Science and Technology Law Commons^™

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

Regulating Care Robots, Valarie K. Blake

Law Faculty Scholarship

Care robots already assist the elderly in some nursing homes around the globe and could be in widespread use in hospitals and private homes sooner than we think. These robots promise great hope for patients: robots can provide increased independence, assistance with daily living, comfort and distraction during procedures, education, and companionship during vulnerable and lonely times in patients' lives. Despite these promising features, there are a number of concerns; care robots, designed with the aim of winning patient trust and affection, have unprecedented access to personal lives as well as recording and sensory capabilities beyond any human. They pose …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

The Social Context Of Oncofertility, Dorothy E. Roberts

All Faculty Scholarship

A field known as oncofertility provides female cancer patients with a variety of ways to preserve their fertility so that they may bear genetically related children after successful cancer treatment. Some women delay cancer therapy so doctors can collect their eggs, which are then cryopreserved in an unfertilized state or used to create embryos through in vitro fertilization for freezing. An experimental procedure for preserving the fertility of prepubertal girls, known as ovarian tissue cryopreservation, involves surgically removing their ovarian tissue and growing the immature eggs to a mature state so they can be frozen and stored until the girls …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …

Old Legacies And New Paradigms: Confusing "Research" And "Treatment" And Its Consequences In Responding To Emergent Health Threats, Gail H. Javitt

Journal of Health Care Law and Policy

No abstract provided.

Protecting Human Research Subjects: A Jurisdictional Analysis, Jennifer Llewellyn, Jocelyn Downie, Robert Holmes

Articles, Book Chapters, & Popular Press

The most recent speech from the throne contained a pledge from the federal government to "work with provinces to implement a national system for the governance of research involving humans, including national research ethics and standards." This commitment signals a desire on the part of the federal government to address concerns about the inadequacies of the current governance of health research involving humans (RIH). To this end, Health Canada's Ethics Division is currently exploring the ways in which such a national governance system for RIH might be implemented. It is important for the federal government, as it moves toward making …

The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher

Scholarly Works

No abstract provided.

On The Human Body As Property: The Meaning Of Embodiment, Markets, And The Meaning Of Strangers, Thomas H. Murray

University of Michigan Journal of Law Reform

For as long as I can recall, newspapers have published brief items in which someone has calculated what the human body is "worth" on the open market. The value of the body-as reduced to its chemical components-was never more than a few dollars. A more accurate accounting, though, would include the market value of transplantable organs and tissues, as well as the potential bonanza to be had should a cell line cultured from that body prove valuable to the biotechnology industry. The bottom line could be anywhere from tens of thousands to perhaps millions of dollars.

Both moral and legal …