On 29 July 2020, the government issued Presidential Regulation No. 99 of 2020 on the Procurement of Vaccines and Vaccination of Corona Virus Disease 2019 (COVID-19) ("Presidential Regulation 99"). Presidential Regulation 99 regulates the (i) COVID-19 vaccine procurement, (ii) COVID-19 vaccination, (iii) funding of COVID-19 vaccine procurement and COVID-19 vaccination, and (iv) support and facilities provided by the ministries, institutions and regional governments.
- Procurement of COVID-19 Vaccines
The procurement of COVID-19 vaccines includes (i) the supply of COVID-19 vaccines and supporting equipment, and (ii) the distribution of COVID-19 vaccines to the receiving points determined by the Minister of Health ("MOH"). The procurement of COVID-19 may be conducted as follows:
- Appointment of a state owned company
The MOH will appoint PT Bio Farma (Persero) to do the procurement of COVID-19 vaccines. This appointment may also include participation of subsidiaries of PT Bio Farma (Persero), i.e., PT Kimia Farma Tbk and PT Indonesia Farma Tbk.
In performing its duties, PT Bio Farma (Persero) may cooperate with other onshore or offshore companies/institutions, and determine the terms and conditions of the cooperation to procure the COVID-19 vaccines.
- Direct appointment of business entities
The MOH may directly appoint a business entity for the procurement of COVID-19 vaccines. Business entities that may be appointed by the MOH are onshore or offshore business entities that fulfill the requirements set out by the MOH. The requirements include (i) a certificate of good drug manufacturing or (ii) a certificate of good drug distribution in accordance with the business line of the business entities.
- Cooperation with international institutions/agencies
The cooperation with international institutions for the procurement of COVID-19 vaccines should be conducted with:
- the Coalition for Epidemic Preparedness Innovations (CEPI)
- the Global Alliance for Vaccines and Immunizations (GAVI), and/or
- other international institutions/agencies
The Minister of Foreign Affairs will be performing the cooperation with CEPI, and the MOH will be performing the cooperation with GAVI and/or other international institutions/agencies.
- Vaccination of COVID-19
The MOH will be conducting the vaccination of COVID-19 by (i) determining the criteria and priority list of vaccine receivers, (ii) determining the priority list of areas where vaccines will be given, (iii) preparing a schedule and procedure for providing the vaccines and (iv) issuing vaccination service standards.
The MOH will cooperate with other ministries, institutions, business entities, and other bodies/agencies to obtain support for (i) medical personnel; (ii) vaccination locations, (iii) logistics/transportation, (iv) warehousing and vaccine inventory, including stock buffer/stock piling, (v) security and/or (vi) socialization and community service. Entities that will provide warehousing and vaccine inventory support are required to have a certificate of good drug distribution. Otherwise, the warehouse and vaccine inventory has to be a pharmaceutical installation owned by the government.
The MOH and the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan or "BPOM") will continue to supervise post COVID-19 vaccination conditions.
- Pricing and Monetary Facilities
The MOH will be determining the price for COVID-19 vaccines. The pricing will consider the type of vaccine, the source of supply and the timing of the performance of the relevant contracts.
The government will grant monetary facilities such as tax and duty facilities in relation to the importation of the vaccines, supporting equipment for the production of COVID-19 vaccines and supporting equipment for vaccination.
The procurement of the COVID-19 vaccines and the vaccination is funded by the state budget. The government may also have capital participation in PT Bio Farma (Persero) to support the procurement of the COVID-19 vaccines and the COVID-19 vaccination.
Based on Presidential Regulation 99, the MOH will be determining the types and quantity of the COVID-19 vaccines that will be used in Indonesia. For the acceleration of the vaccination process, the MOH will (i) accelerate the licensing process and procurement of supporting equipment for COVID-19 vaccination, including the importation licenses and formalities, (ii) issue COVID-19 vaccine service standard, and (iii) other support as necessary.
Further to the above, other ministries, institutions and other agencies will give support for the procurement of the COVID-19 vaccines and COVID-19 vaccinations, including BPOM. BPOM will give support such as (i) granting an emergency use authorization or product registrations for the COVID-19 vaccines, (ii) granting approval for COVID-19 vaccine clinical trials, (iii) issuing certificates of good manufacturing of drugs and certificates of good distribution of drugs, (iv) other necessary support.
The procurement of COVID-19 vaccines and the COVID-19 vaccinations will be conducted in the years 2020, 2021 and 2022. The MOH and the COVID-19 Handling and Recovery of the National Economy Committee may extend the period for procurement of COVID-19 vaccines and vaccinations as necessary.