KUALA LUMPUR, Dec 4 – Malaysia was forced to use compulsory licensing for sofosbuvir after unsuccessful price negotiations with the Hepatitis C drug maker, Gilead Sciences, Health director-general Dr Noor Hisham Abdullah said.
Speaking at the Graduate Institute Geneva, Global Health Centre, in Switzerland, Dr Noor Hisham also claimed that Malaysia was excluded from voluntary licensing for the expensive Hepatitis C medicine, even though Gilead announced in August 2017 the expansion of its voluntary licence agreements for Sovaldi (sofosbuvir) to Malaysia, Thailand, Belarus, and Ukraine — bringing to 105 the total number of countries included in the voluntary licence programme — so that these countries can obtain cheaper generic versions of the direct-acting antiviral treatment from other manufacturers.
In a Facebook post, Dr Noor Hisham said that he was invited by the Graduate Institute Geneva, Global Health Centre, to speak on creative approaches to improving access to medicines globally, namely on ideas from the Hepatitis C experience.
“I was given the podium to speak on Malaysia’s experience, alternate research and development approaches and exercise of compulsory licensing,” he said in the post.
“I took the opportunity to share our journey and the chronology of events. I emphasised that compulsory licensing was not our preferred approach, but being applied only after numerous unsuccessful price negotiation with the patent holder and excluded from the voluntary licensing.”
A compulsory licence for pharmaceuticals is a process where a government allows someone else to produce generics of a drug without the original drug maker’s consent.
The previous Barisan Nasional (BN) administration used a compulsory licence to enable an Egyptian company to manufacture and export to Malaysia a much cheaper generic version of sofosbuvir for use in Ministry of Health (MOH) hospitals.
BN had rejected the US pharmaceutical company’s voluntary licence offer that would still allow for generics, but on Gilead’s terms.
The new Pakatan Harapan administration has continued BN’s compulsory licence policy, with a joint venture between Egypt’s Pharco Corp and local pharmaceutical company Pharmaniaga planning to produce a generic drug, ravidasvir, in Malaysia by year end or March 2020. Ravidasvir is used in combination with sofosbuvir to treat Hepatitis C.
MOH admitted recently that only 0.9 per cent, or 4,500 people, of an estimated 500,000 Malaysians with Hepatitis C have been treated, 20 months after the Malaysian government used a compulsory licence to obtain generics of sofosbuvir.