1 By its application, the European Commission requests that the Court declare that, by adopting Article 94a(1) of the ustawa - Prawo farmaceutyczne (Law on Medicines) of 6 September 2001 (Dz. U. No 126, position 1381), the Republic of Poland failed to fulfil its obligations under Article 8(1) of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce), and under Articles 49 and 56 TFEU.
2 Article 49 TFEU reads as follows: ‘… restrictions on the freedom of establishment of nationals of a Member State in the territory of another Member State shall be prohibited. … Freedom of establishment shall include the right to take up and pursue activities as self-employed persons and to set up and manage undertakings, in particular companies …’
3 Article 56 TFEU provides: ‘… restrictions on freedom to provide services within the Union shall be prohibited in respect of nationals of Member States who are established in a Member State other than that of the person for whom the services are intended. …’
4 Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ 1998 L 204, p. 37), as amended by Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 316, p. 12) (‘Directive 98/34’), was repealed by Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 (OJ 2015 L 241, p. 1), which entered into force on 7 October 2015.
5 The first subparagraph of Article 1(1)(b) of Directive 2015/1535 provides: ‘For the purposes of this Directive, the following definitions apply: …
6 Under the second paragraph of Article 10 of Directive 2015/1535: ‘References to [Directive 98/34] shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.’
7 According to that table, the first subparagraph of point (b) of Article 1(1) of Directive 2015/1535 corresponds to the first subparagraph of point 2 of the first paragraph of Article 1 of Directive 98/34.
8 Article 2 of Directive 2000/31 provides: ‘For the purposes of this Directive, the following terms shall bear the following meanings: … …’
9 Article 8 of that directive provides: ‘1. Member States shall ensure that the use of commercial communications which are part of, or constitute, an information society service provided by a member of a regulated profession is permitted subject to compliance with the professional rules regarding, in particular, the independence, dignity and honour of the profession, professional secrecy and fairness towards clients and other members of the profession. 2. Without prejudice to the autonomy of professional bodies and associations, Member States and the Commission shall encourage professional associations and bodies to establish codes of conduct at Community level in order to determine the types of information that can be given for the purposes of commercial communication in conformity with the rules referred to in paragraph 1 …’
10 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), provides, in Article 87(3) thereof: ‘The advertising of a medicinal product: - shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, - shall not be misleading.’
11 Recital 100 of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ 2006 L 376, p. 36) states: ‘It is necessary to put an end to total prohibitions on commercial communications by the regulated professions, not by removing bans on the content of a commercial communication but rather by removing those bans which, in a general way and for a given profession, forbid one or more forms of commercial communication, such as a ban on all advertising in one or more given media. As regards the content and methods of commercial communication, it is necessary to encourage professionals to draw up, in accordance with Community law, codes of conduct at Community level.’
12 Under Article 4(12) of that directive: ‘For the purposes of this Directive, the following definitions shall apply:
13 Article 24 of that directive provides: ‘1. Member States shall remove all total prohibitions on commercial communications by the regulated professions. 2. Member States shall ensure that commercial communications by the regulated professions comply with professional rules, in conformity with Community law, which relate, in particular, to the independence, dignity and integrity of the profession, as well as to professional secrecy, in a manner consistent with the specific nature of each profession. Professional rules on commercial communications shall be non-discriminatory, justified by an overriding reason relating to the public interest and proportionate.’
14 The ustawa - Prawo farmaceutyczne (Law on Medicines) was amended by the ustawa o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych (Law on the reimbursement of medicines, foodstuffs intended for specific dietary requirements, and medical devices) of 12 May 2011 (Dz. U. No 122, position 696) (‘the Law on Medicines, as amended’).
15 Article 94a(1) of the Law on Medicines, as amended, provides: ‘Advertising for pharmacies and pharmaceutical outlets and the activities thereof shall be prohibited. Information relating to the location and opening hours of pharmacies or pharmaceutical outlets shall not constitute advertising.’
16 Under Article 129b(1) of the Law on Medicines, as amended: ‘Any person who, in breach of the provisions of Article 94a, advertises a pharmacy, a pharmaceutical point of sale or a parapharmacy, or the activities thereof, shall be liable to a fine of up to 50 000 [Polish zloty (PLN) (approximately EUR 12 000)].’
17 The amendments to the Law on Medicines entered into force on 1 January 2012. Article 94a(1) of the Law on Medicines, as amended, prohibits advertising for pharmacies, pharmaceutical outlets, and the activities thereof. That provision states that information relating to the location and opening hours of pharmacies or pharmaceutical outlets is not to constitute advertising. The prohibition at issue carries with it a fine of up to PLN 50 000 (approximately EUR 12 000).
18 On 25 January 2019, the Commission sent a Letter of Notice to the Republic of Poland, by way of which it claimed that that provision is contrary to Article 8(1) of Directive 2000/31, concerning the use of commercial communications which form part of an information society service supplied by a member of a regulated profession, and to Articles 49 and 56 TFEU on the freedom of establishment and the freedom to provide services, respectively.
19 In reply, by letter of 25 March 2019, the Republic of Poland contended, first of all, that the scope of the restriction on freedom of establishment and freedom to provide services which stems from Article 94a(1) of the Law on Medicines, as amended, concerns solely those messages the explicit aim of which is to increase the sale of products on offer in pharmacies. Next, it stated that that provision pursues the general objective of ensuring a high level of protection of public health. Finally, it claimed that that provision does not infringe Directive 2000/31, since a very large proportion of the medical services provided by pharmacists are not part of the activities of pharmacies or pharmaceutical outlets, and are therefore not concerned by the prohibition at issue.
20 On 3 July 2020, not satisfied with the reply given by the Republic of Poland, the Commission sent a reasoned opinion to that Member State, calling on the latter to take the measures necessary to comply with its obligations within three months of receipt of the opinion. Maintaining the position set out in the Letter of Notice, the Commission stated, in that opinion, that the decisions of the administrative authorities and the case-law of the courts of the Republic of Poland demonstrate the considerable scope of the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended.
21 By letter of 1 October 2020, the Republic of Poland responded to the reasoned opinion, setting out the circumstances surrounding the adoption of that provision, which are, it argues, characterised by the presence of negative phenomena on the Polish pharmaceutical market. Furthermore, that Member State indicated that it was disposed to consider amending the wording of that provision.
22 The exchanges being unsuccessful, the Commission decided to bring the present action.
23 In support of its action, the Commission relies on three complaints alleging infringement of (i) Article 8(1) of Directive 2000/31, (ii) Article 49 TFEU and (iii) Article 56 TFEU.
24 As a preliminary point, the Commission, relying on the judgment of 4 May 2017, Vanderborght (C‑339/15, EU:C:2017:335, paragraph 42), states that the aim of Article 8(1) of Directive 2000/31 is to enable members of a regulated profession to use information society services in order to promote their activities. It recalls that the Court found, in paragraphs 43 and 44 of that judgment, that the commercial communications referred to in Article 2(f) of that directive must be subject to compliance with the professional rules of the regulated profession concerned, which cannot, however, impose a general and absolute prohibition of any form of online advertising.
25 The Commission argues that, in the present case, advertising for pharmacies, pharmaceutical outlets and the activities thereof, conducted, in particular, by means of a website created by a person exercising a regulated profession, would fall within the scope of Article 8(1).
26 However, Article 94a(1) of the Law on Medicines, as amended, prohibits any form of commercial communication, including electronically, in particular by means of a website created by a pharmacist working at a pharmacy or at a pharmaceutical outlet. In the Commission’s submission, that provision is therefore contrary to Article 8(1).
27 Consequently, the Commission disputes the merits of the arguments on which the Republic of Poland relies in its response to the reasoned opinion.
28 In the first place, in so far as that Member State claims that a distinction must be made between pharmacists, as a professional category, and the establishments at which they work, which are not confined to pharmacies and pharmaceutical outlets, the Commission contends that a great many pharmacists work at pharmacies or pharmaceutical outlets.
29 In that connection, the Commission observes that, according to a report produced by the Główny Urząd Statystyczny (Central Office for Statistics, Poland), over the course of 2021, 37 300 individuals were authorised to exercise the profession of pharmacist in Poland, and that 26 000 of them, namely 69.7%, work at a pharmacy or pharmaceutical outlet.
30 The Commission adds that, since Article 8(1) of Directive 2000/31 covers all members of a regulated profession, national law cannot be regarded as being compatible with that provision on the sole ground that certain members of the regulated profession in question can conduct their own advertising.
31 In the second place, in so far as the Republic of Poland maintains that the prohibition on advertising applies only to the running of pharmacies and pharmaceutical outlets and not to the services supplied by pharmacists, the Commission claims that that distinction is artificial. Pursuant to Polish law, pharmacies should in fact be owned and run by pharmacists or, at the very least, be managed by pharmacists.
32 That institution takes the view that the concept of ‘commercial communication’, within the meaning of Article 2(f) of Directive 2000/31, includes communication designed to promote, directly or indirectly, goods or services supplied by members of a regulated profession or by an undertaking or organisation in which those members exercise that profession.
33 Consequently, in order to ensure compliance with Article 8(1) of that directive, the Member States are, in principle, required to authorise all such commercial communications. Pharmacists ought thus to be able to resort to advertising not only for themselves and the services that they offer, but also for the pharmacies that they run or by which they are employed.
34 In the third and final place, in so far as the Republic of Poland claims that the Law on Medicines, as amended, authorises pharmacies and pharmaceutical outlets, inter alia, to sell non-prescription medicinal products at a distance, the Commission takes the view that that is a matter separate from those at issue in the present case. The possibility of selling such medicinal products at a distance, in particular through the operation of a website, must in fact be distinguished from the possibility of advertising for a pharmacy and the services that it offers, which may include, in particular, the sale of such medicinal products at a distance. However, Article 94a(1) of the Law on Medicines, as amended, prohibits pharmacies from advertising their distance sales services, as is confirmed, in the Commission’s submission, by several decisions of the Polish authorities.
35 The Commission adds that, even if it were considered that that provision does not prohibit commercial communications relating to products sold online, that provision nevertheless gives rise to a general and absolute prohibition on the use of advertising, contrary to Article 8(1) of Directive 2000/31. In that scenario, certain commercial communications would, admittedly, be permitted. However, other commercial communications would be prohibited.
36 In that connection, the Commission cites several decisions of the Polish courts and administrative authorities, from which it is apparent, in the Commission’s view, that the communications regarded as contrary to Article 94a(1) of the Law on Medicines, as amended, also concern information on the services provided by pharmacies, as well as information on the prices of products, including on the internet.
37 The prohibition on commercial communications on the latter category of information is general and absolute, there being no requirement that these be assessed individually. Thus, according to the Commission, even if the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, does not apply to certain activities of pharmacists, it nevertheless constitutes a total prohibition, within the meaning of the judgment of 5 April 2011, Société fiduciaire nationale d’expertise comptable (C‑119/09, EU:C:2011:208, paragraph 29), regarding Article 24 of Directive 2006/123, which is relevant by analogy, in the Commission’s submission.
38 In its defence, the Republic of Poland contends that, while Article 94a(1) of the Law on Medicines, as amended, prohibits advertising for pharmacies, pharmaceutical outlets, and the activities thereof, that provision does not prohibit advertising for pharmaceutical services. The prohibition laid down in that provision is therefore aimed at operators of pharmacies, who are not exclusively pharmacists, and anyone who can advertise, such as the press and advertising agencies.
39 In that connection, first, the Republic of Poland has submitted various data from the Central Office for Statistics and the Rejestr Aptek (Register of pharmacies, Poland), concerning the number of active pharmacies and the number of licences issued to pharmacists or companies of pharmacists. It infers from that data that the exercise of the profession of pharmacist and the operation of a pharmacy cannot be regarded as being equivalent.
40 Second, the Republic of Poland states that, according to the data published by the Naczelna Izba Aptekarska (Supreme Chamber of Pharmacists, Poland), as at 31 December 2022, nearly one third of pharmacists were employed elsewhere than in pharmacies or pharmaceutical outlets. That Member State explains that pharmacists can be employed, in particular, in universities, scientific institutes, hospitals, clinics, institutions responsible for the inspection and oversight of the production and marketing of medicinal products, institutions for the registration of medicinal products, and non-governmental organisations.
41 It follows, in the submission of the Republic of Poland, that Article 94a(1) of the Law on Medicines, as amended, applies not to all aspects of the activities of pharmacists as a regulated profession, but solely to the activities of a pharmacy or pharmaceutical outlet, which should not necessarily be exercised by a pharmacist. The prohibition stemming from that provision is therefore not absolute and concerns only one of the possible ways in which the profession of pharmacist may be exercised.
42 Furthermore, the Republic of Poland disputes the relevance, in the present case, of the case-law relating to Article 24(1) of Directive 2006/123 for the purposes of interpreting Article 8(1) of Directive 2000/31.
43 Article 8(1) of Directive 2000/31 lays down the principle that Member States are to ensure that the use of commercial communications which are part of an information society service provided by a member of a regulated profession, or which constitutes such a service, is authorised.
44 The aim of Article 8(1) is to enable members of a regulated profession to use information society services in order to promote their activities (judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraph 42).
45 Admittedly, it is apparent from Article 8(1) that commercial communications are only permitted subject to compliance with the professional rules regarding, in particular, the independence, dignity and honour of the regulated profession concerned, professional secrecy and fairness towards both clients and other members of that profession. Nonetheless, Article 8(1) would be rendered ineffective, and the objective pursued by the EU legislature would be undermined if professional rules could impose a general and absolute prohibition of any form of online advertising designed to promote the activity of a person practising a regulated profession (see, to that effect, judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraphs 43 and 44).
46 That interpretation is supported by the fact that Article 8(2) of Directive 2000/31 provides that Member States and the Commission are to encourage the drawing-up of codes of conduct intended not to prohibit that type of advertising, but rather to determine the types of information that can be given for the purposes of commercial communication in conformity with those professional rules (judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraph 45).
47 It follows that, although the content and form of the commercial communications referred to in Article 8(1) of that Directive may legitimately be subject to professional rules, such rules cannot include a general and absolute prohibition of that type of communication (judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraph 46).
48 In the present case, in the first place, it is not disputed that the profession of pharmacist is a regulated profession in Poland.
49 In the second place, the Republic of Poland argues that not all pharmacists work in pharmacies, since the studies that they have completed afford them access to other activities. However, that Member State does not dispute that, as the Commission maintains, according to a report produced by the Główny Urząd Statystyczny (Central Office for Statistics), over the course of 2021, 37 300 individuals were authorised to exercise the profession of pharmacist in Poland, and that 26 000 of them, namely 69.7%, work at a pharmacy or pharmaceutical outlet.
50 Moreover, the data are in line with those of the Naczelna Izba Aptekarska (Supreme Chamber of Pharmacists, Poland), to which the Republic of Poland refers, according to which, as at 31 December 2022, nearly one third of pharmacists were employed outside pharmacies or pharmaceutical outlets.
51 In that regard, suffice it to observe that since Article 8(1) of Directive 2000/31 covers all members of a regulated profession, national law cannot be regarded as being compatible with that provision on the sole ground that certain members of the regulated profession in question are not subject to the prohibition on advertising laid down by that law.
52 Were that indeed the case, the Member States could circumvent that provision by way of prohibitions that do not cover a marginal series of activities exercised by members of a regulated profession.
53 In the third and last place, inasmuch as the Republic of Poland maintains, in essence, that Article 94a(1) of the Law on Medicines, as amended, does not prohibit pharmacies from selling non-prescription medicinal products at a distance, or from providing information on the prices and delivery methods for such products, it is clear that the pharmacies are nevertheless not authorised to advertise their distance sales service.
54 Furthermore, the Republic of Poland has not called into question the fact that several Polish administrative and judicial decisions, to which the Commission refers in its reasoned opinion, applied the prohibition stemming from that provision to the dissemination of information on services supplied by pharmacies and the prices of the products on offer, including on the internet. Quite the contrary: in its response to the reasoned opinion, that Member State acknowledges that the ‘unfortunate wording [of that provision] has led the pharmaceutical regulatory authorities and the courts repeatedly to find that any action other than the communication of the location and opening hours of a pharmacy or pharmaceutical [outlet] constitutes advertising’.
55 In any event, even if the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, were to apply only to part, and not to all, of the activities performed by pharmacists working in pharmacies, that prohibition would be no less general and absolute and, accordingly, contrary to Article 8(1) of Directive 2000/31.
56 In that connection, it should be observed that, as regards Article 24 of Directive 2006/123, it is clear from the case-law that any prohibition on members of a regulated profession engaging in commercial communication is contrary to that provision, even where the prohibition in question concerns only certain, and not all, forms of commercial communication (see, to that effect, judgment of 5 April 2011, Société fiduciaire nationale d’expertise comptable, C‑119/09, EU:C:2011:208, paragraph 29).
57 The Republic of Poland maintains that the case-law relating to Article 24(1) of Directive 2006/123 cannot be applied by analogy to Article 8(1) of Directive 2000/31.
58 In that connection, first, it should be recalled that Article 8(1) of Directive 2000/31 permits commercial communications subject to compliance with certain professional rules.
59 As for Article 24 of Directive 2006/123, this provides, in paragraph 1 thereof, for the removal of all total prohibitions on commercial communications by the regulated professions and, in paragraph 2 thereof, that those communications are to comply with certain professional rules.
60 Authorising commercial communications subject to compliance with certain professional rules, or removing total prohibitions on commercial communications subject to compliance with similar rules leads to a similar result, particularly since commercial communications are defined in an identical manner in the two directives concerned, as is clear from paragraphs 8 and 12 of the present judgment.
61 Next, the fact, on which the Republic of Poland relies, that Directive 2000/31 does not contain any recital comparable to recital 100 of Directive 2006/123, on which the Court relied in the judgment cited in paragraph 56 of the present judgment, is irrelevant. That recital is in fact intended solely to elucidate the scope of the phrase ‘total prohibitions’ on commercial communications, which phrase does not appear in Article 8(1) of Directive 2000/31, since the latter provision concerns the authorisation of commercial communications, and not the removal of prohibitions on such communications.
62 Finally, it follows from the case-law that those directives both give concrete expression to the freedom to provide services enshrined in Article 56 TFEU (judgment of 30 May 2024, Airbnb Ireland and Amazon Services Europe, C‑662/22 and C‑667/22, EU:C:2024:432, paragraphs 46 and 47).
63 Consequently, the arguments put forward by the Republic of Poland as to the application by analogy of the case-law relating to Article 24(1) of Directive 2006/123 in the context of Article 8(1) of Directive 2000/31 must be rejected.
64 In those circumstances, the first complaint must be upheld.
65 It is clear from the case-law that, where a matter has been the subject of harmonisation at EU level, any national measure relating thereto must be assessed in the light of the provisions of the harmonising measure and not those of primary law (see, to that effect, judgments of 14 December 2004, Commission v Germany, C‑463/01, EU:C:2004:797, paragraph 36; of 30 April 2009, Lidl Magyarország, C‑132/08, EU:C:2009:281, paragraph 42; and of 30 May 2024, Airbnb Ireland and Amazon Services Europe, C‑662/22 and C‑667/22, EU:C:2024:432, paragraph 86).
66 Since the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, concerns not only commercial communications which, being part of an information society service, form part of the harmonisation arising from Directive 2000/31, but also any form of advertising, it is necessary also to examine the second and third complaints on which the Commission relies, which concern claims relating to restrictions on freedom of establishment and the freedom to provide services, enshrined in Articles 49 and 56 TFEU, respectively. It is appropriate to examine those claims together.
67 Having regard to freedom of establishment, the Commission claims that the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, deprives persons established in Poland, along with those established in other Member States, who wish to open a pharmacy or pharmaceutical outlet, of the possibility of informing current and potential customers of their activities. It observes that that situation is particularly prejudicial to the latter category of persons, for whom access to the market is made more difficult.
68 As regards the freedom to provide services, the Commission maintains that the prohibition makes it more difficult, for pharmacists established in Poland, to provide services to recipients established in other Member States and, for pharmacists established in other Member States, to supply services in Poland. It also claims that that prohibition restricts the possibility, for customers in Poland, of using the services of pharmacists in other Member States and, for pharmacists in Poland, of receiving advertising services.
69 The Commission states that, during the pre-litigation procedure, the Republic of Poland did not dispute the fact that the prohibition at issue gives rise to restrictions on both the freedom of establishment and the freedom to provide services. That Member State merely maintained that those restrictions were justified by the need to protect public health.
70 Before the Court, the Republic of Poland did not submit any arguments calling into question the existence of restrictions on the freedom of establishment and the freedom to provide services, but maintained that those restrictions were justified by an overriding reason in the public interest relating to the protection of public health.
71 It is settled case-law that all measures that prohibit, impede or render less attractive the exercise of the freedoms guaranteed by Articles 49 and 56 TFEU must be regarded as restrictions on the freedom of establishment and/or the freedom to provide services (judgment of 8 June 2023, Fastweb and Others (Time frame for billing), C‑468/20, EU:C:2023:447, paragraph 81 and the case-law cited).
72 The concept of restriction covers measures taken by a Member State which, although applicable without distinction, affect access to the market for economic operators from other Member States (judgment of 8 June 2023, Fastweb and Others (Time frame for billing), C‑468/20, EU:C:2023:447, paragraph 82 and the case-law cited).
73 In the first place, national legislation which imposes a general and absolute prohibition of any advertising for a certain activity is liable to restrict the possibility, for the persons carrying on that activity, of making themselves known to their potential clientèle and of promoting the services which they offer to their clientèle. Consequently, that national legislation must be regarded as a restriction on the freedom to provide services (judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraphs 63 and 64).
74 In the present matter, that is the case for Article 94a(1) of the Law on Medicines, as amended, as is apparent from the way in which that provision has been applied in the Polish administrative and judicial decisions on which the Commission relied in the reasoned opinion, referred to in paragraph 54 of the present judgment, which - as has been recalled in that paragraph - are not disputed by the Republic of Poland. The restriction on the freedom to provide the services is thus established in the present case.
75 In the second place, that provision prevents any person wishing to operate a pharmacy in Poland from informing potential customers thereof. The effect of the prohibition on advertising laid down in that provision is to make the conditions for access to the market more difficult for new pharmacies.
76 That situation is such as to cause greater prejudice to operators established in Member States other than the Republic of Poland, who must make additional efforts in order to make themselves known to customers residing in Poland. The prohibition on advertising thus constitutes a further obstacle to be surmounted for operators from other Member States who wish to establish a pharmacy in Poland (see, by analogy, judgment of 17 July 2008, Corporación Dermoestética, C‑500/06, EU:C:2008:421, paragraph 33).
77 Accordingly, Article 94a(1) of the Law on Medicines, as amended, also gives rise to a restriction on the freedom of establishment.
78 The Commission recalls that, during the pre-litigation procedure, the Republic of Poland claimed that the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, protects public health, first, by reducing the overconsumption of medicinal products and food supplements and, second, by preserving the professional independence of pharmacists. That institution acknowledges that the protection of public health constitutes an overriding reason in the general interest capable of justifying restrictions on freedom of establishment and the freedom to provide services. However, in the present case, the Republic of Poland has failed, it is argued, to demonstrate that the restrictions stemming from that prohibition were justified by such a reason.
79 The Republic of Poland maintains, before the Court, the position that it set out during the pre-litigation procedure.
80 The Commission argues that a distinction should be drawn between two types of advertising, namely (i) advertising for pharmacies, pharmaceutical outlets and the activities thereof and (ii) advertising for medicinal products.
81 In so far as concerns the first type of advertising, the Commission maintains that the Republic of Poland has failed to establish a connection between the prohibition on advertising and any reduction in the overconsumption of medicinal products.
82 As regards the second type, the Commission states that advertising of medicinal products is not prohibited, provided that this complies with specific conditions, such as the prohibition on promoting medicinal products available only on prescription or the obligation to present the medicinal product in question objectively and without misleading [the public], as well as providing information on the rational use of that product, in accordance with Article 87(3) of Directive 2001/83.
83 Measures defining those conditions in the context of advertising of medicinal products may therefore, in the Commission’s submission, be regarded as linked to the objective of protection of public health, which consists in combating the overconsumption of medicinal products.
84 However, first, according to the Commission, while it is true that, as the Republic of Poland maintains, advertising activities are intended, in principle, to attract new customers and secure the loyalty of long-standing customers, those activities do not necessarily lead customers to purchase more medicinal products. By contrast, the effect of advertising for a pharmacy may be to increase that pharmacy’s market share to the detriment of other pharmacies and other outlets dispensing medicinal products.
85 Second, the Commission argues that, in Poland, certain medicinal products not subject to medical prescription are available in places other than pharmacies or pharmaceutical outlets, such as shops, supermarkets, news-stands or service stations. The sale of those medicinal products in such establishments does not, in the Commission’s submission, require notification or authorisation and, while it is minor compared to the sales made by pharmacies, is nonetheless not inconsiderable, as is shown by a study conducted in 2015, to which the Republic of Poland refers. The sale of medicinal products in such establishments could present a heightened risk to health on account of potential overconsumption or inappropriate use.
86 On that point, it is of little import, according to the Commission, that only certain medicinal products not subject to medical prescription are available in places other than pharmacies, since the number of such medicinal products is relatively high and the overconsumption thereof may cause severe poisoning.
87 The Commission infers from this that the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, is not appropriate for attaining the stated objective of reducing the overconsumption of medicinal products. On the contrary, such a prohibition may run counter to that objective, on account of the fact that certain medicinal products are available over the counter at establishments in which customers do not receive professional advice on how to use such products.
88 In any event, the Commission takes the view that, even if the prohibition stemming from that provision were appropriate for attaining that objective, less restrictive measures would serve to achieve the same outcome.
89 The Republic of Poland contends that the advertising communications of pharmacies are intended to incite/encourage potential customers to use their services and increase sales of products, mainly medicinal products not subject to medical prescription and food supplements. Pharmacy customers are a category of consumers particularly susceptible to advertising, who should be protected against techniques intended to incite them to make more purchases. The use of services offered by pharmacies should therefore not be the result of advertising, but should instead be linked to the health needs of the patient. Having regard to the need to protect health, competition between pharmacies should not be based on advertising, but rather on the maximum quality of the services provided and the reputation acquired thereby.
90 The Republic of Poland adds that the prohibition on advertising for the activities of pharmacies and pharmaceutical outlets should be understood in conjunction with advertising for medicinal products. Pursuant to the first indent of Article 87(3) of Directive 2001/83, advertising of a medicinal product is to encourage the rational use thereof, by presenting it objectively and without exaggerating its properties. That advertising cannot be dissociated, it is argued, from advertising for pharmacies and pharmaceutical outlets. It is therefore difficult to design an advertisement for a pharmacy that would not evoke, on the part of patients, medicinal products or certain services directly or indirectly associated with such products.
91 In that connection, the Republic of Poland specifies that, prior to the introduction of Article 94a(1) of the Law on Medicines, as amended, national general rules on advertising applied to pharmaceutical activities. The outcome was unsatisfactory, it is claimed, since the operators of pharmacies undertook marketing activities aimed solely at economic objectives. Overconsumption, inter alia, of over-the-counter medicinal products and food supplements ensued.
92 The Republic of Poland states that it is impossible to prove the effectiveness of the prohibition stemming from that provision, at least in figures. However, the overconsumption of medicinal products and food supplements remains common in Poland, as is demonstrated by statistical data compared with those of other Member States.
93 Furthermore, the Republic of Poland states that, while establishments other than pharmacies and pharmaceutical outlets - such as herbalists, shops specialising in the sale of medical equipment and retail outlets - are permitted to sell certain medicinal products, that form of marketing concerns only certain medicinal products that are not subject to prescription.
94 The Commission acknowledges that certain national measures which confer control over decisions relating to the protection of public health on the medical professions may be justified.
95 However, a total prohibition on advertising for pharmacies, pharmaceutical outlets and the activities thereof is neither appropriate for ensuring the professional independence of pharmacists, nor necessary to that end.
96 The Commission takes the view that the objective of Article 94a(1) of the Law on Medicines, as amended, set out by the Republic of Poland in its response to the reasoned opinion, which consists in protecting the professional independence of pharmacists from the effects of marketing decisions made by [pharmacy] proprietors who are not pharmacists, cannot be applied to pharmacies operated by pharmacists.
97 Furthermore, even in the case of pharmacies that are not owned or controlled by pharmacists, the Commission’s view is that a total prohibition on advertising is not always appropriate for protecting the decision-making autonomy of pharmacists in situations that have an impact on patient health. The question whether such pharmacies may be advertised is, in the Commission’s submission, completely separate from that of possibly exposing pharmacists to the pressure that pharmacy proprietors who are not pharmacists may exert on them so that they make decisions, in the financial interests of the pharmacy, which are harmful to patient health.
98 In any event, according to the Commission, Article 94a(1) of the Law on Medicines, as amended, goes beyond that which is necessary to attain the objective of the professional independence of pharmacists. Even if a restriction on advertising were appropriate for attaining that objective, a less restrictive measure could consist in permitting advertising for pharmacies in certain circumstances.
99 The Republic of Poland maintains its position that the prohibition stemming from that provision protects pharmacists from any pressure exerted by the proprietors of pharmacies or of pharmaceutical outlets in the aim of increasing sales of certain products.
100 According to settled case-law, a restriction on freedom of establishment is permissible only if, in the first place, it is justified by an overriding reason relating to the public interest and, in the second place, it complies with the principle of proportionality, which implies that it is suitable for securing, in a consistent and systematic manner, the attainment of the objective pursued and that it does not go beyond what is necessary in order to attain that objective (see, to that effect, as regards the freedom to provide services, judgment of 18 June 2019, Austria v Germany, C‑591/17, EU:C:2019:504, paragraph 139 and the case-law cited; and, as regards freedom of establishment, judgment of 6 October 2020, Commission v Hungary (Higher education), C‑66/18, EU:C:2020:792, paragraph 178 and the case-law cited).
101 Moreover, it is for the Member State concerned to demonstrate that those cumulative conditions are met (judgment of 6 October 2020, Commission v Hungary (Higher education), C‑66/18, EU:C:2020:792, paragraph 179 and the case-law cited).
102 In the present case, the protection of public health, on which the Republic of Poland relies in justification of the restrictions on the freedom of establishment and the freedom to provide services stemming from Article 94a(1) of the Law on Medicines, as amended, is amongst the objectives that may be regarded as constituting overriding reasons in the general interest which can justify such restrictions on the freedoms of movement guaranteed by the FEU Treaty (see, to that effect, judgments of 19 May 2009, Commission v Italy, C‑531/06, EU:C:2009:315, paragraph 51, and of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraph 67 and the case-law cited).
103 However, it is necessary to ascertain whether the Republic of Poland, by way of its arguments relating to (i) the overconsumption of medicinal products and (ii) the professional independence of pharmacists, has demonstrated that the prohibition stemming from that provision complies with the principle of proportionality, the content of which has been recalled in paragraph 100 of the present judgment.
104 As a preliminary point, it should be observed that pharmacies may offer services, such as screening campaigns, which are unrelated to the sale of medicinal products but nevertheless fall within the scope of the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, as is apparent from the evidence adduced by the Commission, referred to in paragraphs 54 and 74 of the present judgment. In particular, the Commission refers to a decision of a Polish court which found that an advertisement for the organisation of screening campaigns was unlawful.
105 To that extent, such a prohibition is unrelated to the objective of protection of public health consisting in combating the overconsumption of medicinal products, with the result that that prohibition cannot be regarded as justified.
106 In so far as the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, is aimed at advertising for pharmacies, pharmaceutical outlets and the services thereof, which advertising is linked to the sale of medicinal products, first it must be noted that, contrary to what the Republic of Poland maintains, such advertising may benefit individuals who are likely to purchase medicinal products, inasmuch as it allows them to be informed of lower prices or additional services offered by a specific pharmacy. Thus, further to such advertising, those individuals may decide to purchase their usual medicinal products from a pharmacy other than that where they were customers before, without that giving rise to an increase in the quantities of medicinal products purchased by those individuals.
107 By contrast, the prohibition on such advertising runs the risk of favouring pharmacies that have been present on the market for many years, to the detriment of those wishing to enter that market and offer more or better quality services.
108 Second, it should be recalled that - as the Republic of Poland stresses, moreover - Article 87(3) of Directive 2001/83 provides that the advertising of a medicinal product is to encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, and is not to be misleading. The EU legislature intended, by way of that provision, to permit the promotion of medicinal products without, however, encouraging the overconsumption thereof.
109 Third, as is claimed by the Commission on the basis of a 2015 study to which the Republic of Poland refers in its response to the reasoned opinion, first, it is possible in that Member State to purchase at least some medicinal products not subject to medical prescription other than in pharmacies, in particular in shops, supermarkets, kiosks and service stations. Second, use is made of that possibility to an extent which, whilst remaining lesser compared to purchases made at pharmacies, is not inconsiderable. According to that study, one third of the persons questioned stated that they purchased medicinal products not subject to medical prescription at supermarkets.
110 Fourth, the Republic of Poland acknowledges that overconsumption of medicinal products remains considerable in that Member State, in spite of the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended.
111 Admittedly, the Republic of Poland claims that overconsumption would be even higher without that prohibition, but it is impossible to adduce any evidence to that effect. However, that Member State has failed to set out the reasons why it was not possible for it to collect data on the consumption of medicinal products before that provision entered into force and compare them with data relating to the period thereafter.
112 It follows that the Republic of Poland has failed to demonstrate, having regard to the conditions required by the case-law recalled in paragraph 100 of the present judgment, that the restrictions on freedom of establishment and the freedom to provide services stemming from that provision are appropriate for ensuring that the objective of protection of public health, consisting in combating the overconsumption of medicinal products, is attained.
113 In any event, it must be held that that objective can be pursued by measures that are less restrictive than the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, such as measures to regulate the content of advertising for certain services offered by pharmacies.
114 Consequently, the prohibition stemming from that provision goes beyond that which is necessary to attain the objective of protection of public health consisting in combating the overconsumption of medicinal products.
115 It follows from the case-law that, given the power afforded to the Member States to determine the level of protection that they wish to give to public health, they may also take measures for eliminating or reducing a risk that the professional independence of pharmacists might be compromised (see, by analogy, judgment of 16 December 2010, Commission v France, C‑89/09, EU:C:2010:772, paragraph 66 and the case-law cited).
116 Thus, with regard to the importance of the relationship of trust which must prevail between a pharmacist and his or her customer - who is, in principle, a patient - the protection of the independence of the profession of pharmacist may constitute an overriding reason in the public interest relating to public health (see, by analogy, judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraph 68).
117 The Republic of Poland maintains that the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, protects pharmacists from any pressure, exerted by the proprietors of pharmacies or of pharmaceutical outlets, with a view to increasing sales of certain products.
118 However, first, that argument cannot be applied to pharmacies operated by pharmacists who own the property.
119 Second, in so far as concerns other pharmacies, it cannot be ruled out that the proprietors of pharmacies who are not themselves pharmacists exert pressure, on the pharmacists in their employ, so that the latter make decisions that are harmful to patient health in the financial interests of the pharmacy. However, the Commission rightly claims, in essence, that that issue is not in direct correlation with the question whether pharmacies may be the subject of advertising.
120 The prohibition on any form of advertising for pharmacies, pharmaceutical outlets and the activities thereof is not such as to protect pharmacists from the pressures that the proprietors of pharmacies might exert in order to influence the way in which the pharmacists advise their customers. Such pressure may remain irrespective of whether or not there is advertising for those pharmacies.
121 In any event, it should be observed that the prohibition stemming from Article 94a(1) of the Law on Medicines, as amended, goes beyond that which is necessary to protect the professional independence of pharmacists. A less restrictive measure could consist in authorising such advertising in compliance with conditions which would serve to protect the professional ethics of pharmacists by supervising, closely if necessary, the form and manner which such advertising may have (see, to that effect, judgment of 4 May 2017, Vanderborght, C‑339/15, EU:C:2017:335, paragraphs 74 and 75).
122 In that connection, first, as has been observed in paragraph 108 of the present judgment, advertising of a medicinal product is to encourage the rational use thereof, by presenting it objectively and without exaggerating its properties, and is not to be misleading. Second, inasmuch as the advertising would concern services, in particular screening services, the Republic of Poland has failed to state the reasons why such services might present a danger to public health.
123 In those circumstances, the second and third complaints must also be upheld.
124 In the light of all of the foregoing considerations, it must be held that, by adopting Article 94a(1) of the Law on Medicines, the Republic of Poland has failed to fulfil its obligations under Article 8(1) of Directive 2000/31 and under Articles 49 and 56 TFEU.
125 Under Article 138(1) of the Rules of Procedure of the Court of Justice, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has applied for costs and the Republic of Poland has been unsuccessful, the latter must be ordered to pay the costs. 1. Declares that, by adopting Article 94a(1) of the ustawa - Prawo farmaceutyczne (Law on Medicines) of 6 September 2001, the Republic of Poland failed to fulfil its obligations under Article 8(1) of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce), and under Articles 49 and 56 TFEU; 2. Orders the Republic of Poland to pay the costs.