MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA REGULATION OF MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Considering In View of NUMBER 290/MENKES/PERIIIN/2008 REGARDING CONSENT TO MEDICAL ACTION MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA, that as the implementation of Article 45 Law Number 29 of 2004 regarding Medical Practice, rearrangement on Consent to Medical Action by Regulation of Minister of Health shall be required; 1. Law Number 23 of 1992 regarding Health (State Gazette of the Republic of Indonesia of 1992 Number 100, Supplement to the State Gazette of the Republic of Indonesia Number 3495); 2. Law Number 29 of 2004 regarding Medical Practice (State Gazette of the Republic of Indonesia of 2004 Number 116, Supplement to the State Gazette of the Republic of Indonesia Number 4431); 3. Regulation of Government Number 10 of 1966 regarding Medical Records shall Kept Confidential (State Gazette of the Republic of Indonesia of 1966 Number 21, Supplement to the State Gazette of the Republic of Indonesia Number 2803); 4. Regulation of Government Number 32 of 1996 regarding Health Worker (State Gazette of 1996 Number 39, Supplement to the State Gazette Number 3637); 5. Regulation of Minister. of |Health ~~ Number 920/Menkes/Per/XIl/1986 regarding Efforts on Private Health Service on Medical Sector:MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA 6. Regulation of Minister ~=—of,_~—Health 159b/Menkes/Per/ll/1988 regarding Hospital as already amended by Decree of Minister of Health and Social Welfare Number —_191/Menkes-Kesos/SK/II/2001 regarding Amendment to Decree of Minister of Health Number 157/Menkes/SK/III/1999 regarding Second Amendment to Regulation of Minister of Health Number 159b/Menkes/Per/ll/1988 regarding Hospital; 7. Regulation of Minister. of |Health Number 1575/Menkes/Per/XI/2005 regarding Organization and Management of Ministry of Health as already amended by Regulation of Minister of Health Number 1295/Menkes/Per/XIl/2007 regarding First Amendment to Regulation of Minister of Health Number 1575/MenkesiPer/X\/2005 regarding Organization and Management of Ministry of Health. HAS DECIDED: To Stipulate REGULATION OF MINISTRY OF HEALTH REGARDING CONSENT TO MEDICAL ACTION. CHAPTER | GENERAL PROVISIONS Article 1 In this Regulation of Minister, by: 1 Consent to medical action shall mean consent given by patient or his/her closest family after obtaining complete information on medical or dental actions to take upon patient. Closest family shall mean husband or wife, biological father or mother, biological children, siblings or his/her caretaker. Medical or dental action hereinafter referred to as medical action shall be in form of preventive, diagnostic, therapeutic or rehabilitative one conducted by physician or dentist upon patient.a) 2) (3) (1) (2) 3) (4) MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA Invasive action shall mean any medical action able to directly influence integrity of patient's body tissue. Any medical action having high risk shall be medical action based on certain probability, may cause mortality or defect Physician and dentist shall mean any physician, specialist physician, dentist and specialist dentist graduated from medical or dentistry education both from domestic and foreign area acknowledged by the Government of the Republic of Indonesia pursuant to the prevailing legislations, Competent patient shall mean adult or non-child patient according to prevailing legislations or who has/has once married, having not been disturbed physically, capable to communicate properly, not experiencing mental retardation and not experiencing mental disorder that capable to make decision independently. CHAPTER II CONSENT AND INFORMATION Part One Consent Article 2 Any medical action taken upon patient shall obtain consent. Such consent as referred to in paragraph (1) can be provided either in writing or orally. Consent as referred to in paragraph (1) shall be given after patient obtaining any required information on medical action to take. Article 3 Any medical action having high risk shall obtain written consent, signed by any party having been authorized for giving consent. Medical action not included into provision as referred to in paragraph (1) can be delivered with oral consent Written consent as referred to in paragraph (1) shall be made in form of statement put into special form made for such intention. Consent as referred to in paragraph (2) can be given in form of oral consent or any form of nodding head that can be interpreted as approval.MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA (6) In case oral consent given as referred to in paragraph (2) is regarded as doubtful, written consent can be requested Article 4 (1) In emergency, in order to save patient's life and/or to prevent any defect, no consent to medical action shall be required. (2) Decision to take any medical action as referred to in paragraph (1) shall be made by physician or dentist and recorded into medical record. (3) Incase any medical action as referred to in paragraph (1) is taken, physician or dentist shall be obliged to inform as soon as possible the patient after the patient is conscious or to the closest family Article 5 (1) Consent to medical action can be nullified or withdrawn by that giving consent before the action is begun. (2) Cancellation of consent to medical action as referred to in paragraph (1) shall be conducted in writing by that giving consent. (3) Any consequences caused by such cancellation of approval to medical action as referred to in paragraph (1) and (2) shall be the responsible of the party canceling consent. Article 6 Consent to medical action shall not abolish legal liability in case any failure in taking medical action causing patient’s damage is proven. Part Two Information Article 7 (1) Information on medical action shall be directly given to patient and/or his/her closest family, either requester or not. (2) In case patient is child or unconscious, information shall be given to his/her family or accompanying person (3) Information on medical action as referred to in paragraph (1) shall at least contain as follow: a. Medical action diagnosis and procedure;MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA Objectives of medical action to take; Alternative other action and its risk; Possible risk and complication; and Prognosis towards action to take. >epaog Cost estimation Article 8 (1) Information on diagnosis and patient's health status may include as follows: a. Clinical findings from medical examination up to that time; b. Disease diagnosis, or in case it can not be erected, at leas work diagnosis and comparative diagnosis; ©. Indication or clinical condition of patient requiring any medical action; d. Prognosis in case action is taken and in case no action is taken. (2) Information on medical action to take shall include as follows: a. Objectives of medical action that may be in nature of preventive, diagnostic, therapeutic, or rehabilitative. b, Procedure of action to experience by patient during and after action, as well as side effects or discomfort possibly happens. Other altemative action along with its advantage and disadvantages compared to the action planned to take. 4. Any risk and complication possible to occur in respective alternative actions. ° Expansion of action possibly to take in order to solve emergency condition caused by such risk and complication or other unexpected condition (3) Information on risk and complication of medical action shall include any risk and complication possible to occur following medical action to take, except for: a. any risk and complication being public knowledge b. any risk and complication rarely occurs or those having mild impacts ¢. any unforeseeable risk and complication (4) Information on prognosis shall include as follows: a. Prognosis on life or death (ad vita) b, Prognosis on function (ad functionam);MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA c. Prognosis on recovery (ad sanationam). Article 9 (1) Information as referred to in Article 8 shall be given completely using friendly language or in other way aiming at making understanding easier. (2) Information as referred to in paragraph (1) shall be recorded and documented in medical record bundle by physician or dentist providing with information by mentioning date, time, name, and signature of information provided and information receiver. (3) In case physician or dentist regards that the information may injure patient's health or patient rejects to receive information, physician or dentist may given such information to the closest family accompanied with other medical worker as witness. Article 10 (1) Information as referred to in Article 9 shall be given by physician or dentist treating patient or one of physicians or dentists of physician tem treating patient (2) In case physician or dentist treating patient is indisposed to give information directly, giving information shall be delegated to other competent physician or dentist. (3) Certain health worker may assist in giving information pursuant to his/her authority. (4) Certain health worker as referred to in paragraph (3) shall be any health worker participating in providing with health services directly to patient. Article 11 (1) In case indication of possible expansion to medical action exists, physician that will take any action shall also inform patient. (2) Information on possible expansion for medical action as referred to in paragraph (1) shall be basis of consent Article 12 (1) Expansion of medical action unavailable in previous indication shall only be conducted to safe patient's life. (2) After expansion of medical action as referred to in paragraph (2) is taken, physician or dentist shall inform patient or his/her closest family.MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA CHAPTER Ill PARTY ENTITLED TO GIVE CONSENT Article 13 (1) Consent shall be given by competent patient or his/her closest family. (2) Assessment on patient competence as referred to in paragraph (1) can be conducted by physician or dentist before taking medical action. (3) In case any doubt to consent given by patient or his/her family happens, physician or dentist may request second consent. CHAPTER IV PROVISIONS FOR SPECIAL SITUATION Article 14 (1) Any action on withdrawing/withholding life support upon a patient shall obtain his/her closest family’s consent. (2) Consent on withdrawingiwithholding life support by patient's closest family as referred to in paragraph (1) shall be provided after the family obtained information from related physician team. (3) Such consent as referred to in paragraph (1) shall be given in writing, Article 15 In case medical action shall be taken pursuant to governmental program where the medical action is aimed at public interest, consent to medical action shall not be required. CHAPTER V REJECTION TO MEDICAL ACTION Article 16 (1) Any rejection to medical action can be done by patient and/or his/her closest family after receiving information on related medical action to take. (2) Rejection to medical action as referred to in paragraph (1) shall be made in writing (3) Consequences of rejection to medical action as referred to in paragraph (2) shall be patient's responsibilty (4) Rejection to medical action as referred to in paragraph (1) shall not break relationship between physician and patient,MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA CHAPTER VI RESPONSIBILITY Article 17 (1) Implementation of medical action having obtained consent shall be the responsibility of physician or dentist taking related medical action. (2) Health service facility shall be responsible to the implementation of consent to medical action. CHAPTER VII DEVELOPMENT AND SUPERVISION Article 18 (1) Head of Provincial Health Office and Head of Regency/City Health Office shall develop and supervise by involving relevant professional organization according to their respective duties and functions. (2) Development and supervision as referred to in paragraph (1) shall be directed to improve health service quality. Article 19 (1) In connection with development and supervision, the Minister, Head of Provincial Health Office, Head of Regency/City Health Office, may take any administration actions pursuant to their respective authorities. (2) Administrative action as referred to in paragraph (1) can be in form of spoken warning, written warning up to permit revocation. CHAPTER VIII CLOSING PROVISIONS Article 20 At the time when this Regulation of Minister becomes effective, Regulation of Minister of Health Number 585/MENKES/PER/IX/1989 regarding Consent to Medical Action shall be revoked and declared null and void.MINISTER OF HEALTH OF ‘THE REPUBLIC OF INDONESIA Article 21 This Regulation of Minister shall be effective as of the stipulation date. For public cognizance, it is instructed to publish this Regulation in the State Gazette of the Republic of Indonesia Stipulated in Jakarta On : March 26, 2008 The Minister of Health, signed and sealed Dr. dr. Siti Fadilah Supari, Sp.JP (K)