LAW 3733 - Biotechnology: Law, Regulation and Ethics
Biotechnology is revolutionizing health care and poised at the forefront of research and development for global industries ranging from agriculture to pharmaceuticals, industrial materials (biomaterials), and processes. More than 100 biotechnology based pharmaceuticals have been introduced into the market, and hundreds more – many breakthrough drugs for previously untreatable conditions – are in advanced human clinical trials. Arguably the most regulated commercial endeavor in contemporary society, biotechnology continues to induce changes in science, business, and medicine that raise legal/regulatory, ethical, and social questions. From the unprecedented reliance on intellectual property as a commodity for attracting billions of dollars in financing to the availability of pre-implantation genetic screening of embryos, stem cell research, human cloning, predictive genetic testing for adult onset of breast and other cancers, and the coupling of biotechnology and information technology (bioinformatics) to decipher the human genome and personalize the delivery of pharmaceuticals, biotechnology is changing the world we live in – meaning law, medicine, the economy, and society itself.
This class will explore the history of biotechnology, law and policy evolution and the bioethical concerns that have arisen along the way in response to its development. The course will survey a broad range of law and regulation, including administrative regulation, judicial review, government policy, patent law and licensing. We will examine areas of ethical concern including patenting of naturally occurring substances and organisms, ownership of DNA and its decoded sequences, mRNA technology and its use in vaccines for Covid-19, human subjects research with biotechnological processes and products, gene therapy, stem cell research, cloning, human/animal chimeras, genetic recombination into gametes, genetic enhancement, and pharmacogenetics. Rather than mastering each of these areas, students are expected to develop a “critical mass” of knowledge in overall subject matter.
Credits: 3
Add to Personal Catalog (opens a new window)
|