Pharmaceutical Advertising 2022

Last Updated February 02, 2022

Taiwan

Law and Practice

Authors



Formosa Transnational is a full-service law firm in Taipei established in 1974.  The firm provides legal assistance to high-profile clients from all over the world, including the USA, EU, UK, Japan, Korea, Singapore and China.  With an elite team of 90 attorneys, the firm’s practice includes all types of compliance checks, dispute resolution, fundraising, investments, mergers and acquisitions, employment, competition, franchising, data protection and privacy, and corporate social responsibility, among other fields of law. Its technology law department possesses a strong background in technology and extensive experience in IP laws with its IP attorneys and in-house engineers and scientists. The firm's professionals provide comprehensive services with respect to intellectual property matters such as IP management, prosecution and litigation for patents, trade marks, copyrights, domain names and trade secrets, and advise businesses engaged in all sectors of the pharmaceutical industry and many other industries.

In Taiwan, advertising of medicines is mainly regulated by the Pharmaceutical Affairs Act, the Enforcement Rules of Pharmaceutical Affairs Act, the Consumer Protection Act, the Fair Trade Act, and the Principles for Dealing with Online Pharmaceutical Advertising. In addition, advertising of medicines is also regulated by the IRPMA Code of Practice (the “Code”), a self-regulatory code published by International Research-Based Pharmaceutical Manufacturers Association (IRPMA), which establishes general principles regarding marketing and promotion of medicines.  

The IRPMA is a non-profit, non-governmental organisation comprising European, American, Japanese, and Taiwanese research-based pharmaceutical companies. The Code is drafted based on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice, and it establishes ethical standards for promoting pharmaceutical products to healthcare professionals. In addition to member companies of IRPMA, the distributors, commissioned agents or representatives acting on behalf of all IRPMA member companies should also comply with the Code. 

“Advertising” refers to disseminating promotional messages or content by communication means, including television and radio, films, slides, newspapers, magazines, flyers, posters, signboards, computers, facsimiles, electronic videos, electronic voicemails or other methods to unspecific persons or the general public. Under the Pharmaceutical Affairs Act (the “Act”), the term “pharmaceutical advertisement” refers to advertising the medical efficacy of medicaments to unspecific persons (general public) by communication means aiming to solicit and promote the sale thereof. Also, any interviews, news reports or propaganda containing any information implying or suggesting medical efficacy are regarded as pharmaceutical advertisements. If an information is sufficient to establish a link to a specific medicament and promote consumer use, such information will be considered as pharmaceutical advertising. Only pharmaceutical businesses are allowed to advertise pharmaceuticals. 

The relevant authority has clarified the difference between information and pharmaceutical advertising via administrative orders: if the information meets the following requirements, such information shall not be considered pharmaceutical advertising: 

  • the information is for the purposes of health promotion or disease prevention with a health education function;  
  • the information does not involve specific names of the medicaments; and  
  • the information has an obvious separation from the pharmaceutical advertising content.  

The aforementioned "obvious separation" should be determined with respect to the effects as shown on a case-by-case basis and with the following requirements also being met: 

  • the pharmaceutical advertisement and the information shall not be published on the same page or on consecutive pages; 
  • the pharmaceutical advertisement and the information shall not be broadcast consecutively (there shall be other advertisements broadcast between the pharmaceutical advertisement and the information) nor have the same person to perform or endorse them, which would mislead the consumers to think that the “two” advertisements are the same “one”; and
  • shall avoid any measures misleading the consumers to believe that the pharmaceutical advertisement and the information are the same. 

In addition, if the advertisements of the same medicament are shown on different media and their overall effect meets the definition of “pharmaceutical advertisement” as stated above, then these advertisements should comply with the related laws and regulations on pharmaceutical advertising. For example, if a TV advertisement does not contain the name and the efficacy of a medicament, but such information is provided via consulting a hotline or health education manuals, then the TV advertisement shall be still regulated by related laws and regulations on pharmaceutical advertising. 

Disease Awareness Campaigns and Other Patient-facing Information 

Based on the above, whether the disease awareness campaigns and other patient-facing information qualify as advertising depends on the circumstances. Generally speaking, no differences apply depending on the target audience. If the purpose of the campaign/information is health education (health promotion or disease prevention), the campaign/information does not involve specific medicaments, and there is obvious separation with no misleading information, then such campaign/information would not be considered “pharmaceutical advertising”. 

Press releases regarding medicines are permitted in Taiwan. Once the press release regarding medicines via media is deemed as “pharmaceutical advertising” as defined at 2.1 Definition of Advertising, it shall subject to restrictions on pharmaceutical advertising. The details of restrictions on pharmaceutical advertising are illustrated at 4.2 Information Contained in Pharmaceutical Advertising to the General Public and 6.1 Requirements for Prior Notification/Authorisation

As to the issue of the target audience, pharmaceutical advertising of prescription medicines is only allowed in medical academic journals. For details on advertising prescription medicines, please see 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public

Comparative advertising for medicines is allowed in Taiwan if it is inspected by the relevant authority in advance. Additionally, such advertising must comply with the Principles of Comparative Advertising as set forth by the Fair Trade Commission. For example, a pharmaceutical business shall not make any untrue or misleading statements to promote products in an advertisement, and the business cannot compare its products with products of other pharmaceutical businesses based on different standards or grades. A pharmaceutical business must take care when claiming its product is “the best”, as such description constitutes comparative advertising. 

According to the Enforcement Rules of the Pharmaceutical Affairs Act (the “Enforcement Rules of the Act”), text and images used in a pharmaceutical advertisement are 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 initially approved by the central relevant health authority; 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 the pharmaceutical advertisement. According to the Code, no pharmaceutical product shall be promoted for use in a specific country until the requisite approval for marketing for such use has been given in that country. As such, in Taiwan, it is forbidden to have pharmaceutical advertisements for unauthorised medicines or unauthorised indications.   

However, it is still possible to provide information about unauthorised medicines or unauthorised indications in a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings, in scientific or lay communications media and at scientific conferences, or during a public disclosure of information to stockholders and others. An unauthorised medicine and unauthorised indication can be introduced if such introduction will not be deemed as pharmaceutical advertising.   

As indicated in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, it is possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals as long as such information will not constitute pharmaceutical advertising. Also, according to the “Ethics Code of Medical News or Research Published by Medical Institutions and Health Professionals”, medical institutions and health professionals are allowed to quote such information and the source during a scientific conference as long as it is recognised by credible academic journals or institutions. The Code states that 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:  

  • host country regulations should permit such an arrangement;  
  • 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; 
  • promotional material 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; 
  • 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 
  • an explanatory statement should identify the countries in which the product is registered and make it clear that it is not available locally. 

As indicated in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, it is forbidden to have pharmaceutical advertisements for unauthorised medicines or unauthorised indications, regardless of whether the target is healthcare professionals or not. However, it is allowed to provide such information to healthcare professionals as long as it will not constitute pharmaceutical advertising (see 3.2 Provision of Information during a Scientific Conference). According to the Code, continuing medical education (CME) helps ensure that healthcare professionals obtain the latest and most accurate information and insights on therapeutic areas and related interventions that are critical to the improvement of patient care and overall enhancement of the healthcare system. When providing content to CME activities and programmes, such material must be fair, balanced and objective, and designed to allow the expression of diverse theories and recognised opinions. Content must consist of medical, scientific or other information that can contribute to enhancing patient care. 

As indicated in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, it is forbidden to have pharmaceutical advertisements for unauthorised medicines or unauthorised indications, regardless of whether the target is healthcare institutions or not. It is possible to provide information to healthcare institutions as long as it will not constitute pharmaceutical advertising. See details at 3.2 Provision of Information during a Scientific Conference and 3.3 Provision of Information to Healthcare Professionals

It is not expressly prohibited to publish the availability of compassionate use programmes. However, considering: (i) the compassionate use programme is applied under the circumstance that there is no domestic appropriate drug or alternative treatment; and (ii) the compassionate use programme must be applied by the medical care institutions to the central competent health authority for its special approval to manufacture and import the specific drug for the prevention of a chronic or seriously debilitating disease, or a life-threatening disease, the publication of the availability of compassionate use programmes or other forms of early access must not constitute pharmaceutical advertising or such publication must meet the related laws and regulations of pharmaceutical advertising. 

In Taiwan, any pharmaceutical business that wishes to advertise medicines, whether they are over-the-counter medicines or prescription medicines, must first apply for approval from the relevant healthcare authority. After obtaining approval, the pharmaceutical business can advertise and promote such medicines. The governmental approval process is illustrated at 6.1 Requirements for Prior Notification/Authorisation. The Code provides standards for promotional information:

  • promotions must be consistent with locally approved product information;
  • promotions must be clear, legible, accurate, balanced, fair and sufficiently complete to enable the recipient to form their own opinion of the therapeutic value of the pharmaceutical product; and
  • the advertiser must be able to substantiate the claimed efficacy.  

Moreover, prescription medicines are only allowed to advertise in medical academic journals, not to the general public. As for online advertising of prescription medicines in medical academic platforms, according to the administrative order, the platform must have installed an administrative measure to ensure that only registered healthcare professionals are allowed to view such advertisements.  

Advertisements shall not make any misleading or untrue statements to the audience. Any violation is subject to penalties under the Fair Trade Act, the Consumer Protection Act and the Civil Code. 

Obligatory Information

Before publishing or broadcasting a pharmaceutical advertisement, a pharmaceutical business must submit all text, drawings or images constituting an advertisement to the relevant health authority for approval, and no modifications or alterations to the approved contents are allowed during the term being permitted to publish or to broadcast. The name of the firm, the number of its drug permit licence and the advertisement approval document shall be published simultaneously or disseminated together with the advertisement; the text and images used in a pharmaceutical advertisement are 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 initially approved by the central relevant health authority; the efficacy claimed in the text of an advertisement for Chinese medicine materials must be limited to the efficacy stated in the Compendium of Materia Medica. 

Prohibited Information 

Pharmaceutical advertising shall not do any of the following:

  • publicise the medicament by making use of the name of anther person(s);
  • warrant the efficacy or functions of the medicament by making use of materials or information contained in a book or publications;
  • publicise the medicament by means of releasing an interview or news report; or
  • publicise the medicament by any other improper means. 

Additionally, pharmaceutical advertisements cannot contain any of the following:

  • content involving efficacy related to sexual intercourse;
  • content involving exchanging the drugs for prizes or any incentives whatsoever that are likely to encourage drug abuse;
  • content involving any representation that the use of a particular drug will cure a particular disease or will improve a person's health or physiology in a particular area, or untrue or misleading statements; and
  • exaggeration of a drug's efficacy or safety. 

There is no law or regulation expressly imposing restrictions on interactions between patients or patient organisations and industry. However, salespersons employed by a pharmaceutical business are permitted to promote sales only after their employment has been registered with the relevant health authority of the municipality or county (city). The salespersons may only promote sales to pharmacies, pharmaceutical firms, health and medical care institutions, medical research institutions, and institutions whose registrations have been approved by the relevant health authorities. Salespersons can only sell drugs manufactured or resold by the pharmaceutical business in which they are employed, and cannot conduct any act of peddling, street vending, tearing seals of medicaments, repackaging medicaments without authorisation, or illegally advertising medicaments.   

As the law does not establish the definition of “promoting sales”, there is still room for direct interaction between patients or patient organisations and industry, so long as the interactions do not involve “promoting sales”. The Code also allows interactions between patients or patient organisations and the industry, as long as all interactions with patient organisations are ethical, and the independence of patient organisations must be respected; being the sole funder of the patient organisation or any of its programmes is not allowed.  

Same rules apply to both advertising to the general public and to the health professionals. Contents or information that must be included or that is prohibited are indicated at 4.2 Information Contained in Pharmaceutical Advertising to the General Public. In addition, prescription medicines are only allowed to advertise in medical academic journals, not to the general public. For online advertising of prescription medicines in medical academic platforms, the platform must have installed an administrative measure to ensure that only registered healthcare professionals are allowed to view such advertisements (see 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public).   

In Taiwan, the content of pharmaceutical advertising of a specific medicine must be exactly the same as the content that has been inspected and reviewed by the relevant authority. The text and images used in pharmaceutical advertising are limited to the name of the drug, its dosage form, prescription content, usage quantity, usage method, efficacy, guidelines, packaging, and the name and address of the manufacturer, as approved by the central relevant health authority. Therefore, if the data or other clinical studies are not approved by the relevant authority, they cannot be referred to in the pharmaceutical advertisement. However, there is still room for the use of such information, as long as it complies with related laws and regulations as indicated at 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, 3.2 Provision of Information during a Scientific Conference and 3.3 Provision of Information to Healthcare Professionals

As indicated at 5.2 Reference to Data Not Included in the Summary of Product Characteristics, the content of pharmaceutical advertising must be exactly the same as the content that has been inspected and reviewed by the relevant authority. If such information is not approved by the central relevant health authority, it cannot be referred to in the pharmaceutical advertisement. However, there is still room for the use of such information, as long as it complies with related laws and regulations as indicated at 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, 3.2 Provision of Information During a Scientific Conference and 3.3 Provision of Information to Healthcare Professionals

According to the Code, medical journals or textbooks for academic use can only be offered to individual hospital departments (Benchmarks of Code of Practice). In addition, if the content involves any “pharmaceutical advertising”, the company must comply with the relevant rules governing pharmaceutical advertising.  

Unlike the promotion of sale by pharmaceutical business salespersons, which needs to be registered according to the Act, there are no specific laws or regulations regulating the conduct of medical science liaisons (MSLs). There are no laws or regulations prohibiting MSLs from proactively discussing scientific information on unauthorised medicines or indications with healthcare professionals, as long as the conduct of the MSLs does not constitute pharmaceutical advertising and such conduct complies with the related laws and regulations as indicated at 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, 3.2 Provision of Information during a Scientific Conference and 3.3 Provision of Information to Healthcare Professionals. However, if MSLs are “promoting sales”, the MSLs shall also be registered regardless of whether the company refers to them as salespersons or not. 

Advertisements for medicines are subject to prior authorisation from the relevant health authorities. See 4.2 Information Contained in Pharmaceutical Advertising to the General Public for information that needs to be submitted for approval. No publication or dissemination of pharmaceutical advertising may take place until a pharmaceutical business with a drug permit has completed an application form and submitted the same with photocopies of the drug permit and the approved labelling, usage instructions, packaging, the content of the advertisement and a review fee to the relevant health authority and has obtained approval from that health authority. Also, the term of validity of pharmaceutical advertisements approved by the relevant health authority is one year, which shall commence from the date of issuance of the approval document. An extension may be applied for by the business and approved by the issuing relevant health authority. Each period of extension shall not exceed one year. The central or direct municipal relevant health authority is in charge of approval (and rejection) of pharmaceutical advertisements.

There is no requirement to adopt SOPs or to employ specific personnel to complete the process of applying for pharmaceutical advertisement approval from the relevant health authority. However, an applicant applying for such approval must be the pharmaceutical business which holds the drug permit for the drug that is to be advertised.   

In addition to the general rules specified in the Act and the Enforcement Rules of the Act, advertising on the internet for medicinal products is specifically regulated by the “Principles for Dealing with On-line Pharmaceutical Advertising” (the “Principles”). 

The Principles provide as follows.  

  • A pharmaceutical business is allowed to advertise drugs or medicines on its official website without first applying for an approval, but the content of the advertisements must be identical to the drug permits, and the business must post photos of the drug’s packaging. 
  • As well as advertising on its official website, a pharmaceutical business is allowed to advertise non-prescription medicines on websites targeting the general public by first applying for the approval set forth at 6.1 Requirements for Prior Notification/Authorisation. For prescription medicines, in addition to having the approval, prescription medicines can only advertise in medical academic platforms which have an administrative measure to ensure that only registered healthcare professionals are allowed to view such advertisements. For example, the online platform must require member IDs or professional licence numbers to permit access to the webpage showing the advert for the prescription medicines. 

Pharmaceutical advertising on social media is allowed, so long as the advertisements comply with the rules indicated above such as 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public and 7.1 Regulation of Advertising of Medicinal Products on the Internet.

If a pharmaceutical advertisement contains prescription medicines, the website must have installed an administrative measure such as a requirement to enter a member ID or professional licence number to ensure that only healthcare professionals have access to such advertising content. 

As indicated in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, pharmaceutical companies are allowed to provide disease awareness information and/or materials to patients online, as long as the information is not pharmaceutical advertising and:  

  • is for the purposes of health promotion or disease prevention with a health education function;  
  • does not include specific names of the medicaments; and  
  • has obvious separation from the pharmaceutical advertising content. 

On the other hand, if the disease awareness information and/or materials to patients would be considered as “pharmaceutical advertising”, the laws and regulations governing pharmaceutical advertising must be complied with. 

According to the Code, the purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings (an “Event”) for healthcare professionals organised or sponsored by a pharmaceutical business should be to provide scientific or educational information and/or to inform healthcare professionals about products, as do online scientific meetings. 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:  

  • the host country regulations should permit such an arrangement; 
  • 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; 
  • promotional material (excluding promotional aids) 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; 
  • 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 
  • an explanatory statement should identify the countries in which the product is registered and make it clear that it is not available locally. 

The interaction between healthcare professionals/healthcare organisations and and pharmaceutical companies is mainly regulated by the Medical Care Act, the Physicians Act, and the Guidance for Interaction between Physicians and Vendors, all three of which only provide high-level principles. Corruption under the Criminal Code was previously applied to healthcare professionals at public hospitals, but such application ceased in 2008. The offence of breach of trust under the Criminal Code might still be applied in some particular circumstances. The Code also provides some self-regulatory details regarding such interactions.  

Medical Care Act 

The Medical Care Act aims to advance the comprehensive development of the medical care industry, the reasonable distribution of medical care resources, improvement of the quality of medical care, protection of the rights of patients and the promotion of the national health. It requires “[m]edical care institutions and their staff to refrain from taking advantage of opportunities resulting from medical practice to gain improper benefits”. This applies to both individuals and organisations, but only provides general principles regarding the prohibition against “gaining improper benefits”. Medical care institutions and the staff thereof who violate the aforementioned shall be subject to a fine of no less than NTD50,000 (approximately USD1,666) and no more than NTD250,000 (approximately USD8,333). 

Physicians Act 

The Physicians Act establishes the standards for qualifications, management, practice and duty of physicians. It applies only to physicians and not healthcare institutions. A physician guilty of violating medical ethics in their professional practice shall be disciplined by the Medical Association or the relevant authority. This Act also provides a high-level limitation on the interactions between healthcare professionals and pharmaceutical companies. 

Administrative Guidance 

In 2006, Taiwan’s Department of Health (DoH, which is now the Ministry of Health and Welfare) announced the Guidance for Interactions between Physicians and Vendors. The Guidance states the rules to be followed with respect to the attendance of physicians at medical seminars held by vendors, the receiving of gifts from vendors, the rules for doctors who are invited to provide consultation to pharmaceutical companies, and the principles for physicians and healthcare organisations to follow while conducting research sponsored by vendors. A physician who violates the Code will be disciplined by the Medical Association. 

Corruption According to the Criminal Code 

If the individual accepting bribes is a government employee, corruption, according to the Criminal Code, might apply. There was a time when healthcare professionals working in public hospitals were considered government employees. However, as confirmed by the Supreme Court in 2008, healthcare professionals at public hospitals are not considered civil servants as defined in the Criminal Code. Nevertheless, if the healthcare professional has duties in an administrative or management position at the public hospital, such as with respect to procurement, the individuals  can be charged with corruption if they accept bribes. 

Breach of Trust of the Criminal Code 

If the healthcare professional accepting gifts or money from pharmaceutical companies acts against their professional practice, which then causes damage to the hospital, the healthcare professional may be deemed to have committed a breach of trust. This applies only to individuals and not to organisations, regardless of whether the healthcare professional works for a public or private hospital. 

IRPMA Code of Practice  

The Code provides standards for the ethical promotion of pharmaceutical products to healthcare professionals helping to ensure that member companies’ interactions with healthcare professionals and other stakeholders are appropriate and perceived as such, as well as considerable details regarding acts that pharmaceutical companies must do and must refrain from doing while interacting with healthcare professionals, and the principles for interactions with healthcare professionals. Specific sections include events and meetings, sponsorships, guests, fees for services, gifts, samples provided to healthcare professionals and the monitoring duty of the pharmaceutical companies with respect to the samples they provide, rules covering clinical research and transparency, among others.  

Legislative provisions regarding the matter of benefits provided to healthcare professionals or healthcare organisations are mainly contained in the Medical Care Act and the Physicians Act, which only provide general and high-level limitations. The Medical Care Act could apply to both individuals and organisations, while the Physicians Act applies only to physicians. Corruption or breach of trust under the Criminal Code might apply in some particular circumstances, but only to individuals.  

The Guidance for Interactions between Physicians and Vendors provides more details on this matter. It restricts physicians’ and healthcare organisations’ behaviours regarding benefits, but not those of pharmaceutical companies. In terms of self-regulatory provisions, the Code provides the most details regarding the offering of benefits by pharmaceutical companies. The Code restricts the behaviours of pharmaceutical companies in this regard.  

Both the Guidance for Interactions between Physicians and Vendors and the Code prohibit offering cash or cash equivalents such as gift certificates. The Code also prohibits offering personal benefits, such as sporting or entertainment tickets and electronic items and cultural courtesy gifts, such as gifts given on traditional festivals or flowers and funeral scrolls for funerals. 

The Taiwan legal framework only has general provisions that limit interactions between healthcare professionals and pharmaceutical companies. The Guidance for Interactions between Physicians and Vendors and the Code provide more specific information, as addressed below. 

The Medical Care Act and the Physicians Act provides a high-level requirement that medical care institutions and their staff shall not take advantage of opportunities resulting from medical practice to gain improper benefits. Also, healthcare professionals must not violate medical ethics in their professional practice. 

According to the Guidance for Interactions between Physicians and Vendors, physicians are allowed to accept gifts on the basis that such gifts:

  • shall not violate the laws and the policies of the Medical Association or Guild;
  • shall be reasonable in consistency with local practice, and shall not be expensive;
  • shall not be cash or cash equivalents; and
  • shall not involve an agreement or implication that a particular medical product will be used or that patients will be referred to a particular premises.

Briefly, the core concept is reasonableness and avoiding situations of quid pro quo. Although there is no specific monetary limit set, gifts of cash or cash equivalents are clearly forbidden. 

The Code also provides that “[p]ayments in cash, cash equivalents (such as gift certificate) or personal services (any service unrelated to the healthcare professional’s profession and that confer a personal benefit to the healthcare professional) 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.” In addition, as from 16 May 2018, the Code forbids promotional aids (as defined in benchmarks 6.(2), promotional aids are inexpensive small items bearing the name of the pharmaceutical companies or pharmaceutical products) from being provided to healthcare professionals, requiring that medical supplies cannot be provided to healthcare professionals for their personal use. 

According to the Regulations on Management of Medicament Samples and Gifts, a medicament that meets one of the following requirements can be declared as 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 (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 licence in accordance with the stipulations of the Act; or
  • an application for purposes of public safety or public health or due to major disasters. 

To be imported or manufactured, medicament samples must have obtained approval from the TFDA in advance. In addition, the Regulations provide as follows.  

  • Medicament samples or gifts that have been approved may not be sold, transferred or used for other purposes.
  • Medicament samples for technical improvement purposes may not be used for clinical purposes. 
  • For approved medicament gifts and medicament samples for educational promotion purposes, their package inserts, labels and packaging styles shall be consistent with those registered in the original permit licence. The package volume for medicament samples for educational promotion purposes may not exceed the minimum registered packaging volume. 
  • For medicaments approved as samples or gifts, the outer packaging shall be clearly marked with text stating "Sample" or "Gift". On samples for clinical trial purposes, text stating "For clinical trial" shall be marked.  

The Code also provides principles regarding the offering of samples, as set out below.

  • Subject: the healthcare professionals receiving samples of the medicine at issue shall have the power to prescribe the medicine.
  • Labelling: the samples offered shall be clearly labelled as “samples”.
  • Monitoring and other responsibilities: the pharmaceutical company is required to maintain a monitoring system for tracking which healthcare professional possesses the samples. 

Pharmaceutical companies offering samples are not allowed to collect clinical information from samples offered and may not provide any reward to healthcare professionals receiving such samples.

The Guidance for Interaction between Physicians and Vendors allows doctors to attend medical meetings held or sponsored by pharmaceutical companies, so long as the following principles are met. 

  • The main purpose of the meeting is regarding the improvement of medical quality, promoting the interests of patients and professional information exchange. In addition, at least two-thirds of the meeting time shall be spent on discussion of the topics as set forth/advertised.  
  • Sponsorship accepted by a healthcare professional is limited to registration, travel expenses and meals. If a healthcare professional is invited as a speaker or host, a speaker’s fee or hosting fee is acceptable. 
  • The organiser of the meeting is required to disclose the name of the sponsors and inform attendees of the relationship with/between the organiser, speaker, host and sponsor. 
  • Any material published by healthcare professionals at the meeting must be based on scientific positivism and cannot be affected by the sponsor. Statements regarding alternative diagnosis/treatment must be made fairly.  
  • The organiser of the meeting or attending doctors must reject any improper intervention by the pharmaceutical companies related to the content of the meeting, the way the meeting proceeds and the selection of speakers. 

The Code allows pharmaceutical companies to hold or sponsor events or meetings under certain limitations, as set out below. 

  • The purpose of the event must be related to science and education. 
  • Meetings abroad are not allowed except for international scientific congresses and symposia that derive participants from many countries. All events must be held in an appropriate venue conducive to the stated scientific or educational objectives and the purpose of the event or meeting. Renowned or extravagant venues must be avoided.  
  • Promotional information that appears on exhibition stands or is distributed to participants at international scientific congresses and symposia may refer to pharmaceutical products that 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) 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. 
  • Pharmaceutical companies are also allowed to sponsor healthcare professionals to attend events, provided: 
    1. the event complies with the requirements in this Code as described at 7.1 Regulation of Advertising of Medicinal Products on the Internet
    2. sponsorship of healthcare professionals is limited to payments for travel, meals, accommodation and registration fees; 
    3. no payments are made to compensate healthcare professionals for time spent attending the Event; and 
    4. any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend, purchase, supply, administer or promote any pharmaceutical product.

As set out above, the Guidance for Interactions between Physicians and Vendors allows healthcare professionals to attend events held or sponsored by pharmaceutical companies, provided that the purposes of such events are related to improvements of medical quality, promoting the interests of patients and professional information exchanges. The Code also requires that the purposes of events held or sponsored by pharmaceutical companies be related to science and education. No entertainment or other leisure or social activities should be provided or paid for by member companies. Thus, pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events, and healthcare professionals are also not allowed to attend such non-scientific events, if their attendance is sponsored by pharmaceutical companies. 

The Guidance for Interactions between Physicians and Vendors allows healthcare professionals or healthcare institutions to conduct research sponsored by pharmaceutical companies, provided that: 

  • the research and publication of the results thereof complies with the law, ethics and the requirements of the Helsinki Declaration and strictly adheres to clinical judgement;  
  • the reward for conducting the research shall be evaluated based on the time and effort expended, but, not based on the results of the research; 
  • the name(s) of both the direct or indirect sponsor(s) shall be announced together with the publication of the results of the research; 
  • the healthcare professionals or healthcare institutions and the pharmaceutical company shall fully communicate before the research; and
  • the pharmaceutical company shall not restrict the publication of the research results. 

The Code states that pharmaceutical companies are allowed to offer items of medical utility to healthcare professionals if such items are of modest value, do not offset routine business practices, and are beneficial to enhancing the provision of medical services and patient care, such medical utility must not bear the name of product (both of branded and generic name) but may bear the company logo.  

Both the Guidance for Interactions between Physicians and Vendors and the Code prohibit offering cash or cash equivalents (such as gift certificates) to healthcare professionals. Neither the Code nor the Guidance has relevant content regarding donations of equipment or service from pharmaceutical companies. 

Though there is no specific restriction with respect to rebates or discounts, both the Guidance for Interactions between Physicians and Vendors and the Code prohibit offering cash or cash equivalents to healthcare professionals. Thus, giving rebates is not allowed.   

In addition, the requirements under the Medical Care Act and the Physicians Act indicated in sections 8. Pharmaceutical Advertising: Inducement/Anti-bribery and 9. Gifts, Hospitality, Congresses and Related Payments would apply. If a healthcare professional receives a rebate or discount which is considered to be an “improper benefit” or as “violating medical ethics”, they could be subjected to the imposition of a fine in an amount no less than NTD50,000 (approximately USD1,666) and no more than NTD250,000 (approximately USD8,333) and may be disciplined by the Medical Association or the relevant authority. 

Furthermore, healthcare professionals at public hospitals who are in charge of administrative or management affairs may be found guilty of corruption if they accept rebates. Also, healthcare professionals at public or private hospitals may be found to be in breach of trust for their receipt of rebates if the legal requirements for a breach of trust are met. 

The Guidance for Interactions between Physicians and Vendors allows doctors to act as consultants to pharmaceutical companies or to provide advice, provided that: 

  • professional judgement shall not be affected due to acting as consultant or providing advice to the pharmaceutical company; 
  • obligations to patients shall not be neglected due to acting as consultant or providing advice to the pharmaceutical company; and 
  • subordination or any other relationship with the pharmaceutical company shall be laid open in any speech and/or publication of articles or reports. 

The Code has relevant requirements, including: 

  • a written contract or agreement must be agreed upon in advance of the commencement of the services, which agreement or contract 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 must reflect the fair market value of the services provided. 

The Q&A section of the Code also contains a services fee schedule for healthcare professionals, which provides as follows.  

  • For international congress held overseas, the international norms should be applied. For the symposia held in Taiwan, the international norms can only be applied when the international event is organised by an international society and it is not a satellite programme within the international event. Otherwise, the honorarium for local speaker should be limited up to NTD5,000/hour. 
  • Chairperson/moderator of the advisory board and who may concurrently serve as advisory board member: may be paid up to NTD20,000 (up to NTD10,000 per event as member, up to NTD10,000 as the Chairperson).  
  • Chairperson/moderator and who may concurrently serve as a lecturer: NTD5,000/hour as a lecturer, up to NTD10,000 as the chairman/moderator per event. 

Except for the importation or manufacture of medicament samples, which must have obtained approval from the TFDA in advance, none of the activities referred in this section are presently required by laws or regulations to have prior authorisation or notification. 

There is no particular law or regulation or self-regulatory code that requires pharmaceutical companies to disclose transfers of value to healthcare professionals or healthcare institutions. The Guidance for Interactions between Physicians and Vendors, however, requires the following. 

  • Regarding the event or meeting sponsored by a pharmaceutical company, the organiser of the event or meeting must disclose the name of the sponsors and inform attendees of the relationship/s between the organiser, speaker, host and sponsor (Article 2(3)).  
  • Where healthcare professionals are invited to be consultants or to provide advice to pharmaceutical companies, the subordination or any other relationship with the pharmaceutical company shall be laid open in any speech or publication of articles or reports (Article 5(3)). 

The above-mentioned Guidance for Interactions between Physicians and Vendors at 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value does not distinguish between foreign companies or companies that do not yet have products on the market. Nevertheless, Article 2(3) applies only to the organiser of the event or meeting and Article 5(3) applies only to healthcare professionals. 

For the rules on advertising, the central or direct municipal relevant health authority is in charge of enforcing the Act. The Fair Trade Commission will enforce any penalties for violations of the Fair Trade Act. Administrative disputes related to violations of pharmaceutical advertising rules are adjudicated by the Administrative Courts.  

With regard to inducement, the Medical Care Act and the Guidance for Interactions Between Physicians and Vendors is enforced by the Ministry of Health and Welfare. The Physicians Act is enforced by the Ministry of Health and Welfare and the Taiwan Medical Association. The IRPMA Code of Practice is enforced by the IRPMA. 

If infringement by a competitor involves a fair trade/competition order, the company can bring a complaint to the Fair Trade Commission (FTC), and the FTC will collect evidence and make a decision as to whether to issue an administrative order to fine the competitor for its violation of the Fair Trade Act. If a competitor is not satisfied with the administrative order, it may sue the FTC, and such cases will be heard by the High Administrative Court. If infringement by a competitor constitutes the behaviour as stated in the Fair Trade Act, that is “for the purpose of competition, make or disseminate any false statement that is capable of damaging the business reputation of another”, the company may even file a criminal complaint with the competent district prosecutor's office pursuant to the Fair Trade Act. 

If the infringement by a competitor involves general civil issues, such as disparaging the company’s goodwill or the making of untrue statements, the company may sue the competitor in the local civil courts. 

If the infringement by a competitor involves intellectual property rights or trade secrets, the company may sue the competitor in the Intellectual Property and Commercial Court. 

General penalties for violating advertising rules under the Act are as follows. 

  • Anyone who is not a pharmaceutical business but makes a pharmaceutical advertisement is subject to a fine in an amount ranging from NTD200,000 (approximately USD6,666) to NTD5 million (approximately USD1,666,666); no pictorial or literal description or propaganda regarding the medical efficacy of any product other than the medicaments defined in this Act shall be made, otherwise, the violator shall be issued a fine ranging from NTD600,000 to NTD25 million and the violating products shall be confiscated and destroyed. 
  • Anyone who makes a pharmaceutical advertisement without first obtaining approval from the relevant authority, and anyone who violates the rules by advertising prescription medicines on any media other than in educational journals, and anyone who includes prohibited content in the advertisement will be subject to a fine in an amount ranging from NTD200,000 (approximately USD6,666) to NTD5 million (approximately USD1,666,666).    
  • Media businesses who help to post or play any pharmaceutical advertisement which has not been approved by the relevant authority will be subject to a fine in an amount ranging from NTD200,000 (approximately USD6,666) to NTD5 million (approximately USD1,666,666), and if the media business continues posting or playing said advertisement, it will be subject to a fine in an amount ranging from NTD600,000 (approximately USD20,000) to NTD25 million (approximately USD833,333); under the same Article, any media business that violates the rules by not keeping the record of the advertisement for six months will be subject to a fine in an amount ranging from NTD60,000 (approximately USD2,000) to NTD300,000 (approximately USD10,000).   
  • In addition to the above, the relevant authority may announce the name of the violator and the medicine, and may revoke the drug licence if the violation is serious; the medicine at issue will also be precluded from application for approval for pharmaceutical advertising for a period of two years. 

Penalties under the Fair Trade Act are as follows. 

  • Anyone who makes untrue or misleading statements in an advertisement will be subject to a fine in an amount ranging from NTD50,000 (approximately USD1,666) to NTD25,000,000 (approximately USD833,333), and if such person fails to correct its action after imposition of the fine, said person shall be subject to another fine in an amount ranging from NTD100,000 to NTD50 million until its action is corrected. This is likely to happen with respect to endorsement or comparison advertisements. In addition to the above punishments, doctors or pharmacists are subject to disciplinary measures by their professional associations for violating their professional duties by making untrue or misleading statements in connection with endorsements for medicines. 
  • Anyone making or disseminating any untrue statement for the purpose of damaging the business reputation of another business is subject to both criminal and administrative penalties. For criminal liability, the violator will be subject to detention or imprisonment for no more than two years and may be fined an amount of no more than NTD50 million. For administrative liability, the violator will be subject to a fine in an amount ranging from NTD50,000 (approximately USD1,666) to NTD25 million (approximately USD833,333), and if it fails to correct its action after the fine, it will be subject to another fine in an amount ranging from NTD100,000 to NTD50 million until its action is corrected. This is likely to happen in connection with comparison advertisements. 
  • Anyone engaging in any deceptive or obviously unfair conduct that is able to affect the trading order will be subject to a fine in an amount ranging from NTD50,000 (approximately USD1,666) to NTD25 million (approximately USD833,333), and if it fails to correct its action after the fine, it will be subject to another fine in an amount ranging from NTD100,000 to NTD50 million until its action is corrected. This is likely to happen in connection with comparison advertisements.  

Regarding inducement, medical care institutions and the staff thereof who violate the Medical Care Act will be subject to a fine of no less than NTD50,000 (approximately USD1,666) and no more than NTD250,000 (approximately USD8,333). According to the Physicians Act, a physician found guilty of violating medical ethics in their professional practice will be disciplined by the Medical Association or the relevant authority. The Guidance for Interactions Between Physicians and Vendors was established according to the Physicians Act. Thus, the penalties or measures applicable for violations of the Guidance will also refer to the Physicians Act.   

There is no statutory punishment for violating the requirements of the IRPMA Code of Practice, however, IRPMA has its own Code of Practice Committee. If the Code of Practice Committee confirms the violation of the Code, each violation shall be punishable by a fine of NTD200,000. 

The procedures or measures taken by the self-regulatory authority are not necessarily related to the procedures or measures taken by the courts. One can present the material of procedures or measures taken by the self-regulatory authority to the court, but any violation of the laws and regulations must be heard and decided by a court. The procedures before the court must follow the law and the court can take compulsory measures, while the procedures taken by the self-regulatory authority are self-imposed and, unlike the court, the self-regulatory authority cannot take compulsory measures. 

In the past two years, there have been no significant changes of enforcement in relation to pharmaceutical advertising. However, the regulation of medical devices was shifted from the Pharmaceutical Affairs Act to the Medical Devices Act. The Medical Devices Act  came into effect on 1 May 2021. According to the Medical Devices Act, its provisions shall apply to the management of medical devices, and the provisions of the Pharmaceutical Affairs Act governing medical devices shall no longer be applicable.  

Formosa Transnational

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Taipei City 106
Taiwan

+886 2 2755 7366

+886 2 2708 8435

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Law and Practice

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Formosa Transnational is a full-service law firm in Taipei established in 1974.  The firm provides legal assistance to high-profile clients from all over the world, including the USA, EU, UK, Japan, Korea, Singapore and China.  With an elite team of 90 attorneys, the firm’s practice includes all types of compliance checks, dispute resolution, fundraising, investments, mergers and acquisitions, employment, competition, franchising, data protection and privacy, and corporate social responsibility, among other fields of law. Its technology law department possesses a strong background in technology and extensive experience in IP laws with its IP attorneys and in-house engineers and scientists. The firm's professionals provide comprehensive services with respect to intellectual property matters such as IP management, prosecution and litigation for patents, trade marks, copyrights, domain names and trade secrets, and advise businesses engaged in all sectors of the pharmaceutical industry and many other industries.

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