[Ip-health] Malay Mail: Report: Cabinet approves compulsory licence for Hepatitis C generics

Thiru Balasubramaniam thiru at keionline.org
Wed Sep 13 23:34:58 PDT 2017


Report: Cabinet approves compulsory licence for Hepatitis C generics

Thursday September 14, 2017
10:11 AM GMT+8

Sept 14 ― The Cabinet has approved government-use licences to bring in
generics of Hepatitis C medicine Sofosbuvir, a report said, despite the
drug manufacturer offering Malaysia a voluntary licence.

A government-use or compulsory licence means cheaper generic medication can
be produced without the drug patent holder’s consent, whereas voluntary
licencing, while allowing for significant price reductions, can set price
ranges for the pharmaceutical product, depending on terms of the licence

The Domestic, Trade, Cooperatives and Consumerism Ministry told local daily
The Star that the Health Ministry received approval from the Cabinet to
“execute these rights”.

Last month, the Health Ministry tabled a Cabinet paper on the
implementation of government rights under Section 84 of the Patents Act
regarding the drug.

However, government-use licence means the drug will only be available in
public health facilities. Around 400,000 Hepatitis C patients in the
country will reportedly benefit from this move, especially since a full
treatment costs around RM300,000.

As it is a middle-income country, Malaysia does not receive special pricing
for drugs by pharmaceutical companies.

On August 24, Sofosbuvir manufacturer Gilead Sciences announced its
decision to expand its HIV and Hepatitis C generic licencing agreement to
Malaysia, Thailand, Ukraine and Belarus.

Currently, clinical trials are being conducted with the cooperation of the
Neglected Disease Institute and an Egyptian generic company to manufacture
Sofosbuvir's generic version that is combined with another drug.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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