MMV strongly believes that all patients deserve access to quality medicines.
A WHO report released on 25 February 2011 reveals that a third of 306 antimalarial medicines collected and tested from six African countries failed to meet international quality standards. Reasons for this failure include insufficient active pharmaceutical ingredient (API), an excess of degradation substances, and poor dissolution. In fact in two samples one of the APIs was totally absent. The countries surveyed were Cameroon, Ethiopia, Ghana, Kenya, Nigeria and Tanzania.
The quality of antimalarial medicines (from ACTs to SP) varied across countries: from Ethiopia, where no samples failed quality testing, to Nigeria where the highest incidence of failure occurred (64%). This result implies that a patient in Nigeria is more likely to be treated with a substandard antimalarial than a patient in a country that complies with international quality standards.
Failure rates were noticeably low for WHO-prequalified medicines available in these countries (less than 4%) as well as for imported products manufactured by well-established manufacturers. Clearly, WHO prequalification is a highly effective mechanism for verifying the quality of medicines.
“This report re-emphasises the importance of ensuring the quality of life-saving drugs for the developing world,” said David Reddy, CEO of MMV. “Medicines for Malaria Venture strongly believes that all patients, rich or poor, deserve access to quality medicines. This credo is reflected in our efforts to achieve high international standards for all the antimalarials in our pipeline.”
Apart from evaluating the quality of new medicines, WHO’s Prequalification Programme (PQP) also works with many national regulatory authorities, quality-control laboratories, and manufacturers, in developing countries, to help them acquire the skills needed for ensuring medicines quality. It is actively encouraging countries to use the tools it has developed to assess their regulatory systems, to improve market surveillance and to enhance the quality assurance systems of their pharmaceutical sectors.