New: Promulgation of Criteria for Selecting Medicines for the List of Rare Drugs

At Article 5 of Circular 26/2019/TT-BYT promulgating criteria for selecting drugs into the List of Rare Drugs. To be specific:

Illustrative image (source: internet)

Firstly: A drug is considered for selection into the List of Drugs for the prevention, diagnosis, and treatment of rare diseases when it meets one of the following criteria:

- Drugs for the prevention, diagnosis, and treatment of rare diseases as prescribed by the Minister of Health;- Drugs whose indications are classified and licensed for circulation as rare drugs by one of the reference regulatory agencies.

Secondly: A drug is considered for selection into the List of Unavailable Drugs if it is a drug for which other substitutable drugs are not available on the Vietnamese market or if documentation proves that it offers significant benefits in terms of quality, safety, and efficacy compared to substitutable drugs on the domestic and international market and falls under one of the following cases:

- Drugs for the prevention, diagnosis, and treatment of diseases with a current prevalence rate within a population at any given time not exceeding 0.05% of the population (Prevalence rate) and falling under one of the following cases: genetic diseases; congenital diseases; cancer; autoimmune diseases; infectious diseases; tropical infectious diseases, and other diseases as decided by the Minister of Health based on the advice of a Specialized Council established by the Minister of Health;- Vaccines, diagnostic drugs, or prophylactic drugs with an estimated usage rate not exceeding 8,000 cases per year in Vietnam;- Radiopharmaceuticals, radiodiagnostic agents;- The business of the drug does not generate sufficient profit to cover investment and marketing costs in the Vietnamese market.

Additionally, Circular 26/2019/TT-BYT also regulates the reimbursement of waste costs at medical examination and treatment facilities for drugs on the List of Rare Drugs issued under Decision 37/2008/QD-BYT but not on the List of Rare Drugs issued with Circular 26, which will continue to be applied according to regulations for rare drugs if the drug was imported by the medical examination and treatment facility before October 15, 2019.

See detailed regulations in Circular 26/2019/TT-BYT effective from October 15, 2019.

Thu Ba

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