SlideShare une entreprise Scribd logo
1  sur  3
Télécharger pour lire hors ligne
PHARMACEUTICAL SECTOR IN VIETNAM – OUTLOOK ON THE
EUROPEAN UNION VIETNAM FREE TRADE AGREEMENT (EVFTA)
By Oliver Massmann
Vietnam has made great progress in the quality of the pharmaceutical and medical sector. By
dedicating 5 - 6 % of Gross Domestic Product to healthcare expenses, Vietnam is among
countries with the best outcomes in ASEAN. The adoption of Resolution 19/NQ-CP/2015 on
national competitiveness, Resolution 35/NQ-CP/2016 on supporting the development of
enterprises and the new Pharmaceutical Law dated June 4, 2016 effective from January 1st
2017,
improves the healthcare industry in terms of improved access to medical care. Agreements such
as the EU-Vietnam Free Trade Agreement (EVFTA), the ASEAN Economic Community (AEC)
or the Trans-Pacific Partnership (TPP) to which Vietnam is a member, will further enhance
positive progress in the sector. Besides, guiding documents to implement the Pharmaceutical
Law will be completed in the following months to resolve remaining issues in both local and
foreign industries.
Ensuring a fast and sustainable access to innovative medicine
The expectations arising from the new legislation concern the sustainable access for Vietnamese
patients to innovative medical products and the Government procurement ensuring high-quality
medicines. The establishment of Foreign Invested Enterprises (FIEs) in Vietnam must be
supported in order to guide the local industry into being a core pharmaceutical industry in
ASEAN.
The new pharmaceutical law favors the establishment of FIEs in the pharmaceutical sector since
it is necessary for accessing the most innovative drugs and techniques. Nevertheless, some grey
areas remain as to ensure same access to the pharma market for foreign companies and local
ones. Indeed, representative offices, the most common form of presence for pharmaceutical
companies, are not given the same rights as other entities.
Depriving representative offices of their rights to contract, to import pharmaceutical drugs and
vaccines and to sell them domestically, and even to conduct any profit-generating activities in
Vietnam, inevitably impedes financial investment, development of local facilities and technology
transfer. In order to greatly increase the number of FIES, clear and practical guidelines should be
implemented.
Facilitating administrative procedures
The Vietnamese Government also exempted Local Clinical Trial requirements for some
pharmaceutical products such as drugs or medical equipment. Local Clinical Trials required a 2.5
to 5 year-time to obtain a market authorization and their suppression in part is a great step to a
faster access to innovative medicines. However, the text is unclear as to whether biologics and
vaccines are entitled with this exemption especially when such an exemption would be
contradictory to the EVFTA. Vietnam should respect what it has committed in international
agreements to promote investors’ trust and companies’ establishment.
Another obstacle for Pharma companies’ establishment deals with license and visas registration
taking place every five years; a heavy procedure when the renewal process can take from 18 to
24 months and must be started only 12 months prior to the expiry of the existing visa.
Circular 09/2016/TT-BYT issued by the Ministry of Health on May 5 2016 and effective from
July 1 2016, establishes lists of drugs which must be procured through tender process. If clearly
implemented and added to exclusion of the ban on foreign products in Government Procurement
for originator medicines, this would help reach the goal of a universal access to medical care and
quality medicines for all Vietnamese patients.
Solving Intellectual Property rights issues
The counterfeit medicine is a grave issue that needs to be embraced urgently. Vietnamese
legislation is insufficient in terms of regulations on intellectual property and data protection
rights. International standards have set up many mechanisms to preserve a safer environment for
investment such as adoption of patent protection, an enforcement system or Regulatory Data
Protection (RDP). Therefore, Vietnam should set up a mechanism of automatic granting of RDP
as well as real raise fines and sanctions in case of infringements.
In Vietnam, rights holders (intellectual property, data protection) bear the burden of proof when
claiming an infringement. Besides when submitting an application for patent protection, secrecy
is not automatically ensured and must be explicitly added in the drug registration form. The Drug
Administration of Vietnam receives the applications and is often quite reluctant to grant data
protection for FIEs. Those issues constitute a drag for investment in the pharmaceutical Research
and Development sector for both foreign and domestic investors.
Encouraging Health insurance development
Development of health insurance is quite new and launched thanks to Government’s initiatives.
This explains the importance of public funds in the development of the healthcare sector and yet
they represent a decreasing part in the funds. Indeed, private funds are taking the lead in
investment in health sector as they are expanding along with the market. The agreements signed
by the Vietnamese Government will attract more foreign private investors and accentuate private
funds dominating facet over the industry.
Nevertheless health insurance system in Vietnam mostly relies on contribution of the people and,
since a part of the population entrusts natural and traditional medicine over western medicine,
this goes against a universal health cover for all Vietnamese people.
Outlook on the EVFTA
The EVFTA signed on December 5, 2015 and expected to entry into force by January 2018, is
establishing new requirements and opportunities for both the European and Vietnamese market.
It includes a specific part on the import and export of pharmaceutical products. For instance
Article 14.2 Chapter 2 of the agreement requires Vietnam to create and implement legal
instruments to allow FIEs’ establishment in Vietnam. In addition, this Article also requires
Vietnam to allow FIEs to sell pharmaceuticals legally imported by them directly or through
distributors or wholesalers who are not required to have a Good Storage Practice (GSP)
certificate or directly.
If the Vietnamese legislation is responsible for certification requirements and process, the
EVFTA creates a real influence as it encourages establishment of FIEs and their extended scope
of activities. Therefore we can expect that Vietnamese Regulations will be adjusted to meet with
EVFTA requirements thus creating a more liberalized pharmaceutical market in a foreseeable
future.
Most important issues
- Restrictions on the rights of representative offices together with the complex registration
process are likely to restrain the inflow of pharmaceutical FIEs.
- Regulations on Intellectual Property Rights protecting applicants and their patents would
encourage the Research and Development sector and accelerate the creation of innovative
pharmaceutical products in Vietnam. Besides, the question of counterfeit medicine must be
solved urgently.
- Development of health insurance is limited by its financing system and by the mistrust
some people put in the western medicine. Implementing reimbursement of some medicines and
medical acts would help encourage it.
***
If you have any question on the above, please do not hesitate to contact Mr. Oliver Massmann
under omassmann@duanemorris.com, Oliver Massmann is the General Director of Duane
Morris Vietnam LLC.
Thank you very much!

Contenu connexe

En vedette

Zero Suicide in Healthcare International Declaration (March 2016)
Zero Suicide in Healthcare International Declaration (March 2016)Zero Suicide in Healthcare International Declaration (March 2016)
Zero Suicide in Healthcare International Declaration (March 2016)David Covington
 
見やすいプレゼン資料の作り方 - リニューアル増量版
見やすいプレゼン資料の作り方 - リニューアル増量版見やすいプレゼン資料の作り方 - リニューアル増量版
見やすいプレゼン資料の作り方 - リニューアル増量版MOCKS | Yuta Morishige
 
Payments Trends 2017
Payments Trends 2017Payments Trends 2017
Payments Trends 2017Capgemini
 
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...Scott Levine
 
The Marketer's Guide To Customer Interviews
The Marketer's Guide To Customer InterviewsThe Marketer's Guide To Customer Interviews
The Marketer's Guide To Customer InterviewsGood Funnel
 
The Be-All, End-All List of Small Business Tax Deductions
The Be-All, End-All List of Small Business Tax DeductionsThe Be-All, End-All List of Small Business Tax Deductions
The Be-All, End-All List of Small Business Tax DeductionsWagepoint
 
New York State Family Medical Leave Act- What Employers Should Know
New York State Family Medical Leave Act- What Employers Should KnowNew York State Family Medical Leave Act- What Employers Should Know
New York State Family Medical Leave Act- What Employers Should KnowAnnemaria Duran
 
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?Sotrender
 
Book discoverability template - everything you need to do to get found!
Book discoverability template - everything you need to do to get found!Book discoverability template - everything you need to do to get found!
Book discoverability template - everything you need to do to get found!AuthorDiscovery.com
 
NFDC 2015 내러티브 중심의 디자인
NFDC 2015 내러티브 중심의 디자인NFDC 2015 내러티브 중심의 디자인
NFDC 2015 내러티브 중심의 디자인DongKyun Kim
 
Launch Communication Plan
Launch Communication PlanLaunch Communication Plan
Launch Communication PlanAveretek
 
VIETNAM – NOW OPEN FOR BETTING BUSINESS - BREAKING NEWS – WHAT YOU MUST KNOW
VIETNAM – NOW OPEN FOR BETTING BUSINESS -  BREAKING NEWS – WHAT YOU MUST KNOWVIETNAM – NOW OPEN FOR BETTING BUSINESS -  BREAKING NEWS – WHAT YOU MUST KNOW
VIETNAM – NOW OPEN FOR BETTING BUSINESS - BREAKING NEWS – WHAT YOU MUST KNOWDr. Oliver Massmann
 

En vedette (15)

Zero Suicide in Healthcare International Declaration (March 2016)
Zero Suicide in Healthcare International Declaration (March 2016)Zero Suicide in Healthcare International Declaration (March 2016)
Zero Suicide in Healthcare International Declaration (March 2016)
 
見やすいプレゼン資料の作り方 - リニューアル増量版
見やすいプレゼン資料の作り方 - リニューアル増量版見やすいプレゼン資料の作り方 - リニューアル増量版
見やすいプレゼン資料の作り方 - リニューアル増量版
 
Payments Trends 2017
Payments Trends 2017Payments Trends 2017
Payments Trends 2017
 
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...
Infographic: Medicare Marketing: Direct Mail: Still The #1 Influencer For Tho...
 
The Marketer's Guide To Customer Interviews
The Marketer's Guide To Customer InterviewsThe Marketer's Guide To Customer Interviews
The Marketer's Guide To Customer Interviews
 
The Be-All, End-All List of Small Business Tax Deductions
The Be-All, End-All List of Small Business Tax DeductionsThe Be-All, End-All List of Small Business Tax Deductions
The Be-All, End-All List of Small Business Tax Deductions
 
Culture
CultureCulture
Culture
 
Investment in Myanmar
Investment in Myanmar Investment in Myanmar
Investment in Myanmar
 
New York State Family Medical Leave Act- What Employers Should Know
New York State Family Medical Leave Act- What Employers Should KnowNew York State Family Medical Leave Act- What Employers Should Know
New York State Family Medical Leave Act- What Employers Should Know
 
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?
Email marketing a media społecznościowe – czyli kim Są Twoi subskrybenci?
 
Book discoverability template - everything you need to do to get found!
Book discoverability template - everything you need to do to get found!Book discoverability template - everything you need to do to get found!
Book discoverability template - everything you need to do to get found!
 
¿Qué son los Implantes Dentales?
¿Qué son los Implantes Dentales?¿Qué son los Implantes Dentales?
¿Qué son los Implantes Dentales?
 
NFDC 2015 내러티브 중심의 디자인
NFDC 2015 내러티브 중심의 디자인NFDC 2015 내러티브 중심의 디자인
NFDC 2015 내러티브 중심의 디자인
 
Launch Communication Plan
Launch Communication PlanLaunch Communication Plan
Launch Communication Plan
 
VIETNAM – NOW OPEN FOR BETTING BUSINESS - BREAKING NEWS – WHAT YOU MUST KNOW
VIETNAM – NOW OPEN FOR BETTING BUSINESS -  BREAKING NEWS – WHAT YOU MUST KNOWVIETNAM – NOW OPEN FOR BETTING BUSINESS -  BREAKING NEWS – WHAT YOU MUST KNOW
VIETNAM – NOW OPEN FOR BETTING BUSINESS - BREAKING NEWS – WHAT YOU MUST KNOW
 

Plus de Dr. Oliver Massmann

VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:
VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:
VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:Dr. Oliver Massmann
 
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Dr. Oliver Massmann
 
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...Dr. Oliver Massmann
 
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...Dr. Oliver Massmann
 
Vietnam's National Energy Development Strategy – Key Highlights
Vietnam's National Energy Development Strategy – Key HighlightsVietnam's National Energy Development Strategy – Key Highlights
Vietnam's National Energy Development Strategy – Key HighlightsDr. Oliver Massmann
 
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...Dr. Oliver Massmann
 
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...Dr. Oliver Massmann
 
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Dr. Oliver Massmann
 
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...Dr. Oliver Massmann
 
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...Dr. Oliver Massmann
 
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...Dr. Oliver Massmann
 
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...Dr. Oliver Massmann
 
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...Dr. Oliver Massmann
 
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the World
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the WorldLawyer in Vietnam Dr Oliver Massmann - Vietnam and the World
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the WorldDr. Oliver Massmann
 
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...Dr. Oliver Massmann
 
Dr. Oliver Massmann - Vietnam and the World-240223
Dr. Oliver Massmann - Vietnam and the World-240223Dr. Oliver Massmann - Vietnam and the World-240223
Dr. Oliver Massmann - Vietnam and the World-240223Dr. Oliver Massmann
 
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...Dr. Oliver Massmann
 
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...Dr. Oliver Massmann
 
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...Dr. Oliver Massmann
 
VIETNAM - Country Update Securities and Banking 2024
VIETNAM - Country Update Securities and Banking  2024VIETNAM - Country Update Securities and Banking  2024
VIETNAM - Country Update Securities and Banking 2024Dr. Oliver Massmann
 

Plus de Dr. Oliver Massmann (20)

VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:
VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:
VIETNAM - THE NEW LAW ON CREDIT INSTITUTIONS - WHAT YOU MUST KNOW:
 
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
 
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...
ANWALT IN VIETNAM DR. OLIVER MASSMANN RECHTLICHER HINWEIS ZUM RUNDSCHREIBEN M...
 
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...
VIETNAM - LEGAL ALERT ON CIRCULAR PROVIDING REGULATIONS ON METHOD TO FORMULAT...
 
Vietnam's National Energy Development Strategy – Key Highlights
Vietnam's National Energy Development Strategy – Key HighlightsVietnam's National Energy Development Strategy – Key Highlights
Vietnam's National Energy Development Strategy – Key Highlights
 
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...
Anwalt in Vietnam Dr. Oliver Massmann Corporate Sustainability Due Diligence ...
 
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...
ANWALT IN VIETNAM DR OLIVER MASSMANN MÖGLICHE RATIFIZIERUNG DES ÜBEREINKOMMEN...
 
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
Corporate Sustainability Due Diligence Directive (CSDDD or the EU Supply Chai...
 
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...
Anwalt in Vietnam Dr. Oliver Massmann- Franchising – Eine Strategie als Schlü...
 
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...
POTENTIAL RATIFICATION OF CONVENTION 87 OF THE INTERNATIONAL LABOUR ORGANIZAT...
 
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...
KEY TASKS SET OUT BY THE PRIME MINISTER FOR THE YEAR 2024 AND THE EMERGING MA...
 
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...
Lawyer in Vietnam Dr. Oliver Massmann - Doing Business and Getting Deals Done...
 
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...
Anwalt in Vietnam Dr. Oliver Massmann im Interview mit Asia Business Law Jour...
 
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the World
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the WorldLawyer in Vietnam Dr Oliver Massmann - Vietnam and the World
Lawyer in Vietnam Dr Oliver Massmann - Vietnam and the World
 
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...
VIETNAM - INSURANCE - Regulatory Update Asia Insurance Review interviewing Dr...
 
Dr. Oliver Massmann - Vietnam and the World-240223
Dr. Oliver Massmann - Vietnam and the World-240223Dr. Oliver Massmann - Vietnam and the World-240223
Dr. Oliver Massmann - Vietnam and the World-240223
 
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...
Vietnam - Dr Oliver Massmann interviewed by Asia Business Law Journal - Deal ...
 
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...
Lawyer in Vietnam Dr. Oliver Massmann - The most investor friendly country in...
 
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...
Anwalt in Vietnam Dr. Oliver Massmann-Länderupdate Wertpapiere und Bankgeschä...
 
VIETNAM - Country Update Securities and Banking 2024
VIETNAM - Country Update Securities and Banking  2024VIETNAM - Country Update Securities and Banking  2024
VIETNAM - Country Update Securities and Banking 2024
 

Dernier

The Ultimate Guide to Drafting Your Separation Agreement with a Template
The Ultimate Guide to Drafting Your Separation Agreement with a TemplateThe Ultimate Guide to Drafting Your Separation Agreement with a Template
The Ultimate Guide to Drafting Your Separation Agreement with a TemplateBTL Law P.C.
 
An introduction to Indian Contract Act, 1872 by Shraddha Pandit
An introduction to Indian Contract Act, 1872 by Shraddha PanditAn introduction to Indian Contract Act, 1872 by Shraddha Pandit
An introduction to Indian Contract Act, 1872 by Shraddha PanditSHRADDHA PANDIT
 
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...Anadi Tewari
 
Patents and AI: Current Tools, Future Solutions
Patents and AI: Current Tools, Future SolutionsPatents and AI: Current Tools, Future Solutions
Patents and AI: Current Tools, Future SolutionsAurora Consulting
 
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...SHRADDHA PANDIT
 
Classification of Contracts in Business Regulations
Classification of Contracts in Business RegulationsClassification of Contracts in Business Regulations
Classification of Contracts in Business RegulationsSyedaAyeshaTabassum1
 
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdf
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdfIslamabad High Court Judges wrote a letter to Supreme Judicial Council.pdf
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdfNo One
 
xLran: Open source AI for legal hackers.
xLran: Open source AI for legal hackers.xLran: Open source AI for legal hackers.
xLran: Open source AI for legal hackers.mike689707
 

Dernier (9)

The Ultimate Guide to Drafting Your Separation Agreement with a Template
The Ultimate Guide to Drafting Your Separation Agreement with a TemplateThe Ultimate Guide to Drafting Your Separation Agreement with a Template
The Ultimate Guide to Drafting Your Separation Agreement with a Template
 
An introduction to Indian Contract Act, 1872 by Shraddha Pandit
An introduction to Indian Contract Act, 1872 by Shraddha PanditAn introduction to Indian Contract Act, 1872 by Shraddha Pandit
An introduction to Indian Contract Act, 1872 by Shraddha Pandit
 
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...
ArtificiaI Intelligence based Cyber Forensic Tools: Relevancy and Admissibili...
 
Patents and AI: Current Tools, Future Solutions
Patents and AI: Current Tools, Future SolutionsPatents and AI: Current Tools, Future Solutions
Patents and AI: Current Tools, Future Solutions
 
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...
Women and the World of Climate Change- A Conceptual Foundation by Shraddha Pa...
 
Classification of Contracts in Business Regulations
Classification of Contracts in Business RegulationsClassification of Contracts in Business Regulations
Classification of Contracts in Business Regulations
 
Criminalizing Disabilities & False Confessions
Criminalizing Disabilities & False ConfessionsCriminalizing Disabilities & False Confessions
Criminalizing Disabilities & False Confessions
 
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdf
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdfIslamabad High Court Judges wrote a letter to Supreme Judicial Council.pdf
Islamabad High Court Judges wrote a letter to Supreme Judicial Council.pdf
 
xLran: Open source AI for legal hackers.
xLran: Open source AI for legal hackers.xLran: Open source AI for legal hackers.
xLran: Open source AI for legal hackers.
 

PHARMACEUTICAL SECTOR IN VIETNAM – OUTLOOK ON THE EUROPEAN UNION VIETNAM FREE TRADE AGREEMENT (EVFTA)

  • 1. PHARMACEUTICAL SECTOR IN VIETNAM – OUTLOOK ON THE EUROPEAN UNION VIETNAM FREE TRADE AGREEMENT (EVFTA) By Oliver Massmann Vietnam has made great progress in the quality of the pharmaceutical and medical sector. By dedicating 5 - 6 % of Gross Domestic Product to healthcare expenses, Vietnam is among countries with the best outcomes in ASEAN. The adoption of Resolution 19/NQ-CP/2015 on national competitiveness, Resolution 35/NQ-CP/2016 on supporting the development of enterprises and the new Pharmaceutical Law dated June 4, 2016 effective from January 1st 2017, improves the healthcare industry in terms of improved access to medical care. Agreements such as the EU-Vietnam Free Trade Agreement (EVFTA), the ASEAN Economic Community (AEC) or the Trans-Pacific Partnership (TPP) to which Vietnam is a member, will further enhance positive progress in the sector. Besides, guiding documents to implement the Pharmaceutical Law will be completed in the following months to resolve remaining issues in both local and foreign industries. Ensuring a fast and sustainable access to innovative medicine The expectations arising from the new legislation concern the sustainable access for Vietnamese patients to innovative medical products and the Government procurement ensuring high-quality medicines. The establishment of Foreign Invested Enterprises (FIEs) in Vietnam must be supported in order to guide the local industry into being a core pharmaceutical industry in ASEAN. The new pharmaceutical law favors the establishment of FIEs in the pharmaceutical sector since it is necessary for accessing the most innovative drugs and techniques. Nevertheless, some grey areas remain as to ensure same access to the pharma market for foreign companies and local ones. Indeed, representative offices, the most common form of presence for pharmaceutical companies, are not given the same rights as other entities. Depriving representative offices of their rights to contract, to import pharmaceutical drugs and vaccines and to sell them domestically, and even to conduct any profit-generating activities in Vietnam, inevitably impedes financial investment, development of local facilities and technology transfer. In order to greatly increase the number of FIES, clear and practical guidelines should be implemented. Facilitating administrative procedures The Vietnamese Government also exempted Local Clinical Trial requirements for some pharmaceutical products such as drugs or medical equipment. Local Clinical Trials required a 2.5
  • 2. to 5 year-time to obtain a market authorization and their suppression in part is a great step to a faster access to innovative medicines. However, the text is unclear as to whether biologics and vaccines are entitled with this exemption especially when such an exemption would be contradictory to the EVFTA. Vietnam should respect what it has committed in international agreements to promote investors’ trust and companies’ establishment. Another obstacle for Pharma companies’ establishment deals with license and visas registration taking place every five years; a heavy procedure when the renewal process can take from 18 to 24 months and must be started only 12 months prior to the expiry of the existing visa. Circular 09/2016/TT-BYT issued by the Ministry of Health on May 5 2016 and effective from July 1 2016, establishes lists of drugs which must be procured through tender process. If clearly implemented and added to exclusion of the ban on foreign products in Government Procurement for originator medicines, this would help reach the goal of a universal access to medical care and quality medicines for all Vietnamese patients. Solving Intellectual Property rights issues The counterfeit medicine is a grave issue that needs to be embraced urgently. Vietnamese legislation is insufficient in terms of regulations on intellectual property and data protection rights. International standards have set up many mechanisms to preserve a safer environment for investment such as adoption of patent protection, an enforcement system or Regulatory Data Protection (RDP). Therefore, Vietnam should set up a mechanism of automatic granting of RDP as well as real raise fines and sanctions in case of infringements. In Vietnam, rights holders (intellectual property, data protection) bear the burden of proof when claiming an infringement. Besides when submitting an application for patent protection, secrecy is not automatically ensured and must be explicitly added in the drug registration form. The Drug Administration of Vietnam receives the applications and is often quite reluctant to grant data protection for FIEs. Those issues constitute a drag for investment in the pharmaceutical Research and Development sector for both foreign and domestic investors. Encouraging Health insurance development Development of health insurance is quite new and launched thanks to Government’s initiatives. This explains the importance of public funds in the development of the healthcare sector and yet they represent a decreasing part in the funds. Indeed, private funds are taking the lead in investment in health sector as they are expanding along with the market. The agreements signed by the Vietnamese Government will attract more foreign private investors and accentuate private funds dominating facet over the industry.
  • 3. Nevertheless health insurance system in Vietnam mostly relies on contribution of the people and, since a part of the population entrusts natural and traditional medicine over western medicine, this goes against a universal health cover for all Vietnamese people. Outlook on the EVFTA The EVFTA signed on December 5, 2015 and expected to entry into force by January 2018, is establishing new requirements and opportunities for both the European and Vietnamese market. It includes a specific part on the import and export of pharmaceutical products. For instance Article 14.2 Chapter 2 of the agreement requires Vietnam to create and implement legal instruments to allow FIEs’ establishment in Vietnam. In addition, this Article also requires Vietnam to allow FIEs to sell pharmaceuticals legally imported by them directly or through distributors or wholesalers who are not required to have a Good Storage Practice (GSP) certificate or directly. If the Vietnamese legislation is responsible for certification requirements and process, the EVFTA creates a real influence as it encourages establishment of FIEs and their extended scope of activities. Therefore we can expect that Vietnamese Regulations will be adjusted to meet with EVFTA requirements thus creating a more liberalized pharmaceutical market in a foreseeable future. Most important issues - Restrictions on the rights of representative offices together with the complex registration process are likely to restrain the inflow of pharmaceutical FIEs. - Regulations on Intellectual Property Rights protecting applicants and their patents would encourage the Research and Development sector and accelerate the creation of innovative pharmaceutical products in Vietnam. Besides, the question of counterfeit medicine must be solved urgently. - Development of health insurance is limited by its financing system and by the mistrust some people put in the western medicine. Implementing reimbursement of some medicines and medical acts would help encourage it. *** If you have any question on the above, please do not hesitate to contact Mr. Oliver Massmann under omassmann@duanemorris.com, Oliver Massmann is the General Director of Duane Morris Vietnam LLC. Thank you very much!