Counterfeit labeling is a major challenge for stakeholders in the pharmaceutical industry, with matters of brand integrity at the top of the list of manufacturers' concerns. However, a group of experts say they believe international regulators are focusing too strongly on intellectual property matters and not enough on the other major threat counterfeit drugs create – a risk to public health.
Ten medical researchers – including Paul Newton of the U.K.'s Oxford University – co-authored the essay "The Primacy of Public Health Considerations in Defining Poor Quality Medicines," which was published in the online journal of the Public Library of Science (PLoS).
In it, the experts note that in an attempt to crack down on poor-quality drugs in the global market, international regulators have created confusing classifications, often categorizing counterfeit products and those considered substandard in quality in the same boat.
In doing so, these regulators – the authors pointed one finger squarely at the World Health Organization (WHO) – are essentially facing separate problems with the same approach. And most often, issues of intellectual property seem to take precedence over public health concerns – a backwards notion, argues the authors.
Of course, that doesn't mean IP isn't a problem that needs tackling. Manufacturers have a right to crack down on counterfeit labeling in an attempt to protect their brand and earnings.
But, the authors argue the unbiased WHO needs to take a more consumer-centric approach that draws a distinction between counterfeit drugs – ones that may violate manufacturers' copyright – and substandard medicines – those that are of poor quality and that might harm users.
At the same time, you could argue that the issues are, if not one in the same, at least closely aligned. Even the authors of this paper concede that a WHO-led international treaty on medicine quality might help remedy both problems with one swift move. And companies that adopt stronger supply chain practices that focus on improved label tracking and traceability may also contribute to a solution that leads to higher quality medicine and secure brand integrity.