OPINION
Kuala Lumpur, 4 September 2017 – Gilead Science’s decision on 24 August 2017 to expand its HIV and Hepatitis C generic licensing agreement to include Thailand, Ukraine, Belarus and Malaysia will see increased access for millions to drugs which will improve the quality of life for patients and save lives. This development makes an affordable cure for Hepatitis C (HCV) within reach for Malaysia.
Commenting on this development, Chief Executive for the Galen Centre for Health & Social Policy, Azrul Mohd Khalib said, “More than 400,000 Malaysians between the ages 15-60 years are currently estimated to be living with Hepatitis C, it is imperative to take a viable and realistic approach to ensure that coverage and access to treatment is made as broad and encompassing as possible.”
“With HCV treatment currently costing as much as USD 30 000 per person, this granting of a Sofosbuvir voluntary license by Gilead Sciences will mean that it will be possible for lower-cost generic versions of this life saving drug to be made available in Malaysia. It will allow for the drug to be used in combination with others. Most importantly, it will be possible for thousands of lives to be treated and cured of this disease. This is a game changer in the fight against Hepatitis C in Malaysia.”
“We hope that with this opportunity to enhance access to innovative drugs, the Ministry of Health will be in a better position to work together with non-government organisations, patient groups and the pharmaceutical sector towards achieving its goal of ensuring that everybody who needs HCV treatment can get it and afford to do so,” emphasised Azrul.
The present rate of HCV infection is likely to be much higher as many of those infected are not aware of their status. Disease progression could be up to 20 years. Despite there being no vaccine currently available, unlike with HIV and Hepatitis B, it is possible to cure a person who has chronic Hepatitis C infection. With a cure rate of around 95%, the 12-weeks treatment uses the innovator drug, Sofosbuvir, which is owned by Gilead Sciences. The Government of Malaysia was considering the activation of a government use license under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This would have seen authorization granted by the government without the permission of the patent holder, to import, manufacture a generic version of a patented drug for public non-commercial use.
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