The Rise of Falsified Medicines in the Philippines and the Rest of Southeast Asia
By Teresa May Bandiola
Philippine President, Rodrigo Duterte, is famous for his notorious war on drugs and yet another drug problem seems to steal the spotlight: the war on falsified medicines, augmented by Southeast Asia’s flourishing transnational organized crime.
While such type of crime is not new to Southeast Asia, and some of the crime patterns of today remain basically the same from the past, the region’s geographical proximity to leading fraudulent manufacturers such as China and Pakistan has, somehow, contributed as to why it is vulnerable to this dangerous trade, more so by cyberspace commerce that provides easier accessibility, affordability, and anonymity for both consumers and suppliers.
The World Health Organization (WHO) defines “falsified medical products” as those that deliberately/fraudulently misrepresent their identity, composition, or source. They may be devoid of active ingredient, may contain the wrong active ingredient, or may have the correct active ingredient but with the wrong amount. “Substandard medical products,” on the other hand, are authorized but fail to meet their quality standards or specifications, or both. Even so, both substandard and falsified medical products are often manufactured in very poor and unhygienic conditions by unqualified personnel, may constitute unknown impurities or microorganisms, and most likely end up in areas with constrained access to quality and safe medical products, weak governance, and poor technical capacity. These definitions, however, are further broadened in the Philippine definition of “counterfeit drugs,” which added unregistered products with the Philippine Food and Drug Administration (FDA), regardless of compliance to quality standards or specifications, and selling of such is a violation of Philippine Special Law of Counterfeit Drugs, FDA Act of 2009, and intellectual property. While there is a difference in the WHO and the Philippine definitions of these products, this article will dwell on the shared attributes of such terms.
In July this year, the United Nations Office on Drugs and Crime (UNODC) published a report titled “Transnational Organized Crime in Southeast Asia: Evolution, Growth and Impact” citing counterfeit goods and falsified medicines trade as among the four most active transnational organized crime markets in the Southeast Asia region along with illicit drug market, human trafficking and migrant smuggling, and environmental crimes such as wildlife and timber trafficking. In the UNODC report, it is said that 460 pharmaceutical crime incidents took place within Southeast Asia from 2013 to 2017 while a total of 213 incidents occurred outside the region. Out of these 460 incidents, 193 of which occurred in the Philippines, 110 in Thailand, 93 in Indonesia, and 49 in Vietnam. The reported products that were frequently affected by counterfeiting were genito-urinary drugs (including those for erectile dysfunction), central nervous system (CNS) drugs, and anti-infectives. On one hand, those involved in illicit diversion were cardiovascular drugs, CNS drugs, and alimentary and metabolism drugs. Singapore was cited as the most important transit point for these organized criminal networks. Myanmar, Thailand, and Vietnam were also identified as major transit points, and counterfeit medicines produced in these countries even reached the global markets including Japan, the United States, Germany, and Belgium.
From 2013 to 2017, Pakistan, followed by India and China, were the reported countries of origin of counterfeit or diverted medicines that entered the Philippines while 13 other countries were also identified as sources. In 2015, the Philippines seized worth US$ 125,000 of slimming products, erectile dysfunction medicines, and other illicit medicines that came from Pakistan, China, and India. Also, in December 2014, 660 kg of counterfeit products that were supposed to be delivered to the Philippines from Pakistan were spotted in an air cargo from a Thai Airways flight departing from Karachi, Pakistan via Bangkok. Moreover, the Philippines was reported as the source in 12 incidents of counterfeit or diverted medicines in the United States, Japan, and Germany.
On top of all these is the market penetration of locally-produced counterfeit medicines, especially those over-the-counter ones like paracetamol (or acetaminophen). In the country, this medication is commonly used for pain or fever, and is famously seen in huge advertisements.
The role of corruption
Corruption in the Philippines is nothing to sneeze at. Yet, it plays a fundamental role in the pharmaceutical crime, as syndicates may target sitting or former government officials or their network contacts, even pharmaceutical firm executives. These people may provide detailed information or professional knowledge that take advantage of the nation’s vulnerability that could lead to the illegal manufacture, trade, and distribution of such falsified products.
Falsified medicines contribute to other major health threats
Aside from the detrimental health risks of falsified medicines to the public, these products also threaten the control of infectious diseases at the national, regional, and global levels. Their rampant distribution could give rise in death rates due to non-treated diseases or conditions, the spread of diseases resistant to treatments, and antimicrobial resistance (AMR) which is currently a global health concern with the threat that we are running out of effective antimicrobial drugs because of their misuse or abuse.
In the Philippines, locally manufactured counterfeit anti-tuberculosis medicines (such as Bacciter) have been a concern. And yet, tuberculosis is the 6th leading cause of mortality according to the latest data of the Department of Health (DOH). This government agency also stated that the Philippines currently has the fastest growing HIV epidemic cases in Asia and the Pacific, and is one of 8 countries that account for more than 85% of new HIV infections in the region. In the UNODC report, anti-retroviral drugs for HIV were also among those counterfeit drugs in Southeast Asia.
Falsified medicines’ effect on drug war
As aforementioned, the UNODC report includes both falsified drug market and illicit drug market as parts of the four most active transnational organized crime markets in Southeast Asia.
In particular, methamphetamine, has been progressively produced in and trafficked from northern Myanmar as a result of the displacement of transnational organized crime from other parts of East and Southeast Asia, mainly from China, into remote areas where drug production is easier. In the Philippines, methamphetamine is cited by the Dangerous Drug Board (DDB) National Household Survey as the most commonly abused substance followed by Cannabis sativa and inhalants, respectively.
Additionally, there is also a report about the abuse use of drugs such as tramadol and benzodiazepines which are illicitly manufactured or diverted from the legal market in some Southeast Asian countries.
The Actions Taken
In August this year, the issue on pharmaceutical crime was raised during the 14th Association of Southeast Asian Nations (ASEAN) Health Ministers’ Meeting in Cambodia where Cambodian Defence Minister General Tea Banh urged ASEAN member countries to jointly combat the spread of substandard and counterfeit medicines which are endangering people’s health and welfare and affecting economic growth in the region.
Also in August this year, Philippine Senator, Ralph Recto, had formally asked for a Senate probe on the “presence and prevalence” of counterfeit drugs in the Philippines, after the country was tagged as having the “highest incidence” of fake medicines in Southeast Asia.
In July this year, a medical product alert from the WHO was released against falsified rabies vaccines and anti-rabies serum circulating in the Philippines.
In June this year, the Philippine FDA ordered online stores, Shopee Philippines and Lazada Philippines, to stop selling drug products, at least until they secure proper licenses.
In November 2018, the Philippine FDA warned public vs fake drugs sold online. In the same month, the police arrested an alleged distributor of falsified medicines in Tondo, Manila, with a stash worth P1.2 million.
In April 2018, the Philippine FDA released a warning against fake drugs. In the same month, P20K worth of fake drugs and beauty products was seized in Cotabato Province and a fake medicine distributor was nabbed in Cavite Province.
In March 2018, President Duterte included in his famed drug war the fake drugs. He ordered the police to arrest makers and sellers of such products.
In January 2018, the Philippine Bureau of Customs (BOC) intercepted P128.9 million worth of various illicit drugs in separate shipments that came from Pakistan.
In August 2017, three Pakistani men were arrested in Manila for selling boxes of counterfeit naproxen sodium, paracetamol, and a mix of dextromethorphan, phenylephrine and paracetamol to an undercover police officer.
In November 2015, the Philippine FDA seized P5.9 million worth of fake medicines, double than what was seized in 2014 despite the agency’s effort to combat the problem. It is cited that most of the cases were detected from Metro Manila, Cavite, Pampanga, Isabela, Cebu, Bohol, Leyte, Davao, and Zamboanga having China, Pakistan and India as the main sources although many are also being manufactured locally.
The Search for Remedy
To solve the problem, the UNODC report recommended the following:
a. Cross-border cooperation should be strengthened for systematic gathering of data and information and for enhancement of timely information-sharing and collaborative action on the quality of suspected falsified and substandard medicines.
b. Free Trade Zones (FTZs) in Southeast Asia need to be opened up and made more accessible and transparent.
c. The latest technology also needs to be used to detect and intercept illicit medicines.
d. Outdated laws be revised to respond to the increasingly complex nature of pharmaceutical markets and pharmaceutical crimes.
UNODC also warned against hasty tightening of laws because this may only send the criminal groups to areas with weaker governance and border patrol.
Moreover, the priority of ASEAN to expand the region’s legitimate pharmaceutical and chemical manufacturing capacity and Singapore’s development as a global pharmaceutical ecosystem or “Biopolis of Asia” are expected to improve the lawful commerce in pharmaceuticals and hinder the illicit trade in falsified medicines.
WHO response
WHO launched the Global Surveillance and Monitoring System in 2013 to encourage nations to report incidents of substandard and falsified medical products in a structured and systematic manner. This paves way to a quick response to emergencies and the issuance of alerts in most serious cases. It also facilitates in-depth analyses of the medical products most at risk, the vulnerabilities and weaknesses in health systems, the harm caused to public health, and the need for investment, training, and stronger regulations and standards.
In relation to the system, WHO has now trained a global network of over 550 regulatory staff in 141 Member States and has collaborated with 18 of the largest international procurement agencies.
Since November 2017, WHO has released 20 global medical product alerts and numerous regional warnings, and has provided technical support in over 100 cases.
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This article is an extract of the latest report of the United Nations Office on Drugs and Crime (UNODC) entitled “Transnational Organized Crime in Southeast Asia: Evolution, Growth and Impact” citing falsified medicines as one the four most active transnational organized crime markets in the Southeast Asia region along with illicit drug market, human trafficking and migrant smuggling, and environmental crimes.