Although they don’t always keep up, they certainly follow. This is not an overly controversial thesis, as evidenced by the Judgment of the Provincial Administrative Court in Warsaw of 12/10/2022, mentioned in the title. In the case with file number: V SA/Wa 1244/22.
The main thesis of the court’s ruling is:
The requirement to conduct mail-order sales of medicinal products by placing orders "using a form posted on the facility's website," as defined in § 2(2). 1 point 5 of the Health Minister's order of March 26, 2015. on mail-order sales of medicinal products (Journal of Laws, item 481) is also fulfilled if it is a website provided by an online auction service such as allegro.pl, and acting as an independent website, among others. by providing a distinctive and unique address assigned to the vendor (facility), provided that the site meets the other requirements under § 6 of the aforementioned. regulations.
The Provincial Administrative Court dealt with the case as a result of a complaint filed by a pharmacy operator who had been waiting for a favorable ruling since 2018, when a decision was issued against him by the Provincial Pharmaceutical Inspector on finding violations of requirements for the marketing of medicinal products and ordering their removal. The WIF’s decision was subsequently upheld by the Chief Pharmaceutical Inspector in April this year, and against it the entrepreneur filed a complaint with the administrative court. It is worth mentioning that it took the court less than 5 months to consider and resolve the case.
The WSA’s ruling is significant because it changes the previous, rather rigid position of the judicature in similar cases. However, it should be emphasized that the change is not accidental
and is not only indicative of a change in the court’s interpretation of the regulations, but also, and perhaps most importantly, of the court’s recognition of an important change in the structure and business model of an online drug sales site.
The court referred to the Supreme Administrative Court’s rulings to date, emphasizing the difference in the facts.
In other words, the service’s business model has changed, the court’s approach has changed.
The above was reflected in the wording of the explanatory memorandum, quote:
This means that the party is correct in claiming that the allegro.pl website essentially provides IT tools (cf. also Article 2.1 of the general terms and conditions) and does not mediate the conclusion of contracts (vide Article 2.6). Thus, the sale should be treated as direct within the meaning of Art. 2 item 37aa of the Pharmaceutical Law, i.e. Using the "electronic order form". The court also notes that the judgments of the Supreme Administrative Court, cited by the authority in the above context, ref. II GSK 1603/17, II GSK 1269/16 (CBOSA), were not made on the grounds of an analogous factual situation, because in these cases the Supreme Administrative Court was dealing with a situation of selling medicinal products using the platform itself, i.e. "the website of the intermediary Allegro auction portal" by its user, which was a pharmacy. In the case now under review, on the other hand, the service, as indicated, provides a properly individualized, user (sub)website. So while in the aforementioned cases, the user used to post offers directly using the sales platform, but now has a dedicated page (with a unique address) for this purpose.
Link to the full verdict with reasons:
https://orzeczenia.nsa.gov.pl/doc/3A654A901B
Why exactly are these aspects so important and what can a court ruling change?
In the first place, it hopefully opens the way for greater availability of medicinal products to patients; availability through modern, popular and increasingly widespread channels, while maintaining the legality and safety of the marketing of medicinal products.
If the legislator has provided for the sale of over-the-counter medicinal products by mail order, including via the Internet, one should not necessarily be attached to a single “right” construction of making online sales offers available, i.e.
in a world that is undergoing such dynamic changes.
A separate issue – legal and commercial – is the brokering of medicinal products, which we do not elaborate on in this text.
In the second place, it seems reasonable to assume that the court’s proposed change in the jurisprudential approach will be adopted more broadly and will apply to all online sales sites whose business is based on the court-approved model of providing an individualized (sub)website with a distinctive and unique address (this is also a guideline for such sites).
For today, it was certainly correct to adopt an expansive interpretation of the term “outlet website” and include the activities of sales sites that do not mediate the conclusion of contracts at a distance, but provide users with the ability to create their own pages (platforms) within the main site.
It is not known in what direction the further development of the e-commerce sector will go, but it is possible and worthwhile to actively participate in this development, including from the level of legislation and jurisprudence, which I advocate.
Sale of medicinal products over the Internet, other forms of mail order – products, principles and legal basis.
The sale of medicinal products on the Internet is regulated as an element/form of “mail order,” the legal definition of which can be found in the Law of 06/09/2001. Pharmaceutical Law (Dz.U.2022.2301 t.j.) – hereinafter “PF”.
According to Art. 2(37aa) PF:
37aa) mail order of medicinal products - is an agreement for the sale of medicinal products concluded with the patient without the simultaneous presence of both parties, using means of distance communication, in particular a printed or electronic unaddressed or addressed order form, a serial letter in printed or electronic form, a newspaper advertisement with a printed order form, an advertisement in electronic form, a catalog, a telephone, facsimile, radio, television, automatic calling machine, videophone, videotext, electronic mail or other means of electronic communication within the meaning of the Act of July 18, 2002. On provision of services by electronic means (Journal of Laws of 2020, item 344);
It is not difficult to see that part of this definition and the forms of activity listed in it based on ways of making contact at a distance, which can be considered archaic.
The predominant form of distance selling is becoming direct Internet sales carried out on their own websites or as part of broader sales sites, although there are still cases of posting offers on a website with contact information (phone, e-mail) for placing an order.
Otherwise, mail-order sales of medicinal products (including online sales) are regulated in Art. 68 para. 1- 3m of the PF Law, although it should be remembered that the other provisions of the Law will also apply, both subjectively (the form of activity and the conditions for its conduct) and objectively (medicinal products as an object of marketing).
Developing the provisions of the PF Act is an implementing act – the Decree of the Minister of Health
dated 26/03/2015. on the mail-order sale of medicinal products (Journal of Laws 2015.481), which should be consulted to determine and find out what they are:
- terms and conditions for mail-order sales of medicinal products dispensed without a doctor’s prescription;
- The method of delivering medicinal products to recipients;
- conditions that must be met by the premises of a pharmacy and a pharmacy point conducting mail order sales of medicinal products;
- retention period for documents related to the conduct of mail-order sales of medicinal products;
- minimum information to be posted on websites, on which medicinal products are offered.
In the context of the judgment of the WSA commented above, it is worth noting §2 of the Ordinance in question, according to which:
(1) The condition for the implementation of mail order sales of medicinal products is the placement of an order:
- at the site of a community pharmacy or pharmacy point, hereinafter referred to as "outlets";
- By phone;
- fax;
- via email;
- via a form posted on the facility's website.
In point 5. a form on the facility’s website was identified as one of the forms for placing an order for mail-order sales. This term corresponds to the “electronic order form” indicated in the definition ofmail-ordersales – one of the forms of distance communication, in this case the transmission by one party of a statement of intent to purchase a specific medicinal product from another party.
It was these terms (concepts) that were subjected to practical interpretation by the court, which held that not only a pharmacy’s own website, but also a website provided by an online auction service, and acting as an independent website, among other things. by providing a distinctive and unique address assigned to the vendor (facility), provided that the site meets the other requirements under § 6 of the aforementioned. regulations.
It is important to know:
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- Retail trade (sale) of medicinal products is carried out in pharmacies open to the public, and therefore, for reasons of safety and public health, it is a regulated activity (in addition, also in a regulated manner – in pharmacy points, non-pharmacy trading facilities, in the case of veterinary medicinal products – only animal medical facilities),
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- Only online pharmacies and online pharmacy outlets can sell medicinal products over the Internet,
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- the condition for conducting mail order (online) sales of drugs is the simultaneous operation of a stationary business (it is unacceptable to sell drugs online by an entrepreneur who is not a general pharmacy, a pharmacy point, or even more so by a private individual),
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- In order to be able to sell medicines on the Internet (in the form of mail order), one must meet the formal conditions for starting the activity of a pharmacy, a pharmacy point, apply for and obtain a license to conduct such activity and notify the locally competent provincial pharmaceutical inspector of the intention to start mail order sales of medicinal products, no later than 14 days before the planned start of such activity,
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- the object of circulation (sale) on the Internet (mail order) may be only medicinal products dispensed without a doctor’s assignment (without a prescription), except those whose dispensing is limited by the age of the patient.
It should be borne in mind that undertaking and carrying out the activity of trading in medicinal products without a license, operating a pharmacy open to the public or a pharmacy point in contravention of the conditions of the required license, conducting mail order sales of medicinal products without the required license to operate a pharmacy or a pharmacy point or without reporting such activity are penalized and the law – depending on the type of act committed – provides for both fines and criminal penalties.
