para. 51 122 Killick and Jourdan, supra note 80, p. 6 123 Groupment des Cartes Bancaires, supra note 120, paras. 57, 58, and 90 124 See also Bruzzone and Capozzi, supra note 66, p. 10-1; Killick and Jourdan, supra note 80, p. 6
17 on the market of agreements which are in no way established to be, by their very nature, harmful to the proper functioning of normal competition”.125 To find a restriction of competition by object, regard must be had to agreement’s provisions, its objectives, and the economic and legal context, taking into consideration all its relevant aspects. Parties’ intention is not a necessary factor in determining if an agreement between parties is restrictive, but can be taken into account.126 The context that is to be considered when ascertaining whether an agreement or a decision restricts competition by object is not to be confused with the definition of the relevant market;127 all relevant aspects like nature of the services at issue, as well as the real conditions of the functioning and structure of the markets in particular, irrespective of whether they relate to the relevant market, are to be taken into account.128 As the Advocate General Wahl stressed, looking at the economic and legal context to identify anticompetitive object must “be clearly distinguished from the demonstration of anticompetitive effects” under Article 101(1), suggesting that such consideration can only “reinforce or neutralise the examination of the actual terms of a purported restrictive agreement”.129 Also, he observed demonstrating effects cannot remedy a failure to identify an anticompetitive object.130
In Dole, which dealt with quotation prices coordination for bananas, the Court repeated Groupment des Cartes Bancaires by saying that certain types of coordination between undertakings can be regarded, by their very nature, as being harmful to the proper functioning of normal competition, and that certain conducts, as horizontal price fixing practices, are, based on experience, so likely to distort competition that any analysis of the effects on the market is redundant. On the other hand, effects analysis needs to show presence of factors that show competition has in fact been restricted.131 As in Groupment des Cartes Bancaires, to determine if a type of coordination constitutes a restriction of competition by object, regard must be had, “inter alia, to its objectives and the economic and legal context of which it forms a part”.132 However, the Court then did not go into examining the economic and legal context in detail, like above, but relied mainly on T-Mobile by saying that the exchange of information is liable to be incompatible with the competition rules “if it reduces or removes the degree of uncertainty as to the operation of the market”; it is to be presumed that such concerted practice “had the object of creating conditions of competition that do not correspond to the normal conditions on the market”, even in the absence of anticompetitive effects, and thus constitutes a restriction of competition by object.133
125 Groupment des Cartes Bancaires, supra note 120, para. 58 126 Groupment des Cartes Bancaires, supra note 120, paras. 53, 54, and 78 127 Groupment des Cartes Bancaires, supra note 120, para. 77 128 Supra note 120, paras. 78-82 129 Advocate General Wahl, supra note 68, para. 44 130 Advocate General Wahl, supra note 68, paras. 44 and 139 131 Case C‑286/13 P Dole Food Company, Inc, Dole Fresh Fruit Europe v. European Commission [2015] ECLI:EU:C:2015:184, paras. 114-6 132 Dole, supra note 131, paras. 117 and 118 133 Dole, supra note 131, paras. 121-134
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In Toshiba, who appealed against the ruling of General Court characterising the Gentlemen’s Agreement as a restriction of competition by object, claiming parties to the cartel were not potential competitors, the CJEU restated the settled case law that the alternative nature of the requirement in the Article 101(1) TFEU means that first the precise object of the agreement needs to be considered and if established, effects need not be examined. Recalling Groupment des Cartes Bancaires, ceratin types of coordination can be regarded, by their very nature, harmful to normal competition. To determine this, regard is to be had to the content of agreement’s provisions, objectives, and economic and legal context.134 As established, market-sharing agreements “constitute particularly serious breaches of the competition rules”; in such cases, the analysis of the context may be limited to “what is strictly necessary in order to establish the existence of a restriction of competition by object”.135 Ultimately, the Court dismissed Toshiba’s ground of appeal regarding classification of an agreement as a restriction of competition by object.
Lastly, in Lundbeck, which is currently under appeal, the General Court upheld the Commission’s decision that the payments to generic producers delaying their market entry constituted a restriction of competition by object, as they were found to be potential competitors. Among others, the judgment recognizes that the lack of a marketing authorization does not prevent the existence of actual or potential competition, as, at the time of the conclusion of agreements at hand, “the generic undertakings had real concrete possibilities” of getting an authorization. The General Court also recalled that in establishing potential competition, the Commission did not rely only on obtaining of marketing authorization, but also on specific situation of an undertaking and characteristics of the pharmaceutical sector.136 Concerning the application of principles relating to the notion of restriction of competition by object, the General Court acknowledged the parties to the agreement opted for replacing risk of a normal competitive process and uncertainty regarding the validity of process patents with certainty that generic companies would not enter the market in exchange for reverse payments corresponding approximately to the profits they would make, noting the differences with the Beef Industry Development Society.137 Relying on Groupment des Cartes Bancaires, the agreements were comparable to market exclusion agreements, which is an “extreme form of market sharing and of limitation of production”; the Commission was held to correctly apply the settled law in “determining whether an agreement may, by its very nature, be regarded as restricting competition in a sufficiently serious manner as to be classified as a restriction ‘by object’”.138
134 Case C‑373/14 P Toshiba Corporation v. European Commission [2015] ECLI:EU:C:2016:26, paras. 24-5 135 Toshiba, supra note 134, paras. 28 and 29 136 Case T-472/13 Lundbeck v. Commission [2016] ECLI:EU:T:2016:449, paras. 168-81 137 Lundbeck, supra note 136, paras. 426-31 138 Lundbeck, supra note 136, paras. 432-9
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3.1 Conceptualizing ‘by object’ restrictions in case law While some observers pose the object-effect distinction is at the core of competition law and argue for category-building approach to restrictions of competition by object more in line with the concept of (per se) illegality of an agreement in and of itself,139 this has not necessarily been reflected in the selected judgments. The present research deduced the following elements concerning the restriction of competition by object from the case law presented: it has consistently been held that a practice having a sufficient degree of harm to competition restricts competition by object, from Société Technique Minière on; a restriction of competition by object can be regarded by its very nature harmful to normal competition. It is not necessary to show its actual effects or prove a negative impact on competition.140 Establishing capability (potentiality) of an agreement restricting competition appeared sufficient in T- Mobile, but was later framed in terms of “detailed, individual examination”, so not divorced from its context.141 Thus the content, objectives, and legal and economic context are the factors that determine the anticompetitive nature of an agreement, which is evident for example in GlaxoSmithKline, Pierre Fabre, and also Allianz Hungária,142 as well as in the more recent cases like Groupment des Cartes Bancaires. While the context features prominently since the early case law in finding restrictions of competition in general, it has later been crystalized that assessing sufficiently anticompetitive nature of an agreement means establishing the objective to (appreciably) restrict competition, considering the content of the agreement, parties’ conduct, and its context.143
Allianz Hungária stands out as blurring the object-effect distinction,144 by focusing on the analysis of the structure of the market and market power in ‘by object’ restrictions; to remedy this, the cases that followed, most notably Groupment des Cartes Bancaires, (again) applied a restrictive interpretation of the restriction of competition by object. The Court’s focus on contextuality however requires sufficient degree of harm by nature is not to be assessed in the abstract.145 This research thus suggests we cannot ‘extract’ the abstract notion of or threshold for a restriction of competition by object – we can only establish an anticompetitive object or nature of an actual individual practice at hand, since the context is necessary to understand its logic, mechanism, and function and real significance,146 147 and enables identifying a possible, plausible alternative explanation other than pursuing anticompetitive aim,148 but
139 See also Nagy, supra note 109, p. 541-564 140 See also Colomo and Lamadrid, supra note 67, p. 16 141 See also Advocate General Wahl, supra note 68 142 See also Craig, P. and G. De Burca [2015] ‘EU Law: Text, Cases, and Materials, Sixth Edition’, Oxford University Press, p. 1017-8 143 See also Joined cases 96-102, 104, 105, 108 and 110/82 NV IAZ International Belgium and others v. Commission of the European Communities [1983] ECLI:EU:C:1983:310, para. 25 144 See also Bruzzone and Capozzi, supra note 66, p. 1 145 See also Colomo and Lamadrid, supra note 67, p. 22, 35, 44 146 See also Nagy, supra note 109, p. 541-564 147 See also Advocate General Wahl, supra note 68 148 Groupment des Cartes Bancaires, supra note 120, paras. 74, 75, and 86; see also supra note 100
20 without going into a substantive assessment of consequences and effects to prohibit such a practice,149 as would follow from Allianz Hungária. The analysis of context is particularly relevant for ‘new’ types of collusive behaviour, as examples listed in the Article 101(1) TFEU do not constitute exhaustive list of prohibited collusion.150 As seen, the extensiveness of this contextual analysis depends on whether previous experience exists, like recently in Dole or Toshiba, leading to a more limited analysis (but not putting it aside) than if a conduct at hand is ‘new’, where a more extensive contextual analysis would be required.151 As proposed by Advocate General Wathelet, this line of case law reflects both the list of prohibitions is not exhaustive and that restrictions of competition by object are not to be interpreted widely.152 It will be interesting to follow whether this approach will be applied by the Court of Justice also in Lundbeck.
Before turning to the case study, the relationship between the relevant market, effects analysis, and the economic and legal context, as settled in case law, is briefly discussed. Market definition is “a tool to identify and define the boundaries of competition between firms” with an objective to systematically define the competitors and competitive constraints undertakings involved face. It includes the products regarded interchangeable or substitutable by the consumer due to their characteristics, price, or use.153 Bailey argues market definition plays a limited role in establishing a restriction of competition by object.154 Pursuant to Delimitis, when anticompetitive object of an agreement is not established, an appreciable effect of restricting competition needs to be assessed in the context in which the it occurs and in analysing this, the relevant market must be determined.155 However, as established in Volkswagen AG,156 market definition, when applying what is now the Article 101 TFEU, is obligatory (for the Commission) where it would be impossible, without it, to determine if an agreement is liable to affect trade between Member States and has as its object or effect the a restriction of competition.157 158 The market definition therefore cannot be excluded from finding a restriction of competition by object.
149 See also Groupment des Cartes Bancaires, supra note 120 150 Beef Industry Development Society, supra note 79, para. 23 151 See also supra note 3, para. 150 152 Opinion of Advocate General Wathelet in the case C‑373/14 P [2015] ECLI:EU:C:2015:427, paras. 73, 74, and 90 153 European Commission, supra note 7, paras. 2 and 7 154 Bailey, supra note 71, p. 569-70 155 Case C-234/89 Stergios Delimitis v. Henninger Bräu AG. [1991] ECLI:EU:C:1991:91, paras. 13-6 156 Case T-62/98 Volkswagen AG v Commission of the European Communities [2000] ECLI:EU:T:2000:180, para. 230 157 Bailey, supra note 71, p. 569-70 158 Advocate General Wathelet in Toshiba similarly posited that even though anticompetitive effects need not be demonstrated in ‘by object’ cases, “the restriction of competition in question must clearly be capable of having at least some impact on the market”. To prove appreciability, the Commission is to define the relevant market even when it comes to by object restrictions. See Whish and Bailey in Advocate General Wathelet, supra note 152, paras. 65 and 66 and footnote 33
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Further, to find a restriction of competition by object, the content, objectives, and legal and economic context are the factors that are looked into. Bailey and Whish fear that an “extended review of the economic and legal context in an object case might turn into effects analysis”.159 Although acknowledged,160 this is not reflected in (recent) case law. It is established definition of the context for finding a restriction of competition by object is distinct from the the definition of the relevant market.161 162 Moreover, assessing the effects of restricting competition cannot serve to establish a restriction of competition by object. This was held in Groupment des Cartes Bancaires and later Maxima Latvija, citing Delimitis that effects of an agreement on competition must (also) be assessed in its economic and legal context, assessing among others the “conditions under which competitive forces operate on the relevant market” (emphasis added). After a thorough analysis of the context and specifics of the relevant market, only agreements that are found to have effect of closing-off of the market to an appreciable extent are prohibited.163 To conclude, although intertwined, the presented concepts have distinct functions in establishing a restriction of competition, and are not to be confused.
159 Whish and Bailey, supra note 5, p. 126 160 See, for example, Advocate General Wahl, supra note 68 161 Groupment des Cartes Bancaires, supra note 120, para. 77 162 Advocate General Wahl, supra note 68, para. 149 163 Case C-345/14 SIA “Maxima Latvija” v. Konkurences padome [2015] ECLI:EU:C:2015:784, paras. 23-9
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4 Case study: Hoffmann-La Roche II
This chapter is a case study of Hoffmann-La Roche II. Contextual background and case developments are first presented; specifically, the marketing, therapeutic, and safety profile of the medicines Avastin and Lucentis is examined, followed by outlining of the proceedings before the Italian Competition Authority which led to the preliminary ruling at hand. Then, the CJEU ruling is dealt with first by outlining the Court’s reasoning in Hoffmann-La Roche II and then by analysing its answers pertaining to the definition of the relevant product market and the notion and finding of a restriction of competition by object. Lastly, the normative implications of the ruling are addressed.
4.1 Factual and legal background Bevacizumab (brand name Avastin) and ranibizumab (brand name Lucentis) are biological medicines, developed by the company Genentech, which has been a part of the Roche Group since 2009. In the US, Genentech retained commercial rights on both medicinal products, which entered the US market in 2004 and 2006, respectively. In contrast to the US, in the EU the medicines are marketed separately; the worldwide commercial rights were granted to Roche for Avastin and to Novartis for Lucentis,164 165 on the basis of two separate licensing agreements, which parties entered into with Genentech in 2003.166 167 In the US, Genentech has been able to protect the sales of Lucentis by not registering Avastin for ophthalmic treatments, whereas in the EU “the competition between Avastin and Lucentis (…) led to direct confrontation of Roche and Novartis”.168 169 Avastin is intended for treating various forms of cancers by infusion in the blood; its SmPC states it is not intended for eye injections. In the EU, it obtained a marketing authorization by EMA in 2005. Lucentis has been developed to treat the wet Age- Related Macular Degeneration (AMD) and help slow down the vision loss by means of injection in the eye. In the EU, the EMA approved it in 2007, subject to centralized procedure, like Avastin.170 171
Before Lucentis had been approved, Avastin was already widely used off label for treatment of AMD,172 by splitting the medicine’s vial and injecting a small portion of the medicine in the eye, and its use continued even after the launch of Lucentis. Since the introduction of Lucentis, the majority of patients
164 Arnaudo, L. [2014] ‘The Avastin-Lucentis Case: An Illicit Agreement Between Roche and Novartis Condemned by the Italian Competition Authority’, Italian Antitrust Review, 2, p. 127 165 Arnaudo, supra note 1, p. 349 166 Arnaudo, supra note 1, p. 349 167 Killick and Berghe, supra note 35, p. 103 168 Arnaudo, supra note 1, p. 349 169 Killick and Berghe, supra note 35, p. 103 170 Ibid. 171 Hoffmann-La Roche II, supra note 4, para. 24 172 Hoffmann-La Roche II, supra note 4, para. 27
23 with AMD have been treated with Lucentis, whereas in Italy, more than 40% of patients continued to be treated with Avastin.173 There is a noteworthy difference in costs for the two medicines: while the cost of injection of Lucentis was in Italy set at €1700 and later lowered to €900, the cost of injection of Avastin was between €15 and €81 at its maximum.174 175 176
Considering the biological properties of the medicines at hand, Avastin and Lucentis have different active ingredients,177 but are based on the same mechanism of action.178 First in 2011, independent studies carried out in the US and the UK on efficacy and equivalence of the products stated “no evidence can be provided that bevacizumab is systemically more unsafe than ranibizumab and vice-versa”.179 Roche did not register Avastin for ophthalmic use and, according to the European Consumer Organization,180 was even addressing regulators and governments to prevent its off-label use.181 Later in 2011, Roche requested the EMA to change the SmPC of Avastin to include medicine’s ophthalmic risks, which were to be communicated to healthcare professionals. The EMA indeed changed the SmPC to mention certain side effects associated with the ophthalmic use of the product,182 but not in accordance with the changes proposed by Roche, and refused to allow communication to healthcare professionals. It also modified Lucentis’ SmPC stating systemic health risks are common to all anti vascular endothelial growth factor medicines.183 184 Further, Swedish competent authority and the head of French National Agency for Medicines and Health Products Safety warned against the off-label use of Avastin,185 and, following the reported incidents in Florida and Tennessee, the US Food and Drug Administration alerted that the repackaged injections of bevacizumab for the use in the eye caused “a cluster of serious eye infections”.186
173 Killick and Berghe, supra note 35, p. 103 174 Arnaudo, supra note 164, p. 127 175 Arnaudo, supra note 1, p. 349 176 Killick and Berghe, supra note 35, p. 102 177 Advocate General Saugmandsgaard Øe, supra note 3, para. 2 178 In fact, ranibizumab is a derivative of bevacizumab; they are both monoclonal antibodies derived from the same parent mouse antibody and were developed separately by different teams in Genentech. Initial studies on bevacizumab established the compound works to neutralize human vascular endothelial growth factor to hinder tumour growth. Similar process is also related to eye diseases; thus these applications were also further explored. Arnaudo, supra note 164, p. 127; Arnaudo, supra note 1, p. 348-9; Killick and Berghe, supra note 35, p. 103 179 European Medicines Agency in Arnaudo, supra note 1, p. 350 180 European Consumer Organization [2013] ‘Avastin vs Lucentis. Letter sent to Vice-President Almunia on November 7th, 2013’, available at
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The World Health Organization (WHO) lists bevacizumab among the essential medicines,.187 which was supported by the International Council of Ophthalmology based on safety and effectiveness, with the Council noting the cost-effectiveness of this therapy and recognizing bevacizumab is mainly used off- label and is actually the predominant agent used to treat neovascular AMD worldwide.188
As regards the applicable legal framework, first, the Directive 2001/83/EC, as amended, applies with regards to placing on the market of a medicinal product for human use, the exemptions, pharmacovigilance obligations and related information that should, among others, be presented objectively to the public and not misleading.189 Further, the Regulation (EC) No 726/2004 lays down the authorization procedures and supervision of medicinal products, including the information obligations of marketing authorization holders, who are responsible for the accuracy of the submitted documents, relating to scientific progress, risk-benefit assessment, including as regards the data on the use outside of the terms of the marketing authorization, and to suspected adverse reactions to the medicine in question, concerning both the use within and, from July 2012 onwards, also outside the terms of the marketing authorization.190 191 Then, the Regulation (EC) No 658/2007 governs financial penalties for infringement of certain obligations regarding the granted marketing authorizations.192 Advocate General Saugmandsgaard Øe pointed out that at the time of the main proceedings, Regulation (EC) No 772/2004 providing for a block exemption of certain technology transfer agreements was also applicable.193 Lastly, Italian legislation allows reimbursing off-label uses in absence of an alternative medicine authorized for the same treatment.194 Initially, Avastin was included on the list for the treatment of AMD and other eye conditions, but by 2012 off-label uses of Avastin were totally excluded as reimbursable,195 196 based on certain EMA amendments concerning special warnings and precautions.197 Following the Italian Competition Authority’s decision, however, legislation allowing general off-label ophthalmic uses of Avastin was adopted.198
4.1.1 Proceedings before the Italian Competition Authority Upon receiving complaints submitted by an association of private healthcare clinics and the Italian Ophthalmological Society claiming that Roche and Novartis Groups have had colluded to impede the
187 World Health Organization [2017] ’WHO Model Lists of Essential Medicines’, available at
25 use of Avastin to advantage the commercial performance of (the more expensive) Lucentis, the Italian Competition Authority after a yearlong investigation on 27 February 2014 found that Roche and Novartis, with their Italian subsidiaries, concluded a horizontal agreement with an illicit object. The agreement concerned the sales of Avastin and Lucentis in Italy and was implemented through concerted practices aiming to spread and exaggerate safety concerns of off-label use of Avastin to influence the choices of prescribing physicians.199 The established collusion between Roche and Novartis, “a single and complex horizontal agreement implemented through a multitude of concerted practices”200 that constitutes an unlawful market-sharing agreement and therefore a restriction of competition by object,201 taking place since “at least June 2011”, was intended “to create an artificial product differentiation” between Avastin and Lucentis and infringed Article 101 TFEU.202 Specifically, it was aimed to spread concerns on safety of ophthalmic (off-label) uses of Avastin by exaggerating risks based on ‘alarmist’ interpretation of available data, and to downplay the above mentioned scientific evidence within the medical community and end-users to improve the commercial performance of Lucentis.
The relevant market was defined as medicines used for treating vascular ocular diseases in Italy and included Lucentis, other medicines authorized for treatment of AMD, and also Avastin due to its off- label use to treat the eye condition. Italian Competition Authority stated Avastin and Lucentis are equivalent in eye disease treatment, therefore therapeutically substitutable, and Roche and Novartis were found to be direct competitors.203 204 Among others, it relied on a list approving off-label use of Avastin for eye conditions, several comparative studies, and WHO position to find Avastin and Lucentis competing in the same market.205 Here, Killick and Berghe point to some controversies surrounding the scientific studies it used and to the fact that the EMA did maintain the warnings on adverse effects of off-label use of Avastin.206
The Italian Competition Authority substantiated its finding of restriction of competition by object with Roche’s unsuccessful request to EMA to amend the SmPC (certain side effects of ophthalmic use were included only among the ‘Special warnings and precautions for use’),207 208 209 documents indicating Novartis’ concerns of decreasing sales of Lucentis, Roche’s commercial strategy of non-inclusion of
199 Killick and Berghe, supra note 35, p. 102 200 Advocate General Saugmandsgaard Øe, supra note 3, para. 34 201 Hoffmann-La Roche II, supra note 4, para. 32 202 Hull, D. W. and M. J. Clancy [2018] ‘The Application of EU Competition Law in the Pharmaceutical Sector’, Journal of European Competition Law & Practice, 9(6), p. 397-8 203 Killick and Berghe, supra note 35, p. 103 204 Hoffmann-La Roche II, supra note 4, para. 32 205 Killick and Berghe, supra note 35, p. 104 206 Ibid. 207 Hoffmann-La Roche II, supra note 4, paras. 89 and 90 208 Killick and Berghe, supra note 35, p. 102 209 Arnaudo, supra note 1, p. 351
26 ophthalmic use to Avastin’s indications, the meetings conducted, emails sent between the CEOs of Italian subsidiaries of Roche and Novartis discussing the strategy and referring explicitly to “artificiality of the product differentiation in connection with the modification of the Avastin’s SmPC”, messages on doubts regarding pharmacovigilance issues circulated within Italian branch of Roche, and internal documents of Novartis’ parent company on generating and communicating safety concerns with regards to Avastin’s ophthalmic uses, by means of financing symposia, scientific papers, and cooperation with patient groups, so as to “increase voiced concerns about safety risks of unlicensed therapies”,210 and on the risks of independent studies making healthcare professionals “more confident in using Avastin”. Both Roche and Novartis also commented on legislative proposals in Italy intended to authorize the off- label use of Avastin.211 212 213 In the actual proceedings, Roche stated it was obligated to communicate the detected risks of ophthalmic use of Avastin to medicine regulators, while the Authority maintained such conduct was “based upon a distorted use of legitimate prerogatives and aimed at artificially differentiating Avastin from Lucentis on the basis of safety issues”.214
Apart from finding a restriction of competition by object, the Italian Competition Authority also noted some effects of the infringement. Avastin was established the main competitor of Lucentis due to the widespread off-label ophthalmic use; the Authority showed the modification of the demand attitudes regarding the use of Avastin towards Lucentis, as a result of the arrangement, resulting in consequences in access to treatment and public healthcare expenditure costs, corresponding to €45 million of additional costs as a result of shift to Lucentis during 2012.215 216 217 Arnaudo remarked both parties were to benefit from the agreement; Novartis from having direct gains from sales, while Roche as Genentech’s parent company from getting indirect revenues based on royalties for the sales of Lucentis.218 219 220
With its decision, the Italian Competition Authority imposed pecuniary sanctions for infringement of EU competition law amounting to €90,6 million for Roche and its Italian subsidiary and €92 million for Novartis and its Italian subsidiary. Roche and Novartis appealed the Authority’s findings to the competent administrative court,221 arguing that systematic off-label use is unlawful, especially where an approved alternative is available, and that Avastin and Lucentis are not equivalent in treating eye
210 Ibid. 211 Arnaudo, supra note 164, p. 128 212 Killick and Berghe, supra note 35, p. 103 213 Hoffmann-La Roche II, supra note 4, para. 32 214 Arnaudo, supra note 1, p. 350 215 Hoffmann-La Roche II, supra note 4, para. 33 216 Arnaudo, supra note 164, p. 129 217 Arnaudo, supra note 1, p. 351 218 Arnaudo, supra note 1, p. 352 219 See also European Consumer Organisation, supra note 180 220 See also Hull and Clancy, supra note 202, p. 398 221 Arnaudo, supra note 164, p. 126, 129
27 conditions.222 Unsuccessful, Roche, Novartis, and their Italian subsidiaries brought an appeal before the Italian Council of State, claiming, among others, that Roche and Novartis cannot be regarded as competitors, not even potential. The applicants considered “the parties to the licensing agreement could reasonably have provided in that agreement that Roche would not compete with Novartis, the licensee, on the relevant market. Such a restriction would, fall entirely (…) outside the prohibition laid down in Article 101(1) TFEU”.223 The Council stayed the proceedings and referred questions to the CJEU for a preliminary ruling pursuant to Article 267 TFEU.224
In addition, the Avastin-Lucentis situation gained attention elsewhere in Europe, too. French endorsement of Avastin for additional indications outside its marketing authorization, referring to “no alternative product for a given indication with the same active ingredient” (emphasis added),225 226 was opposed by the biopharmaceutical industry.227 228 The conduct of Roche and Novartis regarding Avastin was also investigated by the French Competition Authority.229 In addition, the European Consumer Organization (BEUC) expressed its concerns about potential anticompetitive practices by Roche and Novartis to (then) Commissioner Almunia, pointing to possible harms to consumers’ health and welfare. BEUC among others stated ophthalmologists fear to prescribe Avastin because of possible civil and criminal liability.230 231 Commissioner Almunia indicated in 2014 that the regulators are looking into the allegations and that the Commission will assess if further action is needed in that respect.232 In September 2018, the UK High Court rejected an application for judicial review of a policy that refers to
222 Hull and Clancy, supra note 202, p. 398 223 Hoffmann-La Roche II, supra note 4, para. 35 224 Ibid. 225 Agence nationale de sécurité du médicament et des produits de santé [2015] ‘Avastin 25mg/ml (bevacizumab) : Avis favorable de la commission bénéfice/risque pour une recommandation temporaire d’utilisation (RTU)’, available at
28 medicines for the treatment of AMD, with Avastin regarded as “preferred treatment option”, submitted by Bayer and Novartis, finding ophthalmic use of Avastin is equally safe and effective and a lawful choice for healthcare professionals treating wet AMD on grounds of cost.233 The CJEU has so far addressed the Avastin-Lucentis situation on three occasions; apart from Hoffmann-La Roche II and Novartis v. Apozyt presented above,234 on 21 November 2018 the CJEU delivered another preliminary ruling in Novartis v. Agenzia Italiana del Farmaco (AIFA) on national reimbursement measures concerning Avastin repackaged into vials and corresponding pharmacovigilance obligations.235 The CJEU recalled the EU rules on pharmaceutical products prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use but do require that they comply with the conditions laid down in those rules.236 The Court among others noted the purpose of pharmacovigilance system, which would be frustrated if repackaging of Avastin to allow for its use off label would not fall within the scope of Directive 2001/83.237 Further, the CJEU recalled repackaging of Avastin for off-label use in the treatment of eye diseases did not require a new marketing authorization and held that reimbursing a medicinal product used off label is not contrary to EU law, subject to EU pharmaceutical rules.238 239
4.2 Issues of law In Hoffmann-La Roche II, the Italian Council of State referred five questions to the CJEU, which essentially dealt with four issues: the role of medicinal products used off label in the definition of the relevant market, the exemption for ancillary arrangements to licensing agreements, the notion of restriction of competition by object, and possible exemptions under the Article 101(3) TFEU and Article 2 of the Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article 81(3) of the Treaty to categories of technology transfer agreements.240 241 Two of these issues the present case study deals with in detail below, namely the definition of the relevant product market and the notion of restriction of competition by object and the relationship between them, The two subsections are both structured in a way that first summarises the Court’s answer and reasoning and then critically analyses the issues of law and addresses possible concerns.
233 Bayer Plc v. NHS Darlington Clinical Commissioning Groups and others [2018] EWHC 2465 (Admin) 234 Supra note 33 235 Case C-29/17 Novartis Farma SpA v. Agenzia Italiana del Farmaco (AIFA), Roche Italia SpA, and Consiglio Superiore di Sanità [2018] ECLI:EU:C:2018:931 236 Novartis v. AIFA, supra note 235, para. 51 237 Novartis v. AIFA, supra note 235, paras. 64 and 65 238 Court of Justice of the European Union [2018] ‘The reimbursement by a national healthcare insurance system of a medicinal product for a use not covered by its marketing authorisation (off-label use) is not contrary to EU law’, available at
29
4.2.1 The definition of the relevant product market As already indicated, defining the relevant product market is essential in understanding competitive pressures and dynamics. Competition between medicinal products in terms of consumer and seller behaviour and product substitutability reveals a complex landscape; Mihaescu and Rudholm provide some illustrative examples concerning the prescription choices by healthcare professionals.242 In this light, Morse identifies a broad range of product market definitions in cases concerning medicines.243 Similarly, Todino and Colombo observe that in the EU, considering the relevant product market for medicinal products, the competition authorities’ approach depends on the issue at hand, stating that in merger control,244 an increasingly narrow market definition is being applied so as to catch any overlap between medicines capable to generate competitive restraints.245 This is evident from practice; in the past merger decisions, the Commission took the therapeutic indications as the starting point for defining the relevant product market,246 but has moved, if appropriate, towards a more narrow definition and substitutability on chemical composition,247 at the level of molecule or group of molecules considered interchangeable so as to exercise competitive pressure on one another,248 especially in cases involving generic companies.249 Contrarily, Article 101 and 102 TFEU cases see the market definition more tailored to the practice in question, setting the market definition in a broader manner so as to catch
242 For example, concerning prescription persistence, especially regarding incumbent products, how increase in information about availability of cheaper generic alternatives can lead to lower brand name prices, or the role of physician’s advice or even the similarity of the product name in consumer choices. See Mihaescu, O. and N. Rudholm [2016] ‘Defining Relevant Markets for Pharmaceuticals’, Bulletin of Economic Research, 69(4), p. 126-8 243 Albeit in the US antitrust context, he identifies market definitions ranging from more narrowly defined, covering medicines that contain a specific compound, to more broadly defined, covering medicines treating a specific disease or condition, basing the market definitions on different factors, for example if the medicines treat the same disease, condition, or indication, if medicines have the same action mechanism or specific chemical compounds, if they have same dosage form or strength and method of administration, prescription or over the counter availability, availability of generic medicine, etc. See Morse, H. M. [2003] ‘Product Market Definition in the Pharmaceutical Industry’, Antitrust Law Journal, 2, p. 634, 643-4 244 Here, the Commission’s practice follows the Anatomical Therapeutic Chemical (ATC) classification system devised by the European Pharmaceutical Marketing Research Association (EphMRA), maintained by EphMRA and Intercontinental Medical Statistics (IMS). This is a hierarchical and coded four-level system, classifying medicinal product according to their indication, therapeutic use, composition, and mode of action; the system is intended to cater to pharmaceutical marketing needs and statistics. See EphMRA [2016] ‘Comparison of the WHO ATC Classification & EphMRA/PBIRG Anatomical Classification’, available at
30 anticompetitive agreements and establish substitutability between therapeutically equivalent medicines or practices aimed at delaying the entry into market of generic medicines.250
Hoffmann-La Roche II deals with whether Avastin, used off label, and Lucentis could be viewed as belonging to the same relevant product market. The definition of the relevant market, the medicines for treating eye diseases, was undisputed; the question was whether Avastin is a part of it or not.251 For the purposes of the judgment, the CJEU joined the second, third, and fourth questions of the referring court, which considered if a relevant product market can be defined independently of the content of the marketing authorization, if a national competition authority may include, for the purposes of application of the Article 101 TFEU, in the relevant market a medicine authorized for the treatment of a given disease as well as a medicinal product used off-label for the same purpose as interchangeable, and if so, if the competition authority must consider if such off-label use complies with EU pharmaceutical regulation.252 253 In relation to this, Roche claimed pharmaceutical rules prevent the products belonging to the same relevant product market and that Avastin and Lucentis are therefore not in competition with each other; consequentially, there “could be no restriction of competition resulting from the collusive conduct identified (…)”.254 However, the Court answered that a medicinal product authorized for the treatment of a certain disease and another product whose marketing authorization does not cover that treatment but is in practice used for that purpose and is substitutable with the former may belong to the same relevant product market. To establish the relationship of substitutability, assessment made by competent authorities and courts is to be taken into account; not only the product characteristics, but also the structure of the market is to be considered, by assessing any effects it may have on the structure of supply and demand.255 256
The reasoning is as follows: the CJEU restated that the relevant product market comprises products regarded as interchangeable or substitutable by the consumers, due to their characteristics, prices, and intended use,257 and that this assessment must also take into consideration the competitive conditions and the structure of supply and demand on the market.258 The CJEU also noted that illegally manufactured or sold products are not interchangeable or substitutable, because of the legal, economic, technical, and reputational risks for manufacturers on the supply side and public health risks on the demand side.259 In Hoffmann-La Roche II, Avastin was placed on the market legally, yet used for the
250 Todino and Colombo, supra note 8, p. 378 251 Advocate General Saugmandsgaard Øe, supra note 3, para. 69 252 Hoffmann-La Roche II, supra note 4, para. 48 253 Hull and Clancy, supra note 202, p. 398 254 Advocate General Saugmandsgaard Øe, supra note 3, para. 55 255 Hoffmann-La Roche II, supra note 4, para. 67 256 Hull and Clancy, supra note 202, p. 398 257 Hoffmann-La Roche II, supra note 4, para. 50 258 Hoffmann-La Roche II, supra note 4, para. 51 259 Hoffmann-La Roche II, supra note 4, para. 52
31 purposes not covered by its marketing authorization. The CJEU in this regard noted that use of medicinal products for therapeutic indications not covered by their marketing authorization is not prohibited and that the relevant directive provides for an exemption, yet that, following established case law, this exception can only be applied under certain conditions, as discussed in detail in the chapter on off-label use.260 Further, the CJEU restated that repackaging of a product does not require authorization, if it is carried out for retail supply by healthcare professionals,261 allowing the Court to establish that the EU rules on medicinal products “prohibit neither the off-label prescription of a medicinal product nor its repackaging for such use but do require that they comply with the conditions laid down in those rules”.262 263
Further, the CJEU clearly stated it is not for competition authorities to assess the conformity of off-label prescribing and repackaging of Avastin with the applicable rules on medicinal products; therefore, when assessing substitutability between medicines used on- and off label, the competition authority must take into account the outcomes of the examination by the competent authority or court by assessing any effects it may have on the structure of supply and demand.264 The CJEU took note that, as regards repackaging and prescribing of Avastin, nothing suggested any unlawfulness had been established by either competent authorities or national courts; further, certain side effects resulting from injecting Avastin in the eye were not included among adverse reactions in the SmPC by the EMA and the Commission, but mentioned only among special warnings and precautions for use.265 The “state of uncertainty surrounding the lawfulness of the repackaging and the prescription of Avastin for the treatment of eye diseases”266 therefore did not preclude defining Avastin and Lucentis as belonging to the same product market. Since prescribing doctors are primarily guided by therapeutic appropriateness and efficacy of medicinal products, the relevant market for the purposes of application of Article 101 TFEU is capable of comprising medicines used for the same therapeutic indications; frequent prescribing of Avastin for eye conditions revealed a specific relationship of substitutability between Avastin and Lucentis.267 This follows the opinion of Advocate General Saugmandsgaard Øe who suggested the relevant product market comprises all products considered actually interchangeable by the consumers and that, in the pharmaceutical sector, the content of marketing authorizations is not necessarily determinative in defining the relevant product market.268 To conclude, the CJEU held that
260 Hoffmann-La Roche II, supra note 4, paras. 54-7 261 Hoffmann-La Roche II, supra note 4, para. 58 262 Hoffmann-La Roche II, supra note 4, para. 59 263 Hull and Clancy, supra note 202, p. 399 264 Hoffmann-La Roche II, supra note 4, paras. 60 and 61 265 Hoffmann-La Roche II, supra note 4, paras. 62 and 63 266 Hoffmann-La Roche II, supra note 4, para. 64 267 Hoffmann-La Roche II, supra note 4, paras. 64-6 268 Advocate General Saugmandsgaard Øe, supra note 3, para. 187
32 marketing authorization does not confine competition authorities in the definition of the relevant product market and thus confirmed the decision by the Italian Competition Authority.269
4.2.1.1 Analysis The regulatory uncertainty concerning the legality of off-label use is at the heart of the definition of the relevant product market in Hoffmann-La Roche II; concretely, whether medicinal products used off- label can form a part of it as substitutes to authorized products. As it appears an important issue of contention, it is first examined how illegal products are approached by competition law in other sectors, especially concerning whether they can exert competitive pressure on products sold and manufactured legally. Drawing an analogy with the Universal Music Group/EMI Music merger, the Commission recognized a widespread consumption of music from ‘illegal’ sources or in a manner infringing copyright law. In assessing the degree of substitution between legal and illegal music it noted they “do not appear to be substitutes from the point of view of the record companies’ direct customers,” the music retailers.270 From the point of end users, the market investigation left unclear whether and to what extent consumers substitute or mix-and-match illegal and legitimate sources of music, pointing to different types of consumers which have different motives for consuming either illegally or legally obtained music.271 Despite the recognized impact of piracy on retail prices and volumes, the Commission concluded there is no substitution between illegal and authorized sources of music at wholesale level, without prejudice to piracy as out-of-market constraint.272 Later, this was also recognized in the Asset/PLG merger, where the Commission considered it is not appropriate to treat legal and illegal music as part of the same relevant product market for wholesale of recorded music, as legal retailers would not consider switching to illegal music suppliers in case of a price increase.273 Even though the Commission stated it has never considered that legitimate and unauthorized supplies of music belong to the same product market, the market reality of piracy exerting a competitive constraint on record companies in certain countries, driving a fall in demand for CD albums, was also acknowledged in the market investigation in the Sony/BMG merger.274
This appears to be reflected in Hoffmann-La Roche II, as the Court stated illegally sold or manufactured products are not to be considered interchangeable or substitutable, due to legal, economic, reputational
269 Parziale, supra note 11, p. 234-5 270 Commission Decision declaring a concentration to be compatible with the internal market and the EEA agreement (Case No COMP/M.6458 - Universal Music Group/EMI Music) [2012] OJ C 220, para. 198 271 Universal Music Group/EMI Music, supra note 270, paras. 202-4 272 Universal Music Group/EMI Music, supra note 270, paras. 213 and 214 273 Commission Decision declaring a concentration to be compatible with the common market (Case No COMP/M.6884 - ACCESS/PLG) according to Council Regulation (EC) No 139/2004 [2013] OJ C 212, para. 16 274 ACCESS/PLG, supra note 273, para. 197, see also Commission Decision declaring a concentration to be compatible with the common market and the EEA Agreement (Case No COMP/M.3333 - Sony/BMG) [2007] OJ C 94
33 and technical risks, as well as public health risks,275 yet it is also necessary to recall that the ruling did not establish off-label use in this particular situation as illegal. In his opinion on this issue, which was followed by the CJEU in the ruling, Advocate General Saugmandsgaard Øe indicates Avastin used off label is capable of exerting effective competitive restraint on Lucentis, following the medical practice which may reflect “the origin of competitive dynamics which demonstrate the actual interchangeability of two medicinal products independently of the content” of their marketing authorizations.276 He further posited that if market definition was limited to the marketing authorization, the demand-side substitutability would not be taken into account, in disregard of how the relevant product market is to be defined.277 Uncertainty regarding lawfulness of off-label placing on the market and prescribing therefore does not preclude products from belonging to the same market as products whose lawfulness of supply is undisputed.278
Further, the Advocate General pointed to several Commission’s decisions in EU merger control that took into account also the products used off label in the analysis of competitive dynamics on the market.279 For example, in the Pfizer/Wyeth merger, off-label usage was acknowledged in regards to certain cancer treatments, specifically regarding the line of treatment, where the products are approved for application in a certain line, but also used off label in further lines of treatment. The Commission indicated that likely that specific products for cancer treatment in case at hand in all lines of treatment constitute the relevant product market.280 In the Teva/Cephalon merger, the market definition concerned the medicines for treating excessive daytime sleepiness; the Commission in this particular case dealt with substitutability for therapeutic uses of products based on specific compounds, taking into account both licensed and off-label uses, the latter for example as regards paediatric uses. The Commission found that, due to off-label use, the application of a particular product in question is diverse and that there is limited substitutability with products based on different compounds, yet that a generic version of the product at hand could substitute the originator for all its uses.281 In the AbbVie/Shira merger, the parties’ activities overlapped in the area of treatment of inflammatory bowel diseases; the Commission concluded the products at hand were part of separate product markets due to different mechanism of
275 Hoffmann-La Roche II, supra note 4, para. 52 276 Advocate General Saugmandsgaard Øe, supra note 3, para. 77 277 Advocate General Saugmandsgaard Øe, supra note 3, para. 81 278 Advocate General Saugmandsgaard Øe, supra note 3, para. 90 279 Advocate General Saugmandsgaard Øe, supra note 3, para. 80 280 Commission Decision declaring a concentration to be compatible with the common market (Case No COMP/M.5476 - Pfizer/Wyeth) according to Council Regulation (EC) No 139/2004 [2009] OJ C 262, paras. 24 and 25 281 Non-opposition to a notified concentration (Case COMP/M.6258 - Teva/Cephalon) [20114] OJ C 46, paras. 88-91
34 action, intended use, and treatment of different symptoms, although some level of off-label use of one product used for treatment of symptoms for which the other was authorized was acknowledged.282
This practice could appease the criticism of including Avastin in the same product market as eye disease medicines due to “Avastin’s lack of marketing authorization to treat AMD” (emphasis added),283 while being marketed legally for cancer treatments. Further, Killick and Berghe posit that after Lucentis received its marketing authorization, off-label prescribing of Avastin seemed largely motivated by financial considerations rather than therapeutic choice; in that case, following previous case law, off- label use could be considered illegal,284 considering Avastin lacked authorization specifically for treatment of AMD. In Hoffmann-La Roche II, medical practice indicated actual substitutability between Avastin and Lucentis, independently of their marketing authorizations. Further, concerning Avastin, the medicine was authorized to be on the market for cancer treatments, and the CJEU did not find anything that would point to its off-label use for eye disease treatment being illegal. Lastly, off-label use has been taken into consideration in relevant decisions in EU merger control in the analysis of the competitive dynamics on the market. This leads to conclusion that in the situations of uncertainty regarding off-label marketing and prescribing, in so far as competent authorities or national courts do not establish unlawfulness of the off-label use, the relevant product market for the purposes of application of Article 101 TFEU comprises products used for the same therapeutic indication, including off-label use.
This ties into another set of concerns, related to competition law encroaching onto the regulatory regime governing medicinal products. Killick and Berghe argue that with its decision, the Italian Competition Authority effectively took a position on therapeutic equivalence and safety of medicinal products by finding the differentiation between Avastin and Lucentis artificial, despite claiming its decision does not prejudge the therapeutic equivalence, but “merely reflects market reality”.285 They argue the promotion of off-label use in disregard of the product’s marketing authorization raises significant public policy concerns, as competition authorities do not possess the necessary expertise to assess safety and efficacy of medicines;286 a valid and pertinent concern indeed. Contrarily, Arnaudo rejects that the Italian Competition Authority’s decision endorsed off-label uses or proposed their extension beyond what is already established in the medical practice and stresses it limited itself to what actually happened as regards Avastin and the efforts aimed at limiting its off-label use in the absence of legal certainty.287 Dolin similarly posits (albeit in the US antitrust enforcement context) that marketing authorization
282 Non-opposition to a notified concentration (Case M.7339 - AbbVie/Shire) [2014] OJ C 397, paras. 6, 11, 13, and 27 283 Killick and Berghe, supra note 35, p. 105 284 Commission v. Poland, supra note 37, paras. 36 and 38 285 Killick and Berghe, supra note 35, p. 106-7 286 Ibid. 287 Arnaudo, supra note 1, p. 352
35 process is important in determining the relevant product market, yet that considering for the purpose of relevant market definition only the medicines that have been authorized is incorrect, as they might not be the only medicinal products for treating a certain condition used in actual practice; when prescribing, the healthcare professional chooses among different medicinal products with different action mechanisms, that might not be formally authorized for that specific purpose, considering patient’s underlying condition, but also their age, even race, presence of additional diseases, medicine’s interactions, side effects, etc.288
In this regard, Advocate General in his opinion seemingly made note of critiques that promoting off- label use by competition law runs contrary to the EU pharmaceutical regime, but took no position on it and confined himself to examining the market dynamics related to off-label use of medicines for the purposes of application of the Article 101 TFEU.289 He underlined that EU competition law pursues independent objectives, suggesting that if competition authorities “find that a medicinal product is in fact widely used off label in spite of (legal) uncertainty, they may validly find that such a medicine is interchangeable with medicines used on label for the same indications and therefore belongs to the same product market as them”.290 Such conclusion can, in his opinion, be reached without the need for competition authorities to remove such uncertainty by assessing the lawfulness of off-label use.291 The Court followed Advocate General’s opinion in saying that it is not for the national competition authorities to verify compliance with EU pharmaceutical rules, leaving such assessment to the authorities with appropriate jurisdiction t or to the national courts.292 Hull and Clancy posit that the Court, as obvious from above, in defining the relevant product market focused on the “standard market definition factors of supply and demand”; it established to determine the relationship of substitutability, the competition authority is to “take account of the outcome of that examination by assessing any effects it may have on the structure of supply and demand”,293 rather than removing the uncertainty by assessing whether the activity complies with the applicable regulatory regimes, further underlining the competition authority is not in a position to do this in the first place.294 This adequately limits competition law within its boundaries as the relevant product market for the purposes of application of Article 101 TFEU is to be defined by looking at the structure of supply and demand, taking into account the decisions of the competent authority or national court.
288 Dolin, G. [2014] ‘Non-Price Competition in “Substitute” Drugs: The FTC’s Blind Spot’, Antitrsut Bulletin, 59(3), p. 583, 586-7, 591 289 Advocate General Saugmandsgaard Øe, supra note 3, paras. 50-2 290 Advocate General Saugmandsgaard Øe, supra note 3, paras. 87 and 88 291 Ibid. 292 Hoffmann-La Roche II, supra note 4, para. 60 293 Hoffmann-La Roche II, supra note 4, para. 67 294 Hull and Clancy, supra note 202, p. 399
36
4.2.2 The restriction of competition by object While the definition of the relevant product market essentially dealt with legal or regulatory uncertainty concerning off-label use, the notion of restriction of competition by object brought the context of scientific uncertainty surrounding it to front. In particular, this question dealt with the information campaign put in place by Roche and Novartis on safety and efficacy issues resulting from off-label use of Avastin. The referring court asked if the Article 101(1) TFEU must be interpreted in such a way that an arrangement put in place between undertakings marketing competing products to disseminate information, in the context of scientific uncertainty, on adverse reactions resulting from the off-label use of one of the competing products to reduce its competitive pressure on the other constitutes a restriction of competition by object.295 The CJEU answered in the affirmative that disseminating information on safety and efficacy of a product might restrict competition by object if it were misleading, framing the practice in question as a market sharing agreement, and therefore established a competition law liability of undertakings colluding to disseminate misleading information about medicine’s adverse reactions.296 297 298
In Hoffmann-La Roche II, the CJEU at the outset recalled its established case law on the notion of restriction by object, stating the concept must be interpreted strictly and can be applied only to “certain types of coordination between undertakings which reveal a degree of harm to competition that is sufficient for it to be held that there is no need to examine their effects”, further noting certain forms of coordination can be regarded as being harmful to the proper functioning of normal competition by their very nature.299 The Court then reminds that in order to establish restriction of competition by object, the content of the agreement’s provisions, its objectives, and the economic and legal context of which the agreement is part must be regarded. In determining the context, the nature of the goods or services affected and the real conditions of the functioning and the structure of the market must be taken into account, as well as the EU pharmaceutical rules.300 Here, the CJEU applied an analogy from Sot. Lélos kai Sia and Others,301 where it examined if state regulation of the prices of medicinal products has an impact on assessing whether a certain conduct harms competition. In Hoffmann-La Roche II, the Court noted that in assessing an existence of a cartel in the pharmaceutical sector, “account must be taken of the impact of EU rules on pharmaceutical products”,302 referring to pharmacovigilance rules, which establish a system in place to collect information on the risks of medicinal products as regards patients’
295 Hoffmann-La Roche II, supra note 4, para. 77 296 Hoffmann-La Roche II, supra note 4, para. 95 297 Hull and Clancy, supra note 202, p. 399 298 Parziale, supra note 11, p. 232 299 Hoffmann-La Roche II, supra note 4, para. 78 300 Hoffmann-La Roche II, supra note 4, paras. 79-81 301 Case C-468/06 Sot. Lélos kai Sia EE and Others v. GlaxoSmithKline AEVE Farmakeftikon Proïonton, formerly Glaxowellcome AEVE [2008] ECLI:EU:C:2008:504, para. 58 302 Hoffmann-La Roche II, supra note 4, para. 80
37 or public health, particularly as regards adverse reactions in humans arising from both on- and off-label uses. As noted, it is for the marketing authorization holder to supply to the EMA, the Commission, and the Member States any new information that might call for the variation of the information needed for marketing authorization.303 Further, the pharmacovigilance rules institute, among others, the conditions for dissemination of information on medicinal products to healthcare professionals and the general public; that information must be presented objectively and must not be misleading.304
The Court considered this question by looking firstly into the (anticompetitive) objectives or rationale behind the arrangement, and secondly into the misleading nature of the information at hand. Following from the decision of the Italian Competition Authority, the objective of the agreement was to create artificial differentiation between Avastin and Lucentis by manipulating risk perception by dissemination alarmist interpretation of data that could influence doctors’ therapeutic choices and downplaying contrary information. Further, the arrangement was also targeted at the EMA with a view to obtain a change in the SmPC.305 Considering the case at hand, the CJEU firstly stressed it is solely upon the holder of the marketing authorization and not for another undertaking to comply with the pharmacovigilance obligations regarding this particular medicinal product. In Court’s view, a situation where two undertakings marketing competing medicinal products collude to disseminate information on a product marketed by only one of them might indicate such dissemination “pursues objectives unrelated to pharmacovigilance”.306 The CJEU therefore relied on the legal context of which the agreement was part, namely the pharmacovigilance obligations, to indicate anticompetitive objective of the said agreement, as the objectives and the conduct at hand were evidently not in accordance with the applicable rules. Secondly, the CJEU established the conditions under which information – in the case at hand subject of a cartel agreement between Roche and Novartis, as per the Italian Competition Authority – that fails compliance with the requirements of completeness and accuracy instituted in applicable rules is to be regarded as misleading, namely if its purpose was i) to confuse the regulatory authorities and have the adverse reactions mentioned in the SmPC so as to enable the launch of a public communications campaign to exaggerate the risks, and ii) to emphasise the public perception of the risks associated with the off-label use of Avastin in a context of scientific uncertainty, which is for referring court to determine. The Court also noted dissemination of such information will likely result in a drop in prescriptions and consequently demand for that type of use of a product, due to the nature of the market for medicinal products, and further that providing misleading information also constitutes an infringement of EU pharmacovigilance rules.307 In these circumstances, the agreement pursuing such
303 Hoffmann-La Roche II, supra note 4, paras. 81 and 82 304 Hoffmann-La Roche II, supra note 4, paras. 83-6 305 Hoffmann-La Roche II, supra note 4, paras. 89-90 306 Hoffmann-La Roche II, supra note 4, para. 91 307 Hoffmann-La Roche II, supra note 4, paras. 92 and 93
38 objectives “must be regarded as being sufficiently harmful to competition to render an examination of its effects superfluous”.308
4.2.2.1 Analysis As regards the notion and finding of restriction of competition by object in Hoffmann-La Roche II, it is obvious that misleading information in conditions of scientific uncertainty plays a central role. It is interesting to note that what in the end the CJEU defines when the information is to be regarded as misleading differs from the approach of the Advocate General Saugmandsgaard Øe in his opinion. While he similarly concludes that the conduct of two undertakings, who agreed to communicate to third parties misleading allegations that one medicinal product is less safe than another, when scientific evidence neither supports nor contradicts them, restricts competition by object,309 he construes the concept of misleading information for the purpose of application of Article 101(1) TFEU in a different manner than the Court ultimately held. For the Advocate General, who suggested a more elaborate approach to the concept of misleading information, information is misleading if it does not “state that the risks created by using the medicine are uncertain, or exaggerating such risks with a lack of objectivity with regard to the available evidence”.310
Advocate General developed two hypotheses; one envisions the undertakings exchanged information about the conduct to be adopted so as to fulfil the pharmacovigilance obligations and the allegations communicated were not misleading. Such conduct would not restrict competition within the meaning of Article 101(1) TFEU, as its legitimate aim would be to ensure transparency and quality of information about a product and enable the recipients of such information to take appropriate decisions. This would in fact contribute to healthy competition and protection of public health, as well as fulfil the requirements of EU pharmaceutical rules.311 The other hypothesis corresponds to arguments that the collusive conduct involved dissemination of information that did not reflect the state of scientific knowledge and were misleading, which leaves Advocate General with “little doubt that collusive conduct (…) does reveal a sufficient degree of harm to competition”.312 As follows from the settled case law, he first examined the content of the allegations and stresses when they are found misleading, communication of such allegations, which includes dissemination of information which is in itself correct but presented selectively or incompletely, impairs the quality of available market information and adversely affects those who create the demand.313 This is the case regardless of scientific (un)certainty on the matter; if
308 Hoffmann-La Roche II, supra note 4, para. 94 309 Advocate General Saugmandsgaard Øe, supra note 3, para. 187 310 Advocate General Saugmandsgaard Øe, supra note 3, para. 160 311 Advocate General Saugmandsgaard Øe, supra note 3, paras. 153, 178, and 179 312 Advocate General Saugmandsgaard Øe, supra note 3, paras. 151 and 156 313 Advocate General Saugmandsgaard Øe, supra note 3, paras. 157 and 158
39 allegations lacked objectivity, they are misleading.314 As regards the objective of the concertation, in the light of misleading nature of the allegations, there is no other explanation but that its aim was exclusion or at least reduction in demand for one product to the advantage of another.315 He also stressed that it is not for the undertakings to assume off-label use “is unlawful and act in concert to eliminate (…) the competitive pressure which those activities exert on the sale of another product”.316 Finally, Advocate General looked into the economic and legal context of which the conduct in question was part, pointing out particular sensitivity and risk aversion of healthcare professionals regarding safety considerations of medicinal products. Further, the misleading nature of information disseminated cannot relate to a legitimate aim of ensuring transparency and protecting public health and brand reputation; risks arising from the off-label use are to be borne by the manufacturer of the medicine, not by other undertakings marketing a competing product.317 In addition, he also addresses subjective intention, which could corroborate the existence of an anticompetitive aim behind the conduct in question.318
Considering the content and the objective of an agreement, in its ruling, rather than focusing on whether the information disseminated is actually false, the CJEU is more brief than the Advocate General Saugmandsgaard Øe and does not follow his proposal. As stated, the Court relates the standard for what is misleading information to the objective of dissemination: if information is inaccurate or incomplete pursuing Regulation (EC) No 658/2007 with a purpose to confuse regulatory authorities and artificially exaggerate risk perception by the public.319 320 Considering the economic function of an agreement, disseminating such kind of information cannot serve a pro-competitive purpose.321 One can argue this was done so as to avoid charging competition authorities with assessing the fulfilment of undertakings’ pharmacovigilance obligations; instead of dealing with actual objectivity of the information disseminated, the CJEU emphasises the objective behind it. It centres predominantly around the applicable EU pharmaceutical rules, which are to be taken into account “(w)here the question arises as to where there is a cartel agreement in the pharmaceuticals sector”.322 This provides for a regulatory – or legal – context, in which the conduct at hand takes place,323 and determines the misleading purpose of the information and therefore the restrictive object.
314 Advocate General Saugmandsgaard Øe, supra note 3, para. 160 315 Advocate General Saugmandsgaard Øe, supra note 3, para. 163 316 Advocate General Saugmandsgaard Øe, supra note 3, para. 167 317 Advocate General Saugmandsgaard Øe, supra note 3, paras. 169-71 318 Advocate General Saugmandsgaard Øe, supra note 3, para. 172 319 Hull and Clancy, supra note 202, p. 399 320 See also Parziale, supra note 11, p. 236 321 Todino and Colombo, supra note 8, p. 378 322 Hoffmann-La Roche II, supra note 4, para. 80 323 See also Todino and Colombo, supra note 8, p. 378
40
This was the first time that the CJEU addressed the dissemination of misleading information concerning safety of a medicinal product in the framework of the notion of restriction of competition by object.324 It, however, was not the first time the Court dealt with misleading information in the pharmaceutical sector; the Court considered this issue in a previous case, AstraZeneca.325 326 This decision concerned abuse of administrative procedures regarding the granting of supplementary protection on a patent right and marketing authorization procedures in the framework of Article 102 TFEU that prohibits any abuse by undertaking(s) holding a dominant position within the internal market. In 2005, the Commission found AstraZeneca’s conduct as abusive under Article 102 TFEU; one of the abuses concerned misrepresentations towards patent offices as AstraZeneca submitted misleading information regarding the start date from which onwards supplementary protection would take place on their ulcer medicine. Among others, this resulted in generic producers loosing time in entering the market and blocking parallel imports.327 The Court of Justice, in the appeal case, upheld the General Court’s judgment, which established when might a misleading statement to the patent office constitute an abuse of dominant position: when submission of misleading information is liable to lead public authorities into error and thus make possible the grant of an exclusive right to which an undertaking is not entitled. Misleading nature is to be assessed on the basis of objective factors; proof of bad faith of an undertaking is not required. Even though public authorities themselves were not in fact misled, it is not sufficient to deem these representations were not capable of succeeding.328 The Court of Justice did make note of AstraZeneca’s lack of transparency to keep for as long as possible its monopoly on the relevant market and confirmed leading public authorities into error by utilizing highly misleading representations is inconsistent with the specific responsibility of a dominant undertaking. This does not mean each and any objectively wrong representation constitutes an abuse of dominance, even if unintentional and immediately rectified; assessment of misleading nature needs to take into account specific circumstances of the case.329 330
In this regard, while AstraZeneca was essentially a case on regulatory gaming, as pointed out by Arnaudo, the decision of the Italian Competition Authority – and, subsequently, the CJEU – was couched in application of Article 101 TFEU to horizontal agreements with a view to share product markets and should not be read in the light of AstraZeneca.331 The criticism posed by Killick and Berghe therefore appears legitimate, as they question whether compliance with the broad pharmacovigilance
324 Parziale, supra note 11, p. 235 325 Case C‑457/10 P AstraZeneca AB and AstraZeneca plc v. European Commission [2012] ECLI:EU:C:2012:770 326 See also Todino and Colombo, supra note 8, p. 378 327 Hancher and Sauter, supra note 27, p. 10-1 328 AstraZeneca, supra note 325, paras. 355-7 and 360 329 AstraZeneca, supra note 325, paras. 93, 98, and 99 330 Hancher and Sauter, supra note 27, p. 11 331 Arnaudo, supra note 1, p. 352
41 obligations can in fact be anticompetitive. They posit that Roche’s communications with the public authorities on the risks associated with off-label use of Avastin might constitute nothing more than the implementation of these obligations, even though Roche might had failed to report some adverse effects associated with the on-label use of its medicines.332
As seen, the guidelines for establishing the misleading nature of information similarly build off of pharmaceutical obligations of undertakings; yet, the CJEU does not say whether the infringement of – or, as put by the Court – “failing compliance with the requirements of completeness and accuracy laid down in Article 1(1) of Regulation No 658/2007”333 would need to be established beforehand following that particular regulation or by the competition authority applying Article 101 TFEU. It seems that the Court resolves this by framing these obligations as providing a context to show the anticompetitive intent.334 Parziale similarly notes that the misleading nature of information depends (primarily) on the purpose of dissemination and reminds that pharmacovigilance obligations regarding a specific product are the responsibility of its marketing authorization holder, including as regards the off-label use. As already indicated, the applicable legal framework is such that dissemination about risk associated with use of a certain product would likely cause a shift in demand,335 as also acknowledged by the Court, which points to commercial, rather than pharmacovigilance purpose of the informational campaign. This is corroborated by the omittance of contradictory evidence from it and the fact that both undertakings would benefit from restricting the off-label use of Avastin.336 Again, this indicates the economic and legal context of an agreement is a ‘vehicle’ for determining its objectives and subsequently its anticompetitive nature, absolving the competition authorities from the need for an assessment of compliance with the pharmaceutical obligations; by taking advantage of scientific uncertainty, the arrangement between Roche and Novartis concerning the two competing products was found to reveal a sufficient degree of harm to competition to be prohibited without the examination of its effects. Todino and Colombo in this regard conclude the nature of the information campaign made it obvious that this was “an unlawful agreement between competing undertakings in breach of Article 101(1) TFEU”.337
Hoffmann-La Roche II advances the contextual analysis in application of Article 101(1) TFEU: pharmaceutical industry is a highly regulated sector that depends on scientific evidence and it is therefore unsurprising pharmaceutical obligations featured prominently in the contextual analysis of the arrangement at hand; its object was determined by analysis of the context, which is to be divorced from the demonstration of its effects, as settled in Groupment des Cartes Bancaires. Citing Beef Industry
332 Killick and Berghe, supra note 35, p. 106 333 Hoffmann-La Roche II, supra note 4, para. 92 334 See also Hull and Clancy, supra note 202, p. 399 335 Parziale, supra note 11, p. 236 336 Hull and Clancy, supra note 202, p. 399 337 Todino and Colombo, supra note 8, p. 377
42
Development Society, the object-effect distinction stems from the settled law that certain forms of collusion are by their nature harmful to normal competition, it can appear peculiar that the CJEU then relied on a paragraph from Asnef-Equifax when recalling how to determine the arrangement’s context, as in that particular case, the consideration of the actual context was referred to with regards to appraisal of agreements’ or practices’ effects. In this regard, the Court in Hoffmann-La Roche II did acknowledge expected reduction in demand is likely to result from dissemination of misleading information, due to characteristics of the medicinal products market; but only in passing and devoted more attention to the applicable legal framework. Since Asnef-Equifax is about understanding (restrictions of) competition – both in terms of object and effects – in its actual context, as follows from the earliest case law, and not assessing it in the abstract, it can be concluded the contextual analysis approaches restrictions of competition in general. In that way it represents a ‘sliding scale’ method,338 with object as its starting or focal point, while maintaining assessment of context to determine anticompetitive object is distinct from actual examination of effects. In that sense, the restrictive interpretation of restriction of competition by object is preserved.
338 See also Todino and Colombo, supra note 8, p. 378
43
5 Normative conclusions
Hoffmann-La Roche II proved to be a significant case addressing the outcomes of the interplay between competition law and pharmaceutical regime in the context of scientific and regulatory uncertainty surrounding off-label use of medicines. In this regard, the Court’s judgment provided some important answers and guidance; this research identified at least four normative and policy implications of the ruling, which are discussed in this concluding chapter.
Firstly, the contested issue before the Court in the case at hand was if products used off-label for a certain indication can be treated as substitutes to products specifically authorized for such indication. Hoffmann-La Roche II appears to consolidate the inclusion medicines used off label in the definition of the relevant product market.339 While products manufactured and sold illegally cannot be treated as substitutable, in the case at hand, Avastin had a valid marketing authorization for cancer treatments. The product was also frequently prescribed for purposes not covered by its authorization, namely for treatment of eye diseases. The Court recalled this is not prohibited, subject to certain conditions established in the regulatory framework and case law, and noted that nothing suggested actual unlawfulness found by a competent authority or national court; the relevant product market was therefore to consist of medicines used for the same therapeutic indication, thus both Avastin and Lucentis. The marketing authorization does not confine the definition of the relevant product market; it is relevant in so far as it might influence the structure of supply and consumers’ behaviour and thus plays “a persuasive role, not a decisive one”.340 This is only logical, as pointed out by the Advocate General Saugmandsgaard Øe, since if marketing authorization would delineate the relevant product market, pharmaceutical companies would “have carte blanche to reach agreements (…) to share markets by ensuring that there was no overlapping of the therapeutic indications” of the medicines placed on the market, in disregard of the practice and reality on the demand side.341 The present research thus reasons the inclusion of medicinal products used off label in the definition of the relevant product market for the purposes of competition law – which, one can assume, raised quite some controversy on the side of the pharmaceutical industry –, merely applies and ‘cements’ the (case) law, as settled.
Nonetheless, Avastin and Lucentis were found to belong to the same market and sufficient degree of harm to competition was established. Was the relevant product market definition therefore necessary in finding a restriction of competition by object? In establishing a restriction of competition by object in Hoffmann-La Roche II, as follows from the ruling, the definition of the relevant product market was relevant in so far as the two products were found competing and the restrictive arrangement concerned
339 See also Parziale, supra note 11, p. 235, 237 340 Parziale, supra note 11, p. 235 341 Advocate General Saugmandsgaard Øe, supra note 3, para. 81
44 the dissemination of misleading information relating to one of them to reduce the competitive pressure on another.342 The essential role in finding such arrangement revealed by its nature a sufficient degree of harm to competition, however, was played by the examination of the economic and legal context – the nature of the products affected and the conditions on the market in question, to a large extent determined by pharmaceutical obligations –, to understand the arrangement’s economic function and real significance.343 Pursuant to Groupment des Cartes Bancaires, context is distinct from the definition of the relevant market; the relevant market does not confine the context of the agreement, rather, the context informs the assessment. Hoffmann-La Roche II adopts this contextual analysis approach in application of Article 101(1) TFEU, which appears especially relevant when faced with a ‘new’ type of restriction of competition. While it might not necessarily satisfy legal certainty and predictability,344 as well as not be well suited for enforcement, such approach appears more responsive to the reality on the market.345
Secondly, Hoffmann-La Roche II set a legal standard for misleading information for the purposes of application of Article 101 TFEU. The legal standard for misleading information related to the pharmaceutical sector prior established in AstraZeneca concerning the application of Article 102 TFEU stated that a misleading statement to the patent office constitutes an abuse of dominant position when such submission is liable to deliberately lead public authorities into error and thus make possible the grant of an exclusive right to which an undertaking is not entitled. This is to be assessed on the basis of objective factors. Advocate General Saugmandsgaard Øe in his opinion in Hoffmann-La Roche II appears to have built off of this standard, as he underlines the objective assessment; for him, the information would be misleading if it does not state the risks of the use of medicine are uncertain or if exaggerates such risks with a lack of objectivity with regards to the available evidence. In Hoffmann-La Roche II, however, the Court stated that information which is not complete and accurate as instituted by applicable rules is misleading if its purpose is to confuse the regulatory authorities to enable the launch of a communication campaign to exaggerate risks and to emphasize the public perception of risks of off- label use in the light of scientific uncertainty. The pharmaceutical legal regime is central to this and the facts that dissemination of such information would likely negatively impact the demand is only briefly referred to. Therefore, whether information is to be considered as misleading depends primarily on the purpose of dissemination of such information, which seemingly provides competition authorities “with a procedural shortcut”, as the emphasis is placed on why the information is disseminated and not on proving the statements are in fact incomplete or inaccurate, as per applicable rules.346 347 Thus, an
342 Hoffmann-La Roche II, supra note 4, para. 95 343 See also Advocate General Wathelet, supra note 152, paras. 147 and 148 344 See also Advocate General Wahl, supra note 68 345 See also Colomo and Lamadrid, supra note 67 346 Hull and Clancy, supra note 202, p. 399 347 See also Parziale, supra note 11, p. 236
45 arrangement pursuing the objectives described is to be considered a restriction of competition by object. Importantly, the standard in Hoffmann-La Roche II sees the (legal) context in which the information is provided as essential in finding an anticompetitive object of an agreement,348 which confirms the current CJEU’s approach in application of Article 101 TFEU is indeed highly contextual, rather than formalistic, supporting the restrictive interpretation of restriction of competition.
Thirdly, both with regards to defining the relevant product market, including the issue of off-label use of medicines, and finding a restriction of competition by object by misleading information under pharmaceutical obligations, concerns were raised that competition law overstepped its boundaries. This is especially so, considering the regulatory and scientific uncertainty surrounding the off-label use of medicines. Killick and Berghe are critical, albeit of the Italian Competition Authority’s decision, as what it considers “normal market reality” appears to “run against the whole logic of pharmaceutical regulatory system”,349 which operates on the basis of granted marketing authorizations and monitoring the adverse effects of medicines in use. Similarly, Hancher and Sauter raised concern how appropriate it is to use competition law tools to remedy issues stemming from regulatory uncertainty.350 It appears both the ruling and the Advocate General’s opinion take these concerns on board. Concerning lawfulness of off- label use, Hoffmann-La Roche II firmly confines competition law within its boundaries, as the relevant product market for the purposes of application of Article 101 TFEU is to be defined by looking at structure of supply and demand, taking into account decisions of the competent authority or national court, and thus comprises products used for the same therapeutic indication, including off-label use. Concerning the notion of restriction of competition by object, Hoffmann-La Roche II seems to build off of the obligation of communication of safety risks to competent authorities and the public in good faith and on a basis of complete supporting scientific evidence,351 so as to establish the nature of the information disseminated and the objective of the arrangement. While the likely reduction of demand that would result from spreading misinformation was acknowledged in passing, the applicable pharmacovigilance obligations are considered quite extensively, as their impact is to be taken into account in the analysis of possible harm to competition, specifically where the question arises on existence of a cartel agreement. Importantly, the CJEU stated it is not up for the colluding undertakings to enforce the pharmacovigilance rules.352
In contrast with (un)lawfulness of off-label use, where it is clear that the medicinal products used off label were considered included in the relevant product market in so far the illegality would be actually established, there is however a degree of uncertainty regarding if and how (much) the incompleteness
348 See also Hull and Clancy, supra note 202, p. 399 349 Killick and Berghe, supra note 35, p. 109 350 Hancher and Sauter, supra note 27, p. 14 351 Parziale, supra note 11, p. 235, 237 352 Hoffmann-La Roche II, supra note 4, para. 91
46 or inaccuracy of information is to be ascertained by the competition authorities and the courts in the light of the criteria provided. The Court seemingly attempts to resolve this by focusing on the purpose behind it, to confuse the authorities and emphasize public perception of risks. The notion of misleading information is thus to be interpreted on a rather flexible basis, leading Parziale to conclude that the ruling in an innovative manner extends competition law scrutiny over the nature of information intended for the public;353 time will tell if its merit is not only conceptual, but also practical. Even so, one could say the guidance on misleading information in Hoffmann-La Roche II at most bolsters the applicable pharmaceutical regime and the responsibilities of marketing authorization holders as regards off-label use of medicinal products, rather than trespasses onto it, as “the provision of misleading information to the EMA, healthcare professionals and the general public (…) also constitutes an infringement of the EU rules governing pharmaceutical matters giving rise to penalties”.354 Reference to pharmaceutical obligations is made to protect competition; in this light, competition law and pharmaceutical obligations are mutually reinforcing. Following Parziale, Hoffmann-La Roche II thus contributes to further defining the (il)legitimate conduct in this regulatory domain in the light of both uncertainty and pharmaceutical obligations concerning the off-label use of medicines.355 A more detailed discussion on whether this is beyond objectives of competition law is pertinent, however it exceeds the scope of the present research.
Lastly, competition in the pharmaceutical sector has so far mostly been confined to therapeutic competition between undertakings competing to be the first on the market with a medicine that is safer, more effective, or meets an unmet medical need; to inter-brand competition or generic competition; and to intra-brand competition and parallel importation.356 357 Carrier and Minniti claim biological medicines are a new ‘frontier’ for the competition law enforcement,358 especially considering these innovative treatments in 2017 already represented about a quarter of global pharmaceutical sales and are expected to reach 30% in 2022.359 The implications of Hoffmann-La Roche II, specifically as regards information campaigns on safety concerns, are relevant for the industry and enforcement in this light as well. As noted, Avastin and Lucentis are biological medicinal products: complex protein molecules produced by living cells. Biological medicines differ from traditional small molecule medicinal products consisting of chemical substances that can be readily analysed and duplicated. The production of biological medicines requires advanced manufacturing processes, which typically define the product itself, and is rather expensive due to its complexity. Biosimilars are defined as biological medicines similar to
353 Parziale, supra note 11, p. 235, 236-7 354 Hoffmann-La Roche II, supra note 4, para. 93 355 Parziale, supra note 11, p. 235, 237 356 For more, see for example Hancher and Sauter, supra note 27, p. 2, 6 357 See also Morse, supra note 243, p. 637-8 358 Carrier, M. A. and C. J. Minniti III [2018] ‘Biologics: The New Antitrust Frontier’, University of Illinois Law Review, 1, p. 1-70 359 Diependaele, L., J. Cockbain, and S. Sterckx [2018] ‘Similar or the Same? Why Biosimilars are not he Solution’, Journal of Law, Medicine & Ethics, 46, p. 776
47 another, already authorized biological medicine. As existing technology does not allow for producing precise replicas of biologics, biosimilars are not considered ‘generic’ biologics. The regulatory framework in place in the EU requires manufacturers to demonstrate similarity to the reference biologic in terms of safety, efficacy, and quality, but not via clinical research of a scope comparable to that required for originator medicinal product, which makes biosimilars less costly to produce. Finally, biosimilar’s SmPC is essentially a copy of the reference medicine’s SmPC. 360 361 362
Competition between biologics and biosimilars is qualitatively different than brand-generic competition,363 as indicated above. The difference in competition in markets for generic medicines and biosimilars has already been recognized by the Commission in merger control, noting that while generic products compete mainly on price, biological products are “intrinsically differentiated due to their complex molecular structure”.364 When it comes to originator biological medicines and biosimilars, they are not identical in terms of their molecular structure and are distinct as regards evidence on their efficacy and safety; it is for each national authority to decide in the substitutability and interchangeability of these products, based on scientific evidence and data available. A limited degree of substitutability has been recognized with regards to patients already in treatment, thus biosimilar competition concerns mostly newly diagnosed patients about to start a treatment. This might impact the commercial strategy of biosimilar market entrants concerning price undercutting and product differentiation.365 Due to the lesser degree of substitution, competition between reference biologics and biosimilars is “expected to be less vigorous” than it is the case between branded and generic medicines.366 Whereas the use of generics is usually encouraged via regulatory or policy initiatives, rather than patients’ or healthcare professional’s decisions and habits, biosimilars will require active promotion. Here, Manning and others note that, specifically concerning the situation of Avastin-Lucentis in the US, the driving product choice was less so driven by financial motivation, but rather by medical assessment of the treating physician.367 This might imply that, while brands might not be inclined to ‘badmouth’ generic medicines due to their equivalence in safety and efficacy profile, promotion, marketing, and awareness raising carry much
360 Ibid. 361 Schiestl, M., M. Zabransky, and F. Soergel [2017] ‘Ten years of biosimilars in Europe: development and evolution of the regulatory pathways’, Drug Design, Development and Therapy, 11, p. 1509-1515, doi: 10.2147/DDDT.S130318 362 Tucker, D. S. and G. F. Wells [2014] ‘Emerging Competition Issues Involving Follow-on Biologics’, Antitrust, 29(1), p. 100 363 Manning, R., C. Stomberg, B. Scher, K. Twigg, and A. Huson [2015] ‘Similar Products at Different Prices: Can Biopharmaceutical Companies Segment Markets?’, International Journal of the Economics of Business, 22(2), p. 232 364 Commission Decision declaring a concentration to be compatible with the common market (Case No COMP/M.7559 - Pfizer/Hospira) according to Council Regulation (EC) No 139/2004 [2015] OJ C 324, paras. 32-4 365 Pfizer/Hospira, supra note 248, paras. 35 and 36 366 Tucker and Wells, supra note 362, p. 101 367 For more on complexities surrounding medical choices in Avastin-Lucentis use, see Manning and others, supra note 363, p. 241
48 more importance in relation to biologics, specifically biosimilars. Disseminating misleading statements might deter the entry of new products and biologics manufacturers might want to influence prescribers by exaggerating differences or communicating false or misleading information against biosimilars,368 thus exploiting scientific uncertainty. Similarly, Tucker and Wells note that safety concerns, “whether well-founded or not”, may result in consumers’ resistance to biosimilars and reduce demand.369
Whereas product differentiation is typically considered a normal commercial practice, it enjoys less legitimacy in the pharmaceutical sector.370 As seen, in the case of off-label use of medicinal products, a combination of scientific and legal uncertainty surrounding it might have allowed businesses to exploit this ‘grey area’ in order to carry out their commercial strategy by manipulating the perceptions of prescribers,371 which was now also found harmful to competition. Further, as regards the pricing, biological medicines have made therapies in many areas more effective, yet at a high price; if the latter, following from product differentiation and market segmentation, is pursued by an agreement between undertakings with a purpose to influence the competitive dynamics on the market, the competition authorities now “appear to have ample and indisputable room for intervening”.372 To conclude, when it comes to biological products or biosimilars and competitive process, both product differentiation practices concerning perceptions of prescribing healthcare professionals and pricing strategies appear to be at the forefront, as illustrated above; following Hoffmann-La Roche II, such commercial approaches of undertakings will probably come under increased scrutiny.
In summary, Hoffmann-La Roche II applies and furthers the contextual, case by case approach to (finding) a restriction of competition, maintaining the restrictive interpretation of the restriction of competition by object. This proves even more pertinent in a situation of scientific and regulatory uncertainty, with a view to ensure commercial strategies of undertakings do not harm the proper functioning of the competitive process.
368 Carrier and Minniti, supra note 358, p. 60-4 369 Tucker and Wells, supra note 362, p. 102 370 Arnaudo, supra note 1, p. 352 371 Parziale, supra note 11, p. 235, 237 372 Ibid. and footnote 36
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Case law, opinions of Advocates General, and Commission decisions Bayer Plc v. NHS Darlington Clinical Commissioning Groups and others [2018] EWHC 2465 (Admin)
Case C-56/65 Société Technique Minière (L.T.M.) v. Maschinenbau Ulm GmbH (M.B.U.) [1966] ECLI:EU:C:1966:38
Case C-234/89 Stergios Delimitis v. Henninger Bräu AG. [1991] ECLI:EU:C:1991:91
Case C-250/92 Gøttrup-Klim and Others Grovvareforeninger v. Dansk Landbrugs Grovvareselskab [1994] ECLI:EU:C:1994:413
Case T-62/98 Volkswagen AG v. Commission of the European Communities [2000] ECLI:EU:T:2000:180
Case C-238/05 Asnef-Equifax, Servicios de Información sobre Solvencia y Crédito, SL and Administración del Estado v. Asociación de Usuarios de Servicios Bancarios (Ausbanc) [2006] ECLI:EU:C:2006:734
Case C‑209/07 Competition Authority v. Beef Industry Development Society Ltd, Barry Brothers (Carrigmore) Meats Ltd [2008] ECLI:EU:C:2008:643
Case C-468/06 Sot. Lélos kai Sia EE and Others v. GlaxoSmithKline AEVE Farmakeftikon Proïonton, formerly Glaxowellcome AEVE [2008] ECLI:EU:C:2008:504, para. 58
Case C-8/08 T-Mobile Netherlands BV, KPN Mobile NV, Orange Nederland NV, Vodafone Libertel NV v. Raad van bestuur van de Nederlandse Mededingingsautoriteit [2009] ECLI:EU:C:2009:343
Case C-501/06 P GlaxoSmithKline Services and Others v. Commission and Others [2009] ECLI:EU:C:2009:610
Case T-321/05 AstraZeneca AB and AstraZeneca plc v. European Commission [2010] ECLI:EU:T:2010:266
Case C-439/09 Pierre Fabre Dermo-Cosmétique SAS v. Président de l’Autorité de la concurrence, Ministre de l’Économie, de l’Industrie et de l’Emploi [2011] ECLI:EU:C:2011:649
Case C-185/10 European Commission v. Republic of Poland [2012] ECLI:EU:C:2012:181
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Case C‑226/11 Expedia Inc. v. Autorité de la concurrence and Others [2012] ECLI:EU:C:2012:7954
Case C‑457/10 P AstraZeneca AB and AstraZeneca plc v. European Commission [2012] ECLI:EU:C:2012:770
Case C-32/11 Allianz Hungária Biztosító Zrt, Generali-Providencia Biztosító Zrt, Gépjármű Márkakereskedők Országos Szövetsége, Magyar Peugeot Márkakereskedők Biztosítási Alkusz Kft, Paragon-Alkusz Zrt., the legal successor of the Magyar Opelkereskedők Bróker Kft v. Gazdasági Versenyhivatal [2013] ECLI:EU:C:2013:160
Case C-535/11 Novartis Pharma GmbH v. Apozyt GmbH [2013] ECLI:EU:C:2013:226
Case C-67/13 Groupment des Cartes Bancaires v. European Commission [2014] ECLI:EU:C:2014:2204
Case C-286/13 P Dole Food Company, Inc., and Dole Fresh Fruit Europe v. European Commission [2015] ECLI:EU:C:2015:184
Case C-345/14 SIA “Maxima Latvija” v. Konkurences padome [2015] ECLI:EU:C:2015:784
Case C‑373/14 P Toshiba Corporation v. European Commission [2015] ECLI:EU:C:2016:26
Case T-452/14 Laboratoires CTRS v. European Commission [2015] ECLI:EU:T:2015:373
Case T-472/13 Lundbeck v. Commission [2016] ECLI:EU:T:2016:449
Case C-29/17 Novartis Farma SpA v. Agenzia Italiana del Farmaco (AIFA), Roche Italia SpA, and Consiglio Superiore di Sanità [2018] ECLI:EU:C:2018:931
Case C-179/16 F. Hoffmann-La Roche Ltd and Others v. Autorità Garante della Concorrenza e del Mercato [2018] ECLI:EU:C:2018:25
Commission Decision declaring a concentration to be compatible with the common market and the EEA Agreement (Case COMP/M.3333 - Sony/BMG) [2007] OJ C 94
Commission Decision declaring a concentration to be compatible with the common market (Case COMP/M.5295 - Teva/Barr) according to Council Regulation (EC) No 139/2004 [2008] OJ C 10
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Commission Decision declaring a concentration to be compatible with the common market (Case COMP/M.5476 - Pfizer/Wyeth) according to Council Regulation (EC) No 139/2004 [2009] OJ C 262
Commission Decision declaring a concentration to be compatible with the internal market and the EEA agreement (Case COMP/M.6458 - Universal Music Group/EMI Music) [2012] OJ C 220
Commission Decision declaring a concentration to be compatible with the common market (Case COMP/M.6884 - ACCESS/PLG) according to Council Regulation (EC) No 139/2004 [2013] OJ C 212
Commission Decision declaring a concentration to be compatible with the common market (Case COMP/M.7559 - Pfizer/Hospira) according to Council Regulation (EC) No 139/2004 [2015] OJ C 324
Joined cases C-56/64 Établissements Consten S.à.R.L. and Grundig-Verkaufs-GmbH v. Commission of the European Economic Community [1966] ECLI:EU:C:1966:41
Joined cases 96-102, 104, 105, 108 and 110/82 NV IAZ International Belgium and others v. Commission of the European Communities [1983] ECLI:EU:C:1983:310
Non-opposition to a notified concentration (Case COMP/M.5865 - Teva/Ratiopharm) [2011] OJ C 7
Non-opposition to a notified concentration (Case COMP/M.6258 - Teva/Cephalon) [2011] OJ C 46
Non-opposition to a notified concentration (Case COMP/M.7339 - AbbVie/Shire) [2014] OJ C 397
Opinion of Advocate General Trstenjak in the case C-209/07 [2008] ECLI:EU:C:2008:467
Opinion of Advocate General Kokott in the case C-8/08 [2009] ECLI:EU:C:2009:110
Opinion of Advocate General Trstenjak in the case C-209/07 [2009] ECLI:EU:C:2008:467
Opinion of Advocate General Trstenjak in the case C-501/06 P [2009] ECLI:EU:C:2009:409
Opinion of Advocate General Mazák in the case C-439/09 [2011] ECLI:EU:C:2011:113
Opinion of Advocate General Wahl in case C‑67/13 P [2014] ECLI:EU:C:2014:1958
Opinion of Advocate General Wathelet in the case C‑373/14 P [2015] ECLI:EU:C:2015:427
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Opinion of Advocate General Saugmandsgaard Øe in the case C‑179/16 [2017] ECLI:EU:C:2017:714
58