The Supreme Court rendered the 108-Tai-Shang-788 Criminal Decision of April 11, 2019 (hereinafter, the “Decision”), holding that import of drugs made in mainland China to Taiwan shall be regarded as an import under Article 40 of the Statute for Relations Between the People of the Taiwan Area and the Mainland Area, and drugs imported without authorization should be deemed prohibited drugs under Article 22, Paragraph 1, Subparagraph 2 of the Pharmaceutical Affairs Law.
According to the facts underlying this Decision, the original decision reversed the portion that imposed an imprisonment penalty on Appellant Yi-ling Yang in first instance decision, and Yi-ling Yang was sentenced, instead, to two years and six months in prison for committing an offense of importing counterfeit drugs. Dissatisfied, the Appellant appealed.
Article 20 of the Pharmaceutical Affairs Law provides: “The term ‘counterfeit drugs’ as used in this Law shall refer to the drugs which are found to fall within any of the following circumstances after inspection or testing: (1) the drugs are manufactured without prior approval; (2) the active ingredients of the drugs are inconsistent with the ingredients thereof previously approved; (3) the drugs are packed or adulterated with the products of others; or (4) the shelf life marking or label of the drugs has been altered or replaced.” However, it was pointed out in this Decision that poisonous or harmful drugs whose manufacture, dispensing, import, export, sale or display is announced to be prohibited pursuant to a specific directive issued by the central health authority, or the drugs which are imported without prior approval of the central health authority, except that the drugs are carried into this country for personal use by passengers or service personnel on board of the means of transportation, shall be the prohibited drugs within the meaning of the Pharmaceutical Affairs Law, as specifically stipulated under Article 22, Paragraph 1, Subparagraphs 1 and 2 of the same law.
It was further pointed out in this Decision that in fact drugs made in mainland China, cannot be approved by the health authorities in Taiwan and cannot be supervised or managed. If drugs made in mainland China are imported or carried into Taiwan, it will be regarded as an import under Article 40 of the Statute for Relations Between the People of the Taiwan Area and the Mainland Area, and if the drugs are imported without authorization, they should be deemed prohibited drugs under Article 22, Paragraph 1, Subparagraph 2 of the Pharmaceutical Affairs Law. Therefore, the counterfeit drugs and prohibited drugs under the Pharmaceutical Affairs Law are different concepts.
According to this Decision, therefore, Appellant Yi-ling Yang was found in the original decision to have purchased yellow capsules containing western medicinal ingredients such as chlorpheniramine, or dexamethasone and black pills containing western medicinal ingredients such as glibenclamide, phenformin from an unknown location in Shenzhen of Guangdong Province in mainland China for importation to Taiwan. If the finding was accurate, the imported drugs should be prohibited drugs according to the above explanation. The original decision violated laws and regulations for inappropriate application of laws since the drugs were regarded as counterfeit drugs and an penalty for an offense of importing counterfeit drugs was imposed. In addition, in consideration of other errors in the original decision as asserted by the Appellant, the portion concerning Yi-ling Yang in the original decision was reversed and remanded.