Jakarta, 22 September 2023.

On the fourth day of session II of the Public Hearing on the Draft Derivative Regulation of Health Law No. 17 of 2023, the Directorate General of Pharmaceuticals and Medical Devices discussed the topic of Blood Services.

This activity invited stakeholders from various sectors, including BPOM, Ministries/Institutions, Directorate General of Customs and Excise, PMI, UPD hospitals in Jakarta, Professional Associations and Organizations, Blood Donor Communities and Societies, Health Services, Pharmaceutical SOEs, Plasma Fractionation Facilities and Expert Practitioners.

Director General of Pharmaceuticals and Medical Devices, L. Rizka Andalusia at the opening said that in the substance of blood services there is something new besides routine blood services organized by the Blood Management Unit (UPD) but also related to the utilization of plasma as a plasma derivative medicinal product.

"We invite relevant stakeholders as representatives of community groups to provide oral or written input to enrich or complete the RPP that we have compiled," said Rizka.

The Blood Services session was attended by the Director of Referral Health Services, Yuli Astuti Saripawan, who also oversaw the substance of Blood Services in the Health Law. Through her presentation, it was conveyed that blood services are health efforts that utilize human blood as a basic material with humanitarian purposes, healing diseases and restoring health, and not for commercial purposes. Blood services consist of blood management and blood transfusion services.

"Blood management includes 8 (eight) parts, namely planning, mobilization and preservation of blood donors, selection of blood donors, blood collection, blood testing, blood processing, blood storage and blood distribution. While blood transfusion services include 5 (five) parts, namely planning, storage, pre-transfusion testing, distribution and medical actions to give blood to patients," explained Director Sari.

The government's responsibilities in blood services include (1) The Central Government and Local Governments guarantee financing in the implementation of blood services and are responsible for the implementation of blood services that are safe, accessible, and in accordance with the needs of the community; (2) The Central Government determines the replacement cost of blood processing and is responsible for preparing blood service standards; and (3) Local Governments are responsible for blood services in their area.

Director of Pharmaceutical and Medical Device Resilience, Roy Himawan through his presentation said that plasma can be utilized for the purpose of healing diseases and restoring health through processing and production into plasma derivative medicinal products.

"Plasma management has several stages, including planning, mobilizing and preserving plasma donors, selecting plasma donors, collecting plasma, testing plasma, storing plasma, distributing plasma," Himawan explained.

Himawan further said that Plasma Derivat Drug Products (PODP) are obtained through the Plasma Fractionation process (sorting plasma into individual protein fractions to produce PODP) by applying plasma processing technology. The plasma used must meet the standards of Good Manufacturing Practices (GMP). In addition, PODP must meet safety, efficacy, and quality standards and obtain a distribution license.

"Plasma fractionation is carried out in domestic plasma fractionation facilities with the following provisions (1) The business entity is a legal entity, established by the Minister, and has obtained a CPOB certificate; (2) It can organize plasma fractionation on a contract basis to overseas plasma fractionation facilities for a maximum period of 3 (three) years in order to provide CPOB-certified domestic plasma fractionation facilities; and (3) In organizing plasma fractionation on a contract basis, plasma shipments abroad must be accompanied by a plasma transfer and use agreement approved by the Government," Himawan continued.

Recording and reporting of plasma collection and plasma fractionation can utilize health information systems that are integrated with the National Health Information System.

The RPP also states that the Central Government is responsible for the availability of safe, efficacious, quality and affordable plasma and PODP according to health service needs and controlling the cost of plasma and PODP processing.

In closing the Director General of Pharmaceutical and Health Services, L. Rizka Andalusia said that the government will control the management and distribution so that the benefits will return to the community. Plasma management planning involves Plasma Banks, UPDs and Plasma Fractionation Facilities by taking into account the need for the amount of blood and the number of UPDs. In addition, plasma management planning refers to the Health Sector Master Plan (RIBK) and uses a health information system that is integrated with the National Health Information System (SIKN).

"This is done so that plasma management can run and resilience and independence in the field of PODP can be carried out and benefit the community, because until now we are still importing all PODP," Rizka concluded. The Ministry of Health will continue to gather input and aspirations from the public as widely as possible. The general public can follow this activity through the Ministry of Health's YouTube channel and can actively participate by providing input and suggestions through the Ministry's website https://partisipasisehat.kemkes.go.id/ during the lesson plan development process.