Malaysia paves the way for compulsory licensing on hepatitis C medicines 

Historic decision will cure more hepatitis C patients – and other countries can follow suit.

Today, 20 September 2017, Malaysia’s Ministry of Health has officially announced the use of a government-issued ‘compulsory license’ on the key hepatitis C drug, sofosbuvir. This ends Gilead Science’s monopoly in the country, opening the door to robust generic competition to bring prices down. It will mean that the government can afford to procure optimal treatment for the estimated 450,000 people living with hepatitis C in Malaysia.

“This is exciting news! Sofosbuvir is the principal drug for hepatitis C infection treatment, and it is very cheap to produce. However, Gilead’s pricing and its patent monopoly make it simply unaffordable for the majority of people who need it. We congratulate Malaysia, and our colleagues there, who strongly advocated for this historic decision,” remarked Solange Baptiste, Executive Director, International Treatment Preparedness Coalition (ITPC).

Compulsory licenses are public health safeguards, included in international agreements and national laws, that allow patent protection to be suspended on specific medicines, and authorise the use of generic drugs in order to protect access to medicines and public health. In 2003, Malaysia became the first country to issue a compulsory licence on an HIV drug, following the adoption of the Doha Declaration on TRIPS and Public Health by the 2001 Ministerial Conference of the World Trade Organization (WTO). Since then, compulsory licenses have been used successfully for HIV antiretrovirals in several countries resulting in significant health budget savings. Several international organisations such as the WHO, and more recently the UN High Level Panel on Access to Medicines, encourage governments to use such safeguards more routinely.

“We applaud the government for taking this step. While seen as a bold move, it is well within the country’s right to issue this compulsory license, and ensure that people in need of treatment can receive the optimal drugs without crippling the health budget through unrealistic and unreasonable pricing. Public health must come before profits,” says Edward Low, MTAAG+’s director.

In recent weeks, Gilead has been manoeuvring to block the decision. Its announcement on 24 August 2017 to expand its voluntary licence with selected Indian generic manufacturers to Malaysia is an example of this. The Malaysian government is right not to limit itself to Gilead’s offer and issue this compulsory license,” says Othoman Mellouk, Intellectual Property and Access to Medicines Lead at ITPC. “Generic versions of sofosbuvir are now available from some companies, such as Pharco in Egypt, between two and seven times less than the price charged by Gilead licensees. The compulsory license is the only way for Malaysia to introduce real and robust generic competition that is needed to achieve significant price reductions.”

The compulsory license is the only way for Malaysia to introduce real and robust generic competition that is needed to achieve significant price reductions.

Since the approval of the drug in 2013, sofosbuvir’s pricing and patents, and Gilead’s tactics to monopolize markets have been at the centre of several controversies worldwide. Partners of the ITPC-led campaign, Make Medicines Affordable, have filed patent challenges on the drug in Argentina, Brazil, Thailand, Ukraine, India, China and Egypt. During the closing ceremony of the International AIDS Conference held in Paris in July, Othoman Mellouk from ITPC denounced publicly Gilead’s anti-access behaviour.

With this bold and courageous step, Malaysia paves the way for other countries.

“Today, hepatitis C infection can be cured at a very cheap price, and the epidemic can be eradicated if treatment is affordable,” says Baptiste. “With this bold and courageous step, Malaysia paves the way for other countries, where patents block access, to also use compulsory licences to ensure that all those in need have access to lifesaving treatment. Treatment activists worldwide will support and work together with their governments to make this happen where it’s needed.”

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