A new, whole-of-governments approach to combating the trade in illicit health products is the focus of a collaboration between the US Food and Drug Administration (FDA), European authorities, and the Organization for Economic Cooperation and Development (OECD). The FDA aims to prevent illegal medical goods, such as counterfeit pharmaceuticals and drugs, from being shipped to America in the first place.
With this international initiative, the FDA is essentially responding to a change in the approach of counterfeiters. According to the officials, that was because with the wake of the coronavirus pandemic, counterfeiters had increasingly transshipped illegal pharmaceutical products through the European Union – back then, especially alleged Covid‑19 drugs and medical goods. For this, the fraudulent drugs had been shipped to an EU country, usually without passing through customs there; before they had then been transported from there to the US market. This practice is often referred to as transshipment. In addition, the counterfeiters and fraudsters would increasingly send many small packages instead of a few larger shipments. Such a practice reportedly increases the risk of illegal medicines not being intercepted and traced by customs.
Several meetings of representatives of authorities and the OECD Task Force on Countering Illicit Trade have already taken place, according to the FDA. The FDA hopes to follow up on previous successes in international cooperation, particularly with the United Kingdom. It said that authorities from the two countries had cooperated in several so-called Operation Lascar initiatives, starting in 2017. For example, the two countries had exchanged customs information. In addition, portable FDA devices had been deployed at international mail centers in London, to detect counterfeit drugs. As a result, during five Lascar operations, the FDA had been able to initiate a total of more than 80 new investigations and to identify more than 3,000 shipments of illegal health products intended for the United States.
“With the majority of health products and particularly human drug products being manufactured overseas, the FDA’s regulatory responsibilities are now global, particularly in such a diversified supply chain and complex geopolitical environment“, an FDA press officer explained.
Positive voices on the new initiative are also coming from the private sector, which is an important partner for the authorities in the fight against illegal health products. The director general of the Transnational Alliance to Combat Illicit Trade (TRACIT), Jeff Hardy, said he is “pleased to see the OECD and the US FDA converge their mandates protecting consumers and patients from harmful fake, falsified and substandard products“.
Globally, counterfeit medicines remain a significant concern. A study published in 2020 by the OECD and EUIPO estimated the value of counterfeit medicines traded worldwide in 2016 at more than four billion euros.