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Malaysia Grants Compulsory Licence For Generic Sofosbuvir Despite Gilead Licence

15/09/2017 by Catherine Saez, Intellectual Property Watch 6 Comments

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A much cheaper version of a groundbreaking hepatitis C medicine is expected to be available soon for the hundreds of thousands of hepatitis C patients in Malaysia, as it decided to grant a compulsory licence to sofosbuvir, according to sources. The decision comes right after the medicine originator decided to expand its voluntary licensing scheme to four more countries, including Malaysia.

[Update] The Malaysian government on 20 September confirmed that it approved “the use of Rights of Government under Patent Act 1983 (Act 291) by exploiting the patented invention of Sofosbuvir tablet 400mg.” According to a press release, “the last time Malaysia instigated the Rights of Government was in 2003 for anti-retroviral drugs (treatment for HIV infection). This sets Malaysia to be the first country to initiate such move in the world.”

​The decision to initiate the Rights of Government, the release said, “was made after the MOH [Ministry of Health] efforts to be included in the Medicine Patent Pool (MPP) and price negotiations with patent holder were unsuccessful.”

The Drugs for Neglected Diseases initiative (DNDi) issued a statement welcoming the move by the Malaysian government. [end update]

The Malaysian AIDS Council said in a release that as many as 500,000 people or 2.5 per cent of the general population are estimated to be living with hepatitis C in Malaysia, and hepatitis C prevalence among young people who inject drugs is estimated to be “between 50 to 67 percent,” because of HIV-hepatitis C co-infections.

According to the release, the cost of the full hepatitis C treatment comes to RM300,000 per patient (US$71,300), leading to very few patients benefitting from it.

In a column in The Star (Malaysia), Martin Khor, executive director of the South Centre, said, “Health Minister Datuk Seri Dr S. Subramaniam indicated in July that the ministry is hoping to get a generic version of the same drug, for RM1,000 (US$ 237) per patient.”

“Clinical trials are being conducted in cooperation with the Geneva-based Drugs for Neglected Diseases initiative (DNDi) and an Egyptian generic company in a project to make available Sofosbuvir, combined with another drug,” Khor wrote.

Malaysia is a middle-income country and thus was excluded from voluntary licence by Gilead. However, according to sources, Gilead announced recently that it would include four middle-income countries (Malaysia, Thailand, Ukraine, and Belarus) to its voluntary licensing scheme.

According to Khor, Malaysia’s consideration of a decision to issue a “government-use” licence might have prompted Gilead to extend its voluntary licence scheme to Malaysia.

According to several sources, it appears Malaysia has an option of using both possibilities at the same time, the compulsory licence, and Gilead voluntary licence. Khor added that “There are limits to what Malaysia can import or produce under the Gilead licence and that restricts the freedom to choose the generic firms it can work with,” calling on the Malaysian government to stick to its decision, since the country can use both schemes.

For background on the issue, see a recent article by University of Leeds researcher Fifa Rahman (IPW, Public Health, 24 August 2017).

Gilead had not responded to questions by press time, nor had the Malaysian mission in Geneva.

 

Image Credits: Malaysian AIDS Council

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Related

Catherine Saez may be reached at csaez@ip-watch.ch.

Creative Commons License"Malaysia Grants Compulsory Licence For Generic Sofosbuvir Despite Gilead Licence" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Filed Under: IP Policies, Language, Themes, Venues, Asia/Pacific, English, Finance, Health & IP, Health Policy Watch, Human Rights, Patents/Designs/Trade Secrets, Regional Policy

Trackbacks

  1. Heading Off Global Action On Access To Medicines In 2018 - Intellectual Property Watch says:
    09/02/2018 at 7:37 pm

    […] IP Watch: Malaysia Grants Compulsory License https://www.ip-watch.org/2017/09/15/malaysia-grants-compulsory-licence-generic-sofosbuvir-despite-gi… (accessed January 8, […]

    Reply
  2. Collective efforts by civil society groups bar the way to Hepatitis C patents - Make Medicines Affordable says:
    12/05/2018 at 3:56 pm

    […] However, in September 2017, Malaysia announced the approval of a government use licence, also known as a compulsory licence, for sofosbuvir. According to a post by hep Coalition, some 500,000 people are infected with hepatitis C in Malaysia. Malaysia is the first country in the world to have taken such a step for sofosbuvir (IPW, Health & IP, 15 September 2017). […]

    Reply
  3. Collective Efforts By Civil Society Groups Bar The Way To Hepatitis C Patents - Intellectual Property Watch says:
    19/07/2018 at 4:11 am

    […] However, in September 2017, Malaysia announced the approval of a government use licence, also known as a compulsory licence, for sofosbuvir. According to a post by hep Coalition, some 500,000 people are infected with hepatitis C in Malaysia. Malaysia is the first country in the world to have taken such a step for sofosbuvir (IPW, Health & IP, 15 September 2017). […]

    Reply
  4. Esfuerzos mancomunados de grupos de la sociedad civil impiden la entrada de las patentes de medicamentos contra la hepatitis C - Intellectual Property Watch says:
    09/08/2018 at 10:37 pm

    […] No obstante, en septiembre de 2017, Malasia anunció la aprobación de una licencia “de uso gubernamental”, también conocida como licencia obligatoria, respecto del sofosbuvir. Según un artículo de hep Coalition, en Malasia hay aproximadamente 500 000 personas infectadas por el virus de la hepatitis C. Malasia es el primer país del mundo que adoptó esa medida respecto del sofosbuvir (IPW, salud y propiedad intelectual, 15 de septiembre de 2017). […]

    Reply
  5. Collective Efforts By Civil Society Groups Bar The Way To Hepatitis C Patents – Health Policy Watch says:
    05/09/2018 at 10:52 pm

    […] However, in September 2017, Malaysia announced the approval of a government use licence, also known as a compulsory licence, for sofosbuvir. According to a post by hep Coalition, some 500,000 people are infected with hepatitis C in Malaysia. Malaysia is the first country in the world to have taken such a step for sofosbuvir (IPW, Health & IP, 15 September 2017). […]

    Reply
  6. Desafios globales en materia de acceso a medicamentos para el año 2018. – Politicas says:
    19/03/2019 at 6:39 pm

    […] IP Watch: Malaysia Grants Compulsory License https://www.ip-watch.org/2017/09/15/malaysia-grants-compulsory-licence-generic-sofosbuvir-despite-gi… (accessed January 8, […]

    Reply

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