Vietnam – Power and Energy– Outlook on the European Union Vietnam Free Trade Agreement (EVFTA)

Vietnam has expressed its commitment to turn to clean and green energy while prioritizing domestic energy in respect with social, economic and energy security goals. The increasing demand of energy is pressuring Vietnam into developing local resources which requires attracting private investment.

Up to now, Vietnam is not self-sufficient to provide the energy corresponding to local demand.  Therefore, in order to reach energy efficiency, Vietnam must put in place a double action: developing the local sector thanks to private investment, and set up management tools to reduce electricity waste by users.

A report issued by the “Made in Vietnam Energy Plan” commission, concludes that Vietnam can continue using indigenous energy resources (gas, coal, hydro, oil, wind, solar) until a future green energy is developed.  As the fire-coaled sector is expected to be revived, renewal of coal power plants would slow down the air quality deterioration caused by older mega-power coal plants. Yet, other measures could be initiated by the Government.

Encouraging natural gas energy

Vietnam is endowed with natural gas whose use should be preferred to coal use. Indeed, natural gas is a more flexible, cheaper and cleaner fuel than coal. Pursuant to many international agreements encouraging green energy development, Vietnam will be more likely to find financing for renewable energy sector than for coal-fired one.

Investment in exploitation of natural gas should be greatly encouraged as it follows international treaties and is a good economic and environmental opportunity. The Government should then prepare policy and regulatory framework to further enhance foreign and local investment, technology and experience sharing, and to develop successful markets.

Furthermore, development of offshore gas-to-power appears to be another beneficial and economical alternative to imported coal. Not only the cost of natural gas exploitation is less expensive than the cost of clean coal import or production considering taxes and royalties related to gas pricing, but it would also attract more investors. In addition, it would release the State from heavy expenses since the International Monetary Fund estimated that health and environmental costs, with the current energy development plan relying on coal, would reach US$15 billion annually by 2030.

Developing Power Purchase Agreements (PPAs)

The German Agency for International Co-operation issued recommendations regarding wind and solar power purchase agreements (PPAs) for renewable energy. They include specific evaluation of costs and tariffs for PPAs to be more bankable. Ensuring their implementation is greatly encouraged to favor a lasting and sustainable development.

Companies which made public commitment to use renewable energy and any other large power consumer should be entitled to sign Direct Power Purchase Agreements (DPPAs) with power suppliers. We find for instance in the cases of Nike, Coca-Cola, Apple, Google etc., Vietnamese legislation does not allow DPPA. By changing this policy, there will be more foreign investment in the value supply chain of green energy.

Controlling electricity use and reducing energy waste

Through a more efficient use of electricity and reduction of energy waste, Vietnam would be considered a competitive and viable alternative for foreign direct investment. Granting tax incentives for individual households and businesses that reduce their energy use, encouraging solar or wind or any other renewable energy, would depressurize the distribution system and educate users.

Development of waste to energy system in local communities would allow a dual benefit: improve health and hygiene as well as increase power supply and facilitate its distribution. The carbon emissions would be automatically diminished.

Establishment of a Power Price Roadmap using market based pricing with variable pricing considering residential, commercial or industrial use, should prevail. A belief that energy price will remain subsidized by the Government supplants any efforts to promote energy efficiency investment and innovation.  Then, knowledge of energy cost may induce consumers and investors to get more efficient equipment and processes.

Recommendations for Government’s regulations

In order to help the Vietnamese Government reach environmental goals, credit enhancement of the state-owned enterprise Electricity of Vietnam (EVN) should be developed. Guaranteeing that EVN will pay for renewable power supplies by increasing international donors will help ensure the projects’ feasibility and encourage investment.

A more sustainable plan can be implemented if enacted with proper policy and regulatory framework. The main recommendation to secure a greener future environment is to lower the part of coal power plants in the power development plan to 2030.

A flexible plan could be established to adjust the future demand and to stop the risk of a higher or lower demand than estimated. This plan should attract more foreign and local sources of investment and reduce reliability on foreign governments. However, establishing mandatory energy efficiencies and construction requirements for housing, office or retail development would also educate and have a positive impact on the renewable energy sector.

Outlook on the EVFTA

The EVFTA signed on December 2nd 2015 is expected to enter into force by January 2018. Relations between Vietnam and the EU will be greatly intensified, especially since Vietnam is the 2nd to sign such an agreement with the EU after Singapore, which does not compete in the same fields. Many investors will flow from the EU to Vietnam and bring new technologies and techniques.

A chapter in the EVFTA is dedicated to sustainable development and we can expect that the EU, a firm defender of green and clean energy, will influence Vietnam to review its power development plan in a foreseeable future.

Most important issues

–       The coal-fired sector is to be revived according to the power development plan whereas cleaner and more economical alternatives are open to Vietnam.

–       The International Monetary Fund has estimated that US$15 billion would be dedicated annually to health and hygiene costs. Air purification or stopping air quality deterioration is an issue to be solved urgently and threatened by the revival of coal energy.

–       Allowing DPPAs would boost investment and innovation in green energy sector and depressurize the distribution system.

–       Educating suppliers, users and investors through Power Price Roadmap, waste-to-energy system and tax incentives is the most effective way to ensure high observance of the Government’s measures regarding environment.


If you have any question on the above, please do not hesitate to contact Mr. Oliver Massmann under, Oliver Massmann is the General Director of Duane Morris Vietnam LLC.

Thank you very much!




The Government has enacted several laws in order to promote infrastructure development especially through private investment. The latest one, Decree 15/2015/ND-CP on public-private partnership investment (the PPP Decree), was very promising regarding the forms of contract concerned, the various sectors targeted, the State support or participation and tender requirements. As a matter of fact, its enforcement revealed that more efforts were needed to achieve a successful PPP program.

To implement the PPP Decree, many documents were adopted in various sectors: project development procedures with Circular 02/2016/TT-BKHDT and Decision No. 06/2016/TT-BKHDT issued by the Ministry of Planning and Investment; financial management of PPP projects with Circular 55/2016/TT-BTC issued by the Ministry of Finance; power and energy tackled by the Ministry of Industry and Trade in Circular 23/2015/TT-BCT and Circular 38/2015/TT-BCT and finally transport sector with Circular 86/2015/TT-BGTVT issued by the Ministry of Transport.

Transparency and clearance of the PPP program

The issues remaining after the PPP Decree implementation concern the viability gap funding (VGF) and the project development fund (PDF) which differentiate PPP projects from Build-Operate-Transfer (BOT) ones. Indeed, through availability payments incurred for PPP project, private operators are guaranteed with a profitable VGF regardless of the users’ fees and of the time before being profitable. Regulations on VGF and PDF should be established in order to fully control the PPP scheme.

Furthermore, infrastructure projects do not necessarily have to comply with PPP requirements since other contracts may be less demanding in terms of obligations and using incentives stated in the Investment Law of 2015. The idea, within the PPP program, is to attract private investors such as banks or credit institutions into financing highly-efficient projects and therefore relieving the State from the projects’ funding. This implies granting of more incentives to motivate foreign and local non-state banks.

Under the former regime concerning BOT contracts, a double licensing system was necessary for investors to qualify at selection stage and then for approval of the project and their own capacity.  The new PPP Decree does not clarify the process therefore a simplified procedure should be adopted.

Some difficulties, stated during the development of the drafts of the PPP Decree, are restraining project lenders. The first one concerns the impossibility of a mortgage on land use right for foreign contractors in BOT contracts and the issue regarding the interpretation of the land law. A provision of this law stipulates that a mortgage of land use rights is only possible if all land rents have been paid, whereas in BOT contracts land is granted for free. The Government decided then that a mortgage under this circumstance was impossible as no rent has been paid. The PPP Decree seems to allow payment of a nominal rent but this does not solve the mortgage problem for BOT foreign contractors. A practical provision should allow a certain land security for private investors.

Uncertainty regarding Government’s guarantees

Another concern tackles the guarantee on convertibility and remittability of VND income. Without such a guarantee, some BOT projects would not be bankable and sponsors even with the guarantee of exchange rate might be left with a residual risk of unconvertible income. A clear position on guarantees of exchange rates for project with VND revenues would remove the uncertainty.

The governing law for projects with a foreign contracting party or guaranteed by a competent authority in case the parties are two Vietnamese entities, may be a foreign law if not contradictory to the Vietnamese conflict of law rules. There is an uncertainty as whether the Government guarantees offtake or revenues for PPP projects or contracts under foreign or international law.

Furthermore, projects in sectors such as transport, renewable energy as well as traditional thermal power projects should be prioritized and if PPP projects’ proposals were not satisfactory, this implies to attract more foreign investors to develop sustainable projects. In this idea, the Vietnamese Government should financially support projects through guarantees or profitable VGF. In addition, establishing new guidelines on the preparation of PPP program will enhance projects’ planning and financing.

Opportunities within the PPP program

Many PPP projects are signed or about to be signed and all information related to PPP programs are compiled in a dedicated website provided by the Ministry of Planning and Investment and the Authorized State Agencies (ASAs), the latest also having its own list of projects. Achieving a successful PPP program and promoting infrastructure development in Vietnam require more efforts which could start with letting investors choose between PPP Decree and Investment Law. Indeed, imposing the PPP Decree as the exclusive way of developing infrastructure would be counter-effective regarding economy competitiveness.

As power demand is increasing in Vietnam, coal-fired power projects are under negotiations to be set in place for the time renewable energy will be sufficient to replace coal-fired energy. Due to the Paris Agreement, private investors in the coal-fired power sector will be getting rarer to turn to green energy projects.

Finally, the road sector is vital for economy and climate and yet, the risk allocation and concession principles as well as precisions on the bidding process are still expected in the Vietnamese legislation. Those issues should be solved to allow foreign investors’ involvement in the development of transport infrastructure.

Outlook on the EVFTA

As the EVFTA, officially signed on December 2nd 2015, is expected to enter into force by January 2018, many consequences will emerge. Concerning access to market, Vietnam will be in a privileged situation as the only country of South-East Asia (except for Singapore which does not stand as a direct concurrent) to have signed such an agreement. Both Vietnam and the EU will access a market of hundreds of millions people.

Besides, Vietnam and the EU’s commitments go further than the World Trade Organization’s ones especially in power/energy sector, maritime transport which shows a real effort to create the most sustainable and profitable environment for business and investment. In this idea, the Vietnamese legislation has been amended to become investor-friendly like the Law on Enterprises, the Investment Law and the PPP Decree. Some regulations still need development or implementation but we can expect new provisions and legislation with the entry into force of the EVFTA.

Most important issues

–       The impossibility of a mortgage on land use rights for BOT foreign contractors must be rearranged urgently by allowing a certain form of land or building security to insure BOT projects.

–       The licensing procedure for BOT investors and contractors should be simplified and regulations on VGF and PDF should be provided.

–       A review of the Government’s guarantees and conditions of granting guarantees should be established as to avoid investors’ discouragement at the preparation phase.

–       Investment in coal-fired sector might become rarer due to the Paris Agreement which encourages investment in green energy.

–       The road sector investment is uncertain when it should be supported to allow foreign investors’ involvement in transport infrastructure development.


Please do not hesitate to contact Oliver Massmann under if you have any questions or want to know more details on the above. Oliver Massmann is the General Director of Duane Morris Vietnam LLC.

Thank you!




Die Regierung hat mehrere Gesetze erlassen, um die Infrastrukturentwicklung vor allem durch private Investitionen zu fördern. Die jüngste Verordnung Nr. 15/2015 / ND-CP über öffentlich-private Partnerschaftsinvestitionen (PPP, engl. Public Private Partnership) war vielversprechend in Bezug auf die betreffenden Vertragsformen, die verschiedenen Sektoren, die staatlichen Unterstützungs- oder Beteiligungs- und Ausschreibungsanforderungen. In der Tat offenbarte die Durchsetzung der Verordnung, dass größere Anstrengungen erforderlich waren, um ein erfolgreiches PPP-Programm umzusetzen.

Zur Umsetzung der PPP-Verordnung wurden Dokumente in verschiedenen Bereichen verabschiedet: es wurden 1. das Verfahren zu Projektentwicklung mit dem Rundschreiben 02/2016 / TT-BKHDT und dem Beschluss Nr. 06/2016 / TT-BKHDT des Ministeriums für Planung und Investitionen; 2. die Finanzverwaltung von PPP-Projekten mittels Rundschreiben 55/2016 / TT-BTC vom Finanzministerium; 3. die Energie vom Ministerium für Industrie und Handel im Rundschreiben 23/2015 / TT-BCT und Rundschreiben 38/2015 / TT-BCT; sowie 4. im Verkehrssektor mit dem Rundschreiben 86/2015 / TT-BGTVT vom Verkehrsministerium ausgestellt.

Transparenz und Freigabe des PPP-Programms

Nach der Umsetzung des PPP-Beschlusses verbleiben Probleme betreffend der Rentabilitätslückenfinanzierung (VGF, engl. viability gap funding) und Projektentwicklungsfonds (PDF, engl. project development fonds), wodurch sich PPP-Projekte vom Betreibermodell (BOT, engl. Build-Operate-Transfer) unterscheiden. In der Tat wird privaten Betreibern – aufgrund der Verfügbarkeit von Zahlungen für PPP-Projekte – eine rentable VGF garantiert, unabhängig von den Gebühren der Nutzer und der Zeit. Verordnungen über VGF und PDF sollten erlassen werden, um das PPP-System vollständig zu kontrollieren.

Darüber hinaus müssen Infrastrukturprojekte nicht notwendigerweise den Anforderungen der PPP entsprechen, da andere Verträge im Hinblick auf Verpflichtungen und Anreize im Investitionsgesetz von 2015 weniger anspruchsvoll sein können. Die Überlegung im Rahmen des PPP-Programms besteht darin, private Investoren wie z.B. Banken oder Kreditinstituten zur Finanzierung hocheffizienter Projekte zu bewegen und damit den Staat von der Projektfinanzierung zu entlasten. Dies impliziert weitere Anreize zu gewähren, um ausländische und lokale nichtstaatliche Banken zu motivieren.

Im Rahmen der früheren Regelung über BOT-Verträge war für die Anleger ein doppeltes Lizenzsystem erforderlich, um sich bei der Auswahl und dann für die Genehmigung des Projekts und ihrer eigenen Kapazität zu qualifizieren. Das neue PPP-Dekret verdeutlicht diesen Prozess nicht, daher sollte ein vereinfachtes Verfahren beschlossen werden.

Einige Schwierigkeiten, die bei der Entwicklung der Entwürfe des PPP-Dekrets festgestellt wurden, beeinträchtigen Projektkreditgeber. Die erste betrifft die Unmöglichkeit  für ausländische Auftragnehmer in BOT-Verträgen Landnutzungsrechte als Sicherungsmittel einzusetzen und die Frage nach der Auslegung des Bodenrechts. Eine Bestimmung dieses Gesetzes sieht vor, dass Landnutzungsrechten nur als Sicherungsmittel eingesetzt werden können, soweit die Pacht vollständig bezahlt wurde, während nach BOT-Verträgen Grundstücke frei gewährt wird. Die Regierung entschied dann, dass Sicherungsmittel unter diesem Umstand unmöglich bereitzustellen ist, da keine Pacht bezahlt wurde. Das PPP-Dekret scheint die Zahlung einer nominalen Pacht zuzulassen, aber dies löst nicht das Problem mit Sicherungsmitteln für BOT ausländische Auftragnehmer. Durch praktische Regelungen sollte Privatanlegern zumindest eine gewisse Sicherungsmöglichkeit durch ihre Grundstücke eingeräumt werden.

Unsicherheit über die Bürgschaften der Regierung

Eine weitere Schwierigkeit betrifft die Garantie auf die Umwandelbarkeit und die Rückzahlbarkeit des Einkommens in Vietnamesische Dong. Ohne eine solche Garantie, wären einige BOT-Projekte nicht diskontfähig und Sponsoren könnte – selbst mit einer Garantie eines gleichbleibenden Wechselkurs – ein Restrisiko bleiben die Einnahmen nicht umwandeln zu können. Eine klarstellende Gewährleistung von Wechselkursen für Projekte mit Einnahmen in Vietnamesischen Dong, würde diese Unsicherheit beseitigen.

Anwendbares Recht für Projekte mit einer ausländischen Vertragspartei, oder zweier vietnamesischer Unternehmen, sofern die zuständige Behörde dies zulässt, kann dann ausländisches Recht sein, solange dies nicht im Widerspruch zum vietnamesischen Kollisionsrecht steht. Es besteht Unklarheit darüber, ob die Regierung Gewinne oder Einnahmen für PPP-Projekte, sowie Verträge nach ausländischem oder internationalem Recht garantiert.

Darüber hinaus sollten Projekte in Branchen wie Verkehr, erneuerbaren Energien sowie traditioneller Wärmeenergie bevorzugt werden, und wenn die Vorschläge der PPP-Projekte nicht zufriedenstellend waren, bedeutet dies, dass ausländische Investoren dafür gewonnen werden sollten, sich vermehrt für die Entwicklung nachhaltiger Projekte einsetzen. Mithin sollte die vietnamesische Regierung Projekte durch Garantien oder profitable VGF finanziell unterstützen. Darüber hinaus wird die Festlegung neuer Richtlinien für die Vorbereitung des PPP-Programms die Planung und Finanzierung der Projekte verbessern.

Chancen im Rahmen des PPP-Programms

Viele PPP-Projekte sind bereits unterzeichnet oder werden noch unterzeichnet und alle Informationen im Zusammenhang mit PPP-Programmen sind auf einer speziellen Website zusammengestellt, die durch das Ministerium für Planung und Investitionen und die Authorized State Agencies (ASAs) veröffentlicht werden, zuletzt auch mit einer eigenen Liste von Projekten. Den Erfolg zu erreichen mit einem PPP und die Infrastrukturentwicklung in Vietnam zu fördern, erfordert weitere Anstrengungen, was beginnen könnte mit einem Wahlrecht von Investoren zwischen der PPP-Verordnung und dem Investitionsrecht. Tatsächlich wäre die Verabschiedung der PPP-Verordnung als die einzige Möglichkeit Infrastruktur zu entwickeln, in Bezug auf die wirtschaftliche Wettbewerbsfähigkeit kontraproduktiv.

Da die Energienachfrage in Vietnam steigt, wird derzeit angedacht bis zu dem Zeitpunkt, an dem erneuerbare Energien ausreichen werden, vermehrt Kohlekraftwerke zu nutzen. Aufgrund des Pariser Übereinkommens werden private Investoren, die Kohlekraftwerke investieren rarer, da der Fokus auf der Grünen Energiebewegung liegt.

Schließlich ist der Straßenbausektor für Wirtschaft und Klima unentbehrlich, und doch bestehen für die Risikoverteilung, die Konzessionsgrundsätze und Klarstellungen des Bieterprozesses noch hohe Erwartungen an die vietnamesische Gesetzgebung. Diese Fragen sollten gelöst werden, um die Beteiligung der ausländischen Investoren an der Entwicklung der Verkehrsinfrastruktur zu ermöglichen.

Ausblick auf die EVFTA

Durch die EVFTA, die am 2. Dezember 2015 unterzeichnet und voraussichtlich bis Januar 2018 in Kraft treten wird, ergeben sich viele Änderungen. In Bezug auf den Marktzugang wird Vietnam in einer privilegierten Situation sein, da es als einziger Staat Südostasiens (abgesehen von Singapur, das eine kaum vergleichbare Ausgangssituation aufweist) eine solche Vereinbarung unterzeichnet hat. Sowohl Vietnam als auch die EU werden auf einen Markt von Hunderten von Millionen Menschen zugreifen.

Darüber hinaus gehen die Verpflichtungen Vietnams und der EU weiter, als die der Welthandelsorganisation – insbesondere im Energiesektor, im Schiffstransportwesen – was die ehrliche Bemühung zur Schaffung eines nachhaltigeren und profitableren Umfelds für Wirtschaft und Investitionen beweist. In diesem Sinne wurde die vietnamesische Gesetzgebung geändert, um Investoren-freundlicher zu werden, wie das Konzernrecht, das Investitionsrecht und die PPP-Verordnung. Einige Verordnungen brauchen noch Entwicklung oder Umsetzung, aber wir können mit dem Inkrafttreten der EVFTA neue Bestimmungen und Rechtsvorschriften erwarten.

Die wichtigsten Fragen

– Die Unmöglichkeit einer Hypothek auf Landnutzungsrechte für BOT ausländische Auftragnehmer bedarf dringender Nachbesserung, indem sie für BOT Projekte eine bestimmte Form von Sicherungsmittel durch Grundstücke oder Eigentum erlaubt.

– Das Genehmigungsverfahren für BOT-Investoren und Vertragspartner sollte vereinfacht und Vorschriften über VGF und PDF erstellt werden.

– Es sollte eine Überprüfung der von der Regierung abgegebenen Garantien und deren Voraussetzungen vorgenommen werden, um zu vermeiden, dass die Anleger in der Vorbereitungsphase entmutigt werden.

– Investitionen im Kohlebereich könnten seltener werden aufgrund des Pariser Abkommens, das Investitionen in die grüne Energie fördert.

– Für Investitionen für Straßenverkehr bleibt ungewiss, wann die Beteiligung der ausländischen Investoren in die Entwicklung der Verkehrsinfrastruktur unterstützt werden soll.


Bitte zögern Sie nicht, Herrn Rechtsanwalt Oliver Massmann unter zu kontaktieren, sofern Sie Fragen haben oder mehr darüber erfahren möchten. Oliver Massmann ist der Geschäftsführer von Duane Morris Vietnam LLC.

Vielen Dank!




Vietnam hat große Fortschritte in der Qualität des pharmazeutischen und medizinischen Sektors gemacht. Durch Erhöhung des Etats im Gesundheitsbereich auf fünf bis sechs Prozent des Bruttoinlandsprodukts zählt Vietnam zu den Staaten mit den besten Ergebnissen in der ASEAN. Die Verabschiedung der Verordnung 19 / NQ-CP / 2015 über die nationale Wettbewerbsfähigkeit, der Verordnung 35 / NQ-CP / 2016 zur Unterstützung der Unternehmensentwicklung sowie des neuen Arzneimittelgesetzes vom 4. Juni 2016 mit Wirkung zum 1. Januar 2017 verbessert die Gesundheitswirtschaft im Hinblick auf den verbesserten Zugangs zu medizinischer Versorgung. Vereinbarungen wie das Freihandelsabkommen EU-Vietnam (EVFTA), die ASEAN-Wirtschaftsgemeinschaft (AEC) oder die transeuropäische Partnerschaft (TPP), in denen Vietnam Mitglied ist, werden die positiven Fortschritte in diesem Sektor weiter vorantreiben. Darüber hinaus werden Leitlinien für die Umsetzung des Arzneimittelgesetzes in den folgenden Monaten abgeschlossen sein, um die verbleibenden Fragen in sowohl örtlichen als auch ausländischen Industrien zu lösen.

Sicherstellung eines schnellen und nachhaltigen Zugangs zu moderner Medizin

Die Erwartungen, die sich aus den Gesetzesvorhaben ergeben, betreffen den nachhaltigen Zugang für vietnamesische Patienten zu innovativen Medizinprodukten und das öffentliche Beschaffungswesen für hochwertige Arzneimittel. Die Gründung von „Unternehmen mit ausländischen Investoren“ (im Folgenden: FIE, engl. Foreign Investment Enterprises) in Vietnam muss unterstützt werden, um die örtliche Industrie zu einer der zentralen pharmazeutischen Industrien der ASEAN zu entwickeln.

Das neue Arzneimittelrecht begünstigt die Gründung von FIE im pharmazeutischen Sektor, da es notwendig ist, Zugang zu den innovativsten Arzneimitteln und Techniken zu erlangen. Dennoch bleiben einige rechtliche Grauzonen, um den gleichen Zugang zum Pharmamarkt für ausländische und lokale Unternehmen zu gewährleisten. Tatsächlich wurden der ausländischen Repräsentanz – der am häufigsten gewählten Form ausländischer Pharmaunternehmen vor Ort – nicht die gleichen Rechte eingeräumt, wie anderen Unternehmen.

Zu verhindern, dass Repräsentanzen Verträge abschließen, Medikamente und Impfstoffen importieren, Medikamente im Inland veräußern, sowie jegliche gewinnbringende Tätigkeiten in Vietnam durchführen, erschwert unweigerlich Finanzinvestitionen, die Entwicklung lokaler Einrichtungen und den Technologietransfer. Um die Zahl der FIE zu erhöhen, sollten klare und praktisch anwendbare Leitlinien eingeführt werden.

Erleichterung der bürokratischen Verfahren

Die vietnamesische Regierung befreite auch einige pharmazeutische Produkte, wie Medikamente oder medizinische Geräte, von der Voraussetzung lokaler klinischer Studien. Zuvor mussten 2,5 bis 5-jährige lokale klinische Studien abgeschlossen werden, um eine Marktzulassung zu erhalten, weshalb die teilweise Lockerung dieser Voraussetzung ein wichtiger Schritt zu einem schnelleren Zugang zu modernen Arzneimitteln ist. Jedoch geht aus dem Gesetzestext nicht klar hervor, ob biologische Präparate und Impfstoffe ebenfalls von dieser Freistellung profitieren, insbesondere wenn eine solche Freistellung den Regeln des EVFTA widerspricht. Vietnam sollte einhalten, was in internationalen Abkommen zur Förderung des Vertrauens von Anlegern und der Unternehmensgründern versprochen wurde.

Weitere Hindernisse für die Niederlassung von Pharmaunternehmen sind die Lizenzvorgaben und die Visaverfahren, die alle fünf Jahre stattfinden. Ein kompliziertes Verfahren, da die Erneuerung zwischen 18 und 24 Monaten dauern kann, das aber nur 12 Monate vor dem Ende des bestehenden Visums begonnen werden kann.

In der Ausschreibung 09/2016 / TT-BYT des Gesundheitsministeriums vom 5. Mai 2016, mit Wirksamkeit seit dem 1. Juli 2016, sind Arzneimittel gelistet, die im Rahmen eines Ausschreibungsverfahrens beschafft werden müssen. Soweit hier eine klare Umsetzung erfolgen und das Verbot des Einsatzes ausländischer Produkte in der öffentlichen Beschaffung von Arzneimitteln aufgehoben werden würde, trüge dies dazu bei das Ziel eines universellen Zugangs zu medizinischer Versorgung und hochwertiger Medizin für jeden vietnamesischen Patienten zu erreichen.

Lösung von Problemen des Patentrechts

Gefälschte Medikamente sind ein ernstes Problem in Vietnam, dem man sich dringend annehmen muss. Die vietnamesische Gesetzgebung ist unzureichend, sofern es um die Regulierung des  Patentrechts und des Datenschutzes geht. In internationalen Abkommen wurden viele Mechanismen geschaffen, um ein sichereres Umfeld für Investitionen zu gewährleisten, wie die Verabschiedung eines Patentrechtschutzes, von Vollstreckungsrecht oder von Datenschutzrichtlinien (im Folgenden RDP, engl. Regulatory Data Protection). Daher sollte Vietnam RDP einführen, sowie Geldbußen und Sanktionen bei Rechtsverstößen einrichten.

In Vietnam trägt derjenige die Beweislast, der einen Anspruch aus seinem geistigen Eigentum, oder eine Verletzung seines Datenschutzes geltend machen will. Darüber hinaus ist bei der Einreichung einer Patentanmeldung die Geheimhaltung nicht automatisch gewährleistet und muss explizit in das Arzneimittelpatentanmeldungsformular beantragt werden. Die Arzneimittelbehörde von Vietnam nimmt die Anträge entgegen und ist oft zurückhaltend, sich gegenüber den FIE zu verpflichten die Geheimhaltung zu gewähren. Diese Problematik stellt ein Hindernis für Investitionen in der pharmazeutischen Forschung und Entwicklung sowohl für ausländische und lokale Investoren dar.

Förderung der Entwicklung einer Krankenversicherung

Die Entwicklung hin zu einer Krankenversicherung wurde erst kürzlich aufgrund von Initiativen der Regierung begonnen. Dies zeigt die Bedeutung des Einsatzes öffentlicher Mittel für die Entwicklung des Gesundheitsbereiches, auch wenn deren Bedeutung bei den Gesundheitsfonds abnimmt. Tatsächlich übernehmen private Fonds die Führung in Investitionen im Gesundheitssektor, da diese sich gemeinsam mit dem Markt stetig ausbreiten. Die von der vietnamesischen Regierung unterzeichneten Abkommen werden mehr ausländische Privatanleger anziehen und private Fonds, die in der Branche dominieren.

Dennoch stützt sich das Krankenversicherungssystem in Vietnam vor allem auf Beitragszahlungen der Bevölkerung, und da ein Teil der Bevölkerung alternative und traditionelle Medizin gegenüber der westlichen Medizin bevorzugt, spricht dies gegen eine umfassende Krankenversicherung aller vietnamesischen Bürger.

Ausblick auf das EVFTA

Das EVFTA, das am 5. Dezember 2015 unterzeichnet und voraussichtlich bis Januar 2018 in Kraft treten wird, eröffnet neue Bedingungen und Möglichkeiten für sowohl den europäischen als auch den vietnamesischen Markt. Es beinhaltet spezifische Regelungen zu Im- und Export von Arzneimitteln. Zum Beispiel wird Vietnam gemäß Artikel 14.2 Kapitel 2 des Abkommens verpflichtet Rechtsinstrumente zu schaffen und umzusetzen, um die Gründung von FIE in Vietnam zu ermöglichen. Darüber hinaus verpflichtet dieser Artikel Vietnam, den FIE die Möglichkeit zu geben Arzneimittel, die direkt von ihnen importiert werden, zu veräußern auf direktem Weg, über Händler oder Großhändler, auch ohne den Nachweis eines Zertifikats für Gute Lagerungspraxis (GSP).

Soweit sich die vietnamesischen Gesetzgebung verantwortlich zeigen wird für die Anforderungen von  Zulassung und die Zulassungsverfahren, würde dies einen nachweisbaren Einfluss des EVFTA begründen, da so die Gründung von FIE und deren erweiterter Tätigkeitsbereich gefördert würde. Daher steht zu erwarten, dass zugrundeliegende vietnamesischen Regelungen angepasst werden, um den EVFTA-Anforderungen gerecht zu werden und so in absehbarer Zeit einen liberalisierten Pharmamarkt zu schaffen.

Die wichtigsten Punkte:

– Beschränkungen der Rechte von Repräsentanzen und das komplexe Registrierungsverfahren dürften die Neugründungen von pharmazeutischen FIE einschränken.

– Regelungen des Patentrechts zum Schutz der Antragsteller und ihre Patente würden die Forschung und Entwicklung fördern und die Schaffung innovativer pharmazeutischer Produkte in Vietnam beschleunigen. Außerdem muss das Problem nach gefälschten Medikamenten dringend bekämpft werden.

– Die Entwicklung der Krankenversicherung ist begrenzt durch dessen Finanzierungssystem und durch das Misstrauen, das manche Menschen in die westliche Medizin haben. Die Einführung eines Rücktrittsrechts bei Medikamenten und medizinischen Dienstleistungen würde dazu beitragen, diese zu fördern.

Bitte zögern Sie nicht, Herrn Rechtsanwalt Oliver Massmann unter zu kontaktieren, sofern Sie Fragen haben oder mehr darüber erfahren möchten. Oliver Massmann ist der Geschäftsführer von Duane Morris Vietnam LLC.

Vielen Dank!







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, Oliver Massmann is the General Director of Duane Morris Vietnam LLC.

Thank you very much!



Lawyer in Vietnam Oliver Massmann Why it is best to start preparing for transactions now in Vietnam ?


Vietnam has concluded the Trans-Pacific Partnership (“TPP”) and the EU- Vietnam Free Trade Agreement (“EVFTA”). Meanwhile, the ASEAN Economic Community (“AEC”), which Vietnam became a full member in 1995, has been established since the end of 2015. With such deep integration into the multilateral and regional economy, Vietnam is expected to be an attractive investment environment for investors and witness a significant growth in the upcoming years.

Vietnam has made progress over 3 continuous years to reach 56th position in 2015 on the Global Competitiveness Index list, a jump of 12 positions compared to 2014. It is noteworthy that Vietnam is more competitive than 6 European Union countries on this list. Even more notably, 4 out of these 6 countries, namely Slovenia, Cyprus, Slovakia and Greece, are considered as advanced global economies, and have the GDP per capita of at least USD17,700, eight times more than Vietnam.

Samsung Electronics Company has decided to choose Vietnam as the Number 1 country to put their world largest mobile and tablet production and invested more than 6 Billion USD after a researching worldwide. Also major Japanese companies are convinced Vietnam is a top investment destination and become the largest investors in Vietnam.

The Vietnamese Government has made great attempts to develop itself by opening its economy to international trade, investments and free movement of people. The following section provides an overview of these free trade agreements and the AEC to help investors understand what is awaiting them ahead and decide their investment in Vietnam.


The TPP was originally known as the Trans- Pacific Strategic Economic Partnership concluded in 2006 among Singapore, New Zealand, Chile and Brunei (P-4 agreement) as a means to promote trade liberalization in the Asia- Pacific Region. As its name indicates, the original purpose of the agreement was only to address economic issues. As the number of participating countries in the P-4 agreement increased, starting with the United States in September 2008 and other countries to follow being Australia, Peru, Vietnam, Malaysia, Canada, Mexico and Japan until July 2013, the agreement is agreed to be “a comprehensive, next-generation regional agreement that liberalizes trade and investment and addresses new and traditional trade issues and 21st-century challenges” by TPP Trade ministers. In June 2015, the United States approved the trade promotion authority for President Obama. The Agreement finally becomes as it is today through tough negotiation rounds, while the last round in Atlanta in September 2015 was considered the most intensive one. The TPP was already concluded on 06 October 2015.

TPP Market Snapshot
·         GDP: US$28,136.0 billion (2012)

·         GDP per capita: US$35,488 (2012)

·         Population: 792.8 million (2012)

·         TPP % of world GDP: 39.0% (2012)

·         TPP % of world population: 11.3% (2012)

·         TPP % of world trade: 25.8% (2012)

The TPP includes thirty chapters with deep focus on comprehensive market access, a fully regional agreement, cross-cutting issues (regulatory coherence, competiveness and business facilitation, small and medium sized enterprises, and development), and new trade challenges (particularly rules on state owned enterprises and government procurement).

The TPP would expand market access in goods and services among its signatories. The market access issues include liberalization of trade barriers protecting dairy, sugar, and rice; tariffs and origin rules affecting textiles, clothing, and footwear; and services trade reforms, especially financial services, insurance, and labor services.

Vietnam would be the largest beneficiary of this trade pact, resulting from its strong trade ties with the United States, high level of protection against its main exports (i.e., apparel and footwear), and its highly competitive positions in industries such as manufacturing where China is gradually losing its competitive advantage. Statistics shows that by participating in the TPP, Vietnam’s GDP would add an additional increase of 13.6% to the baseline scenario.

TTP will help Vietnam make good use of international cooperation opportunities, balance relationships with key markets, approach larger markets including the U.S, Japan, Canada, boost import-export, reduce import deficit, and attract foreign investment. In addition, TTP will also help Vietnam’s economy allocate its resources more effectively, enabling active supports to the processes of restructuring, innovation and improving regulations, and improve administrative reforms.

Higher income will help Vietnam to invest more and grow more

Vietnam is among the largest income gains in TPP

The TPP is now being submitted for ratification in each country before it officially takes effect. Despite all political concerns, we strongly believe that the TPP will finally be implemented in 2018.


The AEC originates from the ASEAN Vision 2020, which was adopted in 1997 on the 30th anniversary of the Association of Southeast Asian Nations, made up of Brunei Darussalam, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand and Vietnam (ASEAN). With a population of more than 600 million and a nominal GDP of about $2.31 trillion, ASEAN is a strong economic community in Asia and also a driver of global growth.

The AEC encompass the following characteristics: (i) a single market and production base, (ii) a highly competitive economic region, (iii) a region of equitable economic development, and (iv) a region fully integrated into the global economy.

The AEC is expected to be an area where goods can circulate freely and in which custom duties on goods will be gradually reduced to 0%. It will establish ASEAN as a single market and production base, making ASEAN more dynamic and competitive with new mechanisms and measures to strengthen the implementation of its existing economic initiatives; accelerating regional integration in the prioritized sectors; facilitating movement of business persons, skilled labor and talents; and strengthening the institutional mechanisms of ASEAN.

The free flow of investment will also offer enhanced investment protection to all ASEAN investors and their investments in other ASEAN member countries, including the settlement mechanism of an investor state dispute based on a non-discrimination principle when investing in other ASEAN countries. Those principles play a very important role in providing investor confidence when making cross-border investment.

Once the AEC is completed, it will be a unified market, a common manufacturing area seeking for more dynamic and competitive development and to create new opportunities for tariff reductions as well as other trade incentives.

AEC Market Snapshot
·         GDP: US$2311.3 billion (2012)

·         GDP per capita: US$3748.4 (2012)

·         Population: 620 million, 60% under the age of 35

·         AEC % of world GDP: ~3.3%

·         AEC % of world population: 9%

·         AEC’s merchandise exports: US$1.2 trillion – ~54% of total ASEAN GDP and 7% of global exports

·         If ASEAN were one economy, it would be the 7th largest in the world – 4th largest by 2050 if growth trends continue


On 02 December 2015, after nearly 3 years with 14 rounds of negotiations, the Minister of Industry and Trade of Vietnam, H.E. Vu Huy Hoang and the European Commissioner for Trade, H.E. Cecilia Malmström have signed the EVFTA. Both parties will finalize the ratification process as soon as possible for the EVFTA to take effect from the beginning of 2018.

The EVFTA is considered one of the most comprehensive and ambitious trade and investment agreements. It is the second agreement in the ASEAN region after Singapore and it will intensify the bilateral relations between Vietnam and the EU.

The agreement has separate chapters on Trade of Goods, Rules of Origin, Customs and Trade Facilitation, Sanitary and Phytosanitary measures and Technical Barriers to Trade, Trade in Services, Investment, Trade Remedies, competition, State-Owned Enterprises, Government Procurement, Intellectual Property, sustainable Development, Cooperation and Capacity Building, Legal and Institutional Issues.

Nearly all customs duties – over 99% of the tariffs will be eliminated. The small remaining number is mainly due to the transition period. Vietnam will liberalize 65% of import duties on EU exports to Vietnam at entry into force and the remaining duties will be eliminated due to the next ten years; EU duties will be eliminated over a seven year period. The market will be opened for most of EU food products, i.e. wine, spirits and frozen pork meat will be liberalized after seven years and dairy products after a maximum of five years. The EU will eliminate duties for some sensitive products in the textile and footwear sector. The EU has offered access to Vietnamese exports via tariff rate quotas (TRQs), because some sensitive agricultural products will not be fully liberalized. Furthermore, the agreement will contain an annex with provisions to address non-tariff barriers in the automotive sector. Vietnamese exports of textile, clothing and footwear to the EU are expected to more than double in 2020 as a result of  the EVFTA.

The EVFTA will help to increase quality of investment flows from EU, accelerate the process of sharing expertise and transfer of green technology and the creation of more employment activities.

The real wages of skilled laborers may increase by up to 12% while real salary of common workers may rise by 13%. The macro economy will be stable and inflation rate is controlled. Vietnam’s business activities will be booming in the next few years once the EVFTA officially comes into force and Government’s policies as well as institutional reforms start showing their positive effects.

Vietnam’s GDP is expected to increase by 0.5% annually, increase in exports is 4-6% per year. If this trend continues until 2020, Vietnam’s exports to EU will increase by USD 16 billion. Until 2025, the EVFTA is estimated to generate an additional 7-8% of GDP above the trend growth rate.

In 2013, the EU was Vietnam’s second biggest trade partner with a total value of trade in goods of EUR 24.2 billion. In the same the EU was also Vietnam’s biggest export market with EUR 21 billion, representing 19% of Vietnam’s total export. Vietnam’s export to EU increased by 28% from 2012 to 2013. In addition, the EU is among the biggest investors in Vietnam, with 1,810 FDI projects in 2013. The EU committed to continuing to support with the foreseen assistance amount of EUR 400 million in the coming six years. EU exports to Vietnam are dominated by high-tech products including electrical machinery and equipment, aircraft, vehicles, and pharmaceutical products. Vietnam’s key export items to the EU include telephone sets, electronic products, footwear, textiles and clothing, coffee, rice, aqua products, and furniture.

Conclusion: Why investment in Vietnam now?

  • Vietnam ties in first place with Singapore, thus it provides highest possible protection for investment
Country Limitation of market access* Country Limitation of market access*
Malaysia medium Myanmar high
Indonesia medium Cambodia medium
Philippines medium Laos medium
Singapore low India high
Thailand medium China medium
Brunei high Vietnam low

*Typical restrictions: number of opened sectors, JV requirement, limits on foreign-owned shares, permission requirement

  • Vietnam has the fastest growing middle class with a very good demographic situation: about 90 Million people of which about 50 percent are under 30 years old.
  • Expectations of Vietnam parties might get unreasonable, the same as after Vietnam acceded to the WTO in 2007 and no projects could be done.
  • Market opening in certain sectors, for example, media, and there could be more competing companies from the AEC with better market access to Vietnam. Thus, it is vital that investors start working on their projects now to position themselves as early as possible before the coming into effect of the trade pacts.


Please do not hesitate to contact Oliver Massmann under if you have any questions or want to know more details on the above. Oliver Massmann is the General Director of Duane Morris Vietnam LLC.


Vietnam – Latest on Seaports and Shipping – Logistics is Everything

With the adoption of the Trans-Pacific Partnership (“TPP”) and the European Union – Vietnam Free Trade Agreement (“EVFTA”) in the upcoming months, we would expect a significant increase in trade between Vietnam and countries being members of the mentioned agreements. In order to reap the huge benefits that these agreement might bring to Vietnam, it is necessary to create an efficient deep sea container terminal. Cai Mep port would be fit for such purpose, in terms of a potential domestic and international transhipment hub and creating balance for demand and supply container terminal in Southern Vietnam. An operating cooperation contract has been signed between CMIT and Saigon Newport as the first attempt to develop Cai Mep as a hub.
Still, there should be more to do from the Government’s side. A competitive environment for the operation of the container terminal must be created. To achieve this objective, we suggest the following actions:
First, reducing port dues for certain sizes of vessels. As a consequence, a greater number of vessels will no longer have to transit via existing hubs such as Hong Kong or Singapore. An estimate of USD 7 million per year in transport costs would be saved and the overall income of the country will increase.
Second, relaxing regulations on cabotage. The current local services on offer do not comply with the required standards. This should be fixed so it is not blocking the progress of creating a hub in Cai Mep.
Third, reforming customs rules. The Vietnam General Department of Customs with the advisory support of the Vietnam Trade Facilitation Alliance in conjunction with the American Chamber of Commerce is currently making great attempts in improving imports and exports procedures. This is also considered as a step towards a competitive environment compared with other ASEAN countries.
Finally, more interaction between the competent authorities and the transport/ logistics stakeholders. The recent Transport and Logistics Partner Quarterly Meeting held by the Ministry of Transport in conjunction with the World Bank is among the government’s efforts to help create a dialogue to exchange problems and workable solutions in the logistics industry of Vietnam.
If the above suggestions are taken seriously, Cai Mep will become a hub and Vietnam would certainly enjoy lots of benefits, include, among others:
o Less pollution for Ho Chi Minh City as a result of truck flow diversion from Ho Chi Minh City to Cai Mep;
o Less traffic and less risk of port congestion thanks to large capacity in Cai Mep region; and
o Capitalizing on the opportunities from the TPP and the EVFTA.

Please do not hesitate to contact Oliver Massmann under if you have any questions on the above. Oliver Massmann is the General Director of Duane Morris Vietnam LLC.



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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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