Enacted in 2009, Indonesia’s current Law on Health (Law No. 36/2009) is due for a refresh. The government realized that the law has not maintained its relevance when it comes to health trends such as digital health, which refers to the provision of health services online (also commonly known as telemedicine). While regulations and policy blueprints, such as Ministry of Health (MOH) Regulation No. 46/2017 concerning National E-Health Strategies, have addressed these shifting trends, Indonesia’s main health legislation has proved inadequate in this regard.
For this reason, the government began making plans for an update to the law, and the first draft Omnibus Health Law was published in March 2023. The law addresses digital health and other important issues in today’s health landscape, and it seeks to promote the use of locally made health supplies. The draft Omnibus Health Law represents a notable step forward, but in its attempt to govern and regulate all aspects of health, there are also some issues in the draft that may overlap with some existing government regulations, such as provisions on Halal certification, compulsory licensing of patents, and addictive substances.
This article outlines some of the draft law’s key aspects as well as some potential issues.
Digital Health
In addressing the growing health trend of telemedicine, the draft law confirms, reinforces, and fills gaps left by Indonesia’s three main regulations concerning telemedicine. namely, MOHR No. 20/2019 concerning Telemedicine, MOHR No. 24/2022 concerning Medical Records, and Medical Council Regulation No. 74/2020 concerning Telemedicine (MCR No. 74/2020).
One of these regulations, MOH Regulation No. 20/2019, allows health service facilities to provide telemedicine services to other health service facilities. This covers telemedicine services related to radiology, electrocardiography, ultrasonography, and telemedicine consultancy services—including those that reflect developments in science and technology. This is the only regulation concerning telemedicine services that will not be revoked once the pandemic status is revoked. It will also remain in effect with further implementing regulations (i.e., government regulations) if MOH Regulation No. 20/2019 does not conflict with them.
Another of the telemedicine regulations, Medical Council Regulation No. 74/2020 regulates telemedicine services between Health Service Facilities and patients directly. However, this regulation only applies during the COVID-19 pandemic, meaning that once the pandemic status is revoked by the government there will be no regulation for telemedicine services between health service facilities and patients. This is the void filled by the draft Omnibus Health Law 2023, which states that health service facilities can provide telemedicine services directly to patients, in accordance with an implementing regulation issued in the future.
The draft Omnibus Health Law does not have any differences with the third existing telemedicine regulation, MOH Regulation No. 24/2022 on Medical Records. According to both the regulation and the draft law, health care personnel must be the ones to generate medical records. Health service facilities are also responsible for the security, integrity, confidentiality, and availability of the data in medical records.
The draft law also requires health system information providers to integrate their information systems with the MOH digital system. This integration will enable healthcare personnel, patients, and related parties to access up-to-date and relevant information.
Promotion of Domestic Health Supplies
The draft Omnibus Health Law also promotes the use of health technology originating in Indonesia (referred to in Indonesian as produk dalam negeri). Under the draft, the government is responsible for ensuring the availability, equity, and affordability of health supplies—especially essential drugs (as listed by the government) and drugs used in nationwide programs. The government’s procurement of these health supplies must prioritize domestic products, and generic drugs with international nonproprietary names marketed in Indonesia can only be produced by local pharmaceutical companies.
The draft Omnibus Health Law appears to exclude access to some innovative drugs. While the government is understandably eager to promote locally produced drugs, it is still necessary to import some innovative drugs when the drug cannot be produced locally or the volume of local production is insufficient.
Halal Certification
The draft Omnibus Health Law states that pharmaceuticals, medical devices, and household health supplies must be safe, effective, beneficial, halal, of good quality, and affordable. It further specifies that these items must meet the halal requirements laid out in Indonesian law.
This contrasts with the current Law on Health (Law No. 36/2009), which does not mention the term “halal.” Indonesia’s halal requirements are stipulated in Law No. 33/2014 on Halal Product Assurance and its implementing regulations issued by the Halal Product Assurance Organizing Body. To avoid any confusion and ambiguity on halal certification requirements, the Omnibus Health Law should align with Law No. 33/2014 and its implementing regulations, particularly regarding products that are exempted from obtaining halal certification.
Patent Compulsory Licensing
In regard to compulsory licensing of patents, the draft law states that to ensure the availability and affordability of patent-protected drugs, interventions can be carried out through patent implementation by the central government or through compulsory licensing.
One consideration here is that Indonesia’s Patent Law No. 13/2016 is also undergoing revision. The government should make sure to align the draft Omnibus Health Law with the Patent Law with regard to patent compulsory licensing to avoid confusion or a lack of clarity. In doing so, the government should also consider compulsory licensing of patents for imported pharmaceutical products that cannot be produced locally.
Safeguards on Addictive Substances
The draft Omnibus Health Law states that the production, distribution, and use of addictive substances should not disturb or endanger the health of individuals, families, communities, and the environment. “Addictive substances” include all materials or products that are addictive in nature and whose use can have detrimental effects on individuals or the community at large. These can include:
- narcotics;
- psychotropics;
- alcoholic beverages;
- tobacco products; and
- other processed products of addictive substances.
Narcotics and psychotropics are not identified as addictive substances in Health Law No. 36/2009, but they are illegal substances in that their production, distribution, and consumption are prohibited and subject to criminal sanctions. The Omnibus Health Law should remove narcotics and psychotropics from this provision of addictive substances because they are illegal substances that are regulated under Law No. 35/2009 on Narcotics and Law No. 5/2007 on Psychotropics.
Next Steps
Once this draft Omnibus Health Law is issued by the government, the implementing regulations for this law will likely be discussed in the legislature. However, there not yet been any indication from the government regarding when draft Omnibus Health Law could be passed into law.
Based on the first draft that has been published, we can see that the Omnibus Health Law in Indonesia will address key issues in the health sector, particularly in the areas of digital health, domestic health supplies, and compulsory licensing. However, further revisions and alignment with existing laws and regulations will be necessary to ensure clarity and avoid conflicts.
For further information, please contact:
Irene Djalim, Tilleke & Gibbins
irene.d@tilleke.com
