Impacts of Pharmacogenetics on Medical Responsibility System in Taiwan

• Main Authors: Yen-TanHsin-Wang, 辛王燕丹
• Other Authors: Wei-In Tsai
• Format: Others
• Language: zh-TW
• Published: 2012
• Online Access: http://ndltd.ncl.edu.tw/handle/49673914187586000251

碩士 === 國立成功大學 === 法律學系 === 100 === Drug safety and severe drug adverse reaction are important medical issues. They have also been the leading sources of medical disputes, in which the question of who is responsible is heatedly debated. In the recent years, personalized medicine has become well appreciated due to the substantial improvement of pharmacogenetics. In this study, we searched for important legislations and publications related to pharmacogenetics, human health right, adverse drug reactions from PubMed, US Food and Drug Administration, World Health Organization, and our Constitution, Civil Code, Criminal Code, Medical Care Act, Physicians Act, Pharmaceutical Affairs Act, Pharmacists Act, Drug Injury Relief Act, National Health Insurance Act, to investigate the influence of novel pharmacogenetic success on the medical responsibility system and human health right in our country. We identify in this work that the legal policy for drug safety and drug adverse reaction from our government actually reflect the aggressiveness of the government to protect human health right for our people. The present research centers on the work of Chen et al., which reported that people with the genes HLA-B*1502 or HLA-B*5801 have high probability of suffering fatal Stevens-Johnson syndrome after they initially take Carbamazepine or Allopurinol, respectively. After publication of Chen et al., Department of Health ( DOH ) very soon announced this study to all medical care institutions and their personnel, as well as to patients. DOH furthermore requires physicians to perform genetic test on patients when Carbamazepine is prescribed; Department of National Health Insurance can pay this medical premium. If a patient refuses to check HLA-B*1502 after physicians explain the side effect of Carbamazepine, and subsequently suffers SJS after the administration of the drug, based on the new announcement and original articles of adverse drug reaction-related laws, he or his family cannot sue the physician for civil suit or even criminal suit, and cannot be permitted to apply for compensation through Drug Injury Relief Act. However, if physicians do not explain the side effect of Carbamazepine before prescribing it, the patients or their families may win civil suit, and medical physicians or medical institutions shall be subject to a fine for this medical negligence. For the case of the correlation between having the gene HLA-B*5801 and higher probability of suffering SJS after initial administration of Allopurinol, DOH does not require physicians to perform genetic test when they prescribe Allopurinol. However, physicians still ought to warn patients the side effect of Allopurinol. Otherwise, medical physicians or medical institutions are subject to a fine for this medical negligence if patients or their families raise civil suit. Patients or families are permitted to apply for compensation through the Drug Injury Relief Act if physicians do not mention side effect of Allopurinol. Taken the above studies and policies together, the announcement or establishment of legal policy by our government for people with the genes HLA-B*1502 or HLA-B*5801, who have extremely high probability to suffer fatal SJS, show that our government aggressively protect human health for people. These new legal announcement and policy in conjunction with previously established laws are sufficient to clearly discriminate the medical responsibility in the case when adverse drug reaction is caused by the initial administration of Carbamazepine or Allopurinol.