On-line Sale of OTC Medicinal Products

Effective as of tomorrow (July 1, 2015), Italian consumers will be able to purchase over-the-counter (“OTC”) drugs on-line.

Legislative decree nr. 17 of 2014 (“Decree”), enacting EU Directive 2011/62, introduced an innovative way of marketing medicinal products for pharmacies and authorized retailers. In order to do so, pharmacies and retailers must meet several conditions, aimed at preventing marketing of counterfeit products.

  1. First of all, pharmacies and retailers must be authorized by either regional entities, provinces or other competent authorities, upon providing the following information:
  • name, VAT and full address of the logistic site;
  • starting date of on-line sale;
  • website address and any other information that may be necessary to identify the seller’s website.

Any change must be communicated within 30 days, subject to forfeiture of the authorization.

  1. Secondly, the seller’s website must contain at least:
  • information relating to the authorizing authority;
  • a link to the Ministry of Health’s website;
  • a specific logo, including a link to the list of the authorized pharmacies and retailers, maintained by the Ministry of Health.

Additionally, the Ministry of Health’s website shall contain a link to a website created by the European Medicines Agency, which will include information on the purpose of the specific logo, as well as on the risks relating to medicinal products that are unlawfully supplied to the public. The Ministry of Health’s website will also contain information relating to the applicable laws and regulations, including any information on differences vis-à-vis other countries as to conditions regulating the supply of medicinal products.

  1. Lastly, distribution shall be carried out in compliance with good distribution practices.

The Italian Agency for Pharmaceutical Products (Agenzia Italiana del Farmaco, “AIFA”) will be in charge of enforcing the new set of rules. AIFA will direct an anti-counterfeiting system in cooperation with the Ministry of Health, the High Institute for Health (Istituto Superiore di Sanità, “ISS”), the Anti-counterfeiting and Health Department of the Police (Nuclei Antisofisticazione e Sanità, “NAS”), and the Customs Authorities. The system will receive reports concerning allegedly counterfeit medicinal products, and AIFA will coordinate seizure of actually counterfeit medicinal products.

Furthermore, the Ministry of Health, upon AIFA’s proposal, will have the power to issue cease and desist orders directed at on-line sellers, as well as orders aiming at blocking the access to websites selling counterfeit medicinal products.

Lastly, on-line sale of prescription drugs will be punished with imprisonment up to one year and a fine between Euro 2,000.00 and Euro 10,000.00, whereas on-line sale of medicinal products by unauthorized individuals or entities will be punished with imprisonment from 6 months to 2 years and a fine between Euro 3,000 and Euro 18,000. On-line sale of counterfeit medicinal products will be instead punished with imprisonment up to 3 years and with a fine between Euro 2,600.00 to Euro 15,600.00.

The measures introduced by the Decree appear balanced. On the one hand they grant an overall wider access to OTC medicinal products along with a presumable price reduction; on the other hand they set forth a solid enforcement system preventing and punishing marketing of counterfeit drugs. As with every innovation in the field of health, only time will tell if benefits and risks are actually balanced.

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