Pharmaceuticals, policy and law最新文献_第2页

Chapter 7 - Asisted fertilization and constitutional rights: A question still open 第七章辅助受精与宪法权利:一个悬而未决的问题

Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160424

F. Florio

引用次数: 0

Chapter 1 - Institutional profiles of clinical trials and its applications 第1章:临床试验的机构概况及其应用

Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160417

C. Bottari

引用次数: 0

Chapter 3 - Profit and non profit clinical trials 第三章-营利性和非营利性临床试验

Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160419

Diego Lorenzetti

引用次数: 0

Non-patent protection of pharmaceuticals in the USA 美国药品的非专利保护

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-140379

J. R. Thomas

{"title":"Non-patent protection of pharmaceuticals in the USA","authors":"J. R. Thomas","doi":"10.3233/PPL-140379","DOIUrl":"https://doi.org/10.3233/PPL-140379","url":null,"abstract":"The Obama administration’s recent health care reform legislation resulted from intense and divisive deliberations over public health policy in the USA. The existence of a fundamental right to health care, the role of the government in health care commerce, and the fiscal sustainability of existing service models were among the issues that were subject to spirited discussion. Widespread recognition that a significant number of individuals in the USA cannot readily afford the medications they require played a central role in the debate. 1 Manyofthe concernsthatpromptedhealth care reformlegislationin 2010hadearlier motivatedthe enactmentof the DrugPrice Competitionand Patent TermRestoration Act of 1984. 2 Congress intended that this legislation, commonly known as the Hatch-WaxmanAct,wouldbalancethe needforinnovativenewpharmaceuticalswith the availability of less expensive generic drugs. The statute includes elaborate provisions governing the mechanisms through which a potential generic manufacturer may obtain marketing approval on a drug that was originally sponsored by another. Among these measures were an exemption from patent infringement for activities associated with regulatory marketing approval, 3 unique litigation mechanisms for managing patent disputes, 4 and a government-sponsored clearing house of pharmaceutical patents. 5 This contribution focuses upon two additional aspects of the Hatch-Waxman Act and related legislation.In Part II, this essay considers patent term extension provisions – at first blush an odd choice given its title. The patent term extension rules","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126037420","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

Legal and Political Competitiveness for Pharmaceuticals 制药业的法律和政治竞争力

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-130370

Marcus Oehlrich, A. Daemmrich

{"title":"Legal and Political Competitiveness for Pharmaceuticals","authors":"Marcus Oehlrich, A. Daemmrich","doi":"10.3233/PPL-130370","DOIUrl":"https://doi.org/10.3233/PPL-130370","url":null,"abstract":"The pharmaceutical industry operates both as an important business sector and a vital contributor to the delivery of health services worldwide. In 2012, the total world market for pharmaceutical products amounted to nearly US$1 trillion (see Table 1). Although global in scope, some 60 percent of sales were in North America and Europe, which comprise only 15 percent of the world’s population. The industry plays an important economic role in many countries by contributing to national income and employing hundreds of thousands of educated workers. Studies in the United States and Germany have found that for each direct employee, the pharmaceutical industry also generates between 1.6 and 3.5 jobs in supporting industries [7, 9]. While Germany long boasted of its role as the “world’s apothecary,” firms in Switzerland, France, the United Kingdom, and the United States also have underwritten decades of research into new medicines and brought several thousand new medicines to market since the late 19th century [1]. However, since the early 2000s, a steady decline in global prescription drug sales has accompanied an international deterioration in the underlying conditions critical to pharmaceutical in novation [6]. Troubles can be found also in a declining number of new chemical or biological medicines approved for markets despite a steady rise in research spending [8]. Policy discussions in some countries reveal a shift against industry arguments that high profit margins on current drug sales are necessary to finance research into future pharmaceuticals. Countries across the OECD instead are looking for ways to reduce health spending and national pharmaceutical budgets have been held constant or even reduced. Policies including reference pricing and demands that the industry demonstrate the cost effectiveness of its products are now widespread, especially in Europe [4]. Articles in this special issue of Pharmaceuticals Policy and Law analyse factors governing the legal and competitive environment for the pharmaceutical sector. Key issues are explored across the full pharmaceutical value chain, including drug discovery, development, authorization, and marketing. The articles demonstrate widespread, typically longstanding, tensions between policies that on the one hand","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125507999","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: 1

Orphan drugs and paediatric medicinal products 孤儿药和儿科药品

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-130369

F. Sprecher

{"title":"Orphan drugs and paediatric medicinal products","authors":"F. Sprecher","doi":"10.3233/PPL-130369","DOIUrl":"https://doi.org/10.3233/PPL-130369","url":null,"abstract":"While the safety and availability of medicinal products for the majority of adult patients has steadily improved in recent decades, for children and people suffering from rare diseases (orphan diseases) there is a lack of approved medicinal products for these patient populations. Since the research and development of medicinal products is associated with high costs, the costs for paediatric medicinal products and medicines for rare diseases (orphan drugs) may barely be covered under normal market conditions due to the small patient populations. In order to prevent the continued exclusion of children and persons suffering from rare diseases from medical progress and to eliminate the deficits in the research and development of medicinal products for these patient groups, the European Union created, along the lines of the U.S. model, a system of incentives and constraints. Since 2000, under Regulation (EC) No. 141/2000 (Orphan Drug Regulation) there has been an incentive system to encourage the research and development of orphan drugs. With the goal of improving the health of children in Europe, Regulation (EC) No. 1901/2006 (Paediatric Regulation) combines economic incentives with the requirement to conduct paediatric studies. This article explains and comments on the specific regulatory framework for orphan drugs and paediatric medicinal products in the European Union.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122319398","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

Healthcare funding: Rare diseases, a priority? AIM's proposals 医疗资金:罕见疾病，优先事项?目标的建议

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2009-0227

W. Budde

{"title":"Healthcare funding: Rare diseases, a priority? AIM's proposals","authors":"W. Budde","doi":"10.3233/PPL-2009-0227","DOIUrl":"https://doi.org/10.3233/PPL-2009-0227","url":null,"abstract":"About 5000 to 7000 rare diseases are recognised. These life-threatening or chronically debilitating diseases are complex and have low prevalence – defined as 2 not more than 5 people affected per 10000 – so general knowledge and expertise about them can be limited. The limited number of patients affected by rare diseases also makes research difficult and potentially unattractive for the pharmaceutical industry. People affected by rare diseases can have difficulties in getting local diagnoses, in referral to suitably specialised health professionals who may be abroad, and in getting good information about their disease in their own language. In some countries or health systems the socio-medical coverage may not be welladapted. These are some of the reasons why a ‘European’ approach – which includes cooperation and coordination – is needed, wanted and supported by all concerned parties and actors in the health sector. Affordability and financial access to specific treatments represent a major challenge for national health systems as well as affected patients and their families. Due to legislation in several continents to encourage the development of drugs for rare diseases, the number of registered socalled ‘orphan drugs’ is increasing and recent statistics show that the costs of such orphan drugs are increasing exponentially. Improving the financial affordability of tremendously high cost individual treatments remains a real challenge and AIM sees here a new opportunity for action at EU level.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"224 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122356547","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: 2

Paediatric Orphan Drugs 儿科孤儿药

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2010-0274

M. Catapano, L. Folgori

引用次数: 0

U.S. healthcare reform and the pharmaceutical market: Projections from institutional history 美国医疗改革和医药市场:从制度历史的预测

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-130367

A. Daemmrich

引用次数: 5

Pharmacoeconomic analyses of treatments for rare disease 罕见病治疗的药物经济学分析

Pharmaceuticals, policy and law Pub Date : 1900-01-01 DOI: 10.3233/PPL-2011-0336

J. Fishman, G. Skrepnek

引用次数: 7