Regulation of Novel Biomedical Technologies
type: CreativeWork
description: This dissertation is the compilation of three separate works of research revolving around the theme of regulation of biomedical technologies that are either emerging or that have undergone significant developments over the past decade or so. Each of these three research works examines a legal response to a technological development in the areas of biotechnology and/or medicine and addresses one or more challenges - ethical, constitutional, legal or one that is related to public policy - created by that response. The first work of research, which was published in the Administrative Law Review in March 2008, examines the legality of the restrictions imposed by the administration of President George W. Bush on the funding of research involving human embryonic stem cells. Reaching the conclusion that the Bush Administration's actions were outright illegal in more than one way, the research highlights existing tensions in the division of decision-making power between the President and executive agencies and between Congress and the President. The second work of research, which was published in the Columbia Science and Technology Law Review in August 2010, reviews the regulation of genetic screening and testing of donated reproductive tissue in the United States. Analyzing the regulation in the federal, state and industry level, the research highlights significant shortcomings of the regulation of this area and, drawing on the experience of other countries, advocates the regulation of this area by the FDA. The third and last work of research of which this dissertation consists is dedicated to the examination of the newly created regime of statutory exclusivities afforded to biological pharmaceuticals under the Biologics Price Competition and Innovation Act (BPCIA) as it compares to the protection afforded to such products under patent law. The research concludes that allowing biological pharmaceuticals to benefits from parallel protection under both patent law and the sta…
abstract: This dissertation is the compilation of three separate works of research revolving around the theme of regulation of biomedical technologies that are either emerging or that have undergone significant developments over the past decade or so. Each of these three research works examines a legal response to a technological development in the areas of biotechnology and/or medicine and addresses one or more challenges - ethical, constitutional, legal or one that is related to public policy - created by that response. The first work of research, which was published in the Administrative Law Review in March 2008, examines the legality of the restrictions imposed by the administration of President George W. Bush on the funding of research involving human embryonic stem cells. Reaching the conclusion that the Bush Administration's actions were outright illegal in more than one way, the research highlights existing tensions in the division of decision-making power between the President and executive agencies and between Congress and the President. The second work of research, which was published in the Columbia Science and Technology Law Review in August 2010, reviews the regulation of genetic screening and testing of donated reproductive tissue in the United States. Analyzing the regulation in the federal, state and industry level, the research highlights significant shortcomings of the regulation of this area and, drawing on the experience of other countries, advocates the regulation of this area by the FDA. The third and last work of research of which this dissertation consists is dedicated to the examination of the newly created regime of statutory exclusivities afforded to biological pharmaceuticals under the Biologics Price Competition and Innovation Act (BPCIA) as it compares to the protection afforded to such products under patent law. The research concludes that allowing biological pharmaceuticals to benefits from parallel protection under both patent law and the sta…
author: Heled, Yaniv
language: English
keywords: Biotechnology--Law and legislation, Biotechnology industries--Law and legislation, Medical ethics, Embryonic stem cells--Research--Law and legislation, Donation of organs, tissues, etc.--Law and legislation, Biopharmaceutics, Biomedical engineering--Government policy, Law, Medicine, Biology
date published: 2011
date modified: 2026-07-24T01:44:25Z
provider: Columbia University
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: Columbia University

PropertyValue
property ID: DOI
value: 10.7916/D8F194F9