Industry Trend Analysis - Malaysian Sofosbuvir Licence Gamble To Set Benchmark For Other Countries - NOV 2017


BMI View: Compulsory licences remain a contentious issue and in the long term, the Malaysian Government ' s decision will undoubtedly increase scrutiny of the country ' s intellectual property laws. However, in the short term, the move will increase pressure on Gilead to respond further by creating more favourable licensing conditions for access to lower cost generic sofosbuvir. The Malaysian G overnment may not follow through with its decision after Gilead acted to increase access in the country, but if it does, similarly positioned countries will watch the outcome with interest.

The Malaysian Government has issued a government use licence for 400mg sofosbuvir tablets, under the Rights of Government under Patent Act 1983 (Act 291). The action marks the first time any country in the world has issued a compulsory licence for the hepatitis C (HCV) drug, the branded version of which is marketed by Gilead as Sovaldi.

According to the Government, there are around 500,000 patients in Malaysia who are infected with HCV, and it is estimated that 2,000 new cases are reported every year. The Government claims that the cost of treatment for the illness is exorbitantly expensive, making it less accessible to patients. As HCV has become a major public health concern, it has become increasingly important to be able to increase access to treatments.

Malaysian HCV DALYs To Rise Sharply
Anticipated Malaysian HCV Disability-Adjusted Life Years, 2015-2030
Source: World Health Organization (WHO)/ BMI

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