KUALA LUMPUR, July 15 — The government asserted that supply of sofosbuvir imported from Egypt through a compulsory licence was sufficient to treat Hepatitis C patients in Malaysia.
Health Minister Dr Adham Baba explained that the compulsory licence — used to obtain generics of Gilead Sciences’ patented Hepatitis C cure, Sovaldi, without the drug maker’s consent — was only meant for treatment in government health facilities.
“Supply of the imported medicine can still accommodate current use in treating Hepatitis C patients,” Dr Adham told Permatang Pauh MP Nurul Izzah Anwar (PKR) in a written parliamentary reply Monday, without specifying how many Hepatitis C patients have been treated with sofosbuvir in Malaysia.
“Therefore, there is still no need to produce or manufacture this drug through compulsory licencing.”
Nurul Izzah had asked the Ministry of Health (MOH) to state its plan in supporting the production of generic versions of drugs through compulsory licensing of sofosbuvir so as to reduce market prices and increase accessibility.
Last November, MOH revealed that only 0.9 per cent of an estimated half a million Malaysians with Hepatitis C, or 4,500 people, have been treated with generics, 20 months after the Malaysian government used a compulsory licence to obtain sofosbuvir.
The reported low treatment rate of Hepatitis C in Malaysia comes despite the slashing of sofosbuvir prices from RM360,000 for a full course of treatment of the original drug, to RM1,248 for the generic version through the government-use or compulsory licence.
Malaysia’s 2017 rejection of US biopharmaceutical company Gilead’s voluntary licence offer for sofosbuvir — which is an agreement between originator and generic manufacturers that allows the production and sale of patented drugs in certain countries, subject to licensing terms — in favour of a compulsory licence had angered the American pharmaceutical industry.
The Pharmaceutical Research and Manufacturers of America (PhRMA) urged the US Trade Representative last February to “blacklist” Malaysia for purportedly denying sufficient protection of US intellectual property rights and fair market access.
Last May, Gilead excluded Malaysia from receiving remdesivir in deals signed with five generic companies in India and Pakistan to manufacture and distribute its experimental Covid-19 treatment to 127 mostly low-income and lower-middle income countries.
Dr Adham also told Nurul Izzah that Gilead has granted Malaysia a voluntary licence to import generic versions of sofosbuvir from India.
He mentioned that two sofosbuvir generic products under the voluntary licence have been registered with the Drug Control Authority and were given permission to be marketed in Malaysia at a much lower price than innovator drugs.
Hepatitis C infection can lead to liver cirrhosis, cancer, and death. About 400,000 people die from the blood-borne viral infection every year that affects over 71 million people worldwide.