Judgments of the Supreme Court

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2019 (Gyo-Tsu) 179

Date of the judgment (decision)

2021.03.18

Case Number

2019 (Gyo-Tsu) 179

Reporter

Minshu Vol. 75, No. 3

Title

Judgment concerning Article 36-6, paragraphs (1) and (3) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and Article 22, paragraph (1) of the Constitution

Case name

Case seeking injunction against designation of pharmaceuticals requiring guidance

Result

Judgment of the First Petty Bench, dismissed

Court of the Prior Instance

Tokyo High Court, Judgment of February 6, 2019

Summary of the judgment (decision)

The provisions of Article 36-6, paragraphs (1) and (3) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices are not in violation of Article 22, paragraph (1) of the Constitution.

References

Article 22, paragraph (1) of the Constitution and Article 36-6, paragraphs (1) and (3) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

The Constitution of Japan

Article 22. (1) Every person shall have freedom to choose and change his residence and to choose his occupation to the extent that it does not interfere with the public welfare.

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

(Provision of Information and Instructions on Pharmaceuticals Requiring Guidance)
Article 36-6 (1) When a proprietor of a pharmacy or a store-based distributer sells or provides pharmaceuticals requiring guidance, for ensuring the appropriate use thereof the proprietor of a pharmacy or the store-based distributer must have a pharmacist engaged in the sale or provision of pharmaceuticals at the pharmacy or at the store provide required information by using documents describing the matters specified by the Order of the Ministry of Health, Labour and Welfare (in the case where such matters are recorded in the form of an electronic or magnetic record, including the matters recorded in the form of an electronic or magnetic record that are indicated by using a method specified by the Order of the Ministry of Health, Labour and Welfare) and provide required instructions based on pharmacological findings, through a face-to-face consultation, pursuant to the provisions of the Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply to the cases where pharmaceuticals requiring guidance are sold or provided to pharmacists.

(3) In the cases provided in the main clause of paragraph (1), when a proprietor of a pharmacy or a store-based distributor is not able to provide information or instructions pursuant to the provisions of the same paragraph, or otherwise it is found that the appropriate use of pharmaceuticals requiring guidance cannot be ensured, the proprietor of a pharmacy or the store-based distributor may not sell or provide pharmaceuticals requiring guidance.

Main text of the judgment (decision)

The final appeal is dismissed.

The costs of the final appeal shall be borne by the appellant of final appeal.

Reasons

Concerning reasons for final appeal stated by the counsel for final appeal, IWAHASHI Takesada

No. 1 Outline of the case

1. Article 36-6, paragraphs (1) and (3) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (prior to amendment by Act No. 84 of 2013, this Act was titled the Pharmaceutical Affairs Act; hereinafter referred to as the "Act") (hereinafter the provisions of these paragraphs are collectively referred to as the "Provisions") provide as follows: when a proprietor of a pharmacy or a store-based distributer (hereinafter referred to as a "store-based distributor, etc.") sells or provides pharmaceuticals requiring guidance (Article 4, paragraph (5), item (iii) of the Act), the store-based distributor, etc. must have a pharmacist provide information and instructions based on pharmacological findings through a face-to-face consultation; and when a store-based distributor, etc. is not able to do so, it may not sell or provide pharmaceuticals requiring guidance.

Rakuten Direct, Inc., which was a company selling pharmaceuticals by mail to a person who is in a place other than a store or by other methods via the internet, alleged that the Provisions are in violation of Article 22, paragraph (1) of the Constitution and filed this case against the appellee to seek a declaratory judgment that it holds the right or position to sell some of the formulations designated as pharmaceuticals requiring guidance by the aforementioned methods. After the judgment in prior instance was rendered, the appellant absorbed Rakuten Direct, Inc. through absorption-type merger and succeeded to the company's rights and obligations.

2. Provisions of the Act, etc.

(1) Pharmaceuticals (excluding those intended exclusively for use on animals; the same applies hereinafter) are roughly divided into pharmacy-only pharmaceuticals (Article 4, paragraph (5), item (ii)), pharmaceuticals requiring guidance (item (iii) of the same paragraph), and OTC pharmaceuticals (item (iv) of the same paragraph), and pharmacy-only pharmaceuticals are defined as pharmaceuticals other than pharmaceuticals requiring guidance and OTC pharmaceuticals. Incidentally, pharmacy-only pharmaceuticals include pharmaceuticals used with a prescription or instruction (those supplied for use by a physician or dentist or for use based on a prescription or instruction given by a physician or dentist; the same applies hereinafter).

Both pharmaceuticals requiring guidance and OTC pharmaceuticals (hereinafter referred to as "OTC pharmaceuticals, etc.") are considered to refer to pharmaceuticals without any serious effect on the human body in terms of their efficacy or effects, which are intended to be used by way of a consumer's choice based on information provided by a pharmacist or other medical industry professionals. Out of OTC pharmaceuticals, etc., pharmaceuticals requiring guidance are pharmaceuticals set forth in (a) to (d) of Article 4, paragraph (5), item (iii) of the Act that are designated by the Minister of Health, Labour and Welfare as those requiring provision of information and instructions based on pharmacological findings by a pharmacist through a face-to-face consultation for ensuring the appropriate use thereof, after seeking the opinion of the Pharmaceutical Affairs and Food Sanitation Council. OTC pharmaceuticals are defined as OTC pharmaceuticals, etc. excluding pharmaceuticals requiring guidance.

The provisions of Article 4, paragraph (5), item (iii), (a) to (d) of the Act set forth poisonous drugs ((c) of the same item) and deleterious drugs ((d) of the same item), in addition to pharmaceuticals that have been determined to be obviously different from pharmaceuticals [which have been] already approved for marketing in terms of active components, quantity, dosage, administration, efficacy or effects, etc. at the time of filing of an application for marketing approval therefor, and for which a period specified by the Order of the Ministry of Health, Labour and Welfare has not expired from the day of approval to which the application relates ((a) of the same item) and pharmaceuticals that have been found to be identical with the pharmaceuticals referred to in (a) of the same item in terms of active components, quantity, dosage, administration, efficacy or effects, etc. at the time of filing of an application for marketing approval therefor, and for which a period specified by the Order of the Ministry of Health, Labour and Welfare has not expired from the day of approval to which the application relates ((b) of the same item).

(2) The Act provides that a store-based distributor, etc. must have a pharmacist sell or provide pharmaceuticals requiring guidance (Article 36-5, paragraph (1)).

In addition, the Act also provides as follows: [i] when a store-based distributor, etc. sells or provides a pharmaceutical requiring guidance, for ensuring the appropriate use thereof, it must have a pharmacist provide required information by using documents describing the prescribed matters and provide required instructions based on pharmacological findings, through a face-to-face consultation (Article 36-6, paragraph (1)); [ii] when a store-based distributor, etc. has a pharmacist conduct the aforementioned provision of information and instructions, it must have the pharmacist confirm the age, usage status of other medicines or pharmaceuticals, etc. of a person who intends to use the relevant pharmaceutical requiring guidance in advance (paragraph (2) of the same Article); [iii] when a store-based distributor, etc. is not able to conduct the aforementioned provision of information or instructions or it is found that the appropriate use of the pharmaceutical requiring guidance cannot be ensured, it may not sell or provide the pharmaceutical requiring guidance (paragraph (3) of the same Article).

On the other hand, regarding the case where a store-based distributor, etc. sells or provides OTC pharmaceuticals, the Act does not require a store-based distributor, etc. to provide required information through a face-to-face consultation although it provides that there are cases where a store-based distributor, etc. must have a pharmacist provide required information in accordance with the category of OTC pharmaceuticals (Article 36-10).

3. The outline of the facts lawfully determined by the court of prior instance is as follows.

(1) Rakuten Direct, Inc. was a store-based distributor that had obtained a license under Article 26, paragraph (1) of the Act with respect to operations to sell or provide OTC pharmaceuticals, etc. at a store, and was a company that had been selling pharmaceuticals via the internet since before June 12, 2014, the date of enforcement of Article 1 of the Act Partially Amending the Pharmaceutical Affairs Act and the Pharmacists Act (Act No. 103 of 2013) that provides for addition of the Provisions to the Pharmaceutical Affairs Act.

(2) OTC pharmaceuticals, etc. include switch OTC pharmaceuticals, which are pharmaceuticals that were approved for marketing as pharmaceuticals used with a prescription or instruction, and for which another marketing approval was newly obtained as being those that are intended to be used by way of a consumer's choice based on information provided by a pharmacist or other medical industry professionals, and direct OTC pharmaceuticals, which are pharmaceuticals that had previously not been approved for marketing even on the premise of use as pharmaceuticals used with a prescription or instruction, and for which marketing approval was newly obtained as being those that are intended to be used by way of a consumer's choice based on information provided by a pharmacist or other medical industry professionals.

The following handling is adopted for switch OTC pharmaceuticals: when granting marketing approval to a switch OTC pharmaceutical, the obligation to implement investigation on safety after marketing (hereinafter referred to as "investigation after marketing") is imposed, in principle, on a person who receives the approval as a condition of the approval under Article 79, paragraph (1) of the Act. The period of the investigation is, in principle, three years.

Direct OTC pharmaceuticals are, in principle, handled as the subjects of reexamination as new pharmaceuticals provided in Article 14-4, paragraph (1), item (i) of the Act. The period designated as the period of investigation for reexamination is ordinarily four to eight years depending on the degree of difference from pharmaceuticals that have already been approved for marketing.

Switch OTC pharmaceuticals with the obligation to implement investigation after marketing, for which the period of the investigation has not expired, and direct OTC pharmaceuticals made subject to reexamination, for which the period of investigation therefor has not expired, are to fall under Article 4, paragraph (5), item (iii), (a) and (b) of the Act as being those for which a period specified by the Order of the Ministry of Health, Labour and Welfare referred to in (a) and (b) of the same item (Article 7-2 of the Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices) has not expired. Of these pharmaceuticals, switch OTC pharmaceuticals and direct OTC pharmaceuticals designated as pharmaceuticals requiring guidance are assessed with regard to the advisability of their sale as OTC pharmaceuticals, in principle, for three years and for four to eight years, respectively. If such pharmaceuticals are confirmed to have no problem, they are to be transferred from pharmaceuticals requiring guidance to OTC pharmaceuticals.

(3) The number of items of pharmaceuticals that fall under the category of OTC pharmaceuticals was 10,374 as of May 30, 2016. On the other hand, the number of items of pharmaceuticals that fall under the category of pharmaceuticals requiring guidance for which sales activity started was 20, including five items that are deleterious drugs, as of June 12, 2014, and the relevant number has been hovering within the range of just about 14 to 23. The size of market for overall OTC pharmaceuticals, etc. was about 894,400,000,000 yen in fiscal 2014 and was about 938,500,000,000 yen in fiscal 2015. Of which, the size of market for pharmaceuticals requiring guidance was about 5,100,000,000 yen in fiscal 2014 and was about 2,600,000,000 yen in fiscal 2015.

No. 2 Concerning the argument that the Provisions are in violation of Article 22, paragraph (1) of the Constitution out of the reasons for final appeal

1. The counsel for final appeal argues that the judgment in prior instance that determined the Provisions, which require that pharmaceuticals requiring guidance be sold or provided by a pharmacist through a face-to-face consultation, to be constitutional contains an error in the interpretation of Article 22, paragraph (1) of the Constitution.

2.(1) Article 22, paragraph (1) of the Constitution guarantees not only the freedom to choose occupation in a narrow sense but also the freedom of occupational activity. As control measures against the freedom of occupation take various forms according to circumstances, their conformity to the same paragraph cannot be uniformly argued. The conformity of a specific control measure to the same paragraph must be carefully determined after considering and weighing the purpose, necessity, and content of the control as well as the nature and content of the freedom of occupation restricted by the control and the degree of the restriction. In this case, the legislative body primarily has the authority and responsibility to conduct the aforementioned consideration and weighing. As long as the purpose of control is found to conform to public welfare, the court should respect a determination made by the legislative body concerning the specific content, necessity, and reasonableness of control measures therefor as legislative policy-related issues as long as the determination remains within the scope of the legislative body's reasonable discretion. The scope of reasonable discretion can naturally be broad or narrow in terms of the nature of the matter (see 1968 (Gyo-Tsu) No. 120, the judgment of the Grand Bench of the Supreme Court of April 30, 1975, Minshu Vol. 29, No. 4, at 572).

(2)A. The purpose of the Act is to improve health and hygiene by providing the control required for securing the quality, efficacy and safety of pharmaceuticals, etc. and for preventing the occurrence or spread of health and hygiene-related hazards caused by the use of those pharmaceuticals, etc. (Article 1). Pharmaceuticals have the risk of producing harmful side effects together with therapeutic efficacy and effects. Out of such pharmaceuticals, pharmaceuticals requiring guidance are pharmaceuticals for which the period of investigation after marketing or the period of investigation for reexamination has not expired and for which safety assessment as pharmaceuticals intended to be used by way of a consumer's choice has not been fixed. The Provisions provide that such pharmaceuticals requiring guidance must be sold or provided by a pharmacist through a face-to-face consultation for ensuring the appropriate use thereof, for the purpose of preventing infringement of the lives and health of the people by the inappropriate use thereof and thereby preventing the occurrence and spread of health and hygiene-related hazards. Such purpose clearly conforms to public welfare.

B. Pharmaceuticals requiring guidance are not chosen by a physician or dentist but are intended to be used by way of a consumer's choice. As mentioned above, their safety assessment as pharmaceuticals has not been established. It should be considered considerably reasonable to require a pharmacist, when selling or providing a pharmaceutical requiring guidance, to collect the maximum information about a person who intends to use it, give appropriate instructions, and confirm the person's understanding of the content of the instructions without fail by providing that a pharmacist must confirm the age, usage status of other medicines or pharmaceuticals, etc. of a user of a pharmaceutical requiring guidance in advance, in order to achieve the purpose of the Provisions as mentioned above.

In addition, the Provisions are considered to be based on the premise of the following evaluation: provision of information and instructions by methods other than a face-to-face consultation, including the use of telephone or email, is inferior to that conducted through a direct face-to-face consultation in terms of confirmation of a relevant person's understanding; for example, through a face-to-face consultation, a pharmacist can confirm the person's understanding of the points to be explained or emphasized without fail by giving flexible responses in light of the response, atmosphere, situation, etc. of the person in the course of direct exchange and conversation; however, methods other than a face-to-face consultation have to solely depend on exchanges by voice, text, etc. Said evaluation cannot be considered to be unreasonable.

C. Pharmaceuticals requiring guidance prescribed in Article 4, paragraph (5), item (iii) of the Act are the only OTC pharmaceuticals, etc. for which sale or provision by a pharmacist through a face-to-face consultation is required. The size of the market for such pharmaceuticals remains at less than 1% of all pharmaceuticals requiring guidance and OTC pharmaceuticals. Those other than poisonous drugs and deleterious drugs are to be assessed with regard to the advisability of their sale as OTC pharmaceuticals within a certain period of time and transferred to OTC pharmaceuticals if there is no problem. The period of control under the Provisions is thus limited.

In light of such market size for pharmaceuticals requiring guidance and the period of control thereof, the Provisions, which require that pharmaceuticals requiring guidance be sold or provided by a pharmacist through a face-to-face consultation, cannot be considered to impose any restriction on the freedom to choose occupation itself. Needless to say, it remains control on the content and form of occupational activities, and it also cannot be considered to be significantly restrictive.

D. In light of the purpose, necessity, content of the control under the Provisions as examined above and the nature and content of the freedom of occupation restricted thereby and the degree of the control, it cannot be said that the determination that the control under the Provisions are necessary and reasonable exceeds the scope of the legislative body's reasonable discretion.

(3) Therefore, it cannot be said that the Provisions are in violation of Article 22, paragraph (1) of the Constitution.

The above should be considered to be clear in light of the purport of the judgment of the Grand Bench of this Court (1970 (A) No. 23, the judgment of the Grand Bench of the Supreme Court of November 22, 1972, Keishu Vol. 26, No. 9, at 586). The arguments made by the counsel for final appeal are not acceptable.

No. 3 Concerning other reasons for final appeal

The arguments made by the counsel for final appeal are alleging unconstitutionality but lack a premise and do not constitute any of the grounds provided in Article 312, paragraphs (1) and (2) of the Code of Civil Procedure.

Accordingly, the Court unanimously decides as set forth in the main text of the judgment.

Presiding Judge

Justice KOIKE Hiroshi

Justice IKEGAMI Masayuki

Justice KIZAWA Katsuyuki

Justice YAMAGUCHI Atsushi

Justice MIYAMA Takuya

(This translation is provisional and subject to revision.)