KUALA LUMPUR: Malaysia has been facing continuous pressure from pharmaceutical companies and their political allies ever since it used compulsory licensing (CL) to gain access to generic versions of a Hepatitis C drug in 2017.
But an international organisation Médecins Sans Frontières (MSF), or known as Doctors Without Borders, has stepped in to support Malaysia's position.
It has sent a letter addressed to Prime Minister Tun Dr Mahathir Mohamad, Health Minister Datuk Seri Dr Dzulkefly Ahmad and Domestic Trade and Consumer Affairs Minister Datuk Saifuddin Nasution Ismail on Monday (Feb 11), expressing solidarity and support for the Malaysian government as well as urging it to continue to reject any pressure from pharmaceutical corporations and their political allies to reverse the government-use licence.
The letter was also sent to Health director-general Datuk Dr Noor Hisham Abdullah.
(The licence is provided for under the rights and flexibilities of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights (TRIPs) even though the drug patent has not expired.)
"Such pressure violates the integrity and legitimacy of the system of legal rights and flexibilities created by the TRIPs Agreement, as reaffirmed by the Doha Declaration for the World Trade Organisation members to meet their rights and public health obligations," said MSF Access Campaign executive director Els Torreele in the letter which was uploaded on msfaccess.org website (msfaccess.org/malaysias-compulsory-license-sofosbuvir-positive-step-public-health-and-innovation) late Monday.
"As you are aware, the United Nations Secretary-General's High-Level Panel on Access to Medicines (HLP) has recognised the problem of access to medicines as a global issue by in 2016.
"As low to high income countries across the globe continue to face significant difficulties with the excessive pricing of medicines by the industry, we commend the Malaysian government's leadership role in supporting innovation and development of more medicines towards, addressing the HIV and HCV (Hepatitis C virus) epidemics," she said.
In mid-2016, The Star carried a front-page article about some estimated 400,000 Malaysians infected with Hepatitis C, with most not being able to afford the RM300,000 12-course treatment.
NGOs had called on the government to invoke the CL to gain access to Sofosbuvir.
Direct-acting antiviral medicines (DAAs) such as Sofosbuvir represent a treatment breakthrough for people with chronic Hepatitis C, with cure rates of up to 95% and with far fewer side effects than previous treatments.
Torreele said in many of the countries where MSF worked, MSF was able to provide generic DAAs at $120 (RM489) per 12-week treatment course of Sofosbuvir and Daclatasvir, which were sourced from quality assured generic manufacturers in Egypt and India.
MSF is an independent, international medical humanitarian organisation that provides emergency medical assistance to populations in distress in more than 70 countries.
To make it feasible to treat patients with quality medicines from more affordable and accessible sources, it relied mostly on generic medicines, said Torreele.
Following the adoption of the Doha Declaration on TRIPs and Public Health in 2003, Malaysia became the first country to issue a CL on a medicine to treat HIV and similarly, in 2017, it was the first country to issue a CL for Hepatitis C treatment, she said.
"These decisions illustrate the Malaysian government's commitment to provide lifesaving medicines to its people," she said.
Last November, Knowledge Ecology International (keionline.org) reported on its website a 78-page PDF obtained from the United States Trade Representative (USTR) under the Freedom of Information Act on communications between Gilead Sciences, Inc and USTR, over Malaysia's decision to grant the CL.
NGOs had deemed the move by Gilead using US authorities' influence to pressure Malaysia to reverse its CL decision as a form of intimidation but Malaysia did not budge.
On Feb 8 this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) had again urged the USTR to "take immediate action to address serious and growing market access and intellectual property barriers in top overseas markets" the markets.businessinsider.com reported.
In its submission for USTR's annual Special 301 Report, PhRMA called on the Trump administration to name Canada, Japan, Korea and Malaysia as "Priority Foreign Countries" - a designation reserved for countries with the worst market access barriers and the most damaging intellectual property practices.