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The battle against counterfeited medicinal products sold online via non-authorised channels

The possibility to sell medicinal products in stores other than pharmacies has been considered over the years, allowing the sale of non-prescription products also in parapharmacies and in the web. The availability of the Internet and a greater knowledge of milder diseases by a wider audience have helped opening regulated online sale channels: the current regulations only permit the marketing of non-prescription medicines and only by authorised online pharmacies.

The authorisation to market medicines in digital channels is characterised by a specific logo that online pharmacies publish in their website. By clicking it, an automatic link refers the user to an official list of all authorised subjects operating legally (registered at the Ministry of Health). Users can verify whether the website address they wish to buy from is also listed.

The left half of the logo, that is the same all over the European Union, include the flag of the country where the remote sale entity is registered (pharmacies and parapharmacies, in the case of Italy), and include a series of technical features ensuring high security levels, in order to prevent any fraudulent use.

Fight against illegal drug trafficking

In Europe, the fight against the illegal traffic of medicines has been firstly boosted by Directive 2011/62/EU, amending Directive 2001/83/EC. This document has introduced a series of preventing and contrasting measures against falsified drugs, and includes the first official definition of a “falsified medicine”, identifying a false “representation” of:

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

In order to monitor the whole distribution cycle of marketed medicines, and therefore to hinder the manufacturing and sale of counterfeited drugs, Italy has introduced drug traceability, ensured through an antifraud sticker printed by the State Printer and Mint (Istituto Poligrafico della Zecca dello Stato, IPZS)m and by a central database at the Ministry of Health, where all data regarding the manufacturing and supply of the numbered stickers applied to drug packs flow into.

Every drug pack is numbered with its own tear-off tab, so that its whole route, from manufacturing to purchase, and even to the collection of the expired product, can be followed. The tracking system was instituted just for the purpose to provide citizens with the certainty that the drugs they are given are original and valid in every respect.

On their side, the Italian Medicine Agency has also committed to a campaign of information and notice to consumers to make them aware of the risks related to online purchases of drugs, outside the official channels. This is due to the fact that the hazards of entrusting unauthorized website and digital operators with one’s health are still not sufficiently taken into account.

Awareness and education campaign

The phenomenon of the online sale of false or counterfeited drugs is more and more spreading globally and need, now more than ever, a strong sensitising and educational campaign addressing consumers as it has become a wide, global and underestimated issue for public health.

In developing countries this concerns very important products (vaccines, antibiotics, and other life-saving products), whereas in developed countries it has been found mostly in lifestyle maintenance drugs such as weight loss products, often sold outside legal channels, or products for erectile dysfunction. More recently, it has extended to drugs related to COVID-19 (either cures or vaccines). The COVID-19 vaccines sold online are illegal and lack of any guarantee regarding quality, efficacy and safety; they are, therefore, potentially hazardous.

A while ago, an Ocse-Euipo study listed the six most serious consequences of the world market of counterfeited drugs:

  1. Harm to people’s health
  2. No sale and damage to the reputation of legitimate manufacturers.
  3. Costs and revenue losses for governments and economies.
  4. Costs to cure patients who suffered from the health’s negative consequences following the consumption of counterfeited drugs;
  5. Environmental pollution originating from erroneous practices of unregulated criminal activities using potential toxic substances;
  6. Social costs in terms of increased organised crime and loss of jobs.

Public attention is focusing on this relevant issue also at political level, as it has been more than once a subject of Parliament interrogations. One of the latest, on 20 October 2020, especially focused on the spreading of COVID-19 drugs, led the European Parliament to inform that there is a Commission proposal regarding a new legislation on digital services establishing a horizontal picture for the responsibilities of online intermediaries, such as hosting providers and online platforms, to contrast illicit contents, including counterfeited drugs.

The network of national authorities for the protection of consumers has adopted, with the Commission’s support, a common position and is cooperating with online platforms to protect consumers from misleading health indications related to COVID-19 and from any similar future situations of damage to collectivity.

They have also informed that on 25 November 2020, the Commission announced the development of an EU tool package to contrast counterfeiting establishing the principles of joint actions, cooperation and data sharing among right holders, intermediaries and authorities enforcing legislation.

Written by: Michela Tonci

Foto di StartupStockPhotos da Pixabay