Pharmaceutical Advertising 2020

Last Updated March 02, 2020

Taiwan

Law and Practice

Authors



Deep & Far Attorneys-at-Law provides consultation services for pharmaceutical and other biotechnology affairs in Taiwan. In addition, the firm helps clients to apply for registration and market approval of medicaments and cosmetics (ie, medicament and cosmetics permit licences) with the TFDA, apply for medicament advertisement approval, and apply for pharmaceutical and other biotechnology patents in Taiwan. The firm's team of more than 40 experts acts on behalf of clients in the above-mentioned matters that arise before the competent authorities in Taiwan. The firm also represents clients in proceedings of civil litigation, administrative complaint, appeal or litigation and criminal complaint or criminal litigation, eg, proceedings before the Intellectual Property Court, the Fair Trade Commission, the district prosecutors offices and the common and administrative courts. Private investigation, amicable settlement and mediation are also within the firm's expertise.

Advertising on medicines is regulated by the Pharmaceutical Affairs Act (藥事法), Medical Care Act (醫療法), Consumer Protection Act (消費者保護法), Fair Trade Act (公平交易法), Pharmaceutical Affairs Act Enforcement Rules (藥事法施行細則), Enforcement Rules of Medical Care Act (醫療法施行細則), Enforcement Rules of Consumer Protection Act (消費者保護法施行細則) and the Enforcement Rules of Fair Trade Act (公平交易法施行細則) in Taiwan. The main law that regulates advertising on medicines is Pharmaceutical Affairs Act.

The self-regulatory organisation in the pharmaceutical industry in Taiwan, the International Research-Based Pharmaceutical Manufacturers Association (IPRMA).

The IRPMA is a non-profit, non-governmental organisation comprising European, American, Japanese, and Taiwanese research-based pharmaceutical companies. Member companies and distributors, commissioned agents or representatives act on behalf of any IRPMA member company and are committed to the ethical standards set out in this Code (see http://www.irpma.org.tw/EN/marketing).

The self-regulation sets the highest standards for the ethical promotion of medicines, in accordance with Taiwanese regulations and internationally defined standards of good practice. As part of its commitment to health, the industry has an obligation and responsibility to provide accurate information about its products to healthcare providers, in order to establish a clear understanding of the appropriate uses of each prescription medicine. According to the self-regulatory codes, all marketing practices must be consistent with high ethical standards and information should be designed to help healthcare providers to improve the services provided to patients. Information provided must be objective, truthful and in good taste (see http://www.irpma.org.tw/EN/marketing).

The term “medicament advertisement” as used in the Pharmaceutical Affairs Act shall refer to the act of advertising the medical efficacy of a medicament by means of communication aiming to solicit and promote the sale thereof (Article 24 of Pharmaceutical Affairs Act). “Advertisement”, as referred to in Articles 22 to 23 of the Consumer Protection Act, shall mean the conduct to disseminate to the general public the content of promotion by means of television, broadcasting, films, slides, newspapers, magazines, flyers, posters, signboards, arches, computers, facsimiles, electronic video, electronic voice or others” (Article 23 of Enforcement Rules of Consumer Protection Act).

In Taiwan, the medicament advertisements includes not only common TV advertisements, newspaper advertisements, radio advertisements, leaflets, posters, but also promotion, samples, sponsorship, embedded advertising and so on. In addition, interviews, news reports or propaganda containing information implying or suggesting medical efficacy shall be regarded as medicament advertisements.

Information and advertising are distinguished by the above-mentioned definition of “advertising”. Campaigns for the purposes of health promotion or disease prevention which has been determined to be able to achieve the function of health education do not belong to medicament advertisement, but to avoid misleading consumers, their content shall not involve specific names of the medicaments and shall be clearly separated from the relevant content of the medicament advertisement. As for the determination of the "clear separation", it should be determined whether the following requirements are met simultaneously with respect to the effects shown in the specific case:

  • the print advertisements of medicaments and health education shall not be published on the same page or consecutive pages;
  • the dynamic advertisements of medicaments and health education shall be separated by broadcasting other advertisements between them and shall not be broadcast consecutively so as to cause consumers to mistake the two advertisements for the same one;
  • the advertisements of medicaments and health education may not be broadcast consecutively or contain performance or endorsement of the same person so as to cause consumers to mistake the two advertisements for the same one; and
  • no other means of publication shall be adopted so as to cause consumers to mistake the advertisement of medicaments and health education are the same one (see 衛署藥字第0950333455號).

In recent years, with the diversification of advertising and marketing strategies, the cross-media advertising modes are increasing gradually. In order to protect the rights and interests of consumers, if the advertisements of the same medicament are published on different media in a complementary way and their overall effect conforms to the definition of Article 24 of Pharmaceutical Affairs Act, all the advertisements should still constitute a medicament advertisement and be regulated. For example, if a TV advertisement does not advertise the name and efficacy of a medicament, but the advertiser provides the consulting hotline or health education manuals and advertises the name and efficacy of the medicament via the consulting hotline or health education manuals, the TV advertisement shall still constitute a medicament advertisement and be regulated (see 衛署藥字第0950333455號).

Based on the above, disease awareness campaigns and other patient-facing information (eg, patient leaflets, patient support programmes) do not qualify as advertising. However, to avoid misleading consumers, the content of disease awareness campaigns and other patient-facing information shall not involve specific names of the medicaments and shall be clearly separated from the relevant content of the medicament advertisement.

No difference applies depending on the target audience.

Press releases regarding medicines are allowed in Taiwan, subject to restrictions on medicament advertisements.

According to Article 68(iii) of the Pharmaceutical Affairs Act, medicament advertisements shall not be made to publicise the medicament by means of releasing an interview or news report. In addition, according to Article 70 of the Pharmaceutical Affairs Act, interviews, news reports or propaganda containing information implying or suggesting medical efficacy shall be regarded as medicament advertisements.

If the content of the press release is related to the promotion of specific medicament products, medical efficacy and the name of the manufacturer so as to attract consumers to buy the medicament, the press release is still a medicament advertisement. Therefore, a press release is not an advertisement for a medicament if it does not advertise a specific medicament product. If the message in the press release is sufficient to link to a specific drug and promote consumer use, the press release is still considered to be an advertisement for a drug (see 部授食字第1030036910號).

In addition, no difference applies depends on the target audience.

Comparative advertising for medicines is allowed in Taiwan.

The restrictions on comparative advertising for medicines are as follows:

  • In comparative advertising, an enterprise should ensure that the contents of its advertising conform to the statements and representations regarding its own and other enterprises' merchandise (Article 3 of Fair Trade Commission Disposal Directions (Guidelines) on Comparative Advertising).
  • An enterprise should approach comparative advertising on the basis of fair, objective, and similar comparative benchmarks (Article 4 of Fair Trade Commission Disposal Directions (Guidelines) on Comparative Advertising).
  • Regardless of whether explicit reference is made to a comparable enterprise in comparative advertising, an enterprise may not act in any of the following conducts in comparing its merchandise with other enterprises’ (Article 5 of Fair Trade Commission Disposal Directions (Guidelines) on Comparative Advertising):
    1. false or misleading representations or symbols about its or other enterprises' merchandise;
    2. comparison of merchandise of different vintage or level;
    3. application of different benchmarks or conditions to similar merchandise;
    4. citing information sources that are not objective, lack a recognised comparative basis, or use inappropriate simplifications or interpretations of cited information;
    5. sceptical, speculative, subjective description for comparison of items without proof or empirical evidence;
    6. use of a partial advantage to claim total superiority, or unilaterally highlighting one's own advantage in a comparison while intentionally ignoring the advantages of another enterprise, resulting in an overall impression based on unfair comparison;
    7. making a representation of the effect for the product in comparison without any scientific theory or experimental basis; and
    8. false or misleading representation regarding important relevant trading facts.
  • An enterprise shall not make or disseminate untruthful statements in comparative advertising for competitive purposes that result in damage to the reputation of another enterprise, whether explicitly named or implied (Article 6 of Fair Trade Commission Disposal Directions (Guidelines) on Comparative Advertising).

Article 66(1) to (3) of Pharmaceutical Affairs Act provides, “(1) For publishing or broadcasting medicament advertisement, pharmaceutical firms shall, before publishing or broadcasting, submit all texts, drawings or pictures constituting an advertisement to the central or municipal competent health authority for approval, and shall forward the approval to mass media enterprises for verification. If the competent health authority who issues the approval discovers the content of the medicament advertisement or the way it displays may be harmful or be possibly endangering to the health of the public, it shall issue an order for immediate stop of the display and for remedy to the situation within the given time; failure to comply may be subject to revoking the approval. (2) No modifications or alterations to the approved contents are allowed during the term being permitted to publish or to broadcast. (3) No mass media enterprise shall publish or broadcast any medicament advertisement which has not been approved, has been different from the approved particular, has been withdrawn, or has not yet made amendments in time as ordered by the central or municipal competent health authority”.

Article 44 of Pharmaceutical Affairs Act Enforcement Rules provides: “No publication or dissemination of an advertisement for a drug may take place until a pharmaceutical firm with a drug permit license has filled out an application form and submitted it to the central competent health authority or the competent health authority of the special municipality or county (or county-level city) along with photocopies of the drug permit license and the approved labelling, usage instructions, and packaging, the content of the advertisement, and a review fee, and the given health authority has reviewed and approved the above matters”.

Article 45(1) of Pharmaceutical Affairs Act Enforcement Rules provides: “Texts and images used in a medicament advertisement shall be limited to the name of the medicament, its dosage form, prescription content, usage quantity, usage method, efficacy, guidelines, and packaging, and the name and address of the manufacturer, as initially approved by the central competent health authority”.

Article 46 of Pharmaceutical Affairs Act Enforcement Rules provides: “The name of the firm and the number of its drug permit licence and the advertisement approval document shall be published simultaneously or disseminated together with any drug advertisement”.

According to the above provisions, in principle, it is impossible to provide information on unauthorised medicines or unauthorised indications.

Article 87(2) of Medical Care Act provides: “Publications of new medical knowledge or research results, health education for patients, or academic publications which do not involve solicitation for medical practices shall not be regarded as advertisements for medical care.” Likewise, it is allowed to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, and the information shall not be regarded as medicament advertisement.

The Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals (醫療機構及醫事人員發布醫學新知或研究報告倫理守則, see 衛署醫字第0900072518 號) provides for some principles of and restrictions on publication of information on unauthorised medicines or unauthorised indications.

In addition, Article 7.1.3 of IRPMA Code of Practice, the self-regulation issued by the IRPMA provides, “Promotional information which appears on exhibition stands or is distributed to participants at international scientific congresses and symposia may refer to pharmaceutical products which are not registered in the country where the Event takes place, or which are registered under different conditions, provided that the following conditions are observed: (1) host country regulations should permit such an arrangement; (2) the meeting should be a truly international, scientific Event with a significant proportion of the speakers and attendees from countries other than the country where the Event takes place; (3) promotional material (excluding promotional aids as described in Article 7.5.2) for a pharmaceutical product not registered in the country of the Event should be accompanied by a suitable statement indicating the countries in which the product is registered and make clear that such product is not available locally; (4) promotional material which refers to the prescribing information (indications, warnings, etc) authorised in a country or countries other than that in which the Event takes place but where the product is also registered, should be accompanied by an explanatory statement indicating that registration conditions differ internationally; and (5) an explanatory statement should identify the countries in which the product is registered and make it clear that it is not available locally”.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference (see 3.2 Provision of Information During a Scientific Conference), Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with for the provision of information on the same to healthcare professionals.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference, Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with for the provision of information on the same to healthcare institutions.

Article 78(1) and (2) of Medical Care Act provides: “(1) For the purpose of improving the level of medical care or prevention of disease in the country, teaching hospitals may conduct human research after formulating a plan and obtaining approval from the central competent authority, or upon entrustment of the central competent authority. Notwithstanding the foregoing, the approval of the central competent authority is not required for human research with aim of evaluating the bioavailability and bioequivalence of generic drugs. (2) Non-teaching hospitals may not conduct human research. However, the preceding paragraph may apply mutatis mutandis to medical care institutions with specific expertise and having obtained the approval of the central competent authority”.

Article 3semel(1) and (6) of Regulations on Human Trials provides: “(1) For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical devices, or medical technologies are available in Taiwan, a medical care institution may draft a subsidiary proposal for a human cell therapy trial that has been approved by the central competent authority and has accumulated a considerable amount of safety data, and may submit the same, together with a photocopy of the original human trial proposal approved, for review in accordance with Paragraph 3 of Article 78 of this Act (ie, Medical Care Act). After approval by the Review Board, the institution may apply to the central competent authority for approval of using the drugs, medical devices, or medical technologies involved on patients who meet the indications but fail to meet the eligibility criteria for original human trial subjects. (6) The disclosure, review, avoidance, inspection, disposition or termination, retention, reporting, publication or promotion of the trial subject consent forms and proposals, as well as the destruction or reutilization of the data thereof, shall be subject to the applicable provisions of this Act (ie, Medical Care Act) and these Regulations (ie, Regulations on Human Trials)”.

Article 15 of Regulations on Human Trials provides: “The medical care institution shall not publish or promote its results during the human trial period.”

According to the above provisions, it is permitted to publish the availability of compassionate use programmes or other forms of early access. However, only approved human trial proposals and approved subsidiary proposals for a human trial of human cell therapy may be published and promoted. In addition, human trial results may not be published and promoted during the human trial period.

Main restrictions that apply to advertising to the general public for over-the-counter medicines are as follows:

Article 66(1) to (3) of Pharmaceutical Affairs Act provides: “(1) For publishing or broadcasting medicament advertisement, pharmaceutical firms shall, before publishing or broadcasting, submit all texts, drawings or pictures constituting an advertisement to the central or municipal competent health authority for approval, and shall forward the approval to mass media enterprises for verification. If the competent health authority who issues the approval discovers the content of the medicament advertisement or the way it displays may be harmful or be possibly endangering to the health of the public, it shall issue an order for immediate stop of the display and for remedy to the situation within the given time; failure to comply may be subject to revoking the approval. (2) No modifications or alterations to the approved contents are allowed during the term being permitted to publish or to broadcast. (3) No mass media enterprise shall publish or broadcast any medicament advertisement which has not been approved, has been different from the approved particular, has been withdrawn, or has not yet made amendments in time as ordered by the central or municipal competent health authority”.

Article 66semel(1) of Pharmaceutical Affairs Act provides, “The term of validity for medicament advertisements approved by the central or municipal competent health authority shall be one year, which shall commence from the date of issuance of the approval document. A period of extension may be applied for and approved by the issuing competent health authority, as necessary. Each period of extension shall not exceed one year”.

Article 68 of Pharmaceutical Affairs Act provides, “Medicament advertisements shall not be made in any of the following manners: to publicise the medicament by making use of the name of other person(s), to warrant the efficacy or functions of the medicament by making use of the materials or information contained in a book or publications, to publicise the medicament by means of releasing an interview or news report or to publicise the medicament by any other improper means”.

Article 47 of Pharmaceutical Affairs Act Enforcement Rules provides: “When any of the following occurs in drug advertising content, that content shall be deleted or its approval shall be denied: Content involving efficacy related to sexual intercourse. The use of methods likely to encourage drug abuse, such as exchanges of drug containers for prizes or the provision of incentives. Any representation that use of a drug will cure a particular disease or will improve a person's health or constitution in a particular area, or the creation of false or misleading scenarios as a means of publicising the drug. Exaggeration of a drug's efficacy or safety”.

Main restrictions that apply to advertising to the general public for prescription-only medicines are as follows:

  • Article 66(1) to (3) of Pharmaceutical Affairs Act.
  • Article 66semel(1) of Pharmaceutical Affairs Act provides.
  • Article 68 of Pharmaceutical Affairs Act.
  • Article 47 of Pharmaceutical Affairs Act Enforcement Rules.
  • Article 67 of Pharmaceutical Affairs Act provides that, “Where medicaments are required to have the prescriptions of physicians or to have been specifically designated by public notice(s) made by the central competent health authority, the advertisements thereof shall be published only in academic medical journals”.

In addition, there are different restrictions between the medicament advertisements on the internet for prescription-only medicines and for over-the-counter medicines. The former may be viewed by professionals only, while the latter can be viewed by the general public (see 7.1 Regulation of Advertising of Medicinal Products on the Internet).

Article 45 of Pharmaceutical Affairs Act Enforcement Rules provides: “Any text or image used in a medicine advertisement containing the name of the medicine, its dosage form, prescription content, usage quantity, usage method, efficacy, guidelines, and packaging, and the name and address of the manufacturer, shall be approved by the central competent health authority. The efficacy stated in the text of an advertisement for Chinese medicine materials shall be limited to the efficacy stated in the Compendium of Materia Medica".

Article 46 of Pharmaceutical Affairs Act Enforcement Rules provides: “The name of the firm and the number of its drug permit licence and the advertisement approval document shall be published simultaneously or disseminated together with any drug advertisement".

Article 47 of Pharmaceutical Affairs Act Enforcement Rules provides: “When any of the following occurs in drug advertising content, that content shall be deleted or its approval shall be denied: Content involving efficacy related to sexual intercourse. The use of methods likely to encourage drug abuse, such as exchanges of drug containers for prizes or the provision of incentives. Any representation that use of a drug will cure a particular disease or will improve a person's health or constitution in a particular area, or the creation of false or misleading scenarios as a means of publicising the drug. Exaggeration of a drug's efficacy or safety”.

The price of the medicine can but must not be mentioned in the medicament advertisement because the indication of the price of the medicine does not involve advertising of the medical efficacy and thus is not regarded as a kind of medicament advertisement.

No special laws impose restrictions on interactions between patients or patient organisations and industry in Taiwan.

However, the IRPMA Code of Practice contains the following provisions (see http://www.irpma.org.tw/EN/marketing3):

Article 2 (Basis of Interactions):

  • Article 2.1 of IRPMA Code of Practice (Basis of Interactions) provides: “Member companies’ relationships with healthcare professionals and other stakeholders are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about pharmaceutical product, providing scientific and educational information and supporting medical research and education”.
  • Article 2.1 of IRPMA Code of Practice (Transparency of Promotion) provides: “Material relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company should clearly indicate by whom it has been sponsored. Promotion should not be disguised.

Article 7 (Interactions with Healthcare Professionals):

  • Article 7.1 of IRPMA Code of Practice (Events and Meetings).
  • Article 7.2 of IRPMA Code of Practice (Sponsorship).
  • Article 7.3 of IRPMA Code of Practice (Guests).
  • Article 7.4 of IRPMA Code of Practice (Fees for Services).
  • Article 7.5 of IRPMA Code of Practice (Gifts and Other Items).

Article 2 (Interactions with Patient Organizations):

  • Article 11.1 of IRPMA Code of Practice (Scope) provides: “The pharmaceutical industry has many common interests with patient organisations. All interactions with patient organisations must be ethical. The independence of patient organisations must be respected”.
  • Article 11.2 of IRPMA Code of Practice (Declaration of Involvement) provides: “When working with patient organisations, companies must ensure that the involvement of the company and the nature of that involvement is clear from the outset. No company may require that it be the sole funder of the patient organisation or any of its programs”.
  • Article 11.3 of IRPMA Code of Practice (Written Documentation) provides: “Companies that provide financial support or in-kind contribution to patient organisations must have in place written documentation setting out the nature of support, including the purpose of any activity and its funding”.
  • Article 11.4 of IRPMA Code of Practice (Events) provides: “Companies may provide financial support for patient organisation meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organisation. When companies hold meetings for patient organisations, companies must ensure that the venue and location is appropriate and conducive to informational communication. In addition, any meals or refreshments provided by a company must be modest as judged by local standards”.

No special laws specify what information advertising directed at healthcare professionals must contain and what information is prohibited. That is, Articles 45 to 47 of Pharmaceutical Affairs Act Enforcement Rules also apply to restrictions on information contained in advertising directed at healthcare professionals.

The price of the medicine can but must not be mentioned in the medicament advertisement because the indication of the price of the medicine does not involve advertising of the medical efficacy and, thus, is not regarded as a kind of medicament advertisement.

Advertising may refer to data on file or other clinical studies that are not included in the Summary of Product Characteristics.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference (see 3.2 Provision of Information During a Scientific Conference), Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with in case that advertising refers to data on file or other clinical studies that are not included in the Summary of Product Characteristics.

Advertising may refer to combination products or companion diagnostics that are not included in the Summary of Product Characteristics.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference (see 3.2 Provision of Information During a Scientific Conference), Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with in case that advertising refers to combination products or companion diagnostics that are not included in the Summary of Product Characteristics.

Companies may provide reprints of journal articles to healthcare professionals.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference (see 3.2 Provision of Information During a Scientific Conference), Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with in case that companies provide reprints of journal articles to healthcare professionals.

MSLs (Medical Service Liaisons) are viewed as a kind of occupation in Taiwan.

MSLs are (informally)permitted to proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals.

Like the provision of information on unauthorised medicines or unauthorised indications during a scientific conference (see 3.2 Provision of Information During a Scientific Conference), Article 87(2) of Medical Care Act, Code of Ethics for Publication of New Medical Knowledge or Research Report by Medical Institutions and Health Professionals and Article 7.1.3 of IRPMA Code of Practice shall be complied with in case that MSLs proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals.

Advertising for medicines is subject to prior authorisation from the regulator. Article 66(1) of Pharmaceutical Affairs Act provides: “For publishing or broadcasting medicament advertisement, pharmaceutical dealers shall, before publishing or broadcasting, submit all texts, drawings or pictures constituting an advertisement to the central or municipal competent health authority for approval, and shall forward the approval to mass media enterprises for verification. If the competent health authority who issues the approval discovers the content of the medicament advertisement or the way it displays may be harmful or be possibly endangering to the health of the public, it shall issue an order for immediate stop of the display and for remedy to the situation within the given time; failure to comply may be subject to revocation of the approval”.

Pharmaceutical dealers whose registered address is in the six municipalities (ie, Taipei City, New Taipei City, Taouyuan City, Taichung City, Tainan City and Kaohsiung City) shall obtain approval from the Department of Health of the local municipal government. Pharmaceutical dealers whose registered address is in any other county or city shall obtain approval from the Food and Drug Administration of the Ministry of Health and Welfare (衛生福利部食品藥物管理署, hereinafter referred to as TFDA).

Article 46 of Pharmaceutical Affairs Act Enforcement Rules provides: “The name of the dealer and the numbers of its drug permit license and the advertisement approval document shall be published or disseminated together with any drug advertisement”. No other specific arrangements companies must have in place for ensuring compliance with the rules on medicinal advertising are required.

There is no requirement to adopt SOPs or employ specific personnel. No qualifications and responsibilities shall be owned by the personnel.

Advertising of medicinal products on the internet is regulated by “Directions on Medicament Advertisement on the Internet (藥物網路廣告處理原則)”.

Directions on Medicament Advertisement on the Internet distinguish the following two types of websites. Websites of drug sellerswho hold a drug permit licence, where  drug sellers who hold a drug permit licence may publish product information on their websites. No approval shall be applied for.

There are also general websites; with respect to advertisement for non-prescription drugs, the advertiser shall apply for approval of the published or broadcasted content. After the content is placed on the website, the website may be viewed by the general public. With respect to advertisement for prescription drugs, the advertiser shall apply for approval of the published or broadcasted content and the control measures for the website. The website will be categorised as a medical website and may only be viewed by professionals. The control measures for the website shall contain software and hardware which are able to identify and record the certificate numbers of the health professionals, the names of the members and the information of the accessors.

Advertising for medicines is allowed on social media.

The following types of advertising on social media are distinguished:

  • advertising of drug sellers who hold a drug permit licence on social media; and
  • general advertising on social media.

Drug sellers who hold a drug permit licence may publish product information on their social media. No approval shall be applied for. However, there are some restrictions on the published product information as follows:

  • Western medicines and medical devices:
    1. drug sellers who hold a drug permit licence shall publish the complete product information as per the instruction of the medicament approved by the TFDA, and the picture of the package or physical appearance of the medicament shall be attached on the social media;
    2. the term “exclusively for export” shall be marked on the instructions for medicaments exclusively for export; and
    3. as for Class I medical devices, only the specification, the photo and the class, item, code and identifying content of the medical device may be published; and
  • Chinese medicines.

Only the name, dosage form, prescription content, usage quantity, usage method, efficacy and guidelines of the medicine, and the name and address of the manufacturer may be published. The physical photo which conforms to the approved label and instruction of the medicine may also be added to the advertisement.

With respect to advertisement for non-prescription drugs (general advertising), the advertiser shall apply for approval of the published or broadcasted content. After the content is placed on the social media, the social media may be viewed by the general public.  With respect to advertisement for prescription drugs, the advertiser shall apply for approval of the published or broadcasted content and the control measures for the social media. The social media will be categorised as a medical social media and may only be viewed by professionals. The control measures for the social media shall contain software and hardware which are able to identify and record the certificate numbers of the health professionals, the names of the members and the information of the accessors.

Companies are required to include access restrictions on websites containing advertisement for prescription drugs. That is, with respect to advertisement for prescription drugs, the advertiser shall apply for approval of the published or broadcasted content and the control measures for the website. The website will be categorised as a medical website and may only be viewed by professionals. The control measures for the website shall contain software and hardware which are able to identify and record the certificate numbers of the health professionals, the names of the members and the information of the accessors (see 7.2 Advertising of Medicines on Social Media).

Companies are allowed to provide disease awareness information to patients online because disease awareness information does not qualify as advertising (see 2.2 Difference Between Information and Advertising).

Disease awareness campaigns and other patient-facing information (eg, patient leaflets, patient support programmes) do not qualify as advertising. However, to avoid misleading consumers, the content of disease awareness campaigns and other patient-facing information shall not involve specific names of the medicaments and shall be clearly separated from the relevant content of the medicament advertisement (see 2.2 Difference Between Information and Advertising).

Article 24 of Pharmaceutical Affairs Act provides: “The term 'medicament advertisement' as used in this Act shall refer to the act of advertising the medical efficacy of a medicament by means of communication aiming to solicit and promote the sale thereof.”  If an interaction between a pharmaceutical company and a healthcare professional or a healthcare organisation constitutes a medicament advertisement as defined by Article 24 of Pharmaceutical Affairs Act, the relevant restrictions shall apply to the interaction.

Article 55 of Pharmaceutical Affairs Act provides: “Medicament Samples or gifts of which have been approved for manufacturing or import, shall not be sold. Regulations governing management of samples and gifts referred to in the preceding Paragraph shall be established by the central competent health authority”. Medicament samples or gifts are governed by Regulations on Management of Medicament Samples and Gifts.

Article 2 of Regulations on Management of Medicament Samples and Gifts provides: “For a medicament that meets one of the requirements of the following subparagraphs, an application may be made to have it declared a medicament sample:

  • The pharmaceutical firm is applying for registration or improvement of manufacturing technology purposes.
  • Due to business needs, the pharmaceutical firm, academic research or trial institute, contract research organisation, medical academic group or teaching hospital is applying for solely research or trial purposes.
  • A specialised teaching hospital or teaching hospital at or above the regional level is applying for purposes of diagnosis and treatment of patients with critical or catastrophic illness.
  • A patient applying for personal uses, certified by a medical institution. However, medical devices that should be operated by a physician or professional are excluded.
  • A medical device company applying for specific exhibitions or demonstration purposes.
  • A pharmaceutical firm applying for educational promotion purposes, given that the medicament has been issued a license in accordance with the stipulations of the Act.
  • An application for purposes of public safety or public health or due to major disasters”.

Article 3 of Regulations on Management of Medicament Samples and Gifts provides: “A medicament gift as referred to in these Regulations refers to a medicament that has been licensed in accordance with the stipulations of the Act, and for which an application has been made to the central health competent authority for the medicament to be a gift for health or medical institutions, hospitals or clinics, or relief agencies for charity purposes”.

According to the Introduction of IRPMA Code of Practice, “pharmaceutical companies’ interactions with stakeholders must at all times be ethical, appropriate and professional. Nothing should be offered or provided by a company in a manner or on conditions that would have an inappropriate influence”. In addition, “the IRPMA Code of Practice (the “IRPMA Code”) based on the IFPMA Code of Practice 2012 version includes standards for the ethical promotion of pharmaceutical products to healthcare professionals, and helps ensure that member companies’ interactions with healthcare professionals and other stakeholders, such as medical institutions and patient organisations, are appropriate and perceived as such”. Article 1.1 of IRPMA Code of Practice provides: “The IRPMA Code covers interactions with healthcare professionals, medical institutions and patient organisations, and the promotion of pharmaceutical products. Member companies should of course, comply with these local laws, regulations and/or codes” (see http://www.irpma.org.tw/EN/marketing3).

These general anti-bribery rules apply to both the benefits provided to individuals and organisations.

There are no differences between the public and private sectors.

Article 24 of Pharmaceutical Affairs Act provides: “The term “medicament advertisement” as used in this Act shall refer to the act of advertising the medical efficacy of a medicament by means of communication aiming to solicit and promote the sale thereof”.

Article 4(1) of Regulations on Management of Medicament Samples and Gifts provides: “To import or manufacture a medicament sample or gift as defined in Article 55, paragraph 1, shall fill out the application form; detail the product name, manufacturer name, place of origin, specification, package form and quantity; state the reason and purpose for application; and use and submit a photocopy of the applicant's qualification document and the materials prescribed in the stipulations of Articles 7 to 15 to the central health competent authority. However, the applications of importing laboratory consumables, which are used for collecting specimens in clinical trial, are eligible for the facilitated customs procedure, which the central health competent authority announced”.

Article 5) of Regulations on Management of Medicament Samples and Gifts provides: “For sample medicaments where the application is being made for purposes of use in major disasters, the stipulations of the preceding article are not applicable. The central health competent authority may approve the samples based on circumstances”.

Article 7 of IRPMA Code of Practice (Interactions with Healthcare Professionals) contains the following provisions:

  • Article 7.1 (Events and Meetings);
  • Article 7.2 (Sponsorship);
  • Article 7.3 (Guests);
  • Article 7.4 (Fees for Services); and
  • Article 7.5 (Gifts and Other Items).

Article 8 of IRPMA Code of Practice (Samples) contains the following provisions:

  • Article 8.1 (Samples); and
  • Article 8.1 (Control and Accountability).

Article 10(3) of IRPMA Code of Practice (Support for Continuing Medical Education) provides: “Companies must follow Article 7 of the IRPMA Code where applicable.”.

These prohibitions on inducements to prescribe apply to both the benefits provided to individuals and organisations.

Pharmaceutical companies may offer gifts to healthcare professionals in the following circumstances:

  • if the offering of the gifts constitutes a medicament advertisement, the relevant restrictions shall apply to the action (see Article 24 of Pharmaceutical Affairs Act);
  • to import or manufacture medicament gifts, an application for approval shall be filed with the TFDA (see Article 4(1) of Regulations on Management of Medicament Samples and Gifts); and
  • Article 7.5.1 (Prohibition of Cash & Personal Gifts) provides: “Payments in cash, cash equivalents (such as gift certificate) or personal service (any service unrelated to the HCP's profession and that confer a personal benefit to the HCP) must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronic items, etc) must not be provided or offered”.

Article 7.5.1 of IRPMA Code of Practice provides: “Payments in cash, cash equivalents (such as gift certificate) or personal service (any service unrelated to the HCP's profession and that confer a personal benefit to the HCP) must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronic items, etc) must not be provided or offered”.

The following limitations apply to pharmaceutical companies providing samples to healthcare professionals:

  • if the provision of the samples constitutes a medicament advertisement, the relevant restrictions shall apply to the action (see Article 24 of Pharmaceutical Affairs Act);
  • to import or manufacture medicament samples, an application for approval shall be filed with the TFDA (see Article 4(1) of Regulations on Management of Medicament Samples and Gifts); and
  • Article 8 of IRPMA Code of Practice (Samples) contains the following provisions:
    1. Article 8.1 (Samples): In accordance with local laws and regulations, free samples of a pharmaceutical product may be supplied to healthcare professionals authorised 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.
    2. Article 8.2 (Control and Accountability): Companies should have adequate systems of control and accountability for samples provided to healthcare professionals. Companies should not collect clinical data and should not make any payment to physicians.

Under the IRPMA Code of Practice, Pharmaceutical companies are allowed to sponsor scientific meetings or congresses and/or attendance by healthcare professionals at these events.

Please refer to Articles 7.1 (Events and Meetings) and 7.2 (Sponsorship) of IRPMA Code of Practice (see http://www.irpma.org.tw/EN/marketing3).

Please refer to Articles 7.1.2 (Events Involving Foreign Travel) and 7.1.3 (Promotional Information at Events) of IRPMA Code of Practice (see http://www.irpma.org.tw/EN/marketing3).

Article 7.1.6 of IRPMA Code of Practice (Entertainment) provides: “No entertainment or other leisure or social activities should be provided or paid for by member companies”. According to this provision, pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences.

Under the IRPMA Code of Practice, in principle, pharmaceutical companies may not provide grants or donations to healthcare professionals or healthcare institutions.

Article 7.5.1 of IRPMA Code of Practice (Prohibition of Cash & Personal Gifts) provides: “Payments in cash, cash equivalents (such as gift certificate) or personal service (any service unrelated to the HCP's profession and that confer a personal benefit to the HCP) must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronic items, etc) must not be provided or offered”.

Article 7.5.2 of IRPMA Code of Practice (Prohibition of Promotional Aids) provides: “Promotional aids (defined in benchmarks 6. (2)) should not be provided to healthcare professionals”.

Article 7.5.3 of IRPMA Code of Practice (Items of Medical Utility) provides: “In accordance with local laws and regulations, items of medical utility may be offered or provided if such items are of modest value, do not offset routine business practices and are beneficial to enhancing the provision of medical services and for patient care. A Medical Utility must not bear the name of product (both of branded and generic name) but may bear the company logo”.

Under the IRPMA Code of Practice, restrictions apply to pharmaceutical companies giving rebates or discounts to healthcare professionals or healthcare institutions.

Article 7.5.1 of IRPMA Code of Practice (Prohibition of Cash & Personal Gifts) provides: “Payments in cash, cash equivalents (such as gift certificate) or personal service (any service unrelated to the HCP's profession and that confer a personal benefit to the HCP) must not be offered to healthcare professionals. Gifts for the personal benefit of healthcare professionals (such as sporting or entertainment tickets, electronic items, etc) must not be provided or offered”.

Under the IRPMA Code of Practice, It is possible to pay for services provided by healthcare professionals.

Article 7.4 of IRPMA Code of Practice (Fees for Services) provides: “Healthcare professionals may be engaged as consultants and advisors for services such as speaking at and/or chairing meetings and events, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration. The arrangements which cover these genuine consultancies or other services must, to the extent relevant to the particular arrangement, fulfil all the following criteria:

  • a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services;
  • a legitimate need for the services must be clearly identified and documented in advance;
  • the criteria for selecting consultants must be directly related to the identified need and the consultants must have the expertise necessary to provide the service;
  • the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need;
  • the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, recommend, purchase, supply, and/or administer any medicine; and
  • the compensation for the services must be reasonable and reflect the fair market value of the services provided”.

Manufacture or import of medicament samples or gifts shall be approved by the TFDA. In addition, medicament samples or gifts whose manufacture or import have been approved shall not be sold.

Article 55 of Pharmaceutical Affairs Act provides: “Medicament Samples or gifts of which have been approved for manufacturing or import, shall not be sold. Regulations governing management of samples and gifts referred to in the preceding Paragraph shall be established by the central competent health authority”.

Article 4(1) of Regulations on Management of Medicament Samples and Gifts provides: “To import or manufacture a medicament sample or gift as defined in Article 55, paragraph 1, shall fill out the application form; detail the product name, manufacturer name, place of origin, specification, package form and quantity; state the reason and purpose for application; and use and submit a photocopy of the applicant's qualification document and the materials prescribed in the stipulations of Articles 7 to 15 to the central health competent authority. However, the applications of importing laboratory consumables, which are used for collecting specimens in clinical trial, are eligible for the facilitated customs procedure, which the central health competent authority announced”.

Pharmaceutical companies are not required to disclose details of transfers of value to healthcare professionals or healthcare institutions.

Foreign companies and companies that do not yet have products on the market are not required to disclose details of transfers of value to healthcare professionals or healthcare institutions.

The TFDA, the Consumer Protection Committee (消費者保護會) and the Fair Trade Commission (公平交易委員會) are responsible for enforcing the laws and regulations on advertising and inducement.

The Ministry of Health and Welfare is responsible for the administrative appeals against the administrative actions rendered by the TFDA.  The Executive Yuan (行政院) is responsible for the administrative appeals against the administrative actions rendered by the Consumer Protection Committee and the Fair Trade Commission.

The administrative courts are responsible for the administrative litigation against the administrative appeal decision rendered by the Ministry of Health and Welfare or the Executive Yuan. The judicial police and the prosecutors offices are responsible for the investigation and prosecution with respect to the offenses governed by the laws and regulations on advertising and inducement.

The common courts are responsible for the examination of the prosecution by the prosecutors. The IRPMA is responsible for enforcing the IRPMA Code of Practice.

Article 21 of Fair Trade Act provides: “No enterprise shall make or use false or misleading representations or symbols on the matter that is relevant to goods and is sufficient to affect trading decisions on goods or in advertisements, or in any other way make it known to the public”.

Article 24 of Fair Trade Act provides: “No enterprise shall, for the purpose of competition, make or disseminate any false statement that is capable of damaging the business reputation of another”.

Article 7 of Fair Trade Commission Disposal Directions (Guidelines) on Comparative Advertising provides: “Any enterprise in violation of Point 5 may violate Article 21 of the Fair Trade Act. Any enterprise in violation of Point 6 may violate Article 24 of the Fair Trade Act”.

According to the above provisions, companies can initiate proceedings against competitors for advertising infringements in the following approaches:

  • filing a civil litigation with the Intellectual Property Court based on Articles 29 and 30 of Fair Trade Act;
  • filing a criminal complaint with the competent district prosecutors office based on Article 37 of Fair Trade Act; and
  • filing an administrative complaint with the Fair Trade Commission based on Article 42 of Fair Trade Act.

Article 91 of Pharmaceutical Affairs Act provides: “Any violator of any of the provisions of Article 65, or Article 80, paragraph 1, subparagraphs 1 through 4 shall be issued a fine of not less than TWD200,000 but not more than TWD5 million. Any violator of the provisions of Article 69 shall be issued a fine of not less than TWD600,000 but not more than TWD25 million, and the violating products shall be confiscated and destroyed”.

Article 96(1) of Pharmaceutical Affairs Act provides: “Any pharmaceutical firm which advertises a medicament in violation of the provisions set forth in Chapter VII hereof shall be punished in accordance with the applicable provisions of this Chapter, and the competent health authority shall announce in the newspaper the name of the person(s) responsible, the name of the medicament, and the act of violation. In the case of serious violation, the permit licence previously granted to the said medicament may be also revoked, and no application for use of the original name of the said medicament shall be made within a period of two years thereafter”.

The self-regulatory authority cannot carry out compulsory procedures and take compulsory measures, but courts can carry out compulsory procedures and take compulsory measures.

There are no recent enforcement trends in relation to pharmaceutical advertising in Taiwan. There has been no significant (publicly known) enforcement action in the past two years.

Deep & Far Attorneys-at-Law

13 Fl., 27 Sec. 3
Chung San N. Rd.
Taipei 104
Taiwan
ROC

+886 2 258 566 88 #8187

+886 2 259 899 00

lawtsai@deepnfar.com.tw www.deepnfar.com.tw
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Law and Practice

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Deep & Far Attorneys-at-Law provides consultation services for pharmaceutical and other biotechnology affairs in Taiwan. In addition, the firm helps clients to apply for registration and market approval of medicaments and cosmetics (ie, medicament and cosmetics permit licences) with the TFDA, apply for medicament advertisement approval, and apply for pharmaceutical and other biotechnology patents in Taiwan. The firm's team of more than 40 experts acts on behalf of clients in the above-mentioned matters that arise before the competent authorities in Taiwan. The firm also represents clients in proceedings of civil litigation, administrative complaint, appeal or litigation and criminal complaint or criminal litigation, eg, proceedings before the Intellectual Property Court, the Fair Trade Commission, the district prosecutors offices and the common and administrative courts. Private investigation, amicable settlement and mediation are also within the firm's expertise.

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