The Black Hole of Black Market Medicine

Selling fake medicine is an opportunity for counterfeiters to make money, but the results for patients can be damaging or fatal. Mexico has cracked down on this problem in recent years but issues remain.

In some industries, counterfeit products can lead to financial losses. In the medical sector, it can lead to death. Fake medicines can be destructive and even devastating but the lack of global coordination is impeding the fight against these illicit drugs despite local efforts to curb their use. In Mexico, trade on the black market is on the rise.

“Counterfeit, altered or contaminated drugs are an issue several clients of ours have faced recently and the prevalence of this occurrence is growing in Mexico. There are several reasons for this, including organized crime,” says Ernesto Algaba, Partner of the Life Sciences Practice at Hogan Lovells BSTL.

The issue is neither new, nor particular to Mexico. China’s state-controlled Shenzhen Evening News newspaper has reported that in 2001, 192,000 Chinese patients had died due to the use of fake drugs.

Globally in 2015, there were 3,002 incidences of counterfeit medicine involving 1,095 pharmaceutical products, according to the US-based Pharmaceutical Security Institute. The three categories of drugs most targeted by counterfeiters are genito-urinary, anti-infectives and CNS. Cardio-vascular medicines, an important category for the Mexican population, saw a 29 percent increase in the number of fakes from 2014 to 2015 and dermatologicals, a category few think to question, experienced a 57 percent rise in the same period.

In Mexico, El Universal reports that between Jan. 1, 2007 and Dec. 31, 2015, the Attorney General’s Office seized 945,152 fake medicines, just under 942,000 of which were seized in Mexico City. Industry reports on how much medicine in Mexico is false varies wildly from as little as 4.5 percent of the total to 60 percent. Reasons for the discrepancy include insufficient controls and the expanse of the supply chain across borders, where one country’s health authorities cannot survey operations in the other.

Although some countries have anti-counterfeit measures in place and are actively seeking and destroying fakes, one of the main issues in the fight is the lack of global coordination against this international plague. Countries have yet to agree on a standardized term to be used and even Big Pharma companies have an opinion on what should be included within the definition of illegal medicine. They insist that counterfeits, which are defined as functioning copies of a patented drug, be included while NGOs protest that although violating intellectual property, they pose little or no health risk. Interpol has several ongoing operations in the pharmaceutical field, including Operation Pangea, which targets the online sale of illegal medicines. The European Council has drafted the MEDICRIME convention, “a binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health,” according to its website.

As for Mexico, Algaba says that “COFEPRIS is working on eliminating these health risks by increasing inspections and visits. It also has an open dialogue with companies to agree on proper measures for suspending and recalling a product and also in finding those responsible.”