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Biotechnology Law

GMOs to Designer Babies

Victoria Sutton

Have you ever wondered how genetically engineered food is regulated? Did you know you can buy a genetically engineered pet fish that glows at a local pet store, and it is not regulated? Do you know about the genetically engineered mosquitos released into the environment to reduce mosquito-borne diseases? Or the goat that is engineered so that it can make a drug for treatment of a human disease? This course will guide you through the web of laws that regulate genetically engineered plants, foods and animals. Comparisons between countries is discussed. Learn what part of life can be patented, whether you will be allowed to design your baby, or think about whether you want to?

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What's inside

Learning objectives

  • Understand how genetically modified organisms and crops are regulated.
  • Recognize how dna can be lawfully used in criminal law and protect privacy.
  • Have knowledge about what may be in store for the future of biotechnology in designer babies and other possibilities.

Syllabus

Introduction

This first video-lecture in this course introduces you to biotechnology and law through the use of a case study which led to a nationwide recognition of the need to take more precautions about the marketing and exposure to untested GMO products. Several legal issues are raised to address these new societal concerns. It is a good introduction to the legal issues that arise in biotechnology.

While biotechnology has made tremendous contributions to making our quality of life better, we are also interested in balancing the harms through law and regulation, and this case study is a good example of that tension in this area.

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1.0 BT In re Starlink
Understand regulation of GMOs and identify agencies that regulate them

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.

2.0 BT Biotechnology Regulatory Framework

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.

3.0 BT Genetically engineered foods and labeling
Regulation of Transgenic Animals

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.

4.0 BT GEPPVs, Yellow Rice, ZMapp

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.

5.0 BT GloFish and Transgenic Horses

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.

6.0 BT AquAdvantage Salmon, ATryn goat

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. 

7.0 BT Oxitec mosquito
Analyze intellectual property law issues in biotechnology

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.

8.0 BT Monsanto v. Schmeiser (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.

9.0 BT Intellectual Property, Chakrabarty etc.
Biotechnology and Criminal Law

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.

10.0 BT DNA and "expectation of privacy"
Biotechnology and International Trade

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.

11.0 BT International Law and GATT
Biotechnology Law and the Future

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.


12.0 BT Designer Babies and Law

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!

13.0 BT Gattaca case study

Good to know

Know what's good
, what to watch for
, and possible dealbreakers
Introduces learners to the basics of biotechnology and law through real-world case studies that make the course highly relevant to today's legal landscape
Instructor is a practicing lawyer who specializes in intellectual property, providing learners the opportunity to gain insights from a recognized expert in the field
Covers a wide range of topics with great depth, from genetically modified crops to transgenic animals, offering a comprehensive understanding of biotechnology law
Provides an analysis of the regulatory framework for genetically modified organisms in the U.S., including the roles of different government agencies, giving learners a practical understanding of how biotechnology is regulated
Includes case studies on genetically modified crops, such as "StarLink" corn and "AquAdvantage" salmon, which illustrate the real-world applications and controversies surrounding biotechnology
Covers ethical and legal issues related to gene editing and human germline modification, providing learners with insights into the cutting-edge advancements and debates in biotechnology

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Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Biotechnology Law: GMOs to Designer Babies with these activities:
Review molecular biology
Review the basics of molecular biology, including DNA structure, replication, transcription, and translation, to strengthen your foundation for understanding genetically engineered organisms.
Browse courses on Molecular Biology
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  • Read through your old textbooks or notes on molecular biology.
  • Solve practice problems or take a quiz on basic molecular biology concepts.
  • Attend a refresher workshop or online course on molecular biology.
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