PETALING JAYA: Malaysia’s landmark decision to invoke a “government-use” licence to get access to affordable versions of a hepatitis C drug will have a major impact on global efforts to open up expensive treatments to more people, the Geneva-based Drugs for Neglected Diseases initiative (DNDi) said.
This should give 400,000 people living with hepatitis C in Malaysia access to sofosbuvir, DNDi executive director Dr Bernard Pécoul said in a statement on Wednesday.
International trade rules allow countries to issue government-use licences when pharmaceutical companies fail to make patented medicines available and affordable.
The last time Malaysia invoked the Rights of Government was in 2003 for anti-retroviral drugs to treat HIV infection, making it the first country in the world to initiate such a move.
Dr Pécoul said the decision was a “strong signal” to other countries where high treatment prices are a barrier to implementing a public health approach to hepatitis C.
DNDi has been running clinical trials in Malaysia in partnership with the Health Ministry and Egyptian drug manufacturer Pharco Pharmaceuticals to test a treatment combining sofosbuvir with the drug candidate ravidasvir.
Pharco has agreed to set the price of the combination treatment at US$300 (RM1,260) per 12-week course once ravidasvir is registered.
On Wednesday, Health Minister Dr Subramaniam said the decision to invoke the Rights of Government was made after attempts by the ministry to be included in the Medicine Patent Pool (MPP) and price negotiations with the patent holder fell through.
The MPP, a UN organisation, aims to lower the prices of medicine for HIV, tuberculosis and hepatitis C.
In July, The Star reported that about 400,000 Malaysians need hepatitis C treatment but cannot afford it as it could cost up to RM300,000.
In another development, Health director-general Datuk Dr Noor Hisham Abdullah said access to an HIV drug had also been extended to Malaysia.
The MPP had informed the Health Minister of the recent expansion of its licence agreement with Bristol-Myers Squibb to increase access to atazanavir, he said.