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課程名稱 |
疫苗法律與政策
Vaccine Law and Policy |
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開課學期 |
114-1 |
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授課對象 |
法律學院 法律研究所 |
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授課教師 |
楊煜煒 |
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課號 |
LAW7850 |
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課程識別碼 |
A21EM67A0 |
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班次 |
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學分 |
1.0 |
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全/半年 |
半年 |
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必/選修 |
選修 |
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上課時間 |
第13 週
星期一10,A,B(17:30~20:10)星期二10,A,B(17:30~20:10)星期三10,A,B(17:30~20:10)星期四10,A,B(17:30~20:10)星期五10,A,B(17:30~20:10) |
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上課地點 |
霖1304霖1304霖1304霖1304霖1304 |
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備註 |
本課程以英語授課。密集課程。
限法律學院學生(含輔系、雙修生)
總人數上限：30人 |
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課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
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課程大綱
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為確保您我的權利,請尊重智慧財產權及不得非法影印
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課程概述 |
This course provides a comprehensive exploration of the U.S. legal and policy frameworks governing vaccines. Key topics include vaccine development and regulation, public and private mandates, legal challenges to exemptions, vaccine injury compensation, and strategies to counter vaccine misinformation. Students will examine the role of U.S. national and international policies in promoting equitable vaccine access and address contemporary issues, such as pandemic responses and intellectual property concerns, through a multidisciplinary lens. |
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課程目標 |
1. Analyze the legal standards and frameworks governing vaccine development, regulation, and distribution.
2. Evaluate public and private vaccine mandates, including constitutional and policy foundations.
3. Examine compensation mechanisms for vaccine-related injuries and associated legal protections.
4. Assess strategies to address vaccine hesitancy, misinformation, and legal responses to anti-vaccine movements.
5. Explore the intersection of intellectual property, public health, and vaccine equity in global and national contexts.
6. Develop a comprehensive understanding of the legal and ethical considerations in pandemic preparedness and response. |
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課程要求 |
1. Active Participation: Engage in class discussions, demonstrating preparedness through assigned readings and case analyses.
2. Final paper: Graduate students submit a research paper exploring a topic related to vaccine law and policy, with the topic pre-approved by the instructor. Undergraduate Develop a brief analysis of vaccine laws in a selected country, focusing on approval processes, mandates, and injury compensation mechanisms.
3. Reading: Complete all assigned readings.
4. Adherence to Deadline: Submit final paper on time; late submissions will not be accepted unless pre-approved under exceptional circumstances. |
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預期每週課前或/與課後學習時數 |
Students are expected to dedicate approximately 2-3 hours per session outside of class to:
1. Completing assigned readings.
2. Conducting research for the final paper or country profile assignment.
3. Preparing for class discussions.
Engaging with supplemental materials and legal analyses provided by the instructor. |
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Office Hours |
另約時間 備註： If you have any questions, please contact the TA at b11a01304@ntu.edu.tw (rather than emailing the professor or the college of law office directly), thank you for the cooperation. |
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指定閱讀 |
1. Required: Yang YT, Reiss DR. Vaccine Law and Policy. Springer, 2023. (https://www.sanmin.com.tw/product/index/011899179)
2. Optional: Relevant case law and legal documents provided during the course. Supplemental readings and materials assigned by the instructor. |
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參考書目 |
https://www.coursera.org/learn/vaccine-law-and-policy |
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評量方式
(僅供參考) |
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No. |
項目 |
百分比 |
說明 |
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1. |
Class Participation |
20% |
Active engagement in discussions and preparedness for class. |
2. |
Final Paper |
80% |
A substantive paper on an approved topic related to vaccine law and policy. Analysis of vaccine laws in Taiwan or a selected country, focusing on regulatory, mandate, and compensation frameworks. |
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Bonus Quizzes/extra credits |
0% |
10%
Periodic quizzes to reinforce understanding of key concepts and cases. |
- 本校尚無訂定 A+ 比例上限。
- 本校採用等第制評定成績，學生成績評量辦法中的百分制分數區間與單科成績對照表僅供參考，授課教師可依等第定義調整分數區間。詳見學習評量專區 (連結)。
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針對學生困難提供學生調整方式 |
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上課形式 |
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作業繳交方式 |
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考試形式 |
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其他 |
由師生雙方議定 |
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週次 |
日期 |
單元主題 |
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第13週 |
November 24 |
17:30-19:15
Topic:
• Introduction to Vaccine Law
o Legal definitions and regulatory frameworks for vaccines.
o FDA approval processes, Emergency Use Authorizations, and safety monitoring.
o Roles of key agencies, including FDA, CDC, and IRB.
o State and federal oversight of vaccine distribution and administration.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 1-3.
Optional:
• Selected case law and materials provided by the instructor.
• FDA guidelines on vaccine approval and safety monitoring. |
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第13週 |
November 24 |
19:20-20:10
Topic:
• Intellectual Property and Market Dynamics in Vaccine Development
o Legal standards for vaccine patents and other intellectual property protections.
o The role of FDA in exclusive marketing rights under the BPCIA.
o Antitrust considerations and proposals to waive vaccine patents in pandemics.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapter 4.
Optional:
• Case law: Diamond v. Chakrabarty (1980), United States ex rel. Krahling v. Merck & Co. (2014).
• Supplemental materials on vaccine patent and antitrust issues provided by the instructor. |
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第13週 |
November 25 |
17:30-18:20
Topic:
• Vaccine Access, Distribution, and Administration
o Funding and equitable distribution of vaccines.
o Roles and qualifications of vaccine prescribers and administrators.
o Minors' consent to vaccination and legal considerations.
o Government prioritization and rationing during vaccine shortages.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 8-11.
Optional:
• Case law: Mazer v. DC Dep’t of Health (2022), In the Matter of Dr. Paul Thomas (2019).
• Supplemental materials on vaccine funding and access strategies provided by the instructor. |
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第13週 |
November 25 |
18:25-20:10
Topic:
• Public Vaccine Mandates and Legal Authority
o Sources of state and federal authority for vaccine mandates.
o Constitutional and policy considerations for public vaccination mandates.
o Balancing public health needs and individual rights.
o Vaccine mandates in family law and child custody cases.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 14-16.
Optional:
• Case law: Jacobson v. Massachusetts (1905), Zucht v. King (1922), Biden v. Missouri (2022).
• Supplemental readings on state and federal vaccination authority and case studies provided by the instructor. |
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第13週 |
November 26 |
18:25-20:10
Topic:
• Employer Vaccine Mandates and Accommodations
o Legal basis for employer-imposed vaccine mandates.
o Options for encouragement, incentivization, and facilitation of vaccinations.
o Legal challenges related to medical and religious accommodations.
o Overview of regulatory agencies and statutes impacting employer mandates (OSHA, ADA, EEOC).
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapter 20.
Optional:
• Case law: Virginia Mason Hospital v. Washington State Nurses Association (2007), Hustvet v. Allina Health Sys. (2018).
• Supplemental EEOC guidance on COVID-19 and ADA implications for vaccination policies. |
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第13週 |
November 26 |
17:30-18:20
Topic:
• Exemptions to Public Vaccine Mandates
o Historical and legal basis for medical, religious, and philosophical exemptions.
o Standards and variations in state exemption laws.
o Legal challenges and public health implications of exemptions.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 17-18.
Optional:
• Case law: Prince v. Massachusetts (1944), Workman v. Mingo County Board of Education (2009).
• Supplemental materials on exemption trends and their impact on vaccine uptake. |
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第13週 |
November 27 |
19:20-20:10
Topic:
• International and Comparative Vaccine Law
o Legal structures for vaccine regulation and distribution globally.
o Comparative analysis of U.S. vaccine laws with international frameworks.
o Global health maintenance and cross-border infectious disease prevention.
o Ethical and legal obligations for vaccine deployment in global contexts.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 18-19.
Optional:
• Case studies on international vaccine initiatives.
• Supplemental readings on global vaccine law trends and policy challenges. |
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第13週 |
November 27 |
17:30-19:15
Topic:
• Vaccine Injury Compensation and Liability
o Overview of the National Vaccine Injury Compensation Program (NVICP).
o Legal standards and controversies surrounding vaccine injury claims.
o Liability protections for manufacturers and administrators.
o Comparative analysis of compensation mechanisms outside the NVICP.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapter 5.
Optional:
• Case law: Bruesewitz v. Wyeth (2011), Althen v. Secretary of Health & Human Services (2005).
• Supplemental materials on NVICP processes and its implications for public health policy. |
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第13週 |
November 28 |
19:20-20:10
Topic:
• Course Review and Future Directions in Vaccine Law and Policy
o Recap of key topics: vaccine mandates, injury compensation, regulatory frameworks, and global perspectives.
o Discussion on emerging trends in vaccine law, including pandemic preparedness and vaccine equity.
o Reflection on legal and policy implications for public health and ethical considerations. |
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第13週 |
November 28 |
17:30-19:15
Topic:
• Legal Responses to Vaccine Activism and Privacy Concerns
o Addressing antivaccine activism: misinformation, legal limits, and public health strategies.
o Balancing privacy rights with vaccine tracking and injury reporting requirements.
o Evaluating government responses to pandemics: legal powers and public perception.
Readings:
Required:
• Vaccine Law and Policy (VLP), Chapters 21-22.
Optional:
• Case law: Blackwell v. Wyeth (2009), Rhea v. Board of Education of Devils Lake (1919).
• Supplemental materials on legal frameworks for public health crisis management and privacy in vaccine reporting. |
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