After passing the Health Law (Law No. 17 of 2023), Indonesia introduced Government Regulation No. 28 of 2024 (GR 28/2024) to detail and clarify its provisions. GR 28/2024 replaces 31 existing health regulations, aiming to strengthen Indonesia’s health system and remove redundant rules.
Below is a summary of key points from GR 28/2024. Due to the extensive changes, this summary is limited. Detailed discussions on the digital health sector and health technologies in Indonesia will be covered in a future publication.
Restrictions and prohibitions on the sale of tobacco products
Under GR 28/2024, the definition of tobacco products has been broadened to include electronic cigarettes. These are now defined as tobacco products in liquid, solid, or other forms derived from tobacco leaves processed through extraction or other methods influenced by technological advances and consumer preferences. This definition does not consider substitute or auxiliary materials used in their manufacture, and it specifies that these products must be provided to end consumers in retail packaging for consumption via heating in an electronic device.
Businesses involved must secure the necessary licenses and perform tests on nicotine, tar content, and other substances for each product variant. They must also comply with stringent packaging standards, including specific design and labeling requirements. Regulations stipulate those businesses producing and/or importing cut tobacco products cannot package more than 50 grams per unit. Additionally, producers and importers of electronic cigarettes with closed systems or disposable cartridges are restricted from packaging nicotine liquid in containers larger than two milliliters per cartridge, with no more than two cartridges per package. Violations of these provisions may result in administrative sanctions, including written reprimands and mandatory product withdrawals.
The regulation further prohibits the sale of any tobacco products:
- through vending machines
- to individuals under 21 years of age or to pregnant women
- as single units (per cigarette) for retail, except for cigars and electronic cigarettes
- in displays located around entrances, exits, or areas frequently trafficked by customers (e.g., near payment areas, children’s food and drink sales areas, and children’s toy sales areas)
- within a 200 meter radius of educational institutions and children’s playgrounds
- via websites, electronic commercial platforms, and social media, unless these platforms include robust age verification features.
The Food and Drug Supervisory Agency (BPOM) is currently preparing a draft regulation on the supervision of the distribution of tobacco products and electronic cigarettes. This draft regulation mandates several critical obligations for business entities regarding nicotine and tar content in products, including:
- obtaining the necessary business licenses as required by law
- adhering to established maximum limits for nicotine and tar levels
- conducting tests for nicotine and tar content for each product variant produced and/or imported, and
- reporting the results of nicotine and tar tests to the Head of BPOM.
Additionally, the draft regulation stipulates that business actors must include the warning, "It is prohibited to sell or provide to persons under the age of 21 and pregnant women," marking a significant increase from the previous age limit of 18 years. Furthermore, in terms of labeling, business actors are prohibited from using terms such as "light," "ultra-light," "mild," "extra mild," "low tar," "slim," "special," "full flavor," "premium," or any other words that imply quality or superiority, feelings of security, image, personality, or words of equivalent meaning.
Hospitals
Despite the revocation of Government Regulation No. 47 of 2021 on Hospitals (GR 47/2021) by GR 28/2024, the permits and classifications for hospitals as regulated in GR 47/2021 remain valid. This continuity will be maintained until new implementing regulations related to hospitals are issued. Furthermore, all derivative implementing regulations of GR 47/2021 also remain valid, provided they do not conflict with GR 28/2024. Hospital permits issued prior to GR 28/2024 are confirmed to be valid and do not require updates at this time.
GR 28/2024 introduces significant changes to hospital management structures, including a clear delineation of roles such as "hospital owner" and "hospital head," which must now be held by separate individuals. It also specifies detailed requirements for "hospital management competence," attainable through education, training, and/or experience. Moreover, GR 28/2024 enhances the clarity of hospitals' business obligations compared to GR 47/2021, ensuring that hospitals are well-informed about how to fulfill these obligations in their operations.
Maternal, infant, and child health
In accordance with previous regulations, GR 28/2024 is designed to organize and enhance health initiatives for various population groups, including mothers, infants, children, adolescents, adults, and older adults. These initiatives must be executed according to safety, quality, and affordability standards. Specifically, in terms of maternal and infant health and alignment with the enactment of the KIA Law, employers are required to promote and support exclusive breastfeeding through several measures:
- developing policies that encourage exclusive breastfeeding
- implementing provisions to support exclusive breastfeeding programs at workplaces through work agreements, company regulations, or employment agreements
- requiring management or workplace organizers to establish internal company regulations supporting breastfeeding
- providing special facilities at workplaces to enable mothers to continue breastfeeding comfortably and privately.
Furthermore, producers or distributors of infant formula milk are strictly prohibited from engaging in indirect or cross-promotions of food products with infant formula milk and/or other breast milk substitute products. Any violations of these stipulations may lead to administrative sanctions, including verbal and/or written warnings issued by authorized officials.
Occupational health efforts
GR 28/2024 states that employers and managers or administrators of all workplaces must carry out occupational health efforts in accordance with occupational health standards. While these standards will be further regulated by the regulations of the Minister of Health and Manpower for the implementation of occupational health standards for workers in companies, it should be noted that the regulations regarding worker health checks are outlined in Law Number 1 of 1970 concerning work safety and in the Regulation of the Minister of Manpower and Transmigration Number Per.02/MEN/1980 concerning worker health examinations in the implementation of work safety (Permenakertrans 02/1980), are still in effect. These regulations mandate that employers conduct periodic health checks on all workers under their leadership, using a doctor appointed by the employer. These periodic health checks aim to maintain workers' health levels after they begin their roles and assess as early as possible any potential impacts from their work, which should be mitigated with preventative measures.
Entitlement to termination of pregnancy for victims of rape and sexual assault
Under GR 28/2024, victims of rape and sexual violence are expressly granted the legal right to terminate pregnancies resulting from such offenses. Furthermore, this regulation classifies pregnancies that endanger the life of the mother as medical emergencies, thereby ensuring access to necessary abortion services.
Women who conceive because of rape or other forms of sexual violence are permitted to seek an abortion. The procedure may be conducted upon presentation of a formal declaration by an investigating authority confirming the occurrence of sexual violence leading to pregnancy. Additionally, victims are entitled to comprehensive support from medical and health personnel during the decision-making process regarding abortion. Should a victim choose to carry the pregnancy to term, they are guaranteed support throughout the pregnancy, during childbirth, and in the postpartum period.
It is important to note that the specifics regarding the permissible gestational age for an abortion currently adhere to pre-existing regulations, which allow termination within 40 days of conception. This stipulation remains effective until the enactment of Law No. 1 of 2023 concerning the criminal code, which extends the permissible period to less than 14 weeks.
Foreign medical professional
As previously highlighted, the use of foreign medical professionals is a matter of careful consideration. Efforts to increase their numbers face challenges, mainly due to the opposition from the Indonesian Doctors Association (IDI). In response, GR 28/2024 has introduced a new provision. This provision allows the deployment of Indonesian medical and health workers abroad, provided it maintains a delicate balance. This balance ensures that the needs of medical and health workers in Indonesia are met while also creating job opportunities for Indonesian medical and health workers abroad.
The key factor in this balance is the adequacy of the number and types of workers to meet domestic needs. Medical personnel and health workers of foreign citizens graduates from abroad, who can practice in Indonesia, only apply to specialist and subspecialist medical personnel and health workers of a certain level of competence after undergoing a competency evaluation for a maximum of two years. They must have a minimum of three years of professional practice experience per their professional field's competence. Details in relation to the requirements and competence of foreign medical professionals to be able to work in Indonesia are provided in this regulation.
Sugar, salt and fat limitation consumption
One of the measures to minimize cases of non-communicable diseases, as outlined in GR 28/2024, grants the central government the authority to set maximum limits for sugar, salt, and fat (SSF) content in processed foods, including ready-to-eat products. This regulatory process, overseen by the government, is designed to ensure the safety and health of the public. The upcoming Ministerial Regulation will further define the specific limits for SSF consumption.
Every party that produces, imports, and/or distributes processed foods must comply with the SSF content limits set by the government and include a nutritional content label on the product packaging that details the SSF content. Additionally, for certain products such as high-sugar cereals or salty snacks, there are restrictions on advertising, promotion, and sponsorship activities at specified times, locations, and target groups, as well as prohibitions on selling or distributing processed foods in certain places such as educational facilities, health service facilities, and children's play areas.
It should be noted that non-compliance with the SSF content mandate is a serious issue that can result in administrative sanctions ranging from written warnings and fines to the revocation of business licenses. Adhering to these regulations is crucial to avoid such consequences.
Domestic preparations of pharmaceutical preparations and medical devices
While GR 28/2024 does not include significant provisions specifically prioritizing domestic pharmaceutical preparations and medical devices, the Indonesian government continues to emphasize the importance of calculating domestic components to meet the needs of health services and national resilience. The regulations governing the use of pharmaceutical preparations and medical devices will be further detailed in forthcoming implementing regulations.
The various new provisions introduced in GR 28/2024 aim to ensure the rights of the Indonesian populace to achieve healthier living conditions. This mandate calls for diverse stakeholders including health professionals, health service facilities, and businesses operating within the health sector to align their operations with this updated regulatory framework. However, from the perspective of business actors in the health sector, the stipulations set forth in GR 28/2024 do not yet offer sufficient detail to fully meet the needs or provide clarity for those newly entering the Indonesian health market. These specifics are expected to be addressed in future implementing regulations, typically overseen by the Ministry of Health.
If you have any questions or require any additional information, please contact Hanim Hamzah and Andina Sitoresmi of Roosdiono & Partners (in association with KPMG Law).
This alert is for general information only and is not a substitute for legal advice.
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