Judgments of the Supreme Court

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2018 (A) 1846

Date of the judgment (decision)

2021.06.28

Case Number

2018 (A) 1846

Reporter

Keishu Vol. 75, No. 7

Title

Decision concerning the meaning of the act of "advertising, describing or circulating statements" as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013)

Case name

Case charged for violation of the Pharmaceutical Affairs Act

Result

Decision of the First Petty Bench, dismissed

Court of the Prior Instance

Tokyo High Court, Judgment of November 19, 2018

Summary of the judgment (decision)

1. The act of "advertising, describing or circulating statements" as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013) means the act of notifying and informing many and unspecified persons of the matters prescribed in the same paragraph concerning a specific pharmaceutical, etc. as a means for encouraging the purchase, prescription etc. of the pharmaceutical, etc.

2. It is reasonable to objectively determine whether a notification can be considered to be a notification that was made as a means for encouraging the purchase, prescription, etc. of a specific pharmaceutical, etc., as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013), while taking into account the content, nature, form, etc. of the notification.

3. Based on the facts of this case (see the text of the judgment), including the fact that the accused submitted academic papers summarizing the results of auxiliary analysis, etc. of a clinical test using a medication for treating high-blood pressure to professional academic journals and had them published in the journals, publication of the same papers in the same journals cannot be considered to be a notification made as a means for encouraging the purchase, prescription, etc. of a specific pharmaceutical, and it thus does not fall under the act as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013).

(There is a concurring opinion concerning 1.)

References

(Concerning 1 to 3) Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013)

Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013)
Article 66 (1) No person must, explicitly or implicitly, advertise, describe or circulate false or exaggerated statements regarding the name, manufacturing process, efficacy and effects or performance of pharmaceuticals, quasi-pharmaceutical products, cosmetics or medical devices.

Main text of the judgment (decision)

The final appeals are dismissed.

Reasons

The reasons for final appeal stated by the public prosecutor, including the argument of violation of a judicial precedent, are substantially arguments of a mere violation of laws and regulations and an erroneous finding of facts, and do not constitute any of the reasons for a final appeal as referred to in Article 405 of the Code of Criminal Procedure.

In consideration of the public prosecutor's arguments, the Court determines, by its authority, whether the crime of violation of Article 66, paragraph (1) of the Pharmaceutical Affairs Act (prior to amendment by Act No. 84 of 2013; the same applies hereinafter) is established.

1. The summary of the charged facts of this case (hereinafter referred to as the "Charged Facts") is as follows.

Accused Company A (hereinafter referred to as the "accused company") is a stock company running the business of manufacturing, selling, and otherwise handling pharmaceuticals, etc., and Accused B (hereinafter referred to as the "accused") is a person who was in charge of operations to analyze or otherwise handle clinical data with regard to a clinical test conducted by physicians who belong to the graduate school of medicine of Medical University D by using a medication for treating high-blood pressure, X, which is manufactured and sold by the accused company (trade name: Y) (hereinafter this clinical test is referred to as the "Clinical Test") as well as subanalysis or auxiliary analysis conducted based on the results of the Clinical Test. In relation to the business of the accused company, the accused described false statements regarding the efficacy and effects of pharmaceutical X by the following acts, respectively: (1) in preparing a paper concerning the auxiliary analysis of the Clinical Test regarding the effects of the combined use of X and a calcium antagonist, which is a medication for treating high-blood pressure, in order to use the results of the auxiliary analysis for the accused company's advertising materials, etc., together with E, who is the chief researcher of the Clinical Test, and F, etc., who are the researchers engaging in the Clinical Test, the accused provided F, etc. with the data of false figures, etc., which the accused had created by dividing the test subjects into administration groups without being based on the definition adopted in the same paper, overstating the numbers of events of brain stroke, etc. for the groups of the test subjects to whom other medicines were administered, which were confirmed in the Clinical Test, and describing values that are not based on the analysis results in relation to the values that serve as the indicators of whether there is a statistically significant difference, and had F, etc. make false statements based on said data, including a statement to the effect that the use of X in combination with another medicine or the additional administration of X reduced the incidence rate of angina and brain stroke significantly compared with other cases in English in the text of the manuscript of the same paper and had F, etc. place the same figures, etc. in the manuscript of the same paper, and also had F submit the manuscript of the same paper to an academic journal issued by a journal publisher having its head office overseas and have the same paper published on the website of the same publisher, thereby making the same paper available for many and unspecified persons; (2) in preparing a paper concerning the subanalysis of the Clinical Test regarding the effects of additional administration of X to high-risk hypertensive patients having a coronary disease, in order to use the results of the subanalysis for the accused company's advertising materials, etc., together with E and G, etc., who are the researchers engaging in the subanalysis, the accused provided G, etc. with the data of false figures, etc., which the accused had created by overstating the number of events of brain stroke, etc. for the groups of the test subjects to whom other medicines were administered, which were confirmed in the Clinical Test, and by conducting analysis on the premise of the same overstatement, and had the same persons make a false statement based on said data to the effect that in the case of the test subjects with a history of a coronary disease, the incidence rate of brain stroke was significantly lower for the group of the test subjects to which X was administered than the groups of the test subjects to whom other medicines were administered in English in the text of the manuscript of the same paper and had G, etc. place the same figures, etc. in the manuscript of the same paper, and also had G submit the manuscript of the same paper in an academic journal published by a journal publisher having its head office overseas and have the same paper published on the website managed by the same publisher, thereby making the same paper available for many and unspecified persons.

2. Article 66, paragraph (1) of the Pharmaceutical Affairs Act provides that "no person must, explicitly or implicitly, advertise, describe or circulate false or exaggerated statements regarding the name, manufacturing process, efficacy and effects or performance of pharmaceuticals, quasi-pharmaceutical products, cosmetics or medical devices."

Regarding the facts, in the judgment in first instance, the court basically found the facts stated in the Charged Facts. However, the court ruled that the act as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act is the act of widely notifying and informing the public of the matters prescribed in the same paragraph as a means for inducing customers and that the act of "describing statements" must also be conducted for the same means. The court then determined as follows: the act of having prepared the papers stated in the Charged Facts (hereinafter referred to as the "Papers") and submitting them to the journals stated in the Charged Facts (hereinafter referred to as the "Journals") to have them published in the Journals is the same as the act of publishing a general academic paper in an academic journal and does not have the nature of the aforementioned means; therefore, that act does not fall under the act of "describing statements" as controlled by the same paragraph. Based on this determination, the court acquitted the accused and the accused company. In the judgment in prior instance, the court also ruled that the act as controlled by the same paragraph must constitute a means for inducing customers (having the nature of a means for induction) and adopted an interpretation that is almost to the same effect as the judgment in first instance. The court of prior instance also upheld the determination in the judgment in first instance concerning whether the accused's act falls under the same paragraph and dismissed the appeals filed by the public prosecutor.

3. The public prosecutor argues as follows: the act of "describing statements" as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act refers to the act of describing the matters prescribed in the same paragraph and widely informing the public of them, and is not required to have the nature of a means for induction; in addition, even if it is considered that the nature of a means for induction needs to be found, the accused's act also falls under the act of "describing statements" as it is found to have the same nature.

The purpose of the Pharmaceutical Affairs Act is to improve health and hygiene by providing the control required for securing the quality, efficacy, and safety of pharmaceuticals, quasi-pharmaceutical products, cosmetics, and medical devices (hereinafter referred to as "pharmaceuticals, etc.") (Article 1), and the same Act imposes strict controls on the manufacturing and sale, etc. of pharmaceuticals, etc. in order to achieve that purpose. In light of the history, etc. of controls on the advertisement of pharmaceuticals, etc. in Japan, in addition to such purpose and intention of the same Act, Article 66, paragraph (1) of the same Act is considered to be aimed at preventing the occurrence of health and hygiene-related hazards caused by the act of having users, including general consumers, or physicians, etc. who prescribe pharmaceuticals, have an erroneous recognition and having them choose, take, or otherwise handle pharmaceuticals, etc. that cannot be considered appropriate as a result of the transmission of false or exaggerated information about the efficacy, effects, etc. of pharmaceuticals, etc., which are commodities and products. In light of such purport of the same paragraph and its interests protected by law, it is reasonable to consider that the act of "advertising, describing or circulating statements" as controlled by the same paragraph refers to the act of notifying and informing many and unspecified persons of the matters prescribed in the same paragraph regarding a specific pharmaceutical, etc. as a means for encouraging the purchase, prescription, etc. thereof.

In consideration of the purport of Article 66, paragraph (1) of the Pharmaceutical Affairs Act as mentioned above and its interests protected by law, how a notification concerning a specific pharmaceutical, etc. is perceived by the recipient of the notification is an important element in determining whether the notification falls under the same paragraph. It is reasonable to objectively determine whether a notification can be considered to be made as a means for encouraging the purchase or prescription, etc. of a specific pharmaceutical, etc., as controlled by the same paragraph, while taking into account the content, nature and form, etc. of the notification.

According to the findings of the judgment in first instance and the judgment in prior instance, as well as the case records, the following facts are found: the Papers are academic papers summarizing the results of the auxiliary analysis and subanalysis of the Clinical Test, which was conducted by researchers belonging to a graduate school of medicine of a medical university as well as physicians, and were written by researchers; the Papers were prepared regarding new medical findings that were allegedly obtained as a result of the same auxiliary analysis, etc. in accordance with standard practice for preparing ordinary academic papers by disclosing the purpose, method, conditions, etc. of the research, indicating the researchers' considerations, and additionally stating the limits of the research; both of the Journals which the Papers were submitted to and published in are professional academic journals in the field of medicine that require peer-review. In light of such content and nature of the Papers and the nature, etc. of the Journals, the main readership of the Papers that were published in the Journals is assumed to be researchers and professionals in the field of medicine, such as physicians, and the submission of the Papers to the Journals and their publication in the Journals can be considered to be the presentation of academic research results to professionals in the same field by the researchers who wrote them. It can be said that such presentation of academic research results in a professional academic journal is, in terms of its nature, naturally expected to be exposed to observation and criticism by professionals in the same field and to be confirmed to be reasonable through discussions, including critical opinions. The nature, etc. of information transmission by publishing the Papers in the Journals as mentioned above does not change due to the accused's act stated in the Charged Facts.

For the reasons described above, the publication of the Papers in the Journals cannot be considered to be a notification made as a means for encouraging the purchase, prescription, etc. of a specific pharmaceutical, and it thus should be considered not to fall under the act as controlled by Article 66, paragraph (1) of the Pharmaceutical Affairs Act.

Therefore, the crime of violation of Article 66, paragraph (1) of the Pharmaceutical Affairs Act is not established in relation to the accused, and the dual criminal liability provisions for the crime are also not applicable to the accused company. The conclusion of the judgment in prior instance to the same effect as above is justifiable.

4. Accordingly, in accordance with Article 414 and Article 386, paragraph (1), item (iii) of the Code of Criminal Procedure, the Court unanimously decides as set forth in the main text of the decision. There is a concurring opinion of Justice YAMAGUCHI Atsushi.

The concurring opinion stated by Justice YAMAGUCHI Atsushi is as follows.

I completely agree with the Court's opinion, but I would like to express my concurring opinion.

The interpretation in the Court's opinion that the act of "describing statements" in question must be conducted as a means for encouraging the purchase, prescription, etc. of a specific pharmaceutical, etc. in order to be included in the subject of control by Article 66, paragraph (1) of the Pharmaceutical Affairs Act was drawn through clarification of the purpose and intention, etc. of the same Act and the same paragraph, and was not drawn by the process of limited interpretation of law in a constitutional manner, which is conducted to ensure compliance with the Constitution that guarantees the freedom of expression and academic freedom, etc. Nevertheless, if wide-ranging acts of preparing, submitting, and publishing academic papers, such as the act in this case, are made subject to the control under the same paragraph, it can probably produce an chilling effect on academic activities that cannot be ignored, because academic papers fall within the core of academic activities and because the subject of control by the same paragraph also includes the act of "describing" not only false but also exaggerated "statements." Therefore, it will consequently pose a problem in relation to academic freedom guaranteed by the Constitution. I would like to additionally state this point.

Presiding Judge

Justice YAMAGUCHI Atsushi

Justice IKEGAMI Masayuki

Justice KOIKE Hiroshi

Justice KIZAWA Katsuyuki

Justice MIYAMA Takuya

(This translation is provisional and subject to revision.)