In 2020, the WCO Secretariat ran the first ever Operation STOP initiative to assist Customs enforcement services in enhancing their capacity to control the medical products which are generally used to diagnose or treat COVID-19. An article listing the achievements of the Operation was published in the 94^th edition of WCO News in February 2021. That year saw the worldwide launch of COVID-19 vaccination campaigns, and the Secretariat took the decision to launch a second Operation STOP, this time adding vaccines to the list of targeted products. Operation STOP II ran from April to September 2021.

Before and during the Operation, webinars on raising awareness surrounding the COVID-19 vaccines were organized in close collaboration with five pharmaceutical companies in order to provide Customs services with an overview of the main features of the vaccines approved by WHO, their legal supply chain and the identified fraud mechanisms. Some companies also updated this information throughout the Operation.

Training sessions on the use of the IPR CENcomm communication tool were also organized to ensure that participating administrations fully understood the tool’s functions and the WCO’s data requirements.

Results

A total of 83 administrations reported 3,434 seizures or detentions relating to illicit targeted products, including 13 seizures or detections of vaccines, which amounted to:

• 5 million units of medicines, as well as the equivalent of 13.4 million doses of COVID‑19 and other vaccines (57%);
• 7 million units of medical devices (43%), mostly face masks.

The term “illicit” refers to those medicines and medical products which have been smuggled or have not been declared, those which are not presented with the requisite documentation, counterfeit or date‑expired medicines or medical products, and medicines or medical products which have been transported in improper conditions.

Many of the targeted products are subject to health authority regulations, and the vast majority of detentions or seizures were made because the products concerned lacked marketing authorization, a declaration of conformity or a licence.

In addition to face masks, the medical devices seized included oxygen therapy devices (5%), such as oxygen concentrators, oxygen cylinders, ventilators and oxygen regulators. Pulse oximeters, used to measure oxygen levels in the blood, were also trafficked. The vast majority of cases (66%) involved a failure to present the requisite documentation.

Most of the 13.4 million COVID-19 vaccine doses (3.7% of all illicit products) were detained on export, due to the absence of requisite documentation and licences. In one instance, 20,000 doses were seized on import because the vaccine in question had not been approved in the destination country and the importer had no authorization. In another instance, 10,000 doses were seized due to improper transport conditions. Two attempts by airline passengers to smuggle vaccines and two further attempts to smuggle vaccines in mail parcels were also reported.

The medicines seized or detained included anti-infective agents, in particular anti-malarials, antibacterials, anti-parisitics and anti-viral agents. Numerous illicit imports of ivermectin – an agent marketed as an anti-parisitic treatment and approved by some countries’ health authorities as a COVID-19 treatment – were reported, including in countries where it is not approved as a medicine for human consumption. The same is true of muscle relaxants, which are likewise used to treat COVID-19 but are not universally approved.

It should be noted that no fewer than 94% of all ivermectin seizures or detentions involved their concealment in mail parcels. All products combined, 1,220 seizures or detentions were carried out on packages transported by postal or express courier operators.

Illicit medicines intercepted due to the absence of requisite documentation or as a result of attempted smuggling are often released once the relevant documentation has been provided or a fine has been paid. In most seizure or detention cases (66%), no further investigation was undertaken to determine whether the products were counterfeit, given that this did not appear necessary. Only 4% of the seizures were made – sometimes in part – on account of intellectual property rights infringements. These cases mainly concerned face masks.

Many Members adopted the “COVID-19 vaccination passport” in 2021, and falsified vaccination record cards then began to emerge. The participating Customs authorities reported only a few attempted cross-border consignments of such documents using mail parcels, although open information sources report numerous such attempts.

The control measures and actions coordinated with other enforcement services led to 16 arrests in six countries for the illegal trafficking of products linked to COVID-19. In Namibia specifically, one individual who sold ivermectin tablets online was arrested by police following an alert issued by Customs.

Some administrations explained that they could not play an active role in the Operation because product quality and conformity control is the responsibility of organizations other than Customs, in particular health agencies. However, the Customs administrations are responsible for ensuring that all products are declared in the proper manner. It is important to note the need to establish close cooperation between the market surveillance authorities and the national Customs administrations. Participating administrations upstream of the Operation were therefore asked to ensure that mechanisms for exchanging the data and information required for effective cooperation were in place. In order to heighten Customs officers’ awareness of this matter, several articles had been published in WCO News No. 94.

Data volume and quality

The figures reported during the Operation do not account for all actions undertaken by Customs to combat the trafficking of products linked to COVID-19. Although the participant countries had a communication platform (IPR CENcomm) at their disposal for exchanging information and reporting completed seizures and detentions, not all participants used it, or at least not exhaustively, for multiple reasons: the form for inputting data was too restrictive or not tailored to its purpose; there was a poor or no Internet connection, a lack of feedback from field officers, no cooperation with health authorities and a lack of resources for inputting data into the IPR CENcomm; and data-sharing restrictions applied in connection with data protection policy.

In addition, the quality of information reported via CENcomm was sometimes not good enough to be used by analysts and investigators. These issues had already been identified during the first iteration of Operation STOP.

More information
Stop@wcoomd.org