You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

August 26, 2016

Vietnam’s New Pharmaceutical Law

Subscribe to Updates
Informed Counsel

The National Assembly of Vietnam adopted a new Law on Pharmacy on June 4, 2016. The new law will take effect on January 1, 2017, replacing the current version which was passed in 2005. In an effort to update certain aspects of Vietnam’s legal framework to be more in line with international practices, the new pharmaceutical law is expected to provide quicker access to drugs for patients, increased consumer protection, and more incentives for local manufacturing of drugs.

Removing the Five-Year Rule for Clinical Trials

Under the Law on Pharmacy of 2005, which is currently in effect, before a new drug can be circulated in Vietnam, it must undergo clinical trials in Vietnam for registration purposes. The drug is only exempted from this requirement if it has already been circulated legally for at least five years in its country of origin. As a result, unless costly and cumbersome clinical trials are performed, Vietnamese patients have to wait at least five years to gain access to new drugs that have already been approved for circulation in other countries.

Under the new Law on Pharmacy, this barrier has been lifted. Accordingly, the clinical trial requirement would be waived for all new drugs, except vaccines, provided that they have sufficient clinical data on safety and efficiency and are circulated in at least one country anywhere in the world. With this change, Vietnamese patients will gain earlier access to new drugs, especially those that treat life-threatening diseases. Pharmaceutical companies will also benefit by not being forced to repeat clinical trials that have already been performed.

Expanding Retail of OTC Drugs

The new Law on Pharmacy allows certain non-prescription drugs, also known as over-the-counter (OTC) drugs, to be sold by a business establishment that does not have a certificate of eligibility for pharmaceutical business. These establishments include, among others, venues that have drug counters or cabinets, such as supermarkets.

Although the list of OTC drugs is not yet available and the relevant establishments still need to satisfy certain criteria on storage conditions and human resources, this is still a major change, as it appears likely to provide consumers with improved access to certain OTC drugs.

Acknowledging Patient Assistance Programs

Article 42 of the new law permits pharmaceutical companies to provide free drugs to health establishments through a patient assistance program. Previously, pharmaceutical companies always had to be concerned as to whether directly conducting such programs would be in breach of the law, as conducting promotional activities in relation to drugs targeting patients is prohibited in Vietnam.

Recognizing Clinical Pharmacology

The new Law on Pharmacy provides a separate chapter dedicated to clinical pharmacology, instead of scattered regulations as in the previous law. The purpose of this chapter is to ensure that drugs will be used in a reasonable, safe, and effective manner. While the contents of this chapter are cursory, its existence suggests that the government views clinical pharmacology and drug safety as an important issue.

Permitting Parallel Imports

  The new Law on Pharmacy specifically allows parallel import of drugs as long as the price of the parallel-imported product is lower than the price of the original brand-name drug currently being circulated in Vietnam. Though the general concept of parallel imports is not new to the pharmaceutical industry in Vietnam, this is the first time that a regulation on parallel imports has been promulgated under a law.

Incentivizing Local Manufacturing

The new Law on Pharmacy clearly shows that national policy prioritizes the purchase of domestically produced products, including domestically manufactured generics and biosimilars, herbal and traditional medicines manufactured from domestic herbal ingredients, and drugs manufactured in domestic facilities meeting good manufacturing practice standards.

Moreover, the new law reflects a preferential treatment for domestically produced drugs over imported drugs that first appeared in the Law on Procurement. That is, when domestically produced drugs are available that satisfy the Ministry of Health’s requirements on medical treatment, price, and supply, the dossier for a drug tender must stipulate that tenderers are not allowed to offer imported drugs. As a result of those regulations, there are more foreign pharmaceutical companies considering the option of going “local.”

Summary

The new Law on Pharmacy represents a milestone achievement in healthcare in Vietnam and is likely to have a major impact on patients and pharmaceutical companies, with the key benefit for consumers being earlier access to pharmaceutical products, due to the removal of the clinical trial requirement. As the new Law on Pharmacy is of critical importance, the government will likely issue a large number of decrees and circulars that will guide the implementation of the new law when it takes effect next year.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

December 6, 2023
New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are
Read More
October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More
October 25, 2023
One significant development in the health sector in Indonesia is the use of information technology and communication in the implementation of health efforts—particularly digital health services such as telehealth and telemedicine integrated into the country’s National Health Information System. This development was addressed in a major new piece of legislation for the healthcare sector in Indonesia. Enacted in August 2023, Law No. 17 of 2023 concerning Health (the “Health Law”) provides the updates needed to support the development of healthcare services in Indonesia. Under the Health Law, health information system (HIS) providers must: Carry out processing of data and health information in the territory of Indonesia, except for certain limited and specific processing activities that may be conducted outside Indonesia when permitted by the relevant authorities and in compliance with relevant regulations. Ensure the reliability of its HIS, including availability, security, maintenance, and integration with Indonesia’s National Health Information System. Provide quality health data and information. Process data and health information, which includes planning, collection, storage, inspection, transfer, utilization, and destruction. Record its data- and information-processing history. Protect every person’s data and health information. Obtain approval from the relevant personal data subject or comply with relevant regulations if the processing of data and health information involves an individual’s health data. Inform the data owner if there is a failure to protect data and individual health information. The Health Law’s personal data protection requirements listed above appear to be aligned with the provisions in Law No. 27 of 2022 concerning Personal Data Protection (the “PDP Law”). Under this law, data and information relating to health are identified as “specific personal data,” the processing of which carries a high potential risk of impacting the relevant personal data subject. In the implementation of digital health services, patients’ personal data or medical records
Read More
October 19, 2023
Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the
Read More