You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

February 22, 2017

Changes to Indonesian Regulations for Sponsorships of Health Professionals

Subscribe to Updates
Informed Counsel

Effective healthcare depends on innovation, and companies operating in the healthcare sector—including pharmaceutical and medical device producers and distributors—are usually eager to educate health professionals about their products and services so that they are up to date on the latest industry knowledge and skills. Often, this can involve providing sponsorships for health professionals to attend relevant events, such as seminars and workshops.

While they want to encourage this form of education, healthcare companies also need to ensure that these sponsorships are compliant with local laws and regulations in each jurisdiction where they are offered. In Indonesia, the requirements in this area have historically been vague, but this has changed with the introduction of a new regulation in late 2016 that clearly sets out the compliance requirements for sponsorships of health professionals.

Background

Under Indonesia’s Regulation of Health Minister No. 14 of 2014 concerning Gratification Control in the Ministry of Health (Regulation 14), marketing-or product research-related sponsorships fall into the category of “gratification which is considered as bribery,” if they are offered to employees of the Ministry of Health. Gratification is one of the criminal acts of corruption, according to Articles 12B and 12C of the Indonesian Anti-Corruption Law No. 20 of 2001, as part of the government’s objective to ensure that government officials are free from corruption, collusion, and nepotism.

The wording of Regulation 14, together with the Anti-Corruption Law, would appear to treat sponsorships as a form of bribery when they are provided to government employees, while leaving nongovernment employees uncovered by the regulation. To clarify this, the Indonesian government and the Medical Professional Association decided that an effective system of controls for sponsorships of both government and nongovernment health professionals was required. The objective of this system would be to allow for sponsorships of health professionals, while putting in place clear measures to ensure that the sponsorships will not affect their ability to provide independent healthcare services.

New Regulation

To meet this objective, on November 29, 2016, the Indonesian Ministry of Health enacted Regulation No. 58 of 2016 concerning sponsorships for health professionals (Regulation 58) to specify the appropriate provisions and limitations for these types of sponsorships. Under this regulation, a “health professional” has been defined as “any person who dedicates themselves in the field of health and has knowledge and/or skill through education in the field of health”. This definition makes it clear that Regulation 58 applies to both governmental and nongovernmental health professionals working in any segment of the industry.

The purpose of Regulation 58 is to ensure that sponsorships, when provided, will not affect the independence of health professionals in providing health care services. For example, sponsorships should not affect the writing of prescriptions or encourage the use of related products of a sponsoring company. To this end, Regulation 58 stipulates that a sponsorship may be granted to health professionals who are government employees, nongovernment employees, or solo practicing health professionals, provided that the sponsorship must:

  • Not affect their independence in providing healthcare services.
  • Not be in the form of cash or cash equivalents (i.e., bank checks).
  • Not be granted directly to the individual—rather, it should be provided through the institution at which the health professional is employed.
  • Be related to the health professional’s areas of expertise.
  • Be granted publicly with accountability and transparency.

A sponsorship for a health professional who is an employee of an institution (whether governmental or nongovernmental) must be granted through their institution by assignment and must be in accordance with their expertise. The institution must announce publicly the health professionals who received the sponsorship. A sponsorship for those in solo practice is exempted from this requirement, and may be granted in accordance with their expertise with no public announcement required.

In addition to sponsorships being granted to health professionals, a sponsorship may also be granted to an institution, an organization of a healthcare facility, or a professional association. These three forms of sponsorship can be used for organizing seminars, scientific or educational meetings, and trainings.

Regulation 58 goes on to stipulate the details of sponsorships granted to health professionals who intend to attend an event as a participant, speaker, or moderator. For a participant, the sponsorship can include the registration fee, travel tickets, or travel accommodations. For a speaker or moderator, the sponsorship can include the registration fee, travel tickets, travel accommodations, or honorarium. The amount of sponsorship received by a health professional as a participant, speaker, or moderator must be in accordance with the unit cost of the actual expenses incurred by  the association or company that is providing the sponsorship.

Reporting and Penalties

Providers or recipients of the sponsorships must report the sponsorship to Indonesia’s Corruption Eradication Commission (Indonesian: Komisi Pemberantasan Korupsi, KPK) no later than 30 days after receiving the sponsorship. Reporting received sponsorships will exempt the recipients and the sponsors from potential criminal sanctions for gratification under the Anti-Corruption Law.

Monitoring of the implementation of Regulation 58 will be conducted by the Minister of Health and local officials (governors, regents, or mayors) in accordance with their respective duties and authorities. Any health professional who violates this regulation may be subject to administrative sanctions, such as verbal or written warnings, and/or revocation of their licenses. Criminal sanctions for inappropriate sponsorships that are deemed to be gratification under the Anti-Corruption Law include imprisonment of one to five years or a fine of IDR 50 million (approximately USD 3,750) to IDR 250 million (approximately USD 18,750).

With the enactment of Regulation 58, companies now have clarity on the procedures for sponsoring activities of both government and nongovernment health professionals. It is expected that this regulation will help to improve the professional development of health professionals, without compromising their ability to independently provide healthcare services to the public.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

May 11, 2026
Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At
Read More
April 29, 2026
Effective June 22, 2026, Thai Industrial Standards (TIS) for food contact paper and cooking paper will be enforced as mandatory for sale in the Thai market. This move has important implications for product licensing and tightens hygiene, labeling, and chemical-safety requirements for food-contact and cooking paper products. Thailand is strengthening its regulatory framework for paper-based culinary materials against a backdrop of accelerating global commitments to ESG and sustainability, as such materials—particularly those derived from natural or recycled fibers—have emerged as key alternatives to plastics in food preparation, cooking, and packaging applications. As a result, regulators worldwide are tightening controls to ensure that sustainability initiatives do not compromise consumer safety, particularly regarding the potential migration of chemical substances into food. Regulatory Framework: Voluntary vs. Mandatory Standards Standards under the TIS regime are generally classified into two categories. Voluntary standards allow manufacturers or importers to apply for a product license and affix the TIS mark to demonstrate product quality and build consumer confidence, but compliance is not legally required. Mandatory standards, by contrast, require manufacturers and importers to obtain a product license and affix the TIS mark before placing products on the Thai market, and noncompliant products cannot be legally sold. Previously, the TIS standards for food contact paper (TIS 2948-2562) and cooking paper (TIS 3438-2022) fell under the voluntary standard regime, meaning that obtaining a TIS license and displaying the TIS mark was optional. However, due to the increasing use of paper in food preparation and cooking, the Thai Industrial Standards Institute has determined that upgrading these standards to mandatory status is necessary to enhance consumer safety. As a result, all paper intended for food contact or cooking purposes must now obtain a TIS product license prior to sale in Thailand. Scope of the Standards The primary distinction between the
Read More
April 22, 2026
A new decree in Vietnam brings significant implementation clarity to the country’s existing extended producer responsibility (EPR) legal framework. An EPR mechanism was first codified in Vietnam in the 2020 Law on Environmental Protection amid ongoing challenges surrounding the collection and treatment of product and packaging waste. The mechanism was progressively detailed through Decree No. 08/2022/ND‑CP and its successive amendments, but the regulatory framework remained insufficiently developed, notably in terms of support mechanisms for waste collection, recycling, and treatment. The newly launched regulations in Decree No. 110/2026/ND-CP (Decree 110), issued on April 1, 2026, and taking effect on May 25, 2026, stipulate fully and clearly the responsibility of manufacturers and importers to recycle products and packaging and to treat waste. Some key provisions of Decree 110 for manufacturers, importers, and related stakeholders are presented below. Subjects of EPR The Law on Environmental Protection assigns responsibility to manufacturers and importers for product and packaging recycling (under Article 54) or waste collection and treatment (under Article 55), depending on the type of products and packaging they produce or import. Decree 110 elaborates on these EPR provisions by specifying the responsible entities and listing out the types of products and packaging subject to recycling and waste treatment responsibilities. Decree 110 clarifies the responsible entities in special cases, such as when products under the same brand are made by multiple manufacturers, when there is a contract manufacturing or entrusted import relationship, and when the manufacturer or importer is part of a corporate group. Notably, exemptions may be applied in some scenarios, such as for manufacturers and importers of products and packaging exclusively for export, temporary import and re-export, or research and testing purposes, as well as for entities with annual revenue from related products not exceeding VND 30 billion. Recycling Responsibilities Decree 110
Read More
March 30, 2026
In response to an emerging crisis on food safety, the government of Vietnam promulgated Decree No. 46/2026/ND-CP (Decree 46) on January 26, 2026, and Resolution No. 66.13/2026/NQ-CP (Resolution 66.13) on January 27, 2026, setting out a number of substantive changes to the procedure and strict requirements for the declaration, registration, and importation of food products. Both instruments took effect upon issuance. However, shortly after they entered into force, food businesses encountered significant implementation challenges, particularly with respect to state inspection procedures at the customs clearance stage for imported products. In response, the government issued Resolution No. 09/2026/NQ-CP (Resolution 09) on February 4, 2026, temporarily suspending Decree 46 and Resolution 66.13 until a new effective date of April 16, 2026. Continued Suspension of Implementation of Decree 46 and Resolution 66.13 After considering feedback gathered by the Ministry of Health from food businesses and other stakeholders during the suspension period, the Vietnam Government Office issued a notice on March 20, 2026, agreeing to extend the suspension until the issuance of an amended Law on Food Safety and its guiding decree. Following this notice, on March 22, 2026, the Ministry of Health prepared a draft resolution to implement the notice and replace Resolution 09. Under the draft resolution, the effectiveness of Decree 46 and Resolution No. 66.13 would continue to be suspended until the amended Law on Food Safety takes effect, except for the provisions under Resolution 66.13 allowing flexibility in documents evidencing product efficacy, which would take effect on April 16, 2026, and remain effective until the Law on Food Safety is replaced (but not later than February 28, 2027). Accordingly, for products subject to the registration declaration procedure, such as health supplements, efficacy may be substantiated by either (i) scientific evidence supporting the declared function and effects of the product
Read More