The Roche-Novartis case: is competition law widening its frontiers?

The preliminary ruling of the Court of Justice of the European Union (CJEU), in the Italian Roche-Novartis case confirms a slow but steady trend towards the widening of competition law frontiers by considering misleading information an infraction of competition law.

As technology and business models develop, we are increasingly seeing regulators grapple with the question of what legal tool should be used to tackle market distortions.  Competition law’s ultimate goal of protecting consumers – and the fact that regulators often have both consumer and competition powers – seem to be prompting competition decisions that blur the lines with consumer law.

Most recently, on 23 January 2018, the CJEU responded to the questions raised by an Italian court in relation to the sanction imposed on Roche and Novartis by the Italian Competition Authority (AGMC) for disseminating misleading information about a pharmaceutical product in order to shift demand to another product. The CJEU considered that such conduct could be understood as an infraction by object of article 101 of the TFEU.

One of the novelties of this case is that we normally associate misleading information with infringements related to consumer protection, rather than competition law. It is also interesting that the CJEU labeled this an infringement by object.  By their nature, the category of infringements by object are those considered so harmful to competition that their anticompetitive effects do not need to be proven (for example, price fixing; exchanges of sensitive information; limiting output/sales; setting minimum resale prices; limiting exports). Giving this infringement the ‘object’ label therefore means that the provision of misleading information may be illegal without any actual impact on competition.

The Italian case and its context

Hoffman-La Roche granted a license to Novartis to market the medicinal (ophthalmological) product Lucentis, which shared its clinical development with the medicinal (oncological) product Avastin. Avastin was marketed in Italy prior to Lucentis and than the latter. For this reason, Italian doctors began to prescribe the off-label use of Avastin for the treatment of ophthalmological diseases, since both products derived from the same active substance.

Under this framework and because the sales of Lucentis (by Novartis) were experiencing losses in Italy, both undertakings agreed to produce and disseminate misleading information about the perception of the risks associated with the off-label use of Avastin in ophthalmology, in order to increase the demand in favor of Lucentis (which was ten times more expensive).

The agreement targeted both doctors and the European and Italian medicines agencies. Following an analysis of the legal context of the case, the CJEU’s understanding was that the objective of the information disseminated was not to fulfil pharmacovigilance or regulatory obligations; but rather was intended to manipulate the perception of the medicines agencies and Italian doctors regarding the off-label use of Avastin, to shift the demand to Lucentis.

Other national precedents

Both in Spain and in France there have been recent cases in which the use of misleading information was sanctioned for being collusive and abusive infringements of competition law.

  • Spain: In 2012, in case S/0256/10 Inspecciones Periódicas de Gas, two trade associations were sanctioned by the Spanish competition authority for sending misleading information to the local administrations that had asked what the official price of mandatory gas inspections should be in their jurisdictions. The sanction was based on Article 1 of the Spanish Competition Act (equivalent to Article 101 of the TFEU). The Spanish competition authority concluded that the use of misleading information was a key factor in the infringement. The defendants took advantage of a change in legislation to mislead local administrations into setting the legislative price above the true market level.

 

  • France: In 2013, in case n° 13-D-11 Sanofi-Aventis, the pharmaceutical company Sanofi-Aventis was sanctioned by the French competition authority (a decision which was subsequently confirmed by the French courts) for the dissemination of misleading information about the characteristics of a medicine related to the treatment of cardiovascular diseases (clopidogrel). Sanofi-Aventis made use of the brand-name recognition of their patented blockbuster Plavix (clopidogrel) to give legitimacy to the dissemination of misleading information about patent-related differences in relation to the generic alternatives. This dissemination was aimed at frightening doctors so that they did not prescribe generics and persuading pharmacists not to substitute Plavix. This conduct was sanctioned as an abuse of a dominant position. Losses to the French health system were estimated at € 30m.

 

Confirmation of a growing trend

In the Italian case, the CJEU referred to the fact that, under European regulations on medicinal products, all information intended for the public and the competent authorities must be presented objectively and without misleading information by the owner of the marketing authorisation.

In addition to the analysis of the legal context, and as a point of connection with the other two cases, the CJEU took into account the broader context of the conduct, and considered that the disclosure of such misleading information may cause doctors not to prescribe the use of Avastin for the treatment of eye diseases. Finally, the CJEU confirmed the view of the AGMC that an agreement between competitors in this sense could be considered as a ‘by object’ infraction (not needing proof of its harmful effects in the market).

The Spanish and the Italian cases have in common the fact that the undertakings took advantage of the legal context to convey the misleading information to the relevant authorities to attain their anticompetitive goals. In contrast, in the French case, the undertaking disseminated the misleading information directly to the market players that could shift the demand towards the generic products.

Ultimately, what all of the cases have in common is that the competition authorities are taking into consideration the use of misleading information to assess whether or not undertakings committed infractions of competition law.

Comment: who said you can’t teach an old dog new tricks?

In spite of the fact that competition rules are “old”, from the cases analyzed we have reached two conclusions:

  • We may be facing the broadening of the “by object box”, which, pursuant to the judgment of the CJEU, could now include agreements to disseminate misleading information (depending on the context of the conduct); and
  • Competition authorities may be able to keep up with the pace of undertakings and the sophistication of their conduct by including “new” behaviors in their repertoire of “tricks”.

By: J. Nicolás Otegui Nieto

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The Court of Justice of the European Union has reached a decision on the collusive practices carried out in Italy by Roche and Novartis when marketing the medicinal products Avastin and Lucentis

The Court of Justice of the European Union has resolved the preliminary question raised by the Consiglio di Stato (the Italian Council of State) and, in accordance with the conclusions of the Advocate General, it concludes that the dissemination of misleading information about a medicinal product could be considered as a breach by object of article 101.1 of the Treaty on the Functioning of the European Union.

On 23 January 2018, the Court of Justice of the European Union (“CJEU“) made a ruling on the preliminary questions raised by the Consiglio di Stato in relation with the sanctions imposed on Roche and Novartis by the Italian Antitrust Authority (“AGCM“), for carrying out practices aimed at disseminating misleading information about a medicinal product to condition its demand in favour of another product that is ten times more expensive (C-179/16). With regard to the background of this matter, please see our previous publication on the Advocate General’s opinion on this proceeding.

In the ruling, the Court considers that an agreement between two companies that market two competing medicinal products to disseminate misleading information about the adverse effects of the use of one of those medicinal products with the clear aim of shifting demand in favour of the other product, constitutes a restriction of competition “by object” in accordance with article 101.1 of the Treaty on the Functioning of the European Union  (“TFEU“).

The CJEU arrived at this conclusion after conducting an interesting analysis of two main issues, the relevant market of both medicinal products (note that Avastin was not authorised for the treatment of eye disease) and the nature of the misleading information disclosed, in light of EU regulations on medicinal products.

In Competition Law, the market definition should include all those products that consumers consider as interchangeable or substitutable with each other. In this case, the market would contain all those products that are used for the same therapeutic purpose. Given that Avastin and Lucentis were owners of valid marketing authorisations at the time of the infraction, the prescribed off-label use of Avastin under medical supervision, led to both medicinal products falling under the same market definition.

With regard to the nature of the misleading information disclosed, and from a regulatory point of view, the CJEU understands that its objective was not related to the fulfilment of pharmacovigilance obligations, but that it was intended to try to create an artificial distinction between Avastin and Lucentis, thereby manipulating the perception of the EMA and the competent authorities in Italy regarding Avastin.

On this point, the CJEU has conducted an interesting analysis of the legal context in which the behavior is defined, making reference to the European regulations on medicinal products in accordance to which the information intended for the public and the competent authorities must be presented objectively and without misunderstandings by the owner of the marketing authorization.

In addition, the CJEU considers that the disclosure of such misleading information may cause doctors not to prescribe the use of Avastin for the treatment of eye problems. Therefore, an agreement between competitors with this objective in mind can be considered as behaviour that is harmful to competition by object, the consequence of which is that it will not be necessary to test the effects of such agreement on the market.

In consideration of the foregoing, it can be said that this ruling is significant since it is the first time that the concept of a restriction by object has been applied to an agreement that (if the premises established by the CJEU are confirmed by the national courts) is aimed at disseminating allegedly misleading information about the safety of a medicinal product.

It is now just a matter of waiting for the ruling of the Consiglio di Stato on the national lawsuit, to validate if the interpretation of the CJEU is accepted and the sanction imposed by the AGCM on Roche and Novartis is confirmed.

By: J. Nicolás Otegui Nieto and Gemma Sammuel.

El Tribunal de Justicia de la Unión Europea se pronuncia sobre las prácticas colusorias llevadas a cabo en Italia por Roche y Novartis en el marco de la comercialización de los medicamentos Avastin y Lucentis

El Tribunal de Justicia de la Unión Europea resuelve la cuestión prejudicial planteada por el Consiglio di Stato (Consejo de Estado italiano) y, siguiendo las conclusiones del Abogado General, concluye que la divulgación de información engañosa sobre un medicamento podría considerarse como una infracción por objeto del artículo 101.1 del Tratado de Funcionamiento de la Unión Europea.

El pasado 23 de enero de 2018 el Tribunal de Justicia de la Unión Europea (“TJUE“) dictó sentencia sobre las cuestiones prejudiciales planteadas por el Consiglio di Stato en relación con las sanciones impuestas a Roche y Novartis por parte de la Autoridad de Defensa de la Competencia Italiana (“AGCM“, por sus siglas en italiano), por llevar a cabo prácticas que tenían por objeto divulgar información engañosa de un medicamento para condicionar la demanda a favor de otro diez veces más caro (C-179/16) . Respecto a los antecedentes de este asunto, véase nuestra anterior publicación sobre la opinión del Abogado General en este procedimiento.

En dicha sentencia, el Tribunal considera que un acuerdo entre dos empresas que comercializan dos medicamentos competidores consistente en difundir información engañosa sobre los efectos adversos del uso de uno de esos medicamentos con el claro objetivo de desplazar la demanda en favor de otro, constituye una restricción de la competencia “por su objeto” de conformidad con el artículo 101.1 del Tratado de Funcionamiento de la Unión Europea (“TFUE“).

El TJUE llega a dicha conclusión tras realizar un interesante análisis sobre dos cuestiones principales, el mercado de referencia de ambos medicamentos (recordemos que el Avastin no estaba autorizado para el tratamiento de enfermedades oculares) y la naturaleza de la información engañosa divulgada, a la luz de la regulación sobre medicamentos de la Unión.

En Derecho de la Competencia la definición de mercado ha de contener todos aquellos productos que los consumidores consideren intercambiables o sustituibles entre sí. En este caso, dicho mercado contendría todos aquellos productos que sirven para los mismos usos terapéuticos. Dado que Avastin y Lucentis poseían autorizaciones de comercialización válidas en el momento de la infracción, el uso off-label de Avastin bajo prescripción y responsabilidad médica, hizo que ambos medicamentos entraran en una misma definición de mercado.

En cuanto a la naturaleza de la información engañosa divulgada, y bajo el punto de vista regulatorio, el TJUE entiende que su objetivo no estaba relacionado con el cumplimiento de obligaciones de farmacovigilancia, sino que iba dirigido a lograr crear una diferenciación artificial entre Avastin y Lucentis, manipulando así la percepción que tenían la EMA y las autoridades competentes en Italia acerca del Avastin.

El TJUE realiza, sobre este punto, un interesante análisis del contexto jurídico en el que se enmarca la conducta, haciendo referencia a la normativa europea sobre medicamentos conforme a la cual la información destinada al público y a las autoridades competentes debe presentarse de forma objetiva y sin equívocos por parte del titular de la autorización de comercialización.

Además, el TJUE entiende que la divulgación de esa información engañosa puede provocar que los médicos no prescriban el uso de Avastin para el tratamiento de problemas oculares, por lo que un acuerdo entre competidores dirigido a este objetivo puede ser considerado como una conducta dañina para la competencia por objeto, teniendo ello como consecuencia que no sea necesario probar los efectos de dicho acuerdo en el mercado.

Por todo lo anterior, podemos decir que dicha sentencia es significativa ya que es la primera vez que el concepto de restricción por objeto se aplica a un acuerdo que (si las premisas establecidas por el TJUE son confirmadas por los tribunales nacionales) tiene por objeto difundir información supuestamente engañosa sobre la seguridad de un medicamento.

Por tanto, ahora solo cabe esperar a la sentencia del Consiglio di Stato en el pleito nacional, para comprobar si acoge la interpretación del TJUE y confirma la sanción impuesta por la AGCM a Roche y Novartis.

Por: Gemma Sammuel y J. Nicolás Otegui Nieto

New State Aid analytical grid for Energy Infrastructures

The European Commission (EC) has updated its State Aid analytical grid on the notion of State Aid to Energy Infrastructure. This working document promises to give undertakings the necessary tools to self-assess whether State Aid is part of their infrastructure projects.

Introduction and applicable criteria for energy infrastructure

The 22 November 2017 the EC has updated its analytical grid in relation to State Aid in the financing of construction, replacement, upgrading and operation of energy infrastructures.

These grids must be complemented by the definitions contained in the Guidelines on State Aid for environmental protection and energy 2014/2020.

The grids apply to energy infrastructure, in particular to transmission, distribution and storage infrastructure for electricity, gas and oil. This guidance will not be applicable to energy production units and district heating and cooling units.

Cases in which the existence of State Aid may be excluded

  • Construction or management of infrastructure in legal monopolies: In legal monopolies, the Transmission System Operator (TSO) and the Distribution System Operator (DSO) are the only entitled entities to operate the network. The legal monopoly excludes competition on and for the market; thus, there is no competition with other alternative energy networks. Cross-subsidization must not exist in cases where the infrastructure operator is active in another (geographical or product) market to be able to exclude possible State aid.
  • Construction of energy infrastructure in natural monopolies: In Member States where it is uneconomical to duplicate electricity or gas infrastructures, distortion of competition may be excluded if the infrastructure cannot be duplicated and no other operators other than TSO/DSO are involved. In addition, alternative financing, apart to that of the TSO/DSO must be insignificant and the infrastructure must not be designed to selectively benefit a specific undertaking. The funds must also not be used to cross-subsidise other activities of the TSO/DSO.

Cases in which potential effect on trade cannot be excluded

The EC highlights that there are certain categories of infrastructures that are built by market actors with market financing; thus, they could not be legal or natural monopolies. Per categories, those infrastructures might be:

  • Electricity: interconnectors and storage facilities that are typically revenue-generating facilities and are activities open to competition.
  • Gas: Gas storage, LNG terminals, import pipelines and interconnectors. Only in specific situations this infrastructures can be part of a legal or natural monopoly, thus, the existence of aid might be ruled out.
  • Oil: Since infrastructure in this market is generally developed by undertakings that compete against each other, aid would normally be considered as State Aid.

Cases where no economic advantage must be granted

We might distinguish three different categories, related to the role of the undertaking:

  • At the level of owner/developer of the infrastructure, State aid can only be ruled out if aid granted by the State is granted under market conditions as if granted by a private investor (same economic terms and conditions of private investors; guaranties; business plan validated by external experts; normal market return; etc.).
  • At the level of operator/concessionaire, the latter should be selected applying the Market Economy Operator Principle, meaning that the concessionaire should not pay less for the use of the aided infrastructure than under normal market conditions. In general, selection must be made applying rules of public procurement in line with the Treaty on the Functioning of the European Union or, applying prior general accepted assessment methodology when there is no tender in place.

When the operator is compensated for rendering services of general economic interest (SGEI), is necessary that (i) the project is necessary for the provision of the SGEI; (ii) compensation parameters are established objectively and transparently in advance; (iii) no compensation beyond net costs and only reasonable profit; (iv) the SGEI is assigned through public procurement or the compensation does not exceeds what an efficient company would require.

  • At the user level, an operator that received aid or that operates State infrastructure might grant an economic advantage to the users of the infrastructure if they are undertakings. In those cases, an economic advantage might be ruled out if the fees for use/access have been set in a competitive, transparent, non-discriminatory and unconditional tender process. In cases of energy and gas transmission networks, aid would not constitute illegal aid if the tariffs are regulated and access is granted on fair and non-discriminatory conditions.

Cases where there is no need to notify the granted aid

As in the past, aid can be granted without notification if it complies with the thresholds laid down in the Commission Regulation (EU) nº 651/2014 declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108 of the Treaty and the Commission Decision, of 20 December 2011, on the application of Article 106(2) of the Treaty on the Functioning of the European Union to State aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest.

Cases where clearance is required

If the aid does not comply with any of the aforementioned criteria, clearance from the EC must be obtained. The assessment, besides taking into account the rules of State Aid (please refer to the link bellow), will also need to take into account the conditions detailed in the Guidelines on State aid for environmental protection and energy 2014-2020 and, if is the case, the European Union framework for State aid in the form of public service compensation (2011).

Link: http://ec.europa.eu/competition/state_aid/modernisation/grid_energy_en.pdf

By: J. Nicolás Otegui Nieto

Connected cars and competition law

The connected car is a reality that will make many regulations interplay. The orchestra of the connected car will perform many tunes, but among others, competition law will take part in the musical score.

Introduction

The connected car will soon become a reality. Whether this is in the form of a fully autonomous car or something halfway between the vehicle we currently know and a fully autonomous car, will depend on the market, innovation within the automotive industry and government regulations.

What is certain is that the connected car will bring many competition law implications for businesses and undertakings that participate in its development. Our aim is to give you a first glance at the possible competition law challenges that the development of the connected car could face.

Realities that will affect the connected car

Among many other realities, the development of the connected car will have an impact in the fields of Original Equipment Manufacturers (OEM’s); joint ventures and mergers between car manufacturers and developers; software and hardware development/production; ownership of data; information sharing and exchanges; smart grids; etc.

We will now mention some of the aforesaid realities or developments from the perspective of some of our traditional competition law “boxes”.

Abuses of dominance and essential facilities

As a first example, nowadays a port in our car allows us to connect a dongle, and to transform it into a connected car. The dongle can gather information that would allow many industries (mapping companies; telecom companies; petrol stations; insurance companies; etc.) to offer a wide variety of services to us. However, what if a dominant telecom company offers all of its clients a dongle for free?

Suddenly, the possibility to connect to this dongles’ network becomes the only way that many companies will have to offer their services to this group of clients (or gather the information to do so) and any conditions and clauses contained in the agreements that such telecom company signs with other companies would need to be scrutinized under competition law rules for abuse of dominance, or even under article 101 of the TFEU.

As a second example, smart grids for recharging batteries of electric cars are already in place in many European cities. Some of these grids are owned and managed by private companies that were granted with administrative authorizations. When the use of electric cars and electric connected cars becomes generalized, these grids could be considered as essential facilities, because there will be no space in crowded European cities to set up new smart grids. Thus, the doctrine on essential facilities will need to be applied to them.

Information sharing

Existing undertakings in the OEM, software and car manufacturer sectors will need to collaborate to develop improved and safer connected cars. This, in principle, is good for competition and for consumers, because we will enjoy better and more affordable products and services.

However, such a close collaboration in the form of information exchanges is very near to possible competition law infringements. The current rules on information sharing and collusive agreements would have to be applied to these types of exchanges, and the competition authorities will need to balance the correct application of those rules without hindering the R+D related to connected cars.

Merger control and joint ventures

There is a growing trend to assess mergers, not only under turnover rationale, but also, in relation to the actual value of the transaction. Thus, undertakings will need to assess with care if the envisaged operation will need to be notified, or even if some commitments need to be proposed to the competition authority reviewing the merger (for instance, offering access on fair, reasonable and non-discriminatory conditions to the technology that the target is developing)

Conclusions

Although traditional competition law boxes may appear to be outdated, at first glance, and clash with new realities such as the connected car, at a second glance, we have seen that they are fit for purpose, but close attention needs to be given in the way competition authorities and undertakings apply them while assessing new realities.

In this new context, companies will need to assess and seek advice on the way competition law rules could be applied to their businesses in relation to developments linked to the connected car to avoid any competition law related concerns.

Spain: a national competition authority at crisis

The Spanish Comisión Nacional de los Mercados y la Competencia (CNMC) is facing a deep institutional, political and technical crisis, and it is about to end the same way it began

The creation of the CNMC

In 2013 there was a trend in Europe for the creation of ‘super-regulators’. In April of that year, the Netherlands launched its Consumer and Markets Authority, that joined together 3 independent regulators and Ireland was already considering doing the same. In that atmosphere, the Spanish Government announced the creation of the Spanish super regulator, which joined together 8 independent authorities, one of which was the competition authority.

The Government argued that this was beneficial for tax payers and for a seamless enforcement of regulation and competition rules, that such a super-regulator would benefit from integration and would deliver legal certainty to market operators, optimizing human and economic resources at the same time.

First internal problems

Leaving the politics to one side, the alleged benefits did not materialize; the creation of the CNMC, in its roots, contained what later became the two main problems of the super regulator.

Firstly, the former heads of some of the eight independent authorities believed that the extinction of their agencies’ and, subsequently, their dismissal was an attack on the principle of independent regulation in their economic sectors and brought the matter to justice.

Secondly, from the beginning, the members of the two chambers of the CNMC (one for regulation and the other for competition) had never reached an understanding on the basic policy. In addition, the members of the competition chamber had never agreed on the way the chamber had to apply competition rules, which affected the proceedings and legal quality of the sanctioning decisions of the CNMC. One of the consequences of this outlook was the resignation of the head of competition advocacy.

These two problems had the following consequences.

Judgement of the Court of Justice of the European Union

The creation of the CNMC meant that the members of the precedent agencies had to be dismissed well before their terms without respecting the rules on dismissal of their independent authorities Consequently, the ex-president and a member of the council of the extinct telecommunications authority appealed their dismissals before the Spanish Supreme Court.

Subsequently, the Spanish Supreme Court raised a question to the Court of Justice of the European Union, asking i) if the creation of the CNMC was in breach of EU Law, and ii) if the unduly dismissal of the heads of an independent authority was contrary to EU Law.

The Court of Justice of the European Union responded that i) the creation of a super regulator was not contrary to EU Law, but, ii) that EU Law was breached by the dismissal of the two members before their terms since the applicable directives expressly mentioned that to guarantee the independence of the regulator, its members could only be ceased by the application of the provisions that regulated their authorities, provisions sanctioned before their appointment, but not after, like the law that created the CNMC.

Judgements of Spanish courts overruling many of the CNMC’s recent decisions

The crisis of the CNMC also affected its decisions and their legal quality. Almost all the decisions of the CNMC contained one or two dissenting votes on matters that ranged from procedural rights to the way the fines were calculated.

Among many other consequences, this situation resulted in the overruling of several CNMC decisions by Spanish courts related to the following topics:

  • Incorrect definition of the relevant market: The CNMC used an old market definition when it fined Telefónica, Vodafone and Orange for a total amount of 120 million € for an abuse of dominance in the short SMS messages market. As a consequence, in a rare judgement the Spanish High Court annulled the decision of the CNMC on the grounds of an incorrect market definition.

  • Incorrect application of the law on vertical restraints: The CNMC incorrectly sanctioned Telefónica when it considered that a contractual clause on retroactive rebates imposed on final consumers was a vertical restraint. The High Court clarified that the parties of the agreement must be present at different levels of the distribution process to apply the law on vertical restraints, but not when one of the parties is a final consumer, thereby annulling the sanction.

  • Rights of defense: In 2 different decisions the competition chamber of the CNMC changed the qualification of the conducts without giving the sanctioned parties the possibility to make allegations. The investigative body of the CNMC originally qualified these as autonomous conducts. In contrast, the competition chamber requalified the conducts as a single and continuous infringement. The High Court overruled the decisions, not due to the change in the qualification, but because the CNMC did not respect the rights of defense of the undertakings.

  • Dawn-raids: The Supreme Court has accepted several applications for annulment related to the way the CNMC issued and drafted inspection orders when no formal investigation was opened. The future judgements will probably focus on whether or not the orders were legal, and/or how the CNMC needs to draft its orders in the future to respect legality when no investigation is open.

  • Single Economic Entity Doctrine: As stated previously, the Spanish High Court considered that the CNMC incorrectly applied the doctrine when it only sanctioned the parent company of the branch that committed the infringement.

These are only a few examples of many judgements against the way the CNMC has been applying competition rules since its creation in 2013.

Imminent separation of the CNMC?

As a consequence of the aforementioned institutional malaise, the judgement of the CJEC and some criticism from the European Commission, at the beginning of 2017 the Spanish Government announced that the CNMC will probably be separated into two independent regulators. The white paper and the public consultation procedures are finished and now the only remaining step will be the drafting of the law creating the new authorities and its sanction by the Congress.

This comes in the dawn of the ECN+ Directive, which is aimed to guarantee the independence of competition regulators. Members of the current competition chamber, at a recent CNMC conference, mentioned that they will fight for more independence, even in a controversial field which is the representation of the CNMC before the courts. Until now, this representation was in the hands of the Abogados del Estado (body of lawyers of the State).

By: J. Nicolás Otegui Nieto

Posible vulneración del Derecho de la Competencia de la UE en el ámbito farmacéutico por comportamientos colusorios dirigidos a influir en el uso de un medicamento

En el marco de una cuestión prejudicial elevada al Tribunal de Justicia de la Unión Europea (TJUE) por el Consejo de Estado Italiano, el Abogado General entendió que el pacto colusorio entre dos farmacéuticas para divulgar información sobre la supuesta menor seguridad de un medicamento respecto de otro, sin pruebas científicas, constituye una restricción a la competencia por objeto en el sentido del artículo 101.1 del Tratado de Funcionamiento de la Unión Europea (TFUE)

El TJUE ha de resolver si las conductas, por las que la Autoridad de Defensa de la Competencia italiana (“AGCM” por sus siglas en Italiano) sancionó a F. Hoffman-La Roche y Novartis con más de 180 millones de euros de multa, configuraron o no una infracción por objeto del artículo 101 del TFUE.

En cuanto al contexto, Hoffman-La Roche cedió a Novartis, por medio de una licencia, la comercialización del medicamento Lucentis (oftalmológico), que compartía su desarrollo clínico con el medicamento Avastin (oncológico), el primero de ellos salió al mercado más tarde que el segundo y era más costoso. Los médicos prescriptores de medicamentos, en este caso en Italia, empezaron a prescribir el uso off-label de Avastin para el tratamiento de malestares oftalmológicos al derivar ambos del mismo principio.

En dicho marco fáctico, y a causa de las perdidas en la venta de Lucentis, ambas farmacéuticas acordaron realizar una campaña mediática, que según la AGCM, tenía por objeto diferenciar de “forma artificial” los medicamentos Avastin y Lucentis manipulando la percepción de los riesgos asociados al uso del Avastin en oftalmología para condicionar la demanda a favor de Lucentis (producto 100 veces más caro). Este acuerdo se aplicó mediante la “elaboración y difusión” de noticias que podían generar preocupación pública sobre la seguridad de los usos intravítreos del Avastín, minusvalorando los datos científicos que indicaban lo contrario.

Ahora, a petición del Consejo de Estado Italiano, -órgano ante el que las dos empresas farmacéuticas recurrieron la decisión de AGCM-, será el TJUE el que deba responder, entre otras cuestiones planteadas, si las afirmaciones divulgadas por ambas empresas pueden ser consideradas una restricción a la competencia por objeto en el sentido del artículo 101.1 TFUE.

Cabe recordar, en primer lugar, qué debe entenderse por restricciones de la competencia por objeto las cuales han sido definidas por la jurisprudencia como acuerdos o prácticas concertadas que implican un “grado de nocividad para la competencia” suficiente que haga prescindible e innecesaria el análisis de los efectos que conllevan en el mercado estos acuerdos y/o prácticas concertadas.

Pues bien, sobre la base de la definición antes referida, el Abogado General ante TJUE concluyó que, para determinar si dichos comportamientos pueden quedar comprendidos dentro del ámbito de la prohibición del artículo 101.1 del TFUE, deberá determinarse si las afirmaciones divulgadas relativas a la supuesta menor seguridad de un medicamento respecto a otros son falsas o engañosas.

Las empresas farmacéuticas implicadas se defendieron justamente indicando que la divulgación de estas afirmaciones relacionadas con la menor seguridad y/o eficacia de un medicamento respecto a otro es necesaria para proteger la salud pública y evitar que los médicos sigan prescribiendo off-label el producto, presuntamente, menos seguro.

No obstante, tanto la AGCM como el Abogado General indican que para proteger la salud pública lo que hubieran tenido que hacer, desde un principio, es cumplir con sus obligaciones de farmacovigilancia, esto es, por ejemplo, comunicar al organismo competente en Italia los inconvenientes revelados del producto, así como asegurarse que la información que se divulga al público es objetiva y no engañosa y se puede contrastar científicamente.

Sin perjuicio de que ha de ser el órgano jurisdiccional nacional quien deba decidir sobre el fondo del asunto, el Abogado General ha entendido que en caso de que dichas afirmaciones no fueran falsas y que quedara suficientemente probado que la finalidad de las mismas era garantizar la transparencia de la información relativa a la seguridad de los medicamentos con el fin de proteger la salud pública, dichos comportamientos no constituirían una restricción de la competencia en el sentido del artículo 101.1 del TFUE, y que probablemente se encontrarían dentro del ámbito de aplicación del artículo 101.3 TFUE, quedando por tanto exentas de la prohibición del apartado primero.

Aunque en su opinión el Abogado General no se pronuncia sobre si la información divulgada por las empresas farmacéuticas implicadas tenía suficiente base científica para no ser considerada engañosa -cuestión a decidir por el Consejo de Estado-, sí consideró, y está es la novedad destacada, que el comportamiento de las empresas en el presente caso, tendiente a excluir a un producto (Avastin) del mercado relevante y reorientar su demanda a favor de otro (Lucentis) por medio de afirmaciones “engañosas” con el fin de obtener un beneficio, puede ser considerado como un comportamiento colusorio que tiene como objeto falsear la competencia, y por ende, constituir una práctica prohibida en el sentido del artículo 101.1 del TFUE.

Habrá que esperar entonces que se pronuncie el TJUE sobre las cuestiones planteadas, así como a la resolución del órgano jurisdiccional italiano, para conocer si sus conclusiones coinciden con las del Abogado General y las de la AGCM, o, en caso contrario, añade nuevos aspectos a examinar en el Asunto C-179/19, que puedan ser determinantes en el comportamiento a seguir en un futuro por parte de las empresas y, especialmente, las que forman parte del sector farmacéutico.

Por: Gemma Sammuel, Cristina Rosanes y J. Nicolás Otegui Nieto