Regulatory Focus™ > News Articles > Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

Regulatory NewsRegulatory News
Posted 15 September 2017 | By Zachary Brennan 

Malaysia Issues Compulsory License for Gilead Hepatitis C Drug


Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access.

Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus.

Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepatitis C medicines for 91 developing countries.

Compulsory License

One of the reasons countries can be hesitant to issue compulsory licenses is that they can be put on a US watch list that points out countries that "deny adequate and effective protection of intellectual property rights," or that "deny fair and equitable market access to United States persons that rely upon intellectual property protection," though the issuance of compulsory licenses is permissible under international law.

And the case for issuing a compulsory license in Malaysia (a move the country has also made previously to increase access to generic HIV drugs more than a decade ago) was made in a recent report that discussed the impact of that first issuance.

The report says this first compulsory license and the subsequent importation of generic HIV medicines reduced the average cost of treatment per month per patient from USD $315 to USD $58, and government treatment capacity increased from 1,500 to 4,000 patients.

"While the Malaysian government has been offered the price of USD $12,000 [for Gilead's sofosbuvir or Sovaldi], bioequivalent generics are available for much less i.e. USD $200-1000, and this means that patients will not be able to access these generics until the expiry of the monopolies," the report contended.

The report also highlighted Ukraine's challenges and legal battles with Gilead over the intellectual property of sofosbuvir.

Meanwhile, some are saying Gilead only decided to include Malaysia in its voluntary license program because the government issued a compulsory license.

In an op-ed in Malaysia's Star published Monday, Martin Khor, executive director of the intergovernmental organization known as the South Centre, said the gov

ernment's decision to issue a compulsory license "is believed to be the main reason why the firm is now including Malaysia" in its licensing deal, though it remains to be seen if the compulsory license will stand or if Malaysia will work with Gilead.



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found