We are glad to announce that the National Agency for Medicines and Medical Devices today issued today, 08.06.2017, the authorization of special needs (ASN), which allows the Romanian Angel Appeal Foundation (RAA) to bring Clofazimine (Lamprene) to Romania today.
Clofazimine is one of the drugs included into the therapeutic regimens of patients with extensive-resistant tuberculosis. For Clofazimine and for the rest of the medicines that we bring to Romania for patients with MDR TB, the evaluation process of the authorization dossier lasts enormously, between four and eight months (yes, eight months!), even though tuberculosis is a public health priority, because it is transmitted by air and untreated or treated patients with incomplete treatment regimens develop drug resistance, spread the disease in the community or die.
”For nearly ten years, we have purchased these medicines through the Global Drug Facility (GDF) of Stop TB International. This international mechanism allows all countries affected by HIV and Tuberculosis epidemics to buy quality medicines at prices below market prices. Thanks to the Global Fund, other donors, and collaboration with the Marius Nasta Institute and the PNPSCT network, we have succeeded in providing a life chance to more than 2,500 patients diagnosed with chemically resistant tuberculosis. ” Dr. Silvia Asandi, RAA General Director
Currently, Romania does not have those sustained legal and financial policies and mechanisms that would allow the Ministry of Health to purchase these medicines from national funds through current public procurement procedures or the GDF mechanism. Medicines such as Capreomycin, Kanamycin, Linezolid, PAS Sodium, Clofazimin, etc. which we provide free of charge to the Marius Nasta Institute for patients all over the country, although recommended by the World Health Organization, can’t yet be purchased by the Health Ministry for the National Program for Prevention, Control and Tuberculosis Control (PNPSCT). The reasons are complex and have been detailed in the World Health Organization’s Technical Assistance Mission Statement on the Revision of the Anti-Tuberculosis Medicines System 2016.
Funding is another major barrier. The funds for the PNPSCT are totally inadequate, unable to cover the need for the purchase of all medicines needed for proper treatment with individualized regimens based on the identified resistance of each patient.
That is why, in parallel with the provision of laboratories, the purchase of medicines and many other support activities that we have develop for the benefit of TB patients and affected communities, our constant concern is to support national efforts in the field of reviewing policies and the legal framework necessary for an effective control of Tuberculosis.