The growth of counterfeit medicines is not a situation limited to occurring in a few countries but is instead, an international problem. Indeed, a new report commissioned by an international pharmaceutical trade body highlights the need for greater coordination among international stakeholders in the fight against counterfeit, or what it also terms, “falsified,” medicines.
An article that ran in Securing Industry notes that the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) report concludes that the World Health Organization (WHO) “is uniquely placed to add value to governments’ efforts to protect against all forms of pharmaceutical crime, along with those of local regulators and other national and international agencies.”
The problem certainly is global. For example, last fall, the U.S. Food and Drug Administration (FDA) announced that it—in partnership with international regulatory and law enforcement agencies—took action against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. The actions that were taken resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.
The IFPMA report, which was conducted by researchers at University College London (UCL) School of Pharmacy and research agency Matrix Insight, states that WHO activities should be linked to regional working groups that engage directly with national level public and private stakeholders in protecting health and assuring pharmaceutical sector regulation and effective policy implementation. Toward that end, it also calls for more investment in efforts to quantify medicines falsification and to provide early warning systems for counterfeits “as soon as they are detected in legitimate supply chains.”
There is already considerable convergence in the anti-falsification measures being adopted at national and regional levels to safeguard patients’ and the public’s health, says David Taylor, from the UCL School of Pharmacy, and one of the authors of the report. Recent research suggests that progress has been achieved, but additional surveillance-backed, systematically-supported and globally-coordinated efforts could do more to protect against falsification and improve health, he says.
As the report points out, both branded and generic medicines can be falsified and sold for profit. Those making the counterfeit medicines avoid not only research and development costs but also that of following good manufacturing practice. Furthermore, as a consequence of evolving technological capabilities, it also is increasingly easy to make difficult-to-detect fake packaging.
As expected, there are significant challenges for this type of international initiative. Chief among them, according to the report, is the ability to maintain funding. Secondly, as previously noted by Taylor, another key challenge is global surveillance and world-wide intelligence gathering, information sharing, and policy formation. The report explains that this high-level governmental leadership function should arguably be coordinated by the World Health Organization working in partnership with other appropriate organizations and individuals.
The report goes on to say that the involvement of other stakeholder groups, ranging from international agencies such as Interpol or the World Customs Union to major NGOs and individual regulatory agencies, consumer and patient organizations, professional and industry bodies and/or local police forces and customs organizations will need to be flexible and appropriate to local conditions. It should be decided in a manner designed progressively to build development capacity and wider inclusiveness, and to ensure the uncensored flow of validated information within and between communities, the report concludes.
What do you think about stopping the flow of counterfeit medicines? Is it best tackled at the national level or is it better to have an organization such as WHO coordinate international efforts?