Omassmann presentation healthcare sector (1017)

www.duanemorris.com

Agenda:

2

• Regulations on Import of Medical Device

• Rules for Procurement by Tender • Opportunity in Public Private

Partnership (PPP) Hospital Project • Practical Issues in Contract Negotiation

www.duanemorris.com

REGULATIONS ON IMPORT OF MEDICAL DEVICE

3

www.duanemorris.com

Regulations on Import of Medical Device • Overview of Medical Device Market in Vietnam:

In 2013, an estimated 92% of the medical device market was supplied by imports, and the sector is growing rapidly

Japan, USA, Singapore and China are the leading suppliers, accounting for 50% of imports in 2012

Local production is limited to basic items such as syringes and hospital beds The value of exports reached US$536.4mn in 2012, with 32.5% of medical

products exported to Japan The value of exports has been growing fast, as overseas companies, mainly

Japanese, use the country as a manufacturing base Vietnam receives a large amount of international aid in the form of loans and

donated medical equipment. A number of small projects are currently taking place in Vietnam, including those funded by the World Bank and the EU

4

Source: Espicom

www.duanemorris.com

Regulations on Import of Medical Device • Regulatory framework on Medical Device:

With a population of more than 90 millions and high demand for treatment using high-end medical devices combined with the limited support

⇒ Vietnam should prioritize to provide a clear and consistent legal framework for import of medical device

BUT current regulations provide: Only basic guidance to importer and distributor of medical

devices and mostly guide the paperwork and registration procedures with the managing state authorities

Distinction between imported medical devices and locally manufactured medical devices by applying for a different regulatory regimes between them

5

www.duanemorris.com

Regulations on Import of Medical Device • Regulatory authority of Medical Device Import:

MINISTRY OF HEALTH (MOH) MEDICAL DEVICES AND FACILITIES SERVICE

DEPARTMENT • Major legislative frameworks on Medical Device Import:

Circular No. 07/2002 of the MOH guiding the registration for the circulation of medical device and facilities

Circular No. 24/2011 of the MOH guiding the import of medical devices

Decision No. 36/2006 of the MOH promulgating the Regulations on the clinical trials of medical devices

6

www.duanemorris.com

Regulations on Import of Medical Device • Definition of Medical Device: Art 02 of Circular No. 24/2011 of the MOH: Medical device is types of equipment, devices, materials, chemicals, including

necessary software which are used alone or in combination, for human for purpose of:

a) Preventing, monitoring, diagnosing, treating, alleviating disease or compensating for an injury.

b) Investigating, replacing, modifying and supporting for surgery during the medical examination and treatment;

c) Supporting and sustaining life; d) Controlling contraception; dd) Disinfecting medical devices (excluding chemicals, insect and bacterium

killing products for family uses and health); e) Specialized transport for health activities;

7

www.duanemorris.com

Regulations on Import of Medical Device • NOTE: Current definition of a medical device largely

overlaps with the one of a medical product

• Definition of medical product: Article 2.1 Circular No. 22/2009 of the MOH: medical product

means a substance or a mixture of substances for human use for disease prevention, treatment or diagnosis or adjustment of bodily physiological functions, including finished drugs, drug materials, vaccines and biologicals, except for functional foods

• No further guidance on the distinction between medical device and medical product 8

www.duanemorris.com

Regulations on Import of Medical Device • What the manufacturer should do: It has to rely on the opinion of

the bodies in charge of registration of such product BUT no guarantee for a consistent opinion because medical device

and medical product are registered with 02 different bodies under the MOH (i.e the Medical Device and Facilites Service Department and the Drug Administration of Vietnam, respectively)

• Unlike in the EU, Vietnam has no doctrine of primary use or intended use by the manufacturer.

• In practice, in case of doubt, the importer should submit a application dossier as a medical device and wait for the decision of the authority

9

www.duanemorris.com

Regulations on Import of Medical Device • Requirement for the Importer of Medical Device:

MUST obtain an Enterprise Registration Certificate or Investment Certificate for trading or importing medical devices in Vietnam

MUST obtain an Import Permit (per each product) to import medical device into Vietnam

MUST satisfying the conditions of technical requirements, site facilities and personnel for medical device trading or importing Appointment of a qualified chief technology officer (E.g. Having a

college degree in biomedical electronic or biomedical physic) Warehouse space to store safely the equipment: Guaranteeing

appropriate protection, means of fire prevention and fighting

10

www.duanemorris.com

Regulations on Import of Medical Device • Classification of Medical Device subject to Import Permit:

By the list of imported medical device subject to Import Permit already approved for circulation: The approved list includes 50 types of medical devices in 03 groups: diagnostic device, treatment device and other devices

Not under the approved list but imported into Vietnam for the first time: Subject to the Import Permit if such device use new methods of diagnosis or treatment

The registration of such device must include clinical evaluation results assessed by the MOH unless being recommended by an international organization

• Device not subject to Import Permit can be imported if satisfying the requirement of application dossier for import

• NOTE: Prohibited to import second-hand consumer medical apparatus under the list of apparatus prohibited to import by the MOH 11

www.duanemorris.com

Regulations on Import of Medical Device • Requirements for Import Permit:

Each Import Permit for each device Notable documents in the application dossier :

Legitimate and valid ISO 13485 or ISO 9001 certification Legitimate and valid Certificate of Free Sale (CFS) for imported medical

device in the producing countries, or Certificate to Foreign Government of FDA, or CE Mark Certificate

Legitimate and valid authorization letter of producing firms or legal distributors for the agencies which are allowed to import and distribute the medical devices in Vietnam

Import Permit is valid for 01 year and non renewable The MOH will review required annual reports sent by the importer

and use it as the basis for recommending renewal of each Import Permit

12

www.duanemorris.com

RULES FOR PROCUREMENT BY TENDER

13

www.duanemorris.com

Rules for Procurement by Tender • Overview of Procurement by Tender in Vietnam:

Being a high growth economy and an emerging market, Vietnam has been investing heavily in infrastructure and used much budget for public procurement

Many opportunities for local and foreign firms to do business with government authorities and state owned enterprises

BUT public procurement is one of the sectors most susceptible to corruption in Vietnam

Officials in charge of equipment purchase contracts can solicit for kickbacks or personal commissions

14

www.duanemorris.com

Rules for Procurement by Tender • Overview of Procurement by Tender in Vietnam:

The number of competitive tenders in the total value of awarded government procurement contracts declined significantly

Vietnam’s procedure for choosing international bidders create uncertainty with lethal loopholes

Who benefits from corruption and non-transparency in government procurement in Vietnam: Chinese contractors! 90% of power, mining, manufacturing, ferrous and chemical projects

of state-owned companies in Vietnam are awarded to Chinese contractors

Example of China State Construction Engineering Corp: CSCEC keeps winning important contracts although it has a poor track record and has even been blacklisted by the World Bank due to bribery charges

15

www.duanemorris.com

Rules for Procurement by Tender • Major regulatory framework for public procurement by tender in

healthcare sector: Law No. 61/2005/QH11 on Tender as amended by Law No. 38/2009/QH12 Decree No. 85/2009 of the Government guiding the implementation of Tender Law

as amended by Decree No. 68/2012 Joint Circular No. 01/2012/TTLT-BYT-BTC of the MOH and the Ministry of

Finance guiding tender of drugs procurement in the medical facilities Circular No. 11/2012/TT-BYT of the MOH providing guidance on preparation of

tender invitation documents for drug purchase in medical facilities

• The law on public investment and procurement is on the process of drafting and pending for issuance

• Vietnam has not yet signed WTO’s Agreement on Government Procurement

16

www.duanemorris.com

Rules for Procurement by Tender • Principles of Vietnam’s tender legal framework:

Assurance of competitiveness in tender process Prohibited acts in tender: Prohibited to g ive, offer, receive or

request anything of value resulting in impartial behavior, or to exert personal influence to distort the bidder selection process. Collusion to alter bids or to arrange winning a bid award is also prohibited

Provision on currency to be used in tender (stipulated in the tender invitation documents on the principle of one currency for one specific volume)

All domestic costs must be quoted in Vietnamese Dong

17

www.duanemorris.com

Rules for Procurement by Tender • Type of Contract under Tender law:

Lump-sum contract Unit price contract Time-based contract Percentage contract

• Negotiation and signing of a tender contract: Must base on Results of the tender Model contract provided in the tender invitation document Requirements of the tender invitation document The tender and any documents clarifying the tender provided by the

selected contractor, The contents that need to be negotiated and finalized by the parties

18

www.duanemorris.com

Rules for Procurement by Tender • Steps of contractor selection:

(i) Assessing the competence and experience of contractors (ii) Evaluating technical expertise (iii) Appraising prices.

• Tender applications that meet the criteria for (i) and a minimum score for (ii) (70-80%, depending on the complexity of the contract) can enter the third phase, the basis for ranking and choosing contractors

=> Contract prices matter substantially, especially compared with technical expertise

• Tender Price Floor: Not yet regulated under applicable laws => The Chinese contractors tend to charge unbelievably low prices that make

little economic sense and cast aspersions on such aspects as technical competence, financial might, working conditions and so on. The repercussions can be grave, as evinced by aforementioned projects

19

www.duanemorris.com

Rules for Procurement by Tender • Drug Procurement by Tender in Vietnam: Same practice of other

Pubic Procurement by Tender: corruption and non-transparency. The price of drug procurement by tender always raises the most concern

Principles of Drug Procurement by Tender: The drugs tender package will be divided according to using needs

Drug tender packages by generic name Drugs tender package by of proprietary- name Oriental drugs tender packages or drugs from medical herbs

Price of tender packages: The total value of drugs in the package. Prices of drugs used in the tender plan shall not be higher than the maximum price of each drug that had been published in the nearest time of the MOH

Contractor selection forms: Open tender in nationwide 20

www.duanemorris.com

Rules for Procurement by Tender • Principles of Drug Procurement by Tender:

Method of tender: 01 package of documents Time for organizing selection of contractors: Comply with the tender law

Form of contract: Comply with the tender law

Review and approval for winning bid: For drugs tender packages by generic name: Each group of drugs is considered for bid

winning only 01 type of drug meeting the technical requirements and quality specified in the tender documents and with bid price evaluated as lowest in the group of drugs

For drugs tender packages under the proprietary name and oriental-drug tender packages or drugs from the pharmaceutical herbs: Each drug shall be considered bid winning only 01 type of drug with bid price evaluated as lowest in the items meeting the technical requirements and quality specified in the tender documents

Giving priority winning selection of drugs produced domestically with similar quality and price not higher than drugs imported at the time of tender

Tender winning price of each drug item: Not higher than approved price of such drug item in the tender plan

21

www.duanemorris.com

Rules for Procurement by Tender • Trans - Pacific Partnership – Door of Public Procurement in

Vietnam will open within next year Trans-Pacific Partnership (TPP) is one of the most ambitious free trade

agreements between 12 countries Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, United States, Singapore and Vietnam where is the home of 40% of the world’s population, produces nearly 60% of global GDP

TTP require to open government procurement contracts to businesses operating in any of those member countries

The procurement rules through TPP prohibit the member country from applying any restrictions imposed on the financial assistance that one level of government provides to another level of government

Vietnam hopes to conclude TPP in first half of 2014 TPP will change level playing field dramatically

22

www.duanemorris.com

OPPORTUNITY IN PPP HOSPITAL PROJECT

23

www.duanemorris.com

Opportunity in PPP Hospital Project • Overview of Healthcare Service Market in Vietnam:

A great potential with an average annual growth rate of 10.3% and total healthcare spending will be estimated at about US$11.3 billions by 2015 from US$7 billions in 2010

Vietnam has 20.5 hospital beds for every 10,000 citizens - low compared to the 33 beds considered to be the minimum level set by the World Health Organization

Private hospitals represent 12% of the total number of healthcare facilities nationwide and will grow dramatically

The overcrowded hospital sector is in great need of investment Vietnamese government provides a range of clear incentives into

healthcare sector: A corporate income tax of 10%, tax exemption over the first 04 years and 50%subsequent tax break in the following years

24

www.duanemorris.com

Opportunity in PPP Hospital Project • Overview of Healthcare Service Market in Vietnam:

A premium investment area when the demand for high-grade healthcare services will inevitably increase

Foreign investor eyeing on Vietnam’s healthcare market Recent notable foreign investment deals:

The Chandler Corporation, a Singapore based company acquired 80% stake with a price US$99 million in Hoan My Medical Corporation, the largest private hospital group

The Triple Eye Infrastructure Corporation, a Vancouver-based healthcare developer invest US$160 million in building a 200-bed international hospital

United Lab, a Filipino pharmaceutical firm, with existing manufacturing facilities in Vietnam to joint venture with High Precision Diagnostic, a fellow Filipino company for opening specialist diagnostic and testing clinic

• 25

www.duanemorris.com

Opportunity in PPP Hospital Project • Investing in Healthcare sector in Vietnam: Any opportunity

for PPP projects? • Regulation on PPP projects: Decision No. 71/2010/QD-TTg on

Pilot Investment under the form of PPP took effective in January 2011

• Criteria for implementing project under the PPP form: Important and large-scale, and urgently required for development of the economy Able to generate a reasonable return on capital to the investor Able to take advantage of the technology, managerial and operational experience, and

effectively utilise the financial capacity of the private sector State capital cap a maximum of 30% of the total investment level State contribution under the form of one or more of (i) direct state capital; (ii)

investment incentives; (iii) relevant financial policies Investment has a senior debt to equity ratio of 70:30

26

www.duanemorris.com

Opportunity in PPP Hospital Project • Status of PPP projects: 24 potential and ambitious PPP projects in

various transportation infrastructure, power and social sectors are preliminarily listed

• Notable proposed PPP projects in Hospital Sector: Phu Xuyen General Hospital: Located in Phu Xuyen district- Hanoi

with capacity of 1,000 beds with an investment of US$161 million under a Build-Transfer contract

Gia Lam General Hospital: Located in Gia Lam district- Hanoi with capacity of 1,000 beds with an investment of US$161 million under a Build-Transfer contract

However, the first and most feasible PPP formed project in Vietnam, Dau Giay - Phan Thiet highway project is still in preparation stage and hoped to commence the construction next year

27

www.duanemorris.com

Opportunity in PPP Hospital Project • The status of 02 PPP Hospital projects is still ambiguous • PPP projects in Hospital Sector: Will still be attractive?

YES, still having many opportunities. BUT waiting for new reform of PPP regulatory framework and more opened and active commitment from the Government

• Why the PPP projects can not be implemented? Current PPP framework considered as pilot: Current framework sets out larger

policies and legal concept but does not contain detailed provisions for implementation The Government's lack of experience and shortage of funds also prevented investors,

especially foreigners, from taking part in PPP projects The state contribution limitation to a 30 per cent of the total investment capital of a

PPP project is an obstacle for the implementation of PPP projects Uncertain whether the cost of land rental, land clearance and compensation to be

counted with the 30 per cent or state-owned enterprises’ capital contributed to the PPP project would be considered as a part of the state contribution

28

www.duanemorris.com

PRACTICAL ISSUES IN CONTRACT NEGOTIATION

29

www.duanemorris.com

Practical Issues in Contract Negotiation • Foreign exchange control:

Vietnam Dong is not freely convertible, subject to control by the State Bank of Vietnam (SBV)

Must specify the cost of all transactions, “payments, price listings, advertisings, evaluating and quotations” in VND

• Governing laws: The law of Vietnam requires to be governed in case having foreign element (e.g.

dispute relating to rights to real estates in Vietnam, dispute of transportation contract with the transporter having head office or branch in Vietnam)

• Dispute settlement: In principle, foreign arbitration is permitted for contracts between foreign and

domestic entities However, recognition and enforcement of arbitration awards in Vietnam is very

arduous

30

www.duanemorris.com

Practical Issues in Contract Negotiation • Competition Law Issues: Competition Law prohibited a number of restrictive agreements and

practices, irrespective of the market share of the involved parties: Preventing, restraining or disallowing the entrance of business development of

competitors Exclusion agreement Bid rigging Agreement prohibited when the combined market share of

participating enterprises makes up 30% or more of the market: Price Fixing Market allocation Restricting or controlling quantities or volumes Imposing unfavorable conditions on the others

31

www.duanemorris.com

DUANE MORRIS VIETNAM LLC

Thank you!

Duane Morris Vietnam LLC Duane Morris Vietnam LLC Pacific Place, Unit V1307/08, 13th Floor, Suite 1503/04, Saigon Tower 83B Ly Thuong Kiet, Hoan Kiem District 29 Le Duan Street, District 1 Hanoi, Vietnam Ho Chi Minh City, Vietnam Tel.: +84 4 39462200 Tel.: +84 8 3824 0240 Fax: +84 4 3946 1311 Fax: +84 8 3824 0241

Contact email: [email protected]

32

mailto:[email protected]

Omassmann presentation healthcare sector (1017)

Business

Transcript of Omassmann presentation healthcare sector (1017)