June 1, 2021

Online sales of counterfeit medicines: AIFA recommendations and actions to combat the issue

On April 9, 2021, the Italian Medicines Agency, or Agenzia Italiana del Farmaco (the “AIFA” or the “Agency”) published a Nota informativa notice containing details regarding risks stemming from online purchases of medicines.

Indeed, the AIFA has noted a disturbing increase in reports of falsified medicines (copies of original products or products not authorized for sale and/or importation as required by law) acquired through unauthorized web channels.

In its notice, the Agency reported some cases of confirmed falsified medicines acquired by consumers on a well-known marketplace with the intent of making citizens aware of the risk of sales of counterfeit medicines by unauthorized websites. That situation poses a danger to public health and the risks may be heightened further during the current pandemic due to medicines being touted as anti-COVID-19 products or vaccines.

Online sale of medicines to the public: The regulatory framework

Pursuant to the Codice del Farmaco,[1] or Drug Code, only medicines that do not require a prescription (nonprescription and OTC – or over the counter, preparations) may be sold online.[2] Furthermore, only pharmacies, parapharmacies, and the health sections of large stores with brick-and-mortar outlets within national borders are permitted to sell such medicines online.[3]

In order to sell medicines online, parties must obtain the relevant authorization from the appropriate region  (or authority delegated by said region) and comply with regulatory requirements, including advance registration in the list of those authorized to conduct remote sales to the public of nonprescription medicines—via a request filed with the Ministry of Health—and placement of a national identifying logo on each page of the website where nonprescription medicines are being sold.

A website used by legally qualified parties to sell medicines to the public must contain all the elements required by the regulations, including the abovementioned national identifying logo with a hyperlink to the list of parties authorized to conduct sales published on the Ministry of Health website. Upon seeing these elements, citizens can rest assured that the website they are using to purchase medicines is lawful.

Furthermore, in a circular dated May 10, 2016, the Ministry of Health indicated that (i) use of intermediary websites, ecommerce platforms, and apps to manage online purchases of medicines sold to the public by authorized websites is forbidden, and (ii) the prices of drugs sold online cannot differ from those applied in brick-and-mortar pharmacies and parapharmacies.

Falsified medicines: Case history and enforcement

At the time the AIFA notice was issued, enforcement regarding online sales of counterfeit medicines had intensified, due at least in part to the pandemic, which is spurring consumers to look online for possible remedies and products that help prevent infection.

For example, last March, the N.A.S. carabinieri (food and drug police force) conducted an investigation targeting pharmaceutical cybercrime that led to the shutdown of fourteen websites that were selling medicines and vaccines in connection to the COVID-19 pandemic.[4] Specifically, these were medicines that were not authorized for sale and of dubious provenance, prescription medicines, and products containing substances damaging to humans.

The Ministry of Health noted that from January 2021 through March 2021 the ministry’s general office for medical devices and pharmaceutical services issued a full twenty-nine shutdown measures.

Several different regulatory and enforcement authorities, including the Ministry of Health, the AIFA, and the N.A.S. (food and drug force), are involved in ensuring that medicines sold remotely to the public via the Internet are safe.

The Drug Code provides a specific procedure for performing oversight and combatting abusive behavior in relation to online drug sales. That procedure is led directly by the Ministry of Health (Art. 142-quinquies). Specifically, the AIFA is required to schedule periodic technical committee meetings (services conferences) to examine cases reported to or discovered by the N.A.S. as part of its oversight activities. Representatives of various authorities, including the Autorità Garante della Concorrenza e del Mercato (the Italian Competition Authority, or AGCM), sit on this committee. Once the services conference has made its assessment, the AIFA may suggest that the Ministry take steps to stop the illegal activity and in urgent circumstances the Ministry may issue an order to shut down sites used for the illegal sales.

Companies with authorization to sell medicines that have been counterfeited frequently participate in this oversight and combatting of illegal activity by reporting to the authorities illegal activities on the web of which they become aware, as well as marketplace platforms where such sales are conducted.

As the consumer protection authority, the AGCM is also involved in such enforcement activity. The agency has sanctioned many cases of illegal sale of drugs (including sanctions of 250 thousand, 200 thousand, and 50 thousand Euros that the AGCM brought against two companies and a private entity, upheld by the Regional Administrative Court of Lazio with ruling No. 765/2017) and in many cases has blocked the illegal sale of drugs on the web as an unfair business practice (most recently in 2020 in relation to anti-COVID-19 products).

It is therefore unsurprising, considering the extent of the overlap between their investigation and oversight, that in 2017 the AGCM and the AIFA entered into a cooperation agreement that calls for them to exchange information on investigations underway in relation to counterfeiting cases and remote sales of pharmaceutical products.

AIFA recommendations

In light of the increase in reporting and the current pandemic scenario, the AIFA recommends that consumers purchase medicines only from authorized websites only, that can be recognized by the presence of the national logo, and it also counsels wariness in response to “unbeatable deals” seen online.

The AIFA also reiterated the importance of reporting by private citizens, healthcare professionals, companies, and associations. That reporting helps the agency safeguard public health as efficiently as possible against risks stemming from illegal and counterfeit products.

Notes

  1. Legislative Decree No. 219 of April 24, 2006 (“D.Lgs. 219/2006”). [1]
  2. Art. 112-quater of D.Lgs. 219/2006. [2]
  3. Commercial enterprises identified by Art. 5, Par. 1, Decree-Law 223/2006. [3]
  4. For further information, see the notizia (notice) published on the Ministry of Health website on March 23, 2021. [4]

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