The widespread circulation of substandard and falsified medicines in South East Asia is a major public health issue. The falsified treatments which are available in this part of the world are increasingly threatening both human life, particularly as they prevent the curb of infectious diseases, and animal health in a predominantly farming region. Furthermore, this type of lucrative trafficking is set to expand with trade liberalization. In this context, it is vital that governments develop regulations, provide suitable capacities and create interstate synergies if the problem is to be solved.
The extent of the problem
Medicine falsification is an illegal activity which is difficult to detect and monitor. It is extremely complicated to estimate the reality of the situation. Since 2013, the WHO has received 1500 reports of substandard or falsified products; the most frequently reported products were antimalarial medicines and antibiotics. Most reports (42%) come from sub-Saharan Africa, 21% from the Americas and 21% from Europe. This is certainly only the tip of the iceberg as many cases are probably never reported. Only 2% of cases of substandard or falsified products reported to the WHO came from South East Asia.
The most recent World Customs Organization (WCO) Illicit Trade Report confirms this impenetrability. In 2016, the WCO did not receive any alerts from South East Asian countries for this type of trafficking, yet the WCO confirms that most of this type of trafficking takes place in, or transits through, this region.
Myanmar, Vietnam and Thailand are major transit points for falsified medicines which are distributed to global markets from ports in Singapore, Malaysia, Vietnam and Thailand. The WCO reports that 50-60% of illicit traffic is shipped via sea. This reality is in part due to free-trade agreements between South East Asian Nations (ASEAN) and these countries, and the standardization of the region’s infrastructure and connectivity.
UNODC says that cross-border shipments of illicit products to and from South East Asia, often via India and China, have increased over the past few years. China and India are the main manufacturing hubs but organized crime syndicates appear to have transferred some manufacturing processes to Vietnam, Myanmar and Cambodia to avoid tougher legislation and benefit from lower production and labor costs. UNODC also reports that the organized crime groups which have been localized in South East Asia vary in type and are often transient: some are part of triads in southern China who have been operating since the 19th century, and other groups form and disband over the duration of a generation, or less. Given, therefore, the lack of investigations and arrests in the countries in which falsified medicines are manufactured, it is almost impossible to wipe out smuggling and medicine imports within these countries.
➢ An Interpol report (1) revealed that in 2009, a network which was possibly connected to a triad distributed falsified erectile dysfunction medicines in nightclubs and brothels in Malaysia. The primary suspect was identified as a triad leader who was working for a Chinese syndicate in Kuala Lumpur. In Cambodia, a network linked to the Japanese yazuka was identified in a falsified medicines distribution case. The trafficking included products such as Viagra for patients in Cambodia (unlicensed pharmacies) and Japan (online).
In recent years, resistance to artemisinin (antimalarial medicine) has been reported in five Mékong countries: Cambodia, Myanmar, Laos, Thailand and Vietnam. This could partly be due to increasing falsified artesunate; one of the main antimalarial medicines for malaria. This was revealed in a groundbreaking study (2) carried out by Paul Newton’s research teams in 2001. A total of 38% out of 104 “artesunate” shop-bought samples in the five countries did not contain an active ingredient. These figures appear to be confirmed in more recent studies which also reveal the rise in substandard medicines in this region.
⊲ A study (3) published in 2017 revealed that 28.5% of antimicrobial treatments screened between 2011 and 2014 were substandard or falsified.
⊲ In 2006, a study carried out in Laos, Myanmar, Vietnam and Cambodia revealed that 68% of antimalarial medicines did not contain the correct amount of active ingredients (Alter Hall, 2006).
⊲ A total of 27% of antimalarial medicine tested in Cambodia in 2006 revealed incorrect levels of active ingredients (Lon, 2006).
However, medicine falsification in this region does not apply solely to antimalarial medicine: all therapeutic classes are affected. Several Interpol operations have increased our understanding of the situation:
– Operation Storm in 2008 uncovered falsified antimalarial tablets in Myanmar (produced in Thailand).
– Operation Storm II in 2010 resulted in a haul of millions of dollars’ worth of spurious antibiotics, antimalarial medicines, contraceptives, tetanus serums and painkillers.
– Operation Jupiter in 2006 in South East Asia revealed that 61% out of 321 samples manufactured by a leading Asian manufacturer (Guilin Pharmaceutical in the Chinese region of Guangxi) were falsified.
To conclude, in 2016, the WHO issued two alerts after discovering that falsified medicines were available in the region:
– Two falsified (4) hepatitis C treatments sold as LEDSO or DAKAVIR
– AMARIL: a falsified (5) yellow fever vaccination
Another growing threat is from falsified veterinary medicines; this is of great concern in a predominantly farming area. In 2013 (6), two Vietnamese men were arrested for this type of trafficking. Every week, the men manufactured and delivered hundreds of falsified antibiotics such as amoxicillin and doxycycline for animals raised for human consumption.
Over the past ten years, national governments have adopted different measures in response to the rising threat from falsified medicines. The adopted measures varied according to local resources, legislation and support from international organizations. Specific measures were applied to national laws and regulations in all the Mekong countries (7) in terms of pharmaceutical management and quality assurance:
– National Drug Law (1992) in Myanmar,
– Pharmaceutical Law (2005) in Vietnam,
– Drug Law (2003) in Thailand,
– Law on the Management of Pharmaceuticals (1996) in Cambodia, and
– the Law on Drugs and Medical Products (2000) in Laos.
In some countries this new challenge has generated amendments to current legislation. In Thailand, for example, the 1967 Narcotics Act was revised several times to introduce measures for “falsified medicines and non-compliant medicines” and tougher deterrents for traffickers.
Legislation in Cambodia has been amended to introduce more efficient deterrents. The 2007 amendment to the former Law on the Management of Pharmaceuticals (1996) provides for various levels of sanctions for different pharmaceutical regulatory infringements; from unlicensed purchases of raw materials, to manufacturing and selling illegal products. In 2011, the Cambodian health minister also deployed monitoring agents to ensure that the Law on the Management of Pharmaceuticals is applied. Their duties include helping the “investigation and elimination of falsified medicines in the Kingdom of Cambodia.” They are also authorized to “temporarily seize falsified, unlicensed and forbidden medicines, expired medical equipment and raw materials, etc.”
Mekong governments have concretely attempted to take action in response to the growing threat from substandard or falsified medicines by expanding their legal arsenals and operational capacities. However, despite the positive impact generated by national initiatives, key challenges remain:
1 – Laws are sometimes outdated and need to be revised if they are to remain applicable to increasingly complex pharmaceutical crimes.
2- A general lack of operational capacities: lack of human resources, equipment and infrastructure in most countries, lack of field training programs, etc.
3- Slack or non-existent laws which enable falsified medicine manufactures to corrupt agents in charge of ensuring that laws are applied.
4- Lack of a global consensus on what is legally a falsified medicine.
5- Lack of interstate cooperation.
6- Considering the challenges linked to rolling out new technologies and developing illegal online pharmacies in the region’s countries.
7- A complex supply chain which is difficult to monitor. In Cambodia, for example, it is thought that (8) there are more than 1,000 regulated medicine stores and almost 2500 illegal medicine stores.
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