Competition law Freedom to provide services15 December 2012updated 24 July 2026

Case C-497/12, Gullotta – excluding some medicines from Italian para-pharmacies [judgment 2015, ECLI:EU:C:2015:436]

C-497/12ECLI:EU:C:2015:436judgmentCURIA ↗EUR-Lex ↗

From the archive — report by Stephen Vousden · restored via the Wayback Machine

Is Italian legislation that prohibits para-pharmacies from dispensing prescription drugs whose cost cannot be claimed from the public health care system, compatible with EU cartel and freedom to provide services laws?

Facts
The Italian State restricts the numbers of pharmacists. It also restricts the numbers of pharmacies through the use of geographic zoning plans. However, these restrictions on both pharmacists and pharmacies have been subject to a liberalisation policy. In 2006, a new law was introduced to allow people to run so-called para-pharmacies alongside traditional pharmacies. In 2012, the law was also changed so that a new pharmacy could be created for every 3100 inhabitants, a number which was considerably lower than the previous threshold of 4500 inhabitants.

There has not, however, been a complete liberalisation of the laws regulating Italian pharmacies and pharmacists. For example, there is differential treatment in the types of medicines which pharmacies and para-pharmacies can sell. A para-pharmacy is not allowed to sell Class C medicines – prescription drugs which are paid for by private citizens but whose cost is not reimbursable from the Italian public health care system. (In England, the equivalent are known as ‘private prescriptions’.)

This reference to the CJEU originates from the Catania branch of the District Administrative Law Court of Sicily [the TAR, Sicilia]. It concerns the differential treatment resulting from the Italian reforms and their compatibility with various sources of EU law. Thus, one aspect of the dispute relates to Article 15 of the EU Charter which grants an individual the freedom to pursue a freely chosen or accepted occupation. The referring court in Catania wonders whether this applies to the profession of pharmacists and what if anything its connection might be to the protection of health. Equally, the court wonders whether the ban on para-pharmacies selling Class C medicines constitutes a barrier to the free exercise of a profession under EU law. It also wonders whether the effect of the ban under Italian law, which grants such a substantial monopoly to traditional pharmacies, is incompatible with EU competition law.

Questions Referred
An unofficial translation of the questions referred by the court in Catania reads:

1. Do the principles of freedom of establishment, non-discrimination and the preservation of competition under Article 49 et seq TFEU preclude national legislation which does not allow a pharmacist, who is qualified and entered in the relevant professional register but does not own a pharmacy on the ‘pianta organica’ [territorial grid], also to offer for retail sale, in the para-pharmacy owned by that pharmacist, pharmaceutical products which are subject to a prescription in the form of a ‘ricetta bianca’ – that is to say, pharmaceutical products the cost of which is borne not by the [national health service] but wholly by the citizen – and which accordingly also establishes in that sector a prohibition on the sale of certain categories of pharmaceutical product, as well as a quota in relation to the number of commercial outlets which may be established in the national territory?

2. Is Article 15 of the Charter of Fundamental Rights of the European Union to be interpreted as meaning that the principle of freedom of establishment is applicable without limitation even to the profession of pharmacist, without the public task of that profession justifying different regimes between owners of pharmacies and owners of para-pharmacies in the sale of medicines mentioned in Question 1?

3. Whether Articles 102 and 106 TFEU must be interpreted as meaning that the prohibition on abusing a dominant position should be applied without limitation to the profession of pharmacist where the pharmacist owning a traditional pharmacy, selling medicines as an effect of an agreement between the [Italian national health service], benefits from the ban on owners of para-pharmacies selling Class C medicines without finding valid justification in the indubitable peculiarities of the pharmacists’ profession due to the public interest in protecting citizens’ health?

Comment
This reference from Catania refers to another reference which has been made from the District Administrative Law Court of Lombardia. In the latter reference, an Italian pharmacist who runs a para-pharmacy has also challenged the Italian reforms only this time by invoking the EU’s Professional Qualifications Directive 2005/36 and the EU Services Directive 2006/123. See further Case C-159/12, Venturini – excluding some pharma products from para-pharmacies.

Perhaps co-incidentally the distribution of pharmacies in a geographical area is now the subject of a reference from an Austrian court. The CJEU has docketed the reference as Case C-367/12, Corinna Prinz-Stremitzer. According to the EUR-Lex website, the Unabhängiger Verwaltungssenat des Landes Oberösterreich has asked:

1. Do the rule of law considerations inherent in Article 16 of the Charter of Fundamental Rights of the European Union and/or the considerations of transparency inherent in Article 49 TFEU preclude a national provision such as point 3 of Paragraph 10(2) of the Apothekengesetz (Law on pharmacies; ApG) at issue in the main proceedings, pursuant to which the condition whether there is a need to establish a new public pharmacy is not specified at least in essence in the legislation itself but its elaboration is left in considerable respects to the national courts, since it cannot be excluded that a scheme of that kind affords a significant competitive advantage to interested parties from Austria, individually and as a whole, over nationals from other Member States?

2. If Question 1 is answered in the negative: Does Article 49 TFEU preclude a national provision such as point 3 of Paragraph 10(2) of the ApG, which in relation to the crucial condition whether a need is deemed to exist sets a rigid threshold of 5500 persons without allowing for any departure from that general rule, since de facto under a scheme of that kind it does not appear possible to ensure (without more) the achievement in a consistent manner of the legislative objective pursued, in terms of paragraphs 98 to 101 of the Court’s judgment in Joined Cases C-570/07 […] and C-571/07 Blanco Pérez and Chao Gómez?

3. If Question 2 is also answered in the negative: Do Article 49 TFEU and/or Article 47 of the Charter of Fundamental Rights of the European Union preclude a provision such as point 3 of Paragraph 10(2) of the ApG which has been interpreted, as result of the case-law of the highest national courts on the notion of assessment of a need, to include additional detailed criteria — such as whether an application has priority in time, the blocking effect of an existing application in relation to subsequent applications, the two-year lockout period following the rejection of an application, criteria for determining the number of “permanent residents” and “incoming users” and for allocating the customer base in the event of an overlap between the 4-km zone surrounding each of two or more pharmacies, etc. — since, as a result, it is not possible to ensure that, as a general rule, the provision will be applied in a manner that is foreseeable and calculable and within a reasonable period and, hence, the legislative provision cannot be considered appropriate, in fact, to ensure the achievement in a consistent manner of the legislative objective pursued (see paragraphs 98 to 101 and 114 to 125 of the Court’s judgment in Blanco Pérez) and/or the provision of an adequate pharmaceutical service must be regarded as de facto not ensured and/or discrimination must be presumed as between interested parties from Austria amongst themselves or between them and interested parties from other Member States?

Outcome. By judgment of 2 July 2015 (ECLI:EU:C:2015:436) the Court ruled, in the words of the operative part: “The questions referred by the Tribunale amministrativo regionale per la Sicilia (Italy), by decision of 9 October 2012, and maintained by that court, are inadmissible. [” The full text is available on EUR-Lex and CURIA.