3 February 2021
The Taichung Branch of the Taiwan High Court rendered the 109-Shang-Su-1298 Decision (hereinafter, the “Decision”), holding that pursuant to Article 22, Paragraph 2 of the Pharmaceutical Affairs Law, a prohibited drug must be a drug stipulated under the Pharmaceutical Affairs Law.
According to the facts underlying this Decision, A was obviously aware that the importation of a drug requires an application to the Ministry of Health and Welfare (hereinafter, the “MOHW”) for registration and for a drug license. Otherwise, the drug would be regarded as a prohibited drug imported without authorization. However, A still imported drugs (hereinafter, the “Products at Issue”) via an auction website from mainland China to Taiwan without authorization and without an approval from the competent authority for sale on an auction website in the name of OO Mall. And then A would send the Products at Issue to the buyers who had entered the bids.
According to the Decision, Article 22, Paragraph 2 of the Pharmaceutical Affairs Law specifically provides that so-called “prohibited drugs” shall refer to “the poisonous or harmful drugs which are prohibited, by an order publicly announced by the central competent health authority, from manufacturing, dispensing, importing, exporting, selling or displaying” or “the drug which are imported without prior approval.” Therefore, a “prohibited drug” must be a drug[1] stipulated under Article 6 of the Pharmaceutical Affairs Law.
The Decision further indicated that since the test results of the Products at Issue did not reveal Chinese and Western pharmaceutical ingredients and the properties could not be identified, there was no way to conclude that they are the drugs under Article 6 of the Pharmaceutical Affairs Law.There is no doubt that the drug is by nature provided for the treatment and prevention of disease or is sufficient to affect the structure and physiological functions of the human body. However, when an article is yet to be defined or qualified, if it is concluded as a drug simply because it is used for the treatment and prevention of human diseases, regardless of its composition and its effect on the structure and physiological function of the human body, the conclusion is not only drawn too loosely and broadly but also the function of the actual law to regulate things will not be achieved. If a certain article absolutely cannot treat or prevent diseases or lacks the function or effect sufficient to affect the structure and physiological functions of the human body, it does not become an effective drug simply because it is used for the treatment and prevention of diseases. Articles which are by nature foods, foodstuffs or health foods (i.e., the health foods defined under Article 2 of the Health Food Control Law) should not certainly be regarded as drugs simply because they are intended to be used for treating or preventing disease or affecting physiological functions.
[1] The drugs under Article 6 of the Pharmaceutical Affairs Law refer to the following raw materials and preparations: drugs which are listed in the Chinese Pharmacopoeia, or in the Pharmacopoeia of other countries, the official National Formularies or any of their supplements recognized by the central competent health authority (Subparagraph 1); drugs which are not included in the preceding subparagraph but are used in diagnosing, curing, alleviating or preventing the diseases of human beings (Subparagraph 2); other drugs which are sufficient to affect the body structure and physiological functions of human beings (Subparagraph 3); or drugs which are used in preparing such drugs set forth in the preceding three subparagraphs (Subparagraph 4).
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