Addis Ababa, 28 August 2006-- African countries have been urged to establish or strengthen their medicines regulatory authorities (MRAs) with a view to checking the proliferation of harmful, inefficacious, counterfeit and substandard medicines in the region.

“Member States should clearly define the mission of MRAs and give them the needed legal authority, appropriate organizational structure and facilities as well as adequate sustainable resources to function”, WHO Regional Director for Africa, Dr Luis Sambo, says in a report he presented Tuesday to the on-going fifty-sixth session of the WHO Regional Committee for Africa taking place in the Ethiopian capital.

Citing the results of a WHO survey carried out in 2004, Dr Sambo states that 90% of MRAs in the region lacked the capacity to carry out their functions. Consequently, such authorities were unable to guaranty the quality, efficacy and safety of medicines.

He added that this situation adversely affected the quality of care in the region, considering the central role medicines play in health care provision.

The 2004 WHO survey showed that 84% of the countries covered lacked adequate staff, while 63% of them were unable to evaluate the quality, efficacy and safety of new medicines principally due to lack of adequate resources. In the specific case of vaccines, 87% of MRAs covered lacked the capacity to evaluate them. “This problem is serious considering that African countries support the development of new vaccines through the Meningitis Vaccine Project and the African AIDS Vaccine Programme”, he said.

To address the situation, Dr Sambo recommended that countries formulate appropriate national medicines policies, put in place appropriate organizational structures, and engage sufficient numbers of experienced and motivated staff.

He also stressed the necessity for the development of guidelines related to the issuing of licences; good practices in medicines manufacture and distribution; oversight of medicines promotion and advertising; and collaboration with experts, health care and research institutions and professional associations.

In the specific case of narcotic medicines, Dr Sambo advised that Member States should continue to follow the practice prescribed in international conventions. He gave the assurance that WHO would continue to collaborate with countries and the International Narcotic Control Board to find a balance between the regulatory requirement for the control of narcotics and the need to make them available and accessible for medical and scientific use.

For further information contact:

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Dr Jean-Baptiste Trapsida
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