The need to rapidly access medicinal products to cure or prevent a possible health threats is particularly challenging under emergency situations, such it might be the current coronavirus pandemic. Shortage of drugs might also occur in the pharmacies, prompting people to look for alternative sources of supply for the desired products. Dietary supplements (e.g. vitamins or herbal extracts) may also look appealing, especially to reinforce the immunity system.
The internet offers a multiplicity of websites where to buy pharmaceutical products and supplements, often for significantly lower prices than those normally applied by pharmacies. There are many risks of fraud linked to this type of products, starting from the often unknown origin both of the website and of products sold thereof. While the European Medicines Agency (EMA) has warned about the risk falsified medicines to treat coronavirus are being sold on the internet, the OECD and the European Office for Intellectual Property (EUIPO) have published a joint report discussing the current status of pharmaceutical counterfeiting.
“The study published today confirms the importance of building a strong system that is able to prevent falsified medicines from entering the legal supply chain through which medicines reach patients”, said Adrian van den Hoven, Director General of Medicines for Europe.
Falsified medicines at the time of the coronavirus
The European Medicines Agency (EMA) issued a note in March to alert the general public not to buy medicinal products to fight the coronavirus epidemic from untrustworthy websites. Falsified medicines might be dangerous for the health of people assuming them, as they may contain altered dosages of the active ingredient (both lower or higher), or even no API at all. Excipients too may be not pharmaceutical grade, thus posing further quality and safety issues. EMA says a great attention should be paid to websites claiming the availability of medicinal products to treat coronavirus which are not other way present on the market, as there is a very high risk they are counterfeited.
European online pharmacies authorised to sell drugs and supplements on the internet can be verified by the presence of the special common logo on their homepage. Clicking on the logo redirects to the official lists of authorised online pharmacies which is managed by each European national competent authority. The lists for each country can be also accessed from EMA’s website.
In case of shortages, EMA’s advice for patients is to contact their doctor, pharmacist or national competent authority in order to receive guidance on possible alternative medicinal products that can be used instead of the missing one.
China and India are the main hubs for falsified medicines
The Falsified Medicines Directive dates back to 2011 and is fully operative since 2019: all medicinal products commercialised on the European market have to carry the 2-D data matrix and anti-tampering device that enable pharmacists to verify their authenticity. Two IT hubs (EMVO & NMVOs) have also been established at the European and national level, respectively, to track all serial numbers in a collaboration effort between legislative and regulatory authorities and industrial stakeholders.
According to the OECD-EUIPO’s report, the global total value of falsified medicinal products was € 4.03 billion in 2016 ($ 4.4 billion). The report analyses data relative to years 2014-2016 and pertaining only international commerce, thus excluding falsified drugs manufactured and commercialised within a single country. Antibiotics and medicines to treat pain are the two more often counterfeited categories; other therapeutic areas which are often object of fraudulent activities include diabetes, HIV, cancer and the so-called “lifestyle” medicinal products, targeted to the maintenance of a correct lifestyle.
The data exposed by the report have been gathered on the basis of seizures of falsified medicines made at customs. China and India, the main pharmaceutical hubs worldwide, are also the main sites of origin of falsified medicines, while transit often involves Hong Kong, Singapore, the Emirates, Yemen and Iran, says the report.
The main points to be considered
Indirect costs have also to be kept in mind, for example resulting from the need to treat health conditions arising from the assumption of low quality falsified medicines by patients, as well as from the possible environment pollution resulting from their improper disposition.
Counterfeiting is a serious threat for the competitiveness of the legitimate pharmaceutical industry. Loss of revenues at the global level due to this kind of practice is estimated by the report to be approx. €1,7 billion. From this perspective, the US appeared to be the country which suffers the most, with 38% of its pharmaceutical companies hit by infringement of their intellectual property rights; Swiss, Germany and France are also greatly affected by the phenomenon.
Distributors are the most vulnerable point at the level of the pharmaceutical supply chain, while according to the report wholesalers suffer for lower criticalities. Another point of attention is linked to postal services, as often shipments of falsified medicines occurs as single, small parcels which are then capillary distributed by Posts or couriers. This represents a challenge as for the possibility to track and prevent the overall phenomenon, says OECD and EUIPO’s experts.
Counterfeiting also requires the ability to closely replicate the packaging in order to render the falsified medicine indistinguishable from the original medicinal product. This sort of re-packing activities is often run, according to the report, in the many free exchange areas present at the international level, that thus represent another criticality needing attention.