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Challenges in Indonesia's
Compulsory License
Sindi Putri
Indonesia AIDS Coalition
Compulsory Licences in Indonesia
• Indonesia had already three Presidential Decree related on pharmacy product :
Presidential Decree No. 83/2004 for Antiretroviral Lamivudine & Nevirapine and
Presidential Decree No. 6/2007 updated the previous decree for Efavirenz.
Presidential Decree No. 76/2012 for Antiviral and Antiretroviral.
• In the President Decree No. 76/2012 there are seven HIV medicines and one
Hepatitis B medicine included, Efavirenz, Abacavir, Didanosin,
Lopinavir/Ritonavir, Tenofovir, Tenofovir/Emtricitabin, and
Tenofovir/Emtricitabin/Efavirenz.
• In 2004 and 2007 it is mentioned that the licensed for local production only and
the use limited in the country.
• In the implementation of the CL, government appointed Kimia Farma a local
government pharmacy.
• There are barrier for local production by KF, they should get the marketing
approval first. The process more than five years to get the marketing approval for
Nevirapine, Lamivudin and Efavirenz.
Compulsory Licences in Indonesia
(2)
• The government decided to use the parallel importation through
Special Access Scheme (SAS)
• The awarded royalty in the amount of 0,5% only.
The Challenges
• The use of compulsory license and or government use was not directly
reduce the drugs price, based on the assessment Indonesia ARV price
consider the highest among other countries.
• The appointment of KF by government to the implementation is not
created the competition.
• The use of compulsory license also is not automatically encourage the
drug registration for example Tenofovir, Tenofovir/Emtricitabin,
Tenofovir/Emtricitabin/Efavirenz because it's still import using SAS since
2012 meanwhile SAS purposed for the drugs that's not available in
Indonesia meaning not registered and usually only one time used.
• In Presidential Decree No. 76/2012, not all medicines used such as
Didanosin.
What Next
• Review the Presidential Decree 76/2012, it's should be updated
based on current situation needs and the Indonesia's New
Patent Law about CL and government use.
• Promoting competition to reduce the price
• Encouraging the fast track registration for ARV medicines with
clear mechanism and requirements
Thank You

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GSIPA2M, Parallel session 2, Making compulsory licenses routine - Sindi Putri

  • 1. Challenges in Indonesia's Compulsory License Sindi Putri Indonesia AIDS Coalition
  • 2. Compulsory Licences in Indonesia • Indonesia had already three Presidential Decree related on pharmacy product : Presidential Decree No. 83/2004 for Antiretroviral Lamivudine & Nevirapine and Presidential Decree No. 6/2007 updated the previous decree for Efavirenz. Presidential Decree No. 76/2012 for Antiviral and Antiretroviral. • In the President Decree No. 76/2012 there are seven HIV medicines and one Hepatitis B medicine included, Efavirenz, Abacavir, Didanosin, Lopinavir/Ritonavir, Tenofovir, Tenofovir/Emtricitabin, and Tenofovir/Emtricitabin/Efavirenz. • In 2004 and 2007 it is mentioned that the licensed for local production only and the use limited in the country. • In the implementation of the CL, government appointed Kimia Farma a local government pharmacy. • There are barrier for local production by KF, they should get the marketing approval first. The process more than five years to get the marketing approval for Nevirapine, Lamivudin and Efavirenz.
  • 3. Compulsory Licences in Indonesia (2) • The government decided to use the parallel importation through Special Access Scheme (SAS) • The awarded royalty in the amount of 0,5% only.
  • 4. The Challenges • The use of compulsory license and or government use was not directly reduce the drugs price, based on the assessment Indonesia ARV price consider the highest among other countries. • The appointment of KF by government to the implementation is not created the competition. • The use of compulsory license also is not automatically encourage the drug registration for example Tenofovir, Tenofovir/Emtricitabin, Tenofovir/Emtricitabin/Efavirenz because it's still import using SAS since 2012 meanwhile SAS purposed for the drugs that's not available in Indonesia meaning not registered and usually only one time used. • In Presidential Decree No. 76/2012, not all medicines used such as Didanosin.
  • 5. What Next • Review the Presidential Decree 76/2012, it's should be updated based on current situation needs and the Indonesia's New Patent Law about CL and government use. • Promoting competition to reduce the price • Encouraging the fast track registration for ARV medicines with clear mechanism and requirements