Health Ministry switches to generic medicine for Hepatitis C

PUTRAJAYA: The Health Ministry is expected to save RM49,500 in medication costs per patient per year in treating Hepatitis C-infected patients by switching to generic medicine – a 99% drop in costs per patient.
It is now paying RM50,000 a year for the patented drug for each patient.
The generic drug costs only RM500 for a year's supply.
There are about 500,000 patients in Malaysia with Hepatitis C.
The government is paying RM100 million for the patented medication to treat just the new cases.
By switching to generic drugs, the ministry will save 100 times in medication costs.
It is estimated that 2,000 new cases are reported every year.
In announcing this today, Health Minister Datuk Seri Dr S. Subramaniam said it would exercise the "Rights of Government" to procure generic medicine for the disease.
"As Hepatitis C has become a major public health concern in Malaysia, it is crucial to increase access to its treatment for the benefit of the nation," he said.
"Therefore, the Cabinet on Aug 4 has approved the use of Section 84 (Rights of Government) under Patent Act 1983 (Act 291) by exploiting the patented invention of Sofosbuvir tablet 400mg."
Stating that the cost per patient will be greatly reduced, Subramaniam said the decision was made after the ministry's efforts to be included in the Medicine Patent Pool (MPP) and price negotiations with patent holder of the Sofosbuvir 400mg tablet medicine were unsuccessful.
"The last time Malaysia instigated the Rights of Government was in 2003 for anti-retroviral drugs (treatment for HIV infection) making Malaysia to be the first country to initiate such move in the world," he said.
According to the law, Section 84 of the Patent Act 1983 (Act 291) gives a minister discretionary powers to exploit a patented invention without the agreement of the owner of the patent under specific circumstances.
Subramaniam added that the procurement of the 400mg Sofosbuvir tablets will be done in accordance with government procurement procedures.
"The implementation of the Rights of Government for the 400mg Sofosbuvir tablet is for use in government facilities only (Health Ministry and armed forces hospitals), whereby at initial phase it will only be offered at 12 Health Ministry Hospitals by year-end," he said, adding that the selection criteria of patients that will receive the treatment will follow clinical guideline set by the clinical specialist.
Hepatitis C is an infectious disease caused by the Hepatitis C virus (HCV) that spreads through blood contact such as blood transfusion, sharing of needles, and contact with poorly sterilised medical equipment among others.
Primarily affecting the liver, the disease if left untreated could cause liver failure, liver cancer, or dilated blood vessels in the oesophagus and stomach. The disease which uniquely only affects humans and chimpanzees is the main cause of liver transplants worldwide.