Malaysia has issued a "government use" licence enabling access to more affordable versions of an expensive and patented medicine to treat hepatitis C. This landmark decision should help the more than 400,000 people living with hepatitis C in Malaysia access sofosbuvir, and could have important repercussions in the global effort to secure access to expensive treatments for this viral disease.
"The government of Malaysia has been unable to provide access to affordable treatment regimens because of the very high price of sofosbuvir in Malaysia," said YB Datuk Seri Dr. S. Subramaniam, the Minister of Health, Malaysia. "To ensure scale-up of our hepatitis C treatment programme, the government wishes to purchase generic sofosbuvir at the lowest possible price and make it available in the public health system throughout the country."
The non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi) has been running clinical trials in Malaysia, in partnership with the Ministry of Health and Egyptian drug manufacturer Pharco Pharmaceuticals, to test a pan-genotypic treatment combining sofosbuvir with the drug candidate ravidasvir.
The clinical trial is ongoing in six hospitals with Clinical Research Malaysia, a non-profit entity owned by the Ministry of Health. Pharco has agreed to set the price of the combination treatment at $300 per 12-week course once ravidasvir is registered. Currently a full course of treatment is available in Malaysia for around $70,000 (MYR 300,000).
"The Malaysian government has reaffirmed its strong commitment to provide access to treatments for hepatitis C. The decision is also a strong signal to other countries where high treatment prices act as a barrier to implementing a public health approach for hepatitis C," said Dr Bernard Pécoul, Executive Director of DNDi.
International trade rules enshrined in the TRIPS Agreement allow countries to issue government use licences when pharmaceutical companies fail to make patented medicines available and affordable to patients.