Under the PRC legal system, advertising on medicines is subject to the following regulations.
The major laws and regulations are:
In addition to the above laws and regulations, industrial associations and institutions also have their own codes of conduct to regulate members՚ promotion and advertising activities. These are normally referred to as "industry benchmarks". The major self-regulatory codes for medicine advertising include:
The self-regulatory codes generally apply to the members of the relevant associations, including member organisations and/or individual members.
For example, the RDPAC Code applies to RDPAC’s member companies (although the annotation of the RDPAC Code further notes that the Code covers all relevant company employees as well as subcontractors that carry out tasks on behalf of the company).
Other self-regulatory codes apply primarily to individual members. For example, the Code of Ethics for Licensed Doctors in China applies to licensed physicians, licensed assistant physicians, scholars and health administrative personnel, as well as healthcare institutions and certain other organisations.
None of these self-regulatory codes are mandatory. They are contractual in nature and reflect a certain level of industry consensus among a large group of market players. Some of these self-regulatory codes may reflect higher standards than laws and regulations. Others elaborate on issues with respect to which the law is silent, such as the scope of communications allowed with respect to off-label use of medicines and the level of substantiation required for promotional purposes.
The definition of advertising under the Advertising Law is broad. Advertising appears to cover any commercial activities whereby business operators or service providers directly or indirectly introduce and recommend products or services they are marketing by using certain forms of media.
The former State Administration for Industry and Commerce (SAIC), now reformed into the State Administration for Market Regulation (SAMR), and the Legislative Affairs Commission of the Standing Committee of the National People’s Congress, summarise the characteristics of advertisements in their interpretations of the Advertising Law. They define an advertisement as a commercial activity that:
For the purposes of this section, “information” in the narrow sense refers to the factual description and introduction of products and services. Under the Law on the Protection of Consumer Rights and Interests, consumers are entitled to know the correct information about the products and services, such as the price, place and date of manufacture, and term of validity.
Advertising, however, is about making recommendations for products or services. Its main purpose is to generate a positive attitude in the audience towards the products or services being presented.
Law Enforcement Perspective on Advertising
From a law enforcement perspective, the “information” part of an advertisement is not subject to legal scrutiny under the Advertising Law. For example, when reviewing the content of an advertisement, the SAMR tends to carve out the information that is required by laws and regulations to be provided to consumers, and will only scrutinise the rest of the advertisement as a “commercial advertisement”.
Qualifying Events as Advertising
Whether disease awareness campaigns may qualify as advertising depends on whether the event is promotional in nature. If a disease awareness campaign simply provides general disease awareness information, then it is not likely to be regarded as advertising. If the information provided can be either individually or collectively viewed as pointing to a specific product, such information may be considered “drug information” and the campaign may be considered promotional in nature and may fall into the scope of advertising. Under the Administrative Measures for Review of Drug Advertisements, “drug information” may include drug names, diseases to which the drugs are applicable (functions and indications) or other drug-related content.
A disease awareness campaign may be aimed at healthcare professionals, patients or the general public, and there is no legal difference based on the type of audience. In practice, however, if a disease awareness campaign targets the general public, product-specific information is generally not allowed to be mentioned; otherwise, law enforcement is more likely to regard the campaign as advertising. Other compliance requirements are discussed in 7.3 Provision of Disease Awareness Information to Patients Online.
The law in China does not prohibit press releases regarding medicines, but the promotion of medicines in the disguised form of press releases without prior regulatory approval is restricted. In practice, press releases are only allowed if they contain a strictly factual description of the medicine, such as the completion of clinical studies, the obtainment of relevant market approval, or the launch of a new product in a new jurisdiction. If the content of the press release exceeds such limited scope and includes elements of advertising/promotion, then it may fall into the scope of advertising and become subject to the Advertising Law.
There are generally no differences between press releases available in the specialised trade press and press releases in mainstream media.
The Advertising Law explicitly prohibits comparative advertising for medicines with respect to the medicine’s efficacy and safety.
Comparison may nevertheless be allowed if the underlying activity is considered to be outside the scope of advertising. Under the RDPAC Code, comparison with other pharmaceutical products is generally allowed if the comparison is based on relevant and comparable aspects of the products and is capable of substantiation. Comparative claims, where possible, must not be misleading.
PRC laws do not expressly prohibit the provision of information on unauthorised medicines or unauthorised indications but this is nonetheless prohibited under the Advertising Law if the sharing or provision of such information constitutes advertising. Under the Advertising Law:
Therefore, in absence of the marketing authorisation, advertising on unauthorised drugs is unlikely to be approved and permitted by the local MPA.
As mentioned at 2.1 Definition of Advertising, the definition and concept of “advertising” is broad. Pharmaceutical companies in China are cautious about providing information on unauthorised medicines or unauthorised indications to avoid what could constitute illegal advertising. Benchmark practice discourages this activity. For example, the RDPAC Code states that no pharmaceutical product may be promoted for use in China until the requisite marketing authorisation for such use has been given by the NMPA.
Also, under the RDPAC Code, in one-on-one visits with healthcare professionals, medical representatives are not allowed to provide information on unauthorised medicines or unauthorised indications without the supervision of medical experts (see 3.3 Provision of Information to Healthcare Professionals).
There is no direct legal prohibition against providing information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals.
According to the RDPAC Code, off-label promotion is prohibited, but the prohibition is not intended to prevent the right of the scientific community and the public to be fully informed concerning scientific and medical progress. Also, the Code is not intended to restrict the full and proper exchange of scientific information concerning a pharmaceutical product.
However, if the information is promotional in nature, law enforcement may easily view it as prohibited advertising, especially if there is a large audience.
Under the Administrative Measures for Medical Representatives, medical representatives are prohibited from misleading doctors on the usage of drugs, exaggerating or misleading the curative effect, concealing known information on adverse drug reaction and the information on adverse drug reaction reported by healthcare professionals. The pharmaceutical company as the marketing authorisation holder of the medicines is required to promptly correct any aforesaid wrongdoing by the medical representatives.
Therefore, when medical representatives are discussing scientific information on unauthorised medicines or indications with healthcare professionals, such information must conform with the aforementioned requirements. It is also advisable to have the competent department of the company review such information in advance to ensure the accuracy of the contents. The RDPAC Code states that pre-approval of off-label communication with healthcare professionals, whether in oral or written form, should be conducted by or under the supervision of medical experts instead of personnel with commercial functions.
Public healthcare institutions in China generally do not procure drugs on their own initiative. Procurement is organised by the government through bidding performed on bidding platforms (including the recent volume-based procurement). Thus, public healthcare institutions usually do not have direct access to information on unauthorised medicines or unauthorised indications for the purposes of preparing budgets.
The concept of compassionate use programmes is only generally mentioned in the Drug Administration Law as a form of early access for patients. The draft measures regulating the use of medicines in extended clinical trials for compassionate use have not yet been promulgated.
PRC laws do not expressly prohibit the publication of compassionate use programmes; however, if the information on a programme that is released to the public cannot be proved necessary for the purpose of an expanded clinical trial for compassionate use, it might constitute advertising, which is not allowed to provide information on unauthorised medicines or unauthorised indications, as discussed in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications.
Not all categories of medicines can be advertised to the general public. The Administrative Measures for Review of Drug Advertisements strictly prohibit advertising for several special categories of medicines such as:
Advertising of all other prescription-only medicines is only permitted in professional pharmaceutical or medical journals jointly designated by the Ministry of Health and the NMPA. Specifically, the Administrative Measures for Review of Drug Advertisements forbid the use of the names of prescription-only medicines to sponsor/title various activities for advertising, and also prohibit the use of any trade mark or trade name identical to the name of a prescription drug to publish any advertisement in a disguised manner in any media other than professional pharmaceutical or medical journals, or the use of such trade mark or trade name in the title of any activity for advertising.
Therefore, only over-the-counter medicines may be advertised to the general public, and such advertising must comply with substantive and procedural legal requirements. Under the Advertising Law, the Drug Administration Law and the Administrative Measures for Review of Drug Advertisements, advertisements for medicines are subject to review and approval from the drug regulatory department of the provincial-level government where the company is located (ie, the local MPA), which is more fully discussed in 6.1 Requirements for Prior Notification/Authorisation.
Format and Medium of Medicine Advertising
There are also certain restrictions with respect to the format and medium of medicine-specific advertising. For example, medicine-specific advertising cannot be disguised as programmes introducing knowledge about health and well-being and such advertising may not be published in media that targets minors.
Medicine-specific advertising must comply with all the requirements that apply to advertising in general. For example, the Advertising Law states that advertising cannot contain national symbols, words such as “national”, “supreme”, or “best”, or obscene, violent or discriminatory language. Statistical citations and patent references must be true and accurate. In addition, advertising cannot degrade the goods and services of others.
Certain restrictions also apply to the format and medium of advertising in general. All advertisements published through mass media must be prominently marked as "advertisement", and a distinction must be made by the advertiser between "advertisement" and "non-advertisement information", so as not to mislead consumers. For example, advertising cannot be broadcast or published in the form of news reports.
Outdoor advertisements cannot be placed on military facilities or traffic signs, or in certain areas controlled by national institutions, cultural heritage sites and scenic spots. Without prior consent or request, advertisements cannot be sent to people’s residences or placed on transportation devices, or sent via electronic messages. Electronic messages must contain the sender’s identity, contact information and ways to unsubscribe from the messages.
Under the Advertising Law, no endorsement can be made in advertising for medicines, not even by a healthcare professional or a celebrity. The Administrative Measures for Review of Drug Advertisements further prohibit the use of the names or images of experts, scholars, physicians, pharmacists and clinical nutritionists as a recommendation or endorsement.
As mentioned at 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public, advertising directed at the general public can only be for over-the-counter medicines. All advertisements must be true, lawful and must not contain any false or misleading content. Advertisers are responsible for the veracity and legitimacy of the content.
Under the Advertising Law and the Administrative Measures for Review of Drug Advertisements, pharmaceutical advertising of a drug must include contraindications, adverse reactions and the drug advertisement approval number. For over-the-counter medicines, the advertisement should clearly use the abbreviation “OTC” and the following language: “Please follow the instructions for the drug or purchase and use it under the guidance of a pharmacist”. For required content, fonts and colours must be clearly visible and legible. When released on TV, films, the internet and display screens, such content must be continuously displayed in the advertisement (rather than for only five seconds as required by previous regulations).
Also, pharmaceutical advertising cannot contain:
Items Prohibited in Pharmaceutical Advertising
The Administrative Measures for Review of Drug Advertisements prohibit all of the following in pharmaceutical advertising:
(1) either openly using or using in disguised form the names or images of state organs, functionaries of state organs, military entities or military personnel, and the use of military equipment, facilities, etc for advertising purposes;
(2) using the names or images of research institutes, academic institutions, industry associations or experts, scholars, physicians, pharmacists, clinical nutritionists, patients and others for recommendation or as endorsement;
(3) using express or implied statements, contrary to valid science, that the product can cure all diseases, adapt to all symptoms and all groups of people, or that it is necessary for normal life and disease treatment;
(4) including content that induces unnecessary anxiety and fear among the public about their health status and the diseases they suffer from, or that lead to public misunderstanding that they will suffer from a certain disease or the disease will worsen if they do not use the product;
(5) the use of words and expressions like "safe", "safe, non-toxic and with no side effects" and "minor toxic side effects"; or expressed or implied statements that the ingredients are "natural", thus ensuring safety;
(6) including content that induces purchase, such as "hot sales”, “rush to buy or use on a trial basis", "family necessities”, “free treatment” and “free gifts"; comprehensive evaluation such as "evaluation, ranking, recommendation, designation, selection and awards"; or content such as "refund if not effective” and “insurance with insurance companies" that encourages consumers to arbitrarily and excessively use drugs, health food and formula food for special medicinal purposes; or
(7) including content such as the name, address, contact information, service items and service methods of the medical institution, as well as such medical services as free treatment, medical consultation hotline, special out-patient service, etc.
Bullet points two to five might also trigger false advertising claims and subject the advertiser to strict penalties, as discussed in 11.3 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe.
PRC law is silent on interactions between patient organisations and the industry, such as whether companies can sponsor patient organisations’ meetings.
The latest RDPAC Code emphasses that the independence of patient organisations must be respected. No member company may require that it be the sole funder of the patient organisation or any of its programmes. If member companies wish to provide financial support or in-kind contribution to patient organisations, they must have written documentation setting out the nature of the support. Further, the primary purposes of such meetings or activities funded by member companies should be professional, educational, and scientific in nature, or otherwise support the mission of the patient organisation. In addition, any meals or refreshments provided must be modest as judged by local standards.
Regarding the direct distribution of drugs to patients under the Provisions for Supervision of Drug Distribution, prescription-only medicines and a sub-category of over-the-counter medicines are generally prohibited from being offered to patients for free, as in “buy one, get one free”, or other quantity-related promotions. Donating prescription-only medicines to patients in a charity activity is not explicitly regulated under current Chinese laws and regulations. However, it is widely understood that patient aid programmes (PAPs) are, by nature, a charity activity that aims to provide drug assistance to financially burdened patients seeking to obtain drugs that are critical to their lives. Offering free prescription-only medicines is not prohibited under charitable PAPs conducted by qualified persons.
Both over-the-counter medicines and prescription-only medicines can be advertised to healthcare professionals (other than the categories for which advertising is entirely prohibited under PRC law). For prescription-only medicines, the advertising should be marked “This advertisement is for medical and pharmaceutical professionals only” in a prominent position.
Otherwise, the requirements and prohibitions for advertising directed at healthcare professionals are similar to the requirements and prohibitions for advertising directed at the general public that were discussed in 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public and 4.2 Information Contained in Pharmaceutical Advertising to the General Public.
Under the Advertising Law and the Drug Administration Law, drug advertising may not refer to anything that is inconsistent with the medicine’s instructions (similar to the summary of product characteristics in Europe) as approved by the authorities. The Administrative Measures for Review of Drug Advertisements specify that, where a drug advertisement involves a drug name, indications or major functions, pharmacological effects, etc, it may not go beyond the scope of approved instructions. Therefore, advertising may not refer to data on file or other clinical studies that are not already included in the instructions.
Information on combination products needs to be included in a medicine՚s instructions (similar to the summary of product characteristics in Europe) under PRC law on the grounds that all usage information is legally required to be specified in a medicine՚s instructions. Therefore, in principle, there should be no information on combination products that is not included in the medicine’s instructions, and advertising of such information is prohibited in that it is inconsistent with the medicine’s instruction, as discussed in 5.2 Reference to Data Not Included in the Summary of Product Characteristics.
The law in China does not prohibit companies from providing reprints of journal articles to healthcare professionals. Although generally allowed under the RDPAC Code, quotations from medical and scientific literature or from personal communications should be faithfully reproduced (except where adaptation or modification is required in order to comply with any applicable regulations or administrative rules, in which case, it must be clearly stated that the quotation has been adapted and/or modified) and the precise sources identified. Quotations should not change or distort the intended meaning of the author or the significance of the underlying work or study.
Medical science liaison (MSL) is not a legal term under PRC law. However, medical representatives as professional personnel may assume some similar functions to those of MSLs as defined in the Administrative Measures for Medical Representatives, such as transmitting relevant information about medicines to healthcare professionals, assisting healthcare professionals in the rational use of the medicines, collecting and giving feedback on the clinical use of drugs and information on the demands of hospitals. The marketing authorisation holder (MAH) is required to file the information of its medical representatives and the medical representatives from contract sales organisations.
Although the law does not expressly prohibit medical representatives from discussing scientific information on unauthorised medicines or indications with healthcare professionals, according to the Administrative Measures for Medical Representatives, medical representatives are prohibited from undertaking drug sales targets, misleading doctors on the usage of drugs, etc.
As discussed in detail in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications and 3.3 Provision of Information to Healthcare Professionals, in practice, pharmaceutical companies in China are cautious about providing information on unauthorised medicines or unauthorised indications to avoid what might be constituted as illegal advertising.
As discussed at 4.1 Main Restrictions on Advertising Pharmaceuticals to the Public, drug advertisements should be reviewed and approved, and obtain an approval number for the drug advertisement. The validity period of the approval must be consistent with the shortest validity period of the medicinal product registration certification or the manufacturing permit, and if no valid period is prescribed in such documents, the valid period for the approval will be two years.
After the approval is granted, the local MPA will file the approved advertising with the NMPA for record. Approved advertisements may be published nationwide in accordance with the PRC law.
There is no legal requirement to adopt standard operating procedures (SOPs) or employ specific personnel. However, according to the RDPAC Code, a designated company employee with sufficient knowledge and appropriate qualifications should be responsible for approving all promotional communications. Alternatively, a senior company employee could be made responsible provided that they receive scientific advice on such communications from adequately qualified scientific personnel. In practice, large and medium-size pharmaceutical companies normally have their own SOPs guiding companies’ advertising practices in order to guarantee legal compliance. Legal and/or compliance teams or external counsel may be involved to conduct compliance reviews of certain advertisements.
If the company entrusts an advertising agency to provide advertisement design or production or agent services on a commission basis, the Advertising Law requires advertising agencies and advertisement publishers to inspect and verify the relevant certification documents, and check the advertising contents in accordance with the law and administrative regulations.
Under the Interim Measures for the Administration of Internet Advertising, internet advertising may take various formats such as text, images, audio, video, or other forms on websites, web pages, or in applications (such as WeChat). In addition to all the requirements and restrictions regarding advertising in general (see 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public and 4.2 Information Contained in Pharmaceutical Advertising to the General Public), a few additional requirements apply to internet advertising. For example, internet advertising cannot interfere with people’s normal use of the network. Online pop-ups should be clearly marked with a closing sign to ensure a one-click closure. Advertisers may not deceive users into clicking on the advertising content. No advertisement or advertisement link may be attached to the emails sent by advertisers or their agents without the recipient’s prior permission. It is also prohibited to publish advertisements for prescription drugs on the internet.
In addition, the entity providing information on pharmaceuticals to online users via the internet is subject to the Qualification for Internet Drug Information Services issued by the competent local MPA according to the Administrative Measures for Online Drug Information Services. It is also prohibited to publish product information on narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, medicines for drug rehabilitation treatment, and pharmaceutical preparations prepared by healthcare institutions on such websites that provide online pharmaceutical information.
The law in China does not explicitly require companies to include access restrictions on websites containing advertising or other information intended for healthcare professionals. In practice, many companies do have this arrangement in place, such as asking whether the user is a healthcare professional or conducting an identification verification before the user can access the contents on specific web pages or columns publishing scientific information on diseases and prescription drugs, to avoid being perceived as advertising prescription drugs to the public on the internet.
Provision of disease awareness information and/or materials to patients online is not legally prohibited but might be regarded by law enforcement as advertising if the information provided can be viewed as being promotional in nature or pointing to a specific product, as discussed in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.
According to a summary of the relevant laws, provision of disease awareness information and/or materials to patients online, or in other ways to the general public, must be compliant with the following requirements:
Pharmaceutical companies are generally allowed to sponsor online scientific meetings or attendance by healthcare professionals of these online events. As with sponsoring of off-line scientific meetings, bribery in any form, such as provision of a participation subsidy, is strictly prohibited (see 9.3 Sponsorship of Scientific Meetings).
PRC law is silent on the criteria required for an online meeting to be viewed as an “international” event. In practice, this generally depends on where the speakers and attendees come from. With reference to the RDPAC Code, it defines an “international” event as a scientific meeting where a significant proportion of the speakers and attendees come from countries other than the country in which the meeting takes place.
PRC law does not explicitly require prior authorisation in relation to healthcare professionals’ participation in online scientific meetings, while in practice, pharmaceutical companies normally require doctors to obtain prior consent from their working hospital to ensure healthcare professionals are permitted to participate. Under the RDPAC Code, healthcare professionals should be informed of the details of the intended medical interaction programmes in advance, especially for online interactions through push email, social media, etc.
Separately, there are no special statutory requirements on (i) sharing handouts, materials, etc, during an online conference; or (ii) accessing conference recordings, materials, etc, after the date of the conference. For handouts and materials of an advertising nature, see 5. Advertising to Healthcare Professionals. Also see 3.2 Provision of Information During a Scientific Conference, which discusses providing information on unauthorised medicines or unauthorised indications.
The Interim Measures for the Administration of Internet Advertising cover advertising on social media as part of “internet advertising”. Therefore, advertising on social media is generally allowed to the extent that internet advertising is allowed. Both pharmaceutical companies and their employees need to comply with the relevant medical advertising regulations as specified herein when publishing pharmaceutical advertisements on social media. If a pharmaceutical company or its employees illegally advertise drugs in social media articles, live streams or WeChat Moments, they will be punished.
The anti-bribery legal system includes laws at both the administrative and criminal levels.
At the administrative level, the legal framework regulating commercial bribery is set out by the Drug Administrative Law, the Anti-Unfair Competition Law, together with the Interim Provisions on Banning Commercial Bribery, and a number of replies by the former SAIC on the handling of commercial bribery acts. The Drug Administrative Law states that:
The key provision under the Anti-Unfair Competition Law states that business operators may not resort to bribery, by offering money or goods or by any other means, to any of the following entities or individuals, in order to seek a transaction opportunity or competitive advantage:
Penalties for violation include fines, confiscation of illegal gains and revocation of business licences in serious cases. The legal representative, main person-in-charge and directly responsible staff may be prohibited from engaging in drug production and distribution activities for life.
Public Healthcare Institutions
In practice, with respect to public-funded healthcare institutions, law enforcement takes the view that the purchasing of medicines “pierces” through the healthcare institution and should actually be viewed as transactions that take place between the pharmaceutical industry and the patients/medical insurance fund. Under this theory, the patients/medical insurance fund becomes the counterparty to the transaction, and both healthcare institutions and healthcare professionals, with their power to prescribe medicines to patients, fall into the scope of entities and individuals having the power or influence to affect a transaction. As a result, the general anti-bribery rules apply to benefits provided to healthcare professionals and benefits provided to public healthcare institutions.
Other than an administrative penalty, a pharmaceutical entity that conducts commercial bribery may also be discredited with an adverse record of commercial bribery by the provincial health commission. In this case, public medical institutions or medical and health institutions that receive financial funds from local government in that provincial region may not purchase medicines, medical equipment or medical supplies from such pharmaceutical entity within two years after the publication of the adverse records. If a pharmaceutical entity has adverse records of commercial bribery two or more times within five years, no public medical institutions or medical and health institutions that receive financial funds across the country can purchase medicines, medical equipment or medical supplies from that pharmaceutical entity. In addition, under the Guiding Opinions of National Healthcare Security Administration on Establishment of the Creditworthiness Evaluation System for Drug Pricing and Procurement by Bidding, if the pharmaceutical entity takes part in commercial bribery, it will have an adverse credit and may be subject to negative treatment such as a warning, automatic risk heads-up in centralised procurement, and even suspension of listing or procurement, tendering and delivery of drugs.
At a criminal level, the Criminal Law prohibits both individuals and entities from bribing several types of recipients. These include:
Penalties for individuals include fines or confiscation of property and criminal detention or fixed-term imprisonment ranging from three years to life imprisonment. For entities, penalties include fines and criminal detention or fixed-term imprisonment for up to five years for the responsible individuals.
The Drug Administration Law prohibits drug marketing licence holders, drug manufacturers, distributors and their agents from providing any property or other improper benefits to the responsible person, the procurement personnel, physicians, pharmacists and other relevant individuals of a health institution that uses their drugs. The listed categories of individuals are also prohibited from receiving these benefits.
Under the RDPAC Code, if a member company engages healthcare professionals to serve as the company’s consultants or advisers, one of the requirements for such an engagement is that the hiring of the consultants or advisers to provide the relevant service must not be an inducement to prescribe, recommend, purchase, supply and/or administer any medicine.
In regulatory practice, benefits provided to healthcare organisations for inducement to prescribe may be deemed as improper benefits and are therefore also forbidden. See 8.1 General Anti-bribery Rules Applicable to Interactions between Pharmaceutical Companies and Healthcare Professionals for further detail.
The Interim Provisions on Banning Commercial Bribery promulgated by the SAIC permit gifts of “small value” to be provided in the course of customary business practice and would not consider these to be commercial bribery. However, there is no legal guidance on the maximum amount of "small value".
Gifts (such as sporting or entertainment tickets, social courtesy gifts) for the personal benefit of healthcare professionals, either directly or through clinics and institutions, are prohibited under the RDPAC Code. Providing or offering cash, cash equivalents or personal services is also prohibited.
However, promotional aids of minimal value (not more than RMB100 in value per item) and minimal quantity may be provided or offered to healthcare professionals solely for the promotion of over-the-counter medicines if relevant to the practice of the healthcare professional. Similarly, items of medical utility to enhance the provision of medical services and patient care are also conditionally permitted under the RDPAC Code with a limit of RMB500 per item. Even if each individual item is appropriate, such offering should not be made on more than an occasional basis.
According to the RDPAC Code, samples of a limited quantity of a pharmaceutical product may be supplied directly to healthcare institutions so healthcare professionals can familiarise themselves with the product, but these should be delivered through a qualified third party. Samples should be marked so that they cannot be resold or otherwise misused. Member companies should have adequate systems of control and accountability for samples provided to healthcare professionals through healthcare institutions with respect to the distribution, delivery and acceptance of samples.
Pharmaceutical companies are generally allowed to sponsor scientific meetings and the attendance by healthcare professionals.
Under the Administrative Measures for Review of Drug Advertisements, the sponsored event cannot be titled the same as the name of any prescription-only medicine and cannot be titled the same as a trade mark or trade name that is identical to the name of a prescription-only medicine.
Under the RDPAC Code, member companies may sponsor healthcare professionals to attend medical interaction programmes if such sponsorship complies with the following requirements:
Under the Interim Provisions on Banning Commercial Bribery promulgated by the SAIC, commercial bribery includes both monetary bribery and other means, where “other means” refers to non-monetary benefits, such as tours and field trips in China or abroad.
Similarly, under the RDPAC Code, no entertainment or other leisure or social activities may be provided or paid for by member companies. Cultural, sports or other non-scientific events in relation to scientific conferences may easily fall into the scope of “entertainment or other leisure or social activities” and, therefore, are generally prohibited by the RDPAC Code.
Moreover, under the Nine Criteria, healthcare professionals are prohibited from participating in entertainment activities arranged, organised or paid for by pharmaceutical manufacturers, distributors or their agents.
Pharmaceutical companies may provide grants or donations to healthcare institutions in accordance with the Administrative Measures for the Receipt of Public Welfare Donations. However, pharmaceutical companies are not allowed to specifically appoint the healthcare professionals from the healthcare institutions as the recipients of donations.
Under the above Measures, the recipient institutions are encouraged to use a third-party agency to confirm the value of non-monetary donations, and the ways in which recipient institutions can spend the donations differ depending on the type of donations.
Additionally, in practice, donations of equipment or services may be higher risk than monetary donations because, in addition to potentially violating the Measures, a wrongful donation of equipment or services may also be seen as offering equipment or services in connection with the sale of medicines under the prohibited buy-one-give-one model, thus violating the Provisions for Supervision of Drug Distribution.
As discussed in 3.4 Provision of Information to Healthcare Institutions, the procurement of drugs in China is organised by the government through bidding on bidding platforms. The Drug Administration Law explicitly prohibits drug marketing licence holders, pharmaceutical manufacturers, distributors and healthcare institutions from giving or receiving rebates or other improper benefits in the purchase and sale of drugs.
Moreover, under the Nine Criteria, healthcare professionals are prohibited from accepting any rebate offered by pharmaceutical manufacturers, distributors or their agents in any name or form.
It is possible to pay for services provided by healthcare professionals at fair market value under certain circumstances. For example, companies may invite healthcare professionals to give lectures or to serve on the company’s advisory boards and attend board meetings.
The RDPAC Code sets out a large number of restrictions on the amount of payment allowed. Chief among these restrictions are: the hiring of the healthcare professional 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.
Companies’ SOPs may set out more specific restrictions on the amount of speaker fees, consultation fees and relevant expenses for meals and transportation, and may require employees to provide documents to prove the services provided by the healthcare professionals.
The law in China does not explicitly require prior authorisations or notifications in relation to gifts, hospitality, congresses and related payments described in this section. In practice, however, employers often do require that employees obtain prior consent from their employer before engaging in such activities.
In particular, doctors employed by medical institutions cannot practise outside the registered medical institution without due record-filing, and their personal activities are more closely managed by the registered medical institutions. Their activities in relation to gifts, hospitality, congresses and related payments described in this section will likely require the employer’s prior consent.
The law in China does not provide explicit disclosure requirements for pharmaceutical companies.
The RDPAC Code states that if material relating to pharmaceutical products and their uses, whether promotional in nature or not, is sponsored by a member company at medical interaction programmes between member companies and healthcare professionals, that material should clearly indicate by whom it has been sponsored. Medical interaction programmes hosted or sponsored by member companies, whether promotional in nature or not, should clearly indicate by whom they have been hosted or sponsored. If a member company sponsors medical interaction programmes organised by a third party, the above disclosure should be made subject to the knowledge and consent of the organiser.
Under the Administrative Measures for the Receipt of Public Welfare Donations, the recipient institution must establish a publication system for donation information and must publish donation receipt information to the society in an authentic, accurate, timely and complete manner via their web portals or local major news media.
There are no explicit legal transparency requirements targeting foreign companies. As self-regulatory codes are contractual in nature, if a company undertakes to be bound by certain self-regulatory codes, it will be subject to the same transparency requirements regardless of whether the company is domestic or foreign and regardless of whether its products are already on the market.
Until 2018, the SAIC and its local branches were responsible for enforcing the rules on advertising and the rules on inducement. Since the government restructuring in 2018, the SAIC has become part of the SAMR which, together with its local branches, is responsible for enforcement actions. The restructuring enabled the SAMR to combine the SAIC’s enforcement mechanism and the NMPA’s familiarity with the pharmaceutical industry, as a result of which, supervision of this industry has been strengthened.
The RDPAC Code
The RDPAC Code has also created its own dispute resolution system, providing member companies with the opportunity to file complaints against competitors and to request that the association enforce its rules through the established panel review, mediation or sanction procedures.
The People՚s Court
In the event that a pharmaceutical advertisement is recognised as false advertising, causing damage to the legitimate rights and interests of consumers, the consumers may file a lawsuit with the People’s Court and claim for damages.
Companies can initiate proceedings against competitors in court for advertising infringements on the basis of the Anti-Unfair Competition Law and the Civil Procedure Law. Companies may also file complaints against competitors with the SAMR or its local branches in accordance with the provisions in the Law on Administrative Penalty. Additionally, member companies may also initiate panel review or meditation procedures as established by the RDPAC Code.
The penalties or measures for violating medicines advertising rules are mainly found in the Advertising Law and the Administrative Measures for Review of Drug Advertisements. The penalties and measures include ordering the cessation of the publishing of the advertisement, ordering the advertisers to eliminate negative impact, imposing fines, confiscating advertising fees and revoking business licences and approval documents for the advertisement. The penalties can be imposed on the advertiser, the advertising agency or the advertising publisher. The penalties imposed are listed in the National Enterprise Credit Information Publicity System for public notification.
For example, in the case of false advertising, law enforcement will order that the advertisement be stopped and that the advertiser eliminate the negative impact. The advertiser may be fined, and its business licence may be revoked; further, the local MPA may revoke the advertisement’s review and approval document and not accept applications from the advertiser for one year.
In serious cases, there may also be criminal responsibilities. For example, false advertising may result in criminal detention or fixed-term imprisonment of up to two years for advertisers, advertising agencies or advertising publishers. Criminal fines may also be imposed separately or concurrently.
With regard to inducements to prescribe, if a case involves commercial bribery, then the penalties under the Anti-Unfair Competition Law and the Criminal Law discussed at 8.1 General Anti-bribery Rules Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals will become relevant.
There is no direct relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by the courts. The former is not a prerequisite for the latter. Specifically, regarding the RDPAC Code, there has yet to be any case where a court has considered a decision under the RDPAC Code as a basis for the court’s decisions.
From 2017 to date, an increasing number of cases have been investigated and penalised by the law enforcement authorities. This might be relevant to the 2018 government restructuring discussed in 11.1 Pharmaceutical Advertising: Enforcement Bodies. It is anticipated that cases related to pharmaceutical advertising might increase after the Administrative Measures for Review of Drug Advertisements have been implemented for a longer period of time and before the advertisers become familiar with the new rules, because they impose new requirements on advertisers and clearer guidance to law enforcement officials.
In practice, the main reasons that penalties are imposed on illegal pharmaceutical advertising include:
(1) the pharmaceutical advertising is published without approval;
(2) the pharmaceutical advertising of prescription-only drugs is publicly published on media other than the pharmaceutical or medical journals designated by the Ministry of Health and the NMPA;
(3) the pharmaceutical advertising does not list contraindications or adverse reactions and goes beyond the scope of its instructions; and
(4) the drugs advertised are not permitted to be advertised, eg, narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs.
In a recent high profile law enforcement case, an over-the-counter pharmaceutical company published its pharmaceutical advertising three times on a popular domestic variety show and was fined RMB900,000 for the reasons specified in bullet points one and three above. In March 2021, a branch of the SAMR in Shanghai imposed a fine of RMB200,000 on a pharmaceutical entity for the reasons specified in bullet points one and two above because the pharmaceutical entity had published an article via online media recommending a prescription-only drug.
In China, veterinary medicine advertising should also comply with the Advertising Law. In addition, the Regulations on the Administration of Veterinary Medicines and the Regulations on the Review and Publication of Veterinary Medicine Advertisements also stipulate the contents, publication and supervision of veterinary drug advertisements.
Veterinary medicine advertisements also need to be reviewed before they can be published. Veterinary medicine advertisements that are published in key national media shall be reviewed and approved by the veterinary administrative department under the State Council, and veterinary medicine advertisements that are published in local media shall be reviewed and approved by the provincial veterinary administrative department. The SAMR is responsible for the supervision and management of veterinary medicine advertising.
According to the laws and regulations in China, the following veterinary medicines may not be advertised:
In terms of the content, veterinary medicine advertisements must not:
If a company violates the relevant regulations, it will be required to stop publishing such advertisements, eliminate the impact, and will be fined or have its business licence revoked.
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China – the Regulation of Pharmaceutical Advertising in 2022
Following the amendments to the PRC Advertising Law in 2021 (with harsher penalties put in place), in China, 2022 was a year of generally smooth transition in respect of the legislation and regulation on pharmaceutical advertising. Meanwhile, newly emerging forms of advertising have turned out to be more active in the pharmaceutical area, bringing more tension and uncertainties regarding the legality of such new forms.
Developments in Legislation and Regulation
In general, 2022 provided no significant changes from the perspective of legislation or government supervision for pharmaceutical advertising in China. That said, some minor updates were still seen, along with the enactments of various implementing rules.
For example, the State Administration of Market Regulation (SAMR), aligned with other national ministries and commissions, released the Guideline on Further Regulating Celebrities’ Endorsements in Advertising on 31 October 2022. Specifically, with regard to pharmaceutical advertising, these guidelines provide that celebrities are not allowed to endorse medical treatment, drugs or medical devices, which serves as a re-emphasis of the regulation of pharmaceutical advertising under the PRC Advertising Law.
Additionally, starting from 20 June 2022, the district level of the health committee in Shanghai is delegated by the municipal health committee to review and grant approval on pharmaceutical advertising, in accordance with the decision of the Shanghai municipal government on Delegating a Batch of Administrative Review and Approval Matters (Hu Fu Gui (2022) No 1) and the Notice on Delegation of “Pharmaceutical Advertisement Review and Approval” (Hu Wei Yi Bian Han (2022) No 94) issued by the municipal health committee. The authority for reviewing pharmaceutical advertising has thus transitioned from the municipal level to the district level of the health committee.
Newly Emerging Forms of Pharmaceutical Advertising – Case Studies from a Regulatory Perspective
In light of the quarantine policy and travel restrictions imposed on China throughout much of 2022 due to the COVID-19 pandemic, online business has become increasingly popular, which has bred multiple new forms of activity – including online health-educational articles or TV programmes, online lectures, short videos/films, coupons, and even consumer reviews – that may likely fall within the scope of “advertising”, a concept of specific denotation under Chinese law.
According to Article 46 of the PRC Advertising Law, if any of the aforementioned newly emerging forms of activity is considered an advertisement, such promotional content will be subject to pre-screening procedures by the approval authority before formal launch. Given the unorthodox nature of these forms, it is likely to be difficult, and sometimes controversial, to identify whether they should be regarded as advertisements.
Some examples of these new forms of activity are discussed and analysed below in order to diffuse confusion, and this article is intended to help navigate these advertising-related “grey areas”.
Articles or TV programmes introducing health knowledge
As revealed from an administrative judgment by the Dalian Intermediate Court, for articles released on the official website of a hospital, if introducing a patient case with information on drugs and treatment for a specific disease, such article would be considered as mainly for promotional purposes and should thus constitute advertising. In this connection, if the hospital fails to go through the pre-approval procedures for pharmaceutical advertising, administrative penalties would be imposed.
Additionally, in accordance with a judgment by the Shashi District Court in Jinzhou City, if a TV programme broadcasts health or wellness lectures and actually provides specific drug information, such “lectures” would be considered advertisements. Failure to obtain the authority’s pre-approval would lead to administrative penalties being imposed on the relevant TV station.
Short films inserted into TV or online programmes
Short films which are inserted into a TV or online programme, with specific content promoting a drug, are also vulnerable to being penalised if the advertiser fails to go through the procedures of administrative pre-approval.
For example, a pharmaceutical company was fined by the Shanghai AMR after promoting its products in a short film that was inserted into a popular online talk show programme (the Roast Meeting). In the short film, the actors in the talk show programme orally introduced an ointment product, with promotional language including “colourless, tasteless and refreshing, this is really good and it can relieve itching quickly”. Such short films are considered advertisements and thus give rise to the aforementioned administrative penalties.
Pay-per-click advertising provided by online search engines
Pay-per-click (PPC) advertising, if involving pharmaceutical products or medical services, is also subject to regulatory requirements for pharmaceutical advertising.
This was indicated in an administrative decision by the AMR of Guangzhou City, where a company providing search engine services was punished for its PPC advertisements service.
In this case, a company purchased the keywords of “reducing blood sugar” from an online search engine to promote its medical treatment service. The promotional content retrieved from the said keywords included “the feedback from patients: blood sugar has dropped steadily”, which were ruled to be false advertisements. Additionally, the search engine company offered PPC advertisement services for pharmaceutical advertisements, in which the content actually released was inconsistent with that approved by the local health committee.
The AMR of Guangzhou City held that the search engine service provider was obliged to review the targeted advertising to be released (including to check whether it was false advertising or compliant with other applicable laws from a regulatory perspective) before providing its PPC advertising services. Since the search engine company failed to do so, the AMR of Guangzhou City decided to confiscate its illegal gains, and imposed a fine.
Links directing to sales pages of pharmaceutical products or medical treatment
Links directing to specific sales pages of pharmaceutical products or medical treatment are under the supervision of pharmaceutical advertising.
In accordance with an administrative decision of the AMR of Dongcheng District, Beijing Municipality, a company that was engaged in providing online video-on-demand (VOD) song request systems and the relevant operation of interstitial advertisements, was fined for displaying an on-screen link directing to sales pages of cosmetology services when a song was paused. The linked pages contained wording such as “photon skin rejuvenation full mode”, “whitening”, “spot lightening”, and “skin rejuvenation”, thus rendering the activity as being regarded as pharmaceutical advertising.
The AMR found that the VOD provider violated the law for failing to obtain pre-approval for pharmaceutical advertising. Moreover, as the price information contained in the directed link was inconsistent with the price information shown in the following pages for online purchasing, the advertisement was further found to be confusingly misleading. The VOD provider was subjected to an administrative fine of CNY300,000.
Coupons relating to pharmaceutical products or services
Providing coupons and/or promotional information for specific pharmaceutical products or services risks being considered as advertising by the relevant authority in certain scenarios.
As ruled by an administrative decision of the AMR in Haishu District, Ningbo City, promotional information relating to pharmaceutical services provided by a social media account through an article and the corresponding in-built applet would be subject to the regulation of advertisements.
In this case, the company operated a WeChat official account titled “Ningbo You Dian Niu” (meaning “Ningbo City is a little bit awesome”) and a relevant in-built applet. The company co-operated with a dental clinic to promote the relevant dental services, by means of:
The local AMR considered that the aforementioned content should be regarded as advertising. Given such content failed to be pre-approved by the health committee, the AMR imposed an administrative fine on the company.
Additionally, there was a case where provision of coupons for medical treatment services (even without specific accompanying promotional language) was taken to be advertising activity. As opined by the AMR in Xiaoshan Disctrict, Hanghzou, if the relevant medical institution provided coupons and promotional vouchers (indicating specific items of medical cosmetology with corresponding prices, and contact information of the medical institution) at conferences or lectures in the relevant industry, such activity would constitute advertising, and failure to obtain pre-approval from the health committee would be subject to administrative punishment imposed by the relevant authority.
Monetary incentives for positive consumer reviews
Consumer reviews towards specific goods or services are unlikely to be considered as advertisements in normal circumstances. That said, if the consumer reviews are made under monetary incentives provided by the sellers or service providers, it is possible that such reviews or comments would be regarded as advertisements, and thus be subject to regulation of applicable laws.
For instance, an aesthetic and medical company, by means of executing a “Diary Cashback Agreement”, entrusted its patients to publish a post-operative diary on the Soyoung platform (a popular forum and platform for communication of beauty and medical cosmetology in China), so as to generate positive publicity for the medical institution –whereby the institution would provide the patients with cash in return. Under such arrangement, a patient (Ms Huang) posted seven “diaries” within one year. The authorities in Shenzhen took the view that such patient reviews had actually fallen within the definition of advertising. Since the law prohibits hospitals from exploiting the names or images of patients in proving their medical services, such arrangement constituted a violation of the regulations in respect of pharmaceutical advertising.
Additionally, there have also been cases in Nanjing and Shanghai where operators in the medical cosmetology industry fabricated consumer reviews by engaging vendors in an illegal manner. Such activities were considered as misleading advertisements and violated the PRC Anti-unfair Competition Law. The cases were listed as the representative cases in the medical cosmetology field by the State Administration of Market Regulation (Third Batch) in 2021.
In light of what has been discussed in this article, the authors believe that it is critical for pharmaceutical companies and related advertising publishers to show initiative and adopt internal compliance protocols to review whether the aforementioned online health-educational articles or TV programmes, online lectures, short videos/films, coupons, and even consumer reviews will constitute advertising under the PRC Advertising Law.
In practice, two scenarios are worth heeding for internal regulatory protocols:
However, given that the intention of entrustment is implicit, the Chinese regulatory authorities will in any case have to check and identify whether the released content is directly connected to specific goods, services or promotional materials.
In general, if the information released by a third party is directly linked to the aforementioned content, a high possibility that the pharmaceutical company intends to entrust the third party with publishing advertisements can be inferred, and the authorities may investigate along this line to check whether such entrustment exists via verification of contracts or other communication records. In fact, if the newly emerging forms of materials are obviously false or misleading, or disparage the goods or services of competitors, the possibility of being reported and punished by the authorities will further increase.
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