Circular 26/2019/TT-BYT Lists of orphan drugs

CIRCULAR

On lists of orphan drugs^[1]

Pursuant to April 6, 2016 Law No. 105/2016/QH13 on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

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

The Minister of Health promulgates the Circular on lists of orphan drugs.

Article 1.Scope of regulation

This Circular issues lists of orphan drugs and provides purposes for issuance and principles of formulation of, and criteria for selection of drugs to, the lists of orphan drugs.

Article 2.Lists of orphan drugs

The lists of orphan drugs issued in the Appendix to this Circular include:

1. The list of drugs for prevention, diagnosis and treatment of rare diseases.

2. The list of unavailable drugs.

Article 3.Purposes of issuance of the lists of orphan drugs

1. The list of drugs for prevention, diagnosis and treatment of rare diseases shall serve as a basis for:

a/ State competent agencies to consider exemption from or reduction of requirements on clinical data or exemption from one or more than one stage of clinical trial before licensing the sale of drugs prescribed in Clause 3. Article 18 of the Minister of Health’s Circular No. 32/2018/TT-BYT of November 12, 2018, prescribing the registration of drugs and drug materials (below referred to as Circular No. 32/2018/TT-BYT);

b/ Competent state agencies to study data from drug stability studies as prescribed at Point a, Clause 2, Article 25 of Circular No. 32/2018/TT-BYT;

c/ State management agencies to give priority in terms of the order and procedures for registration for sale of drugs as prescribed in Clause 1, Article 34 of Circular No. 32/2018/TT-BYT;

d/  State management agencies to license the import of drugs in accordance with law;

dd/ Making the payment of drug wastage costs under the regulation on drug wastage rates of drugs and payment of drug wastage costs at medical examination and treatment establishments.

2. The list of unavailable drugs shall serve as a basis for related agencies and organizations to implement the provisions at Points c, d, and dd, Clause 1 of this Article.

Article 4.Principles for formulation of the lists of orphan drugs

The lists of orphan drugs shall be formulated in adherence to the following principles:

1. To base on guidelines on diagnosis and treatment and specialized and technical processes issued by the Ministry of Health, the World Health Organization (WHO), and referential management agencies (including the European Medicines Agency (EMA), and medicine agencies of the US, Japan, UK, Switzerland, and Australia) or prestigious domestic, regional and international medical associations (including the Vietnam National Heart Association, associations for the study of liver in Asia and Europe; American College of Rheumatology and European League Against Rheumatism; European Society of Cardiology; American College of Cardiology; American Diabetes Association, and other prestigious medical associations).

2. To review and inherit the lists of orphan drugs previously issued under regulations of the Minister of Health.

3. To refer to the regulation on classification of rare diseases and the classification and lists of orphan drugs issued by WHO, referential management agencies and other related management agencies.

Article 5.Criteria for selection of drugs to the lists of orphan drugs

1. A drug shall be considered for selection to the list of drugs for prevention, diagnosis and treatment of rare diseases if:

a/ It is  used for prevention, diagnosis or treatment of a rare disease according to the Minister of Health’s regulation; or,

b/ It is a prescription drug classified and licensed for sale as an orphan drug by one of the referential management agencies.

2. A drug considered for selection to the list of unavailable drugs is a drug whose alternative drugs are not available in Vietnam’s market or which is backed by sufficient documents proving that it has considerably higher quality, safety and efficacy than its alternative drugs available in the domestic and international markets, which falls into one of the following cases:

a/ The drug is for prevention, diagnosis or treatment of a disease with the prevalence rate in a population at a given time not exceeding 0.05% which is a genetic disease; innate disease; cancer; autoimmune disease; infectious disease; tropical infectious disease or another disease decided by the Minister of Health with the counseling of a specialized council established by the former;

b/ The drug is a vaccine or a drug for diagnosis or prevention of a disease, which is estimated to be used in no more than 8,000 cases per year in Vietnam;

c/ The drug is a radioactive drug or tracer;

d/ The trading of the drug cannot generate a profit which is large enough for covering investment and marketing costs in Vietnam’s market.

Article 6.Effect

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

2. Decision No. 37/2008/QD-BYT of November 20, 2008, promulgating the lists of orphan drugs for treatment (below referred to as Decision No. 37/2008/QD-BYT), ceases to be effective on the effective date of this Circular.

Article 7.Transitional provisions

For drugs which are on the lists of orphan drugs issued together with Decision No. 37/2008/QD-BYT but not on the lists of orphan drugs issued together with this Circular and have been imported by medical examination and treatment establishments before the effective date of this Cicuclar, the payment of drug wastage costs at medical examination and treatment establishments must still comply with regulations applicable to orphan drugs.

Article 8.Referential provisions

In case the legal documents and provisions referred to in this Circular are modified, amended or replaced, the modifying, the amending or replacing documents or provisions shall prevail.

Article 9.Organization of implementation

1. Based on the principles of formulation and criteria for selection of drugs to the lists of orphan drugs, and the proposal of the units prescribed in Clause 2, Article 10 of this Circular, and related organizations and individuals, or based on the conclusions of the counselling council for grant of certificates of sale of drugs and drug materials, the  Drug Administration of Vietnam shall propose a list of orphan drugs which need to be added  to or removed from the lists of orphan drugs so as to suit realities, consult related agencies, organizations and units, medical examination and treatment establishments, and enterprises, and request the Legal Department to appraise such lists before submitting it to the Minister of Health for issuance of a decision amending and supplementing the lists of orphan drugs.

2. In case the Ministry of Health issues a decision amending and supplement the lists of orphan drugs as prescribed in Clause 1 of this Articles, the payment of wastage costs at medical examination and treatment establishments for drugs which are on the previously issued lists of orphan drugs but not on the amended and supplemented lists must still  comply with the regulations applicable to orphan drugs, in case such drugs have been imported by medical examination and treatment establishments before the decision amending and supplementing the lists of orphan drugs takes effect.

Article 10.Implementation responsibility

1. The Drug Administration of Vietnam shall assume the prime responsibility for, and coordinate with competent agencies in, implementing this Circular, and update the decision amending and supplementing the lists of orphan drugs on the Ministry of Health’s portal and the Drug Administration of Vietnam’ website within 3 days after the Minister of Health signs such decision.

2. Pharmacy establishments and medical examination and treatment establishments shall:

a/ Comply with this Circular;

b/ Propose amendments and supplementations to the lists of orphan drugs to suit realities, ensuring prompt supply of drugs for disease prevention and treatment.

3. The Chief of the Office, the Chief of the Inspectorate, directors of departments, and heads of agencies and units under the Ministry of Health, directors of provincial-level Departments of Health, heads of health agencies of ministries and sectors, and related organizations and individuals shall implement this Circular.

Any problems arising in the course of implementation of this Circular should be reported to the Drug Administration of Vietnam for consideration and settlement.-

For the Minister of Health
Deputy Minister
TRUONG QUOC CUONG

* The lists of orphan drugs issued together with this Circular are not translated.