Advertising Unapproved Drugs: Medical Advertising Guidelines and Website Operation Precautions | TASAKI PHAMA

Medical Advertising Guidelines Regarding Advertising of Unapproved Drugs

The Pharmaceuticals and Medical Devices Act (PMD Act) and medical advertising guidelines impose strict regulations on the advertising of unapproved drugs. These regulations are crucial for protecting public health and safety. At Tasaki Pharma, we comply with these regulations and strive to provide appropriate information.

Unapproved drugs refer to drugs that have not been approved as pharmaceuticals in Japan. Although they may be approved overseas, information on their indications and safety may not be sufficiently established in Japan because they have not undergone procedures such as clinical trials. Therefore, advertising of unapproved drugs is generally prohibited.

The medical advertising guidelines strictly restrict the advertising of unapproved drugs, as it may be considered “exaggerated advertising” or “false advertising.” Specifically, it is prohibited to publish information about the efficacy or safety of unapproved drugs that is not based on scientific evidence, or to use expressions that suggest superiority compared to approved drugs. Definitive expressions such as “completely cures” or “absolutely safe” should be avoided, as they may mislead patients. For example, even if a drug is approved overseas for a specific type of cancer (e.g., Pembrolizumab, Nivolumab), advertising that guarantees its efficacy is not permitted if it is unapproved in Japan.

Information on unapproved drugs should also be provided carefully on medical institutions’ websites and in-house postings. It is important to ensure the accuracy and objectivity of the information and avoid misleading expressions, as it may be considered advertising.

Limited Exemption and Consent Forms for Posting Unapproved Drugs on Websites

The medical advertising guidelines include provisions for “limited exemption” regarding the advertising of unapproved drugs. This means that advertising of unapproved drugs is exceptionally permitted only if certain conditions are met. The conditions for limited exemption are very strict, and medical institutions are required to respond carefully.

The main conditions for limited exemption are as follows:

• Clearly state that the drug is unapproved.
• Clearly state the route of acquisition (e.g., personal import from overseas).
• Provide information on the existence and information of drugs approved in Japan.
• Provide information on safety (side effects, risks, etc.).
• Provide information on treatment costs.
• Clearly state the consultation service for unapproved drugs.

When posting this information on websites or in-house postings, it is important to explain it in plain language so that patients can easily understand it. It is also necessary to update the information regularly and always provide the latest information.

When using unapproved drugs, it is essential to obtain consent from the patient. The consent form should include detailed information on the name, efficacy, safety, side effects, risks, and treatment costs of the unapproved drug, and the patient should sign it after fully understanding it. The consent form also plays an important role in building a relationship of trust between the medical institution and the patient and reducing legal risks.

As for the drug name to be stated in the consent form, it is desirable to include the generic name (e.g., Pembrolizumab), the English name (e.g., Keytruda), and the brand name as necessary. The specific type of cancer to be treated (e.g., non-small cell lung cancer, melanoma) should also be specified so that patients can make a decision based on their own condition.

Precautions for Providing Information on Unapproved Drugs

Information on unapproved drugs must be provided carefully and accurately under the responsibility of the medical institution. In addition to complying with the medical advertising guidelines, it is important to prioritize the interests of patients and strive to provide appropriate information.

Please note the following points when providing information:

• Provide information based on scientific evidence.
• Provide objective information.
• Avoid exaggerated or misleading expressions.
• Provide the latest information.
• Answer patients’ questions carefully.

For example, it is important to refer to information published by public institutions such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and provide patients with information from reliable sources. However, caution is required because overseas information may differ from the situation in Japan.

It is desirable to clearly indicate a consultation service for unapproved drugs on the medical institution’s website or in-house postings and to establish a system that allows patients to consult easily. It is also effective to establish a training system so that medical professionals such as pharmacists and nurses can fully acquire knowledge about unapproved drugs and respond appropriately to questions from patients.

Summary

Advertising of unapproved drugs is strictly regulated by medical advertising guidelines. When a medical institution posts information on unapproved drugs on its website, it is necessary to meet the conditions for limited exemption and obtain consent from the patient. When providing information, it is important to provide accurate information based on scientific evidence and prioritize the interests of the patient.

The use of unapproved drugs can be a new treatment option for patients, but it also involves risks. Medical institutions need to provide patients with sufficient information and support them so that they can choose treatment at their own discretion. Tasaki Pharma will contribute to the health and safety of patients by cooperating with medical institutions and supporting the provision of appropriate information on unapproved drugs.