Jagged Little Pills

Traditional household wisdom asks: why pay more for a label? It may be true that house brand toothpaste gets the job done and that imitation vanilla may deceive the unseasoned palate; but many consumers fallaciously - and dangerously - apply the principle to their choice of medicines. Witness the volume of suspiciously-inexpensive drugs boldly advertised on websites and in spam.

Contrary to popular belief, counterfeit drugs are rarely the same product in a different package. In fact, only about 15 percent¹ of these products might possibly (but not certainly) be expected to achieve their purpose.

Based on reports to the World Health Organisation, almost one third of counterfeit medicines contain no active ingredients at all. Twenty percent contain either too much or too little and another twenty percent contain the wrong active ingredient altogether. Not only are the immediate effects unpredictable, these products may make the symptoms worse or even provoke additional health problems.

At the macro level, counterfeit medicines add to the burden on public health systems, which often have limited resources to begin with. Counterfeit vaccines and antibiotics, for example, do not effectively protect against infectious diseases and lead to the development of antibiotic resistant disease strains, to the detriment of entire populations. Over time, these consequences damage public perceptions of health care systems and decrease trust in medical professionals.

While no global study has been carried out, experts believe there are more counterfeit medical products on the market each year, both globally and within the region. Active pharmaceutical ingredients (APIs), used in the production of counterfeit medicines, are widely circulated in international trade and are imported, exported and shipped through many APEC economies.

Earlier this year, the APEC Anti-Counterfeiting Medical product and pharmaceutical product Safety Seminar² drew industry experts and government officials from 10 APEC economies and 6 non-APEC Latin American economies to consider ways to address the issue. Specifically, they asked: how can governments most effectively combat trade in counterfeit medical products?

The need for a coordinated response is underlined by the global economic crisis, as APEC economies prepare for recovery by facilitating and encouraging trade. Trade liberalisation depends on the confidence of consumers and governments that goods are legitimate, safe and effective. Therefore, abolishing trade in counterfeit medical products not only promotes the health and safety of the people of APEC, it allows economies to fully realise the benefits of globalisation.

To date, APEC economies have made notable efforts to abolish counterfeit medical products. Chile and Malaysia, for example, have very effective public awareness programmes. police raids and confiscation occur in Thailand and the US; and China shuts down any websites selling unapproved APIs.

Jeffrey Gren, Director of Health and Consumer Goods, US Department of Commerce explains that, "these activities serve as a base on which to build. But a multi-faceted approach, and inter- and intra-government coordination, is needed to make significant progress in addressing this global problem."

Ideally, say experts, a coordinated response should include a shared definition of counterfeit medical products, global cooperation in enforcement and investigations, common legislation and regulatory requirements, criminal and administrative penalties, designated points of contact for counterfeit medical products in all ApEC economies and effective public awareness campaigns.

The seminar served as a starting point, with economies considering various definitions, examining best practices, and drafting concrete plans of action. Apart from coordinated domestic responses, participants cited as imperative that governments should adopt a holistic approach, coordinating practices within their own sectors, with other governments throughout the APEC region as well as with the private sector:

Intra-government cooperation encourages the various departments - regulatory, legal, judicial, health - within each member economy to put an end to the entry and distribution of counterfeit medical products.

Inter-government cooperation among APEC economies is also important so that relevant officials can share information and improve enforcement and prosecution of counterfeiters, while also raising public awareness. For example, if one member economy's customs office becomes aware of a large shipment of an API being shipped to another APEC economy which is likely to be used in the production of counterfeit medicines, officials from both economies' customs and law enforcement may coordinate their actions for a more thorough investigation.

The seminar also served as a platform on which to establish closer working relations among industry experts and government officials. In fact, these relationships were recognised as invaluable to the success of initiatives.

Explains Thomas T. Kubic, president and CEO of the pharmaceutical Security Institute, "Cooperative, trusting relationships have been developed as a direct result of the Anti-counterfeit Medical products project. We look forward to building on these efforts, as anti-counterfeiting experts work to rid the region of unsafe destructive fake medicines."

Having developed an anti-counterfeit medical products action-plan, the next challenge is for economies to implement it. Several specific project proposals are already underway and subsequent steps may include: the establishment of a common definition; gathering of more definitive data to determine the extent of counterfeiting in the ApEC region; harmonised legislation and penalties for prosecuting counterfeiters within APEC economies; and launch of a communication and public awareness action plan.

"previous APEC seminars in Singapore and Mexico City have been a good start," says Gren. "APEC economies now need to move forward with the next stage and work together to combat this global problem."