Journal of law and health最新文献

{"title":"Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan.","authors":"Ping-Hsun Chen","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan's proposal includes both measures. Taiwan's patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The scope of patentees who may benefit from the mechanism is larger than what is required. In addition, the system requires a generic drug company to notify the patentee at the time of filing the drug application if the generic drug company asserts invalidity or non-infringement which the generic drug company must prove. Furthermore, the health authority is allowed to stay the issuance of a generic drug permit while the patentee is suing the generic drug company in the court.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37070750","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}

{"title":"Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan.","authors":"Ping-hsun Chen","doi":"10.2139/ssrn.3290083","DOIUrl":"https://doi.org/10.2139/ssrn.3290083","url":null,"abstract":"The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan's proposal includes both measures. Taiwan's patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The scope of patentees who may benefit from the mechanism is larger than what is required. In addition, the system requires a generic drug company to notify the patentee at the time of filing the drug application if the generic drug company asserts invalidity or non-infringement which the generic drug company must prove. Furthermore, the health authority is allowed to stay the issuance of a generic drug permit while the patentee is suing the generic drug company in the court.","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68582023","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}

{"title":"Weird Science: Frankenstein Foods and States as Laboratories of Democracy.","authors":"Jennifer McGee","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont's Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National Standard with the requirements of Vermont's Act 120 and concludes that Vermont's labeling law offered a better safeguard for consumer sovereignty because it included a larger range of products and required a label that immediately relayed disclosures to consumers.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071626","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}

{"title":"Germ-Line Gene Editing and Congressional Reaction in Context: Learning From Almost 50 Years of Congressional Reactions to Biomedical Breakthroughs.","authors":"Russell A Spivak,&nbsp;I Glenn Cohen,&nbsp;Eli Y Adashi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science's potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs--Recombinant DNA, in vitro fertilization, Cloning, Stem Cells--to better analyze how Congress is, and should, regulate this exciting and promising science.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37070749","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}

{"title":"Circling the Drain: Regulating Nutrient Pollution from Agricultural Sources.","authors":"William Gutermuth","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of the current laws governing nutrient pollution and tap water quality. Part IV analyzes the source of the problem and demonstrates that agriculture is largely responsible. Lastly, Part V suggests that the problem of nutrient pollution can be resolved through a reinterpretation of the Clean Water Act's definition of a point source.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071625","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}

{"title":"Healer, Witness, or Double Agent? Reexamining the Ethics of Forensic Psychiatry.","authors":"Matthew U Scherer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In recent years, psychiatrists have become ever more prevalent in American courtrooms. Consequently, the issue of when the usual rules of medical ethics should apply to forensic psychiatric encounters has taken on increased importance and is a continuing topic of discussion among both legal and medical scholars. A number of approaches to the problem of forensic psychiatric ethics have been proposed, but none adequately addresses the issues that arise when a forensic encounter develops therapeutic characteristics. This article looks to the rules governing the lawyer-client relationship as a model for a new approach to forensic psychiatric ethics. This new model focuses on the expectations of the evaluee and the ways in which the evaluating psychiatrist shapes those expectations to determine how and when the rules of medical ethics should apply to forensic psychiatric encounters. This article describes and analyzes three previously proposed approaches to that question and the closely related question of when and how a doctor-patient relationship can form in the context of a forensic psychiatric evaluation. It also explains why each of these prior approaches does not sufficiently address the issues that arise when a forensic encounter takes on therapeutic characteristics. Finally, it proposes a new approach that draws inspiration from the rules governing the lawyer-client relationship.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071630","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}

{"title":"Mending Invisible Wounds: The Efficacy and Legality of MDMA-Assisted Psychotherapy in United States' Veterans Suffering with Post-Traumatic Stress Disorder.","authors":"Jonathan Perry","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Though Veteran Affairs has provided crucial life sustaining--and often lifesaving--treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA's facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of suicide. If there is any hope of treating this debilitating psychotic phenomenon--or at least containing its rapid growth and addressing its profound depth--alternative remedies as a means must not be ignored for a normative end. Accordingly, this note argues that physicians must be able to treat PTSD victims through MDMA-assisted psychotherapy, an alternative remedy to PTSD treatment that has shown overwhelming promise in domestic and international medical research. In doing so, it first discusses 21 U.S.C.A. Sec. 812, which labels MDMA as a Schedule I substance and prohibits healthcare professionals from using MDMA-assisted psychotherapy to treat PTSD victims. Next, the note asserts that the Drug Enforcement Agency (DEA) erroneously categorized MDMA as a substance lacking an accepted medical use and lack of safety under medical supervision. The note sets out studies, domestic and international, where clinical testing of MDMA-assisted therapy to treat PTSD have been met with overwhelmingly positive results. Finally, the note argues that MDMA's accepted medical use, low physical and psychological dependence, and known safety under medical supervision support its classification as a Schedule III under the CSA, and that the 1986 classification of MDMA as a Schedule I narcotic was, and continues to be, an arbitrary and capricious agency interpretation of an otherwise viable piece of congressional legislation.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071631","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}

{"title":"Expansion of Employee Wellness Programs Under PPACA Creates Additional Barriers to Healthcare Insurance for Individuals with Disabilities.","authors":"Amy B Cheng","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>There are many barriers to healthcare for the general population that has been documented throughout the years, with one particularly affected group being individuals with disabilities. One identified healthcare barrier for individuals with disabilities is the inability to gain access to the healthcare system through health insurance. While many attempts have been made to resolve this issue, serious problems have yet to be resolved. The Patient Protection Affordable Care Act (PPACA) attempted to solve the issue by expanding Health Insurance Portability and Accountability Act of 1996's (HIPAA) current regulations on employee wellness programs. The relevant regulations govern employee wellness programs to allow employers to offer their employees greater incentives for meeting employer-defined health targets. This expansion has an adverse effect because it disadvantages groups like individuals with disabilities by penalizing them through higher premiums or cost sharing when they are unable to meet wellness targets. This article argues PPACA's requirement for employee wellness programs provides additional barriers to healthcare insurance for individuals with disabilities. Part I of this Comment describes how the healthcare industry discriminates against individuals with disabilities by continuing to deny them meaningful access to healthcare through payment of higher premiums. Part II examines how the wellness program provision allows employers to shift the cost of medical coverage to the employee for failure to participate in the wellness program. Part III summarizes how the ADA's reasonable requirement places an obligation on employers to make reasonable accommodation to individuals with disabilities, which will improve the health of working individuals with disabilities. Part IV concludes with suggestions for further reform.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071628","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}

{"title":"Save Thousands of Lives Every Year: Resuscitate the Peer Review Privilege.","authors":"Alan G Williams","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Doctors make mistakes--preventable medical mistakes--that kill or seriously injure patients. The best way to reduce these preventable errors is through a medical peer review process typically referred to as a \"morbidity and mortality conference.\" However, over the past twenty years, federal and state courts, state legislatures, and state voters have effectively gutted the morbidity and mortality conference (M+M) as a remedial and preventative tool, resulting in tens of thousands of unnecessary deaths every year. Doctors need our help restoring the effectiveness of M+Ms. Congress has created the means to do so; now, all the courts need do is use it. Otherwise, what has been happening over the last two decades will continue--physicians will fear the M+M, will either not participate in M+Ms or not participate fully, medical errors will not be thoroughly investigated and corrected, and the same preventable medical mistakes will continue to occur because physicians are scared if they admit during an M+M that they committed an error then, in a subsequent medical malpractice lawsuit, their admission will be used against them to prove negligence and liability. Part I of this essay summarizes the extent of the problem--many call it a crisis--of preventable deaths plaguing U.S. hospitals. Part II explains peer review, both in the context of physician credentialing/hiring and M+Ms, and the legal protections afforded under the provisions of immunity, confidentiality, and privilege. Part III discusses how federal and state court decisions, state legislative enactments, and voter initiatives have weakened existing protections for peer review, especially regarding M+Ms. Part IV describes the PSQIA and how it can--and should--be the solution to preventable hospital deaths. Part V concludes with a summation of the argument that courts employ the PSQIA privilege to protect M+Ms, and that physicians and hospitals do their part by fulfilling the requirements of the PSQIA such that they may invoke the privilege therein contained.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071629","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}

{"title":"Funding Long-Term Services and Supports (LTSS) for Working Aged Disabled Americans.","authors":"Helen L Rapp","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>There are a multitude of dilemmas faced today by over 3 million significantly disabled Americans, many of whom depend on Medicaid for Long-Term Services and Supports (LTSS) in obtaining the services they need to simply live. While the landmark 1990 Americans with Disabilities Act (ADA) has done a lot to improve the lives of people with disabilities, the reality is that using Medicaid as the vehicle for funding LTSS places unreasonable restrictions on disabled people who want to live independent lives and be as successful as possible. The Federal Government must change funding for LTSS in order to provide disabled Americans with real choices regarding living arrangements and maximize their earning potential without fear of being deprived of support they cannot live without. Part II of this note provides background information on LTSS (what they are, who uses them, what they cost, and how they are currently funded). Part III examines the Medicaid Program and specifically Medicaid HCBS17 Waiver Programs, which provide the bulk of LTSS funding today. A brief history of the federal laws, amendments, and policies that have impacted Medicaid LTSS are provided. Part IV analyzes an alternative to Medicaid for LTSS funding for those working-age disabled individuals who would not otherwise be Medicaid eligible. This section specifically focuses on recommendations from the congressionally established Commission on Long-Term Care and a pilot program proposed by the American Association for People with Disabilities (AAPD). Finally, Part V concludes that the Federal government must take action to establish a stand-alone, non-Medicaid Program to provide LTSS for working-age disabled Americans who are capable of working and living independently.</p>","PeriodicalId":73804,"journal":{"name":"Journal of law and health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37071632","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}