COVID-19 Vaccine and Drug Advertisement
In the age of pandemic, the issue of medical treatment and advanced medication are in the light of global concern as they are accounted for as an opportunity to alleviate the spread of so-called COVID-19.
In this edition, our law firm is going to address the issue of drug and medical device advertising regulations in Thailand as in the following year it is forecasted that there should be an array of newly developed medication tackling the viruses from various medicinal developers including China, US as well as in Thailand. It is interesting to address that to what extent the regulatory matters are able to control the accuracy of the content. Our law firm also roughly draws the regulatory matters in this regard stipulated in certain aforementioned countries.
In Thailand, it is required for those who would like to advertise drugs and medical devices to file an application so as to obtain the approval prior to the advertisement in any channel of media or through the marketing or advertising materials. The Food and Drug Administration (FDA) is the governmental body handling these related matters apart from the consideration of drug licenses as pharmaceutical entrepreneurs generally know. The regulations in the space of medicine advertisement are drawn to refrain customers or product users from deception or misunderstanding on the ingredients contained, the effectiveness, symptoms related and so forth.
Specifically in the case of harmful drugs, it is highly concerned that customers should not be misled resulting in improper or abuse of medicine in aspects of quantity, frequency and prohibitions. Additionally, There are certain kinds of drugs the user is required to obtain prescription prior to the purchase that should be under strict and limited regulatory scheme including the media practice. The requirements stipulated by the FDA regarding the advertisement vary from each type of drug according to including harmfulness. In contrast, there are certain requirements which equally and interrelatedly impose on drugs and medical devices including the prohibition of false, overstated information and unproved effectiveness or characteristics of medication.
Interestingly, in the general marketing space, the comparison advertisement is allowed so each entrepreneur is able to clearly illustrate to what extent their products are superior to others. However, in the medication space, it is prohibited to clearly illustrate as such. To explain, the products which are under one particular manufacturer are allowed to be compared with the characteristics but in the aspect of different owners it is prohibited. This excludes the comparison in relation to academic aspects without other names of entrepreneur illustrated in the advertising materials. Basically, all advertisement must be underpinned by scientifically proved evidence so as to obtain the approval from the FDA.
In the space of medical devices, the Medical Device Act, B.E. 2551 (A.D. 2008) is the main regulatory provision governing medical devices in various legal aspects. Under this act, medical devices are categorized into 3 groups as follows
Manufacturer or Importer is required to obtain a license before manufacturing or importing medical devices provided that the products are Condoms, Blood bag, Rubber gloves for surgical operations, HIV infection tester kits or Contact lenses.
Manufacturer or importer is required to provide the characteristics of the product before manufacturing or importing the product provided that the Medical devices are Equipments or products used in physical therapy, Alcohol tester kits, Implanted silicon breast prosthesis, Device or equipment for external use in breast enhancement or breast firming, Ophthalmic Viscosurgical, Urine test kit for Amphetamine.
Medical devices which are not categorized as said two matters
The categories specified above are not permanently limited as the FDA might additionally amend so as to conform with upcoming regional trade agreement or treaties. The Medical Device Act, B.E. 2551 (A.D. 2008) is not the only regulation covering this space. There are also the Notification on Guidelines, Procedures and Restrictions of Medical Device Advertising, B.E. 2553 (A.D. 2010) (“Notification”) which handles the label and advertisement in this matter together with certain acts including Consumer Protection Act, B.E. 2522 (A.D. 1979), Direct Sales and Direct Marketing Act, B.E. 2545 (A.D. 2002), Medical Facility Act, B.E. 2541 (A.D. 1998), Medical Professional Act, B.E. 2525 (A.D. 1982) which we can see that some of these are not specifically designated to apply with medicinal devices.
In aspects of drugs, there is the Drug Act, B.E. 2510 (A.D. 1967) (“Drug Act”) governing in this regard with the supervision of The Drug Bureau under the FDA exercising its power. By far, the Drug Act provides the categories of drug as follows
Modern-packaged drugs other than those categorized as dangerous or specially-controlled drugs
In this regard, there are certain ministerial notifications covering the label and advertisement control of drugs as well as the internal guidelines which are the Guidelines on Drug Advertising, B.E. 2551 (A.D. 2008) (“Guidelines”) specifying details apart from the act. Similarly, there are certain regulations that apply to the drug likewise in the medical devices which are Consumer Protection Act, B.E. 2522 (A.D. 1979), Direct Sales and Direct Marketing Act, B.E. 2545 (A.D. 2002), Medical Facility Act, B.E. 2541 (A.D. 1998) and Medical Professional Act, B.E. 2525 (A.D. 1982).
Due to the increasing of supply chain in years ahead in relation to medicine specifically the prospect manufacturers and developers of the COVID-19 vaccine or medication, it is worth to observe that to what extent at the time where a few manufacturers are starting to announce their successful laboratory test with the COVID-19 medication or vaccine will be practically control in terms of aggressively overstated specification of the medication. Optimistically, false declaration of medicinal characteristics is detrimental to the credibility of the developer and manufacturer themselves. However, if we focus on the possibility of not declaring a great amount of false information but the minimally deceptive specification, it is possible that it might not severely affect the credibility as a whole but they might obtain certain short run benefits of doing so. Hence, the regulations regarding the drug advertisement should be carefully considered at the aforementioned point of time so as the customers are able to refrain from purchasing or using not exactly right medication as it might be advertised.
Advertising is defined by the Medical Device Act as means any form of action taken in order for the public to see, hear or know of any statement, for commercial purposes, including for sales promotional purposes. Additionally, sales promotion is defined under said act as the provision of information, persuasion, or any actions taken in order to promote sales. Specifically, to advertise the medical devices, the owner must obtain the approval from the FDA prior to any advertisement which the first category of the medical device and certain parts of the second category are subject to the prohibition that limits the advertisement to those who are healthcare professionals. To define the scope of healthcare professionals, the Medical Device Act stipulates medical and public health practitioners of pharmacy, dentistry, first- class veterinary sciences, physical therapy, medical technology, or other medical and public health practices as prescribed in the relevant ministerial notification. Apart from aforementioned restrictions, the medical devices are able to be advertised to ordinary consumers. However, all categories of medical devices are governed by the regulations that the advertisement must not show the properties, qualities, volumes, standards, components or origin of the medical device which are false or exaggerated; show a guarantee of, or praise for, the properties of the medical device by any particular person;provide a reward by means of gambling in any form; show properties which indicate the capabilities to prevent, heal, relieve or remedy a disease or symptom which is forbidden to be advertised as stipulated in the relevant ministerial notification; or show any wording which causes a material misunderstanding in relation to the medical device. This is the limitation towards the medical devices which are not Fake medical devices, Substandard medical devices, Deteriorated medical devices, Medical devices that are unsafe to use, Medical devices which are not produced or imported in accordance with the issued license or notified specification and Medical devices whereby the licenses or specification certificates which have been issued in relation to such medical devices have been revoked as these products are fully prohibited from advertising and it might constitute criminal offences.
In terms of drugs, there are regulations in relation to labels and packaging inserts (folded documents inside the package as we generally take it for granted) which whether you are manufacturers, importers or sellers you have to strictly conform. There are two categories of drugs to be concerned in this regard which are the controlled and dangerous drugs and the non-controlled and dangerous drugs. The latter group can be advertised through audio, visual or printed media once it is approved by the FDA after the submission of those advertising materials for the FDA’s consideration. The advertising materials can be published after obtaining the approval but they are regulated under certain stipulated conditions of the FDA.
The advertisement of drugs is prohibited from boasting that a drug or its ingredients are capable of miraculous cures or total treatment; nor state that a drug can relieve, cure or prevent diseases or illnesses; nor use other words with a similar meaning. Additionally, it must not exaggerate or falsely declare the properties of the drug. Lastly, creating an understanding that the drug contains any medicinal substance or ingredient it does not actually contain, or, if it contains a particular medicinal substance or ingredient, creates an understanding that it is in a quantity other than that which it actually contains are forbidden. Impolite words, phrases or action are also prohibited as well as singing and dancing. It is interesting that the advertisement cannot contain the illustration of suffered symptoms. The promotional campaign consisting of gift and lucky draws is prohibited as it could generate sales in improper ways. The FDA itself additionally has the particular conditions stipulated for the advertisement which are not illustrated within the act.
Apart from the act, ministerial regulations and the notifications which relates to the advertisement of medical devices and drugs, there are codes of ethics which stipulate and enforce on a voluntary basis. To explain, the infringement of the ethics codes do not constitute an illegal act but probably the expiration of membership of the profession association. The ethics code includes Code of Sales and Marketing Practices imposed by the Thai Medical Device Technology Industry Association (THAIMED Code) and PReMA’s Code of Sales and Marketing Practices issued by the Pharmaceutical Research & Manufacturers Association (PReMA Code).
Last issue we have to highly concern is the risk of the bribery conduct in relation to advertisement of certain drugs or medical devices to healthcare professionals. To explain, certain healthcare professionals are officials of the governmental bodies. Take doctors for an example. Doctors working in public hospitals are officials by the virtue of Thai law. Additionally, they might work in private hospitals from time to time. Thus, ensuring the status of healthcare professionals is highly essential for manufacturers, importers or sellers who might wish to have healthcare professionals as part of an advertising campaign according to the prohibition of giving, offering or agreeing 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, which is contrary to the official’s functions or duties pursuant to Section 144 of the Penal Code constituting the bribery offenses.
The advertising or promotional activities in relation to medical devices and drugs are highly sensitive in aspects of extra prohibitions compared to general advertisement as well as the risk of criminal offences which involuntarily but easily constitute.
Note: Isaraporn & Partners is a Bangkok based law firm in Thailand providing legal services including high complexity legal issues domestically and internationally.