15 September 2023
On 11 July 2023, Indonesia's house of representative (known as Dewan Perwakilan Rakyat Indonesia/DPR RI) approved the 2023 draft health law. A month later, the President enacted Law No. 17 of 2023 on Health ("Health Omnibus Law") through the state secretariat. The Health Omnibus Law contains provisions on matters such as pharmaceutical preparations, medical devices, healthcare services, healthcare technology (including telehealth and telemedicine), R&D and other compulsory measures.
The Health Omnibus Law revokes 11 previous laws:
1. Law No. 419 of 1949 on Prescription Drugs
2. Law No. 4 of 1984 on Plagues
3. Law No. 29 of 2004 on Medical Practice
4. Law No. 36 of 2009 on Health ("Previous Health Law")
5. Law No. 44 of 2009 on Hospitals
6. Law No. 20 of 2013 on Medical Education
7. Law No. 18 of 2014 on Mental Health
8. Law No. 36 of 2014 on Healthcare Professionals
9. Law No. 38 of 2014 on Nursing Practices
10. Law No. 6 of 2018 on Health Quarantine
11. Law No. 4 of 2019 on Midwifery
The Health Omnibus Law contains numerous new provisions, but many provisions of the revoked laws are still maintained under the Health Omnibus Law.
The implementing regulations of the revoked laws have been determined to be valid as long as they do not contradict the provisions of the Health Omnibus Law. Given the wide range of topics that need to be covered, we plan to divide our alert on Health Omnibus Law into several alerts. In this client alert, we will cover notable key provisions relating to pharmaceutical preparations and medical devices that may be of interest to businesses in the healthcare services sector. For context, under the Health Omnibus Law, 'pharmaceutical preparations' is defined as drugs, drug materials and natural drugs, including natural drug materials, cosmetics, health supplements and quasi-drugs.
On 11 July 2023, Indonesia's house of representative (known as Dewan Perwakilan Rakyat Indonesia/DPR RI) approved the 2023 draft health law. A month later, the President enacted Law No. 17 of 2023 on Health ("Health Omnibus Law") through the state secretariat. The Health Omnibus Law contains provisions on matters such as pharmaceutical preparations, medical devices, healthcare services, healthcare technology (including telehealth and telemedicine), R&D and other compulsory measures.
The Health Omnibus Law revokes 11 previous laws:
1. Law No. 419 of 1949 on Prescription Drugs
2. Law No. 4 of 1984 on Plagues
3. Law No. 29 of 2004 on Medical Practice
4. Law No. 36 of 2009 on Health ("Previous Health Law")
5. Law No. 44 of 2009 on Hospitals
6. Law No. 20 of 2013 on Medical Education
7. Law No. 18 of 2014 on Mental Health
8. Law No. 36 of 2014 on Healthcare Professionals
9. Law No. 38 of 2014 on Nursing Practices
10. Law No. 6 of 2018 on Health Quarantine
11. Law No. 4 of 2019 on Midwifery
The Health Omnibus Law contains numerous new provisions, but many provisions of the revoked laws are still maintained under the Health Omnibus Law.
The implementing regulations of the revoked laws have been determined to be valid as long as they do not contradict the provisions of the Health Omnibus Law. Given the wide range of topics that need to be covered, we plan to divide our alert on Health Omnibus Law into several alerts. In this client alert, we will cover notable key provisions relating to pharmaceutical preparations and medical devices that may be of interest to businesses in the healthcare services sector. For context, under the Health Omnibus Law, 'pharmaceutical preparations' is defined as drugs, drug materials and natural drugs, including natural drug materials, cosmetics, health supplements and quasi-drugs.