The European Union Intellectual Property Office (EUIPO) and the Organization for Economic Cooperation and Development (OECD) have published a report on counterfeit pharmaceuticals worldwide.
This report is based on an analysis conducted in 2019—which found that imports of counterfeit and pirated goods totaled $509 billion in 2016, or about 3.3% of global trade—but focuses on the pharmaceutical sector.
In 2016, international trade in counterfeit pharmaceutical products totaled $4.4 billion, representing 0.84% of global trade in pharmaceutical products.
Counterfeit medicines pose not only potential economic harm to this sector but also significant health risks, as counterfeit medicines are often not properly formulated and may contain dangerous ingredients.
This report, which covers the period from 2014 to 2016, shows that the counterfeit drugs seized included medications for serious illnesses, including malaria, HIV/AIDS, and cancer. They also included antibiotics, lifestyle-related treatments, pain relievers, diabetes medications, and central nervous system drugs.
India remains the leading source of counterfeit pharmaceutical products, accounting for 53% of the total value of counterfeit pharmaceuticals and medicines seized worldwide in 2016. Following India are China (30%) and the United Arab Emirates (4%).
Among the countries most affected by the trade in counterfeit pharmaceutical products are the United States, the United Kingdom, France, Austria, Germany, and Switzerland. Specifically, with regard to counterfeit pharmaceutical products shipped to the European Union, India remains the primary source economy, accounting for 47% of the total value of counterfeit pharmaceutical products and medicines seized by EU customs authorities, followed by China, with 37%.
With regard to modes of transport, between 2014 and 2016, courier, postal, and express services were the primary modes of transport for counterfeit pharmaceuticals and medicines exported to EU economies, both in terms of value and volume.
Among the factors driving the trade in counterfeit medicines and pharmaceutical products are profitability—in some cases, the profit margin reaches 7,900%—; the low risk of detection, due to the difficulty customs officials face in accessing simple field tests to help them classify suspicious products; low risk of prosecution, since most counterfeits are only detected once they reach retailers or patients, and it is often difficult to trace them through complex supply chains or to prove where the criminal activity took place; and lenient penalties—the global average prison sentence for trademark counterfeiting is 6 years.
Regarding the impact of counterfeit medicines, the report reveals the serious consequences that can result from the use of counterfeit medicines.
One of the sources consulted, the World Health Organization, indicated that counterfeit and substandard antimalarial drugs may be responsible for the deaths of 116,000 people in sub-Saharan Africa.
Counterfeit medicines not only affect individuals on a personal level, but also directly impact legitimate drug manufacturers, who suffer consequences such as loss of revenue, damage to their brand, and increased costs for security measures.
In an effort to combat counterfeit drugs, governments and the industry have worked hand in hand to combat substandard and counterfeit pharmaceutical products. It is worth noting, for example, that in 2016 the MEDICRIME Convention—drafted by the Council of Europe—was launched, providing countries with a model legal framework to address counterfeit medicines and other types of pharmaceutical crimes that threaten public health.
This treaty calls for multilateral collaboration among nations, disciplines, and sectors, and lays the groundwork for cooperation with and among international organizations such as INTERPOL, Europol, UNODC, the World Customs Organization, and the WHO, in order to put an end to this international threat to public health.
In short, the fight against counterfeit medicines is always an urgent, ongoing, and unavoidable necessity for society as a whole. The current global COVID-19 crisis will serve as a tragic reminder of the serious harm caused by the sale of counterfeit pharmaceutical products and of the urgency of putting an end to such practices worldwide.
Author: Alberto Gallo