NCPA - National Center for Policy Analysis

The World Needs Better Medicine

July 15, 2013

In the last year, several institutions (the World Health Organization, the United Nations Office on Drugs and Crime, and the United States Institute of Medicine) have turned their attention, with varying degrees of effectiveness, to the problem of dangerously poor quality medicines. While substandard medicines are found everywhere in the world, it is the poorest countries with the weakest capacity for drug regulation and quality control that suffer the most, say Agnes Bingawaho and her coauthors.

Everyone agrees that poor quality medicines are undesirable, but not everyone agrees on how to define them. It is clear that iatrogenic (caused by medical examination or treatment) harm arises from at least two distinct, concurrent problems:

  • Medicines that are accidentally or negligently "substandard" as a result of various failures in manufacturing, handling, regulation or some combination of these.
  • Medicines that are deliberately "falsified" -- neither being of the correct standard nor being properly registered through a country's regulatory authority -- and that call out for criminal law measures to suppress.
  • In all cases, the result is a potentially dangerous medicine, whether occasioned by criminal activity, accident or negligence.

In a recent study, Rwanda had the lowest prevalence of poor quality tuberculosis drugs among African countries in the sample. This positive finding may be associated with Rwanda's efforts to ban the sale of monotherapies, ensure that private sellers of important medicines are qualified, and prioritize the prevention of falsified medicines entering the country.

It is time for the tuberculosis control community to recognize the causes and consequences of falsified and substandard drugs, and to mobilize a global response. Evidence-driven actions at the national level are essential and should be supported by multilateral donors, but will not be sufficient to solve this global problem.

Drawing on experiences in Rwanda scaling up pharmacovigilance for malaria and tuberculosis, there should be a global treaty and leadership by the World Health Organization (WHO) to address manufacturing and trade in substandard and falsified medicines. Such a treaty will be possible only with visionary and transparent leadership from WHO on behalf of its member states. As the dangers of drug-resistant tuberculosis fed by poor quality medicines illustrate all too well, the world loses ground with each passing day that WHO delays.

Source: Agnes Bingawaho et al., "Combatting Substandard and Falsified Medicines: A View from Rwanda," PLOS Medicine, July 2, 2013.


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