Taiwan - The Drug Injuries Caused By Adverse Reactions To A Drug As Defined Under The Drug Injury Relief Act Refer To Injuries That Are Directly Caused By The Use Of The Drug.

Legal News & Analysis - Asia Pacific - Taiwan - Dispute Resolution

23 October 2020


The Supreme Administrative Court rendered the 109-Pan-Zi-167 Decision on March 27, 2020 (the “Decision”), in which it held that in the Drug Injury Relief Act, injuries from adverse reactions to a drug refer to those that are directly caused by the use of drug.

Individual A, who is the father of Appellant in this case, was treated for psoriasis with an immunosuppressant and developed adverse reactions such as jaundice, fatigue, lethargy, unsteady walking and unconsciousness.  After he was subsequently hospitalized, he died on the day when he was discharged from hospital.   Appellant applied to the Taiwan Drug Relief Foundation commissioned by the Ministry of Health and Welfare, one of the Appellees in this case, for drug injury relief payment.  Appellee Drug Relief Review Committee (the “Review Committee”) concluded both in its review and its reconsideration that Appellant’s application failed to meet the requirements for drug injury relief payment.  The Review Committee’s decision was vacated in the administrative appeal before the Executive Yuan, which caused the Taiwan Drug Relief Foundation to investigate the matter again and submit a report to the Review Committee for another round of review.  However, the Review Committee still believed that the application did not meet the criteria for drug injury relief.  Dissatisfied with such finding, Appellant thus brought an administrative action to set aside the decision to deny the drug injury relief and compel the Appellee to instead grant the drug injury relief payment.  After suffering a dismissal of its administrative action, Appellant appealed.

According to the Decision, drug injury relief under the Drug Injury Relief Act can only be provided for the scope of drug injuries defined under Article 3, Subparagraph 1 of the same, then the application will be examined for whether any of the disqualifying circumstances in Article 13 existed.  To achieve effective utilization of drug injury relief resources and fulfill the objectives of the drug injury relief system, the scope of  “death, disability or serious illness” drug injuries caused by adverse reactions as defined in the Drug Injury Relief Act  refers only to injuries that are directly attributable to the use of a drug.  If the use is not the direct cause of the injury, even though there are no Article 13 disqualifying circumstances present, the conclusion to deny drug injury relief payment will still be upheld.

The Decision then reasoned that because the immunosuppressant drug at issue reduced immunity capabilities when it is used, the body is less capable to fight underlying infections.  As a result, the dormant hepatitis B virus was reactivated and triggered the acute relapse of chronic hepatitis B.  Although it cannot be ruled out that the use of the immunosuppressant triggered the hepatitis B virus and indirectly caused liver damage, since this was not an adverse reaction directly caused by the drug and was also not directly related to the use of the immunosuppressant at issue, the criteria for providing drug injury relief payment were not met.  It is then difficult to find any inconsistency with medical practice in Appellee’s ruling to exclude the immunosuppressant as the direct cause of A’s liver damage; and the previous decision’s holding that the drug at issue was not the direct cause of A’s death through liver failure was also consistent with the evidence presented without violation of the evidentiary and empirical principles.  Therefore, Appellee’s rejection of Appellant’s drug injury relief application was proper, and Appellant’s assertion that the previous decision was inconsistent with medical knowledge is thus groundless.


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Ankwei Chen, Lee Tsai & Partners

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