In a historic verdict, the Supreme Court affirms the equivalence of homeopathic and allopathic medicines for the crime of trade of failed medicines
With sentence no. 35627/2019 the Supreme Court – Criminal Section I – convicted the owner of a pharmacy held responsible for the crime of Commerce of failed medicines, ex art. 443 penal code for having sold to a customer an expired homeopathic medicine and for having held in stock more than 194 expired medicines, (half of which homeopathic).
The pharmacist’s defence was based on the non-assimilability of homeopathic medicines to (allopathic) medicines.
In detail, the owner of the pharmacy defended his position by arguing that the medicines in question, as homeopathic, would not have therapeutic efficacy and that therefore the conduct of trade or administration was not suitable to configure the objective element of the crime referred to in Article 443 of the Criminal Code, (focused on the concept of an imperfect medicinal product), nor, even less, was the different offence under Article 453 of the Criminal Code applicable. (culpable crimes against public health).
The Supreme Court did not accept the defensive argument.
On this point, in fact, the Judges of the S.C. stated with extreme clarity that “it is not in the least doubtful whether the homeopathic drug can be traced back to the concept of medicinal product, given the broad definition for the purpose provided by the Legislative Decree No. 219 of 2006, article 1, paragraph 1, point a), which includes “any substance or combination of substances presented as having curative or prophylactic properties in human diseases”, (point 1 of the provision), as well as “any substance or combination of substances which may be used in or administered to man for the purpose of restoring, correcting or modifying physiological functions, exerting a pharmacological, immunological or metabolic action, or establishing a medical diagnosis“.
From the legislative point of view, the verdict shows that Europe has also intervened on this matter, adopting a European Directive (no. 2001/83/EC) by which it has been specified that the Community code, which includes medicinal products for human use, also includes homeopathic products. These in fact are subject to a specific registration procedure, to the respect of safety standards and – as a regulation – to drug supervision.
(For further information on homeopathic medicinal products, please refer to the link to the Italian Medicines Agency– Agenzia Italiana del Farmaco).
With these preliminary remarks, framing the facts of the trial within the current regulatory framework, the Supreme Court has decided to confirm the content of the sentence imposed on the pharmacist, stating that: “even the expired homeopathic medicine constitutes an “imperfect medicine” for the purposes of the offence provided for by Article 443 of the Criminal Code“.
In summary, according to the criminal law, the homeopathic drug is equated to a medicinal product.
The sentence is also interesting for other profiles addressed in the grounds, related to the organization of pharmacies and the relevance of organizational deficiencies on the profile of the psychological element of the crime.
The defensive argument argued challenged the absence of willful intent in the established facts committed by the owner of the pharmacy, justifying the presence of 194 expired medicines in stock as a simple lack of organization of a negligent nature, not suitable to supplement the willful intent required by the incriminating rule of Article 443 of the Criminal Code.
Also this defence argument did not convince the Judges of the S.C. On this point, in fact, the Supreme Court has specified how the crime in question is punished as general fraud. Specifically, the requirement of fraudulent intent of the crime of Commerce of faulty medicines is configured by the conscious detention for the commerce of expired or imperfect medicines, the proof of which can take place by means of external indexes, symptomatic of the awareness of the acting subject. Well, based on the evidentiary circumstances that emerged in the trial, the disorganization of the pharmacy could not be interpreted as mere negligence or carelessness.
On the contrary, the deficient organizational modalities and the general neglect of specific professional duties were evaluated as revealing indices of an attitude of absolute indifference of the pharmacy owner. This indifference to the disorganisation of the pharmacy made the marketing of expired medicines predictable and likely. Therefore, with regard to the subjective element of the offence, the evidence of the trial allowed the so-called possible malice (dolo eventuale- nda), i.e. the acceptance of the risk of verification of the legal event envisaged by the incriminating law, (i.e. the trade or possession of expired medicines), to be considered as proven.
Finally, in its ruling, the Supreme Court expressly excluded that the case could be traced back to the newly introduced, and lighter, administrative fine of “possession of expired, faulty or imperfect medicines”, enacted by Law no. 3 of 11 November 2018.In the above mentioned legislative intervention, in fact, a reason was provided for the exclusion of the punishability from the crime of “Trade or Administration of faulty medicines”, (and from the hypothesis of “Culpable offences against health” pursuant to Article 452 of the Criminal Code), in all cases where it appears, in relation to the small quantity of such medicines, the manner of storage and the total amount of reserves, that it can be concretely excluded the destination to the market of the same.
However, the thesis has not convinced the Judges, who have judged the facts as serious and fully attributable to the crime originally challenged.
The Court of Cassation thus confirmed the conviction, affirming the principle that the offence of “trade of malfunctioning medicines” provided for by Article 443 of the Italian Criminal Code also includes the possession and marketing of an expired homeopathic medicine.
