Circular No. 26/2019/TT-BYT on the List of Rare Medicines

CIRCULAR

Regulations on the List of Rare Medicines

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Pursuant to the Medicine Law No. 105/2016/QH13 dated April 6, 20166;

Pursuant to the Government Decree No. 75/2017/NĐ-CP dated June 20, 20177 providing for the functions, tasks, powers, and organizational structureu organ Circular No. 30/2018/TT-BYT dated October 30, 2018 issued by the Minister of Health on the List and ratio, conditions for payment regarding chemical drugs, biological products, radioactive drugs, and labeled substances within the scope;

At the proposal of the Director of the Drug Administration Pharmaceuticals,

Ministry of Health issues this Circular regulating the List of Rare Medicines.

Article 1. Scope of Regulation

This Circular promulgates the List of Rare Medicines, specifies the purpose of promulgation, principles of construction, and criteria for selecting medicines to be included in the List of Rare Medicines.

Article 2. The List of Rare Medicines

The List of Rare Medicines issued as an Appendix to this Circular includes:

1. The List of medicines for prevention, diagnosis, and treatment of rare diseases.

2. The List of medicines not readily available.

Article 3. Purpose of Promulgating the List of Rare Medicines

1. The List of medicines for prevention, diagnosis, and treatment of rare diseases serves as a basis for:

a) State agencies with competent authority to consider waiving or reducing clinical data, exempting one or several phases of clinical trials before granting marketing authorization for medicines according to Clause 3, Article 18 of Circular No. 32/2018/TT-BYT dated November 12, 2018 of the Minister of Health on drug registration and raw materials for drugs (hereinafter referred to as Circular No. 32/2018/TT-BYT);

b) State agencies with competent authority to consider stability research data for medicines according to point a, Clause 2, Article 25 of Circular No. 32/2018/TT-BYT;

c) State management agencies to prioritize procedures and processes in drug registration for circulation according to Clause 1, Article 34 of Circular No. 32/2018/TT-BYT;

d) State agencies to grant import permits for medicines according to the provisions of the law;

đ) Implementing the reimbursement of medicine loss costs according to the regulations on medicine loss rates and reimbursement of loss costs at medical examination and treatment facilities.

2. The List of medicines not readily available serves as a basis for relevant agencies and organizations to implement the provisions at points c, d, and đ, Clause 1 of this Article.

Article 4. Principles of Constructing the List of Rare Medicines

The List of Rare Medicines is constructed based on the following principles:

1. Based on diagnostic and treatment guidelines, professional technical procedures issued by the Ministry of Health, the World Health Organization (WHO), reference regulatory authorities (including: European Medicines Agency (EMA), the United States, Japan, the United Kingdom, Switzerland, Australia) or reputable medical associations domestically, regionally, or globally (including: Vietnam Cardiology Association; Asian and European Liver Biliary Association; American College of Rheumatology and European League Against Rheumatism; European Society of Cardiology; American College of Cardiology; American Endocrine and Diabetes Association and other reputable medical associations).

2. Reviewing and inheriting the List of Rare Medicines previously promulgated according to the provisions of the Minister of Health.

3. Referring to the classification of rare diseases, classification, and list of rare medicines of the World Health Organization, reference regulatory authorities, and other related regulatory authorities.

Article 5. Criteria for Selecting Medicines to be Included in the List of Rare Medicines

1. A medicine is considered for selection into the List of medicines for prevention, diagnosis, and treatment of rare diseases when it meets one of the following criteria:

a) A medicine for prevention, diagnosis, and treatment of rare diseases according to the provisions of the Minister of Health;

b) A medicine with an indication classified and granted marketing authorization as a rare medicine by one of the reference regulatory authorities.

2. A medicine is considered for selection into the List of medicines not readily available if there are no other medicines available on the Vietnamese market that can replace it or if it has documentation proving significant quality, safety, and efficacy benefits compared to other substitutable medicines on the domestic and international markets and falls under one of the following cases:

a) Medicines for prevention, diagnosis, and treatment of diseases with a prevalence rate of no more than 0.05% of the population (Prevalence rate) and fall under one of the following cases: Genetic diseases; congenital diseases; cancer; autoimmune diseases; infectious diseases; tropical infectious diseases, and other diseases determined by the Minister of Health according to the advice of the specialized council established by the Minister of Health;

b) Vaccines, diagnostic drugs, or preventive drugs with an estimated usage of no more than 8,000 cases per year in Vietnam;

c) Radioactive drugs, labeling substances;

d) The business of such medicines does not generate sufficient profit to cover investment and marketing costs in the Vietnamese market.

Article 6. Effectiveness

1. This Circular takes effect from October 15, 2019.

Decision No. 37/2008/QĐ-BYT dated November 20, 2008 on the issuance of the List of Rare Medicines for Treatment Requirements (hereinafter referred to as Decision No. 37/2008/QĐ-BYT) ceases to be effective from the date this Circular takes effect.

Article 7. Transitional Provisions

The reimbursement of loss costs at medical examination and treatment facilities for medicines included in the List of Rare Medicines issued according to Decision No. 37/2008/QĐ-BYT but not included in the List of Rare Medicines issued together with this Circular shall continue to be applied according to the regulations for rare medicines in cases where such medicines were imported by medical examination and treatment facilities prior to the date this Circular takes effect.

Article 8. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

1. Based on the principles of construction, selection criteria for rare drugs, and on the basis of proposals from units specified in Clause 2 of Article 10 of this Circular, from other relevant organizations and individuals, or based on the conclusions of the Advisory Council for issuing drug registration certificates, the Department of Drug Management proposes a list of rare drugs that need to be updated and supplemented or removed to suit the actual situation, solicits extensive opinions from relevant agencies, organizations, units, healthcare facilities, enterprises, and requests the Legal Affairs Department to organize a review before submitting to the Minister of Health for issuance of the Decision amending and supplementing the List of Rare Drugs.

2. In cases where the Ministry of Health issues a Decision amending and supplementing the List of Rare Drugs as stipulated in Clause 1 of this Article, the reimbursement of losses incurred at healthcare facilities for rare drugs included in the immediately preceding issued List of Rare Drugs but not included in the amended and supplemented List of Rare Drugs shall be carried out according to the regulations applicable to rare drugs if such drugs were imported by healthcare facilities prior to the effective date of the Decision amending and supplementing the List of Rare Drugs.

Article 10. Responsibility for Implementation

2. Pharmaceutical establishments and healthcare facilities are responsible for:

a) Implementing the provisions of this Circular;

b) Proposing amendments and supplements to the List of Rare Drugs to suit the actual situation, ensuring timely provision of drugs for disease prevention and treatment work.

3. The Director of the Ministry's Office, the Inspector General, Heads of Departments, Directors of Bureaus, and General Directors under the Ministry of Health, Heads of subordinate agencies and units under the Ministry, Directors of Health Services of provinces and centrally-administered cities, Heads of health agencies under Ministries and sectors, and related organizations and individuals are responsible for implementing this Circular.

During implementation, if there are any difficulties, it is recommended that agencies, organizations, and individuals promptly reflect them to the Department of Drug Management for consideration and resolution./.