Rwanda is the only African nation among 17 sampled in a new study in which no fake tuberculosis or antimalarial treatments were detected.
The study, co-authored by American Enterprise Institute (AEI) scholar Roger Bate and Agnes Binagwaho, the Minister of Health for Rwanda, attributed the country’s success to the government taking legal and technical steps to ensure the quality of its drug supply chain. Rwanda was able to do this because it brought TB control into the publicly funded health system to a greater extent than other countries.
Aware of the dangers of poor quality drugs for TB and malaria, in the late 1990s Rwanda mandated that all drug contracts awarded by the Ministry of Health must be to manufacturers with WHO-approved certificates of Good Manufacturing Practices.
Rwanda’s low prevalence of poor quality TB drugs among the countries in the sample could also be associated with its efforts to ban the sale of monotherapies, ensure that private sellers of medicines are qualified, and prioritise the prevention of fake medicines entering the country.
Rwanda's Bureau of Standards verifies certification documents and, together with the Customs Services Department and the Ministry of Health, inspects each shipment of drugs upon importation into the country. Where counterfeit medicines are found, these authorities work with the Rwandan police and Interpol to arrest the organised criminals responsible.
The global scope of the danger of fake medicines is strongly hinted at by another study conducted by Bate and colleagues in February this year.
The improvement of Rwanda's supply chain and drug surveillance systems have played an important role
Among 713 samples of isoniazid and rifampicin purchased at community pharmacies in 19 cities of 17 countries, 65 (9.1%) of the samples had insufficient active pharmaceutical ingredient (API) and failed basic quality control tests. Of those samples 18 (of 65, or 27.7%) were definitely falsified, since they had zero API and obviously fake packaging. The remaining products with insufficient API (47 of 65, or 72.3%) were either substandard or falsified.
The study authors said there was not enough evidence to determine whether these products could have been faulty by accident (the hallmark of substandard drugs) or faulty by criminal intent (the hallmark of falsified drugs), although both are dangerous.
Bate and Binagwaho argue that the improvement of Rwanda’s supply chain and drug surveillance systems, combined with equity-oriented strategies for increasing geographic and financial access to high quality drugs through the public sector, have played an important role in the country's steep declines in mortality due to TB and malaria. Between 2000 and 2011, the country’s TB mortality rate declined 77.1%, and reported annual malaria deaths dropped 85.3% from 2005 to 2011.
Rwanda is contributing to the drafting of a regional law against falsified medicines with other member states of the East African Community, and plans to advocate for clear language distinguishing between generic and falsified medicines. The country is also a party to the recently launched East African Community Medicines Regulatory Harmonisation Initiative.
A global treaty is now needed to guarantee sustainable progress towards higher quality medicines
‘It is time for the tuberculosis control community to recognise the causes and consequences of falsified and substandard drugs and to mobilise a global response,’ the authors said.
‘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.’
They propose that a global treaty is now needed to guarantee sustainable progress towards higher quality medicines by bringing regulatory, technical, legal, and financial mechanisms to bear together.
‘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,’ they say.