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Fighting counterfeit pharmaceuticals: A primer

Packaging technology, regulation, guidelines and industry combining to address global counterfeiting of pharmaceuticals.

Bosch track and trace
Bosch track and trace

Counterfeit pharmaceuticals are a major ongoing threat to patients and pharmaceutical manufacturers. Not only do they result in reduced treatment efficacy and sometimes failure, but they also harm manufacturer reputations, reduce revenues, and lower return on investment (ROI) in research and development. In fact, they are responsible for an estimated 2,000 deaths daily worldwide and represent a grey industry anticipated to be worth up to $205 billion touching Europe, America, Japan, and emerging markets. And the problem is worsening.

According to a directive from the European Union, the number of counterfeit medicines seized at its outer border has tripled between 2006 and 2009 to reach approximately 7.5 million items, not including patent issues. The issue of counterfeit pharmaceuticals was previously primarily related to lifestyle medicines, but now innovative and life-saving drugs are increasingly falsified, with dangerous implications for the patients relying on these drugs to survive.

As the counterfeit drug problem continues to grow with widespread media attention, public confidence in public health systems as well as in pharmaceutical brands is eroding. There is an urgent need for governments and pharmaceutical manufacturers to unite to implement programs that protect consumers.

An evolving and threatening black market
Since the 1980s, counterfeit drugs have increasingly threatened the pharmaceutical industry, with various factors contributing to this growth. Due to globalization, regional economies, societies, and cultures have become integrated through communication, transportation and trade, making it easier for counterfeiters to trade and transport falsified drugs. Additionally, the economic crisis had a global effect, leading cash-strapped consumers to find more cost-effective pharmaceutical sources, which served to bolster counterfeiting in the healthcare industry.

The rise of the Internet has also facilitated the purchasing of counterfeit drugs. More than 50% of medicines purchased on the Internet from illegal Web sites that conceal their physical addresses have been found to be counterfeit. However, counterfeit products increasingly find their way into the legal supply chain.

Previously, online pharmacies were traditional targets, where counterfeit drugs were typically sold in small quantities to individuals, resulting in only limited gain for counterfeiters. Now, counterfeiters are switching their focus to pharmaceutical wholesalers supplying medicines worth hundreds of thousands of pounds, euros, or dollars traded in a single transaction, causing more widespread damage and public affliction.

Counterfeiting is greatest in regions where regulatory and enforcement systems for medicines are weakest. In developing countries, one in four medicines sold in a street market is estimated to be counterfeit, according to the World Health Organization (WHO).

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