On October 18, 2023, the Bureau of Goods and Services Procurement (or known as ‘PBJ Bureau’) of the Ministry of Health conducted a socialization on the implementation of Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue, in an effort to improve and increase the use of domestic products.
The implementation of substitution to domestic medicines and medical devices is based on the Presidential Regulation Number 12 of 2021 Article 66 Mandatory Use of Domestic Products, paragraph (1), (2) and (5) and Presidential Instruction Number 2 of 2022 First Dictum (point 8), which summarizes that:
a. Ministries/Institutions/Regional are required to use domestic products, including the design building and national engineering.
b. The use of domestic products shall be carried out in a case where a domestic product has a value of at least 40% from the sum of Domestic Component Levels Value (TKDN) and Company’s Benefit Weight (BMP).
c. For domestic products that has a value of at least 40% from the sum of Domestic Component Levels Value (TKDN) and Company’s Benefit Weight (BMP), the TKDN score should be at least 25%.
d. The procurement of import goods can be carried out in the case where the goods could not be produced domestically, or the domestic production volume is not able to meet the needs.
In this substitution to domestic medicines and medical devices, the National Public Procurement Agency (LKPP) and / or the Sectoral e-Catalogue has the authority to:
- Request and / or receive information or data for the purpose of:
a. Review and/or audits.
b. Monitoring and evaluation of provision of the medicines and medical devices.
c. Tracing any indications of manipulation & violations in the utilization of e-Catalogue application features. - Manage based on unilateral consideration and, without prior notice, may perform the necessary actions including but not limited to:
a. Termination of the e-Catalogue Provider in the e-Catalogue Application;
b. Freeze e-Purchasing transactions;
c. Unleash products on the e-Catalogue Application;
d. Close accounts; and/or other necessary actions. - Make changes to the e-Catalogue Provider Terms and Conditions.
- Impose sanctions to e-Catalogue Providers in accordance with the applicable laws and regulations and/or Terms and Conditions of e-Catalogue Provider.
Freeze and Unfreeze process in the e-catalogue will be applied in the substitution to domestic medicines and medical device procedures with the following criterion:
| FREEZE CRITERION | UNFREEZE CRITERION |
|---|---|
| 1. Medicines and medical devices needed are already domestically produced and have a distribution permit; and/or | 1. Domestically produced medicines could not fulfil the National needs plan, proven by data shown in the sectoral e-catalogue reflecting the National needs plan, and capacity and amount of production by the domestic pharmaceutical industries.; |
| 2. The capacity and amount of domestically produced medicines from pharmaceutical industries listed in the sectoral e-Catalogue has met the National needs plan; and/or | 2. Domestically produced medical devices could not fulfil the National needs plan, proven by the needs plan document and data reflecting the capacity of domestically produced medical devices; and/or |
| 3. The production capacity of domestic medicines and medical devices has met the National needs plan with product specifications that are suitable for health services. | 3. Imported medical devices have parameters and/or product specifications that are not capable to be produced by domestic industries. |
Medical Devices provider may submit an application to unfreeze their products in the e-Catalogue by following below steps:
- Scan the barcode as mentioned in this guideline to fill out the Unfreeze Application form, as well as attaching the Unfreeze Request Letter addressed to the head of PBJ Bureau.
- Submit their product list by following the template provided in this link .: Permohonan Unfreeze Katalog Sektoral Kemenkes | s.Link Kemenkes RI :. (kemkes.go.id)
The implementation process of PBJ Bureau for freezing/unfreezing of products in the e-catalogue is shown in below flowchart
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