An Analysis of “Right to Try” Laws in the U.S.: the Construction of Such Right, the Institutional Design, and Reflections on Taiwanese Regulations

Project: A - Government Institutionb - Ministry of Science and Technology

Project Details

Description

Determining the definition and the scope of a “right” is one of the most essential missions for scholars and practitioners of law, and a critical feature that distinguishing law from other disciplines as well as social systems. It is especially challenging to construct a right – sometimes a constitutional right when there is very little foundation could be found in legal text i.e. positive law. When the prevalence of democracy, moral relativism and the rapid shift of material conditions of a modern society both coming into play, the normative discourse becomes more challenging since it must include factors regarding governance and science-technology. Accordingly, interdisciplinary approaches are the “new norm” of legal methodology to realize rule of law under the complexity of a modern society. The issue “right to try” in the U.S. is thus a great example to demonstrate those aforementioned challenges. People (terminally ill, in most cases) advocate for a “right” to use experimental drugs and treatments before formally approved by FDA that originally evolved from the idea of “expanded access” or “compassionate use”: the former concept emphasizes on ethics, human dignity and natural law, while the later one is framed more technical and “legal”. To investigate issues as aforementioned, this research project will cover four major topics. The project will begin with an overview of current state legislations and federal regulations. Second, institutional challenges and governance issues will be identified from the perspective of legal realism and regulatory theory. Third, in order to analyze and construct a normative i.e. right-based argument, this project will discuss those challenges and issues through the lens of ELSI study, and the interactions between natural law, ethics, positive law, and the social movements of “right construction” and their impact. Last but not least, this project will advise on relevant Taiwanese law (e.g. Regulation on Human Trials, and regenerative medicine) and the theory of interdisciplinary approaches to law that is based upon the discussions made in earlier topics.
StatusFinished
Effective start/end date8/1/187/1/19

Keywords

  • right to try
  • expanded access
  • compassionate use
  • drug regulation
  • bio-medical ethics
  • interdisciplinary legal study
  • ELSI
  • unwritten constitutional rights
  • substantive due process