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Restrictive terms will lead to 50mil HCV deaths

Globally it is estimated that around 170,200 million individuals around the world are currently living with the Hepatitis C virus (HCV), with an additional 3-4 million becoming infected every year and 350,000+ deaths annually. HCV is clearly one of the greatest public health threats of this century and possibly even the next. Unlike HIV, HCV is curable.

In Malaysia, it is estimated that as at 2010 the HCV infections were at 397,515. According to a report in The Star dated June 8, 2014, the present rate of infection is likely to be much higher as often many infected with hepatitis C are not aware of their status.

In this context, new oral medicines bring significant new hope for many people infected with the Hepatitis C virus with its better cure rates and lesser side effects. However, hopes for universal affordable curable treatment were dashed with Gilead’s announcement on Sept 15 of a voluntary licence on two direct-acting oral antivirals (DAAs) used to treat HCV infections, sofosbuvir (Sovaldi®) and ledipasvir.

This licence contains restrictive terms aimed at limiting generic competition that would increase the supply of the much needed medicines and maintaining Gilead’s market monopoly, condemning to death many of the 50 million HCV patients living in territories excluded from the scope from the voluntary licence such as Malaysia, Thailand, Philippines and China.

It is particularly appalling that Gilead’s market hold is based on questionable patents: Pre-grant patent oppositions have been filed with the Indian Patent Office while in Egypt the sofosbuvir patent was rejected.

In most countries, including many in the list covered by the Gilead voluntary licence, the patent applications are still under consideration. Yet, based on these ‘patents’, the Gilead licence locks in leading generic producers making it very difficult for them to produce generic versions of the anti-virals for the excluded m iddle-income countries.

The terms of the licence are such that generic competition will not be maximised, and consequently affordable prices cannot materialise immediately.

Gilead has undermined generic competition, which is key to bringing down prices and increasing access to the new medicines. A study by researchers at Liverpool University (UK) has found that with large-scale generic production, a twelve-week course of sofosbuvir could cost as low as US$101 and ledipasvir only US$93.

Currently sofosbuvir is priced by Gilead at US$1,000 per pill in high-income countries, or US$84,000 for 12 weeks’ treatment, and around US$900 for the same in low-income countries.  Developing countries, which are categorised as ‘middle-income’ (such as Malaysia) are likely to pay prices significantly higher than the US$900 price, especially in the private market.

We urge the Malaysian government to use available flexibilities in the World Trade Organisation Agreement on Trade-related Aspects of Intellectual Property Rights, including compulsory licence to ensure access to affordable new oral medicines for Hepatitis C.  

We also urge the Malaysian Intellectual Property Office to adopt strict patentability criteria with the aim of avoiding secondary patents and patent evergreening. (Evergreening is a term popularly used to describe patenting strategies that are intended to extend the patent term on the same compound.)


This statement is issued by the Positive Malaysian Treatment Access and Advocacy Group (MTAAG+) & the Third World Network (TWN).

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