An extract from The Healthcare Law Review, 4th Edition
The licensing of healthcare providers and professionalsi Regulators
In Vietnam, the provision of healthcare services and providers of these services are mainly governed by the Law on Medical Examination and Treatment as amended from time to time and other relevant guiding documents. Any institutional healthcare provider is required to obtain an operational licence appropriate for their operational scale and scope of activities (the Operational Licence). Similarly, any healthcare professional is required to have a practising certificate (the Practising Certificate). The Operational Licence and the Practising Certificate shall be issued by the MOH and the provincial Department of Health (DOH) depending on the form of the institutional healthcare provider and the workplace of the healthcare professional.
In addition, for the purpose of ensuring the quality of healthcare services provided for citizens, the MOH, the DOH, the Minister of the MOH and the Director of the DOH, in particular, are entitled to revoke these licences and certificates in some specific cases (e.g., as detailed in Section IV.ii. below) and have responsibilities for the establishment of advisory or inspection committees to advise during procedures for granting of licences and certificates and inspect any violations.ii Institutional healthcare providers
Under Vietnamese Law, an institution providing healthcare services can be organised under the following forms: hospital; medical assessment establishments; general clinics; specialised clinics, family doctor clinics; traditional medicine diagnosis and treatment clinics; obstetrics clinics; diagnosis establishments; health service establishments; commune-level health centres and equivalents; and other forms of medical examination and treatment centres. To obtain an Operational Licence, an institutional healthcare provider must first satisfy all the conditions as prescribed in applicable regulations, prepare and submit the application dossier to the competent authorities for their review and inspection. Then, the Operational Licence shall be issued.
Providing healthcare services is a conditional business line. One of the conditions is that each healthcare service provider is required to be granted with appropriate licences before provision of such services. Providing medical examinations and treatment without an Operational Licence is a prohibited activity and there are no exceptions or exemptions. The institutional healthcare providers without a valid Operational Licence are subject to a monetary penalty of up to 140 million dong, and suspension of their operations for a period up to 12 months, assuming the provider obtains an Operational Licence in the interim period.
The procedure for obtaining Operational Licences includes three main steps: (1) submitting the application dossier to the competent authorities (i.e., the MOH or DOH); (2) reviewing the application dossier and conducting on-site inspections; and (3) depending upon the results from Step 2, the competent authorities issue either the Operational Licence, request to revise and modify the application dossier, or send a notice with reasons for not issuing an Operational Licence.
There are general conditions applied to all medical examinations and treatment establishments, such as having a fixed location (except for a mobile establishment), having adequate medical equipment and instruments appropriate for the scope of professional medical activities and each healthcare facility must have one person in charge with technical expertise. Moreover, each form of medical examination and treatment establishment has specific conditions on facilities and infrastructure, medical devices, and qualifications of key personnel.
The Operational Licence shall be revoked under any one of the following cases:
- the Operational Licence was issued ultra vires;
- the institutional healthcare provider fails to meet conditions specified under the Law on Medical Examination and Treatment;
- the institutional healthcare provider fails to operate after 12 months from the date of the issuance of their Operational Licence; or
- the institutional healthcare provider suspends its operations for 12 consecutive months or terminates its operation.
Additionally, an Operational Licence may be suspended for up to six months in the event of certain violations, including if the institutional healthcare provider: (1) operates at a place other than that recorded in the issued Operational Licence; (2) employs HCPs who do not have Practising Certificates or have Practising Certificates revoked or suspended; (3) lends out, borrows or rents their Operational Licence; (4) provides medical examination and treatment services beyond the scope of their Operational Licence, except for emergency treatment; and (5) experiments or applies new methods for medical examination and treatment without the approval of the MOH Minister or DOH Director. A healthcare establishment subjected to a penalty is entitled to complain about such decision or decisions in accordance with procedures prescribed in the Law on Complaints and Denunciations. In particular, it can file a complaint with the same authority issuing that issued the penalty, or it may file a petition with the administrative court. In practice, violations (e.g., provision of medical examination and treatment services beyond the scope in the Operational Licence, except for an emergency treatment, or not satisfying the conditions on facilities as required by law) are often detected in private healthcare facilities, especially private clinics.iii Healthcare professionals
Extensive regulation is applied to all HCPs providing healthcare services in Vietnam. HCPs comprise doctors; assistant doctors; nurses; midwives; technicians; herbalists; and owners of family herbal remedies or treatment methods. Under Vietnamese law, pharmacists are not considered HCPs but are governed by the Pharmaceutical Law.
HCPs are entitled to practise technical techniques in accordance with the scope of their Practising Certificates. The individual practitioner's scope of practice is determined by a range of factors that gives them the authority to perform a particular role or task. The scope of practice for HCPs in Vietnam is determined under Circular 35. Pursuant to which, several important factors are considered including, among others: (1) quality of medical examination and treatment and patient safety; (2) professional licences and certificates; and (3) available support and resources. Failure to practice in accordance with his or her permitted professional scope might subject a healthcare professional to a monetary penalty of up to 40 million dong and the suspension of their Practising Certificate for a period of up to 12 months.
By law, HCPs must obtain Practising Certificates from the MOH or the provincial DOH, depending on their workplace and nationality in order to practice in Vietnam. The Practising Licence has an indefinite term and is valid nationwide. For obtaining the Practising Certificate, the healthcare practitioners must satisfy certain requirements, including: (1) having regulatory medical qualifications; (2) having confirmation on practice experience; (3) having certificates for practising medical examination and treatment; and (4) not being prohibited from professional practice or work related to medical or pharmaceutical professions under any judgement or decision of a court, or as the result of being criminally prosecuted, serving penal sentences, etc. In case of revocation, the healthcare professional may apply for re-registration of their Practising Certificate provided that they must comply with all above requirements and must obtain the certificate on completing continuous medical education.
If a foreigner practitioner wishes to practice healthcare in Vietnam, this person must have the following to obtain a Practising Certificate: (1) relevant professional qualifications and practical experience); (2) a certificate on language proficiency in medical examination, and medical treatment from a licenced education establishment; (3) a criminal record or equivalent document certified by competent authorities of the practitioner's home country; and (4) a work permit issued by a competent labour authority.
In Vietnam, medical errors fall into the category of 'professional and technical errors in medical examination and treatment'. According to the law and courts' approach, the legal responsibility due to professional and technical errors will be incurred by individual healthcare professionals rather than the institutional healthcare establishments. Indeed, under the determination of a professional council – established by either the institutional healthcare establishment where the healthcare professional is working or by the in-charge healthcare provincial authority – a potentially negligent healthcare professional can be suspended from practising for having committed (1) a violation of regulations on responsibilities for care and treatment of patients, (2) a violation of professional and technical regulations and professional ethics, or (3) an infringement of patients' rights. The professional and technical error asserted must have resulted in a serious consequence to the health or the life of a patient. The healthcare professional will, therefore, lose their Practising Certificate, unless the accident occurred and (1) the healthcare professional has complied with professional and technical regulations in medical examination and treatment, or (2) it was an emergency case in which technical devices and equipment were lacking and qualified healthcare professionals were unavailable, or (3) during a force majeure event.
Under the Law on Medical Examination and Treatment, a healthcare establishment is required to purchase liability insurance for their healthcare professionals (including, among others, doctors, doctor assistants, nurses, midwifes). Thus, in addition to individual responsibility allocated to the HCP, the relevant healthcare establishment or its insurer (where applicable) is required to compensate for any losses and damages incurred by patients and their relations. Furthermore, according to law, a conclusion of the professional council in relation to the professional and technical errors serves as a basis for the litigation agencies (e.g., courts, prosecutors) to consider in dispute settlement. If the patients or their relations disagree with the professional council's conclusion, they can lodge a complaint to the supervisory authority (i.e., the in-charge healthcare provincial authority if the professional council is established by the institutional healthcare establishment, or the MOH if the in-charge healthcare provincial authority established the professional council) or submit a claim to the competent court. As a matter of litigation practice, despite getting a conclusion from the professional council, the conclusions of a few competent agencies (e.g., the Forensic Medicine Center of Ho Chi Minh City, the National Institute of Forensic Medicine) have been used as the basis for hearings at the court of first instance.
The Hoa Binh case is one of the most relevant cases regarding the liability of institutional and individual healthcare providers in Vietnam. In 2017, nine out of 18 patients, who were all receiving dialysis treatment at an artificial kidney unit of Hoa Binh General Hospital, simultaneously died after having manifested vomiting, itching and dizziness. Prosecutors judged the causes of such incident were: (1) the water supply for filtering; (2) haemodialysis; and (3) the equipment had not been properly inspected. The managing doctor of the Active Resuscitation Department was prosecuted for 'unintentionally committing fatal actions'. The People's Court of Hoa Binh province eventually sentenced the managing doctor to 30 months' imprisonment.