Is Malaysia facing a US sanction on generic Hepatitis C drug?

On Feb 11, Médecins Sans Frontières, also known as Doctors without Borders (MSF), submitted a letter of support to the Ministry of Health (MoH) on the issuance of a government license on Sofosbuvir, a drug to treat Hepatitis C.

MSF also agreed there was a need to speed-up the process of manufacturing the generic version of the drug.

The high price of Sofosbuvir

As of now, Sofosbuvir is the most effective drug to treat Hepatitis C, recording a cure rate of up to 95% and very few side effects compared to other drugs in use.

However, Gilead, the company that holds the patent for Sofosbuvir is selling the drug for a whopping RM4,000 per pill. For a treatment course of 12 weeks, complete with other adjuncts, the cost is said to be RM336,000.

When drugs are manufactured for a fraction of the original cost, the government is able to subsidise the medication, thereby allowing more people access to healthcare as medication becomes more affordable.

If the government succeeds in enabling manufacturers from Egypt or India to produce Sofosbuvir’s generic pills, MSF estimates the cost of a 12-week treatment course can drop to as low as RM480.

MSF themselves rely on generic drugs in their humanitarian missions.

301 Report: A response from US pharmaceutical bodies

The issuing of the license on the Sofosbuvir patent is a stepping stone for a paradigm shift in treating Hepatitis C, and in Malaysia’s efforts to combat and control the burden of chronic diseases.

Although the move will benefit millions of patients, it has not come without retaliation.

Pharmaceutical Research and Manufacturers of America (PhRMA) submitted a letter to the United States Trade Representative (USTR) to include Malaysia in the 301 Report as a Priority Foreign Country (PFC).

The 301 Report identifies barriers on American intellectual properties, copyrights, patents and trademarks in international trade.

In the letter, PhRMA appealed to USTR for Malaysia to be listed as one of the PFCs, the worst classification for countries found to provide inadequate or ineffective protection on intellectual properties and copyrights.

If listed, Malaysia could face economic sanctions from the US which will undeniably affect other aspects of trade and diplomacy between the two nations.

It is apparent that capitalist pharmaceutical companies are lobbying Congress and are heavily influencing the USTR’s decision to proceed with the sanction.

The commitment of the government to ensure access to affordable healthcare is not only noble and praiseworthy, but should be continued for society’s wellbeing.

This article first appeared in and was reviewed by Panel Perubatan Hello Doktor. The Hello Health Group does not provide medical advice, diagnosis or treatment.