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  • Interpretation
  • No.767【Patients Who Have Common and Foreseeable Adverse Drug Reactions Are Not Eligible for Drug Injury Relief】
  • Date
  • 2018/07/27
  • Issue
    • Is Article 13, Subparagraph 9 of the Drug Injury Relief Act, which excludes patients having the common and foreseeable adverse drug reactions from drug injury relief, in violation of the principle of clarity and definiteness of law (Rechtsbestimmtheitprinzip), or the principle of proportionality?
  • Holding
    •        Article 13, Subparagraph 9 of the Drug Injury Relief Act provides: “[a] person who has the conditions below is not eligible for any drug injury relief: …. 9. The common and foreseeable adverse reactions from drug usage.” This provision does not violate the principle of clarity and definiteness of law (Rechtsbestimmtheitprinzip) or the principle of proportionality. Neither does the provision contravene the constitutional protections of the right of existence, the right to health, nor the intention of Article 10, Paragraph 8 of the Additional Articles of the Constitution that the state should emphasize medical and health care as well as social welfare services.
  • Reasoning
    •        The petitioner Yuan-Chi Tzeng alleged that she was hospitalized in the National Taiwan University Hospital due to continuous high fever on September 23, 2007. During hospitalization, the petitioner was diagnosed with military nontuberculous mycobacterial infections and malignant lymphoma, and the physician treated her diseases with the drug “Amikin” containing the component amikacin. The drug caused ototoxic adverse reactions that deprived the petitioner of her hearing. The petitioner was diagnosed with bilateral hearing loss on January 14, 2008 (the medical certificate said that amikacin in the drug caused bilateral loss hearing). She was later evaluated to be of severe hearing impairment and moderate physical handicap on August 13, 2009 and subsequently applied for drug injury relief on October 12, 2009.The Drug Injury Relief Committee of the Department of Health of the Executive Yuan (which is now under the Ministry of Health and Welfare of the Executive Yuan due to governmental reorganization) reviewed this case in its 128th meeting on June 8, 2010 and denied the petitioner’s eligibility for drug injury relief. The Department of Health of the Executive Yuan made the Letter Shu-Shou-Shi-0991408756 on July 6, 2010 (hereinafter “the Original Administrative Disposition”) accompanying with the review result and the Committee meeting minutes to the Taiwan Drug Relief Foundation, recommending it deal this case according to the review results and regulations concerning drug injury relief. The petitioner filed an administrative appeal but was denied by the Administrative Review Yuan-Tai-Su-0990108400. The petitioner then brought an action against the foregoing administrative decisions. The Taipei High Administrative Court Judgement 100-Su-421 (2011) reversed the Original Administrative Disposition and the Administrative Review and ordered the authority to approve the petitioner’s application for drug injury relief. The Supreme Administrative Court Judgement 101-Pan-66 (2012) nevertheless vacated and remanded the previous judgement to the Taipei High Administrative Court. The Taipei High Administrative Court Judgement101-Su-Geng-Yi-49 (2012) dismissed the petitioner’s action. The Supreme Administrative Court Judgement 102-Pan-485 (2013) (hereinafter the “Final Decision No.1”) dismissed the petitioner’s meritless appeal as the final judgement. The petitioner initiated a rehearing action, which remained to be dismissed by the Supreme Administrative Court Judgement 102-Pan-780 (2013) (hereinafter the “Final Decision No.2”).
      
    •        Articles 13, Subparagraph 9 of the Drug Injury Relief Act (hereinafter “the provision at issue”) applied in the Final Decision Nos.1 and 2 provides: “[a] person who has the conditions below is not eligible for any drug injury relief: …. 9. The common and foreseeable adverse reactions from drug usage.” The petitioner contended that the provision at issue excluded people who use drug properly but suffer from “common and foreseeable” adverse reactions from receiving reliefs. According to the petitioner, the provision at issue was not predictable for regulated persons and contravened the principle of clarity and definiteness of law (Rechtsbestimmtheitprinzip). The provision at issue also lacked reasonable legislative purposes and legitimacy in conflict with the principle of proportionality. It also violated Article 22 of the Constitution, Article 10, Paragraph 7 and Paragraph 8 of the Additional Articles of the Constitution. The petitioner thereby brought an action to this Constitutional Court for interpretation. This Court decided that the action complied with the requirements set forth in Article 5, Paragraph 1, Subparagraph 2 of the Constitutional Court Procedure Act and should be admitted. We hereby render this Interpretation based on the following reasons:
      
    •        The state should emphasize social welfare works, such as social relief and assistance, welfare services, social insurance and medical care. Priority should be given to funding social relief and assistance. All aforementioned have been explicitly stated in Article 10, Paragraph 8 of the Additional Articles of the Constitution. The state has a wide variety of social welfare and relief measures to protect people*s health and medical care. A significant example is the drug relief injury system, where the state proper compensates victims of drug injuries within a rational range, in order to help those victims suffering from a proper usage of legal drug promptly (see Article 1 of the Drug Injury Relief Act). The system is coherent with the intention of the constitutional protection of the people’s right of existence and right to health (see J.Y. Interpretation No. 753).
      
    •        The requirements of the principle of clarity and definiteness of law does not necessarily mean that all legal terms must be definite and exhaustive. The legislators could still properly use indefinite legal concepts in the stipulation during lawmaking, taking into consideration the complexity of the living facts to be regulated by law and the adequacy of application of the law into specific cases. According to precedents of this Court, the principle of clarity and definiteness of law shall be maintained if: the meanings of the legal terms are not incomprehensible from the legal text, the legislative purpose, and the relativity of the whole legal system; the regulated persons could possibly predict whether a specific fact is subject to the law; and the indefinite legal terms could be scrutinized and defined by the judiciary (see J.Y. Interpretation Nos. 594, 617 and 690).
      
    •        The so-called “common and foreseeable adverse reactions from drug usage” provided in the provision at issue is an indefinite legal concept. The meanings of “common” and “foreseeable” are not incomprehensible for the general people based on their experience of daily life and language. The “adverse reaction” from drug usage has also been clearly defined in Article 3, Subparagraph 4 of the Drug Injury Relief Act. Even though general regulated persons (i.e. patients and their family) cannot completely ensure whether their drug uses fulfill the requirements of drug relief, it should be reasonably expected that they could predict the foreseeability of adverse reactions of drug use, the chance of the adverse reactions, and the possibility of receiving drug injury reliefs, with the assistance from their physicians’ duty to inform (that is, the medical institution or the physician should inform the patient or his/her family of the patient’s condition, the course of treatment, disposition, medication, expected conditions, and possible ill effects; see Article 81 of the Medical Care Act and Article 12-1 of the Physicians Act) and labeling on drug bags or statements on package inserts. In terms of the meaning of common and foreseeable, the authority defines “common” in the provision at issue to be the incidence of adverse reactions greater than or equal to one percent, by referring to the international classification standard (seethe pre-organization Department of Health, Executive Yuan Letter Shu-Shou-Shi-1001404505 of October 7, 2011). Additionally, the aforementioned standard has been invoked by the Drug Injury Relief Reviewing Commission assembled under Article 15 of the Drug Injury Relief Act, and many cases in practices have been accumulated available for references. Therefore, the meaning of the indefinite legal concept is either difficult to define or decide by an adequately constituted agency with its professional knowledge. Nor is it impossible to be ultimately confirmed the judiciary. To sum up, there is no incoherence between the provision at issue and the principle of clarity and definiteness of law.
      
    •        The Court has been taking a relatively loose standard when reviewing the legislation of social policy, given its involvement of the distribution of state resources (see J.Y. Interpretation Nos. 485 and 571). Matters regarding the compensated objects, the eligibility, and the scope of exemption of drug injury relief pertain to the legislation of social policy. Legislators shall enjoy greater discretion to make proper laws by considering the state’s financial capacity, the effective use of resources and other actual conditions.
      
    •        The reasons the provision at issue totally denying common and foreseeable adverse drug reactions from drug injury relief are found on: the financial balance of the drug injury relief fund, the utilization of limited resources, and the prevention of drug manufacturers from refusing to produce or import drugs with real curative effects but possibly causing common and foreseeable serious adverse reactions at the same time (see the Ministry of Health and Welfare Letter Shu-Shou-Shi-1041400607 of March 26, 2015). The legislative purpose can be seen to be legitimate. Furthermore, a certain degree of foreseeable risk lies in the mechanism of the drug action, which patients and their family may reasonably predict with the assistance of physicians’ inform, or labeling on drug bags or the statements on package inserts, as previously addressed. The provision at issue refusing common and foreseeable adverse drug reactions from drug injury relief builds on the concern of risk sharing. It helps reach the abovementioned purposes without significant unreasonableness and does not violate the principle of proportionality. Therefore, the provision at issue is not in conflict with the Constitution to guarantee people*s right of existence, right to health and the intention of Article 10, Paragraph 8 of the Additional Articles of the Constitution that the state shall emphasize medical care and social welfare works.
      
    •        Last but not least, legislators excluding common and foreseeable adverse from drug injury relief because patients and their family could reasonably foresee the chance of adverse reaction and autonomously decide to bear the risk. The relevant authority or agency should confirm that the patients and their family could reasonably predict the common and foreseeable adverse reactions when using drugs through being sufficiently informed by medical professions or reading labeling on drug bags or statements on package inserts. It is of no doubts that the provision at issue should be interpreted with this obligation. The provision at issue does not contravene the Constitution; however, the relevant authority should reconsider the scope of non-relief timely, by weighing the general development trend of the pharmaceutical industry, the public interest and sustainability of the drug injury relief system, and the principle of social equity and the reasonableness of social compensation. The non-relief scope should not be over extended to hinder victims of drug injuries from seeking compensation. In addition, the Court holds the petitioner’s claim based on the violation of Article 10, Paragraph 7 of the Constitution to be irrelevant to the provision at issue. These matters are hereby explicated.
      
    •        The petitioner also asserted the pre-organization Department of Health of the Executive Yuan Letter Shu-Shou-Shi-1001404505 of October 7, 2011 to be in violation of principle of clarity and definiteness of law. However, the Court does not find the petitioner providing objectively specified grounds of unconstitutionality of the above Letter. For this part, the petition was not made in accordance with Article 5, Paragraph 1, Subparagraph 2 of the Constitutional Court Procedure Act, and thus should be dismissed in accordance with Article 5, Paragraph 3 of same Act.
      
    • ______________________
      
    • *Translated by Chao-Tien Chang
      
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