What Pharmaceutical MNCs need to know about Emergency Authorizations in Vietnam? Lessons learned from COVID-19 Pandemic
In this article, we will focus on the potential lessons learned by multinational pharmaceutical companies in Vietnam (BIG PHARMA), and Vietnam’s Ministry of Health (MOH), in obtaining and issuing licenses for vaccines during the COVID-19 pandemic. We identify the criteria and procedures, as well as predict some emerging patterns applied by the MOH to the market authorization for life-saving pharmaceutics in Vietnam in the coming years (regardless of whether there is a pandemic).
Vietnam succeeded in containing the first waves of the COVID-19 epidemic by applying the measures recommended by the World Health Organization (WHO): (a) early implementation of preventive quarantine measures; and (b) isolation of potentially infectious people, social distancing, etc. Although these measures initially prevented the spread of the pandemic in Vietnam, it ultimately came at a significant economic cost that disproportionately affected rural, poor, and historically disadvantaged communities. Nevertheless, experts are clear that the COVID-19 pandemic will not be the last epidemic/pandemic to impact Vietnam and, therefore, a good understanding of these unprecedented situations is essential to BIG PHARMA, among others.
Although obtaining “market authorization” for pharmaceuticals, including vaccines, to enter the Vietnamese market has historically been a 3-5 year process, Vietnamese law has a specific statutory regime for urgent or emergency situations. Below, we discuss, analyze, and make some forward looking comments about this emergency statutory regime.
Article 67: Urgent/Disastrous Circumstances Provisions
According to Article 67 of Decree 54, import licenses for vaccines are not required in Vietnam if such vaccine(s) are: (1) registered in at least one foreign country; and (2) approved by the MOH as suitable for urgent epidemic control or disaster relief. However, the procedures for securing approval from the MOH are not clear in the event of an epidemic or disaster; precedent suggests that the MOH and other relevant Government bodies will issue specific regulatory guidance in such cases. As applied to Covid-19, this process took approximately four (4) months.
Article 68: The “Special Treatment” Provisions
According to Article 68 of Decree 54, under “special circumstances” import licenses for vaccines and other pharmaceutical therapies will be issued if the following procedures are followed:
Step 1: The Pharmaceutical MNC must submit an application dossier for an import license to the Drug Administration of Vietnam, which identifies and explains the special circumstances that merit an expedited import license;
Step 2: The MOH must either issue the import license or send a written request to amend or supplement the initial submission within 15 days from the date of submission. The party seeking the import license has 6-months to amend or supplement its dossier, and the dossier is invalid after 12 months elapse; and
Step 3: Within 10 working days from the date of issuance of the drug import license, the MOH will publish information about the pharmaceutical product or vaccine on its electronic portal, including information about the importer, manufacturer, quantity, drug name, import license number, and API circulation registration number for each active ingredient.
Comparison and Analysis of Article 67 and 68 of the Decree 54
On its face, the Article 67 licensing processes appears to be simpler, less bureaucratic, and based primarily on the circumstances/situation, compared to Article 68. Indeed, under Article 67, the mere fact that the vaccine is registered in a foreign country is sufficient to meet the primary requirement for an import license for the relevant pharmaceutical product or vaccine to enter the Vietnamese market. But, as noted, Article 67 is not clear, especially concerning the process for requesting approval from the MOH, and the criteria to determine if the pharmaceutical is suitable for “urgent control of an epidemic or for disaster relief” in Vietnam. In the absence of such criteria, the MOH has vast discretion to determine whether to issue an import license pursuant to Article 67.
Under Article 68, on the other hand, Vietnamese law takes a more practical approach. During the COVID-19 pandemic, as well as in other circumstances, Article 68 has facilitated vaccine(s) and pharmaceutical therapies entry into the Vietnamese market on an expedited schedule. Although the Article 68 procedure may appear lengthier and more regulatory, in fact Article 68 is subject to fewer grey areas, as it was drafted in a very pragmatically, whereas Article 67 leaves far more room for regulatory interpretation, discretion and uncertainty.
We believe the lessons learned during COVID-19 may be applied broadly to both global/regional pandemics and epidemics, as well as demonstrate a possible novel means to engage the MOH for registration of “normal” pharmaceuticals and medical devices that would avoid the current 3–5-year timeline. We urge organizations representing BIG PHARMA’s interests in Vietnam (e.g., Business Associations, Attorneys) to utilize the precedent developed during the COVID-19 pandemic to seek market authorization for life-saving pharmaceuticals, medical devices and therapies not currently available in the Vietnamese market.
If you have questions about this article or any legal issues related to the life sciences, please contact the author.
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