Orphan Drugs & Rare Diseases
Marval, O’Farrell & Mairal / Vietnam
Keen to learn more about orphan drugs & rare diseases in Vietnam? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 119.
1. What is the definition of Rare Diseases in your country?
There are no legal documents in Vietnam providing a definition of “rare diseases.”
2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)
An orphan drug is a drug that is used for prevention, diagnosis, or treatment of a rare disease or a drug that is not always available as stipulated by the Minister of Health or Ministry of Health (MOH).
The MOH has issued Circular No. 26/2019/TT-BYT dated 30 August 2019 promulgating the list of orphan drugs. Under this list, the name of the active ingredients, route of administration, dosage form, concentration/strength, and indication are included.
3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)
The primary legislation for pharmaceuticals in Vietnam is the Law on Pharmacy No. 105/2016/QH13, which was issued on 6 April 2016 and took effect on 1 January 2017.
Subordinate legislation includes Decree No. 54/2017/ND-CP guiding the implementation of the Law on Pharmacy, which was issued on 8 May 2017 and took effect on 1 July 2017, as amended by Decree No. 155/2018/ND-CP, which was issued and took effect on 12 November 2018.
Further regulations on other matters such as labelling and package inserts, drug quality, clinical trials of drugs and marketing authorization (“MA”) are regulated by the Ministry of Health in its ministerial circulars. In particular, the marketing authorization of drugs follows Circular No. 32/2018/TT-BYT of the MOH dated 12 November 2018 on MA for drugs and medicinal ingredients (“Circular 32”), as amended by Circular No. 29/2020/TT-BYT dated 31 December 2020 and Circular No. 23/2021/TT-BYT dated 9 December 2021.
In short, there are two routes for obtaining authorization for circulation of an orphan drug in Vietnam:
(i) Obtaining an import license: This is applicable to an orphan drug granted marketing authorization in at least one country in the world. The import license is valid for a maximum of one year and there is a limit on the drug quantity.
(ii) Obtaining a MA: This is applicable to all drugs including orphan drugs. The MA is valid for a maximum of five years and there is no limit on the drug quantity.
4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?
No, there are no specific provisions for relaxed clinical trials/scientific evidence requirements in respect of orphan drugs.
5. Is there an expedited pathway for Orphan Drugs?
The registration dossier for obtaining a MA for an orphan drug may be subject to the quick evaluation procedure of the DAV if requested by the applicant. The theoretical timeline for this evaluation procedure is only six months from the receipt date of a complete drug registration dossier, while it is 12 months for the normal evaluation procedure.
6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?
No; foreign MA licenses are not recognized in Vietnam for any drugs, including orphan drugs.
7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan drugs?
Yes, orphan drugs can be reimbursed in Vietnam but there is no specific reimbursement procedure for this type of drug.
8. How are the prices of Orphan Drugs regulated?
As with other types of drugs, pharmaceutical establishments must declare their drug prices to the DAV. After an MA has been issued, the importer/manufacturer must declare to the DAV the estimated wholesale price and (optionally) the estimated retail price for the drug before the first lot is circulated in Vietnam. Any change in the declared price must be re-declared to the DAV.
Distributors should not sell drugs at prices higher than the declared prices, and the declared prices should not be higher than the prices of the same drugs in ASEAN countries where such drugs are imported and sold.
9. In case of reference price based on a basket of countries, what countries are included?
The prices in other ASEAN countries will be referred to.
10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?
11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?