Vietnam faces the risk of drug shortages in 2023

On September 8th, Mr. Do Xuan Tuyen – Deputy Minister of Health – said “More than 10,000 marketing authorizations (MA) of drugs will expire on December 31st. If the Law on Pharmacy is not amended, there will be a shortage of drugs soon”. He also recognized that administrative procedures are causing many difficulties for businesses, and even leading to drug shortages for treatment and examination in some regions.

Up to now, the Drug Administration of Vietnam (DAV) has announced nearly 10,000 MAs being extended until the end of 2022 according to Clause 5, Article 6, Resolution 12 (allowing many special mechanisms and policies for Covid-19 prevention). However, this resolution is only valid for the next three months. With the current processing times, the DAV is handling about 1,000 applications every two months. Thus, Mr. Tuyen thinks there will be a risk of delay in extending expired MAs in November-December 2022 and 2023.

Shortcomings and Disadvantages of the existing Law on Pharmacy

Mr. Chu Dang Trung, Head of the Legal – Inspection Department in DAV, said that one of the reasons causing the recent drug shortages at hospitals is the delay in licensing and extending the MA, leading to the number of applications remaining over the years. From 2017 to 2019, there was no extended MA; in 2020 and 2021 were 10 and 62 extended MAs, respectively.

According to Article 56 of the Law on Pharmacy, to extend the MA of drug and medicinal ingredients, the application must be appraised and consulted by the Advisory Council to grant this MA.
“Regulations on extension procedures and documents are complicated, prolonged application & evaluation process, leading to interruption of production, import, circulation, and supply of drugs due to expired MAs,” Mr. Trung said.

Which is a suitable solution?

Application of automatic MA extension

Mr. Trung proposed to amend the regulations on MA extension in the direction that no appraisal is required. An enterprise submits for a MA license, and extension proceeds are automatic. In fact, some countries have applied automatic extensions for drugs with no quality violations and have not detected serious side effects by the ADR Monitoring Centers. In that situation, businesses only need to apply for an extension.

Maintaining the valid of Resolution 12

To immediately solve this risk, besides amending the Law on Pharmacy, experts propose to continue maintaining the effect of Resolution 12 until the revised Law on Pharmacy is promulgated and effective.

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