Italian Medicines Agency Agenzia Italiana del Farmaco

Fight of pharmaceutical crime

Fight to pharmaceutical crime

The fight against pharmaceutical crime – a definition that includes all those illegal phenomena occurring in the pharmaceutical sector – entails the management of cases concerning:

  • production and distribution of falsified or illegal medicines;
  • theft and laundering of medicinal products;
  • promotion and sale of medicinal products through unauthorised websites.

AIFA pays particular attention to the problem of falsified or illegal medicines.

 

fight to pharmaceutical crime

What is a falsified medicine: Directive 2011/62/EU (Leg. Decree no. 17 of 19 February 2014)

Directive 2011/62/EU, amending Directive 2001/83/EC, introduces a number of measures to prevent and combat the problem of falsified medicines. It contains the first official definition of ‘falsified medicinal product’, that is any medicinal product with a false representation of:

  • its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
  • its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder;
  • its history, including the records and documents relating to the distribution channels used.

Falsification involves brand-name and generic medicines, life-saving medicines and lifestyle saving medicines. A falsified medicinal product may contain the same substances as the original one, different substances and/or dosages; it may contain no active substance or even be composed of contaminated and dangerous ingredients. These different types all have poor quality and poor safety in common, since production and distribution do not comply with the quality standards set out in the Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

What is an illegal medicine

Illegal medicine means a medicinal product without the necessary authorisation for being marketed or imported into the national territory. In this regard, the current legislation provides that medicines from foreign countries can only be imported in certain cases and always subject to an import authorisation issued by the competent authorities, i.e. AIFA and the Ministry of Health.

 

Thefts of medicines

AIFA, in cooperation with the Ministry of Health and the Anti-adulteration and Health Units (NAS) of the Carabinieri police, started a dialogue with stakeholders in 2013. As a result, a database of stolen medicines was implemented, that is managed by the Agency and is constantly updated with information from MAHs, depositaries, suppliers, hospitals and the police. The database is intended to organise all available information on stolen medicines in a structured way, in order to allow for  its analysis. Such tool proved extremely useful in 2014, when the “Vulcano” police operation was launched and carried out.

Currently, more than 80 pharmaceutical companies and groups take part in this initiative, accounting for around 49% of the total products authorised in Italy.

The database is for internal use and is not accessible. On an ad hoc sharing platform, the monthly report, which contains all non-sensitive data present in the database, is accessible to accredited users only.

As part of the European Fakeshare project, a further sharing platform was created to extend the functionalities of AIFA’s stolen medicines database to other countries as well. The timely reception of information on theft events is essential to prevent any possible attacks to the legal supply chain, both at national and international level. To support this process, AIFA has set up an ad hoc system. This features an online form that can be downloaded from the AIFA website. This form should be filled in with the relevant information and then sent to the dedicated e-mail address medicrime@aifa.gov.it, preferably within 48 hours from the event. This way AIFA can promptly update its database and inform the actors to whom such stolen products could be offered, as well as to issue a quick alert to the Italian and European network. 

Management of reports of illegal and/or falsified medicines

Part of the control activity carried out by the Office concerns the handling of alerts relating to the finding of suspected medicinal products at customs or within the national territory.

In particular, this activity includes in a series of checks for ascertaining, where possible, the origin/nature of the medicinal products and their composition through laboratory analyses carried out by the Institute of Health (ISS) on the basis of an agreement between the Agency and the ISS.

The Office participates actively in the annual monitoring activities, one of which is PANGEA, an international operation to fight against illegal drug trafficking, coordinated by INTERPOL and the World Customs Organisation.

At national level, activities are carried out by the bodies that participate in the National Anti-Counterfeit Task Force (previously called IMPACT Italia): AIFA, Ministry of Health, Customs Agency, NAS unit of the Carabinieri police, ISS for the subsequent analytical investigations.

During the week dedicated to checks, all consignments containing – or suspected to contain medicinal products – are inspected at the identified customs premises.

Data from recent operations confirm that the number of Italians turning to unofficial channels – such as unauthorised websites – for the purchase of medicines continues to be high. The most commonly purchased medicines are those for treating erectile dysfunctions, which account for more than 60 % of the medicines seized. However, this phenomenon is not confined solely to such particular product category. It is much wider. Other illegal or falsified medicines seized include analgesics, antivirals, anorectics and anti-inflammatory medicines.

These different types of medicines all have in common an essential critical aspect, that is the danger to health, both public and of the individual, due to the uncontrolled conditions in which they are produced, and to the improper use, which usually happens without medical supervision.

Citizens and health professionals may report any suspected cases by filling in the attached form.

 

Management of reports of stolen medicines

AIFA, in cooperation with the Ministry of Health and the Anti-adulteration and Health Units (NAS) of the Carabinieri police, started a dialogue with stakeholders. As a result, a database of stolen medicines was implemented, that is managed by the Agency and is constantly updated with information from MAHs, depositaries, suppliers, hospitals and the police. The database is intended to organise all available information on stolen medicines in a structured way, and to allow for  its analysis.

AIFA therefore invites interested parties to report any useful information on events related to the theft of medicines by sending the filled-in “Theft reporting form” to the e-mail address medicrime@aifa.gov.it. This way, data made available by companies that already populate the theft database are integrated. The purpose of these activities is to quickly share information on stolen medicines at national and international level, which, as recent cases have shown, may become the subject of illegal trafficking.

 

Management of infringements reports of legislation regarding the sale at a distance of medicinal products to the public

Pursuant to article 142-quinquies of Legislative Decree 17/2014 (which amends Legislative Decree 219/2006), the investigation activity on websites, which have allegedly violated the regulation concerning distance selling of medicines to the public, is attributed to a body responsible for carrying out inquiries on illegal online pharmacies (Conferenza dei Servizi Istruttoria sulle farmacie online illegali). This body is composed by AIFA, the NAS unit of the Carabinieri police, the Ministry of Health, the Ministry of Economic Development as well as the Antitrust Authority and the IT Registry as observers.

Alerts sent to AIFA are examined and the steps to be taken for ascertaining infringements are assessed by the Conferenza. At the end of the investigation, the documentation is forwarded to the Ministry of Health, which is responsible for adopting measures, including in urgent cases, which provide for the closing down of businesses found to be illegal.

Reports should be sent to: qualita.prodotti@pec.aifa.gov.it

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