Journal of health care law & policy最新文献_第2页

Clinical Negligence: Is Bolam Still Relevant? 临床疏忽:博兰是否仍然相关?

Journal of health care law & policy Pub Date : 2009-01-26 DOI: 10.2139/ssrn.1333165

I. Unachukwu, A. Unachukwu

引用次数: 0

The Proposed Patient Mobility Directive and the Reform of Cross-Border Healthcare in the EU 拟议的病人流动指令和欧盟跨境医疗保健改革

Journal of health care law & policy Pub Date : 2008-09-01 DOI: 10.2139/ssrn.1277110

W. Sauter

{"title":"The Proposed Patient Mobility Directive and the Reform of Cross-Border Healthcare in the EU","authors":"W. Sauter","doi":"10.2139/ssrn.1277110","DOIUrl":"https://doi.org/10.2139/ssrn.1277110","url":null,"abstract":"This paper provides a discussion of the Commission's July 2008 proposal for a Directive on the application of patients' rights in cross-border healthcare (the proposed patient mobility Directive). It does so against the background of an overview of the preceding patient mobility case law of the European Court of Justice that is based on the freedom to provide services of Article 49 EC, from Kohll and Decker in 1998 to Watts in 2006. The findings are that the proposed patient mobility Directive is not a full codification of the case law as it leaves out certain guarantees developed by the Court, while it adds some new elements of harmonisation. The Court had in principle accepted public interest justifications for prior authorisation requirements with respect to hospital treatment and focused on developing substantive and procedural guarantees of patients' rights such as the criteria for \"undue delay\", in which case authorization for treatment abroad must be granted. The Commission takes a different approach, by both requiring Member States to actually demonstrate the need for a prior authorization regime and at the same time itself providing evidence that this is in most cases unlikely to be warranted. Because the criteria for \"undue delay\" would no longer be used to determine when authorizations must be granted there will be no clear EU standard to apply if any authorisation requirements survive. The main innovation of the proposal are new patients' rights to accountability and transparency which apply not just to mobile patients but to all patients in each Member State. This represents a first step from negative integration (liberalisation) to positive integration (harmonisation). Moreover transparency and accountability will generate pressure for further change, not just in relation to the cross-border provision of services, but more broadly across the healthcare sector.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2008-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77080391","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: 7

Effects of Immigration on Health Insurance Status of Natives 移民对本地居民健康保险状况的影响

Journal of health care law & policy Pub Date : 2008-08-06 DOI: 10.2139/ssrn.1250302

Yuriy Pylypchuk

引用次数: 1

Will the Slowdown in U.S. Health Cost Growth Continue? A Factor Market Perspective 美国医疗成本增长的放缓会持续下去吗?因子市场视角

Journal of health care law & policy Pub Date : 2008-03-01 DOI: 10.2139/ssrn.1105033

J. Sabelhaus

引用次数: 1

Are There Missing Girls in the United States? Evidence from Birth Data 美国有失踪的女孩吗?出生数据的证据

Journal of health care law & policy Pub Date : 2008-02-01 DOI: 10.2139/ssrn.824266

Jason Abrevaya

引用次数: 51

FDA's Approvable and Related NDA/BLA Actions FDA可批准和相关的NDA/BLA措施

Journal of health care law & policy Pub Date : 2008-01-01 DOI: 10.2139/SSRN.1105509

F. Cohen

{"title":"FDA's Approvable and Related NDA/BLA Actions","authors":"F. Cohen","doi":"10.2139/SSRN.1105509","DOIUrl":"https://doi.org/10.2139/SSRN.1105509","url":null,"abstract":"This report offers the first comprehensive analysis of FDA approvable actions. During 1998 through 2005, 87 NME drug-product NDAs (NME-NDAs) received at least one approvable action by CDER prior to final approval. The proportion of NME-NDAs receiving at least one approvable action increased from 1998 through 2002 then abruptly fell in 2003 and remained at the lower relative level through 2005. Compared with CDER-approved products never receiving an approvable letter during first NDA review, NDAs issued an approvable letter were associated with longer mean time to first FDA review action: 10.1 versus 8.07 months and with longer mean total review time: 23.1 versus 9.02 months. Compared with CDER-approved products never receiving an approvable letter during first NDA review, drug programs receiving an approvable letter were significantly less likely to have been granted priority review or to have been designated as fast-track. CDER review division was the only analyzed variable independently predicting whether an NME-NDA was ultimately approved following an approvable action. NME-NDAs requiring a new clinical trial following the first review cycle were associated with prolongation of total review time. A total of 19 therapeutic recombinant protein BLAs were issued the CBER-equivalent of an approvable letter prior to approval. There was a strong correlation between the number of review cycles and total review time (R = 0.72). Compared with CBER-approved therapeutic programs not receiving an approvable letter during first BLA review, programs deemed approvable were significantly more likely to have been granted orphan-drug status. Approvable BLAs were associated with significantly longer mean time to first FDA review action: 8.97 versus 7.05 months and with significantly longer mean total review time: 21.3 versus 7.05 months. Issues delaying BLA approvals were qualitatively similar to those delaying NDA approvals. The strategic and tactical implications of these findings are discussed.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72491577","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

Developments in Long-Term Care Insurance in Japan 日本长期护理保险的发展

Journal of health care law & policy Pub Date : 2008-01-01 DOI: 10.2139/ssrn.1115186

O. Mitchell, J. Piggott, Satoshi Shimizutani

引用次数: 7

An International, Moral & Legal Perspective: The Call for Legalization of Surrogacy in India 从国际、道德和法律的角度:印度对代孕合法化的呼吁

Journal of health care law & policy Pub Date : 2007-07-02 DOI: 10.2139/SSRN.997923

R. Sharma

{"title":"An International, Moral & Legal Perspective: The Call for Legalization of Surrogacy in India","authors":"R. Sharma","doi":"10.2139/SSRN.997923","DOIUrl":"https://doi.org/10.2139/SSRN.997923","url":null,"abstract":"The advent of new scientific reproductive technologies has conjured up novel and seemingly intractable normative debates about bioethics and contemporary values in the field of family law. Surrogacy, incontrovertibly, is the most controversial of them all. In recent times, India is witnessing a spurt in cases of commercial surrogacy due to two factors: a medical tourism boom fuelled by low medical costs and a status-conscious middle class seeking to fulfill its financial needs. Commercial surrogacy, however, is against public policy enshrined in Article 23 of the Constitution of India and Section 23 of the Indian Contract Act, 1872. The courts are still to grapple with the legal implications of surrogacy agreements and the state of law, as a whole, remains inadequate due to complex ethical and moral questions involved. Thus, there is a need for the legislature to shed its odious inertia and balance individual rights against public policy considerations through legislation. This paper endorses the need for legalization of non-commercial surrogacy from the perspective of positive fundamental right of procreation guaranteed under Article 21 of the Constitution of India and the compelling state interest in maintaining the \"rule of law\" supported by international practice. Furthermore, it suggests a legal framework consisting of elements which are indispensable for addressing moral and ethical concerns surrounding surrogacy.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2007-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89198163","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: 4

Rationing the Public Provision of Healthcare in the Presence of Private Supplements: Evidence from the Italian NHS 在私人补充存在的情况下配给公共医疗保健:来自意大利国民保健制度的证据

Journal of health care law & policy Pub Date : 2007-05-01 DOI: 10.2139/ssrn.950249

D. Fabbri, C. Monfardini

引用次数: 0

Dedicated Doctors: Public and Private Provision of Health Care with Altruistic Physicians 敬业的医生:公共和私人提供的医疗保健与无私的医生

Journal of health care law & policy Pub Date : 2007-01-11 DOI: 10.2139/ssrn.958693

J. Delfgaauw

引用次数: 32