This country-specific Q&A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Taiwan.
What laws are used to regulate advertising on medicines in your jurisdiction?
The Pharmaceutical Affairs Act (the “PAA”) is the primary law regulating advertising on medicines. The Pharmaceutical Affairs Act Enforcement Rules (the “PAAER”) further provide the relevant detailed matters for the PAA. With respect to the online advertisements, the competent authority, i.e., the Taiwan Food and Drug Administration (the “TFDA”), promulgated the Guidelines on Online Drug Advertisements.
On the other hand, the Consumer Protection Act and the Fair Trade Act govern the advertisements of common merchandise, which covers medicines. Further, the Taiwan Fair Trade Commission (the “TFTC”) promulgated two Disposal Directions on advertising:
Disposal Directions (Policy Statements) on the Use of Endorsements and Testimonials in Advertising; and
Disposal Directions (Guidelines) on Comparative Advertising.
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?
a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?
1) The IRPMA Code of Practice
The IRPMA Code of Practice, an ethical standard for pharmaceutical marketing promulgated by the International Research-Based Pharmaceutical Manufacturers Association (the “IRPMA”), applies to the conduct of members and their agents. The other third parties may determine on their own whether to adopt the Code. Specifically, the IRPMA is a non-profit and non-governmental organization, comprising multinational research-based pharmaceutical companies. Based on the 2012 IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) Code of Practice, IRPMA established its Code of Practice to ensure the ethical marketing between its members/agents and relevant stakeholders, e.g., healthcare professionals, medical institutions and patient organizations.
Among others, the IRPMA Code of Practice indicates various marketing and advertising-related guiding principles, such as:
accurate, balanced and scientifically valid data on products should be provided;
promotion must be ethical, accurate, balanced and must not be misleading; and
privacy and personal information of patients should be respected.
2) The Pharmacy Code of Ethics
The Pharmacy Code of Ethics applies to the conduct of pharmacists. Among others, Article 33 of the Code provides that pharmacists shall not endorse a product without scientifically proven data or approved efficacy. Article 43 of the same Code provides that pharmacists shall not use exaggerated advertisements or improper means for soliciting patients or the public, or promoting sales of medicines.
b) What is the legal status of the self-regulatory codes?
Violation of the IRPMA Code of Practice may be subject to certain disciplines within the organization, but is not naturally illegal.
Nevertheless, if violating the Pharmacy Code of Ethics, in accordance with Article 21.6 of the Pharmacists Act, the pharmacists shall be submitted to disciplines by pharmacists’ association or competent authority.
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?
a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?
In accordance with Articles 4 and 24 of the PAA, there are three requirements for advertising of medicines:
act of advertising the medical efficacy;
by means of communications means; and
aiming to solicit and promote the sale thereof.
The PAA treats the advertising in a broad manner. In accordance with Article 70 of the PAA, any interviews, news reports or propaganda containing information implying or suggesting medical efficacy shall be regarded as advertising of medicines.
According to the TFDA, an advertisement of medicines should provide the drug name and efficacy, by which consumers may be able to consider to purchase the drug; further, a promotional activity aiming at facilitating public health and education should not be treated as an advertisement of medicines if it does not meet all requirements under Article 24 of the PAA. In reference of this explanation, if the patient information leaflets lack any of the above three requirements, it may not be treated as an advertisement of medicines under the PAA.
b) Does the definition apply equally to all target audiences?
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
The same standards mentioned previously also apply to press releases. If the press releases do not involve medical efficacy, such is not advertising on medicines, and no restrictions shall apply. If, however, the press releases contain information implying or suggesting medical efficacy, it would be regarded as an advertisement of medicines (see Article 70 of the PAA). In addition, in accordance with Article 68 of the PAA, advertising of medicines shall not be made by means of releasing a news report.
It can be determined on a case-by-case basis on whether a press release pertains to an advertisement of medicines. For instance, if a pharmaceutical company issues a press release stating that it obtained a drug license permit for treating cancer, it would be arguable whether such shall be treated as an advertisement of medicines, and the competent authorities in central government, i.e., TFDA, and in local governments, i.e., the municipal regulatory bodies, may hold different viewpoints on this issue.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
The PAA and the relevant laws do not require companies to set internal regulations on the approval of advertising of medicines.
However, under Article 12 of the IRPMA Code of Practice, IRPMA members/agents should establish and maintain appropriate procedures to ensure compliance with applicable codes and laws, to monitor all marketing activities, and provide the staff with appropriate education.
Do companies have to have material approved by regulatory bodies prior to release?
Yes. In accordance with Articles 65 to 66-1 of the PAA, only pharmaceutical company is allowed to make advertisements of medicines. Before publishing or broadcasting the advertisements, pharmaceutical company shall submit all texts, drawings or pictures constituting an advertisement to the TFDA or municipal regulatory bodies for approval, and shall forward the approval to mass media enterprises for verification. If the competent authority who issued the approval discovers the content of the advertisement of medicines or the way it displays may be harmful or likely be endangering to the health of the public, it shall order to stop the publishing or broadcasting immediately and request to right the wrong within a given time; failure to comply may be subject to revoking the approval.
The term of validity for advertising of medicines approved by a competent authority shall be 1 year, which is renewable.
Specifically, in accordance with Article 44 of the PAAER, a pharmaceutical company applying for approval of advertising of medicines shall fill out an application, and submit it to the competent authority along with photocopies of the drug permit license, the approved labeling, package insert, packaging, the content of the advertisement, and an examination fee.
In accordance with Article 68 of the PAA, an advertisement on medicines shall not be made in an improper manner (e.g., making use of the name of other person(s), warranting the efficacy or functions by making use of the materials or information contained in a book or publications, releasing an interview or news report, etc.). In accordance with Article 45 of the PAAER, texts and images used in the advertisement shall be limited to the name of the drug, its dosage form, prescription content, usage quantity, usage method, efficacy, guidelines, and packaging, and the name and address of the manufacturer, as approved by the TFDA.
Further, in accordance with Article 47 of the PAAER, the advertising content shall not involve either of the following situations:
efficacy related to sexual intercourse;
the use of methods likely to encourage drug abuse;
any representation that use of a drug will cure a particular disease or will improve health in a particular area, or the creation of false or misleading scenarios; or
exaggeration of efficacy or safety.
In accordance with Article 46 of the PAAER, the name of the pharmaceutical company, the number of its drug permit license, and the advertisement approval document shall be published simultaneously together with any drug advertisement.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
According to the TFDA, if an advertisement involves comparative advertising, the pharmaceutical company shall submit relevant supporting documents for its review. In practice, the competent authority will check whether the same comparing standard is applied for the products being compared. Also, when an advertisement involves the comparison with competitor’s product, it may be more difficult to get an approval from the authorities.
As the common merchandise, the advertising of medicines shall follow the TFTC Disposal Directions (Guidelines) on Comparative Advertising. Specifically, if an advertisement involves the comparison with competitor’s product, such should describe the truthfulness based on the fair and objective comparison. In the event that an advertisement addresses a false or misleading representation, or untruthful statements, it may violate the Fair Trade Act (the “FTA”).
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?
In accordance with Article 69 of the PAA, information on unauthorised medicines or unauthorised indications shall not be advertised. Even if such information is provided to the healthcare professionals during a scientific conference, it is still likely that such information may be treated as illegal advertisements if it can somehow lead a consumer to identify and purchase the medicines.
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.
Basically, the same procedural rules apply to advertising to the general public for prescription only medicines and over the counter medicines. Please see Question 6 for details.
Nevertheless, comparing to over the counter medicines, the media on which prescription only medicines can be advertised are more limited. In accordance with Article 67 of the PAA, prescription only medicines can only be advertised through academic medical journals.
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 such restrictions under the PAA or the relevant regulations. Nevertheless, IRPMA Code of Practice set some restrictions as follows:
To ensure ethical interactions with patient organizations, member companies must clearly declare its involvement from the outset. Any member company shall not request to be the sole funder of a patient organization or its plans. Member companies that provide financial support must have in place written documentation setting out the details of the support. Member companies may provide financial support for patient organization to hold professional, educational, and scientific meetings. The meeting venue and location shall be appropriate and conducive to informational communication. Any meals or refreshments must be modest as judged by local standards.
The interactions with industry shall be intended to benefit patients and to enhance the practice of medicine, be focused on informing of pharmaceutical product, scientific and educational information, and support medical research and education. Material relating to medicines should clearly indicate by whom it has been sponsored.
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 standards for advertising are the same regardless of the target audience. As such, please refer to the answers in Questions 6 & 9.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
In accordance with Article 23.1 of the FTA, “No enterprise shall compete for trading opportunities by means of improper offerings of gifts or prizes.” Article 4 of the Regulations Governing the Amount of Gifts and Prizes Offered by Businesses set the caps for gifts:
For products or services priced over NT$ 100, the cap value of the gift shall be 1/2 of the selling price of the product; and
For products or services priced less than NT$ 100, the cap value of the gift shall be NT$ 50.
Nevertheless, Article 3.1 of the same Regulations provides that a promotional act which does not require trading as part of the conditions would not be consider as a gift.
Article 3 of the Guidelines on Interaction between Physicians and Pharmaceutical Companies (the “Physicians Interaction Guidelines”) provides that a gift by pharmaceutical companies shall meet the following requirements:
The gift received by a physician shall be inexpensive and in line with the local customs.
It is prohibitive that a physician receives money, or gift voucher equivalent to cash or securities.
A physician is not allowed to agree or imply to use a certain drug or transfer a patient to a certain hospital as a consideration for the gift.
Article 35 of the Pharmacy Code of Ethics asks that pharmacists shall not accept any gifts, from patients or their families, which may affect integrity.
In accordance with Article 7.5 of the IRPMA Code of Practice, payments in cash, cash equivalents (such as gift certificate) or personal service must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals must not be provided or offered. Also, promotional aids should not be provided to healthcare professionals.
Moreover, unless meeting the requirements under the Ethics Guidelines for Civil Servants, any gifts to healthcare professionals who are public servants may trigger the offences under the Anti-Corruption Act. Specifically, under Articles 2.3 and 4 of the aforesaid Ethics Guidelines, the public servants shall not receive the gratuities exceeding the amount of NT$ 500, or, if given collectively by more than one party, exceeding NT$ 1,000. The public servants, in the event of wedding engagements or alike, are also prohibited from receiving the amount exceeding NT$ 3,000, or NT$ 10,000 per year from the same source, in the course of non-official dealings.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
The medicament offered as a sample or as a gift is regulated differently under the PAA. Specifically, there are two separated filings with the TFDA for offering samples and gifts of medicament to healthcare professionals.
In accordance with Article 3 of the Regulations on Management of Medicament Samples and Gifts, pharmaceutical companies may file an application for an approved medicament to be a gift for health or medical institutions, hospitals or clinics, or aid agencies for charity purposes.
In accordance with Article 2 of the aforesaid Regulations, an application may be made to have a medicament be declared a sample, based on one of the following purposes.
For drug registration or for improvement of manufacturing technology.
Solely for research or trial purposes.
For purposes of diagnosis and treatment of patients with critical or catastrophic illness.
For personal uses, certified by a medical institution.
For educational promotion of an approved medicament.
For purposes of public safety or public health or due to major disasters.
Under Article 8.1 of the IRPMA Code of Practice, if permitted by the local laws and regulations, free samples of a pharmaceutical product may be supplied to healthcare professionals authorized to prescribe that product in order to enhance patient care. Samples should be marked as such so that they cannot be resold or otherwise misused.
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 PAA and the relevant regulations are silent on these issues. Nevertheless, the Physicians Interaction Guidelines and IRPMA Code of Practice set some restrictions as follows.
In accordance with Article 2 of the Physicians Interaction Guidelines, with respect to a meeting/congress for physicians, the time for academic-related content shall account for at least 2/3 of the total time of the meeting/congress. A pharmaceutical company’s payment made to a physician is limited to the following list: the registration fee for the meeting/congress, and expenses for travel, accommodation, and meals. If a physician is invited to be a lecturer or a host, reasonable lecture or host fee is allowable. An organizer of a meeting/congress shall actively disclose the name of sponsor and inform the attendees of the relationships between the organizer, lecturer, host, and sponsor. An article published by a physician in a meeting/congress shall be in line with the empirical principle in science, which shall not be affected by a sponsor, and shall illustrate an alternative treatment in balance. An organizer or a physician shall reject that a pharmaceutical company improperly intervenes the content, the way of publishing, and an appointment of a lecturer in a meeting/congress.
In accordance with Article 7.1 of the IRPMA Code of Practice, the purpose of meeting/congress for healthcare professionals organized or sponsored by a pharmaceutical company should be to provide scientific or educational information and/or to inform healthcare professionals about products. All meetings/congresses should be held in an appropriate manner, and extravagant or venues renowned for their leisure offerings or entertainment facilities should be avoided. Refreshments and/or meals should be moderate and be exclusively provided to participants. As a general rule, the hospitality provided should not exceed what healthcare professional recipients would normally be prepared to pay for themselves.
Physicians Interaction Guidelines do not provide further restrictions on meetings/congresses taking place abroad, but under Article 7.1.2 of the IRPMA Code of Practice, no member company may organize or sponsor such meetings/congresses unless there is a justifiable reason.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
The cultural, sports or other non-scientific events in relation to scientific conferences is permissible merely if the requirements under Article 2 of the Physicians Interaction Guidelines are met. Also, in accordance with Article 7.1 of the IRPMA Code of Practice, the purpose of those events is not allowed to affect the purpose of the conferences, which should be to provide scientific or educational information and/or to inform healthcare professionals about products. Please refer to the answers in Question 14.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
The PAA and the relevant regulations are silent on these issues. Nevertheless, the Physicians Interaction Guidelines and IRPMA Code of Practice set some restrictions as follows.
With respect to physicians, Article 4 of the Physicians Interaction Guidelines states that if a physician performs a test sponsored by a pharmaceutical company, the direct or indirect sponsor shall be disclosed as the result is published. The compensation, based on the time and efforts devoted to the test, is allowable, but a sponsor shall not restrict publishing any content of the results. Article 5 of the same Guidelines states that if a physician is engaged to provide consulting service to a pharmaceutical company, his professional judgment shall not be affected, his duties on a patient shall not be loosened. Also, the relationship with the pharmaceutical company shall be disclosed when delivering a lecture or publishing an article or a report.
In accordance with Article 7.4 of the IRPMA Code of Practice, it is allowed to pay healthcare professionals fair compensation when they are engaged as consultants and advisors. Specifically, a written agreement containing nature of services and the basis for payment must be executed in advance of the commencement of the services. A legitimate need for the services must be documented. The healthcare professionals must have the expertise to provide the services. The number of the healthcare professionals engaged shall be reasonable. Any professional judgments of the professionals on medicine shall not be affected. The cap of the compensation is set in Article 3 of the Benchmarks of Code of Practice.
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?
The details on grants or donations can be found in answers to Question 12.
While monetary grants or donations to physicians, pharmacists, or healthcare professionals are not allowed under applicable guidelines or codes, such can be granted or donated to healthcare institutions. Also, under Article 7 of the Benchmarks of Code of Practice, the donations shall not affect their purchasing, prescribing and pricing of medicines.
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?
No regulations in this regard.
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?
As stated in answers to Question 6, the advertisements of medicine shall be approved before publishing or broadcasting.
According to the Guidelines on Online Drug, the holder of a drug permit license is allowed to publish product information on its own website, without prior application. However, the published information shall be identical to what specified on the package insert. The website shall also disclose the appearance of the package and the drug product.
If a third-party website intends to publish advertisement of medicine, the advertisement shall be approved by the competent authorities in advance. Nevertheless, when the advertisement involves prescription only medicines, an access restriction on the website is required to ensure only professionals may review the content thereon.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
If the healthcare professionals (HCP) or healthcare organizations involve public servant, anti-bribery rules may be applicable. Specifically, malfeasance in office is a crime under Article 122 of the Criminal Code. Further, the Anti-Corruption Act and the Civil Servant Service Act prohibit public servants from taking an unlawful bribe/gift.
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
As stated in answers to Questions 12, 14 to 17, and 20, the appliable rules include the Anti-Corruption Act, Civil Servant Service Act, Physician Interaction Guidelines, Pharmacy Code of Ethic, and IRPMA Code of Practice.
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 TFDA, municipal regulatory bodies, and TFTC are responsible for the violations of the PAA and FTA. Also, the court can grant reliefs for advertising infringements in violation of the FTA.
The criminal prosecutors are responsible for investigating the offense of anti-bribery rules. The prosecutors may indict the offenders and ask the district courts to impose penalties on the offenders.
Violations of Physician Interaction Guidelines or Pharmacy Code of Ethic will be subject to disciplines by Committee on the Discipline of Physicians, pharmacists’ association or competent authority.
Violations of IRPMA Code of Practice may be subject to certain disciplines within the organization.
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
The most direct way will be initiation of a civil proceeding with the court against competitors by arguing the violation of the FTA, especially on false advertising or defamation. The plaintiff may ask for damages and injunction. Also, it is possible to file a complaint with the TFTC for it to render an administrative penalty in accordance with the FTA.
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 administrative penalties imposed by regulatory bodies, e., TFDA, municipal regulatory bodies, and TFTC, include the administrative fine ranging from NT$ 50,000 to NT$ 25,000,000. The TFTC may also ask certain corrective actions.
The criminal penalties imposed by the court can be significant, which may be a fine capped at NT$ 4 million and a life imprisonment or below.
During a civil proceeding, the court may grant relief of damages and injunction. The damages can be calculated based on the monetary gain received by the infringing person. Further, the punitive damages up to three times of the proven damaged amount can be awarded if the violation is intentional.
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?
Separate procedures and measures can be conducted in parallel.
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.
There has been no significant enforcement action in the past two years.
Based on our observation, most of the recent cases in relation to pharmaceutical advertising fall into either of the following three categories:
advertising the medical efficacy for non-medicine goods;
failure to have the advertisements of medicines approved by the competent authorities in advance; and
a non-pharmaceutical company providing advertisements of medicines.