Thai law prescribes strict rules for the advertising of pharmaceutical products. Permission must be granted to sell drugs through radio, television slide or motion picture, or in print.[1] What should companies be aware of when advertising pharmaceutical products, particularly to the public, as opposed to healthcare professionals?
What is a ‘drug’?
The advertising of substances in Thailand is governed by the Drug Act, B.E. (1967) (‘Drug Act’).[2] A ‘drug’, covers substances that are:[3]
✓ recognised by pharmacopoeia and specified by the Public Health Ministry (official list of medicinal drugs with their effects and directions for their use).
✓ intended for use in the diagnosis, treatment, relief, cure or prevention of human or animal disease or illness.
✓ pharma chemicals or semi processed pharma chemicals.
✓ intended to affect the health, structure or function of the human or animal body.
However, under (1), (2), and (4), some substances are excluded, such as those intended for agriculture or industry as specified by the Public Health Ministry; those used as food for humans; operating goods; medical apparatus; cosmetics; medical devices and components thereof; and those to be used in science laboratories for research, analysis, or verification of diseases, which are not directly administered to the human body.[4]
What cannot be advertised?
‘Advertising’ covers promotion through general media, such as radio, television, online and print, including press releases.[5] The official industry association, Pharmaceutical Research and Manufacturers Association’s (PReMA) has issued a code of practice regarding the advertising of pharmaceutical products in Thailand. This code suggests that providing information about a product to the lay press may be done only in the public interest or to communicate subjective achievement, without raising false hopes.[6]
Only household remedies, or traditional drugs specifically listed by the Ministry of Public Health, can be advertised directly to consumers and the public. In addition, they cannot be dangerous drugs, which may only be distributed by a pharmacist or a doctor. The majority of drugs in Thailand are categorised as dangerous drugs, including ibuprofen and cetirizine.
Companies must submit a marketing approval application, with samples, to the Thai Food and Drug Administration (FDA) for review and registration, whether it is for substances or medical devices. In addition, companies must inform the FDA of any marketing proposals, which have been approved or are pending approval overseas.
An advertisement for the sale of a drug cannot exaggerate or falsely show its therapeutic properties or capacity to treat, mitigate, cure, or prevent a diseases or illness. The Drug Act prescribes that no drugs shall be advertised impolitely or by means of singing or dancing, or by depicting the distress or suffering of a patient. In addition, drugs cannot be advertised by means of gifts or lottery drawings.[7]
The Consumer Protection Act of B.E. 2522 (1979) (the ‘Consumer Act’) governs advertising in general in Thailand. Any statements that are false, exaggerated or cause misunderstanding of the essential elements of the goods or services will be considered unfair to consumers.[8] Consequences for violations of the act could range from orders to rectify the offending statements or prohibitions of certain statements to severe criminal penalties.[9]
The Secretary-General of the FDA has the power to issue cease and desist orders on advertising. If the offending advertisement has misled the public, the FDA can order the offending entity to issue a corrective statement. Individuals breaching any of these laws will be liable to imprisonment not exceeding 6 months, a fine of no more than 10,000 Baht, or both.
Codes of Practice
PReMA’s Code of Practice defines ‘Promotion’ as any activities undertaken, organised, or sponsored by a pharmaceutical company designed to encourage prescriptions, supply or consumption of its products through all methods of communication, including but not limited to print; electronic media; email or exhibitions.[10] The Code has guidelines encouraging patient education through educational materials that is current, accurate and balanced, and should include “Please consult your physician”.[11]
The PReMA CEO can apply one or more sanctions upon the finding of a breach of one or more of the codes.[12] The sanctions could include referral of the complaint to the IFPMA,[13] suspension the company’s membership, or a fine, among other options.
Another association, the Thai Pharmaceutical Manufacturers Association (“TPMA”), has also issued the ‘TPMA Codes of Sales and Marketing Practices’ providing general principles regarding the sale of products to healthcare professionals and details the requirements for each method of advertisement.
Both industry associations published codes of practice. Although not legally binding, businesses breaching those codes could incur sanctions such as fines and suspension of memberships. These sanctions could have a significant impact on a business by affecting its reputation and credibility. Given Thailand’s intention of becoming a medical hub, pharmaceutical companies wishing to have a part in this plan should be aware of codes of practice, in addition to legal requirements, so as not to damage the industry’s reputation.
[1] Drug Act, section 88 bis.
[2] Drug Act, Chapter XI Advertisement.
[3] Drug Act, section 4.
[4] Drug Act, section 4.
[5] The Regulation of the Office of the Food and Drug Administration Regarding the Requirements on Advertising the Sale of Drug, B.E. 2545 (2002) (‘FDA Regulation’).
[6] Code 13.2 Media release.
[7] Drug Act, section 89-90.
[8] Consumer Act, section 22.
[9] Consumer Act, sections 47-48.
[10] PReMA Code of Practice (2019) 12th Edition, section 1.2.
[11] Code 12.2 Patient education.
[12] Code 18 Sanctions.
[13] International Federation of Pharmaceutical Manufacturers’ Association.