KUALA LUMPUR, Sept 14 ― The Cabinet has approved government-use licences to bring in generics of Hepatitis C medicine Sofosbuvir, a report said, despite the drug manufacturer offering Malaysia a voluntary licence.
A government-use or compulsory licence means cheaper generic medication can be produced without the drug patent holder’s consent, whereas voluntary licencing, while allowing for significant price reductions, can set price ranges for the pharmaceutical product, depending on terms of the licence contract.
The Domestic, Trade, Cooperatives and Consumerism Ministry told local daily The Star that the Health Ministry received approval from the Cabinet to “execute these rights”.
Last month, the Health Ministry tabled a Cabinet paper on the implementation of government rights under Section 84 of the Patents Act regarding the drug.
However, government-use licence means the drug will only be available in public health facilities. Around 400,000 Hepatitis C patients in the country will reportedly benefit from this move, especially since a full treatment costs around RM300,000.
As it is a middle-income country, Malaysia does not receive special pricing for drugs by pharmaceutical companies.
On August 24, Sofosbuvir manufacturer Gilead Sciences announced its decision to expand its HIV and Hepatitis C generic licencing agreement to Malaysia, Thailand, Ukraine and Belarus.
Currently, clinical trials are being conducted with the cooperation of the Neglected Disease Institute and an Egyptian generic company to manufacture Sofosbuvir's generic version that is combined with another drug.