獸醫輸血醫學之法制研析

Abstract

獸醫輸血醫學，係將動物血液及相關血品應用於動物臨床醫療之專業領域。百年來於人類醫療領域中已漸成熟完備的輸血醫學作業，近十餘年因動物保護意識抬頭、人與伴侶動物間關係發展日益親密，加以動物醫療技術一日千里，獸醫輸血醫學已成為我國動物醫療領域發展蓬勃的新興技術。然而因該領域之專業準則於國內尚非普及，且動物血液資源因「物以稀為貴」而蘊藏龐大商機，又因中央及地方主管機關所規劃之相關準則，與國際上獸醫輸血醫學的研究成果有所扞格，致使近年動物捐血或輸血之爭議頻傳。因我國對於獸醫輸血醫學幾無明確之法律規範以資管制，進而導致於現行動物醫療環境下，如何確保捐血動物之健康與受血動物之安全，對獸醫師仍無具體可依循之準則或規範，對動物飼主面對相關爭議時更如霧裡看花。 動物醫療領域之法制規範混亂，觀諸我國不同法律間、對於「動物」之法律地位與法律意義不明，即非難以想像。「動物」之自然意義，於生物學之解釋上或許相對明確，但「動物」之法律意義，即因眾多法律之立法目的與保護法益不同，而有所差異。因我國法制對「動物」並無整體性之明確定位，甚至於不同法律間、有相互矛盾與缺漏之處，則於面對動物醫療規範乃至於獸醫輸血醫學法制時，即需確認此類法制之規範客體為何？目前於我國法之體系解釋與目的解釋下，將「動物」解釋為權利客體之「物」，暫時或能做為繼續討論之基礎，然而此基礎能否達成動物保護之目的，仍有待未來行政機關與立法機關妥為規劃整體法制並加以改善，使體系性之立法考量得以實現。 「動物」之法律地位與法律意義，雖於不同法律制度間有所差異，但究非毫無規範，然而對於「動物」之醫療行為，現行法上即欠缺明文規定。獸醫師相關法規對獸醫師執行業務之內容或許有所提示，但對於其實質內涵或責任義務則無明確規範。我國管制動物醫療領域之法規，目前仍屬晦暗不明，故本論文在此探討民法、消費者保護法、獸醫師法與動物保護法，對於動物醫療之適用範圍。然而就提供血品部分，筆者認為於國立屏東科技大學獸醫輸血醫學中心建立之後，國內「符合當時科技或專業水準可合理期待」之安全性標準，即至少應以該中心所建立之血品標準為依據。對於未能提供合格血品者，應課予無過失責任，以期能保障消費者權益並提升商品與服務之品質。考量目前臨床醫療對於動物血品之需求，國家除規劃相關法制外，亦應建置獸醫輸血醫學機關，則公職獸醫師於其中所扮演之角色與相關適法服務之重要問題，於此一併加以討論與建議。 觀察外國相關領域之經驗，國際上已建立有獸醫輸血醫學與動物血庫運作準則，並廣為世界各國相關單位參考及依循。此外，英國與美國加州對動物血庫皆訂有完整規範之法案，且主管機關亦有詳細之授權規範與指導原則。上述規範主要均藉由捐血動物之篩選、捐血程序之操作及血品貯存與運輸條件之管控，以確保動物福利與血液品質。英國法規禁止對肉用動物輸血、亦禁止對捐血動物進行鎮靜或麻醉，可能間接影響當地動物血庫對於貓隻捐血項目之發展；反之，美國加州法規則著重於推廣社區動物血庫、亦即藉由召募伴侶動物維持營運者，而試圖減少或停止閉鎖群動物血庫之營運。英國獸醫主管機關對輸血醫學前端，即捐血動物來源、動物管理方式與捐血程序等方向著重規範，此與美國加州獸醫主管機關對輸血醫學後端，即血品製程、血品保存條件與保存期限等內容規範嚴密，兩者之監管重點亦有所不同。 多年來獸醫師、動物飼主、相關團體、國會與縣市議會對我國獸醫輸血醫療資源需求甚為關注，並提出許多不同方向之倡議，惟主管機關迄今仍遲遲未能有所進展，甚至先前所提出之標準與國際標準落差懸殊，難以想像何以藉此達成動物保護之目的。筆者認為，建立獸醫輸血醫學之法制規範與行政機關，不僅關涉國內廣大伴侶動物飼主群體之需求、得使動物醫療領域專業品質向上提升，對於新興人畜共通傳染病、如血液媒介性疾病之公共衛生與疾病管制等面向，亦為至關重要之議題。我國目前已有學者引進外國動物血庫之實務準則與運作方式，建立本土化之獸醫輸血醫學中心，國內亦有人類輸血醫學法律制度與實務操作之經驗可資借鏡，相關單位實責無旁貸，應戮力完成獸醫輸血醫學法制規範與國家獸醫輸血醫學機關之建置，並藉由行政監督與預算管控，提升動物用血品之安全性，消弭不肖業者藉此謀取私人暴利之機會，進而維護全民的生命、身體、健康等重要法益得受保障。

Veterinary transfusion medicine is a professional field that applies animal blood and related blood products to clinical animal care. Transfusion medicine has been gradually mature and complete in the field of human medical care for a century. In the past ten years, due to the rise of animal protection awareness, the increasingly close relationship between humans and companion animals, and the rapid development of animal medical technology, veterinary transfusion medicine has become a booming emerging technology in the field of animal medical care in our country. However, the professional standards in this field are not yet universal in our country, and animal blood resources contain huge business opportunities because they are “rare and valuable”. Furthermore, due to the relevant standards planned by central and local competent authorities are inconsistent with international research results on veterinary transfusion medicine, controversies over animal blood donation or blood transfusion have frequently arisen in recent years. Since our country has few clear legal regulations to regulate veterinary transfusion medicine, there are still no specific guidelines or norms for veterinarians to follow on how to ensure the health of blood-donating animals and the safety of blood-receiving animals, and it is even more confusing for animal owners when facing relevant disputes. The legal regulations in the field of animal medical care are chaotic. It is not unimaginable to think about the unclear legal status and legal meaning of "animals" among different laws in our country. The natural meaning of "animal" may be relatively clear in terms of biological interpretation, but the legal meaning of "animal" varies due to the different legislative purposes and protection of legal interests in many laws. Since our country's legal system does not have a clear overall positioning of "animals", and there are even contradictions and gaps in different laws, when facing animal medical regulations and even the legal system of veterinary transfusion medicine, it is necessary to confirm what the normative objects of such legal systems are? Currently, under the system interpretation and purpose interpretation of our country's laws, the interpretation of "animals" as "things" as the object of rights may temporarily serve as the basis for continued discussion. However, whether this foundation can achieve the purpose of animal protection still requires future administrative agencies and legislative bodies to properly plan and improve the overall legal system so that systematic legislative considerations can be realized. Although the legal status and legal meaning of "animals" vary between different legal systems, they are not completely unregulated. However, there is a lack of clear provisions in current law regarding medical treatment of "animals." The relevant laws and regulations for veterinarians may reveal the content of the business performed by veterinarians, but there are no clear regulations on their substantive content or responsibilities and obligations. The regulations governing the field of animal medical care in our country are still unclear. Therefore, this paper discusses the scope of application of Civil Code, Consumer Protection Act, Veterinarian Act and Animal Protection Act to animal medical care. However, as for the supply of blood products, I believes that after the establishment of the Veterinary Transfusion Medicine Center of the National Pingtung University of Science and Technology, domestic safety standards that “meet and comply with the contemporary technical and professional standards with reasonably expected safety requirements” should at least be based on the blood product standards established by the Center. Those who fail to provide qualified blood products should be held liable under strict liability, in order to protect the rights and interests of consumers and improve the quality of goods and services. Considering the current clinical medical demand for animal blood products, in addition to planning relevant legal systems, the goverment should also establish a veterinary transfusion medicine institutions. The role played by public veterinarians and important issues related to legal services are discussed and suggested here. Observing the experience of foreign countries in related fields, international standards for veterinary transfusion medicine and animal blood bank operations have been established, and are widely referenced and followed by relevant units around the world. In addition, both the United Kingdom and California in the United States have complete regulations regulating animal blood banks, and the competent authorities also have detailed authorization regulations and guiding principles. The above-mentioned specifications mainly ensure animal welfare and blood quality through the screening of blood donation animals, the operation of blood donation procedures, and the control of blood storage and transportation conditions. British regulations prohibit blood transfusions in meat animals and prohibit sedation or anesthesia of blood donation animals, which may indirectly affect the development of local animal blood banks for cat blood donation projects. On the contrary, the California law focuses on promoting community blood banks, that is, those who maintain operations by recruiting companion animals, and attempts to reduce or stop the operation of closed-colony blood bank. The British veterinary authority focus on regulating the front end of transfusion medicine, that is, the source of blood donation animals, animal management methods and blood donation procedures. This is different from the California veterinary authority in the United States, which has strict regulations on the back end of transfusion medicine, that is, the blood product manufacturing process, blood product storage conditions and shelf life. Over the years, veterinarians, animal owners, relevant groups, Congress, and county and city councils have paid close attention to our country’s demand for veterinary transfusion medical resources, and have put forward many initiatives in different directions. However, the competent authorities have so far been unable to make any progress, and even the standards previously proposed are far from international standards. It is difficult to imagine how this can be used to achieve the purpose of animal protection. The author believes that the establishment of legal norms and administrative agencies for veterinary transfusion medicine will not only address the needs of the vast domestic companion animal owner groups, but also improve the professional quality of the animal medical field. It is also a crucial issue for public health and disease control of emerging zoonotic diseases such as blood-borne diseases. At present, scholars in our country have introduced the practical guidelines and operating methods of foreign animal blood banks to establish localized Veterinary Transfusion Medicine Center. There is also domestic experience in the legal system and practical operation of human transfusion medicine that can be used as a reference. Relevant units have unshirkable responsibilities and should work hard to complete the legal regulations on veterinary transfusion medicine and the establishment of a national veterinary transfusion medicine agency. Through administrative supervision and budget control, they will improve the safety of animal blood products and eliminate opportunities for unscrupulous businesses to seek huge private profits, thereby safeguarding the life, body, health and other important legal interests of the entire people.