Going with a government use licence could represent a pyrrhic approach to a long-term problem with possible consequences and complications.
Kuala Lumpur, 14 September 2017 – The Galen Centre for Health and Social Policy emphasizes on the need to ensure a reasonable and practical approach to the issue of Hepatitis C treatment in Malaysia as opposed to winner-takes-all.
Commenting on today’s The Star news report, Chief Executive Azrul Mohd Khalib said, “With the voluntary license now being offered by Gilead Sciences, the government might want to consider negotiating the best possible deal within that framework as opposed to resorting to a government-use license, which is a measure of last resort.”
“With their decision last month to extend its generic licensing agreement for Sofosbuvir to include Malaysia, it is now possible to plan, implement and produce a low cost drug to treat and cure Hepatitis C (HCV) in this country. We can negotiate for technical support, concessions and additional assistance from the pharmaceutical company.”
“This hard-won development would see increased access to a treatment which will improve the quality of life for patients and most importantly, save lives,” emphasised Azrul. “It represents a moral victory for the government which has worked hard to enhance access for Malaysians to innovative drugs and treatment to treat emerging health challenges.”
“Implementing a government-use license would be outside that framework. It could represent a pyrrhic approach to a long-term problem with possible consequences and complications such as reduced access to future innovative drugs for other diseases, including non-communicable diseases, perceived to be unfriendly to innovation and intellectual property rights, becoming a less attractive location for clinical trials, and being on the watch list of certain trading partners.”
“It is critical to ensure that treatment is affordable for the government and accessible to the patient. Patients also need to actually be found and treated. With infection to disease progression taking up as long as 20 years, screening and treatment adherence could be just as critical as cost in ensuring a successful outcome in the fight against HCV. These issues should not be neglected or kept at the wayside,” concluded Azrul.
Compulsory licenses are emergency instruments provided under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The government, without the permission of the patent holder, is able to import, manufacture a generic version of a patented drug for public non-commercial use. They enable governments to be able to move rapidly with as much legal flexibility to provide its citizens with life-saving drugs and treatment in the event of an emergency or public health crises. They become necessary when patent holders are unable, unwilling or uncooperative to meet such demand.
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