Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single "Policy Perspective" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as "covering" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.
{"title":"Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not","authors":"Christopher M. Holman","doi":"10.2139/ssrn.2001574","DOIUrl":"https://doi.org/10.2139/ssrn.2001574","url":null,"abstract":"Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents \"present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing.\" His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single \"Policy Perspective\" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as \"covering\" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122261534","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}
While studies of cannabis use are numerous, the voices of consumers of cannabis are rarely heard. Even less prevalent are the voices of young people living with a mental illness, whose perceptions, attitudes and experiences are crucial to construction of effective health strategies and campaigns. This paper seeks to enhance understanding of the perceived and experienced links between cannabis use and mental health by young adults between the ages of 18 and 30 years who are living with a mental illness. With reference to insight gained from focus groups comprising members of this cohort, motivations for use and non-use of cannabis are discussed. Reappraisal of cannabis from a relatively safe and ‘soft’ drug to one that is implicated in psychosis and mental illness renders the experience of this cohort particularly relevant to public policy and debate. To the extent that cannabis can precipitate a predisposition to mental illness — thus catalysing a risk factor that may not be known in advance — it is vital that we know more about the perceptions of young people who are already confronting mental illness and their attitudes to cannabis use. Such knowledge can potentially lead both to more effective health promotion campaigns in relation to this cohort, and more effective engagement of young people in general (where, in the context of cannabis use and mental health, youth itself is a risk factor).
{"title":"Perceptions and Experiences of Cannabis Use by Young Adults Living with a Mental Illness: A Qualitative Study","authors":"Pam Stavropoulos, S. McGee, Meg Smith","doi":"10.2139/ssrn.2012862","DOIUrl":"https://doi.org/10.2139/ssrn.2012862","url":null,"abstract":"While studies of cannabis use are numerous, the voices of consumers of cannabis are rarely heard. Even less prevalent are the voices of young people living with a mental illness, whose perceptions, attitudes and experiences are crucial to construction of effective health strategies and campaigns. This paper seeks to enhance understanding of the perceived and experienced links between cannabis use and mental health by young adults between the ages of 18 and 30 years who are living with a mental illness. With reference to insight gained from focus groups comprising members of this cohort, motivations for use and non-use of cannabis are discussed. Reappraisal of cannabis from a relatively safe and ‘soft’ drug to one that is implicated in psychosis and mental illness renders the experience of this cohort particularly relevant to public policy and debate. To the extent that cannabis can precipitate a predisposition to mental illness — thus catalysing a risk factor that may not be known in advance — it is vital that we know more about the perceptions of young people who are already confronting mental illness and their attitudes to cannabis use. Such knowledge can potentially lead both to more effective health promotion campaigns in relation to this cohort, and more effective engagement of young people in general (where, in the context of cannabis use and mental health, youth itself is a risk factor).","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127189836","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}
This article demonstrates experimentally that individuals making decisions about their health management are affected by the decision making environment and that law and policy can serve important roles in improving the decision environment. With the support of a generous grant from the Robert Wood Johnson Foundation, we conducted two series of experiments. First a lab experiment with approximately 700 respondents and next a web-based experiment with over 3000 respondents, including 300 medical doctors. In each of the experiments, in addition to manipulating the decision making environment and choice sets, we manipulated the state of the decision maker. In the first series of experiments we used the psychological mechanism of cognitive depletion and in the second series we tested the effects of cognitive overload. Most broadly, unlike past measures of risk aversion, our studies demonstrate that preferences for risk are not fixed in an individual but rather are highly sensitive to the role, context, and state of the decision maker in patterned ways. The project provides new evidence that cognitive processes affect decision making and judgment of risk, often leading to medically suboptimal choices. The lab studies suggest that often people process risk sub-optimally, e.g. favoring potentially harmful omissions over less harmful acts and being influenced by the order of warnings or choices, rather than their substantive value.
{"title":"Healthy Choices: Regulatory Design and Processing Modes of Health Decisions","authors":"Orly Lobel, On Amir","doi":"10.2139/ssrn.1876734","DOIUrl":"https://doi.org/10.2139/ssrn.1876734","url":null,"abstract":"This article demonstrates experimentally that individuals making decisions about their health management are affected by the decision making environment and that law and policy can serve important roles in improving the decision environment. With the support of a generous grant from the Robert Wood Johnson Foundation, we conducted two series of experiments. First a lab experiment with approximately 700 respondents and next a web-based experiment with over 3000 respondents, including 300 medical doctors. In each of the experiments, in addition to manipulating the decision making environment and choice sets, we manipulated the state of the decision maker. In the first series of experiments we used the psychological mechanism of cognitive depletion and in the second series we tested the effects of cognitive overload. Most broadly, unlike past measures of risk aversion, our studies demonstrate that preferences for risk are not fixed in an individual but rather are highly sensitive to the role, context, and state of the decision maker in patterned ways. The project provides new evidence that cognitive processes affect decision making and judgment of risk, often leading to medically suboptimal choices. The lab studies suggest that often people process risk sub-optimally, e.g. favoring potentially harmful omissions over less harmful acts and being influenced by the order of warnings or choices, rather than their substantive value.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121058260","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}
In the United States, the prevention of costly chronic diseases is an important ambition of healthcare reform. In many European countries, preventive health services are widely distributed in the workplace, through the complex infrastructure of occupational safety and health law. European and national laws impose on employers the duty to prevent risks to workers’ health. In France, as in many European countries, workplace doctors specializing in preventive medicine enable the employer to fulfill the prevention duty. The law requires employers to provide regular preventive checkups to all employees. Occupational physicians monitor employees’ health and engage in workplace policymaking to minimize environmental factors that can exacerbate employees’ chronic diseases. In the United States, employers are increasingly taking an interest in providing onsite preventive health services in order to cut healthcare costs. To identify and understand some of the challenges for integrating preventive health into the American workplace, this Article explores why and how American company clinics function so differently from French workplace health services. The workplace clinics in the two countries are governed by two fundamentally different employment law regimes, which have significant consequences for their ability to optimize employees’ health and pursue public health goals.
{"title":"Preventive Health at Work: A Comparative Approach","authors":"Julie C. Suk","doi":"10.5131/AJCL.2010.0030","DOIUrl":"https://doi.org/10.5131/AJCL.2010.0030","url":null,"abstract":"In the United States, the prevention of costly chronic diseases is an important ambition of healthcare reform. In many European countries, preventive health services are widely distributed in the workplace, through the complex infrastructure of occupational safety and health law. European and national laws impose on employers the duty to prevent risks to workers’ health. In France, as in many European countries, workplace doctors specializing in preventive medicine enable the employer to fulfill the prevention duty. The law requires employers to provide regular preventive checkups to all employees. Occupational physicians monitor employees’ health and engage in workplace policymaking to minimize environmental factors that can exacerbate employees’ chronic diseases. In the United States, employers are increasingly taking an interest in providing onsite preventive health services in order to cut healthcare costs. To identify and understand some of the challenges for integrating preventive health into the American workplace, this Article explores why and how American company clinics function so differently from French workplace health services. The workplace clinics in the two countries are governed by two fundamentally different employment law regimes, which have significant consequences for their ability to optimize employees’ health and pursue public health goals.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116557732","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}
Patents prevent anyone but the patent-holder from manufacturing, using, or distributing discoveries and inventions for twenty years from the date of filing. In order to be patentable, an invention needs to be useful, non-obvious, and represent an original design or process rather than an abstract concept or item commonly found in nature. Patents related to genetics received their first legal test in 1980, when the U.S. Patent and Trademark Office (USPTO) granted protection to a genetically engineered bacterium that consumed oil and was useful in cleaning oil spills. The legality of this patent was affirmed in Diamond v. Chakrabarty, where the Supreme Court observed that although “[t]he laws of nature, physical phenomena, and abstract ideas” were not patentable subject matter under § 101, the claimed invention in the case was distinguished from nature as “a product of human ingenuity having a distinctive name, character and use.” The Court held that although the invention comprised a living thing, the patentee had produced a new bacterium with “markedly different characteristics” from the original. The bacterium was, therefore, “not nature’s handiwork but [the patentee’s] own.” Although Chakrabarty settled the question of whether manufactured genes can receive patent protection, it did not address the patentability of naturally occurring genes. In the absence of such definitive legal guidance, the USPTO routinely issues patents on human deoxyribonucleic acid (DNA) sequences, reasoning that the material has been purified from its natural form through human intervention and is thus sufficiently “touched by man” to be beyond the scope of nature. From 1980 to 2009, the USPTO issued between 3,000 and 5,000 patents on human genes, encompassing nearly 20% of the human genome. In addition, the USPTO has issued nearly 50,000 patents involving human genetic material, yet the fundamental validity of such patents has never been reviewed until now. In March 2010, a district court decision in New York brought attention to the role of gene patents in the advancement of biomedical research. In Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP”), the Southern District of New York enforced a strict standard for subject matter patentability by invalidating seven patents relating to the human breast cancer genes BRCA1 and BRCA2 (collectively “BRCA”). The court reasoned that not only were the coding sequences and mutations of BRCA results of natural phenomena but that, the purified forms of BRCA maintain essentially the same structures and functions as their natural forms and therefore fall outside the scope of patent law protection. Although the decision primarily addressed the patent’s subject matter, the court also noted the possible social implications resulting from how patents affect access and innovation in biomedical research. Contrary to concerns raised by the plaintiffs in AMP, empirical studies indicate that gene patents
专利从申请之日起20年内禁止除专利权人以外的任何人制造、使用或传播发现和发明。为了获得专利，一项发明需要是有用的，非显而易见的，并且代表了一种原始的设计或方法，而不是自然界中常见的抽象概念或项目。1980年，美国专利商标局(USPTO)批准了一种基因工程细菌的保护，这种细菌可以消耗石油，并有助于清理泄漏的石油。当时，与遗传学相关的专利首次受到法律考验。这项专利的合法性在Diamond v. Chakrabarty案中得到了肯定，最高法院在该案中指出，尽管“自然法则、物理现象和抽象概念”不是第101条规定的可申请专利的主题，但本案中所主张的发明有别于自然，是“具有独特名称、特征和用途的人类聪明才智的产物”。法院认为，尽管该发明包含了一种生物，但专利权人产生了一种与原细菌“特征明显不同”的新细菌。因此，这种细菌“不是大自然的杰作，而是(专利权人)自己的”。虽然Chakrabarty解决了人造基因是否可以获得专利保护的问题，但它没有解决天然基因的可专利性问题。在缺乏这样明确的法律指导的情况下，美国专利商标局通常会颁发人类脱氧核糖核酸(DNA)序列的专利，理由是该物质已经通过人类干预从其自然形态中纯化出来，因此已经足够“被人类接触”，超出了自然的范围。从1980年到2009年，美国专利商标局颁发了3000到5000项人类基因专利，涵盖了近20%的人类基因组。此外，美国专利商标局已经发布了近5万项涉及人类遗传物质的专利，但这些专利的基本有效性直到现在才得到审查。2010年3月，纽约地方法院的一项裁决引起了人们对基因专利在推进生物医学研究中的作用的关注。在分子病理学协会诉美国专利商标局(“AMP”)一案中，纽约南区通过宣布七项与人类乳腺癌基因BRCA1和BRCA2(统称为“BRCA”)相关的专利无效，强制执行了严格的主题可专利性标准。法院认为，BRCA的编码序列和突变不仅是自然现象的结果，而且纯化形式的BRCA与自然形式的BRCA基本保持相同的结构和功能，因此不属于专利法保护的范围。尽管该判决主要涉及专利的主题，但法院也注意到专利如何影响生物医学研究的获取和创新可能产生的社会影响。与原告在AMP案中提出的担忧相反，实证研究表明，基因专利并不妨碍对生物医学研究数据的获取，也不会对科学家选择从事的研究主题产生重大影响。这些结果表明，虽然基因专利不会阻碍创新，但它们可能也不是创新所必需的，至少在基础层面上是如此。然而，一些学者仍然坚持认为，专利保护是必要的，以确保有足够的资金用于进一步的研究、开发和营销他们的创新。本说明侧重于专利法在鼓励或阻碍生物医学研究领域创新方面的作用。具体来说，本文分析了基因专利背后的政策理由，并探讨了这些理由是否有效地适用于BRCA基因的专利。第一部分建立了对专利、基因和基因专利的基本认识。第2部分提供了关于AMP案例中的参数和持有的更详细信息。第三部分介绍了传统的专利保护原理，并将其应用于基因专利。第四部分考虑了围绕基因专利的担忧，以及鉴于专利与生物医学研究之间关系的实证研究结果，这些担忧是否现实。第四部分还考察了地方法院在AMP案中的裁决是否与知识产权背后的政策目标和行业现实相一致。最后，本文的结论是，一般来说，专利不会阻碍创新。然而，广泛发布组合物权利要求，如Myriad在AMP中持有的权利要求，可能会阻碍专利持有人不从事的研究领域的研究(如治疗学)。本说明建议通过将专利权利要求的焦点缩小到基因组合物的应用上，而不是组合物本身，可以解决这一问题。
{"title":"Seeing the Forest Through the Trees: Gene Patents & the Reality of the Commons","authors":"Tina Renee Saladino","doi":"10.2139/SSRN.1800527","DOIUrl":"https://doi.org/10.2139/SSRN.1800527","url":null,"abstract":"Patents prevent anyone but the patent-holder from manufacturing, using, or distributing discoveries and inventions for twenty years from the date of filing. In order to be patentable, an invention needs to be useful, non-obvious, and represent an original design or process rather than an abstract concept or item commonly found in nature. Patents related to genetics received their first legal test in 1980, when the U.S. Patent and Trademark Office (USPTO) granted protection to a genetically engineered bacterium that consumed oil and was useful in cleaning oil spills. The legality of this patent was affirmed in Diamond v. Chakrabarty, where the Supreme Court observed that although “[t]he laws of nature, physical phenomena, and abstract ideas” were not patentable subject matter under § 101, the claimed invention in the case was distinguished from nature as “a product of human ingenuity having a distinctive name, character and use.” The Court held that although the invention comprised a living thing, the patentee had produced a new bacterium with “markedly different characteristics” from the original. The bacterium was, therefore, “not nature’s handiwork but [the patentee’s] own.” Although Chakrabarty settled the question of whether manufactured genes can receive patent protection, it did not address the patentability of naturally occurring genes. In the absence of such definitive legal guidance, the USPTO routinely issues patents on human deoxyribonucleic acid (DNA) sequences, reasoning that the material has been purified from its natural form through human intervention and is thus sufficiently “touched by man” to be beyond the scope of nature. From 1980 to 2009, the USPTO issued between 3,000 and 5,000 patents on human genes, encompassing nearly 20% of the human genome. In addition, the USPTO has issued nearly 50,000 patents involving human genetic material, yet the fundamental validity of such patents has never been reviewed until now. In March 2010, a district court decision in New York brought attention to the role of gene patents in the advancement of biomedical research. In Association for Molecular Pathology v. United States Patent and Trademark Office (“AMP”), the Southern District of New York enforced a strict standard for subject matter patentability by invalidating seven patents relating to the human breast cancer genes BRCA1 and BRCA2 (collectively “BRCA”). The court reasoned that not only were the coding sequences and mutations of BRCA results of natural phenomena but that, the purified forms of BRCA maintain essentially the same structures and functions as their natural forms and therefore fall outside the scope of patent law protection. Although the decision primarily addressed the patent’s subject matter, the court also noted the possible social implications resulting from how patents affect access and innovation in biomedical research. Contrary to concerns raised by the plaintiffs in AMP, empirical studies indicate that gene patents","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127470947","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}
Pub Date : 2011-03-17DOI: 10.36646/mjlr.45.1.off-label
B. Liang, T. Mackey
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire consequences for patient safety and the prevention of healthcare fraud and abuse. Worse still, because of these policies, vulnerable disease patients and their physicians are often unaware of appropriate off-label treatments, and the lack of information places these patients at risk. To address these concerns, we propose the creation of a targeted and regulated off-label promotion system that enables vulnerable patient populations to access life-saving treatments and simultaneously creates clear incentives to avoid inappropriate off-label promotion. This federal legislation would create FDA-targeted exemptions of off-label prohibitions for vulnerable patient populations, if certain requirements of enrollment, risk management, and pharmacovigilance are met. Any proposed off-label promotion would also be pre-reviewed by the FDA to ensure that the program was safe and properly monitored. To create incentives for appropriate off-label marketing and avoid the problem of repeat corporate offenders, additional penalties would be available without preempting other causes of action. This system of carrots and sticks would increase drug access for vulnerable patient populations while discouraging illegal marketing that could threaten patient safety and public health.
{"title":"Off Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access and Limiting Inappropriate Pharmaceutical Marketing","authors":"B. Liang, T. Mackey","doi":"10.36646/mjlr.45.1.off-label","DOIUrl":"https://doi.org/10.36646/mjlr.45.1.off-label","url":null,"abstract":"Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or \"off-label\" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire consequences for patient safety and the prevention of healthcare fraud and abuse. Worse still, because of these policies, vulnerable disease patients and their physicians are often unaware of appropriate off-label treatments, and the lack of information places these patients at risk. To address these concerns, we propose the creation of a targeted and regulated off-label promotion system that enables vulnerable patient populations to access life-saving treatments and simultaneously creates clear incentives to avoid inappropriate off-label promotion. This federal legislation would create FDA-targeted exemptions of off-label prohibitions for vulnerable patient populations, if certain requirements of enrollment, risk management, and pharmacovigilance are met. Any proposed off-label promotion would also be pre-reviewed by the FDA to ensure that the program was safe and properly monitored. To create incentives for appropriate off-label marketing and avoid the problem of repeat corporate offenders, additional penalties would be available without preempting other causes of action. This system of carrots and sticks would increase drug access for vulnerable patient populations while discouraging illegal marketing that could threaten patient safety and public health.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2011-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126574679","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}
"From the Bitterness of disease man learns the sweetness of health." - Catalan ProverbIndia is a leading player in the medical tourism industry. It is increasingly emerging as the destination of choice for a wide range of medical procedures. The medical tourism market in India was estimated at $333 million in 2004. It is anticipated to grow by 25 percent annually and to become a $2 billion-a-year business opportunity by 2012. Andhra Pradesh is slowly picking up the heat of Medical Tourism. Hyderabad is the 1st City in AP to catch the fire.To gain more from health tourism, the state government has to be in search of opportunities. Alternative Medicine (AM) is one such avenue which has proven to be a great contributor in Kerala.The paper identified the popular alternative medicines in AP. The paper unravels "Bathini Fish medicine" which is very popular in AP, attracting lakhs and lakhs of tourists from within and outside India. An analysis of the economic value of "Bathini Fish medicine" as an Alternative medicine is discussed. It studies the advantages gained by various entrepreneurs through the people who visit Hyderabad on the purpose of this medicine. The paper explores the challenges being faced by the medicine. The paper suggests various strategies for further growth and development of this medicine and to turn out it as a health tourism opportunity.The paper concludes with the scope of Health Tourism in AP and how "Bathini Fish Medicine", an alternative medicine can be taken as an advantage to grow Health Tourism in AP.
{"title":"A Voyage of Medical Tourism through Alternative Medicine (With Reference to Bathini Fish Medicine in Hyderabad)","authors":"P. Murthy, Jyothsna Priyadarsini K.","doi":"10.2139/ssrn.1738802","DOIUrl":"https://doi.org/10.2139/ssrn.1738802","url":null,"abstract":"\"From the Bitterness of disease man learns the sweetness of health.\" - Catalan ProverbIndia is a leading player in the medical tourism industry. It is increasingly emerging as the destination of choice for a wide range of medical procedures. The medical tourism market in India was estimated at $333 million in 2004. It is anticipated to grow by 25 percent annually and to become a $2 billion-a-year business opportunity by 2012. Andhra Pradesh is slowly picking up the heat of Medical Tourism. Hyderabad is the 1st City in AP to catch the fire.To gain more from health tourism, the state government has to be in search of opportunities. Alternative Medicine (AM) is one such avenue which has proven to be a great contributor in Kerala.The paper identified the popular alternative medicines in AP. The paper unravels \"Bathini Fish medicine\" which is very popular in AP, attracting lakhs and lakhs of tourists from within and outside India. An analysis of the economic value of \"Bathini Fish medicine\" as an Alternative medicine is discussed. It studies the advantages gained by various entrepreneurs through the people who visit Hyderabad on the purpose of this medicine. The paper explores the challenges being faced by the medicine. The paper suggests various strategies for further growth and development of this medicine and to turn out it as a health tourism opportunity.The paper concludes with the scope of Health Tourism in AP and how \"Bathini Fish Medicine\", an alternative medicine can be taken as an advantage to grow Health Tourism in AP.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115784442","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}
This paper will attempt to establish a workable definition of bioethics as well as the general principles associated with bioethics. Upon submitting that for consideration, the scope of this paper will include how this can be used in addressing the current and possibly future issues that bioethics can be a part of addressing as compared to where the law will need to continue to adjudicate issues that cannot be addressed via simply bioethics.
{"title":"Bioethics & Law: Bioethics","authors":"V. Agrawal","doi":"10.2139/SSRN.1650954","DOIUrl":"https://doi.org/10.2139/SSRN.1650954","url":null,"abstract":"This paper will attempt to establish a workable definition of bioethics as well as the general principles associated with bioethics. Upon submitting that for consideration, the scope of this paper will include how this can be used in addressing the current and possibly future issues that bioethics can be a part of addressing as compared to where the law will need to continue to adjudicate issues that cannot be addressed via simply bioethics.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124767414","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}
Over the past three decades, collaborative arrangements between academic biomedical researchers and private industry have grown dramatically, resulting in medical innovations that have benefited society greatly. However, a growing chorus of criticism directed at private companies that sponsor and conduct biomedical research casts doubt on the very ethos of science. Academics and anti-business activists have waged a campaign against industry-sponsored clinical trials that denies the fundamentally commercial nature of such research and hinders medical progress. These critics point to a small number of unfortunate and tragic cases in which financial conflicts of interest may have played a role in research-related injuries and deaths in order to unjustifiably condemn the profit motive in biomedical research as a whole.
{"title":"Shackling Innovation the Regulation of Industry Supported Clinical Trials","authors":"S. Fry-Revere, Matthew Ray, D. Malmstrom","doi":"10.2139/SSRN.2713171","DOIUrl":"https://doi.org/10.2139/SSRN.2713171","url":null,"abstract":"Over the past three decades, collaborative arrangements between academic biomedical researchers and private industry have grown dramatically, resulting in medical innovations that have benefited society greatly. However, a growing chorus of criticism directed at private companies that sponsor and conduct biomedical research casts doubt on the very ethos of science. Academics and anti-business activists have waged a campaign against industry-sponsored clinical trials that denies the fundamentally commercial nature of such research and hinders medical progress. These critics point to a small number of unfortunate and tragic cases in which financial conflicts of interest may have played a role in research-related injuries and deaths in order to unjustifiably condemn the profit motive in biomedical research as a whole.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"94 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125250033","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}
This report was commissioned by the No-Fault Compensation Review Group in Scotland. It provides an up-to-date analysis of existing no-fault schemes in New Zealand, Sweden, Denmark, Norway, and Finland, as well as limited schemes which operate in Virginia and Florida in the United States. Drawing on such analysis, the report considers a number of specific elements such as the advantages and disadvantages of no-fault schemes; choice of model; equality of coverage; cost and affordability; access to justice; and linkages to patient complaints processes, professional accountability and patient safety. The report was designed to assist the Group in its deliberations on whether a no-fault compensation scheme for medical injury should be established in Scotland. The Group’s report setting out its findings and recommendations was published in 2011.
{"title":"No-Fault Compensation Schemes for Medical Injury: A Review","authors":"A. Farrell, S. Devaney, A. Dar","doi":"10.2139/SSRN.2221836","DOIUrl":"https://doi.org/10.2139/SSRN.2221836","url":null,"abstract":"This report was commissioned by the No-Fault Compensation Review Group in Scotland. It provides an up-to-date analysis of existing no-fault schemes in New Zealand, Sweden, Denmark, Norway, and Finland, as well as limited schemes which operate in Virginia and Florida in the United States. Drawing on such analysis, the report considers a number of specific elements such as the advantages and disadvantages of no-fault schemes; choice of model; equality of coverage; cost and affordability; access to justice; and linkages to patient complaints processes, professional accountability and patient safety. The report was designed to assist the Group in its deliberations on whether a no-fault compensation scheme for medical injury should be established in Scotland. The Group’s report setting out its findings and recommendations was published in 2011.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2010-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116549158","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}
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