Since the first wave of Covid pandemic began globally, countries focused more resources on pharmaceuticals, including Vietnam, as both economic development and overcoming the impact of the Covid epidemic became national goals.

1. In term of market demand

Deputy Director of the Drug Administration (Ministry of Health) Mr. Le Viet Dung said the size of Vietnam’s pharmaceutical market now meets the needs of 100 million people. The total value of medicine consumption by 2020 was 6.23 billion USD, of which, the value of domestic production reached 2.9 billion USD, and the value of imported medicines was about 3.5 billion USD. The pharmaceutical sector is rapidly expanding with about 250 manufacturing plants, 200 import and export establishments, 4,300 wholesale agents and more than 62,000 resellers.

However, in recent years, the development of Vietnam’s pharmaceutical industry has fallen short of expectations and has not been commensurate with the country’s potential. Hence, now is an excellent time for investors to enter Vietnam’s pharmaceutical market and benefit from preferential policies and government incentives on investments.

2. In terms of policy

In recent years, Vietnam has successfully entered free trade agreements with other countries for expanding trade. In particular, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP“) signed in 2018 and the Free Trade Agreement between Vietnam and the European Union (“EVFTA“) signed in 2021 are of great significance.

Within the framework of these two agreements, many documents guiding cooperation and investment have been stipulated. In ‘Circular No. 09/2020/TT-BKHDT’ (Circular 9), preparation of bidding dossiers for procurement of goods and packages within the CPTPP agreement were laid down effective from January 15th, 2021. ‘Decree No. 95/2020/ND-CP’ laid down guidelines for procurement bidding under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership and mentioned the term “intra-regional tendering”.

  • The term refers to tendering activity in which only the contractors from the signatory countries in FTA can participate in the bidding and such contractors must offer goods originating in those countries. Point c, Article 3.1 of ‘Circular 9’ provides the basis for determination of intra-regional tendering as follows:
    • In case of intra-regional tendering, the bidding dossier clearly states that only intra-regional tendering contractors are allowed to offer goods originating from the participating States. A member country is a country that meets the following conditions:
    • Has Signed the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (hereinafter referred to as CPTPP) on March 8th, 2018,
    • At the time of approving bidding dossiers of bidding packages, CPTPP agreement takes effect with that country.”

As such, investors from countries that have joined the CPTPP such as Japan, Australia, Singapore, and so on, who can ensure that the offered goods are originating from their country will be able to participate in the bidding under the same conditions as Vietnamese contractors, without further constraints. Intra-regional tendering also increases the chance of being selected from the participating countries in the Agreement instead of having to compete with many other countries that are not a signatory to the Agreement.

  • In addition, the Circular has provisions to loosen some conditions on foreign contractors such as:
    • Must not set conditions that will limit the participation of contractors or create an undue advantage for contractors causing unfair competition based on specified mark or origin of the goods, naming of the country, group of countries or territories leading to discrimination, unless in case of intra-regional tendering as prescribed.
    • Must not require a contractor to sign a contract to perform one or more contracts with the procurement authority of a particular country or territory or the contractor to have experience in providing goods or services within the territory of that country or territory as criteria for removal of the contractor.

These regulations have partly opened doors for foreign companies to enter the pharmaceutical market in Vietnam. The Ministry of Health issued ‘Decision 2442/QD-BYT’ on May 17th, 2021, on EVFTA implementation. In order to promote full and effective implementation of EVFTA, the Ministry of Health will carry out a number of legal and institutional developments, such as continuing to review the regulations on management of medical equipment in ‘Decree No. 36/2016/ND-CP’, ‘Decree No. 169/2018/ND-CP’, and ‘Decree No. 03/2020/ND-CP’ on management of medical equipment to comply with EVFTA during implementation, developing a Circular guiding the procurement of pharmaceuticals as committed in EVFTA, enforcing regulations on import of refurbished medical equipment, etc.

3. In terms of the market situation of the Vietnamese pharmaceutical industry

The most recent trends include the acquisition of companies, factories, or shareholdings in Vietnamese pharmaceutical companies. In 2016, ‘Abbott’, a global healthcare company, acquired ‘Gloomed Pharmaceuticals’, one of Vietnam’s major domestic pharmaceutical manufacturers. Most recently, in 2019, ‘Taisho’, one of Japan’s top five pharmaceutical “empires” with total assets of $ 7.2 billion, gradually acquired shares of ‘Hau Giang Pharmaceutical Company, increasing its share ownership above 50%.

Investors can choose the type of business suitable to their business objectives within the framework of the Investment Law 2020 and specialized laws on pharmaceuticals and health. Currently, the permitted forms of investment under the Investment Law (2020) include:

“Article 21. Form of investment:

  1. Investment in the establishment of economic organizations
  2. Investment in capital contribution, purchase of shares and contributed capital
  3. Investment in the implementation of investment projects in the form of BCC contracts
  4. New forms of investment and types of economic organizations as prescribed by the government.”

In terms of business lines, depending on the main operation of the company, investors can choose the industry accordingly. Some of the professions related to the pharmaceutical business can be chosen such as medicine manufacturing, pharmaceutical chemistry and pharmaceuticals, technical testing and analysis, etc.

4. In addition to complying with the law on investment

Enterprises in general, especially in the pharmaceutical industry, must also meet the conditions of specialized laws. Pursuant to Article 2.43 of the ‘Law on Pharmacy 2016’, it is stipulated that:

“Pharmaceutical business is the implementation of one, some or all stages of the investment process, from production to consumption of products or the provision of services related to drugs and drug-making materials on the market for gaining profit.”

Accordingly, in order to carry out pharmaceutical business, depending on the scope of operation, companies must be granted certificates and licenses to operate. Some types of certificates and licenses must be registered such as ‘certificates of eligibility for pharmaceutical business’, ‘certificates of “Good practice of drug production” (for drug production establishments)’, and ‘certificates of meeting GMP pharmaceutical packaging standards (for packaging production establishments directly with drugs)’.

Furthermore, foreign investors can initially promote their business by signing distribution contracts with pharmaceutical distributors in Vietnam. This allows consumers to become acquainted with their products and brands. To do this, investors should study the conditions for pharmaceutical product distribution as well as the protection of trademarks, product designs, and patents in the Vietnamese market.

Covid-19 pandemic has changed the consumers’ habits, making pharmaceutical #and health-care products becoming more valuable. Consumers tend to seek for new products in addition to existing products, resulting in massive purchasing demands. This is an excellent opportunity for new investors to enter the Vietnamese pharmaceutical market and expand their market share in the business.

The article is based on laws applicable at the time noted as above and may no longer be appropriate at the time the reader approaches this article as the applicable laws and the specific cases that the reader may wish to apply may have changed. Therefore, the article is for referencing only.