Hepatitis C patients in Malaysia urgently need access to affordable Sofosbuvir.
Hepatitis C, a fatal but curable disease, is a global health concern. 700,000 people around the world die every year due to Hepatitis C. Globally 150 million people have chronic infection. In Malaysia, it is estimated that at least 453 000 people are infected with hepatitis C virus (HCV). This is a low estimate as many people are unaware they may be infected.
The standard treatment for HCV is conventional Interferon Alfa (IFN)/Pegylated Interferon Alfa (PEG- IFN) with Ribavirin but this regimen has severe side effects and is intolerable to many patients. The recent launch of oral direct acting anti-virals (DAAs) is revolutionizing HCV treatment with a good efficacy profile, shorter treatment duration with limited side-effects.
Sofosbuvir, in particular, used in combination with another medicine (e.g. with Ribavirin or even better with Daclatasvir) is known to effectively treat HCV infection particularly Genotypes 1 and 3 that are most common in Malaysia. SOF and Daclatasvir are also on WHO’s Essential Medicines list. But SOF is extremely expensive. It costs USD 84,000 for 3-month medication (USD1,000 per tablet). In Malaysia a patient paid RM387, 000 (approx. USD 87,430) for a 24-week course.
Gilead has filed many patent applications related to SOF in many countries, which prevents many people living with HCV access to more affordable medicines, as no other generic manufacturers can sell in those countries. These applications have been challenged in some countries (e.g. in India and in Europe). Some applications have also been rejected (e.g. in Egypt, India and China) as their patent offices did not consider SOF to be a real novel or innovative invention.
Unfortunately, Malaysia has granted several patents to SOF. This means that unless concrete steps are taken by the Malaysian government to address the patent barriers, patients in Malaysia will be denied access to cheaper generic versions of SOF.
We urgently request:
1. The Ministry of Health to take immediate steps to address intellectual property barriers including by using flexibilities such as compulsory license to make Sofosbuvir based treatment regimens available in Malaysia at an affordable price. Generic SOF is presently available for various Indian generic manufacturers for less than US$300 for 28pill bottle.
2. The Malaysian Intellectual Property Office (MyIPO) must apply more rigorous standards in the examination of patent applications to prevent frivolous patents that promote patent “evergreening”. MyIPO needs to be aware that its decision whether or not to grant a patent has a major impact on people lives. It is simply unacceptable that MyIPO is granting patents on applications that are rejected in other countries.
3. The Malaysian authorities need to introduce administrative pre and post grant oppositions systems in the Malaysian Patent Act to enable more rigorous examination of patent application.