The distribution of counterfeit drugs represents a significant and ever increasing public health concern. Estimated to generate $70 billion in annual sales worldwide, fake or ineffective medications can harm or kill patients, increase legitimate medicine costs, fund criminal activity and even fuel drug-resistance in diseases such as tuberculosis and malaria.
Developing countries are disproportionately affected—researchers reported in The Lancet that more than a third of antimalarial drugs are falsified in sub-Saharan Africa, for example—but no country is immune. As recently as last Tuesday, the US Food and Drug Administration (FDA) issued yet another warning to healthcare providers in the country over batches of counterfeit Avastin (bevacizumab), the blockbuster cancer medication marketed by South San Francisco’s Genentech. This was the third such alert for Avastin in a year.
Although internationally acknowledged as a major public health problem, the fight against counterfeiting has been marred by issues of inconsistent regulatory responses, unclear solutions and even the ambiguity over definition of the term ‘counterfeit’. In response, the US Institute of Medicine, with funding from the FDA, released a report today detailing the scope of the problem and offering recommendations for solutions.
The committee emphasized the need for cooperation between international governments, big pharma companies and civil society groups, such as academia, non-governmental organizations and non-profits—all of which have had contentious relationships of late when it comes to combating counterfeits. (See our April 2010 ‘focus on counterfeit drugs’ for more.)
For example, some member states of the World Health Organization (WHO), including India and Brazil, have accused Western governments of being influenced by major pharmaceutical companies and attempting to use anti-counterfeit measures to stifle unpatented, unregistered or generic drug competition. Versions of these drugs with legitimate formulations represent the only affordable sources of medication in many low-income communities, and some are labeled as counterfeit even if they are neither fake nor ineffective.
“I was shocked in talking with all the stakeholders how deep the suspicion was, and how it caused really a harmful dynamic and lack of cooperation,” committee chair Lawrence Gostin, a global health legal scholar at the Georgetown University Law Center in Washington, DC, told Nature Medicine.
To mitigate some of the issues of trust and re-direct the focus to public health, Gostin and his fellow committee members recommended using the term ‘counterfeit’ only when trademarks have been violated. Instead, the label ‘falsified’ should be used for drugs that misrepresent identity or source, or ‘substandard’ for those that do not meet accepted pharmacopeial benchmarks. They urged the WHO adopt these clearer terms, which they hope will help shift the debate toward efforts to implement or improve detection and surveillance, instead of rancor over intellectual property. The panel also stressed that governments in low- and middle-income countries must be more proactive in regulation, inspection and enforcement efforts.
Domestically, the US-based committee found the need to implement a universal track-and-trace system that can follow the specific locations of pharmaceuticals after manufacturing. This would, the panel claimed, reduce concerns over falsified or substandard medicines entering secondary wholesaler inventories, especially foreign ones that service online pharmacies. Counterfeit Avastin entered the US, for example, though a Canadian internet pharmacy in this manner. California plans to implement a strict pharmaceutical track-and-trace program by 2017, but the panel emphasizes the need for a mandatory national system, similar to the rule proposed last year by the FDA to require medical devices to carry unique identifying tags for tracking.
While the cost and difficulty of implementing the recommendations issued by the report are sure to be high, Gostin hopes that stakeholders will realize the urgent need to invest, and to coordinate their efforts. “Our key hope is [they will focus on] the public health problem,” he says.