The 720 patients with MDR TB shall get the necessary drugs after all
The treatment of 720 patients with MDR TB within the framework of the “Stop TB in Ukraine” Program with the second-line anti-TB drugs will be carried out, despite the fact that not all of these drugs are accessible in Ukraine.
In order to implement the planned program of treatment of the 720 patients with drug-resistant TB the Rinat Akhmetov’s Foundation for Development of Ukraine agreed with the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) and the Ministry of Health of Ukraine a one-time import to Ukraine of the second-line anti-TB drugs kanamycin and capreomycin that meet the international quality standards (WHO prequalification, GMP – “Good manufactures practice”), but don’t have the certificate of registration of the Ministry of Health of Ukraine.
In general, for the treatment of patients it is planned to purchase 6 second-line anti-TB drugs: kanamycin, capreomycin, levofloxacin, PAS, ethionamide and cycloserine. However, kanamycin and capreomycin approved by the WHO are not registered in the Ministry of Health of Ukraine, and could not be procured before, since the registration in Ukraine is a requirement of the Global Fund. The foreign manufacturers refused to register their products in Ukraine, and the Ukrainian manufacturer – “Kievmedpreparat” - is to complete a complicated procedure of WHO prequalification for these drugs before the Global Fund agrees their use.
In order to address this situation the Global Fund recommended to apply the procedure of the one-time import of unregistered drugs to Ukraine. The procurement of the anti-TB drugs will be conducted through the Global Drug Facility (GDF). However, the contractor demanded a guarantee that the Ministry of Health would allow a one-time import of these drugs, so the Rinat Akhmetov’s Foundation for Development of Ukraine appealed to the Ministry of Health to provide such guarantees, and received a positive response.
As reported, on January 13, 2012 the Foundation received a letter from the Ministry of Health, signed by the Deputy Minister of Health Tolstanov K.A., by which the Ministry guarantees to grant the permission for the one-time import of kanamycin and capreomycin to Ukraine.