Since 2003, 42 people have died from bird flu in Vietnam. The scientists fear that the highly virulent H5N1 strain could mutate into a form, which can be transmitted from infected birds to humans and between humans, sparking a pandemic. The WHO has warned that 8.2 million Vietnamese could be infected by bird flu and 820,000 Vietnamese would die of the disease if the pandemic happened.
The Pharmaceutical Administration Department of the Ministry of Health has reached an agreement with the Swiss pharmaceutical company Roche AG and therefore, will be the first country in the world to produce under license the antiviral drug, oseltamivir phosphate (TAMIFLU®). Roche will select the Vietnamese generic drug manufacturers that can produce it in quantities large enough to meet the anticipated demand in case of a flu outbreak. The first production of TAMIFLU® is foreseen early 2006.
Roche had been reluctant in sharing the formula of TAMIFLU®, but WHO and other international bodies have mounted pressure as the disease emerges as an international health crisis.
In line with the Doha Declaration (2001), Vietnam has the right to grant compulsory licenses in case of prevention and treatment of disease. The Ministry of Health had clearly indicated that Vietnam could even decide to issue compulsory licenses if Roche did not agree to its request.
The fact that Vietnam can issue compulsory licenses in case of public health has probably impelled Roche to agree to the sub-license to Vietnam. It would be of little economic benefit for Roche to reject the request for sub-license since the payment, which will be received by Roche if the compulsory licence was issued, would be substantially lower than the payment in case of sub-license.
In the event of a state of emergency, any country in the world, Vietnam included, would emphasize on the protection of people’s health before respecting intellectual property rights which belong to multinational pharmaceutical companies. In view of this development, several countries, including China and India, are negotiating with Roche about licenses to produce TAMIFLU®.