September 20, 2017, New York, NY—The Government of Malaysia reaffirmed its commitment to affordable access to hepatitis C treatment by issuing a compulsory license on sofosbuvir (Sovaldi). TAG lauds this landmark decision for enabling the entry of generic competition, which will effectively reduce prices.
Malaysian civil society organizations, including Third World Network, Malaysian AIDS Council, and Positive Malaysian Treatment Access and Advocacy Group, have tirelessly pushed for expanded access to direct-acting antivirals (DAAs) in the public health sector. Last month, Gilead announced Malaysia’s inclusion in a voluntary license (along with Belarus, Thailand, and Ukraine) to permit generic DAA imports from India. Civil society groups urged the government to move ahead with issuing a compulsory license to guarantee high quality generics from an Egyptian manufacturer, which did not fall under the voluntary license.
Compulsory licenses allow a generic company or government institution to manufacture a patented medicine for the “supply of the domestic market” without the consent of the patent holder. However, using these policy flexibilities, enshrined in the global TRIPS Agreement, comes at a risk. Countries, particularly in the global South, may face political pressure or trade repercussions from governments and companies for employing these policy tools. Malaysia’s compulsory license prevents a monopoly control on sofosbuvir, while also paying a royalty to remunerate Gilead. This move helps to reconcile an imbalance between the intellectual property system and protecting public health.
Around half a million people are living with HCV in Malaysia yet DAAs have been priced well out of reach for most patients—a 12-week course of treatment costs up to US$12,000 [MYR 50,000], or nearly half the average annual household income. Healthcare costs and medical bills amount to 35% of Malaysians’ income.
“There’s no justification for Gilead’s exorbitant pricing in a middle-income country like Malaysia: Sofosbuvir can be produced for less than US$100 per average treatment course at volume. Once again, Gilead treats this essential medicine as a luxury good, squeezing maximum revenue from the few who can afford it rather than pricing for universal access,” said Annette Gaudino of Treatment Action Group.
“Patients around the world can no longer be held hostage at Big Pharma’s drug prices. Malaysia has set an example for other countries to fully use policy flexibilities, such as compulsory licenses, when companies like Gilead obstruct expedient delivery of affordable life-saving medicines,” said Bryn Gay of Treatment Action Group. “This decision reinforces people’s fundamental rights to health, the benefits of scientific progress, and access to medicines.”
People living with HCV will now have more treatment options. Sofosbuvir is one of the most widely prescribed DAAs worldwide, and is over 90% effective in curing chronic HCV infection across all genotypes when combined with other antiviral medications. Clinical trials are underway in Malaysia—a collaborative partnership between the Ministry of Health, Drugs for Neglected Diseases initiative, and Pharco Pharmaceuticals—to investigate the potentially new pangenotypic combination, sofosbuvir and ravidasvir.