Health Omnibus Law Series – Patients’ Consents For Medical Actions

This Newsflash is part of our Health Omnibus Law Newsflash series with respect to the issuance of Law No. 17 of 2023 dated August 8, 2023 on Health (the “Health Law”). As noted in our previous Newsflashes, the Health Law is issued using an omnibus method, revoking several laws and regulations in the health sector (including, among others (i) Law Number 29 of 2004 on Medical Practices (“Law 29/2004”) and (ii) Law Number 36 of 2014 on Health Workers (“Law 36/2014”).

In brief, the Health Law is issued with the intention to enhance public health development for the achievement of national objectives in safeguarding the entire Indonesian citizen to advance the general welfare.

One of the key provisions under the Health Law is the provision on the approvals of medical or dental practice and healthcare workers actions. The several changes from the previous provisions stipulated in Law 29/2004 and Law 36/2014 are as follows:

Consolidation of Provisions Regarding Approval of Action by Medical or Dentistry Practice and Approval of Action by Health Worker

Previously, the approval of action by Medical or Dentistry Practice was stipulated under Law 29/2004, while the approval of action by Health Workers stipulated in a separate regulation i.e., the Law 36/2014. Currently, the Health Law consolidated these two provisions under Paragraph 5 of the Health Law regarding the Approval of Action by Healthcare Services.

The Health Law also governs the new term i.e., “Medical Action” to describe and cover the actions that undertaken by both Physicians or Dentists

Additional Prior Explanation for Obtaining Consent from Patients

Article 45(3) of Law 29/2004 and Article 68(3) of Law 36/2014 govern a similar specific explanations that must be provided before the patients were requested to grant a consent for the action of the health service, which are as follows:

[Article 45, paragraph (3) of Law 29/2004]

    • diagnosis and medical procedure methods;
    • purpose of the medical procedure;
    • alternative procedures and the risks;
    • possible risks and complications; and
    • prognosis of the procedure.

[Article 68, paragraph (3) of Law 36/2014]

    • procedures for healthcare services;
    • purpose of the healthcare service procedure;
    • alternative procedures;
    • potential risks and complications; and
    • prognosis of the procedure.

Similar to the above, the Health Law also govern the same provisions with the above with the additional explanation on the (i) indications and (ii) risks if the action was not performed. We set out below the provision on the explanation obligation under Article 293 paragraph (3) of the Health Law:

    • diagnosis;
    • indications;
    • performed Healthcare Service Actions and their purposes;
    • potential risks and complications;
    • alternative procedures and their risks;
    • risks if the action was not performed; and
    • prognosis after undergoing the action.

♦ Requirement of the Written Consent

Previously, Law 29/2004 and Law 36/2014 only govern that written consent must be signed by the patient or their representative. Currently, Article 293 paragraph (8) of the Health Law specifically govern that the signing of written consent must be witnessed by a Medical Professional or Healthcare Worker.

Emergency Action Consent

Please note that Law 29/2004, Law 36/2014, and Health Law govern the exemption of obtaining consent for emergency actions in order to protect the patient’s best health needs, e.g., in the condition to preserve life and/or prevent disability for the patients. In this regard, Article 293, paragraph (9) of Health Law further stipulates that the consent is not required, if in such emergency situation, the patient was not eligible to provide consent and there was also no other person eligible for providing such consent for the patient.

♦ Requirement of Explanation on Health Service Cost

Article 294 of the Health Law stipulates that patients are entitled to receive explanations from Healthcare Facilities with respect to the costs of the Healthcare Services they received. This provision in the Health Law complements the provision under Law 36/2014, which does not cover the explanation of cost calculation for the performed procedures, and Article 45, paragraph (3) of Law 29/2004, which only broadly mentions that patients should be provided with explanations regarding the incurred cost. The explanation of the cost as stipulated on Health Law is to give the patient the hospital price transparency and to prevent the medical bill surprise.

♦ Requirement on the Health Service Programs from the Government

Article 295 of Health Law stipulates that the Health Services Program from the government does not need a consent from patients. However, the healthcare services must still be communicated to the recipients of those health services. This provision aligns with the provision in Article 69 of Law 36/2014 and Article 15 of Ministerial Regulation 290/2008 concerning Approval of Medical Actions, which is a derivative regulation of Law 29/2004.

October 30, 2023

 

AKSET

Please contact Johannes C. Sahetapy-Engel (jsahetapyengel@aksetlaw.com), Raymont Travis (rtravis@aksetlaw.com), or Azzahra Saffanisa Sudiardiputri (asudiardiputri@aksetlaw.com) for further information.

 

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