Regulatory Reforms
Tilleke & Gibbins / Vietnam
1. Are there proposals for reform or significant change to the healthcare system?
Law on Medical Examination and Treatment
The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the current Law on Medical Examination and Treatment No. 40/2009/QH12 dated 23 November 2009.
Among other changes, the draft law provides for a mandatory requirement on Vietnamese language that will be applicable to non-local healthcare practitioners. Under the draft law, foreign and overseas Vietnamese practitioners are required to be fluent in Vietnamese and to use Vietnamese in examination and giving prescriptions. The satisfaction of Vietnamese proficiency must be examined by a medical education institution appointed by the MOH. A practitioner that does not satisfy this requirement must register the language that will be used in their practice and equip themselves with a translator. Such translator, if non-Vietnamese, also needs to satisfy the examination on Vietnamese proficiency hosted by a medical education institution appointed by the MOH.
Law on Pharmacy
The National Assembly published a draft of an amended Law on Pharmacy revising and supplementing some articles of the 2016 Law on Pharmacy. Among other changes, the draft provides a list of drugs for external use whose application dossiers for MA will be submitted to the provincial DOH (not the DAV), new regulations on bioequivalence of generic drugs, and new principles of the assessment of drug prices declared and re-declared by establishments trading drugs.
Circular on Drug Registration
The MOH published a new draft circular on the registration of drugs and medicinal ingredients to replace Circular 32/2018/TT-BYT on the same subject on 29 December 2021. Notable changes compared to the previous circular include, among others, requirements for a drug CPP and new specific provisions on quality documentation in the case of materials having a certificate of suitability (CEP).
2. When are they likely to come into force?
The revised Law on Medical Examination and Treatment, Law on Pharmacy and circular on drug registration are scheduled to be released in the near future.
