This country-specific Q&A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Thailand.
What laws are used to regulate advertising on medicines in your jurisdiction?
The Drug Act, B.E. 2510 (1967) (the “Drug Act“), is the main law which is used to regulate advertising on medicines in Thailand. The Drug Act provides a broad definition of a “drug” that covers substances recognized in a pharmacopoeia approved by the Minister of the Ministry of Public Health and intended for use in the diagnosis, treatment, relief, care, or prevention of a human or animal disease. Once it is clear that a particular product has the characteristics of a drug (and more importantly that it does not have characteristics that are excluded under the Drug Act), the advertisement of such drug will be subject to the requirements and restrictions under the Drug Act.
General provisions in the Consumer Protection Act, B.E. 2522 (1979) (the “CPA“), could also apply to the extent it is not contradictory to specific provisions in the Drug Act.
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
There is no specific self-regulatory code on the advertising of medicines that is applicable to the whole industry. However, there are codes of conduct adopted by two main trade associations that govern various promotional and marketing activities of their members. These associations are the Pharmaceutical Research and Manufacturers Association (the “PReMA”) and the Thai Pharmaceutical Manufacturers Association (the “TPMA”)
These codes do not have legal effect Violation of the codes of practice by members of the associations may lead to sanctions, such as suspension of membership and /or some fines.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
Yes. Advertisement is broadly defined to be any act by any means which propagates information about medicine for commercial purpose. The Regulation of the Office of the Food and Drug Administration Regarding the Requirements on Advertising the Sale of Drug, B.E. 2545 (2002) (the “Regulation”) issued under the Drug Act, elaborate further as follows:
i) “advertising the sale of drugs through general media” means advertising for the sale of drugs via radio, loudspeakers, television, picture projection, or film, through print, such as via a brochure, handbill, book, newspaper, magazine, bulletin, billboard, or other materials, or online.
ii) “advertising the sale of drugs directly to healthcare professionals (“HCPs”)” means advertising the sale of drugs directly to medical and veterinary practitioners through any media, such as medical journals, brochures, handbills, billboards, posters, or other materials, or online.
Advertising is defined to include any printed matters, e.g. a brochure, handbill, book, newspaper, magazine, bulletin, billboard, or other materials, or online.
As there are two types of advertising the sale of drugs, each type of advertising has different requirements and restrictions pursuant to the Drug Act. For example, the advertisement for the sale of drug directly to the HCPs must also refer to a study or research that is reliable and in accordance with the international standard. In any case, the advertising information must not be false or exaggerated.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Press releases regarding medicines would also be deemed to be advertising to the general public. Therefore, they must meet the requirements under the Drug Act. For example, the information must not be false, exaggerated, or off-label. The approval must also be obtained before the publication. The applicant must apply for the FDA’s approval before any advertisement may be used. It normally takes 15 working days for the FDA to consider and approve the advertising of drugs through general public, while the advertising the sale of drugs directly to the HCPs normally takes 30 working days from the official submission of the application provided that the documents are in good order. The timeline could be extended for another 20 days if the official is of the view that there is an issue that must be reviewed by the working committee. Any amendment of the approved advertisement must be approved by the FDA as well.
However, material which is educational or academic in nature (and which contains only academic information) and available at an academic conferences would not be deemed as advertising, and thus not subject to the approval requirement under the Drug Act.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
There is no specific law that prescribes that companies must have internal code or standard practice for approval of advertising of medicines.
Do companies have to have material approved by regulatory bodies prior to release?
Yes, see item 4, above.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
Comparative advertising for medicines is prohibited under the Drug Act.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
Given that all advertisement language must be approved and used as per such approval, they may not be used beyond the approved content and the provision of information on unauthorised medicines or unauthorised indications or off-label advertising is prohibited. However, information on unauthorized medicines or unauthorized indications may only be provided to HCPs at academic conferences, and the discussion must be done on generic chemicals name basis (no drugs under specific trademark may be discussed).
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
The Drug Act categorizes drugs as modern, traditional, dangerous, specially controlled, household, packaged and herbal drug. While the dangerous drug and specially controlled drug which require doctor’s prescription could be considered prescription only medicines, other categories of drug could be considered over the counter medicines. The advertisement of over the counter medicines would be subject to the general requirements under the Drug Act. However, the Drug Act provides that the specially-controlled drug and the dangerous drug cannot be advertised to the public.
The main rules that apply to advertising to the general public are that the content of advertisement must not contain information that is false, exaggerated, misleading or different from the details registered with the FDA. An advertisement must not use information that cannot be proven.
In addition to the main requirements set out in the Drug Act, there are several other laws and regulations are relevant, including the Consumer Protection Act, B.E. 2545 (2002), the Medical Professionals Act, B.E. 2525 (1982), and the ASEAN Harmonisation Guidelines, which cover topics such as labeling requirements.
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
There are no specific legal restrictions on interactions between patients or patient organizations and industry.
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
The main requirements and restrictions on advertising directed at HCPs are similar to those for advertising to the general public. In addition, references to research and studies can also be provided. The provided reference must be reliable, and be in line with the international standards. Furthermore, any reference to the effectiveness or dose of a drug must also come from a reliable source, and related statements (such as dose efficacy or indications) must be in line with the package insert.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
The gifts may be given on a traditional, customary or cultural occasion, or on an occasion on which it is general social practice to give gifts. In any case, no government official may receive any gifts with a value in excess of Baht 3,000 (approximately USD 100) on a single occasion from a person that are not relatives.
Furthermore, under the current Medical Council Regulations on the Preservation of Medical Ethics, B.E. 2549 (2006), all HCPs (whether deemed government officials or not) shall not accept any gifts worth more than Baht 3,000 from the operators of businesses related to healthcare products.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
Pharmaceutical companies are allowed to provide samples to HCPs or the medical institutions through their system of sample receiving. They must be deemed samples. The product samples should be used to enhance patient care and should not be distributed to induce drug prescription. The value of the provided samples should be nominal, and should not be given in return for the companies retaining or obtaining business, or to gain an improper or unfair advantage. The company should obtain appropriate documentary evidence in relation to the provision of samples.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
The sponsorship for HCPs to attend events is permissible if there is a legitimate and appropriate academic or educational purpose.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
There is no specific restrictions on the organization of non-scientific conferences by pharmaceutical companies but doing so might be mistaken as giving anything of interest to the officials (in case of public hospitals HCPs) should there be any relevant procurements involving those relevant HCPs.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
It is possible for a pharmaceutical company to pay for services provided by HCPs, as long as there is a legitimate reason to hire them. Fees for services should be the reasonable and represent fair-market rate. There are also no laws or regulations that require HCPs to obtain pre-approval from their employer before signing a service contract with a pharmaceutical company. However, the pharmaceutical company should inform the HCP’s employer of its intent to enter the service contract, especially if the HCPs are deemed to be government officials.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
It may be permissible for companies to provide grants or donations to healthcare institutions if there is a legitimate reason to do so whether the grant or donation is monetary or in kind. However, the companies should not provide the grants or donations directly to the HCPs or such donations might be accused as a “quid pro quo” should there be any procurement or other contract awarded by the relevant HCPs.
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
The advertising of drug by any means, including online advertising, is also subject to the approval, requirements and restrictions for advertisement of drugs under the Drug Act. There are two fundamental requirements for advertising drugs.
a) The drugs must meet pre-approval requirements for advertising. Before advertising any drug by any means, the content and wording that will be used in the advertisement must be submitted to the FDA for approval.
b) The content of advertisements must comply with the conditions set by the FDA. In the approval process, supporting evidence such as scientific or academic information must be provided.
When the companies provide a drug advertising intended for HCPs on the websites, the companies should provide access restrictions, e.g., user identification and passwords, so that only HCPs can access the advertisements.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
There are no specific anti-bribery rules that apply to communications between pharmaceutical companies and HCPs or healthcare organizations. However, representatives of pharmaceutical companies should not communicate with HCPs when HCPs are performing their duties or diagnosing patients.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
The Penal Code and the Act Supplementing the Constitution Relating to the Prevention and Suppression of Corruption, B.E. 2561 (2018) (the “Anti-Corruption Act“) are the main laws that govern the offering of benefits or inducements to the HCPs, especially if the HCPs are deemed to be government officials.
A person may be guilty of bribery if he or she gives, offers, or agrees to give property or any other benefit to an official in order to induce the official to do or refrain from doing any act, or to delay the performance of any act, in a manner contrary to the official’s functions or duties. To prove bribery, there must be dishonest intent, and benefits being given to make the official perform or not perform his or her duty on a quid pro quo basis.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
The FDA is the government authority who is responsible under the Drug Act, including the rules on drug advertising. The National Anti-Corruption Commission (the “NACC“) is responsible for enforcing and control the rules on inducement and bribery under the Anti-Corruption Act. In addition, the Central Criminal Court for Corruption and Misconduct Cases is the authoritative court for bribery cases.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
The company may not initiate proceedings against competitors for advertising infringements unless the advertising causes damage to the company, e.g. the advertising that contains unfair or misleading comparisons, or comparisons implying therapeutic advantage to the company’s product.
For the violations of the advertisement that require administrative remedies, companies can initiate proceedings against competitors by notifying the FDA on anonymous basis. When a complaint is made, some follow-up questions might be asked, and evidence will be requested from the complainant. The FDA will then take over, and begin by gathering preliminary information about the product and the responsible person. The advertisement will then be analyzed to determine whether an infraction occurred. Furthermore, the FDA conducts post-marketing control to monitor product compliance after approval has been granted.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
The Drug Act specifies fines for business operators who violate medicine advertising rules. For example, pharmaceutical companies which advertise without approval from the FDA shall be liable to a fine of up to Baht 100,000 (approximately USD 3,000). The Anti-Corruption Act and the Penal Code also provide criminal penalties that an individual who commits bribery offense to the official shall be liable to an imprisonment not exceeding 5 years or fine not exceeding Baht 100,000, or both.
If a person who has committed the bribery offense is related to a juristic person (e.g. an employee or agent), and the offense is committed for the benefit of the juristic person without appropriate internal control of that juristic person to prevent the commission of the offense, that juristic person shall be subject to a fine at least equal to, but no more than twice that value of the damage occurred or assets received from the commission of the offense.
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Measures taken by the self-regulatory authority are separate from measure taken by the government authorities. The procedures before or measures taken by the self-regulatory authority are intended to create an ethical framework, which should be taken by the members. The self-regulatory authority may impose sanctions to members who violate their codes of practice (e.g. suspension of membership or commercial fine). On the other hand, the procedures before or measures taken by government competent authorities or court can be enforced separately. The measures can be taken by virtue of laws that impose legal sanctions (criminal fine and imprisonment) without any relationship to the measures taken by the self-regulatory authority.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
One of the recently published (April 2019) complaints related to counterfeit medicinal product, claiming the product would treat hearing loss. The product was advertised through a website, the domain of which was registered abroad. The FDA found that the manufacturer of this product did not apply for a manufacturing license from the FDA and the advertisement was promoted by a non-licensed HCP.
The FDA regularly conducts post-marketing control, including an inspection of non-compliance for drug advertising. Typically, the FDA focuses on counterfeit products.