On February 24, 2022, the proceedings before the Supreme Administrative Court ended - all due to the amendment to the Pharmaceutical Law Act, which entered into force on June 25, 2017, and yet still causes problems with the interpretation of its provisions. The judgment in question (file reference no II GSK 477/20) turned out to be positive for entrepreneurs who owned pharmacies under the "old rules", contrary to the position of the Supreme Pharmaceutical Chamber itself. The Supreme Administrative Court adopted the position that analysis of the transitional provision (Article 2 of the Act amending the Pharmaceutical Law) leads to the conclusion that the so-called "old permits" granted before the entry into force of the amendment in question may be executed under the old rules, and the new requirements arising from Art. 99 section 4 The amended Pharmaceutical Law does not apply to them, even if the proceedings to change the "old" authorization were initiated after the Act amending the Pharmaceutical Law came into force.
Amendment to the pharmaceutical law by the Act of April 7, 2017.
"AdA" - Pharmacy for Aptekarz - because this is the amendment we are talking about (Act of April 7, 2017, Journal of Laws 2017.1015), introduced new, more restrictive regulations regarding, among others, the restrictions in connection with obtaining a permit to operate a public pharmacy and who may own it. Until now, the owners could include, among others, general partnerships whose members included not only pharmacists, but also people without such education - currently, there is a strict rule that only pharmacists with the right to practice the profession can be the owners.
In 2019, a case was pending before the Provincial Administrative Court regarding an appeal against the decision of the Chief Sanitary Inspector - the complaining company applied for a change to the decision issued in 2016 to operate a publicly available pharmacy - this change was to concern, among others, change of the entity operating the pharmacy. Problems with the interpretation of the provisions of the already amended Act and permits obtained under the "old" provisions, before the amendment, brought the case to the Supreme Administrative Court
Discussion of the key elements of the judgment's justification
As mentioned above, the complaining company applied for a change to the already obtained decision - therefore one of the most important arguments cited by this party was the incorrect interpretation of Art. 99 section 4 of the Pharmaceutical Law Act of September 6, 2001 (Journal of Laws of 2021, item 974). According to the current wording of this provision, the right to obtain a permit to run a public pharmacy is held by a pharmacist who has the right to practice the profession, runs a sole proprietorship or a general partnership or partnership whose subject of activity is solely to run pharmacies, and whose partners (partners) are only pharmacists with the right to practice the profession. The Supreme Administrative Court agreed with the party, citing, among other things, Art. 2 section 2 of the Act, which introduced the current wording of the above article: Permits to operate publicly available pharmacies issued before the date of entry into force of the Act remain valid. According to the adjudicating panel, if the legislator wanted to adapt the activities already conducted to the new regulations, it would certainly introduce the necessary regulations - this would be necessary to preserve the rights acquired from authorizations already granted. Moreover, art. 1 of the amending Act states that the provisions currently in force shall apply to proceedings initiated and not completed before the date of amendment - therefore, applying the new provisions to permits already obtained, also on the provisions before the amendment, would be contrary to paragraph 1, dysfunctional and even unfair. – if one entity could obtain a new permit under the "old" rules, while another entity already holding an "old" permit could not obtain a change to it under the existing rules. The NSA also emphasizes that none of the standards it does not follow that new regulations should apply to old permits - and possibly to what extent. The very issue of the fact that the complaining company applied for a change to an already issued permit and did not apply for one was also raised by the Supreme Administrative Court as an incorrect interpretation and application of the provision by the authority examining the company's application.
In the justification, Article 99, section 4 (and other paragraphs of this provision) was defined as competence provision – according to the court when interpreting these provisions constitutional principles regarding the legal basis for the operation of public authorities are important, including the principle of the rule of law and trust in public authorities. That is why such principles are usually based on norms arising directly from the Constitution of the Republic of Poland or are included in law codifications, so as to give citizens a sense of fair and lawful treatment, enabling them to acquire and maintain rights. An excerpt from the literature is cited to support this remark:
Such an interpretation of these provisions that they can be applied in proceedings other than those for granting a permit is unacceptable because it would violate the constitutional principle of legalism (expressed already in art. 7 Constitution of the Republic of Poland) requiring public authorities to act on the basis and within the limits of the law. The will of the legislator, especially when creating provisions of public law, in particular substantive administrative law, when there are significant limitations and even rigors in its sphere, should be expressed in a specific, clear and clear way for the addressees of its norms (primarily for entrepreneurs and bodies applying law). The competences of public authorities cannot be presumed or interpreted broadly, and the linguistic interpretation of the competence provision is of fundamental importance when determining the scope of competences.
Another argument of the Supreme Administrative Court was the justification for the draft amendment to the Act of April 7, 2017: the measures proposed in the project lead to the intended goals, i.e. they stop the opening new ones pharmacies and pharmacy points in their current form – therefore, according to the adjudicating panel the purpose of this change was not to in any way impede the activities of entities that run operating pharmacies on the basis of "old" permits.
Interestingly, one of the documents subject to evidence was a letter from the Minister of Health addressed to the Ombudsman for Small and Medium-sized Entrepreneurs. In the proceedings before the Provincial Administrative Court, the court did not refer to this in any way, however, the Supreme Administrative Court noted that, according to the Minister of Health, the provisions that provide for maintaining the binding force of permits issued before its entry into force, and at the same time do not require their holders to adapt to the new requirements introduced by the Act they do the unfounded statement adopted by the Provincial Administrative Court and the GIF that the permit requirements are retroactive.
Protecting fundamental principles
As mentioned earlier, the judgment is also very important from the point of view of the principles applicable in our legal system - this includes, among others:
– the principle of the rule of law (Article 6 of the Code of Administrative Procedure, Article 7 of the Constitution of the Republic of Poland) – Public administration bodies operate on the basis of legal provisions; Public authorities operate on the basis and within the limits of the law;
– the principle of resolving legal doubts in favor of the party (Article 7a § 1 of the Code of Administrative Procedure) – JIf the subject of administrative proceedings is to impose an obligation on a party or to limit or revoke a party's rights, and there are doubts in the case as to the content of a legal norm, these doubts are resolved in favor of the party, unless this is opposed by the disputed interests of the parties or the interests of third parties affected by the result. proceedings has a direct impact;
– the principle of trust in public authorities (Article 8 § 1 of the Code of Administrative Procedure) – Public administration bodies conduct proceedings in a way that inspires confidence of its participants in public authorities, guided by the principles of proportionality, impartiality and equal treatment.
The above ruling showed how important these principles are in our system and the protection of citizens from public authorities, which in a sense have a higher position than us. In the discussed case, it turned out to be very important to mention these regulations - with the change of the Pharmaceutical Law Act, which is now considered to be more restrictive, the application of its provisions without these principles would lead to incorrect interpretation of the provisions, to the detriment of many citizens.
Taking into account the above judgment and guided by the interpretation of the Supreme Administrative Court, it is rightly argued that other restrictions introduced by the "AdA" amendment, including the limit on operating 1% generally available pharmacies in the voivodeship (Article 99(3) of the Pharmaceutical Law) or the limit of 4 pharmacies for effective obtaining an authorization (Article 99(3a) of the Pharmaceutical Law) do not apply to holders of "old" authorizations. How far will this obviously correct interpretation of the law go? We will find out after subsequent verdicts.