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Agreement Paves Way for Transfer of Technology to Produce Anti-leprosy Medication in Brazil
Posted on 16 December 2010 by
On Wednesday 15th December 2010, the Brazilian Ministry of Health (MoH) and the pharmaceutical laboratory Novartis signed an agreement to transfer the technology for national production of the active agent in clofazimine, one of the medications used in the treatment of leprosy (known as Hansen’s disease in Brazil).
This agent will be produced by an officially recognised laboratory in Brazil that will be determined by the MoH, and will only be used within the national public health network. The expectation is that Brazil has the full capability to produce clofazimine within the next five years.
Over this period, Novartis will also donate to the Brazilian Government the three standardised medications used to treat the disease: rifampicin, dapsone and clofazimine. This will be done in the standard MDT blisters with three agents for multi-bacillary (MB) cases and two for paucibacillary (PB) cases. The two PB medications – rifampicin and dapsone – are already produced in Brazil, but separately. The use of these multi-drug combinations favours adherence to treatment.
The donation of clofazimine will no longer be done through international organisations and will be done in sufficient quantities to ensure the regular treatment of leprosy patients in the Brazilian Unified Health System (SUS) as well as a strategic surplus to be managed by the MoH. A technical team composed of representatives from the MoH and Novartis will monitor the implementation of this agreement to ensure the continued and adequate supply of medications, in addition to the details of the transfer of technology.
From 2011 to 2015, a total of 700,000 tablets of clofazimine will be donated to Brazil for the treatment of adults and children, totalling 3.5 million tablets over the period. In relation to the other medications, another 2.9 million MDT-MB blisters and 1 million MDT-PB blisters will be donated to cover adult and paediatric treatment.
In Brazil, the annual number of new cases of the disease has been falling since 2003. That year, 51,941 new cases were registered. In 2009, this had been reduced to 37,610 new cases. With regards to transmission in children under 15 years of age – the main indicator used by the MoH to monitor the active transmission of the disease – the number of cases in 2009 was 2,669, compared with 3,444 in 2006. As for the cure rate, in 2008, 81.2% (33,611) of cohort cases were cured and released from treatment.
Translated from Portuguese by Duane Hinders, Consultant in Brazil.
Notice on Brazilian Ministry of Health Portal in Portuguese:
Categories: Brazil, Technical information