Press release

Paris, 22 September 14

The health and safety of Africans are seriously threatened by the scourge of illicit and/or counterfeit pharmaceutical products, many of which are dangerous. Faced with a rise in this extremely worrisome illegal trafficking, customs authorities are on the front lines when it comes to stopping illegal imports and protecting consumers.

The International Institute of Research Against Counterfeit Medicines (IRACM) and the WCO decided to join forces for the third successive year in order to conduct a sweeping large scale customs operation, called « Operation Biyela 2 », to fight the trafficking of products that are a threat to the health and safety of consumers in 14 Sub-Saharan, West and East African nations.

Operation Biyela 2 mobilized 14 African customs organizations[1] for a ten day period (26 May to 4 June 2014), with the aim of carrying out simultaneous inspections of shipments of goods that could potentially contain illicit and/or counterfeit pharmaceutical drugs that pose a potential threat to the health of local populations.

Such 113 million pharmaceutical products were intercepted, for the most part in Benin, Tanzania, and Democratic Republic of Congo (DRC). Most of the shipments came from either China or India.

A majority of the pharmaceutical drugs seized by African customs authorities are related to primary care (32% analgesics, 17% anti-inflammatory drugs, 5% antibiotics), as well as drug therapy (17% of the intercepted products were anti-tuberculosis drugs).

The operation also resulted in, for the first time, significant detection of illicit veterinary products: more than one million intravenous drugs in Benin, more than one million tablets and vials in Mozambique, and more than 100,000 intravenous drugs in Togo.

“The number of interceptions effected during this operation shows once again the scope of the scourge of illicit and counterfeit pharmaceutical drugs in Africa. The response can be described in a nutshell as follows: strengthened cooperation, based particularly on information sharing at the national level, and on the part of customs authorities, other regulatory agencies, and public health officials; and at the international level between customs authorities,” said WCO secretary general, Kunio Mikuriya. “This second edition of Operation Biyela involving 14 African nations once again underscores the key part played by customs authorities in protecting consumers’ health, and the need to give customs authorities all the resources necessary to accomplish their mission, by continuously strengthening their capacities,” he added.

As with all illegal activities, it is particularly difficult to precisely quantify the scope of trafficking in counterfeit medications. However, three years of cooperation between the World Customs Organization (WCO) and the International Institute of Research Against Counterfeit Medicines (IRACM) do provide at least a partial picture of how this trafficking is unfolding in a number of African nations.

Over the course of a more than three year partnership, the three operations that were conducted in major African sea ports (Vice Grips 2, Biyela and Biyela 2) allowed for the interception of almost
756 million illicit and/or counterfeit pharmaceutical products valued at more than 370 million US dollars, and prevented these products from reaching consumers.

The frequency of cases and the size of the batches intercepted by the customs, the increase in types of pharmaceutical products involved (which range from cough medicine to insulin, contraceptives and antibiotics), the “quality” of the counterfeit products, the ever changing techniques used by drug counterfeiters, and the trafficking routes involved: all of these indicators are in the process of being analyzed – and suggest that far from diminishing, the traffic in counterfeit drugs is in fact increasing steadily.

“Customs operations of this nature are absolutely essential. Customs authorities are the first line of defense against the scourge of counterfeit medications; but this fight also needs to be carried out on other fronts, particularly in the judicial system and in legislatures. We are dealing here with scoundrels, Mafiosi, and unscrupulous traffickers. It is essential that all national and international authorities at long last become aware of this problem and take action to protect the lives of patients,” says IRACM director, Bernard Leroy.

Like all criminal activities, trafficking in counterfeit medications takes root in situations where it is most likely to flourish: namely in places where legislatures are unable, or unwilling to cope with the situation, where legal assistance is non-existent, where population is not well informed, where medications are in short supply, where supply chains are complex, where regulatory and inspection resources are lacking, where corruption is rife, etc. In light of these various factors, it is clear that if action is merely confined to national borders, we have no hope of winning the war against counterfeit medications.

The International Institute of Research Against Counterfeit Medicines (IRACM) is actively in the process of creating model laws aimed at helping the countries affected to trace lines of supply, bring traffickers to justice, and seize their assets, and thus better fight trafficking in counterfeit medications.