A new paper exploring counterfeit and substandard medicines shows the presence of even a minimally-developed regulatory program can have a profound impact on ensuring consumers have access to genuine, quality medicines.
The study, "Counterfeit or Substandard? The Role of Regulation and Distribution Channel in Drug Safety," was published as a National Bureau of Economic Research (NBER) working paper and authored by Roger Bate and Aparna Mathur of the American Enterprise Institute, and Ginger Zhe Jin of the University of Maryland.
The study took a sample of 1,437 units of the antibiotic Ciprofloxacin from 18 low-to-middle-income countries around the world, including China, India, Russia, Thailand, Turkey, Brazil, Egypt and Kenya. The authors then tested the samples using the Global Pharma Health Fund's e.V Minilab protocol to determine if the medicines were genuine and met quality standards.
Of the samples tested, 9.88% failed the researchers' tests, and 41.5% of those failures were determined to be counterfeit. The remaining failed samples were determined to be substandard, containing less than 80% of the required active ingredient.
A deeper analysis of the samples shows product registration has a powerful deterrent effect against counterfeit products. Products registered with the World Health Organization (WHO)'s prequalification program passed at a 98.5% rate, while products registered with local authorities passed at a 93.5% rate. Unregistered products only passed 69.8% of the time.
Products registered with western regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) fail at an even lower rate, with 98.9% of products passing inspection.
Supply chain integrity also had a similar deterrent effect on counterfeit medications. Of the samples obtained at chain pharmacies, 98% of samples passed testing, while just 79.9% of samples obtained at non-chain pharmacies passed testing.
The study presents some interesting findings for emerging regulatory systems grappling with limited resources and issues related to regulatory capacity. While Bates notes just 20% of the WHO's 191 member states have a "well developed drug regulation" program, even low-cost regulatory programs can have a profound effect on reducing counterfeit medications in the market.
"The strong association between product registration and drug quality in our sample demonstrates that the process of registration is of significant value, even allowing for the fact that counterfeiters are more likely to target registered products," write the authors.
But the authors warn the regulations must contain "significant market surveillance, strong enforcement and sufficient penalties for those who are caught breaking the rules" in order to be effective. This will likely involve the coordination of regulatory authorities with local law enforcement authorities.
"The registration and regulatory processes can only combat counterfeit products with the assistance of good anti-counterfeit laws and their enforcement by separate policy authorities," write the authors. "Increasing post market surveillance would help regulators identify more counterfeit problems, but without assistance from law enforcement authorities such expenditures might not show results."
American Enterprise Institute - Counterfeit or substandard? The role of regulation and distribution channel in drug safety