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- 08 / 09 / 2019 -
Investor’s right on medical import under EVFTA

On June 30, 2019, Vietnam and EU signed Vietnam – EU Free Trade Agreement. The Agreement will come into effect after competent authorities of two parties ratify the Agreement.
In Chapter 2 on national treatment and market access for goods of EVFTA, Article 2.15 provides that “Viet Nam shall adopt and maintain appropriate legal instruments allowing foreign pharmaceutical companies to establish foreign-invested enterprises for the purposes of importing pharmaceuticals which have obtained a marketing authorisation by Viet Nam’s competent authorities. Without prejudice to Viet Nam’s schedules included in Annex 8-B (Viet Nam’s Schedule of Specific Commitments), such foreign-invested enterprises are allowed to sell pharmaceuticals which they have legally imported to distributors or wholesalers who have the right to distribute pharmaceuticals in Viet Nam”. According to this Article, investors from EU have the right to establish an enterprise in Vietnam in pharmaceuticals import.
Moreover, according to service commitments of Vietnam in WTO and EVFTA, foreign-invested enterprises cannot distribute pharmaceuticals in Vietnam because this is excluded from these two Free Trade Agreements. Therefore, foreign-invested enterprises only have the right to import pharmaceuticals to sell to distributors according to Article 44.1(d) of Law on Pharmaceuticals 2016.
In the past, foreign-invested enterprises were not able to import pharmaceuticals since Decree No. 102/2016/ND-CP provides that these enterprises had to have the right to distribute pharmaceuticals to do so. However, as the content above, foreign-invested enterprises can not distribute pharmaceuticals.
However, the right to import pharmaceuticals of foreign-invested enterprises only mentions in EVFTA but other Free Trade Agreement. Moreover, Law on Pharmaceuticals 2016 only provides about “importer not having the right to distribute pharmaceuticals” (i.e importer who is foreign-invested enterprise). Therefore, it seems that pharmaceuticals import market is only opened to EU investor.