Malaysia Grants Compulsory Licence For Generic Sofosbuvir Despite Gilead Licence

A much cheaper version of a groundbreaking hepatitis C medicine is expected to be available soon for the hundreds of thousands of hepatitis C patients in Malaysia, as it decided to grant a compulsory licence to sofosbuvir, according to sources. The decision comes right after the medicine originator decided to expand its voluntary licensing scheme to four more countries, including Malaysia.

[Update] The Malaysian government on 20 September confirmed that it approved “the use of Rights of Government under Patent Act 1983 (Act 291) by exploiting the patented invention of Sofosbuvir tablet 400mg.” According to a press release, “the last time Malaysia instigated the Rights of Government was in 2003 for anti-retroviral drugs (treatment for HIV infection). This sets Malaysia to be the first country to initiate such move in the world.”

​The decision to initiate the Rights of Government, the release said, “was made after the MOH [Ministry of Health] efforts to be included in the Medicine Patent Pool (MPP) and price negotiations with patent holder were unsuccessful.”

The Drugs for Neglected Diseases initiative (DNDi) issued a statement welcoming the move by the Malaysian government. [end update]

The Malaysian AIDS Council said in a release that as many as 500,000 people or 2.5 per cent of the general population are estimated to be living with hepatitis C in Malaysia, and hepatitis C prevalence among young people who inject drugs is estimated to be “between 50 to 67 percent,” because of HIV-hepatitis C co-infections.

According to the release, the cost of the full hepatitis C treatment comes to RM300,000 per patient (US$71,300), leading to very few patients benefitting from it.

In a column in The Star (Malaysia), Martin Khor, executive director of the South Centre, said, “Health Minister Datuk Seri Dr S. Subramaniam indicated in July that the ministry is hoping to get a generic version of the same drug, for RM1,000 (US$ 237) per patient.”

“Clinical trials are being conducted in cooperation with the Geneva-based Drugs for Neglected Diseases initiative (DNDi) and an Egyptian generic company in a project to make available Sofosbuvir, combined with another drug,” Khor wrote.

Malaysia is a middle-income country and thus was excluded from voluntary licence by Gilead. However, according to sources, Gilead announced recently that it would include four middle-income countries (Malaysia, Thailand, Ukraine, and Belarus) to its voluntary licensing scheme.

According to Khor, Malaysia’s consideration of a decision to issue a “government-use” licence might have prompted Gilead to extend its voluntary licence scheme to Malaysia.

According to several sources, it appears Malaysia has an option of using both possibilities at the same time, the compulsory licence, and Gilead voluntary licence. Khor added that “There are limits to what Malaysia can import or produce under the Gilead licence and that restricts the freedom to choose the generic firms it can work with,” calling on the Malaysian government to stick to its decision, since the country can use both schemes.

For background on the issue, see a recent article by University of Leeds researcher Fifa Rahman (IPW, Public Health, 24 August 2017).

Gilead had not responded to questions by press time, nor had the Malaysian mission in Geneva.

Image Credits: Malaysian AIDS Council