Printable Version

Spring 2017
5367 Biotechnology & the Law - EVANS- 26403

Professor(s): Barbara Evans (FACULTY)

Credits: 3

Course Areas: Health Law 
Intellectual Property and Information Law

Time: 10:30a-12:00p  MW  Location: 144  BLB

Course Outline: This course provides a practice-oriented survey of major regulatory frameworks for commercializing new biotechnology products and protecting consumers and workers from the risks these products pose. This year’s course has been updated to add coverage of important legal and policy developments during the past 12 months. The course starts off with a quick introduction--in terms accessible to students with no scientific background—to the profusion of biotech products expected to enter the market and change our world during the next 5 – 15 years. Future biotech products go far beyond the familiar categories of medical products and genetically modified foods. Products already available or in development include at-home gene editing kits that will rupture the tightly controlled research and development pathways of the past and confront regulators with a wave of citizen science and small-scale, do-it-yourself manufacturing; artificially intelligent biological robots that may soon compete with you for a job; bioprinted sheets of new skin and scalp that may keep today’s law students looking young for as long as you live; DNA-based memory devices capable of storing the cumulative knowledge of mankind in a teaspoon and wireless machine/brain interfaces that will put that knowledge at your disposal (but, sadly, not in time for the take-home final in this course!); designer pets (pink dogs?) and babies and de-extincted species; biotech industrial processes that can generate limitless quantities of spices, fruits, eggs, and meat but which threaten to displace millions of agricultural workers; and new sources of climate-change-neutral energy. With profound scientific advances on the near-term horizon, the White House Office for Science & Technology Policy, in July 2015, launched a major overhaul of the U.S. Coordinated Framework for Regulation of Biotechnology, last modernized in 1992. Prof. Evans, who has been closely involved in these efforts, will introduce the key regulatory frameworks you need to know to work in the biotech sector (FDA, EPA, USDA, consumer and occupational safety, and privacy regulations) and press you to help conceive solutions to the profound social, economic, and policy challenges regulators will face as a profusion of new biotech products comes on stream in the next 5 – 15 years.

Course Syllabus: Syllabus updated 1/17/17

Course Notes:   This course qualifies as EENR course as well.

Prerequisites: No  No science background is required. This course does not duplicate Genetics and Law. Students are free to take either or both courses in either order.

First Day Assignments: Please review the following short case studies of new biotech products and come to class prepared to discuss the safety and regulatory concerns you feel about products like these:

Intro 1 - Navigating the Regulatory Landscape Biopesticide Case Study

Intro 2 - Navigating the Regulatory Landscape Oxitec Case Study

Intro 3 - Navigating the Regulatory Landscape Genetically Modified Plant Case Study

Intro 4 - Navigating the Regulatory Landscape Synthetic Squalane Case Study

Intro 5 - Navigating the Regulatory Landscape Biomining Case Study

Final Exam Schedule: Take home exam      

This course will have:
Exam: In-class midterm (50%) and take-home final (50%).
Paper: No

Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type:

Bar Course: No

Course Materials (11/4/2016 2:48:56 PM)

No book required for this course

Course Materials: No casebook. All course materials will be posted on the UH electronic blackboard.

No casebook. All course materials will be posted on the UH electronic blackboard.