Delivering drugs to the public outside a pharmacy via a third party: Considerations on a recent ruling by the Criminal Court of Cassation

It’s official: Under certain conditions it is not an offense for drugs—including prescription drugs—to be received by and distributed to the public, potentially even outside the pharmacy channel. The Sixth Criminal Section of the Court of Cassation stated this in ruling number 48839 of November 10, 2022. The Supreme Court addressed the question of whether a non-pharmacist can commit the offense of abusive exercise of the profession of pharmacist, pursuant to Article 348 of the Criminal Code. The scenario considered was that of someone running a business other than a pharmacy who, based on specific agreements with a pharmacy, delivers medicines to customers on behalf of that pharmacy—in this case by allowing the medicines to be picked up at retail stores.

According to the Court of Cassation, someone who participates in the sale of medicines merely by delivering products to customers who ordered them from a pharmacy is not engaged in the business of dispensing and selling medicines to the public, and therefore the conduct does not constitute this type of offense.

Background

The case has to do with an initiative by a pharmacist and a number of store owners to enable pharmacy customers to pick up pharmaceutical products (both ethical and OTC/SOP) from stores.

The pharmacy would deliver the medicines to a store chosen by the customer, upon receipt of a relevant order and a doctor’s prescription, if required. The customer could then go to the chosen store to pick up the medicine(s), which were packaged and placed in sealed envelopes bearing the name of the pharmacy, with the name of the customer and the receipt inside. According to the judgment, the customer sometimes paid the store owner directly when picking up products.

Charges

In the first instance, the pharmacist and the owners of the stores involved were indicted and convicted jointly and severally by the Court of Messina for abusive exercise of the profession of pharmacist under Article 348 of the Criminal Code. In agreeing to receive medicines from the pharmacy for subsequent delivery to patients, the store owners allegedly dispensed and sold medicines to the public, and the law says that only pharmacists may perform these activities.

However, those findings were not upheld by the Court of Appeals of Messina. After the defendants filed an appeal, this court overturned the decision in the first instance and, with a judgment on February 11, 2022, acquitted the defendants fully, because the claimed event did not occur. The decision was then appealed by the general prosecutor and the civil parties before the Court of Cassation.

Court of Cassation decision

The Court of Cassation declared the appeals inadmissible and confirmed the acquittal issued by the appellate court judges. On the basis of the evidence, the court held that receiving and dispensing medicines in agreement with pharmacies as the store owners had did not constitute the sale or dispensing of medicines to the public, as none of the actions typical of the profession of pharmacist had been performed outside the pharmacy premises.

Grounds

The pharmacy sent the medicines ordered by patients (including prescription medicines) from the pharmacy to the stores in their packaging, inside sealed envelopes bearing the name of the pharmacy. Though sometimes payment for the medicines was made directly to store owners, the payments were deemed “clearly intended for the pharmacist,” as the envelopes contained receipts issued by the pharmacy to patients.

The only thing the store owners did was to receive the medicines and deliver them to the patients, without overriding or replacing the pharmacist by performing activities reserved for the pharmacist by law. Therefore, the defendants’ conduct was deemed not to be abusive exercise of a profession.

The court also found no subjective element of the offense, in this case willful misconduct, since it had not been proven that the defendants were aware of and intended to carry out activities pertaining to the profession of pharmacist without being entitled to do so.

Lastly, the pharmacist was originally convicted under Article 348 of the Italian Criminal Code in conspiracy with business owners, but the court ruled that this was erroneous, since it presupposed that the offense in this case had been committed by those not qualified as pharmacists who were not listed in the relevant register. If anything, the pharmacist should have been charged with an administrative offense under Article 122 TULS, which sanctions the sale of medicines outside of a pharmacy. In any case, the court posited that all dispensing and selling activities to be performed by a pharmacist took place on the pharmacy premises and not at the premises of the store owners.

Impact on medicine delivery services by third parties

With reference to non-pharmacists dispensing medicines to the public, the Court of Cassation ruling pertains only to the legality of such conduct from a criminal point of view. It provides useful indications for differentiating between the mere material activity of product delivery—which is lawful—and activity reserved by law for pharmacists.

These clarifications are significant to assessing online drug home-delivery platforms. Home-delivery methods are not regulated (except in very general terms), so such rulings become important as possible guidelines.

Generally, delivering medicines to places other than pharmacies, and in particular to the homes of patients, is governed by the pharmacist’s code of ethics (Article 30), which expressly allows professionals to organize home delivery (and theoretically delivery to places other than homes, in agreement with patients) of pharmaceutical products, provided that before delivery the patient supplies the original prescription and that medicines are guaranteed to be safely and properly stored during transport and delivery.

Still, there is nothing to prevent a pharmacist from making use of third-party logistics services (indeed, this may prove the rule rather than the exception, as typically pharmacies do not have their own delivery staffs).

Specific agreements are needed

To do this, a pharmacist must enter into specific agreements with parties assigned to transport and deliver medicines, and the pharmacist remains responsible for proper storage of the products during home delivery. Of course, in some cases factors such as the types of medicinal products involved or the condition of the premises where delivery is made may advise against or prevent delivery of medicinal products to places other than pharmacies.

Principles based on the judgment

An increasing number of home-delivery services operate via digital platforms. Other services are arranged and operated by third parties that have entered into agreements with pharmacies.

In such cases, one can imagine “reservation” systems for medicines that allow a patient to delegate the platform holders (or any subdelegates, such as couriers) to purchase the products in the name of and on behalf of the patient, provided that in the case of prescription medicines the prescription is sent to the pharmacy in advance and the purchase is made at the pharmacy by the patient’s delegate. According to the representation mandate, in such cases purchase made by the delegate in the name of and on behalf of the patient is made directly and immediately by the patient. Of course, a platform intended for the “reservation” of medicines must be structured in such a way that it does not violate the specific rules governing the promotion and sale of medicines online.

Additionally, patient confidentiality must be guaranteed. This is particularly precarious when third parties are involved in the distribution of medicine. It is ensured primarily by adopting measures that do not allow the third party in charge of delivery to know the type of medicine going to the patient. The contents of this judgment stating that in this case a medicine was delivered to a store “in a sealed envelope with the pharmacy’s name on it” seem to point in that direction.