Over-the-counter drugs can’t be sold in mobile shops | In Principle

Under current Polish law, it is illegal to sell OTC drugs from a motor vehicle. This was acknowledged by the Chief Pharmaceutical Inspectorate and confirmed by the Province Administrative Court in Warsaw in its judgment of 23 March 2021 (case no. VI SA/Wa 2691/20).

A business was considering operating mobile stores selling over-the-counter drugs in addition to food. In an application to the province pharmaceutical inspector, the business asserted that a mobile shop is often the only chance to buy essential items in small towns where there are no brick-and-mortar shops. OTC medicines are among the most necessary products, and, according to the applicant, mobile shops can ensure the same level of safety of trade as generally accessible stationary shops.

The mobile stores were to source the OTC drugs from pharmaceutical wholesalers and travel between towns where there are no pharmacies or easily accessible stationary stores. When it reached a village and stopped the vehicle, the mobile shop would operate like a generally accessible stationary store. The products, including OTC drugs, would be sold directly to the end user (patient) without the possibility of wholesale purchases. The vehicles (mobile stores) would provide appropriate conditions for the storage of medicinal products, in particular with regard to temperature and humidity. Thus, the applicant claimed, the mobile shops would ensure that the quality of medicinal products was maintained, just as in the case in generally accessible brick-and-mortar shops.

Questions to the province pharmaceutical inspector

In connection with these plans, the business applied to the province pharmaceutical inspector for an individual interpretation under Art. 34 of the Business Law of 6 March 2018, asking the following questions:

1. Whether a mobile shop, i.e. a shop operated in a motor vehicle (for example a van) equipped with the necessary devices and installations as in any generally accessible shop, may be regarded as a generally accessible shop within the meaning of Art. 71(1)(3) of the Pharmaceutical Law, and as a consequence, can a mobile shop engage in retail trade in medicinal products supplied without a doctor’s prescription, known as OTC drugs?
2. If so, are the staffing and storage requirements for OTC drugs in mobile stores the same as for all generally accessible stores?

The province pharmaceutical inspector found that in light of the regulations in force, a mobile shop operated from a vehicle does not meet the conditions to be considered a generally accessible shop, an establishment of non-pharmacy trade referred to in Art. 71(1)(3) of the Pharmaceutical Law.

Appeal to the Chief Pharmaceutical Inspector

The business appealed against this decision to the Chief Pharmaceutical Inspector (GIF), who upheld the decision of the authority of first instance. The Pharmaceutical Law does not contain a legal definition of a generally accessible store. The legal literature states that “generally accessible shops include in particular food stores (including large-format stores), press outlets and petrol stations” (L. Ogiegło, Pharmaceutical Law: Commentary, 3^rd ed. (SIP Legalis, 2018)). In the regulator’s view, the body of first instance was correct in holding that generally accessible stores “by definition are establishments operated in buildings and in a stationary manner.”

In support of its position, the regulator cited Art. 71(3)(4) of the Pharmaceutical Law, under which “the minister for health shall determine, by way of regulation … the requirements that should be met by the premises and equipment of non-pharmacy trade outlets and pharmacy points.” Thus, according to GIF, the lawmakers determined that retail trade in medicinal products issued without a doctor’s prescription conducted by all outlets of non-pharmacy trade (i.e. herbal and medical shops, specialist medical supply shops, and generally accessible shops) should take place “on premises,” which cannot be a motor vehicle (e.g. a van). By the same token, a mobile shop operated in a vehicle cannot be considered a generally accessible shop within the meaning of Art. 71(1)(3) of the Pharmaceutical Law, where retail trade in medicinal products issued without a doctor’s prescription is allowed.

Complaint to the province administrative court

The business then filed a complaint with the Province Administrative Court in Warsaw, which, however, shared the standpoint of the Chief Pharmaceutical Inspectorate.

Under Art. 71(1) of the Pharmaceutical Law, retail trade in medicinal products without a doctor’s prescription, excluding veterinary medicinal products, can be conducted (apart from pharmacies and pharmaceutical points) by:

1. Herbal and medical stores
2. Specialised medical supply stores
3. Generally accessible stores.

Together, these three types of stores are referred to as “outlets of non-pharmaceutical trade.” On the other hand, as GIF had already pointed out, Art. 71(3)(4) of the Pharmaceutical Law contains a delegation to the minister for health to determine by regulation:

• Requirements to be met by premises and equipment of non-pharmacy trading facilities and pharmaceutical points
• Requirements regarding the storage and distribution of medicinal products in these facilities,

taking into account the safe application of medicinal products.

In the opinion of the Province Administrative Court in Warsaw, the Chief Pharmaceutical Inspector was right to point out that this regulation unequivocally implies that retail trade in medicinal products issued without a doctor’s prescription in outlets of non-pharmacy trade should take place on premises. Admittedly, it does not follow from the wording of the Regulation of the Minister of Health of 2 February 2009, issued on the basis of this authorisation, that the premises of a generally accessible store in which retail trade in OTC drugs is conducted have to meet any specific requirements, as the parliament did not introduce any specific rules in this respect. However, in the court’s opinion, the lack of specific requirements for such premises does not mean that it is possible to sell these products on a retail basis in a shop operated in a motor vehicle.

Following the reasoning of the Chief Pharmaceutical Inspector, the administrative court stressed that the Pharmaceutical Law does not contain a legal definition of the notion of premises, but repeatedly uses this term, and thus the understanding of the notion of “premises of a generally accessible shop in which retail trade in medicinal products issued without a doctor’s prescription is conducted” should be uniform and not differ from the way the parliament defines “premises” in other provisions of the Pharmaceutical Law. Therefore, in the court’s opinion, the regulator correctly relied on:

• Art. 68(3j) of the Pharmaceutical Law, according to which the premises of a generally accessible pharmacy or a pharmacy point selling medicinal products by mail order has a place separated from a dispatch room, storage room, or delivery and storage area intended for the preparation of a medicinal product for mailing
• Art. 97(2) of the Pharmaceutical Law, which specifies requirements for premises of generally accessible pharmacies, stating, among other things, that:
  • A generally accessible pharmacy may constitute a separate building or be located in a building intended for other purposes, provided that it is separated from other premises in the building and other activities (section 1)
  • The premises of a generally accessible pharmacy comprise a primary area and an auxiliary area, and the dispatching room included in the primary area should create conditions ensuring access for disabled persons (section 2)
  • The basic area of a generally accessible pharmacy should not be less than 80 m² (section 3, sentence 1).

For these reasons, the Province Administrative Court in Warsaw concluded that the GIF decision was lawful.

A vehicle cannot be an outlet of non-pharmacy trade

This ruling appears to be correct. Pharmacies are institutions of the public health system, which determines the rules of their operation.

The tasks of the Pharmaceutical Inspectorate include oversight of pharmacies and other units conducting retail and wholesale trade in medicinal products and medical devices. The Pharmaceutical Law regulates in detail trade in medicinal products, also for public health and safety reasons. The protection of human health can be undermined not only by inadequate access to medicines, but also when access to medicines is too easy, leading to their misuse. This justifies the supervision of pharmacies and other entities conducting retail and wholesale trade in medicinal products by the Pharmaceutical Inspectorate. In contrast, such supervision would be excluded or significantly reduced in the case of retail sales of OTC drugs in a mobile store, i.e. a store operated in a motor vehicle.

Although the Pharmaceutical Law does not contain a definition of “premises,” this does not mean that retail sales of medicinal products can be conducted just anywhere. A comprehensive analysis of the legal provisions does not justify the claim that such sales can take place in a mobile store. A linguistic and systematic internal interpretation of the Pharmaceutical Law leads to the conclusion that the premises of a generally accessible store where retail trade in medicinal products issued without a doctor’s prescription is conducted should constitute real property. It is enough to indicate, for example, the provisions in the Regulation of the Minister of Health of 2 February 2009, specifying the requirements for premises of a pharmacy point or herbal and medical shop, which state that under the pharmaceutical regulations, premises are understood as real property, whereas no regulation provides grounds for assuming that premises, for purposes of pharmaceutical regulations, may be understood to include a motor vehicle as well.

Natalia Falęcka-Tyszka, attorney-at-law, Life Science & Healthcare practice, Wardyński & Partners