Crime flourishes during periods of economic hardship. The rise in the counterfeit drug trade certainly bears that out. Sales of fake drugs have increased sharply in recent years both on-the-ground and online.
Counterfeit medicines are a public health threat, particularly in developing countries, and cost the pharmaceutical industry sector billions annually.
Many groups have a stake in combating the sales and distribution of counterfeit drugs -- pharmaceutical companies, patient advocacy groups, government regulators, law enforcement agencies, researchers, manufacturers, security companies, licensed online pharmacies and Internet technology companies.
Latest Developments
During Operation Pangea lV, an Interpol-led effort by police, customs and drug regulators in 81 countries seized about $2.4 million worth of illicit and counterfeit pills during the September 20-27, 2011,action.
In November 2010 the European Trade Commission (EC) completed work on the draft Anti-Counterfeiting Trade Agreement, ACTA, which calls for tougher protections for intellectual property, new enforcement tools to prevent the sale of counterfeit drugs and greater international cooperation to address the problem. Australia, Canada, Japan, Korea, Mexico, Morocco, New Zealand, Singapore, Switzerland, and the United States took part in the negotiations.
U.S. Pharmacopeia (USP), the standards-setting authority for prescription and over-the-counter medicines, is building a counterfeit drug database to support regulators and enforcement agencies worldwide. Scheduled for a 2011 launch, the database will list the name of seized drugs, the location of seizure, and the product's description and deficiencies.
A review of more than 7,000 online pharmacies by the National Boards of Pharmacy (NABP) found that about 96 percent of them were operating in violation of state or federal laws and outside the pharmacy practice standards. About 84 percent of the sites didn't require a valid prescription, according to the NABP.
Technology CompaniesMany technology and security companies have flocked to the problem.
Sproxil, a Somerville, Massachusetts--based company, has pilot-tested its anti-counterfeit technology with a Merck distributor in Nigeria. Using a mobile phone, a consumer (or regulator) can text a numeric code found on the product package to a Sproxil server to confirm authenticity. If the product is a counterfeit or pirated medicine, the brand owner can lock down their supply chains to prevent further distribution.
Sproxil developed its system specifically for use in emerging markets in Africa, Asia and Latin Ameria, where most counterfeit activity occurs.
GLOBALPCCA, another technology partnership, has developed a radio frequency identification system for drug authentication in Kenya. Under this system, tags are attached to drug packaging. Customers scan the tags with pen reader, which lights green for a positive verification.
Background
Both branded and generic drugs are subject to counterfeiting. Fake drugs can contain insufficient or too much of an approved medicine's active ingredient. Sometimes counterfeits have the right amount of active ingredients but the product has been contaminated with other ingredients or in unsanitary manufacturing conditions.
Problems associated with counterfeit drugs include poisoning, drug interactions and illness or death due to insufficient amounts of active ingredients. In some cases, populations fighting malaria or tuberculosis who were exposed to counterfeits with too low dosing of active ingredients built up a resistance to the drug treatment.
The World Health Organization estimates that 10 percent of prescription drugs sold worldwide are counterfeit. In parts of Africa, Asia and Latin America, up to 30 percent of medicines sold are counterfeit or contaminated. In Western countries, only about 1 percent of prescription drugs are counterfeits.
From a business standpoint, counterfeits force pharmaceutical companies to expend more to protect intellectual property rights. Counterfeit drugs cost pharmaceutical companies $75 billion annually in lost revenue and brand degradation, according to WHO estimates.
The World Health Organization estimates that 10 percent of prescription drugs worldwide are either counterfeit, adulterated or contaminated. More than 2,000 children per day die as a result of taking counterfeits in Africa alone, according to a WHO report.
