HC70A & SAS70A Winter 2009 Genetic Engineering in Medicine, Agriculture, and Law Professors Bob Goldberg & John Harada Lecture 9 Science & The Constitution: Regulating Science & Genetic EngineeringTEXT READING Chapters 12 & 13SELECTED REFERENCES 1. Cloning & The Constitution, By I.H. Carmen (1985) 2. A Practical Companion To The Constitution, By J.K. Lieberman (1999) 3. The Recombinant DNA Controversy: A Memoir, By D. S. Fredrickson (2001) 4. Genetics: Ethics, Law, and Policy, By Lori B. Andrews et al. (2002) 5. Patent, Copyright, & Trademark, By S. Elias & R. Stim (2005) 6. Stem Cell Century, By Russell Korobkin (2007) 7. Biotechnology and The Law, By H.B. Wellons et al. (2007)THEMES 1. Historical Attempts to Regulate Science-The Genetic Engineering Controversy 2. Government of the United States 3. What is in the Constitution About Science-Directly & Indirectly? 4. Can Scientific Inquiry and Research Be Regulated? 5. Can Experimentation Be Regulated Directly? 6. Case Studies in Regulating Science Directly 7. Can Science Be Regulated Indirectly? 8. Regulating Science-A SummaryThe Genetic Engineering Controversy: 1974-1986 Attempts to Regulate Genetic Engineering at the Local, State, & Federal LevelsCohen-Boyer-1973 Berg Letter (1974), Asilomar (1975), NIH Guidelines (1976)5/24/772/20/771/17/77 “Threats of diseases and monsters that could be brought about by recombinant DNA…..gene splicing should be banned within the city limits.”2/7/7710/25/772/8/77 1/12/78 Allows P1, P2, & P3 Research Following NIH Guidelines Allows Research Following NIH Guidelines6/21/86 Biotech CompaniesWhat About Recent Attempts to Regulate Science at the Local, State, & Federal Levels?What About Other Legal Issues Dealing With Genetic Engineering?Life Is Patentable 6/17/1980A Brief History of Patenting “Life”Jensen & Murray (2005) Science 310,239-240 (October 14, 2005)Who Owns Your Genes: Human Gene Patents Scientific American, February 2006 20% of Human Genes Have Been Patented (2006)Who Has Patents on Your Genes? Scientific American, February 2006Organization of the United States Government Checks & Balances NO Precedent For This Form of Government in 1789-”Invented” From Scratch!The critical importance of Marbury is theassumption of several powers by theSupreme Court. One was the a uthority todeclare acts of Congress, and by implicationacts of the president, unconstitutional ifthey exceeded the powers granted by theConstitution. But even more i mportant, theCourt became the arbiter of theConstitution, the final authority on what thedocument meant. As such, the Supreme Courtbecame in fact as well as in theory an equalpartner in government, and it has played thatrole ever since.Marbury v. Madison-1803Activist Judges? Voting Rights, Civil Rights, Age & Gender Discrimination Affirmative Action, etc, Chief Justice John MarshallArticle or Amendment What Is Application? Article I, Section 8.1 Promote the General Welfare Article I, Section 8.8 Patents & Copyrights Article I, Section 8.18 Make All Laws to Execute (Police Powers) Amendment I Freedom of Speech Amendment IV` Searches & Seizures Amendment V Due Process-Privacy-Federal Amendment X Powers Reserved to the States (Police Powers) Amendment XIII Slavery Amendment XIV Due Process-Privacy-State Preamble Promote the General Welfare How Does the Constitution Affect Science Directly or Indirectly?What Does the Constitution Say Directly About Science? Is the Word “Science” in the Constitution?1. Article I - Section 8.8 The Congress shall have the Power: [8] “To Promote the Progress of Science and the useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their Writings and Discoveries” Keyword: Inventors not Science. Wanted to Promote Economic Development & Promote a National Economics Policy Grounded in Property Rights. That is, Entrepreneurship! PATENTS!!2. Article I - Section 8.18 The Congress shall have the Power: [18] “To make all Laws which shall be necessary and proper for carrying into Execution the forgoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department of Officer thereof. Key Concept: Congress Established Patent and Trademark Office (USPTO) and Intellectual Property lawsHow Does the Constitution Deal Indirectly With Science? Without Using the Word Science or Mentioning the Progress of Science and Discoveries?1. Preamble “We the People of the United States, in order to form a more perfect Union, establish justice, insure domestic tranquility, provde for the common defense, promote the General Welfare……” Key Concept: General Welfare-Which Can Apply to Almost Everything Dealing With Science, Health, Medicine, Agriculture, and Safety!2. Article I - Section 8.1 The Congress shall have the Power: [1] “To lay and collect Taxes, Duties, Imposts, and Excises, to pay the Debts and provide for the common Defense and general Welfare of the United States; but all Duties, Imposts, and Excises shall be uniform throughout the United States” Key Concept: Provide For the General Welfare-Which Can Apply to Almost Everything Dealing With Science, Health, Medicine, Agriculture, and Safety!2. Article I - Section 8.1 Congress Established Under This Article: • Smithsonian Institute (1846) • National Academy of Sciences (1863) • National Bureau of Standards (1901) • Public Health Service (1912) • National Institutes of Health (1930) • National Science Foundation (1946) • USDA, EPA, FDA, CDC, NASA, etc., etc Key Concept: All Vested Under Constitutional Grant to Congress to Promote the General Welfare-All Involved in Science, Medicine, Agriculture, & Technology Activities3. Amendment I Freedom of Speech and Expression: “Congress shall make no Law respecting an establishment of religion, prohibiting the free exercise thereof; or abridging freedom of speech, or of the press, of the right of the people peacefully to assemble, and to petition the Government for a redress of grievances.” Key Concepts: Freedom to Think About Science, Publish, and Discuss Science in Meetings and Laboratories4. Amendment IV Searches and Seizures: “The right of the people to secure their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no