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The journal of biolaw & business最新文献

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Regulation of biotechnology by executive orders: questions about constitutionality, legality and overall fairness to the American public. 通过行政命令管理生物技术:关于合宪性、合法性和对美国公众的整体公平性的问题。
The journal of biolaw & business Pub Date : 2005-01-01
Peter Cuomo
{"title":"Regulation of biotechnology by executive orders: questions about constitutionality, legality and overall fairness to the American public.","authors":"Peter Cuomo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In the biotechnology field, researchers often face complex moral and social issues while pursuing their scientific goals. Congress may regulate much of that research by debating the issues and placing restraints on funding granted by the government. In modern times, our presidents have also made some of those funding decisions through the issuance of executive orders. Presidents may issue executive orders with binding legal effect, despite having little constitutional authority to do so. Unless a new president takes office, only Congress or the courts can invalidate an executive order. In the regulation-sensitive biotechnology industry, presidents may exert profound influence by announcing executive orders. Former President Clinton and President George W. Bush are just the latest presidents who have used such orders to influence biotechnology as they have deemed appropriate. In doing so, those presidents have assumed a degree of unilateral lawmaking power over an industry that is fundamentally important to every citizen. This article stresses the need for the other branches of our government to discontinue granting unconstitutional legislative power to the president, and bring more social and scientific balance to important biotechnology policy decisions.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 2","pages":"30-42"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25907223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Government support for embryonic stem cell research. 政府对胚胎干细胞研究的支持。
The journal of biolaw & business Pub Date : 2005-01-01
Afton Ekemo
{"title":"Government support for embryonic stem cell research.","authors":"Afton Ekemo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>State funding and political support for embryonic stem cell research facilitate progress.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 4","pages":"66-7"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25977718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
California Stem Cell Research and Cures Act: what to expect from stem cell research? 加州干细胞研究与治疗法案:对干细胞研究有何期待?
The journal of biolaw & business Pub Date : 2005-01-01
Joe Panetta, John Wetherell, Michelle Mehok
{"title":"California Stem Cell Research and Cures Act: what to expect from stem cell research?","authors":"Joe Panetta,&nbsp;John Wetherell,&nbsp;Michelle Mehok","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>On November 2, 2004 California voters approved Proposition 71, the California Stem Cell Research and Cures Act (\"Act\"), a $3 billion bond measure to advance stem cell research over the next ten years. The Act also created the California Institute for Regenerative Medicine (CIRM) and the Independent Citizens Oversight Committee (ICOC) which will govern the Institute, and make grants and loans for stem cell research and research facilities. This article will cover the history of the \"Act\", its potential impact on NIH's current stem cell program, and what are other states doing to compete with California's revolutionary efforts. In addition, the article will discuss the criteria for California's grant applicants under the Act and the legal issues surrounding the new discoveries funded by the Act.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 4","pages":"3-12"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25977714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The medical examination in United States immigration applications: the potential use of genetic testing leads to heightened privacy concerns. 美国移民申请中的医疗检查:基因检测的潜在使用加剧了对隐私的担忧。
The journal of biolaw & business Pub Date : 2005-01-01
A Maxwell Burroughs
{"title":"The medical examination in United States immigration applications: the potential use of genetic testing leads to heightened privacy concerns.","authors":"A Maxwell Burroughs","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The medical examination has been an integral part of the immigration application process since the passing of the Immigration Act of 1891. Failing the medical examination can result in denial of the application. Over the years the medical examination has been expanded to include questioning about diseases that are scientifically shown to be rooted in an individual's genetic makeup. Recent advances in the fields of genomics and bioinformatics are making accurate and precise screening for these conditions a reality. Government policymakers will soon be faced with decisions regarding whether or not to sanction the use of these newly-developed genetic tests in the immigration application procedure. The terror threat currently facing the United States may ultimately bolster the argument in favor of genetic testing and/or DNA collection of applicants. However, the possibility of a government mandate requiring genetic testing raises a host of ethical issues; including the threat of eugenics and privacy concerns. Genetic testing has the ability to uncover a wealth of sensitive medical information about an individual and currently there are no medical information privacy protections afforded to immigration applicants. This article examines the potential for genetic testing in the immigration application process and the ethical issues surrounding this testing. In particular, this article explores the existing framework of privacy protections afforded to individuals living in the United States and how this and newly-erected standards like those released by the Health and Human Services (HHS) might apply to individuals seeking to immigrate to the United States.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 4","pages":"22-32"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25977716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Synthetic biology: navigating the challenges ahead. 合成生物学:应对未来的挑战。
The journal of biolaw & business Pub Date : 2005-01-01
Arjun Bhutkar
{"title":"Synthetic biology: navigating the challenges ahead.","authors":"Arjun Bhutkar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The emerging field of synthetic biology is broadly defined as the area of intersection of biology and engineering that focuses on the modification or creation of novel biological systems that do not have a counterpart in nature. Potential applications of this technology range from creating systems for environmental cleanup tasks, for medical diagnosis and treatment, to economical generation of hydrogen fuel. This technology is in tis nascent state and there are a number of concerns surrounding its potential applications and the nature of research being performed. With the potential to create hitherto unknown \"living organisms\", it raises a number of challenges along different dimensions. This article reviews the current state of the technology and analyzes synthetic biology using different lenses: patentability, ethics, and regulation. It proposes a classification system for the products of synthetic biology and provides recommendations in each of the above areas (patentability, ethics, and regulation) in the context of this classification system. These recommendations include an improved framework for patentability testing, ethical principles to guide work in this area, a controlled approval process, and reference frameworks for regulation.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 2","pages":"19-29"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25907222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ethics and policy perspectives on personalized medicine in the post-genomic era. 后基因组时代个体化医疗的伦理和政策观点。
The journal of biolaw & business Pub Date : 2005-01-01
Melissa R Landon
{"title":"Ethics and policy perspectives on personalized medicine in the post-genomic era.","authors":"Melissa R Landon","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The completion of the human genome project and the accompanying biotechnological revolution hold great promise for the creation of pharmaceutical agents to combat not only previously incurable diseases, but also those for which therapeutics exist, yet they either cause severe adverse effects or exhibit no benefit in subsets of the population. In many instances variation in therapy response can be attributed to genetic differences, more particularly single nucleotide polymorphism (SNPs). Detection of the genetic differences which affect drug response, commonly referred to as pharmacogenomics, may result in further classification of diseases, and consequently, the development of 'personalized' therapies. While of potential great benefit, the widespread use of pharmacogenomic data poses social, ethical, and economic risks that need to be addressed by regulatory agencies such as the Food and Drug Administration (FDA). This paper explores some of the common problems associated with the use of pharmacogenomic data including validation of the data, patient confidentiality, social stratification, economic risks faced by pharmaceutical and insurance companies, and offers suggestions for regulatory procedures to ensure the appropriate use of the data in drug development and clinical trials.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 3","pages":"28-36"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25839801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetic discrimination and the need for federal legislation. 基因歧视和联邦立法的必要性。
The journal of biolaw & business Pub Date : 2005-01-01
John J Quick
{"title":"Genetic discrimination and the need for federal legislation.","authors":"John J Quick","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The advent of the Human Genome Project signaled a new era in preventative care. However, this Project threatens to create a new form of employment discrimination, which legislation has yet to sufficiently address. Courts are attempting to utilize a variety of currently enacted laws to combat such discrimination but it is clear that this may be an inadequate deterrence. To combat this problem, a new set of laws and regulations will need to be enacted to ensure that the interests of employers are upheld while maintaining proper protection of employees from genetic discrimination. This paper focuses on genetic testing in the workplace and the need for Federal legislation.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"8 1","pages":"22-6"},"PeriodicalIF":0.0,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25906658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
How molecular medicine transforms policy (and everything else). 分子医学如何改变政策(以及其他一切)。
The journal of biolaw & business Pub Date : 2004-01-01
Marcia A Kean, Keith F Batchelder
{"title":"How molecular medicine transforms policy (and everything else).","authors":"Marcia A Kean,&nbsp;Keith F Batchelder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Molecular medicine (also known as pharmacogenomics, pharmacogenetics, gene-based medicine, personalized medicine), after being heralded prematurely as the next revolution in medicine, is in the process now of becoming the first big change in healthcare of the 21st century. Because its scientific, clinical, ethical, financial, and regulatory implications are so far-reaching, it is important to define who and what will be affected in order to put the right societal systems and policies in place to cope with the change. Leaders of the personalized medicine field will be those organizations that see the wave and prepare to adjust their traditional planning, relationships, attitudes and management approach.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"7 3","pages":"16-9"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40900118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding orphan drug regulations: an EU and U.S. comparative analysis. 理解孤儿药法规:欧盟和美国的比较分析。
The journal of biolaw & business Pub Date : 2004-01-01
Aurelie Grienenberger
{"title":"Understanding orphan drug regulations: an EU and U.S. comparative analysis.","authors":"Aurelie Grienenberger","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Whereas orphan regulations exist in almost all ICH regions, they may correspond to significantly different types of reality in terms of principles and regulatory requirements. The apparent similarity in regulations may lead to misunderstanding and cultural gaps between sponsors and regulatory authorities. Based on the European and the US experience, we decipher the main points stumbling blocks that US sponsor may strike when applying for an orphan designation in the EU. An update of the orphan drugs designations is provided as well as the upcoming challenges that orphan regulations will meet with the development of pharmaco-genomics and personalized medicines.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"7 3","pages":"58-61"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40900119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The business of human embryonic stem cell research and an international analysis of relevant laws. 人类胚胎干细胞研究业务及相关法律的国际分析。
The journal of biolaw & business Pub Date : 2004-01-01
Ella De Trizio, Christopher S Brennan
{"title":"The business of human embryonic stem cell research and an international analysis of relevant laws.","authors":"Ella De Trizio,&nbsp;Christopher S Brennan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Few sciences have held out such therapeutic promise and correspondingly stirred so much controversy in countries throughout the world as the developing science surrounding human embryonic stem cells. Since the first reported development of several lines of human embryonic stem cells in 1988, many governments around the world have attempted to address the thorny ethical issues raised by human embryonic stem cell research by the passage of laws. In some cases these laws have directly regulated governmental funding of the science; in other cases they have created a legal environment that has either encouraged or discouraged both governmental and private funding of the science. This article first differentiates human embryonic stem cells from other types of stem cells and frames the ethical controversy surrounding human embryonic stem cell research, then surveys laws governing human embryonic stem cell research in various scientifically advanced countries located throughout the Pacific Rim, Europe and North America and explains the impact these laws have had on governmental and private funding of human embryonic stem cell research.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"7 4","pages":"14-22"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24926817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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