Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
To publish advertisements for medicinal products and medical devices, approval from the local drug regulatory authority is necessary.
Advertisements should be identifiable so that consumers can identify them as advertisements. The mass media must not publish advertisements disguised in the form of news reports. Advertisements published through the mass media must be clearly marked as advertisements, be distinguished from other non-advertising information and not mislead consumers. Except for advertisements for medical care, drugs and medical devices, any advertisements involving the function of treating a disease is prohibited, and no medical terms or terms that may confuse the promoted products with drugs and medical devices is allowed.
Special drugs (eg, narcotic drugs, psychotropic substances, toxic drugs for medicinal use and radioactive drugs), pharmaceutical precursor chemicals, medicines, medical devices and methods for drug dependence treatment cannot be advertised (this includes internet advertising). Other prescription drugs can only be advertised in medical and pharmaceutical publications designated by the competent authority.
Advertisements for drugs and medical devices must not contain the following content:
- assertions or guarantees of effectiveness and safety;
- descriptions of the cure rate or efficiency rate;
- comparisons in terms of effectiveness and safety;
- the use of advertising spokespersons for recommendation and certification; and
- other content prohibited by law and administrative regulations.
Drug and medical device advertisements published on websites should be reviewed and approved by the drug regulatory authority. The word ‘advertisement’ and the serial number of the advertisement review approval should be indicated. Promotional articles and videos on internet medical platforms that specify the manufacturers of drugs or medical devices and explain the efficacy of their use will be recognised as advertisements for drugs or medical devices and, therefore, are also subject to review and approval.Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
The Anti-Unfair Competition Law stipulates that distributors shall not use goods or other means to bribe the following entities or individuals to seek business opportunities or competitive advantages:
- the staff of the counterparty to the transaction;
- the entity or individual entrusted by the counterparty to handle the relevant affairs; and
- the entity or individual who uses their power or influence to affect the transaction.
The above regulations apply to drug and medical device manufacturers or distributors promoting products to medical and nursing staff.
The Chinese Physician Ethics Code requires that physicians shall not conduct research that is contrary to science and ethics because of funding from pharmaceutical enterprises and shall not promote any medical products or conduct academic promotion for personal benefit. Physicians shall not participate in or accept banquets or gifts, or travel, study, visit or carry out any other leisure and social activities that affect the impartiality of medical treatment, and must provide reports and explanations in the event of enterprises’ funding for public interest, clinical research or academic promotion in accordance with the regulations.Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
The Circular on the Issuance of Opinions on Strengthening Pharmaceutical Management in Medical Institutions to Promote Rational Use of Drugs stipulates that medical institutions must publicise and file invitations to academic conferences, training programmes, among others, that are organised or sponsored by enterprises.
The Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices stipulate that the marketing authorisation holder must record the names of medical representatives on the website designated by the competent authority and make them public. The academic promotional activities of medical representatives must be carried out openly and filed with the designated departments of medical institutions.
The Circular on the Issuance of the Administrative Measures for the Acceptance of Public Welfare Donations by Health and Family Planning Entities (Trial) provides that medical institutions receiving donated goods should disclose and publicise information about the donated goods and their uses.
The Chinese Physician Ethics Code requires that for research funded by pharmaceutical enterprises, physicians should declare the presence of funding when publishing, displaying or advocating research results.
Enforcement of advertising rulesEnforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
The regulatory bodies for drug and medical device advertisements are mainly the drug regulatory authority and the market supervision authority. Advertisements for drugs and medical devices are reviewed by the drug regulatory authority before publication. After making a review decision, the drug regulatory authority will copy the approval documents to the market regulatory authority at the same level. For websites that provide internet drug (including medical device) information services, they must obtain the internet drug information service qualification certificate issued by the provincial drug regulatory authority.Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Depending on the severity of the violation, there are different penalties. The types of penalties include fines, confiscation of advertising fees, revocation of business licences, revocation of advertising registration certificates, cancellation of the advertiser’s advertising review approval documents and suspension of the advertising application review for one year. The fine is generally between 200,000 and 1 million yuan. If the act constitutes the crime of false advertising, then the advertiser, advertising operator and advertising publisher will face a fixed-term imprisonment of up to two years or criminal detention, with or without a fine.
Pricing and reimbursementPricing
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
Medicine prices are determined by either the government or the market. Government-priced drugs are limited to narcotic drugs and first-class psychotropic drugs. The prices of all other drugs are set by the market, as the control of circulation margins has been abolished and the distributors set the prices on their own.
The scope of the basic medical insurance drugs is managed through the formulation of the Basic Medical Insurance Drug List. The cost of drugs included in the List is paid by the basic medical insurance fund in accordance with national regulations, and the prices of exclusive drugs are determined through access negotiations. For non-exclusive drugs, the state organises centralised procurement, the procedure of which determines the prices. The payment standards of other non-exclusive drugs are determined by an access bidding method. Narcotic drugs and first-class psychoactive drugs, which are government-priced, are paid at the price set by the government.
At present, public hospitals implement a ‘zero-profit’ policy for drug pricing, which means public hospitals sell drugs to patients at their original purchase price. However, private hospitals and pharmacies do not apply this policy.
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
Some medicinal products, such as vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs, are subject to special regulations. The Vaccine Administration Act strictly regulates research, registration, circulation, vaccination, etc, in respect of vaccines. Furthermore, the State Council promulgated a series of regulations for these specially regulated drugs, including Regulations on Control of Narcotic and Psychotropic Drugs (revised in 2016) and Administrative Measures for Control of Radioactive Drugs (revised in 2017). In addition, all those specially regulated drugs are prohibited from online distribution.Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
The following regulations are mainly applied to online distribution of drugs and medical devices:
Drug Administration Law (revised on 26 August 2019)
E-Commerce Law (revised on 31 August 2018)
Cybersecurity Law (revised on 7 November 2016)
Regulations for the Implementation of the Drug Administration Law (revised on 2 March 2019)
Regulation on the Supervision and Administration of Medical Devices (revised on 9 February 2021 )
Administrative Measures for Internet Information Services (revised on 8 January 2011)
State Council departmental rules
Measures for the Supervision and Administration of the Online Sale of Medical Devices (revised on 20 December 2017)
Measures for the Supervision and Administration of Medical Devices (revised on 17 November 2017)
Measures for the Administration of Drug Information Service over the Internet (revised on 17 November 2017)
Good Supply Practice for Pharmaceutical Products (issued on 13 July 2016)
Measures for the Supervision and Administration of Circulation of Pharmaceuticals (issued on 31 January 2007)
Other regulatory documents
Good Supply Practice for Medical Devices (issued on 12 December 2014)
Interim Regulations on Approval of Internet Drug Trading Services (issued on 25 December 2005)