Marunouchi Soleil Law Office
Familiar with the business related to beauty and health, he is active as a team leader of the "Health & Beauty Team" at the legal office of Marunouchi Soleil. Many seminars and lectures on advertising regulations, landscape law, medicinal machine law, and special commercial law.
In Japan, when manufacturing and selling pharmaceuticals and medical devices, approval of efficacy and safety by the Ministry of Health, Labor and Welfare is required, but there are many treatments with unapproved pharmaceuticals and medical devices that have not been approved.
Advertising of the name and efficacy of unapproved drugs and medical devices in order to sell them is prohibited by the Pharmaceutical Machinery Law. Respecting that purpose, advertising of unapproved drugs and medical devices is prohibited in principle even in the "Medical Advertising Guidelines", but advertising is possible on websites that meet certain conditions . We will check in what cases it will not be a violation.
In Japan, in addition to pharmaceuticals and medical devices, there is the so-called "Pharmaceutical Machinery Law," which is a law for ensuring quality, effectiveness, and safety in quasi-drugs and cosmetics.
The official name of the Pharmaceutical Machinery Law is "Act on Securing Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Law)", and when importing or manufacturing and selling pharmaceuticals and medical devices, It stipulates that approval by the Ministry of Health, Labor and Welfare is required .
The purpose of approval by the Ministry of Health, Labor and Welfare is to prevent the circulation of harmful or defective products in medicines and medical devices that affect human life and health. Therefore, approved drugs and medical devices are approved by the Ministry of Health, Labor and Welfare for their efficacy, efficacy and safety .
However, not all medicines and medical devices used in medical institutions in Japan have been approved by the Ministry of Health, Labor and Welfare. There are some treatments with drugs and medical devices that have not been approved. In particular , many of the drugs and medical devices in Japanese beauty care are unapproved , and the number of treatments with approved drugs and medical devices is smaller.
Drugs and medical devices that have not been approved by the Ministry of Health, Labor and Welfare are called "unapproved drugs" and "unapproved (medical) devices ."
In Japan, it is possible for doctors to import overseas pharmaceuticals and medical devices for use in treatment, and treatments using unapproved devices (including pharmaceuticals) are permitted .
Since unapproved drugs and pharmaceutical devices are not approved for sale in Japan, if a medical institution is performing treatment using unapproved devices (including pharmaceuticals), the doctor of the medical institution will import them individually. It will be. To obtain it, the doctor himself imports it from overseas or asks an import agency to import it.
In this case, the Ministry of Health, Labor and Welfare has not completed the procedures for approval and permission of pharmaceutical products, etc., but it is possible to import and use them by submitting a "medicine supervision certificate" at the time of customs clearance. The drug supervision certificate will be issued on the spot if there are no deficiencies by submitting the required documents to the competent welfare bureau (local branch office of the Ministry of Health, Labor and Welfare) and meeting the requirements.
Only the importer, the doctor, can use the imported medicines and medical devices. If the medical institution has multiple doctors, each doctor can use the medicines and medical devices by performing the import procedure .
Import of unapproved equipment (including pharmaceuticals) is permitted only if it meets any of the following purposes.
A) Imported for personal use a) Imported for use by doctors for treatment c) Imported for company-based clinical tests d) Imported for doctor- or dentist-based clinical tests e) For test research and in-house samples Imported into) Imported for employee training G) Imported for exhibitions) Imported (re-imported)
K) Imported as a raw material for poisonous / deleterious substances or pharmaceuticals (self-consumption)
E) Imports to work places other than home or post office general delivery) Other imports
In Japan's aesthetic medicine, the background to the large number of treatments using unapproved medicines and medical devices is the problem that approval takes money and time.
The actual approval review work is undertaken by the Pharmaceuticals and Medical Devices Agency (PMDA), and the Ministry of Health, Labor and Welfare will be notified of the review results when the review work by PMDA is completed. Upon receiving the notification, the Ministry of Health, Labor and Welfare discusses with the Pharmaceutical Affairs and Food Sanitation Council (Pharmaceutical Affairs Subcommittee) and reports approval or disapproval to the applicant.
PMDA is an independent administrative agency, Pharmaceuticals and Medical Devices Agency (PMDA), which provides prompt relief for health hazards caused by side effects of pharmaceuticals and infections through biological products (health hazard relief). , Guidance and examination (approval examination) from pre-clinical trial to approval regarding the quality, efficacy and safety of pharmaceuticals and medical devices, and collect, analyze and provide information on post-marketing safety. Through (safety measures), we aim to contribute to the improvement of national health.
Source: PMDA "What is PMDA?"
In addition, in order to apply for approval, a clinical trial (clinical trial) must be conducted to obtain results for approval. Although clinical trials cost a lot of money, there is no certainty that approval may not be obtained because the criteria for efficacy are not clear in aesthetic medicine. Therefore, it can be said that only a limited number of manufacturers spend money and time to obtain approval.
On the other hand, it is said that it is easier to obtain approval overseas than in Japan, probably because there are few countries like Japan where individual import of unapproved equipment by doctors is permitted. In the United States, there are many applications for approval examination due to the wide market of medical devices and the progress of technological development, and in South Korea, the period of approval examination is stipulated by law and the fee is low. Approval circumstances for (including pharmaceuticals) are different.
Therefore, even if it is not approved in Japan, it has been approved by the US FDA (Food and Drug Administration), which is the Ministry of Health, Labor and Welfare of Japan, and has obtained the CE mark certifying that it meets the European safety standards. There are many cases where approval has been obtained from .
In the case of treatment with pharmaceuticals and medical devices that have not been approved by the Ministry of Health, Labor and Welfare, the individual doctor will be responsible for any troubles, and "it will take time to deliver because it is necessary to send money overseas". Consumables are also unapproved and must be imported each time. ”Tends to take more time and effort than approved equipment. Although the burden is heavier than approved devices, doctors are legally permitted to use unapproved medicines and medical devices .
However, caution is required when advertising unapproved drugs and medical devices, and advertising of pre-approved drugs and medical devices is prohibited under Article 68 of the Pharmaceutical Machinery Law . Even if it is approved by the FDA (Food and Drug Administration), it will not be included in the "advertiseable items" unless it is treated with drugs or medical devices approved in Japan.
The medical advertising guidelines stipulate what can be advertised in medical advertisements. The content that can be advertised is called "advertiseable matter", and in principle, only "advertiseable matter" can be advertised .
Since the advertiseable items do not include the therapeutic effect, in principle, the therapeutic effect cannot be advertised regardless of whether it is approved or not . However, in the medical advertising guidelines, if it is a website that displays information that patients, etc. request and obtain by themselves, or other similar advertisements, the following "requirements for releasing restrictions on advertiseable items" can be stated for medical devices ( It is also stipulated that advertisements (including posting of product photos) regarding the product name, manufacturing method, efficacy, effect or performance of (pharmaceutical products) are possible .
For websites that display information that patients, etc. request and obtain by themselves, and other similar advertisements, the restrictions on advertiseable items can be released by stating the following "Requirements for releasing restrictions on advertiseable items". I will. Normally, there are only 1 to 4 requirements for releasing the restrictions on advertiseable items, but for treatments using unapproved drugs and medical devices, it is necessary to describe 5 or less in addition to this.
For 6 to 8, the following description is required.
Medical device (or drug) acquisition route: Private import by doctors
Please also check "Pharmaceuticals that should be noted when importing personally" (Ministry of Health, Labor and Welfare website) .
There is no device (pharmaceutical product) that has the same performance (efficacy) as ○○ and has been approved in Japan.
○○ is a device (pharmaceutical product) that has the same performance (efficacy) as ○○ and has been approved in Japan.
○○ has been approved by the FDA (US Food and Drug Administration) for improving acne scars and fine wrinkles. The side effects of this approval are as follows.
Mild inflammation, swelling, redness, itch (all side effects listed)
When stating that approval has been obtained overseas, it is kind to describe the effect for which approval has been obtained, as approval is obtained for each effect / efficacy .
For example, suppose that the medical device A is said to "thinn stains," "improve pore problems," and "have a hair removal effect." However, there are cases where the hair removal effect is approved but not the improvement of spots and pore problems.
On the other hand, if there are no approved countries in major Western countries, it means that there is a lack of information, so it is necessary to clarify that serious risks may not be revealed. It is said that it will not be.
According to the Medical Advertising Guidelines, if any of the following requirements are met, it will be judged as an advertisement.
Beauty medical institution (clinic) sites are advertisements because they are "attractive" and "specific".
In addition, since the pamphlets distributed in the hospital are limited to patients who have already undergone medical examinations on the receiving side, they are not "attractive", so they are positioned as information provision rather than advertisements, and it is possible to introduce unapproved devices.
If you advertise a treatment using an unapproved device without satisfying the restriction release requirements, you will be advertising a matter that is not possible to advertise and it will violate the Medical Care Act, so the administration such as a suspension order requesting the suspension of advertising it may be subject to disposal. In addition, if you do not comply with administrative sanctions, you may be subject to criminal penalties (fines and imprisonment) .
When advertising treatments using unapproved devices, it is necessary to make sure that the restriction release requirements are met.