Pharma wary of counterfeiting becoming crime against humanity

Pharma wary of counterfeiting becoming crime against humanity

International Criminal Court in The Hague, Netherlands

Industry sources say calls to make counterfeiting a crime against humanity could help raise awareness, but add that they might not make a practical difference

A petition sent this week calling for counterfeiting to be declared a crime against humanity could help grab policy makers’ attention but might not change much in practical terms, say pharma industry and legal sources.

While sources say they welcome the new effort from the Anti-Counterfeit Network Africa (ACN) to put counterfeit medicines higher on governments’ agendas, they are sceptical of whether prosecution at the International Criminal Court (ICC) would be a viable enforcement option.

The ACN, a non-profit based in Uganda, made the call for counterfeiting to be considered a crime against humanity in a petition sent to the ICC this week on November 1.

In its letter, the ACN questioned why politically motivated crimes against humanity, such as those occurring during armed conflict, were treated more seriously than the distribution of lethal counterfeit drugs.

Counterfeiting, the ACN claimed, “probably accounts for more human deaths and bodily injuries than any other crime in the world”.

The petition specifically called for the Rome Statute, which governs the ICC, to include counterfeiting as a crime against humanity when it caused “indiscriminate and widespread death, bodily harm, and injury” to consumers.

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It is no surprise that the petition can from an Africa-based organisation, and that it focused mainly on the threat of counterfeit pharmaceuticals.

Africa is the worst affected region by counterfeit drugs. In 2017, the World Health Organization reported that 42% of all fake drug seizures took place there.

One case study revealed that more than 8 million substandard malaria tablets were distributed throughout sub-Saharan Africa in 2012 alone.

Drugs such as these could be responsible for approximately 120,000 deaths a year, according to estimates from the London School of Hygiene and Tropical Medicine.

While it’s difficult to capture exact figures, reports such as these demonstrate why anti-counterfeiting groups in low and middle income countries want to highlight the damage caused by fake medicines.

Pankaj Aseri, anti-counterfeiting lead for India and south Asia at Novartis, says that no matter the precise number of people who have died, the scale of the problem is such that it must be taken seriously.

“Is it serious enough to be considered a crime against humanity? That’s a matter of debate, but it definitely deserves this attention,” he says.

Aseri says he would support the ACN’s campaign, if only for the spotlight it would put on the threat posed by counterfeit drugs.

“We know vaccines can save lives, but counterfeit vaccines could harm the health of a nation,” he adds.

Mixed emotions

Cyntia Genolet, associate director for Africa engagement at the International Federation of Pharmaceutical Manufacturers & Associations, agrees that the problem deserves greater attention, but isn’t sure the ICC is the right forum.

“We should strengthen what’s already there,” Genolet says, citing tools such as the Medicrime Convention drafted by the Council of Europe – the first international project to “really focus on falsified medicines”.

“It’s starting to work, but it’s not yet where we’d like it to be,” she adds.

Just 18 countries have ratified the convention, Genolet points out, suggesting that strengthening projects such as these would be the natural place to start in ramping up anti-counterfeiting efforts.

“The resources are scarce, and you need to focus them,” Genolet says. “I don’t want the efforts to be diffused between different tools.”

Lorenzo Litta, chief business officer at domain management and brand protection service provider Brandit and chair of INTA’s Unreal Campaign, has come across the idea of counterfeiting being a crime against humanity before.

“It’s an extreme perspective, and I’m not in favour of anything that is extreme. But I understand the rationale.”

He notes that counterfeit drugs are very limited in Europe and other high-income regions. In other places, however, there are “villages that could be destroyed”.

In that context, the push to make counterfeiting a crime against humanity “is not that crazy”, Litta says.

“My guess is that it is primarily designed to raise awareness, to get the relevant people paying attention.”

Matter of perspective

Stuart Adams, principal at Rouse in London and chair of INTA’s EU anti-counterfeiting committee, admits that it initially feels wrong that counterfeiting would be lumped in with crimes against humanity such as genocide.

But it’s all a matter of perspective, he says. “Mention counterfeiting to anyone here [in the UK], they think about watches and sports gear. They’re not thinking about pharmaceuticals and agrichemicals.

“When you see that people are being killed in large numbers and view it through that lens, I can see where they’re coming from,” Adams says.

He notes that it seems improbable that anyone would be prosecuted at the ICC for counterfeiting anytime soon, however.

“If there’s a counterfeit out there that kills somebody, they’re already guilty,” Adams says. “You don’t need to take someone to the ICC for that, you just need to catch them.”

The best way to look at the ACN’s proposal, then, might be as an opportunity to put counterfeit drugs at the top of the agenda.

On that basis, Aseri of Novartis thinks the industry would welcome it.

“I’m not sure how it would go at the ICC, but in general, industry professionals would say that the issue needs more attention,” he says.

With greater attention, however, comes more pressure on brand owners to ensure their own practices stand up to scrutiny.

This, Adams says, is a huge challenge for any brand owner that wants to shine a spotlight on the social ills associated with counterfeiting.

Demanding that counterfeiting be treated as a crime against humanity could put brand owners in an awkward position, should their own supply chains be compromised, or if any of their own health and safety or labour practices face criticism.

“With the best will in the world, it’s nearly impossible for any brand owner to totally police their supply chain,” Adams says. “You have to make sure your own house is in order.”

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