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​ 

December 6, 2023
New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are
Read More
October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More
October 25, 2023
One significant development in the health sector in Indonesia is the use of information technology and communication in the implementation of health efforts—particularly digital health services such as telehealth and telemedicine integrated into the country’s National Health Information System. This development was addressed in a major new piece of legislation for the healthcare sector in Indonesia. Enacted in August 2023, Law No. 17 of 2023 concerning Health (the “Health Law”) provides the updates needed to support the development of healthcare services in Indonesia. Under the Health Law, health information system (HIS) providers must: Carry out processing of data and health information in the territory of Indonesia, except for certain limited and specific processing activities that may be conducted outside Indonesia when permitted by the relevant authorities and in compliance with relevant regulations. Ensure the reliability of its HIS, including availability, security, maintenance, and integration with Indonesia’s National Health Information System. Provide quality health data and information. Process data and health information, which includes planning, collection, storage, inspection, transfer, utilization, and destruction. Record its data- and information-processing history. Protect every person’s data and health information. Obtain approval from the relevant personal data subject or comply with relevant regulations if the processing of data and health information involves an individual’s health data. Inform the data owner if there is a failure to protect data and individual health information. The Health Law’s personal data protection requirements listed above appear to be aligned with the provisions in Law No. 27 of 2022 concerning Personal Data Protection (the “PDP Law”). Under this law, data and information relating to health are identified as “specific personal data,” the processing of which carries a high potential risk of impacting the relevant personal data subject. In the implementation of digital health services, patients’ personal data or medical records
Read More
October 19, 2023
Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the
Read More