Biotechnology Law

This video-lecture takes you through the federal government's first attempt to regulate the emerging technology of biotechnology. This regulatory framework was the roadmap to how biotechnology is regulated in the U.S. and continues to be used decades after its first publication, with some changes. This video lecture will help you understand which agency in the federal government addresses each aspect of biotechnology regulation in the U.S.

This video-lecture introduces you to the regulation of genetically modified organisms, with a focus on crops. You will understand more about how these GMO crops are carefully regulated.

This video-lecture introduces you to the strange new world of plants that produce pharmaceuticals! You will begin to understand the steps taken to ensure safety, and what kind of nutrients and pharma are being produced in these plants. Two examples, are used here: one plant that produces Vitamin A for areas of the world that are deficient in Vitamin A; and a tobacco plant used to grow a vaccine for use against the Ebola virus.

In this video-lecture, you will see the first transgenic animals that were commercialized in the U.S. The Glofish is the first, which entered the market but was not regulated by FDA. This lecture will analyze the FDA decision not to regulate the Glofish. The case which is discussed raises important legal issues for associations of animal breeders who want to protect the integrity of their breeds of animals, but genetic engineering is challenging what that means.

In this video lecture, the first transgenic animal for use as a human food is examined in terms of the regulatory pathway used to approve its use. The AquAdvantage Salmon is a case study that raises many of the issues about safety to the environment as well as safety to the public.

This video-lecture analyzes the regulation of a transgenic mosquito and a transgenic goat, both altered to improve the human condition, but both may have impacts on the environment. 

This video-lecture will raise one of the challenging problems in intellectual property and genetically modified crops. Here, you will see the struggle between fairness to farmers and the monopoly legally granted to patent holders of these genetically modified crops, which causes a clash of farming culture, with new risks to using patent-protected GMO crops. The case discussed in this video-lecture is a case from Canada.

If you ever wondered how we ever decided that life could be patented, this is video-lecture will answer that question for you. Explore the basics of intellectual property, including patent law and trade secret law as it applies to biotechnology and you should gain a good understanding of how the protection of biotechnology inventions is structured.

This video-lecture explores the legal issues that are raised with law enforcement collecting DNA from criminal suspects or convicted felons. How much do we want to allow the government to collect and use these DNA is a balancing test between our need to protect public safety and our right to privacy. New issues which include abandoned DNA, and how that may be used, is also explored in this lecture.

This video lecture helps to explain the long-standing prohibition on the EU importation of GMOs from the U.S. and other countries. How international law accommodates the needs of free trade, the concerns about risk to countries and how these are balanced with regard to biotechnology are all discussed in this lecture.

This video lecture explores the legal and ethical issues that arise with our growing ability to alter not only human genes but the human germline. Currently, altering the human germline is prohibited in the U.S. and the U.K., but we are rapidly gaining the ability to make changes that many people would feel are positive. Think about how you feel about what laws we should consider having in our societies or whether there should be any constraints on designing babies.

This video-lecture includes scenes from the movie, Gattaca, a scientific dystopic movie made in 1997 about the future of the ability to manipulate the human genome. From the previous lecture, you see that we are getting very close to this, and this movie is a good way to test what legal and ethical issues we should be addressing and whether we want a future like Gattaca. I encourage you to watch the entire movie, if it is available to you.

The lecture refers to a discussion board, so please ignore that. However this section does have the usual quiz. Enjoy!