GUIDE FOR THE HEALTHCARE MARKET IN VIETNAM

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1 GUIDE FOR THE HEALTHCARE MARKET IN VIETNAM 2016

2 FOREWORD The realization of projects regarding the healthcare market in Vietnam meets several regulatory challenges, for example when foreigners wish to invest in medical institutions or import medical products. In this guide, we want to give interested investors an overview of the most important legal aspects. Based on our advisory experience in this field, the guide introduces Vietnam s rapidly growing healthcare market, foreign investment in medical and dental institutions, and regulations on medical equipment and pharmaceuticals in Vietnam. Wehopethatyouwill findtheguideuseful. Ho Chi Minh City, June, 2016 Dr. Jörg-Michael Scheil

3 CONTENT Chapter I Vietnam s growing healthcare market Chapter II Foreign investment in medical and dental institutions Chapter III Medical Equipment Chapter IV Pharmaceuticals

4 CHAPTER I VIETNAM S GROWING HEALTHCARE MARKET Due to the rapid economic growth and poverty reduction, Vietnam attained lower middle-income country status in The transformation of Vietnam s economic structure has brought relief to the need to achieve better quality, sustainable growth and ensure a greater balance between economic, human and sustainable development. Over the years, Vietnam has made considerable efforts to ensure access to quality healthcare services for the entire population by upgrading its health system, expanding insurance coverage and increasing state spending in this sector. Examples of central policies in the past are the introduction of user fees, the legalization of private medical practices (1989), the initiation of public health insurance schemes at the national level (1992) and the central government takeover of the responsibility to pay salaries to public health staff at commune level (1994). Currently, Vietnam spends almost 7% of its GDP on healthcare. This is almost twice what India spends and not much less than the 9% spent by much richer Japan of its GDP on healthcare. Vietnam s healthcare services and pharmaceuticals markets were worth $10.6 and $3.3 billion respectively in 2013, plus, an annual nominal growth rate of approximately 15 per cent until 2018 for both is expected. According to the World Health Organization (WHO), Vietnam has a population of 93,448,000 people in The growth rate is about 1% per year, which equals roughly a million births per year. The combination of rapid economic growth, upgrade of the healthcare system and a growing population make Vietnam s healthcare market interesting to invest in. As the demand for better healthcare is increasing from a population that is becoming wealthier, there are many challenges to Vietnam s healthcare market that foreign investors aim to address through their involvement. Therefore, it remains important to keep an eye on this flourishing market and stay updated on this field.

5 CHAPTER II FOREIGN INVESTMENT IN MEDICAL AND DENTAL INSTITUTIONS According to Vietnam s WTO commitments, there are no limitations in market access for foreign investors in the hospital, medical and dental services in cross border supply and consumption abroad. Considering commercial presence in Vietnam, foreign service suppliers are permitted to provide services through the establishment of 100% foreign-invested hospital, joint venture with Vietnamese partners or through business cooperation contract. Only certain minimum capital requirements apply in this field. The minimum investment capital for a commercial presence in hospital services should be at least US$20 million for a hospital, $2 million for a policlinic unit and $200,000 for a specialty unit.

6 CHAPTER III MEDICAL EQUIPMENT The demand for imported medical equipment is growing. According to research by the Danish Embassy in Vietnam, demand is especially high for operating theatres; whereas, increased demand is expected for emergency equipment, sterilizing equipment, patient monitoring equipment and imaging diagnostic equipment such as CT scanners, color ultrasound machines, MRIs and X-ray machines. Currently, the main medical device purchasers are government-funded hospitals, which account for 70% of the market and purchase equipment through bidding. The regulation of Vietnam s medical devices falls under the Department of Medical Equipment and Health Works (DMEHW) within the Ministry of Health (MOH). Locally manufactured medical devices are regulated by the Ministry of Science and Technology (MOST). 3.1 Participation in biddings Foreign bidders can participate in biddings; however, certain limitations in the bidding process apply to them. The Vietnamese Law on Bidding, which passed on 26 November 2013, obliges foreign bidders to associate with domestic contractors in international bidding, either through a consortium or through subcontracting, except when there are no domestic contractors capable to execute any portion of the procurement package. National preferential treatment in international bidding applies to foreign bidders where (i) in the case of supply of goods, costs for domestic production of such goods amount to 25% or more of the value of the bidding package or more; or (ii) in the case of provision of consulting services, non-consulting services and civil works for capital investments projects, domestic bidders (who are in consortium with the foreign bidders) take over 25% of the value of the bidding package or more.

7 CHAPTER III MEDICAL EQUIPMENT However, some improvements can be expected under the Free Trade Agreement between the EU and Vietnam (EVFTA). Negotiations between parties were officially concluded last December and the EVFTA is expected to be ratified by late Vietnam will allow EU companies to bid for its public contracts, not only with ministries (for infrastructure, such as roads and ports, with Electricity of Vietnam (EVN) and Vietnam Railway Corporation), but also with 34 public hospitals listed in an annex to Chapter 9 EVFTA. Moreover, it is regulated in the EVFTA that Vietnam shall accord European goods and services national and non-discriminatory treatment with respect to any measure regarding government procurement. Therefore, a locally established supplier shall not be treated less favourably on the basis of the degree of foreign affiliation or ownership. This clause would appear to mean that the local partner or local content restrictions in the Procurement Law could cease to apply to European bidders in the near future; nevertheless, details of implementation remain to be clarified. 3.2 Local distribution In the past, foreign medical device companies could only sell their devices through local wholesale distributor firms, which would then distribute to smaller distributors in their network. This restriction was removed in 2007, and several foreign medical device companies have now set up their own distribution firms and channels in Vietnam.

8 CHAPTER III MEDICAL EQUIPMENT 3.3 Required documents for import Medical devices require the following documents for their import dossier: Application form for import permit; Business registration certificate or investment certificate; Manufacturer s quality certificate (either ISO or ISO 9001 certification or FDA/CE approval of the device manufacturing site); Free sale certificate from the country of origin; Legitimate and valid authorization letter of producing firms or distributing firms for the agencies that are allowed to import and distribute the medical devices; An original catalogue, instruction manual and technical guide (including a Vietnamese translation); A certificate of quality standards, methods of testing; The device s composition breakdown listing all its chemical ingredients and operational license with safety and quality and hygiene standard testimonies or cosmetic good manufacture practice certificate. Newly imported medical devices associated with new therapies or new functions may require clinical tests that are conducted in Vietnam. Imported devices with a specific import license or with prior foreign approval (FDA, EC mark, ISO 14385) are not required to be registered.

9 CHAPTER IV PHARMACEUTICALS Hospitals in Vietnam mostly purchase pharmaceuticals through bidding, which is subject to a price ceiling per medicament set by the regional health department. Foreign investors are prohibited from distributing pharmaceuticals and should cooperate with a domestic wholesaler. Approximately 60% of pharmaceutical end products, 90% of active pharmaceutical ingredients, and most raw materials for the production of pharmaceuticals are currently imported. Foreign enterprises are responsible for an estimated 20% of domestic pharma production. Domestic clinical trials are required for marketing approval pertaining to pharmaceuticals that have not been made available in their country of origin for more than five years. This includes newly imported medical devices associated with new therapies or new functions. Imported biological products and new batches of vaccines should undergo quality testing by the National Institute for Control of Vaccine and Biologicals. The capacity for such trials and tests is very limited, which causes delays. Furthermore, approvals are valid for five years. Lastly, pharmaceuticals require a free sales certificate, GMP certification and authorized letter, plus certificate of analysis and samples. Imported goods additionally require a certificate of pharmaceutical product (CPP) from the country of manufacture or packaging.

10 CONTACT Schulz Noack Bärwinkel Rechtsanwälte Suite 302, Empire Tower Ham Nghi Street, District 1 Ho Chi Minh City, Vietnam Tel Fax snb.vietnam@snblaw.com

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