In early 2005, a 23-year-old complaining of fever was taken to a rural hospital in eastern Myanmar and diagnosed with an uncomplicated form of malaria. He was treated with a standard dosage of an inexpensive oral antimalarial known as artesunate, a derivative of a key malarial drug that had already successfully treated hundreds in the area. Yet on the third day, the man fell into a coma with kidney failure. Stronger medicines administered at a second and then third hospital were unable to fight off the increasing numbers of malarial parasites in his bloodstream. He died shortly after.
As it turned out, the artesunate he’d been given was fake. Labelled as manufactured by Chinese company Guilin Pharmaceutical, the tablets were part of a large batch purchased by the public hospital that turned out to be bogus. In this case, the supposedly life-saving drug contained little more than paracetamol. Incensed by what should have been an easily preventable death, the village committee collected all the artesunates they could find from local shops, built a bonfire, and sent them up inflames.
Almost 15 years later, the scourge of fake medicines continues in Southeast Asia, a hub for cross-border drug smuggling, with new cohorts of fraudsters able to slip poor quality medicines into the largely unregulated supply chain with increasing sophistication, making detection harder than ever.
Fraudulent medicines in Southeast Asia
Lacking the sophisticated fraud detection systems of more developed countries, and helped along by the increasing ease of trade within ASEAN, as well as low penalties for the manufacture and sale of fake medicines, the region offers the perfect low-risk, high-reward climate for fraudsters.
An oft-quoted 2017 figure from the World Health Organisation (WHO) estimates that one in 10 medicines in lower- and middle-income countries are so-called “fakes”, the catch-all term for what the WHO defines as substandard and falsified medicines. By definition, substandard medicines don’t contain enough of the active ingredient to function properly—while legally manufactured, they become poor quality through improper storage, the passing of time or manufacturing errors. Falsified drugs, on the other hand, imply a criminal intent to deceive. Mislabelled packages can hold medicines that contain a fatal level of the active ingredient, as well as other toxic chemicals—some common examples are cornstarch and chalk, but in extreme cases medicines have been discovered to contain rat poison, floor wax, paint thinner or methamphetamine.
The biggest international operation conducted in the region uncovered 20 million fake and illegal medicines in the region across Cambodia, China, Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam.
The consequences for poorer nations can be catastrophic. According to a United Nations Office for Drugs and Crime (UNODC) report, medical products trafficked to Europe and the United States tend to be lifestyle medicines such as erectile dysfunction pills, but fraudulent medicines that end up in Southeast Asian markets are more likely to be essential, lifesaving drugs, particularly antimalarials and antibiotics.
The biggest international operation conducted in the region was headed by Interpol in 2009, and uncovered 20 million fake and illegal medicines in the region across Cambodia, China, Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam.
Yet for years Southeast Asian governments have been accused of not admitting to the reality of the problem and for lacking the political will to address the issue. Only in November last year did a conference spearheaded by Cambodian Prime Minister Hun Sen in Phnom Penh see regional health leaders from Laos, Myanmar, Thailand and Vietnam openly declare their commitment to tackling the long-standing health crisis of fake drugs. This was a first for the region.
The fake drug trade
The global fake drug trade is notoriously complicated, and can be incredibly difficult to track. Marie Lamy, Director for Access and Policy at the Asia Pacific Leaders Malaria Alliance (APLMA) tells New Naratif that “it’s such a complex industry that it’s virtually impossible to trace back the route of medicine that’s been deemed poor quality and find out what the source of that was."
India and China are known manufacturing hubs, yet the costly and time-consuming process of forensic analysis—on both a molecular level as well as on the packaging itself—needed to trace the origins of these medicines means there’s little comprehensive or reliable data, and sample sizes are small.
Trade routes are equally complex. Fraud or other errors can be introduced at any point in the supply chain, from the point of manufacture to the packaging, procurement, storage and eventual distribution to pharmacies, private clinics, and public hospitals.The culprits are also multifaceted: from smaller-scale backyard manufacturers to sophisticated factory operations or even licenced manufacturers purposely using cheaper and often dangerous ingredients to cut corners, says the UNODC.
On the ground, the greatest risk of encountering poor quality medicines comes from outside major cities, especially along border areas, where regulatory checks are few and far between. An unwitting pharmacist or shopkeeper near the bottom of the supply chain struggling to fill the shelves with medicines from authorised sources is more likely to get stock from wherever they can, says Lamy. “It’s like a guy coming from a nearby country on his motorbike and saying, ‘I’ve got some antimalarial pills from Vietnam, do you want some?’”
A culture of self-medication, especially among migrant populations who aren’t able to easily access public health facilities, also acts as a catalyst for the trade. “There’s almost an actual black market,” says Lamy. “If they are ready to self-diagnose and self-treat, they just say, ‘I’m sure I’ve got malaria. I know what I’ve got to do. I’ve had it before.’ Then they just get it from their buddy here, who got it from I don’t know where. And that’s how you fuel this trade.”
Experts say that it’s ultimately extremely difficult to measure and understand the scale of the problem, leading to the issue as a whole being put on the back burner. “Medicine quality problems are hard for policy makers to see the evidence,” says Paul Newton, an Oxford University researcher at the Lao-Oxford-Mahosot-Wellcome Research Unit in Vientiane. “It’s hard to prove that a patient suffered as a result of poor quality medicine.”
“These are the perfect crimes,” echoes Tim Mackey, director of Health Care Research and Policy at the University of California and fellow at the WHO Collaborating Center for Governance, Accountability and Transparency in the Pharmaceutical Sector. “That’s the problem. If you’re a cancer patient and you get counterfeit cancer drugs, you can’t even prove that you died from the counterfeit drug—you might have died from cancer.”
This lack of hard evidence and difficulty in tracing the fraud’s origins make prosecution difficult. But experts say that punishments often fall short of the crime being committed, especially compared to similar crimes such as the trafficking of narcotics. Fake medicines can also often be lumped into the “counterfeit” category, which suggests an infringement of intellectual property rather than a potentially deadly issue of public health. “There’s a lot of difference in the impact on people between the counterfeiting of an expensive brand name handbag and the falsification of essential medicines,” says Newton.
Steps forward and steps back
Souly Phanouvong, Director of Global Public Health Asia at United States Pharmacopeia (USP), acknowledges that much work has been done by governments and external donors in reducing the amount of poor-quality medicines in recent years across the region.
While data is scarce and comparing figures can be misleading, studies in 2000 and 2002 showed that the numbers of poor quality artesunates—the key antimalarial for a dangerous multidrug-resistant strain of malaria—in mainland Southeast Asia ranged between 38% and 53% of the drugs in the market, while Phanaouvong’s research in2013 saw the average failure rate for a mixture of antimalarial medicine drop to 12% in Cambodia.
But keeping the situation at that level has been a challenge too. Phanouvong explains that these low figures have led to a termination of external financial assistance in ensuring medicine quality in the region.“The striking story,” he says, “is that after 2016, [some of] the governments and donors felt that the quality of medicines, including [for] malaria, was not the big issue anymore in the region.”
With diminishing attention paid to the issue, the situation appears to be worsening. A 2017 study in Laos, Thailand, Vietnam and Myanmar showed the failure rate again reaching as high as 30% for some antimalarials, including the presence of a banned malarial treatment known as oAMT.
“This has led to the failure in the sense of the sustainability of the effort in continuing the fight against poor quality medicines in the region,” Phanouvong tells New Naratif. “It’s a very sad story.”
“If you’re a cancer patient and you get counterfeit cancer drugs, you can’t even prove that you died from the counterfeit drug—you might have died from cancer.”
Not only is another new study showing that the number of poor quality antimalarial medicines is again on the rise, but Phanouvong says regional governments are contesting some of the data, preventing USP from being granted the clearance to publish the results.
A USP document seen by New Naratif states that 30% of the antimalarial samples taken from four unspecified countries in the Greater Mekong Subregion failed quality assurance tests. Phanouvong stresses that “the survey reveals and confirms with strong evidence that poor quality antimalarial products remain available, accessible and used in both the public and private sectors in countries in the region, posing a serious threat to all efforts toward malaria elimination in the Greater Mekong Subregion.”
Since many governments in the region continue to have a vested interest in the extremely lucrative pharmaceutical industry, there is often a lack of willingness or commitment to addressing the problem or publishing accurate data.
“A lot of global health partners have steered clear of medicine quality concerns because it’s a very politically sensitive [issue],” says Lamy. “Sometimes you also have government officials and regulators themselves involved in this industry and so it’s a true conflict of interest.”
Lamy’s own research suggests enforcement officials with low salaries in both Laos and Cambodia take advantage of the weak enforcement of rules and regulations in rural areas by becoming wholesalers or suppliers of pharmaceuticals, and that in Cambodia there have been reports that control agents from the Department of Drugs and Food own pharmacies or manufacturing sites within the country.
Data and monitoring
Keeping data hidden could come as a result of a general lack of transparency in the management of health budgets, says Lamy, and that there is a tendency to play the blame game across both national and international lines. Governments may frame the problem as a regional one and shift the blame to neighbouring countries, or else fault the consumer for purchasing medicines from an unlicensed source. This could be out of a fear that outsiders may perceive the country as having low regulation and poorly enforced laws because of corruption or otherwise.
Further research in Thailand revealed a reluctance to admit to any problem in the first place. Diseases like malaria and poor quality medicines are dismissed as problems for less developed neighbouring countries, as well as mobile and migrant populations.
Cross-border smuggling also makes data collection more complicated, says Mackey, and could give a skewed view of the problem: “When you pick up a medicine, it could be at any part of the supply chain. So if a customs person picks it up at a border entry, is it tagged to that country even though its destination country might have been different?”
“The other thing is that it’s just not a good story,” says Mackey, explaining that Southeast Asia receives much of its antimalarials and antibiotics from large global health organisations and development agencies, such as the Global Fund and USAID. “No global organisation wants to say that we initiated this counterfeit medicine programme [and] we found hundreds of people that might have died from drugs that we bought. That’s not a great story to have.”
“If we don’t deal with this issue now, if we don’t raise awareness of its importance, we’re just going to lose the fight against some diseases that we can actually get rid of.”
A culture of under-reporting means that only 2% of cases of substandard and falsified medicines reported to the WHO from 2013 to 2017 came from Southeast Asia. Cambodia is one of the only countries in the region that reports data to the WHO’s central surveillance system, which Lamy suggests could be because of pressure from external partners such as the French government. “On health concerns Cambodia is often seen as lagging behind its neighbours a little bit,” she says. “Maybe this is an opportunity for them to take the lead on regional health security concerns and actually share some best practices.”
This lack of reporting, evidence, and concrete prosecutable cases relegate what Mackey calls a “hidden epidemic” to the side-lines. Yet for Lamy, the potential global impacts are hard to understate, and whether commitment will turn into action remains to be seen.
“It’s very simple,” she says. “If we don’t deal with this issue now, if we don’t raise awareness of its importance, we’re just going to lose the fight against some diseases that we can actually get rid of. And the problem by having substandard and falsified medicine circulating around is that we have an increased risk of drug-resistant malaria spreading. It’s already a concern in Cambodia and medicine quality is one of the contributing factors to that… It may spread even beyond the Greater Mekong Subregion’s borders and then we have not just a regional health security concern but a global one. And the GMS will be the heart responsible for that in the first place. So that would be absolutely traumatic.”
