Q&A about the Novartis MDT leprosy donation

What is the cause of leprosy?
Leprosy is an infectious disease caused by a bacillus, Mycobacterium leprae. M. leprae multiplies very slowly, and the incubation period of the disease is about five years. Symptoms can take as long as 20 years to appear. Leprosy is not highly infectious. It is transmitted via droplets from the nose and mouth during close and frequent contact with untreated multibacillary cases.

What are the symptoms of leprosy?
Leprosy mainly affects the skin and nerves. If untreated, there may be progressive and permanent damage to the skin, nerves, limbs and eyes. When leprosy manifests with one to five patches on the skin it is classified as paucibacillary (PB) leprosy, which is not infectious. If there are more than five patches or generalized infiltration of the skin it is classified as multibacillary (MB), which is considered infectious until treated. With minimal training, leprosy can be easily diagnosed on the basis of clinical signs alone. The PB and MB classification is for treatment purposes.

What is the treatment for leprosy?
Multi-drug therapy (MDT), the WHO-recommended treatment, consists of three drugs: dapsone, Rimactane® (rifampicin), and Lamprene® (clofazimine). MDT kills the pathogen, cures patients and interrupts the transmission of the disease. PB and MB patients treated with MDT are cured within six and twelve months respectively. Patients are no longer infectious to others after the first dose of MDT. It is safe, effective and easily administered under field conditions. Virtually no relapses and no resistance of the bacillus to MDT have been detected.

What are the key elements of the Novartis MDT leprosy donation?
Since 2000, the Novartis Group (Novartis Pharma, Novartis Foundation for Sustainable Development and Sandoz) has been providing high-quality multi-drug therapy (MDT) free of charge to all leprosy patients in the world through the World Health Organization (WHO). The MDT donation is administered under the terms of an Memorandum of Understanding that continues until the end of 2010. Additionally, Novartis provides the funds for managing the donation, transport, insurance and independent quality control of MDT. The value of the Novartis MDT donation from 2000 to 2009 was USD 60 million.

What impact has the MDT donation had?
Leprosy elimination through MDT is a public health success story. Over the past 20 years more than 14 million patients have been cured and the disease prevalence rate has dropped by 90%. The WHO estimates that 4.5 million people have been cured as a result of the Novartis MDT donation. The availability, free of charge, of a global supply of high-quality MDT has helped to bring leprosy services closer to affected communities, through general health services rather than specialized clinics. This is particularly important for poor communities, most at risk of leprosy, who cannot afford to travel far for treatment. Leprosy is a leading cause of permanent physical disability. MDT has dramatically reduced the risk of disability, thereby relieving the social and economic burden of the disease and protecting people from the downward spiral of social exclusion and destitution.

Why is Novartis donating MDT?
Novartis developed Lamprene® (clofazimine) and Rimactane® (rifampicin), two of the three drugs used in MDT. In 1995, the WHO launched the global supply of MDT with a drug fund provided from 1995-1999 by the Nippon Foundation of Japan. From 1998 onwards, Novartis became the only supplier of high-quality MDT, the other supplier having been excluded due to sub-standard drug quality. The decision by Novartis President, Dr. Daniel Vasella, to provide MDT free of charge to all patients through the WHO was made at a critical juncture and ensured the continued availability of free treatment. This decision was a practical expression of Novartis corporate values and the belief that special efforts need to be made in tackling the diseases of poverty.

Which countries are eligible for the donated drugs?
Governments and government-authorized organizations involved with leprosy work only need to submit a request to the WHO in order to obtain MDT free of charge. Currently, almost 100 countries, including a number of OECD countries, rely on MDT supplies through the Novartis-WHO collaboration.

What is the role of the Novartis Foundation in the MDT donation?
The Novartis Foundation supports the WHO in the distribution of the donation, fosters dialog among the stakeholders engaged in leprosy control and participates in strategic discussions.

Where are the drugs manufactured?
The MDT drugs are manufactured at the Kolshet plant of Sandoz India (Mumbai). The plant has received Good Manufacturing Practice (GMP) certification from the European Health Authorities.