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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?
The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act) regulates the advertising and promotion of medicinal products and medical devices. Under the PMD Act, the following elements are required for the advertisement to be recognised as an advertisement for pharmaceuticals and medical devices:
The PMD Act prohibits advertisements for pharmaceuticals and medical devices that:
In addition to the PMD Act, the Good Advertising Standards for Drugs, notified by the Ministry of Health, Labour and Welfare (HLW), prohibit the advertising of drugs and regenerative medicine products supplied for use by physicians or dentists with prescriptions, or instructions from such physicians or dentists.
Further, the Act Against Unjustifiable Premiums and Misleading Representations (AUPMR) generally regulates advertising. Unjustified or misleading advertising is prohibited.
The Act on Specified Commercial Transactions generally requires businesses who advertise on the internet for services enabling the consumer to receive an order through mail, telephone or email to display certain information in such advertisements, such as price, timing and method of payment.
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 Guidelines for Ethical Drug Marketing Information Provision Activities, published by the HLW Ministry, specify marketing information provision activities that must be conducted by marketing authorisation holders of drugs, their consignees and partners, medical representatives, medical science liaisons and drug wholesalers on appropriate advertising or actions similar to advertising in the marketing information provision activities of ethical drugs.
Sales information provision activities must satisfy all of the following requirements;
It is prohibited to engage in any of the following acts in sales activities so as not to induce improper use or misuse:
The fair competition codes, which are voluntarily established by trade associations with respect to matters relating to representations or premiums and are approved by the Fair Trade Commission and the Director General of the Consumer Affairs Agency based on the AUPMR, prohibit unfair inducement. The Fair Competition Code for Prescription Drugs prohibits pharmaceutical companies from offering premiums to medical institutions as a means of unjustly enticing them to trade in prescription drugs.
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?
Under the Clinical Research Act 2018, a manufacturer with marketing approval for pharmaceuticals that provides benefits to an entity that conducts clinical research, such as research funds or other benefits, must enter into an agreement specifying the amount and details of such research funds or other benefits as well as other matters specified by an HLW Ministry ordinance.
In addition, a manufacturer with marketing approval for pharmaceuticals must make information publicly available on the provision of money or other benefits (excluding research funds or other benefits) to a person who conducts clinical research or a person who has a special relationship with such a person as specified by an HLW Ministry ordinance, transparency of which is to be ensured to contribute to ensuring the confidence in clinical research by the use of the internet or other means specified by the relevant ordinance.
The Japan Pharmaceutical Manufacturers Association has established its Code of Practice and Code of Conduct for all executives and employees of its member companies to interact with researchers, medical professionals and patient groups. In addition, to ensure the transparency of cooperation with research and medical institutions, among others, member companies are required to prepare guidelines on transparency and disclose the details of funding to medical institutions. Such details include research and development expenses, manuscript writing fees, lectures and meeting expenses to be published on their websites each fiscal year.
The Japan Federation of Medical Device Associations has also established its Guidelines for Transparency with Medical Institutions in the Medical Device Industry to ensure and improve the transparency and reliability of relationships between member companies and medical institutions. As a company that plays a part in medical care, member companies of the associations are strongly required to put patients first and implement highly transparent corporate activities rooted in a high level of ethics. They are also required to disclose information on payments to medical institutions.
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.
Based on the PMD Act, the HLW Ministry may issue a business improvement order to a business operator that advertises in violation of the PMD Act.
In addition, the Ethical Drug Advertising Activity Monitoring System is now active, as commissioned by the HLW Ministry. The HLW Ministry selects medical institutions to be monitors, has them report cases in which they have received advertising materials used for inappropriate advertisement and sales information from pharmaceutical companies, and evaluates them through a review committee composed of experts with the aim of utilising them in administrative guidance.
The Product Information Review Committee of the Japan Pharmaceutical Manufacturers Association has prepared a voluntary code for the purpose of ensuring that member companies comply with the rules regarding the creation and use of promotional materials, found in the Prescription Drug Promotion Codes contained in the Pharmaceutical Manufacturers Association Code of Practice. The committee conducts mutual reviews under a self-regulatory framework.
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
Under the PMD Act, breaches of restrictions on advertising pharmaceuticals for specified diseases and regenerative medicine products can be punished with imprisonment with labour for up to one year or a fine of up to ¥1 million, or both.
The following can be punished with imprisonment with labour for up to two years or a fine of up to ¥2 million, or both:
In addition to the above, an administrative monetary penalty of 4.5 per cent of sales is imposed in the case of false or exaggerated advertising for pharmaceutical products.
Under the PMD Act, media that carries advertisements can be sanctioned, in addition to manufacturers of pharmaceuticals and medical devices.
Breaches are also subject to suspension orders from the HLW Minister or prefectural governors.
If false information is believed to have been used, the secretary general of the Consumer Affairs Agency (CAA) can ask the advertiser to substantiate the information in accordance with the AUPMR. If the advertiser provides evidence of the information but it is found to not prove the claims, the CAA’s secretary general can issue a cease and desist order, and an administrative monetary penalty of 3 per cent of sales related to the goods and services shall be charged for up to three years with respect to misrepresentation of good quality.
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
Yes. Article 30-9 of the Stimulants Control Act, as revised and enacted on 1 April 2020, sets out the requirements for the dispensing or sale of raw materials for stimulants. Furthermore, the Narcotics and Psychotropics Control Act, as revised and enacted on 1 August 2021, establishes the necessary regulations for the production and distribution of narcotics and psychotropics.
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
With regard to medicinal products, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act) was reformed on 1 April 2022 to repeal the requirement that face-to-face consultation is necessary when a prescription is first dispensed to a patient. In Japan, online prescription consultation for certain drugs was provisionally legalised in April 2020 to deal with the covid-19 pandemic. This reform made online prescription consultation permanently legal.
On the other hand, for over-the-counter (OTC) drugs, a licensed pharmacy can sell Types I to III pharmaceuticals online but not pharmaceuticals that require guidance if the pharmacy obtains a licence to sell online. Several requirements, including those listed below, must be satisfied to obtain such a licence:
Furthermore, when selling OTC drugs online, the licensed pharmacy must disclose on its website certain information, and pharmacists and registered sales representatives are required to provide information and consultation services just as they do in the physical stores.
For medical devices, there are no general rules regarding online dispensing, sale and supply. However, regulatory instructions concerning appropriate sales are sometimes provided by the relevant authority, depending on the items.
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?
Pharmaceuticals are broadly classified into two categories: ethical drugs and OTC drugs.
Ethical drugs are drugs prescribed by doctors in medical institutions for use in treatments covered by health insurance, the price of which is listed in the National Health Insurance (NHI) Drug Price Standards. The cost of drugs listed in these standards will be reimbursed by national security systems. As at July 2022, there are approximately 13,000 ethical drugs on the list.
OTC drugs, on the other hand, are drugs that do not require a prescription and can be purchased at pharmacies. The prices of OTC drugs are referred to as the manufacturer's suggested retail price or selling price, which is the same as the price of ordinary products.
For a newly approved pharmaceutical to be included in the NHI Drug Price Standards (and become an ethical drug), an application to be included in the standard is necessary. A marketing authorisation holder usually makes this application after the approval is granted.
When the application is made, the Minister of Health, Labour and Welfare will determine the NHI drug price by using either of the following methods and notify the applicant of the determined price:
The NHI price of a drug, once established, is subject to review every two years.
For generic drugs and biosimilars, the NHI drug prices will be determined at the lower rate when first listed in the NHI Drug Price Standards )50 per cent of the original drug for a generic drug and 70 per cent of the original drug for biosimilars). The NHI prices of these drugs are also subject to modification every two years.
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