Provisional text
OPINION OF ADVOCATE GENERAL
SZPUNAR
delivered on 18 December 2025 (1)
Case C‑604/24
FARMAKEIO YZ & SIA O.E.
v
Ypourgos Anaptyxis kai Ependyseon,
Ypourgos Ygeias,
intervener:
Panellinios Farmakeftikos Syllogos
(Request for a preliminary ruling from the Symvoulio tis Epikrateias (Council of State, Greece))
( Reference for a preliminary ruling – Medicinal products for human use – Non-prescription medicinal products – Prohibition of the sale at a distance to the public – Protection of public health – Proportionality test )
I.      Introduction
1.        This case relates to the interpretation of Article 85c of Directive 2001/83/EC (2) concerning the marketing of medicinal products online. The first paragraph of that provision establishes the conditions that apply to the offer for sale at a distance of medicinal products to the public by means of information society services. The second paragraph recognises the power of a Member State of destination of those medicinal products to impose conditions, justified on grounds of public health protection, for the retail supply of such products. The referring court asks the Court to clarify the scope of that power in order to determine whether a Member State may prohibit the online sale of certain non-prescription medicinal products (‘NPMs’).
II.    Legal context
A.      European Union law
1.      Directive 2001/83
2.        Article 1(20) of Directive 2011/62/EU (3) inserted into Directive 2001/83 Title VIIA, entitled ‘Sale at a distance to the public’, which includes, inter alia, Article 85c, which is worded as follows:
‘1.      Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in [Directive 98/34/EC (4)] under the following conditions:
(a)      the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established;
(b)      the person referred to in point
(a) has notified the Member State in which that person is established of at least the following information:
(i)      name or corporate name and permanent address of the place of activity from where those medicinal products are supplied;
(ii)      the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services;
(iii)      the address of the website used for that purpose and all relevant information necessary to identify that website;
(iv)      if applicable, the classification in accordance with Title
VI of the medicinal products offered for sale at a distance to the public by means of information society services.
Where appropriate, that information shall be updated;
(c)      the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 6(1);
(d)      without prejudice to the information requirements set out in [Directive 2000/31/EC (5)], the website offering the medicinal products contains at least:
(i)      the contact details of the competent authority or the authority notified pursuant to point
(b);
(ii)      a hyperlink to the website referred to in paragraph 4 of the Member State of establishment;
(iii)      the common logo referred to in paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of medicinal products. The common logo shall contain a hyperlink to the entry of the person in the list referred to in point
(c) of paragraph 4.
2.      Member States may impose conditions, justified on grounds of public health protection, for the retail supply on their territory of medicinal products for sale at a distance to the public by means of information society services.
…
6.      Without prejudice to [Directive 2000/31] and the requirements set out in this Title, Member States shall take the necessary measures to ensure that other persons than those referred to in paragraph 1 that offer medicinal products for sale at a distance to the public by means of information society services and that operate on their territory are subject to effective, proportionate and dissuasive penalties.’
2.      Directive 2000/31
3.        Article 3 of Directive 2000/31, entitled ‘Internal market’, provides:
‘1.      Each Member State shall ensure that the information society services provided by a service provider established on its territory comply with the national provisions applicable in the Member State in question which fall within the coordinated field.
2.      Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society services from another Member State.
3.      Paragraphs 1 and 2 shall not apply to the fields referred to in the Annex.
4.      Member States may take measures to derogate from paragraph 2 in respect of a given information society service if the following conditions are fulfilled:
(a)      the measures shall be:
(i)      necessary for one of the following reasons:
–        public policy, in particular the prevention, investigation, detection and prosecution of criminal offences, including the protection of minors and the fight against any incitement to hatred on grounds of race, sex, religion or nationality, and violations of human dignity concerning individual persons,
–        the protection of public health,
–        …
(ii)      taken against a given information society service which prejudices the objectives referred to in point
(i) or which presents a serious and grave risk of prejudice to those objectives;
(iii)      proportionate to those objectives;
(b)      before taking the measures in question and without prejudice to court proceedings, including preliminary proceedings and acts carried out in the framework of a criminal investigation, the Member State has:
–        asked the Member State referred to in paragraph 1 to take measures and the latter did not take such measures, or they were inadequate,
–        notified the Commission and the Member State referred to in paragraph 1 of its intention to take such measures.
5.      Member States may, in the case of urgency, derogate from the conditions stipulated in paragraph 4(b). Where this is the case, the measures shall be notified in the shortest possible time to the Commission and to the Member State referred to in paragraph 1, indicating the reasons for which the Member State considers that there is urgency.
…’
B.      Greek law
4.        Ministerial Decision GP oik. 22609/19 April 2022, adopted jointly by the Minister for Development and Investments and the Minister for Health, amending Article 116 of Joint Ministerial Decision D.YG3a/G.P. 32221/2013 of the Minister for Development, Competitiveness, Infrastructure, Transport and Networks, on the one hand, and the Minister for Health (6) on the other
(‘the contested act’), specifies the categories of medicinal products for which sale at a distance is authorised and provides, in Article 1:
‘The sale at a distance to the public of medicinal products subject to medical prescription shall be prohibited.
For other medicinal products, sale at a distance to the public by means of information society services is permitted, by electronic pharmacy establishments that have been certified in that regard by the [pharmaceutical association], pursuant to Joint Decision G5(b)/G.P.oik. 20293/15 March 2016 of the Minister for the Economy, Development and Tourism and the Minister for Health, designating the competent authority for the certification of electronic pharmacy establishments [(FEK] B’
787)], only for medicinal products which, in accordance with their marketing authorisation, are classified or have been placed in the sub-category of medicinal products for general sale within the category of [NPMs], pursuant to Decision No
G5(a)51194/14 July 2016 of the Minister for Health ([FEK] B’
2219)].
Those infringing those provisions shall be subject to a fine of twenty thousand euro (EUR 20 000) to one hundred thousand euro (EUR 100 000) and, in the event of a repeated offence, of fifty thousand euro (EUR 50 000) to two hundred thousand euro (EUR 200 000), by decision of the Board of Directors of the [National Organisation for Medicines]. Those penalties shall be imposed together with any other penalty provided for.’
III. The facts of the case in the main proceedings, the procedure before the Court and the questions referred for a preliminary ruling
5.        The applicant in the main proceedings, Farmakeio YZ & Sia, owns a brick-and-mortar pharmacy. Its corporate purpose is, inter alia, the online sale of ‘goods from the pharmacy permitted by pharmaceutical legislation’.
6.        By application of 25 May 2022, that company requested the Symvoulio tis Epikrateias (Council of State, Greece), the referring court, to annul the contested act, which amends the previous legislation in so far as it authorises the sale at a distance to the public, by means of information society services and certified electronic pharmacy establishments, of medicinal products which, in accordance with their marketing authorisation, are classified in the sub-category of generic medicinal products, within the category of NPMs.
7.        Under the previous legislation, certified electronic pharmacy establishments were allowed to sell, without distinction, all NPMs and medicinal products not reimbursed by social security bodies. By contrast, the classification of medicinal products in the sub-category of generic medicinal products, now provided for by national legislation, is done by a competent national authority on the basis of the following criteria: (a) they have already been classified as NPMs or they meet the conditions for that classification, provided there are no new scientific data that would lead to them being re-classified as medicinal products subject to prescription; (b) they are medicinal products intended to treat a clear symptom (‘headache, nausea, and so forth’) or an incident; (c) the dosage schedule is simple; (d) their interactions with other commonly administered treatments are minimal; (e) they do not require special storage conditions; (f) they come in small packages; and (g) there is no serious and substantiated evidence of serious risks associated with their long-term use.
8.        In support of its application, the applicant in the main proceedings submits that the contested act, in so far as it authorises the online sale only of medicinal products falling within that sub-category, is contrary, inter alia, to Article 85c(1) of Directive 2001/83. The applicant further submits that no medicinal product has been classified in that sub-category, such that the legislation authorising the sale of certain medicinal products remains a dead letter. Moreover, it submits that there are no grounds of public health protection that justify the restrictive measure at issue under Article 85c(2) of that directive.
9.        The authorities issuing the contested act and the pharmaceutical association contend that the adoption of that act under Article 85c(2) of Directive 2001/83 was justified in the public interest. They argue that the possibility for electronic pharmacy establishments to sell all NPMs and non-reimbursed medicinal products without distinction, under the previous system, would have resulted in over 1 000 medicinal products being made available on the internet, at the risk of making it more difficult to monitor excessive consumption of medicinal products and the trafficking of counterfeit or inappropriate medicinal products.
10.      The pharmaceutical association also submits, first, that the online sale of medicinal products, including NPMs, poses risks to public health since it ‘essentially deprives the pharmacist of the opportunity of controlling who the end user is’ and removes the ‘guarantee of safety [that] is inherent when a pharmacist dispenses medicinal products in person’, whereas such risks do not exist in the case of generic medicinal products on account of their particular characteristics. In addition, according to the Greek State and the pharmaceutical association, the supply of all NPMs and non-reimbursed medicinal products by electronic pharmacy establishments does not meet any need in Greece ‘because of the excellent and rational geographical distribution’ of pharmacies in Greece. Finally, the pharmaceutical association relies, in support of its claims, on the examples of other Member States of the European Union (namely, Cyprus and Portugal) which, it maintains, restrict the supply of NPMs online.
11.      Under those circumstances, the Symvoulio tis Epikrateias (Council of State) decided, by decision of 16 July 2024, received at the Court on 16 September 2024, to stay the proceedings and refer the following questions to the Court of Justice for a preliminary ruling:
‘1.      Must Article 85c(1) of [Directive 2001/83] be interpreted as precluding a national provision which permits the sale at a distance to the public by means of information society services, by electronic pharmacy establishments, not of all [NPMs], but of one sub-category only thereof (in the present case, generic medicinal products)?
2.      Or, on the contrary, does Article 85c(2) of [Directive 2001/83] permit the national legislature to prohibit sales at a distance to the public by means of information society services, by electronic pharmacy establishments, of certain [NPMs], on grounds of public health protection?
3.      If the answer to question
(b) is in the affirmative, are the grounds relied on in the present case by the Greek state and the Panhellenic Pharmaceutical Association to justify the restriction in question (combating overmedication and the trafficking of counterfeit or inappropriate medicinal products, and so forth) grounds of public health protection within the meaning of Article 85c(2) of [Directive 2001/83]?
4.      If the answer to question (c) is in the affirmative, is the national court to review the proportionality of the restrictive measure by carrying out negative screening, that is to say, is it to assess only whether the restriction appears to be manifestly inappropriate or manifestly unnecessary, or, conversely, is the court to carry out positive screening, that is to say, is it to assess whether the restriction appears to be an appropriate and strictly necessary measure for public health protection?’
12.      Written observations were submitted by the applicant in the main proceedings and the pharmaceutical association, the Greek and Italian Governments and the European Commission. No hearing was held.
IV.    Analysis
A.      The first and second questions referred
13.      By its first and second questions, which I propose to examine together, the referring court seeks to ascertain, in essence, whether Article 85c(1) and (2) of Directive 2001/83 precludes a national provision prohibiting electronic pharmacy establishments from selling certain NPMs to the public, by means of information society services, on grounds of public health protection.
14.      To answer that question, it is necessary to determine, first, the scope of the obligation – imposed on Member States under Article 85c(1) of Directive 2001/83 – to authorise the offer for sale at a distance to the public by means of information society services of NPMs (section
1), and second, the limits of the power of a Member State, recognised in Article 85c(2) of that directive, to impose conditions justified by the protection of public health upon the retail supply of medicinal products on its territory (section
2).
1.      The obligation to authorise the online sale of medicinal products
15.      As regards Article 85c of Directive 2001/83, the Court has already held that, in accordance with its first paragraph, the Member States must authorise the distance selling to the public, by means of information society services, of NPMs. A prohibition under the legislation of a Member State on the offer for distance selling to the public is permissible only in respect of medicinal products subject to prescription. (7)
16.      In addition, still with regard to NPMs, Article 85c(1) of Directive 2001/83 provides that Member States are to ensure medicinal products are offered for sale at a distance to the public by means of information society services in accordance with a series of conditions set out therein.
17.      It should be noted that Title
VIIa of Directive 2001/83, which includes, inter alia, Article 85c, was introduced by Directive 2011/62 with a view, as stated in recital 21 thereof, to addressing an ‘important threat to public health’ relating to the sale of falsified medicinal products to the public on
the internet. Directive 2011/62 was therefore a measure by which the EU legislature sought to address the risks associated with the growth in the marketing of medicinal products online.
18.      Although the recitals of Directive 2001/83 mention a single objective – namely the protection of public health by combating falsified medicinal products – its provisions must be interpreted in context. The aim of that directive, which was adopted on the basis of Article 95
EC (now Article 114 TFEU), as stated in one of its opening recitals, is to establish a framework that does not hinder trade in medicinal products within the Union. (8) From that perspective, by means of Article 85c, which is integral to it, the directive pursues a twofold objective: to establish an appropriate legal framework for the marketing of medicinal products online within the internal market and to address the risks that, according to the EU legislature, have increased as a result of such marketing.
19.      In those circumstances, first, Article 85c(1) of Directive 2001/83 provides that Member States are required to authorise the sale at a distance to the public, by means of information society services, of NPMs with a view to establishing a framework that does not hinder trade in medicinal products within the Union. (9) Second, guided by the objective of health protection, the same provision lays down the conditions relating to persons, medicinal products and websites which must be met by the distance selling of medicinal products to the public by means of information society services and which the Member States must ensure are complied with. (10)
20.      Thus, where the conditions laid down in Article 85c(1) of Directive 2001/83 are met, a Member State may not, in principle, prohibit the activity of an information society service consisting of offering NPMs for sale. The conditions imposed on that activity therefore seem to be, at least in principle, harmonised by that directive.
21.      For the sake of completeness, it should be noted that the condition laid down in Article 85c(1)(a) of Directive 2001/83, relating to persons authorised or entitled to carry out the online sale of medicinal products, has
special status in so far as the Member States are competent to determine such persons. Indeed, according to that provision, the existence of any authorisation or entitlement must be examined having regard to ‘the legislation of the Member State in which that person is established’.
22.      Apart from that specific condition, however, the conditions that apply to the sale of NPMs by means of an information society service are subject to harmonisation under Article 85c(1) of Directive 2001/83. That observation leads me to examine Article 85c(2) of that directive, which concerns the conditions introduced by Member States for the retail supply of medicinal products on their territory.
2.      The conditions for retail supply
23.      Article 85c(2) of Directive 2001/83 concerns the power of a Member State to impose conditions justified by the protection of public health upon the retail supply of medicinal products on its territory. Before examining those conditions, it must first be determined whether a prohibition of the online sale of certain medicinal products could constitute a ‘condition for retail supply’ within the meaning of that provision.
24.      Given the vague and ambiguous nature of the term ‘supply’, it is difficult to answer that question on the basis of a textual interpretation alone. (11) The expression ‘condition for retail supply’ should thus be interpreted in context and in the light of the aims pursued by Directive 2001/83.
25.      In that regard, the concept of ‘retail supply’ is also used, at least in some language versions, (12) in Article 40(2) of Directive 2001/83, which provides that certain processes are not subject to the obligation to hold the authorisation required for the manufacture of medicinal products. According to that provision, ‘such authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes’. That circumstance may be an indication that, in the case of Directive 2001/83, the concept of ‘retail supply’ includes certain processes carried out in the context of the distribution of medicinal products, although not wholesale distribution. It follows that that concept, within the meaning of Article 85c(2) of that directive, refers to processes carried out with a view to providing the customer with a medicinal product which go beyond merely supplying goods.
26.      That interpretation is corroborated by recitals 21 to 24 of Directive 2011/62, which concern the matters covered by Article 85c(2) of Directive 2001/83.
27.      For example, recital 21 of Directive 2011/62 states that ‘specific conditions for retail supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the [TFEU]’.
28.      Furthermore, recital 22 of Directive 2011/62 states that, ‘when examining the compatibility with Union law of the conditions for the retail supply of medicinal products, the [Court of Justice] has recognised the very particular nature of medicinal products, whose therapeutic effects distinguish them substantially from other goods. The Court of Justice has also held that … it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved. Since that level may vary from one Member State to another, Member States must be allowed discretion as regards the conditions for the supply on their territory of medicinal products to the public’.
29.      Furthermore, recital 23 of Directive 2011/62 states that, ‘in particular, in the light of the risks to public health and given the power accorded to Member States to determine the level of protection of public health, the case-law of the Court of Justice has recognised that Member States may, in principle, restrict the retail sale of medicinal products to pharmacists alone’.
30.      Recital 24 of the directive states that, ‘therefore, and in the light of the case-law of the Court of Justice, Member States should be able to impose conditions justified by the protection of public health upon the retail supply of medicinal products offered for sale at a distance by means of information society services. Such conditions should not unduly restrict the functioning of the internal market’.
31.      Those four recitals of Directive 2011/62 and the judgment in Apothekerkammer des Saarlandes and Others (13) – to which recitals 22 and 23 of that directive refer – suggest that the conditions for supplying medicinal products to the public concern, inter alia, the way in which medicinal products are marketed at retail level and, in particular, the possibility of restricting the retail sale of medicinal products solely to pharmacists enjoying genuine professional independence.
32.      The power of the Member States to ‘in principle, restrict the retail sale of medicinal products to pharmacists alone’, mentioned in recital 23 of Directive 2011/62, is now recognised in Article 85c(1)(a) of Directive 2001/83, which provides that the Member States determine the natural or legal persons authorised or entitled to supply medicinal products to the public at a distance.
33.      The power of the Member States to adopt other conditions for the supply of medicinal products offered for sale online is recognised in Article 85c(2) of Directive 2001/83. Having regard to the considerations set out in points 24, 25 and 31 of this Opinion, that power allows a Member State to determine how such medicinal products are marketed by means of the conditions relating to the processes carried out with a view to their distribution to customers in its territory.
Given that that
power includes certain obligations and prohibitions relating to operations concerning all medicinal products, the prohibition on marketing certain medicines is also covered a priori by that power.
34.      However, that same power is circumscribed in several respects by EU law. In particular, exercising that power cannot call into question either the obligation imposed on Member States by Article 85c(1) of Directive 2001/83 or the effectiveness of that provision.
35.      In that regard, recital 24 of Directive 2011/62 states that ‘Member States should be able to impose conditions justified by the protection of public health upon the retail supply of medicinal products offered for sale at a distance by means of information society services’ and that ‘such conditions should not unduly restrict the functioning of the internal market’ (emphasis added), which could be the case if the obligation to authorise the online sale of medicinal products was unilaterally called into question by a Member State.
36.      That interpretation is supported by the judgment in
Doctipharma, which provides useful guidance on the interpretation of Article 85c(2) of Directive 2001/83. In that judgment, the Court considered the question of whether Member States may, on the basis of Article 85c of that directive, prohibit the provision of a service consisting of connecting, by means of a website, pharmacists and customers for the sale of NPMs from the websites of pharmacies that have subscribed to that service.
37.      In that judgment, the Court made a distinction between a service that consists of selling NPMs and an intermediation service in which the provider does not act as seller. The Court held that, in the latter scenario, the service in question does not fall within the concept of ‘conditions for the retail supply’ of medicinal products offered for distance selling to the public within the meaning of Article 85c(2) of Directive 2001/83, nor could it be prohibited on the basis of that provision. (14) Indeed, in the words of the Court, Article 85c(1) of that directive explicitly provides that Member States are to ensure that medicinal products are offered for sale at a distance
to the public by means of information society services. It would therefore be inconsistent to hold that the use of such a service could be prohibited by the Member States on the basis of Article 85c(2) of that directive. (15)
38.      It should be noted that this request for a preliminary ruling does not concern a condition that would prevent the marketing of medicinal products online by means of a specific information society service, but a condition excluding certain medicinal products from being sold online. Nevertheless, it is possible to apply to the present case, with some adjustments, the reasoning followed by the Court in the judgment in Doctipharma.
39.      In that respect, as regards the conditions relating to medicinal products, Article 85c(1)(c) of Directive 2001/83 provides that Member States are to ensure that medicinal products are offered for sale at a distance by means of information society services provided, inter alia, that they comply with the national legislation of the Member State of destination, in accordance with Article 6(1) of that directive, which provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State or by the Commission. The supply of medicinal products over the internet is possible only if they have a marketing authorisation in the Member State of destination. (16)
40.      If a medicinal product has such an authorisation valid on the territory of a Member State, and that authorisation has not been revoked or suspended, that Member State may not prohibit, under Article 85c(2) of Directive 2001/83 and without affecting the possibility of selling that medicinal product in a traditional pharmacy, the online sale of that medicinal product on its territory. A fortiori, a Member State may not establish a sub-category of NPMs and prohibit their sale online without infringing the obligation imposed on it under Article 85c(1) of that directive.
41.      The decision of the French Council of State referred to
in the order for reference (17) seems to be based on the same reasoning. That court held that a regulatory act which, with the exception of a sub-category of medicinal products (‘officinal formula medicinal products which may be sold over the counter to the public in retail pharmacies’), prohibits the online sale of NPMs is not consistent with Directive 2001/83. That decision suggests that Member States have no room to manoeuvre when it comes to the possibility of excluding certain NPMs from sale online.
42.      The power recognised in Article 85c(2) of Directive 2001/83 therefore allows a Member State of destination of medicinal products to determine how they are marketed by the conditions relating to the processes carried out with a view to the retail distribution on its territory, without, however, being able to call into question the possibility of offering them for sale online.
43.      That consideration is not contested by the statements of the pharmaceutical association, according to which several Member States have introduced restrictions on the sale of medicinal products online. It follows from this reference for a preliminary ruling that the pharmaceutical association refers, in particular, to the solutions adopted under Cypriot law (18) and Portuguese law, (19) which are also referred to
in its written observations. (20)
44.      Both my analysis of the relevant legislation and the information on the official websites of the competent national authorities (21) clearly indicate that some Member States reserve for pharmacists not only the sale of NPMs, but also their supply to customers. A practice also exists of establishing sub-categories of NPMs, in order to impose specific conditions on their retail supply.
45.      Whilst I do not wish to express a view on the compatibility with EU law of the solutions adopted by a particular Member State, I note that it is worth making a distinction between national measures which determine the arrangements for the marketing of NPMs, whose offer for sale must in principle be authorised by the Member States under the conditions laid down in Article 85c(1) of Directive 2001/83, and those which, like the measure at issue in the main proceedings, prohibit the sale of such medicinal products online or have such an effect.
3.      Interim conclusion
46.      It follows from the foregoing considerations that, on the one hand, a Member State is required to authorise the offer for sale at a distance of NPMs to the public by means of information society services under the conditions laid down in Article 85c(1) of Directive 2001/83. (22) On the other hand, where those conditions are met, a Member State of destination of those medicinal products cannot derogate from that obligation by relying on the conditions for the supply of such medicinal products on its territory, provided for in Article 85c(2) of that directive. (23) Nor may a Member State, on the pretext of introducing conditions justified by the protection of public health, limit the scope of that obligation. (24)
47.      For the reasons I have just given, I propose to answer the first and second questions referred for a preliminary ruling by stating that Article 85c(1) and (2) of Directive 2001/83 precludes a national provision prohibiting electronic pharmacy establishments from selling certain NPMs to the public, by means of information society services, on grounds of public health protection.
48.      In those circumstances, there is no need to answer the third and fourth questions referred for a preliminary ruling, in so far as they have been posed in the event that the Court answers the first two questions in the sense that a Member State of destination of NPMs may prohibit their sale on its territory. I shall nonetheless examine them for the sake of completeness, in case the Court does not concur with my analysis.
B.      The third question
49.      By its third question, the referring court seeks to ascertain whether the grounds relied on to justify the prohibition at issue in the main proceedings – namely combating ‘overmedication’ and the ‘trafficking of counterfeit or inappropriate medicinal products’ – constitute valid grounds of public health protection within the meaning of Article 85c(2) of Directive 2001/83.
50.      Indeed, as is clear from the wording of that provision, Member States may impose retail supply conditions only if they are ‘justified on grounds of public health protection’.
51.      In the first place, although NPMs do not pose high risks to human health, comparable to those related to the consumption of prescription medicinal products, the Court has acknowledged that it cannot be excluded that certain risks are also connected with their use. (25) It is evident that the conditions introduced with a view to ‘combating overmedication’ of such medicinal products, understood as the prevention of their excessive consumption and improper use, may be justified by the protection of public health. The Court has recently ruled to that effect by stating that the measures taken to address the risks which may also arise from excessive or ill-considered use of NPMs have the essential aim of safeguarding public health. (26)
52.      In the second place, the same applies to the justification concerning the strengthening of the security of supply chains of medicinal products in order to prevent the placing on the market of medicinal products containing sub-standard or falsified ingredients, or no ingredients or ingredients in the wrong dosage. Indeed, the EU legislature recognised, in recital 2 of Directive 2011/62, that the availability of such medicinal products to patients represents an important threat to public health. The directive was adopted to combat that threat on the basis, inter alia, of Article 168(4) TFEU. As a general rule, that legal basis is used with the aim of contributing to the attainment of public health protection objectives. National measures taken to combat the risks associated with counterfeit or inappropriate medicinal products therefore also seek to protect public health.
53.      For those reasons, if the Court deems it necessary to examine the third question, I would propose to answer it that the grounds for combating the ‘overmedication’ of non-prescription medicinal products, understood as the prevention of their excessive consumption and improper use, and the ‘trafficking of counterfeit or inappropriate medicinal products’, constitute valid grounds of public health protection within the meaning of Article 85c(2) of Directive 2001/83.
54.      For the sake of completeness, the fact that, in Article 85c(1) of Directive 2001/83, the EU legislature has harmonised certain aspects of the offer for sale of medicinal products online, in order to protect public health against the threat related to the sale of falsified medicinal products, cannot prevent a Member State from exercising the power recognised in Article 85c(2) of that directive in order to pursue the same objective. Indeed, the potentially redundant or excessive nature of a condition introduced by a Member State must be examined when assessing its proportionality. I will now turn to the fourth question referred for a preliminary ruling, which relates to this issue.
C.      The fourth question
55.      The fourth question is posed in the event that the Court should answer the third question in the affirmative and find that the grounds relied on to justify the prohibition at issue in the main proceedings constitute valid grounds under Article 85c(2) of Directive 2001/83. In such an eventuality, the referring court seeks to ascertain whether that provision must be interpreted as meaning that the national court must review that prohibition having regard to its proportionality and, if so, the extent of the review to be carried out. More specifically, the referring court wonders whether the national court should merely ascertain whether that prohibition is manifestly inappropriate or manifestly unnecessary for the protection of public health, or whether it must ascertain whether the restriction is appropriate and strictly necessary for that purpose.
56.      I would point out that the following considerations will only be relevant if the Court does not share my analysis of the first and second questions and agrees with my proposed answer to the third question.
57.      As regards the fourth question referred for a preliminary ruling, the referring court does not state the reasons that led it to question the proportionality of the prohibition at issue in the main proceedings. However, it must be considered that, since it is hearing an application for annulment of the contested act, that court is also required to rule on that aspect in order to examine whether that prohibition is compatible with Article 85c of Directive 2001/83.
58.      In that regard, recitals 21 and 24 of Directive 2011/62, on the matters covered by Article 85c of Directive 2001/83, state that the conditions for the retail supply of medicinal products offered for sale online may be imposed ‘within the limits of the [TFEU]’ and ‘should not unduly restrict the functioning of the internal market’.
59.      Those statements are an indication that the exercise of the power of Member States under Article 85c(2) of Directive 2001/83 is subject to criteria that largely overlap with those that the national measures impeding the fundamental freedoms guaranteed by the TFEU must meet. (27) To assess whether the prohibition at issue in the main proceedings is compatible with EU law, it is therefore appropriate to consider, in assessing its proportionality, whether that prohibition pursues an objective laid down in that provision, whether it is capable of guaranteeing that objective and whether it goes beyond what is necessary to attain that objective.
60.      Moreover, there is nothing to suggest that, by means of Directive 2011/62, when specifying the conditions under which a Member State may justify a restriction on one of the fundamental freedoms of the internal market, the EU legislature intended to depart from the classic proportionality test.
61.      In that respect, the conditions introduced by a Member State in exercising the power conferred on it by Article 85c(2) of Directive 2001/83 concern the marketing of medicinal products by means of an information society service. Therefore, they are likely to distort considerably the functioning of the internal market to the detriment of economic operators established in other Member States and their customers.
62.      On the one hand, that power concerns the conditions that a Member State may introduce for the retail supply of medicinal products on its territory. There is no indication that it is limited to the conditions applicable to service providers established in a particular Member State.
63.      On the other hand, the Court considered, in its case-law prior to the entry into force of Directive 2011/62, as regards the examination of a restriction on the free movement of goods under Article 28 TEC (now Article 34 TFEU), that the emergence of the internet as a method of cross-border sales means that the scope and, by the same token, the effect of the prohibition on mail-order sales must be looked at on a ‘broader’ scale. Indeed, such a prohibition is more of an obstacle to pharmacies outside the Member State that introduced it than to those within it. Although there is little doubt that as a result of the prohibition, pharmacies in that Member State cannot use the extra or alternative method of gaining access to the national market consisting of end consumers of medicinal products, they are still able to sell the products in their dispensaries. However, for pharmacies not established in the Member State concerned, the internet provides a more significant way to gain direct access to that market. (28)
64.      The interpretation whereby the conditions, within the meaning of Article 85c(2) of Directive 2001/83, must be subject to a classic proportionality test is corroborated by the more recent case-law which refers to that provision.
65.      Thus, in the judgment in A (Advertising and sale of medicinal products online), (29) after stating that a prohibition of an extensive advertising campaign sought to protect public health under Article 85c(2) of Directive 2001/83, the Court provided guidance allowing the referring court to rule on the question whether that prohibition, on the one hand, was appropriate to ensure the attainment of the objective pursued and, on the other hand, did not go beyond what was necessary to guarantee attainment of that objective. (30)
66.      In the light of the foregoing, should the Court consider it necessary to examine the fourth question, I would propose to answer that the national court examining whether a condition introduced by a Member State complies with Article 85c(2) of Directive 2001/83 must ascertain whether that condition is appropriate and does not go beyond what is necessary to attain the objective of protecting public health.
67.      Without prejudice to the foregoing observations, relating to the examination of the proportionality of the conditions for the retail supply of medicinal products on the territory of the Member State concerned, I maintain the position, put forward in point 47 of this Opinion, that Article 85c(1) and (2) of Directive 2001/83 precludes a national provision prohibiting electronic pharmacy establishments from selling certain NPMs to the public, by means of information society services, on grounds of public health protection.
68.      For the sake of completeness, I will accompany my analysis of the questions referred for a preliminary ruling with some observations on the cross-border dimension of the marketing of medicinal products online, which the Commission referred to in its observations. My remarks will be limited: this question is not central to the present case and I have already examined it in depth in my Opinion in Doctipharma.
D.      The cross-border dimension of e-commerce
1.      Overview of the issue
69.      Since the cross-border dimension is currently a significant aspect of the e-commerce of medicinal products (31) and since the way in which NPMs are marketed varies from one Member State to another, (32) the question arises whether a Member State can apply its own conditions for the retail supply of medicinal products on its territory to a provider established in another Member State.
70.      The cross-border dimension of the marketing of goods online by means of information society services is partially regulated by Directive 2000/31. Although recital 11 of that directive states that it is without prejudice to the level of protection for, in particular, public health as established by EU law, the sale of NPMs is not totally excluded from the scope of that directive, as illustrated by the references to it in Article 85c(1)(d) and (6) of Directive 2001/83, which state that their provisions apply without prejudice to the former directive.
71.      Article 3 of Directive 2000/31 is based on the application of the principles of control in the home Member State and mutual recognition, so that, within the coordinated field defined in Article 2(h) of that directive, information society services are regulated solely in the Member State on whose territory the providers of those services are established. Exceptionally, Article 3(4) of that directive allows a Member State of destination of information society services, under certain conditions, to derogate from the principle of free movement of information society services. (33) The mechanism established in Article 3 of that directive thus plays a role in cross-border situations where an information society service provider established in one Member State is likely to be confronted with a measure which falls within the
coordinated field adopted by another Member State. (34)
72.      In that regard, as the Commission observes, the wording of the contested act suggests that the prohibition at issue in the main proceedings applies without distinction to providers established in Greece and to those established in other Member States. However, the referring court considers that it is not necessary to examine that prohibition in the light of Directive 2000/31 and that its compatibility with EU law must be examined exclusively under Article 85c(2) of Directive 2001/83.
73.      In that regard, it should be noted, first of all, that the case in the main proceedings does not have a cross-border dimension. Indeed, the referring court is Greek, the dispute concerns the national legislation of that Member State and the applicant in the main proceedings appears to be established in Greece.
74.      Second, the referring court is ruling on an action for annulment brought by the applicant in the main proceedings. In that regard, the referring court is examining, having regard to Article 85c of Directive 2001/83, whether the contested act is lawful; it is not apparent from the request for a preliminary ruling that it may also rule on the cross-border dimension of the prohibition at issue in the main proceedings.
75.      Lastly, if Article 85c(1) and (2) of Directive 2001/83 precludes a prohibition concerning the retail supply of medicinal products which a Member State intends to impose on its territory, it is no longer necessary to examine that provision in the light of Directive 2000/31. In effect, that prohibition will then be contrary to EU law and a Member State may not impose it either on national providers or on those established in other Member States. The analysis of Article 3 of that directive is therefore relevant only if the prohibition at issue in the main proceedings is deemed to be a condition for the retail supply of medicinal products, within the meaning of Article 85c(2) of Directive 2001/83, and that provision, read in conjunction with paragraph 1 thereof, does not preclude such a prohibition. However, according to my proposed answer to the first and second questions referred for a preliminary ruling, Article 85c(1) and (2) of that directive does preclude such a prohibition, so it is not necessary to examine its compatibility with Directive 2000/31.
76.      In those circumstances, the following observations are purely incidental and serve to outline the broader context of the online marketing of medicinal products.
2.      The coordinated field under Article 3 of Directive 2000/31
77.      The mechanism established in Article 3 of Directive 2000/31 applies only to national measures which fall within the coordinated field, within the meaning of Article 2(h) of that directive. Under that provision, the coordinated field concerns, according to point
(i) thereof, requirements relating to the provision of the service in question, of that provision
in particular its content, including requirements applicable to contracts. However, it excludes, according to point
(ii) thereof, requirements applicable to goods as such, to the delivery of goods and to services not provided by electronic means.
78.      The question therefore arises whether the prohibition on selling certain medicinal products online constitutes a requirement falling within the coordinated field, within the meaning of Directive 2000/31, or whether it is excluded on the ground that it applies to goods as such.
79.      In that regard, the Court suggested, in the judgment in
Deutscher Apothekerverband, (35) that a prohibition on the sale by mail order of all NPMs does not relate to the actual characteristics of the products but governs the arrangements for their sale.
80.      Admittedly, it could be argued that the prohibition at issue in the main proceedings indirectly determines the characteristics of medicinal products that can be sold online and is therefore excluded from the coordinated field. Indeed, that prohibition does not apply to NPMs that are classified, according to their characteristics, (36) in the sub-category of generic medicinal products. Viewed in that light, the prohibition is intended to exclude from sale medicinal products that do not meet those characteristics.
81.      Nevertheless, the classification of the prohibition at issue in the main proceedings as a requirement applicable to goods is unconvincing, because in Greece, all NPMs may be sold in a traditional pharmacy. Accordingly, that prohibition does not determine the characteristics of the goods as such, but prevents a form of legal sale of certain medicinal products – that is to say, their sale by means of an information society service – such that it must be considered a requirement falling within the coordinated field, within the meaning of Directive 2000/31.
82.      The prohibition at issue in the main proceedings is therefore likely to constitute a condition for the retail supply of medicinal products, within the meaning of Article 85c(2) of Directive 2001/83, as well as a requirement which falls within the coordinated field of Directive 2000/31. If it were to be concluded that that prohibition should also be examined in the light of Directive 2000/31, then the relationship between the provisions of those two acts of EU law would have to be examined.
3.      The relationship between Directives 2000/31 and 2001/83
83.      For the reasons set out below, I take the view that, as regards the requirements falling within the coordinated field, which amount to conditions for the retail supply of medicinal products within the meaning of Article 85c(2) of Directive 2001/83, that provision must be understood as a lex specialis in relation to Article 3(4) of Directive 2000/31, in so far as it provides for the possibility of restricting the free movement of information society services on grounds of public health protection. I did not rule out that interpretation of the relationship between those two provisions in my Opinion in Doctipharma. (37)
84.      In the first place, contrary to Article 85c(6) of Directive 2001/83, paragraph 2 of that provision does not state that it applies without prejudice to Directive 2000/31.
85.      In the second place, unlike certain acts of EU law whose recitals make a direct reference to the mechanism established in Article 3 of Directive 2000/31, (38) recital 24 of Directive 2011/62 merely states, without referring to the conditions laid down in Article 3(4) of the former directive, that the conditions for the retail supply of medicinal products should not unduly restrict the functioning of the internal market.
86.      In the third place, on the one hand, the conditions to be fulfilled for a Member State of destination of an information society service to be able to derogate from the free movement of such services, provided for in Article 3(4) of Directive 2000/31, are particularly stringent. (39) On the other hand, given that health and life rank foremost among the assets and interests protected by EU law, Member States have a certain discretion regarding the level of protection they seek to provide for public health on their territory. To ensure that Member States are able to exercise that power in accordance with the conditions applicable to restrictions on the fundamental freedoms of the internal market, Article 3(4) of Directive 2000/31 must be replaced by Article 85c(2) of Directive 2001/83.
87.      In those circumstances, as regards the scope of Article 85c(2) of Directive 2001/83 concerning the cross-border dimension of e-commerce, that provision must be regarded as a lex specialis in relation to Article 3(4) of Directive 2000/31 in so far as it provides for the possibility for a Member State to restrict the free movement of information society services from other Member States on grounds of public health protection.
V.      Conclusion
88.      In the light of the foregoing, I propose that the Court answer the questions referred by the Symvoulio tis Epikrateias (Council of State, Greece) as follows:
Article 85c(1) and (2) of 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, as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011,
must be interpreted as meaning that
it precludes a national provision prohibiting electronic pharmacy establishments from selling to the public, by means of information society services, certain non-prescription medicinal products, on grounds of public health protection.
1      Original language: French.
2      Directive 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), as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’).
3      Directive of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ 2011 L 174, p. 74).
4      Directive 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).
5      Directive 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’) (OJ 2000 L 178, p. 1).
6      FEK B’
1965/20.4.2022.
7      See judgment of 29 February 2024, Doctipharma (C‑606/21, EU:C:2024:179, paragraph 41; ‘the judgment in Doctipharma’). See also judgment of 27 February 2025, Apothekerkammer Nordrhein (C‑517/23, EU:C:2025:122, paragraph 74).
8      See recital 3 of Directive 2001/83.
9      See point 15 of this Opinion.
10      See the judgment in Doctipharma (paragraph 42).
11      See, to that effect, my Opinion in Doctipharma (C‑606/21, EU:C:2023:585, point 44; ‘my Opinion in Doctipharma’).
12      See French- and English-language versions.
13      Judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraphs 34 and 35).
14      See the judgment in
Doctipharma (paragraph 53).
15      See the judgment in Doctipharma (paragraphs 55 and 56).
16      See judgment of 8 July 2021, Pharma Expressz (C‑178/20, EU:C:2021:551, paragraph 53), according to which ‘where the offer for sale at a distance of medicinal products to the public is not prohibited by the legislation of the Member State of destination of the medicinal products … the supply of medicinal products over the internet is therefore possible only if they have a marketing authorisation in the Member State of destination’. I would point out that paragraph 53 of that judgment, mentioning the fact that the supply of medicinal products for sale at a distance to the public may be prohibited by the legislation of the Member State of destination of those medicinal products, seems to involve prescription medicinal products.
17      See decision of 17 July 2013, M. L. and Others,  Nos 365317, 366195, 366272 and 366468, ECLI:FR:CESSR:2013:365317.20130717.
18      As far as Cypriot law is concerned, Article 3(1) of Regulatory Administrative Act No 281/2001 provides that medicinal products, as ‘goods for society’, may only be dispensed by a pharmacist. That requirement seems to be interpreted in the sense that the online sale of medicinal products is not permitted. See https://www.moh.gov.cy/Moh/phs/phs.nsf/All/23DFAFA481BB9FEAC225857D0030E9B2?OpenDocument. The categorical nature of that prohibition is relaxed by Article 4A(2) of the Pharmaceuticals and Poisons Act, which provides that medicinal products listed in a table annexed to that act may also be sold without the intervention of a pharmacist.
19      Although the pharmaceutical association does not provide information on the solutions adopted in Portuguese law, my research suggests that the law makes a distinction between on the one hand, NPMs that may be supplied exclusively in pharmacies and, on the other hand, those that are not subject to exclusive supply in pharmacies. According to the relevant provisions, namely Article 9(1), (2) and (5) of Decree-Law No 307/2007, medicinal products belonging to the first category mentioned above must be dispensed by a pharmacist on grounds of public health protection, whereas those belonging to the second category must be dispensed by personnel at the point of sale of the medicinal products. Those provisions also state that the competent director of the pharmacy or competent manager of the point of sale are responsible for providing the information necessary for the proper use of a medicinal product.
20      Without providing more detailed information in that regard, the pharmaceutical association also refers to Croatian law as an example of a system prohibiting the online sale of NPMs. Under Article 136(1) of the Medicinal Products Act, natural and legal persons carrying out pharmaceutical activities in Croatia may offer NPMs for sale to the public at a distance
by means of information society services. In addition, Article 136(2) of the Medicinal Products Act provides, inter alia, that a person wishing to carry out that activity must be registered on the list of entities offering medicinal products for sale online. According to the information on the website of the competent national authority, that list does not currently have any entries. See: https://www.halmed.hr/en/Promet-proizvodnja-i-inspekcija/Baza-dozvola-za-proizvodnju-i-promet/Prodaja-lijekova-na-daljinu-putem-Interneta/
21      See footnotes 12 to 14.
22      See point 20 of this Opinion.
23      See point 37 of this Opinion.
24      See point 42 of this Opinion.
25      See, to that effect, judgments of 1 October 2020, A (Advertising and sale of medicinal products online) (C‑649/18, EU:C:2020:764, paragraph 94; ‘the judgment in A (Advertising and sale of medicinal products online)’), and of 22 December 2022, EUROAPTIEKA (C‑530/20, EU:C:2022:1014, paragraph 43).
26      See judgment of 22 December 2022, EUROAPTIEKA (C‑530/20, EU:C:2022:1014, paragraphs 39 to 41).
27      See my Opinion in Doctipharma (point 71).
28      See, to that effect, judgment of 11 December 2003, Deutscher Apothekerverband (C‑322/01, EU:C:2003:664, paragraphs 73 and 74).
29      See the judgment in A (Advertising and sale of medicinal products online) (paragraphs 68 and 69).
30      See the judgment in A (Advertising and sale of medicinal products online) (paragraphs 68 and 73).
31      See, to that effect, my Opinion in Doctipharma (point 56).
32      See points 43 and 44 of this Opinion.
33      See judgment of 30 May 2024, Airbnb Ireland and Amazon Services Europe (C‑662/22 and C‑667/22, EU:C:2024:432, paragraphs 53).
34      See, to that effect, recently, judgment of 27 April 2023, Viagogo (C‑70/22, EU:C:2023:350, paragraphs 25 to 28).
35      Judgment of 11 December 2003 (C‑322/01, EU:C:2003:664, paragraph 68).
36      See point 7 of this Opinion.
37      Point 63 of this Opinion.
38      See my Opinion in WebGroup Czech Republic and Others (C‑188/24 and C‑190/24, EU:C:2025:709, points 123 and 179).
39      See my Opinion in Airbnb Ireland and Others (C‑662/22 to C‑667/22, EU:C:2024:18, point 4).