The advertising of medicines in Vietnam is mainly governed by the following regulations:
In addition, regulations on drug advertising are also mentioned in two professional pharmaceutical trade association guidelines:
The PG Code applies to all Pharma Group members and all of their employees (whether on indefinite term, definite term, or seasonal labour contracts) as well as third-party agencies representing the interests of Pharma Group member companies. The VNPCA Code applies to all VNPCA members and related organisations and individuals.
Neither of these codes has legal value.
“Advertising” is defined as the implementation of various means to present to the public products, goods and services for profit; products and services not for profit; and organisations and individuals which are trading and providing the presented products, goods and services, except for news, social policies and personal information.
There is no specific definition of drug advertising under current regulations in Vietnam – only the general definition of advertising.
“Drug information”, under regulations in the law on the collection and provision of such information, means information about a drug, including indications, contraindications, dosage, administration, adverse effects, and information relevant to the quality, safety and efficacy of the drug provided by responsible facilities on behalf of pharmaceutical authorities, healthcare professionals and those using the medication.
The current regulations are silent on the provision of drug information to authorities and those using the medication; only regulations on the provision of drug information to medical and healthcare professionals are available. Specifically, drug information can be provided to healthcare professionals through one of three forms:
The biggest difference between drug information provision and drug advertising is the main targeted subjects – healthcare professionals for drug information and users/consumers of the medication for drug advertising. In addition, drug advertising is only allowed for drugs satisfying all of the following conditions, ie, they must:
Under the Law on Advertising, print products and events are means of advertising; and any materials (such as patient leaflets) or programmes aiming to provide patients with information about drugs are subject to regulations on drug advertising.
There are no specific regulations on press releases for medicinal products in Vietnam.
Under the Law on Advertising, it is prohibited to use advertising that directly compares the prices, quality or efficiency of the advertiser’s products with those of other products of the same kind (including medication).
It is only permissible to provide drug information for drugs that have been granted MA or import licences. For drugs with import licences, the only form of drug introduction allowed is seminars. Thus, it is not possible to provide information on unauthorised medication.
In addition, the grounds to create drug information to be provided to healthcare professionals include only:
Thus, it can be interpreted that it is not permitted to provide information about indications that have not yet been approved by the authority.
Pre-information Procedure
Before releasing drug information documents or conducting drug introduction seminars, it is necessary to obtain a certificate of drug information content (approval) from the Drug Administration of Vietnam (DAV) for drug information documents, or from the provincial Department of Health for drug introduction seminars.
It is not required to obtain approval from the authorities before conducting drug information provision via drug introducers (medical representatives), provided they have been granted specific medical representative cards for such activity.
As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, it is not possible to provide information on unauthorised medication or indications, regardless of the form of information provision.
Pre-information procedure
Before conducting a scientific conference directed at healthcare professionals, it is necessary to obtain a certificate of drug information content from the provincial Department of Health.
In addition, at least three working days before holding the conference, the establishment that has been granted the certificate of drug information content must send the provincial Department of Health written notification of the time and place of the conference, accompanied by a copy of the granted certification of drug information content.
Furthermore, if there is a change to the time or place mentioned in the certificate of drug information content, the establishment must notify the local Department of Health where the conference is being organised at least one working day before the conference date.
Companies are not allowed to provide healthcare professionals with information about medicines/indications that have not yet been approved by the authority. Thus, it is not possible for companies to send information on unauthorised medicines or unauthorised indications to healthcare professionals.
Information on unapproved indications (off-label use) of an active ingredient, or unapproved active pharmaceutical ingredients may be discussed in a non-promotional scientific exchange, if approved by the Vietnamese authorities in charge.
Information on unauthorised medicines or unauthorised indications may be sent to healthcare institutions in the context of clinical trials. Such communications will not be considered as drug advertising or promotion; rather, the communication would be stipulated in the clinical trial agreements or related documents.
The regulations are silent on the publication of compassionate use programmes. In practice, such programmes may be published. For example, the MOH announced a programme on early access to unapproved Molnupiravir for the treatment of COVID-19.
It is strictly prohibited to advertise prescription medicines. Advertising is allowed only for over-the-counter (OTC) medication which is not subject to restrictions on use and does not need to be given under the supervision of a physician as recommended by a relevant state agency, and which has valid MA licences in Vietnam.
An approval (in the form of a certificate) on drug advertising content must be obtained from the DAV before conducting the advertising activity relating to the advertising content. The advertising activity must comply with the approval.
Requirements for Drug Advertising Content
Drug advertising content must include the following:
If the advertisement has audio, it must be presented with the following content:
Prohibited Content
The information and images below may not be used in drug advertising content.
In addition, advertising content is required to conform with: (i) the Vietnamese National Drug Formulary; (ii) the medicine package insert and labels approved by the MOH; and (iii) professional documents/instructions relating to the medicine issued or accepted by the MOH. This means, in principle, that it is not permitted to include information in the advertising content that is not included in these documents.
Drug Prices
The main policy for medicinal product pricing in Vietnam is that drug manufacturers, exporters, importers, MA holders and wholesalers/distributors are free to set the prices of their products, and compete on prices, but are still liable to the law. Pharmaceutical establishments must declare their drug prices to the DAV but no approval for the declared price is issued by the authority.
None of the documents (i), (ii) or (iii) mentioned above include the drug price. Thus, the drug price should not be mentioned in the advertising.
Under Vietnamese Law
It is prohibited for medical representatives of companies selling medication to approach patients, to collect information regarding the medical records or medical prescriptions of patients; or to discuss or require information related to patients.
Under the PG Code
“PG members must not answer requests from individual members of the public for advice on personal medical matters. Enquirers must be referred to their personal physicians. This includes toll-free information services. Medical representatives must never discuss medical matters with patients in any forum, including health fairs, pharmacies, hospitals, and physicians’ waiting rooms, even if approached directly by a patient, nor may they instruct patients on how to use company products. Patients must be advised to seek advice directly from their physician, who, in turn, may contact PG members for further information. Disease awareness campaigns or patient education program[me]s can be supported by PG members by providing a grant to a competent medical association which is authorised to conduct such campaigns.
PG members may support the work of independent patient associations but must ensure that their involvement has been declared and is transparent, that all of the arrangements comply with this Code and applicable Laws, and that a written agreement is in place. PG members must not influence the operation of the funded patient associations. The independence of this association must be fully kept.”
Under the VNPCA Code
No specific provision is mentioned. In interactions with all relevant parties, a member company is committed to:
Drug information provided to healthcare professionals must include the following: the name of the medicine, its composition, concentration, strength, dosage form, indications, contraindications, dosage and administration, the use of the medicine in specific sectors of the population, information related to warnings and safety, and other necessary information.
Similar to drug advertising to the general public, the grounds to create drug information for provision to healthcare professionals include: (i) the Vietnamese National Drug Formulary; (ii) the medicine package insert approved by the MOH; and (iii) professional documents/instructions relating to the medicine issued or accepted by the MOH. Thus, in principle, information that is not included in the documents above may not be provided. Accordingly, the drug price should not be mentioned in drug information content provided to healthcare professionals.
As mentioned in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, drug information provided to healthcare professionals must be included in specific documents, including the approved package insert. The Summary of Product Characteristics ("SmPC") is only required for new drugs under regulations in Vietnam while the package insert will be required for any drugs (new and generic) registered in Vietnam. The content of the package insert is similar to that of the SmPC.
If a piece of information is not mentioned in the documents above, the pharmaceutical entity first needs to register such information with the DAV by submitting a variation dossier (Variation 39: Adding and/or updating information to provide product information and advertising) to obtain the DAV’s approval for the use of the document/information for provision of drug information.
See 5.2 Reference to Data Not Included in the Summary of Product Characteristics. Any information not included in the three documents mentioned in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals needs to be approved first by the DAV in terms of a variation registration dossier before it can be used in product information and advertising.
Medical representatives who are in charge of directly providing drug information to healthcare professionals of pharmaceutical establishments are prohibited from providing drug information that is not as accurate as the information submitted to or verified by the regulatory authority, and from publishing drug information or documents that are not verified by the regulatory authority.
Thus, companies are not allowed to provide reprints of journal articles to healthcare professionals referring to medical and scientific information on unapproved new uses for approved drugs.
There is no specific definition or requirement for medical science liaisons (MSLs) in Vietnam. However, as with medical representatives, it is presumably not permitted to proactively discuss information on unauthorised medicines or indications with healthcare professionals at an MSL.
Approval must be obtained from the DAV for various aspects of a drug advertisement, such as the content, layout and form, and the applicant must comply with the approval in the course of advertising. The advertising of drugs before obtaining the DAV approval is prohibited.
There are no specific regulations on what arrangements companies must have in place to ensure compliance with the rules on medicinal advertising. There are only requirements for medical representatives who are in charge of directly providing drug information to healthcare professionals. In particular, medical representatives must meet the following requirements:
Medical representatives must be granted a “medical representative card” by the pharmaceutical business.
Advertising of medicinal products on websites follows general regulations on drug advertising specified in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
If the advertising content has multiple pages or is a sound or video recording with multiple scenes, the pages or scenes of the advertisement must appear consecutively, pausing long enough for viewers to read all the information; plus pages and scenes with product information must be stationary and not moving so that viewers have time to take in the product information. The advertising script included in the application for content approval must describe how the content pages will appear for multi-page advertisements.
The advertising of medicines in this form must be separate and multiple medicines must not be advertised at the same time, to avoid misunderstanding.
Advertising medicines on social media is not prohibited, provided that the relevant advertising content has been previously approved by the DAV.
In principle, drug information documents can only be provided to the correct (approved) subjects. This means that if information is approved to be provided to healthcare professionals, websites containing the information must include access restriction so that only healthcare professionals can access them.
Pharmaceutical businesses may not provide disease awareness information and/or materials to patients online. Companies can only support disease awareness campaigns or patient education programmes by providing support to a competent medical association which is authorised to conduct such campaigns.
Regulations on online scientific meetings are similar to those for offline meetings in Vietnam.
Pharmaceutical companies are allowed to sponsor scientific meetings or congresses and/or virtual attendance by healthcare professionals at these events; no special restriction is stipulated under Vietnamese law. However, the sponsorship should be in compliance with corresponding guidelines from relevant pharmaceutical associations, if any.
Under Decision No 06/2020/QD-TTg of the prime minister dated 21 February 2021 on the organisation and management of international conferences and seminars in Vietnam, an “international conference or seminar” is defined to cover any conference or seminar involving foreign elements which is organised in the form of a face-to-face meeting in Vietnamese territory or in the form of an online meeting with at least one location for streaming in Vietnamese territory, including:
“Vietnamese organisations” are those established under Vietnamese law and managed by a Vietnamese authority, such as central state or local administrative agencies. “Foreign organisations” include those permitted by an authority to operate in Vietnamese territory.
Online conferences may be considered “international” events if they meet the definition above.
Before being held, online international meetings must be registered with the authority in Vietnam. This also means that the content of such meetings will be evaluated by the authority, based on Vietnamese law.
There are no specific rules on accessing conference recordings, materials, etc, after the date of the conference. In practice, attendees can typically access such recordings or materials after the conference.
The key legislation governing anti-bribery and anti-corruption matters in Vietnam is the Anti-corruption Law and Penal Code. Under this law, corruption-related offences, including the giving and promising of bribes, the receiving of bribes, the “brokerage” of bribes, and embezzlement are strictly prohibited and the violators may be subject to criminal liability. Given the broad definitions under the Anti-corruption Law, any persons who have certain positions and authority in both the public and private sectors can be deemed “office holders” liable for offences relating to bribery.
For the act of giving/promising bribes, the law does not distinguish between bribes given to an individual office holder or to an organisation. In theory, giving or promising bribes to healthcare organisations or healthcare professionals, especially those who concurrently hold managerial titles in a healthcare organisation, is strictly prohibited and may be subject to criminal liability.
In practice, corruption or bribery charges are applied to individuals rather than organisations. Depending on the value of the benefits given and the severity of the crime, the penalty for an individual will be a monetary fine ranging from VND20 million to VND200 million (about USD880 to USD8,800) or six months’ to 20 years’ imprisonment.
It is prohibited for medical representatives to use material benefits to influence healthcare professionals or those using the medication to make them write more prescriptions or purchase more of the medication.
Vietnamese Law
It is not specified by Vietnamese law under what circumstances pharmaceutical companies may offer gifts to healthcare professionals (HCPs).
PG Code
“Gifts (examples include but are not limited to sporting or entertainment tickets, sight-seeing travels including sight-seeing travels in conjunction with events, electronic items, social courtesy gifts, wreaths, etc) provided to healthcare professionals ("HCPs") (either directly or indirectly) are prohibited. Providing or offering cash, cash equivalents or personal services is also prohibited.
Items of medical utility
Educational items that enhance Patient Care
The total value for items of medical utility, informational and educational items that enhance Patient Care given to HCPs must be less than VND2,000,000 per HCP per year (cumulative).
Items of medical utility, informational and educational items that enhance Patient Care must never be given to HCPs or medical institutions, organisations or associations for the personal benefit of the HCP or to influence the recommendation, prescription, purchase or usage of medicines and must never be formative of a quid pro quo arrangement.”
VNPCA Code
“Companies should not pay/give cash or gifts to healthcare professionals.
The company may offer gifts that are items that have educational, medical or patient benefit (eg, medical books) to health workers. These gifts must conform to the specialised field of health workers.”
The VNPCA Code does not provide a specific threshold limit for such gifts.
The provision of samples is considered as a type of product promotion. Under the applicable law on product promotion, promoted or promotional products may not include medicines for human use, including those permitted for circulation as regulated by the Ministry of Health (except where the sales promotion is dedicated to traders involved in selling medication). As such, providing medical samples as a product promotion activity to HCPs is prohibited in Vietnam.
The same prohibition is also regulated under the PG Code and VNPCA Code. However, these codes additionally provide three exemptions: (i) samples for tenders as requested by the hospitals; (ii) samples of vaccines and biological products for quality-testing purposes by a relevant authority before circulation in the market; and (iii) samples requested by the health authorities.
Vietnamese Laws
It is not specified under Vietnamese law whether pharmaceutical companies may sponsor scientific meetings or congresses and/or attendance by HCPs at these events.
PG Code
“Sponsorship to individual HCPs to attend events
Specifically regarding sponsorship for HCPs to attend international events, there must be commitment from HCPs who attend the event to share the benefit of knowledge gained on their return to Vietnam, such as through presentation to other HCPs (no honorarium shall be provided) or a report to their organisation or other academic/medical institution."
Events organised in foreign countries
"PG members must not organise or sponsor HCPs to attend events that take place outside of their home country unless it is appropriate and justified to do so from a logistical or security point of view. PG members can organise or sponsor HCPs to attend international events, as these derive participants from many countries. In this case, the host country regulations and standards can be applied, unless otherwise provided by Vietnamese laws.”
VNPCA Code
“Any financing of companies offered to individual healthcare professionals may not be tied to conditions and/or obligations and/or suggestions to prescribe, recommend use, or promote any medicines.”
Vietnamese Laws
It is not specified under Vietnamese law whether pharmaceutical companies may organise or sponsor cultural, sports or other non-scientific events at scientific conferences.
PG Code
“PG members must not organise or sponsor recreational events such as tours, sports, leisure activities, year-end parties for medical institutions, anniversary events of medical institutions, etc. PG members are prohibited from offering any kind of compensation to HCPs for participation in the events.”
VNPCA Code
It is not specified under the VNPCA Code whether pharmaceutical companies may organise or sponsor cultural, sports or other non-scientific events at scientific conferences.
Vietnamese Law
It is not specified under Vietnamese law whether pharmaceutical companies may provide grants or donations to HCPs or healthcare institutions.
PG Code
VNPCA Code
“Funding, scholarships, subsidies, support, consulting contracts, education, etc, should not be provided to healthcare professionals to exchange, set the conditions of recommended use or drug prescription, or influence the ethics and independence of the related healthcare professionals. Companies should only sponsor, grant scholarships, subsidise, etc, with the purpose of supporting legal education, scientific research and/or medical research.”
Providing rebates or discounts on drugs to HCPs is considered a type of product promotion and is prohibited under Vietnamese law.
The law is silent on providing healthcare institutions with discounts. However, the procurement of any products and services by a public healthcare institution must comply with the Law on Tender, where the tender price must be approved by the relevant authority. Normally, the price listed in such tender contract is the listed price without discount.
Vietnamese Laws
It is not specified under Vietnamese law whether it is possible to pay for services provided by HCPs.
PG Code
“HCPs may be engaged as consultants and advisors for services such as: speaking at and/or chairing meetings and events, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, translating medical documents, interpretation at medical meetings, writing a medical article and/or giving medical training, and participating in market research, where such participation/services, involves honorariums.
The arrangements covering legitimate provisions of such services must meet the following conditions:
i) The engagement does not interfere with the interest of the HCP's employer and the employer has no objection against the engagement;
ii) A written contract with the engaged HCP is put in place which specifies the nature of the services to be provided and the basis for payment of those services;
iii) Payment to HCP service providers must be based on market criteria and be proportionate to the time devoted, the work done and the responsibilities assumed and must be adequately documented. Payments of service fees must not be made in advance. Cash payment is prohibited;
iv) Only engage HCP service providers where there is a legitimate need for their services clearly identified and documented in advance, and: the criteria for selecting consultants must be directly related to the identified need; the consultants must have the expertise necessary to provide the service; the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need; the compensation for the services must be reasonable and reflect the fair market value.
The amount of the honorarium for local speakers/moderators at local meetings should be at fair market value. The honorarium for foreign speakers at local meetings or local speakers at international meetings should be at the level of normal practice in the speaker’s home country.”
VNPCA Code
“A healthcare professional who renders counselling services or is a rapporteur should be paid a reasonable remuneration and travel expenses, accommodation and meals to provide services as per market cost.”
No prior authorisations or notifications (eg, employer consent, regulatory authority approval) are required in relation to any of the activities described in this section.
Under Vietnamese law, every individual and organisation in the private sector has the right to report acts of corruption and bribery where they are aware of such misconduct.
In terms of transfers of value not subject to anti-corruption and anti-bribery issues, the law is silent on disclosure requirements and reporting obligations towards the health authorities relating to any sponsorship, donation or grant to HCPs and healthcare institutions, or the seminars and events organised by a pharmaceutical company.
However, details of donations, sponsorships and gifts will be assessed and represented as part of the auditing process, and reported as per the request of a relevant authority, on a case-by-case basis.
These transparency requirements do not apply to foreign companies and/or companies that do not yet have products on the market.
The DAV, along with inspectors under the MOH and local Departments of Health, monitors compliance with advertising regulations.
The authorities (including DAV or MOH inspectors) may initiate proceedings against entities for drug advertising infringements when the infringements are discovered. Companies may proactively alert the authorities about any infringements. It is not necessary for most pharmaceutical advertising infringements to be handled in court, unless they are related to the advertising of counterfeit drugs or are instances of repeated false advertising.
Violations of regulations on pharmaceutical advertising can be subject to a fine of up to VND80 million (about USD3,400). In addition, the relevant companies may be forced to suspend operations for three to six months, or the material and financial benefits from the acts may be confiscated, depending on the specific case. Furthermore, the violator will be forced to recall and remove infringing elements in some cases; and where the infringing element cannot be removed, the product will have to be destroyed.
When self-regulatory authorities notice any pharmaceutical advertising infringements, they may apply internal sanctions, such as suspending the violator’s membership. The self-regulatory authorities may also alert the authorities about the infringements.
There does not appear to be any other relationship between measures taken by the self-regulatory authority and the procedures before or taken by courts/authorities.
In COVID-19 situations, many entities have released false advertisements on anti-COVID-19 products. The MOH and other authorities have proactively conducted inspection activities to handle infringements relating to COVID-19 prevention and treatment.
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