In view of increasingly diverse marketing and advertising strategies and approaches in recent years, communications about products on TV, radio or print media can no longer attract public attention due to continued advancement of technologies. As the Internet and wearable devices have become part of our daily lives, it is common to receive all kinds of advertising information through light-weight and small handsets. Thanks to the convenience made possible by technologies, everyone can promote or receive all kinds of product endorsement advertisements through or by way of the Internet. In view of the sanitation and health of the citizens, a relatively strict attitude towards pharmaceutical advertisements is adopted in Taiwan. In addition to the requirement that “pharmaceutical advertising may not be engaged by anyone other than pharmaceutical companies,” the placement and broadcast of such advertisement is also subject to prior review. This essay introduces the essence in examining drug advertisements concerning medical devices and makes recommendations concerning relevant examination standards.
Scope of examination of drug advertisements
Facing current developments of communications media, the ways by which advertisements are placed are no longer limited to print media, TV or radio. The popularization of the Internet has also brought changes to the communications of advertisements. Since information on the Internet is closely linked and one link leads to another website page, advertising seems to have transformed from the traditional promotion style of “all-you-can-see” display into a boundless world of advertising display. More information can be provided to consumers through dedicated consultation telephone numbers, websites or QR Codes included in advertisements. However, when advertisements of medical devices are examined by the Ministry of Health and Welfare (hereinafter, the “MOHW”), should details about dedicated consultation telephone numbers, consultation websites or information linked by QR Codes also be included in the scope of examination?
Under the Pharmaceutical Affairs Law, application shall be filed with the competent authority for an approval of the language, pictures or expressions of an advertisement per se before the advertisement is placed and broadcast (Article 66 of the Pharmaceutical Affairs Law). In practice, the competent authority has attempted to expand the scope of determination of drug advertisements through cross-media examination. According to the MOHW, “in view of increasingly diverse advertising and marketing strategies in recent years with ever-increasing advertising models across media, if advertisements for the same drug are placed on different media in coordinated manners with the overall efficacy satisfying the definition under Article 24 of the Pharmaceutical Affairs Law, this shall still be regulated as drug advertising in order to protect consumer rights and interests. For example, although a television commercial does not promote the name and efficacy of a drug, if it still provides a consultation telephone number or health education handbook and advertises the name and efficacy of the drug in the consultation telephone number or handbook, such television commercial should still be regulated as a drug advertisement” (the Wei-Shu-Yao-Zi 0950333455 Circular). In addition, “…an advertising act is constituted when the contents of promotion can be communicated to many unspecified persons to achieve the effect of solicitation for commercial benefits. Therefore, if specific products are sold in a website, all contents and links within the website and contents such as websites and webpages linked by the said website fall within the scope of advertising…” (the Wei-Shu-Shi-Zi 0950014814 Circular). Therefore, even if there is only a QR Code or link attached in the advertisement but contents in such QR Code or link disclose the effects or efficacy of relevant medical devices, it is still possible that such advertisement is regarded as a drug advertisement since its “overall effect still meets the definition under Article 24 of the Pharmaceutical Affairs Law.” In practice, such cross-media examination standard makes an advertisement much more likely to be regarded as a pharmaceutical advertisement and reduces the likelihood of placement of medical devices advertisements by medical device manufacturers. In this connection, how can a medical device advertiser create an advertisement attractive to consumers without claiming the efficacies and applications of medical devices?
The examination on drug advertisements under the Pharmaceutical Affairs Law is conducted in the following steps:
1. It is necessary to determine if information relating to goods or services released on the promotion media to solicit trading opportunities (including interviews, reports and promotions) for the purpose of selling an enterprise’s goods or services contains any content that promotes, suggests, and implies medical efficacies or applications. If not, this is not a drug advertisement and is thus not governed by the Pharmaceutical Affairs Law (Articles 24 and 70 of the Pharmaceutical Affairs Law).
2. If it is a drug advertisement, it is necessary to determine if the advertiser is a pharmaceutical company. The law requires that only a pharmaceutical company may place a drug advertisement (Article 65 of the Pharmaceutical Affairs Law).
3. When placing the above drug advertisement, the pharmaceutical company is required by law to file the language, pictures or expressions of such advertisement with the health authority on the level of the central government or a municipality under the direct jurisdiction of the Executive Yuan for approval. (Article 66 of the Pharmaceutical Affairs Law and Article 44 of the Enforcement Rules of the Pharmaceutical Affairs Law) If the contents of an advertisement so placed involves advertising contents prohibited under the Pharmaceutical Affairs Law (e.g., advertising contents involving sex-related efficacies, promotion of drugs via misrepresentations and falsifications, or exaggeration of the efficacies and safety of drugs), such contents will be deleted at the time of examination. (Article 47 of Pharmaceutical Affairs Law)
4. The contents of an advertisement placed by a pharmaceutical company shall be the same as those submitted for examination.
Based on the foregoing, whether an interview, report or promotion placed or broadcast by the people is a “drug advertisement” should depend on the following two criteria: whether the promotion “seeks to solicit sales” and whether the contents of the advertisement involve “medical efficacies.” If the above two criteria are met, all interviews, reports, promotions or advertisements for medical devices fall within the scope of regulations on drug advertising and require an approval from the competent authority (the MOHW or the department of health of a municipality) before they may be released.
Determination of “medical efficacies”?
Whether a promotion actually intends to solicit sales is relatively easy to understand. However, the definition of “medical efficacies” is difficult to clarify in order to determine the type or extent of a description which meets the definition of “medical efficacies” given by the competent authority. This is not specifically stipulated by law. The essence of examination on “medical efficacies” is inferred below based on relevant rules or circulars released by the competent authority.
The Laws and Regulations for Medical Device Advertising and Examination Principles (hereinafter, the “Examination Principles”) promulgated by the Food and Drug Administration of the MOHW (hereinafter, the “Administration”) to address the drug adverting examination standards for medical devices are referenced for the advertising examination standards for medical devices. The Examination Principles enumerate several types of advertising contents which require no submission for approval. To wit, if only the following contents are included in the advertisement, since such advertisement is not a drug advertisement, it requires no submission for approval: e.g., the name and/or price of the product, the name, address and telephone number of the manufacturer, which do not involve efficacies, applications and adverting.
Article 69 of the Pharmaceutical Affairs Law provides: “Those which are not drugs within the meaning of this Law shall not be labeled or advertised for medical efficacies.” Pursuant to the MOHW’s interpretation, a medical device with medical efficacies may be applied to human bodies, should go through human and clinical trials to substantiate their medical efficacies and safety, and should not be marketed until they are examined and registered. Therefore, the determination of medical efficacies should be preconditioned by “application to human bodies.” In addition, medical efficacies are determined by determining if a product claims to prevent, improve, mitigate or treat specific physiological conditions or claims to work on certain symptoms and if this is sufficient to mislead general consumers into believing that the use of such product can prevent, improve, mitigate or treat certain symptoms. (The Wei-Shu-Yao-Zi 0940034824 Circular of August 26, 2005).
The MOHW’s determination of “medical efficacies” pursuant to the Standard for Determining Advertising Expressions formulated by the MOHW to prevent advertisements for other items from falling within the scope of drug advertising may also be referenced. Pursuant to the Table for Determining if Expressions in Food Advertisements Involve Exaggerative or Misleading Expressions or Medical Efficacies (hereinafter, the “Food Advertisement Determination Table”), it shall be determined that medical efficacies are involved if the following expressions are used: 1. It is claimed that diseases or specific physiological conditions can be prevented, improved, mitigated, diagnosed or treated; 2. It is claimed that substances in human bodies which lead to diseases can be reduced; 3. It is claimed that the product is effective to diseases, disease syndromes or symptoms; 4. It involves the efficacies of traditional Chinese medicinal materials; or 5. Any publication or book is cited or excerpted or medical efficacies are mentioned in the name of others.
The Administration’s relevant circulars concerning if an advertising expression involves medical efficacies are exemplified as follows:
Contents of Advertisements Administration’s Determination
The product claims that “cellulite can be mitigated and metabolism and circulation can be promoted, calorie intake and fat deposition can be reduced (FDA-Xiao-Zi 0990025963). Since this does not suggest that undesired physiological conditions or certain symptoms can be improved, this does not pertain to any medical efficacy.
The product indicates or claims “messaging effect, warming effect, elimination of fatigue, promotion of blood circulation” (FDA-Xiao-Zi 0990020766). “Promotion of metabolism” is a common expression and does not involve any treatment effect and exaggeration, and only the expression “promotion of immunity” involves physiological functions. Therefore, no medical efficacy is involved.
The product claims “…a whole new ground-breaking anti-allergy technology is found… (FDA-Xiao-Zi 0990022393). This does not pertain to any medical efficacy.
The product claims “…to shape the contour of the belly and create a slender and nice waistline…”(FDA-Xiao-Zi 0990019322). This does not pertain to any medical efficacy.
The product also claims to “improve allergic constitution and reduce allergic skin disorders” (FDA-Xiao-Zi 0990028949). This is suspected to involve medical efficacies.
The advertisement claims that “this is used by intraoral spraying…works to kill germs for oral mucosa infected with pathogenic microorganisms” (Wei-Shu-Yao-Zi-0940023064). This involves medical efficacies.
To determine if the promotion or advertisement of medical devices is a drug advertisement, a general review of the above Pharmaceutical Affairs Law, the Examination Principles, the Food Advertisement Determination Table and relevant circulars from the MOHW indicates that this depends on whether such advertisement “claims to prevent, improve, mitigate, diagnose, or treat diseases or specific physiological conditions” or “claims to work on diseases or disease syndromes or symptoms” or causes the consumers to believe in such functions to solicit or promote the sales of such medical devices. For example, for common medical devices in practice such as contact lenses, dentures or shaping tights, if it is advertised that they can treat near-sightedness, restore vision, align teeth, or shape leg contours to prevent bending of legs, it is very likely that the competent authority may determine such advertisements are drug advertisements since such expressions involve medical efficacy descriptions.
Potential issues involving drug advertising examination
At the outset, since the MOHW adopts a comprehensive examination approach such as “cross-media examination” and defines the criteria for drug advertising broadly, testimonials released by the general public concerning their evaluations, use experiences and recommendations may fall within the scope of “drug advertising” for comparisons before and after usage and description of circumstances and efficacies concerning the use of medical devices The deployment of hyperlinks by ordinary citizens may even be determined to contain an article which is a drug advertisement due to the contents of the hyperlinked website. In fact, when ordinary citizens deploy hyperlinks, they can only confirm the status of the website at the time of deployment and cannot guarantee any changes to the website after the deployment. Since this will practically impose an obligation like that of a webmaster on the general public, this is practically unfeasible.
Moreover, in light of the inherent constraint on a drug advertisement (e.g., Article 67 of the Pharmaceutical Affairs Law requires that the advertisement of a drug prescribed by medical doctors shall be placed in academic medical journals only), the medical device manufacturers almost cannot disclose the advantages or disadvantages in using the medical devices in places readily accessible to the consumers, and the consumers hereby are much unlikely to conduct any comparison to make a choice before their purchase. Instead, the consumers can only obtain relevant information from doctors or academic medical journals. Although the Grand Justices rendered Judicial Interpretation No. 414, which concluded that restrictions on the commercial speech in drug advertisements are constitutional, still the Grand Justices mentioned at the end of the interpretation reasons that “however, since advertisements seek to provide information and a free flow of commercial information is also significantly beneficial to society, the matters, scope and contents of drug advertisements which require prior approval should be reviewed and revised from time to time under the principle of proportionality by the competent authority based on regulatory needs.” Therefore, the matters, contents and scope of a drug advertisement which require prior approval by the competent authority should also meet the principle of proportionality.
Finally, to prevent the public from making wrong choices based on misinformation in the interest of public health, if the purpose is to prevent the consumers from receiving wrong information, legislators or the competent authority may try imposing the requirement that a warning concerning the use of the medical devices or the manner for consulting medical institutions (e.g., “Since this medical device is a Level 2 medical device which requires a doctor’s prescription, please contact medical institutions or relevant specialty doctors for relevant information concerning this medical device”) should be specified in a conspicuous place in the advertisement so as to strike a balance between the consumers’ information right and the protection of national health. The popularization of the Internet and massive information flows have contributed to more consumer needs for information and better ability to interpret information and to more cross-comparison channels to ascertain the accuracy of information. Instead of dealing with rampant erroneous rumors on the Internet, perhaps it is more advisable to ease restrictions on drug advertising so that pharmaceutical companies with the best knowledge of the medical devices can stand out and explain the characteristics and usage methods of their products, supplemented by professional comments on the use of such products and assessment on the conditions of patients by professional doctors so that the consumers can obtain more information before purchasing the products. Perhaps this approach can better facilitate the consumers to obtain the information that enables their best decisions as compared with the current across-the-board prohibition or prior approval of the information a medical device maker seeks to convey to its consumers regarding its medical devices under current laws.