On 11 March 2019, the Ministry of Health issued a note in response to a request from Federfarma (i.e., the Italian federation representing private pharmacies that are affiliated with the Italian National Health Service) for an opinion on certain procedures relating to the sale and dispensing to the public of Sop medicines (i.e., drugs which can be bought without medical prescription), which include the use of vending machines. The Ministry has taken up a very restrictive position on this point, providing a strict interpretation of the applicable legislation. In this respect, the question arises as to whether a different and more progressive interpretation of this legislation can be regarded as being sustainable.
The subject of the request for the Ministry’s opinion
The opinion requested from the Ministry concerns the compatibility with current legislation on the sale of medicines of a commercial activity consisting in the selling to the general public of Sop medicines through a vending machine that is located outside the pharmacy, connected, through an app, to the website of that pharmacy, which is authorized for the online sale of medicines. The Ministry considered that the activity in question was unlawful, since it involved the sale of medicinal products beyond the authorized channels, in violation of Article 122 of Royal Decree No. 1265/1934, according to which “the sale to the public of medicinal products by dose or form of medicine is permitted only to pharmacists and must be carried out in the pharmacy under the responsibility of its holder” (now also in para-pharmacies under Legislative Decree No. 223/2006).
The Ministry’s reasoning
The Ministry’s arguments can be summarized as follows:
The Ministry’s position is the result of a strict interpretation and application of both the rules on distance selling and the above-mentioned Article 122 of Royal Decree No. 1265/1934. However, any of these issues might be subject to a different reading.
The boundaries of online sales
Unfortunately, the Ministry’s note does not contain enough details about how the purchase of the medicines would have taken place, in order to be able to understand whether the transaction could be considered to be concluded online or through access to the vending machine. If, in fact, the purchase was completed online and through a code or a similar tool, the user could only withdraw the product from the distributor, it could hardly be excluded that the case falls into the category of an online sale.
In this case, the purchase would take place from a pharmacy authorized website, in accordance with the law (Article 112-quater of the Pharmaceutical Code) and the use of the machine would concern only the dispensation procedures and not the purchasing ones. Insofar as, according to Article 122 of Royal Decree No. 1265/1934, “the sale to the general public of medicinal products […] shall be permitted only to pharmacists and shall be carried out within the pharmacy under the responsibility of its holder”, it could be considered that the mere act of dispensing, through an automatic machine, a medicinal product that has already been purchased through authorized channels, does not fall within the scope of that prohibition. This is especially true if we consider that the vending machine, although located outside the pharmacy, is placed under the control and responsibility of the pharmacist who manages it, reloads it, and verifies the state of preservation and safety of the products inserted therein.
Sale through the vending machine
If the transaction cannot be qualified as an online sale, it is necessary to ask the question: is the sale of drugs through a vending machine permitted by law? As mentioned above, a strict interpretation of Article 122 leads to the conclusion that the sale of medicines can only take place (with the exception of the e-commerce of Sop through an authorized websites) “in the pharmacy” and “under the responsibility of its holder”. Sales through vending machines would therefore be prohibited.
However, one might question the significance of these requirements, which, according to the Ministry’s reading, would lead to the exclusion of both the use of vending machines located outside the pharmacy and the use of an “automated procedure”. In other words, the question arises as to whether, in order to meet these criteria, direct intervention by a pharmacist is always necessary, or whether it is possible to envisage intermediate solutions involving the presence of automated systems, while still complying with the law.
Is the individual always necessary?
Indeed, if, as the Ministry itself states in its note, the pharmacist is solely responsible for the sale of the drug and must carry out, as a professional obligation, the verification of the integrity of the drug sold, its proper storage and the consistency with what was ordered, it would be reasonable to think that these duties can be performed by the pharmacist, even if s/he is using the aid of automated tools, as long as they are placed under his/her control and responsibility.
For instance, in the case of online sales of drugs on authorized pharmacy websites, one could imagine a system in which products purchased online leave the pharmacy’s warehouse with the help of automated machinery and support staff members who are under the supervision and responsibility of the pharmacist, but without his/her direct intervention.
Need to modernize the sector
In conclusion, this note from the Ministry, although undoubtedly supported at a legislative level (not surprisingly, by a Decree of 1934!), is perhaps not much in line with the need for modernization in the sector, which is showing an increasing need for new legislation, or at least for “evolving” interpretations of the old ones, taking into account the changing times, the new technologies available, and the tools that would today make it possible to provide citizens with additional, and often better, services, always respecting the requirements for safety and health protection.