Συμβούλιο της Επικρατείας (ΣτΕ)-Ολομέλεια
National case details
Registration ID: ΟλΣτΕ 201/2020
Instance: Appellate on fact and law
Case status: Final
Area of law
Relevant principles applied
Identification of the case
- Health care (art. 35 CFREU)
- Greek Constitution
- Law 3845/2010 (GG A’ 65)- annexation of the ‘Memorandum of Understanding’ between the Greek State, the Commission and the IMF
- Law 4509/2017 (GG A’ 201) “Granting a License to Establish a Pharmacy”
- Presidential decree n. 64/2018 on “Regulations of the profession of pharmacist-Establishment of a pharmacy” (GG A’ 124/11.7.2018)
- Directive 2018/985 (28.6.2018) - on the control of proportionality and suitability before the introduction of restrictions on the exercise of regulated professions
- CFREU art. 35
Summary of the case
The case concerns the regulation by law of the status of access to the profession of pharmacy and the exercise of the business activity of the retail sale of medicines, which must take into account the peculiarity of pharmacies, in which commercial activity is combined with responsible scientific services and the social mission of the pharmacist. The risk of squandering the financial resources allocated from the state budget to the insurance organizations for the health care of the insured may also be taken into account. The legislator may impose restrictions not only on the practice of the profession of pharmacy, but also on the establishment and operation of a pharmacy. The legislation which had been in force prior to that contested in the case provided for the granting of a license to establish a pharmacy only to pharmacists. However, in order to comply with the requirements of the ‘Memorandum of Understanding’ regarding the liberalization of closed professions, the contested legislation was established.
The court found that authorizing provision of article 64 par. 1 par. A of n.4509/2017, which provides the possibility of granting a license to establish a pharmacy to natural persons who are non-pharmacists or the establishment of a commercial company for the operation of a pharmacy, is not contrary to the Constitution. The regulations of p.d. 64/2018 (which are currently contested by the applicant Pharmaceutical Association of Attica), are within the limits of the authorization and are not contrary to articles 5 par. 1, 5 par. 5 and 21 par. 3 of the Constitution. It also held that the long-term maintenance of a legislative regime favorable to a certain category of persons does not prevent the legislator from introducing regulations other than those in force in the past, even if existing interests are affected. The principles of protected trust or legal certainty are not violated, nor is the viability of pharmacies, which already operate in the form of a sole proprietorship or a personal company, directly endangered. Provisions of the ECHR and the Charter of Fundamental Rights of the EU are not violated. The restrictions established in articles 2 par. 3 and 2 par. 64/2018 also apply to pharmacists' cooperatives. The specific restrictions/incompatibilities defined in par. 5 c of art. 2 of p.d. 64/18 are within the limits of the authorizing provision. It is unacceptably requested that the contested p.d. is canceled because the conditions set by Directive 2018/985 have not been met, because the deadline for its transposition had not expired at the time of issue of the contested decree. Legally the p.d. 64/2018 was issued following a proposal by the competent Minister of Health, as authorized by law. The cancellation request was rejected.
- Civil judicial enforcement
Imposed on the applicant Association the court costs of the Greek State.
Τhe Constitution stipulates that everyone has the right to freely develop their personality and to participate in the social, economic and political life of the Country, as long as it does not infringe on the rights of others and does not violate the Constitution or good morals, and that everyone has the right to protection of their health.[para.13] Restrictions on these rights must "respect the principle of proportionality."[para.13] the State regulatory intervention in the business activities related to the provision of health services, including the establishment and operation of pharmacies, is justified by an overriding reason of public interest, which consists, above all, in the need to protect citizens' health. , and is permissible, provided that the principle of proportionality is not infringed.[para.13]
Before the contested arrangements, the legislature, starting from the notion that the protection of public health is effectively ensured by the granting of a pharmacy license only to pharmacists, strictly prohibited the granting of a license to persons other than pharmacists, the participation of non-pharmacists in the private companies for the operation of pharmacies, with a few exceptions concerning the participation of relatives, as well as the creation of capital companies for this purpose.[para.14] However, the above restrictions, although they have been maintained in the legal order for a long time, are not the only way required by the Constitution to effectively protect public health in the exercise of the relevant activity.[para.14] In this case, with the provision of article 64 par. 1 case a of n.4509/2017, pursuant to which the contested decree was issued, it is now possible to grant a license to establish a pharmacy to natural persons who are not pharmacists, as well as the possibility of setting up a commercial company of any form - except anonymous - for pharmacy operation.[para.14] The authorizing provision of Law 4509/2017, which aims at the partial liberalization of the licensing regime of pharmacies, as special shops, in the context of broader structural changes for the economic development of the country, with the aim of attracting investment, strengthening competition, combating unemployment of pharmacists, the reduction of prices for pharmaceutical products and the consequent improvement of consumer choices, while providing for appropriate safeguards to public health and the fiscal balance of social security systems is not contrary to the Constitution.[para.14]
The contested regulations of the p.d. 64/2018, which are within the limits of the authorization, are not contrary to the Constitution, and in fact to the provisions of articles 5 par. 5 and 21 par. 3 which require the legislator to take the appropriate measures for the protection of public health. In particular, these arrangements shall ensure, in a systematic and coherent manner, the purpose pursued by the legislature, namely the removal of unjustified obstacles to business freedom in the licensing of pharmacies and the exercise of the relevant activity, in order to strengthen competition, which contributes to the economic development of the country and the protection of the consumer public, but at the same time, by introducing the appropriate and necessary guarantees and restrictions, the constitutional obligation to protect public health is not jeopardized.[para.16]
The provision of the possibility to persons who do not have the same qualifications as the pharmacists to obtain an establishment license and to participate in a pharmacy operation does not violate the one guaranteed by art. 4 par. 1 principle of equality, nor does it constitute a degradation of the personality of pharmacists as scientists, in violation of art. 2 par. 1 and 5 par. 1 of the Constitution, as it is unjustifiably projected, given that as foreseen, with the new regulations, pharmacists remain, however, solely scientifically responsible for the most basic operation of the pharmacy, i.e. the provision of the appropriate medicine to the patient / consumer. [para.17]
The legislator is not hindered in principle by the principle of protected trust or by the need for the existence of legal certainty, to introduce regulations different from those in force in the past, even if existing interests are affected.[para.18] Furthermore, these regulations do not directly endanger the viability of pharmacies.[para.18]
The plea alleging that the contested rules infringe the provisions of Articles 2 and 8-11 of the ECHR and Article 35 of the CFREU must also be rejected.[para.19] This is because – even if it was to be considered that the above provisions of the ECHR refer to the obligation of the state to take measures in favor of public health when regulating the licensing system of pharmacies -, they do not guarantee a different degree of public health protection in relation to the above provisions of the Constitution, which as already accepted are not violated. In addition, the party refers to Article 35 of the EU Charter (2000 / C 364/01) - which after the entry into force of the Treaty of Lisbon has the same validity as the EU Treaties and binds on the Member States when acting within EU law), the above reason must be rejected, in particular, because it is based on an incorrect legal version, since in this case, Law no.4509/2017 and the contested p.d. 64/2018 were established within the margin of appreciation provided by EU law, but mainly within the framework of the Greek legal order.[para.19]
It was further argued that the contested p.d. be canceled because the conditions set for its adoption by Directive 2018/985 (28/6/2018) on the control of proportionality and suitability before the introduction of restrictions on the exercise of regulated professions have not been met. However, since the Directive has direct effect only after the expiry of the period for transposition into the domestic legal order of the Member States, in this case the period for transposition of that Directive (30/7/2020 in accordance with Article 13 thereof) expires at the time of issuance of the contested p.d., this reason is inadmissible.[para.22]
The application was dismissed in its entirety as unfounded. [para.24]
Role of the Charter and role of the general principles on enforcement
The claim of the applicant that art.35 CFREU was violated was rejected because the contested legislation had been established within the margin of appreciation of the MS and mainly within the framework of the Greek legal order.
• Art.2(1): Respect and protection of human dignity are a primary obligation of the State.
• Art.4(1): Greeks are equal before the law. (equality principle)
• Art.5(1): Everyone has the right to freely develop their personality and to participate in the social, economic and political life of the State, as long as they do not infringe on the rights of others and do not violate the Constitution or good morals.
Law 4509/2017 (GG A’201/22.12.2017)
• Art.1: A license to establish a pharmacy is granted: a) to natural persons who have the status of pharmacist, b) to natural persons who do not have the status of pharmacist and c) to cooperatives members of the Federation of Greek Pharmacists' Cooperatives (OSFE). The permit is granted by a decision of the locally competent Regional Governor. The licensee may operate a pharmacy either as a sole proprietorship or as a commercial company of any kind, except this societe anonyme. By presidential decree, on the proposal of the Minister of Health, the terms, conditions, restrictions, procedure and any other necessary details regarding the granting of a license to establish a pharmacy, as well as regarding the operation of pharmacies either as sole proprietorships or as commercial companies of any kind, except the public limited company. "
b. Article 3 of Law 1963/1991 (AD138) is replaced as follows:
“Applications for obtaining a pharmacy license are judged in the following order of preference: a) If there are applications from pharmacists and / or private non-pharmacists with applications from pharmacists' cooperatives members of the OSFE, pharmacists and / or individuals are preferred who are evaluated according to the criteria in case b 'and then the cooperatives.
b) If there are applications from pharmacists and private non-pharmacists, the application is preferred in the following order: aa) the one who does not have, at the time of granting the establishment license, another pharmacy establishment license himself and in the case of the private non-pharmacist and the declared by bb) in which the license to practice the profession of pharmacist (pharmacist on request or the person declared responsible by the applicant individual) is the oldest, cc) in which the pharmacist (the applicant pharmacist or the applicant ) is preceded in time by the receipt of his / her university degree in pharmacy and in case of modern receipt of the degree, the pharmacist with the highest degree, and dd) of the large family or the child of a large family.
c) If there are requests from more than one pharmacist, the order of preference between them arises in accordance with the criteria of indent b) of this paragraph, proportionally applicable.
d) If there are applications from more than one non - pharmacist, the order between them shall be determined in accordance with the criteria in subparagraph (b) of this paragraph, which shall apply mutatis mutandis."
Presidential Decree n. 64/2018 (GG Α’ 124/11.07.2018)
The Council of State explicitly addressed the Pharmaceutical Association’s claims of a violation of arts. 2,8,9,10,11 ECHR and art. 35 CFREU and stated that none of these rights were infringed by the contested regulations which grant the possibility of establishing a pharmacy also to non-pharmasists.
An important issue addressed by the Court was whether the protection of public health is effectively ensured or jeopardised by the contested measures and recognized that the effective protection of public health is not threatened, since pharmacists remain solely responsible for the most basic operation of the pharmacy, i.e. the appropriate medicine to the patient/consumer.[para.17]
The Court refers to the fact that the Memoranda of Understanding provided for the “liberalization of closed professions”, except for those for which "restitution is required, on the basis of the principles of necessity, proportionality and the public interest"[para.9] and further stated that any restrictions on the Constitutional rights must "respect the principle of proportionality"[para.13] It reiterates that “in view of the principle of proportionality, the restrictions imposed by law must be appropriate and necessary for the attainment of the public or social interest pursued by the legislature and must not be disproportionate to it.”[para.13]
Elements of judicial dialogue
- Dialogue among same level national courts within the same Member State
Only references to previous case law of the same court (the Council of State).
To receive guidance on the interpretation and to provide support for all the arguments expressed and accepted by the Court in its reasoning.
legislative reform- annulment of the contested presidential decree 64/2018.
Additional notes on the decision
The request for annulment was rejected.
The decree and its regulations remained in force.