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Cross-border healthcare and recognition of medical prescriptions issued in another Member State 跨国界保健和承认在另一会员国开出的医疗处方
Pharmaceuticals, policy and law Pub Date : 2017-04-01 DOI: 10.3233/PPL-170445
Francisco Miguel Bombillar Sáenz
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引用次数: 2
Political and regulatory key factors of transparency and independence in terms of vaccination in Spain: Information, participation and lobbies 西班牙疫苗接种透明度和独立性的政治和监管关键因素:信息、参与和游说
Pharmaceuticals, policy and law Pub Date : 2017-04-01 DOI: 10.3233/PPL-170450
N. Cuenca
{"title":"Political and regulatory key factors of transparency and independence in terms of vaccination in Spain: Information, participation and lobbies","authors":"N. Cuenca","doi":"10.3233/PPL-170450","DOIUrl":"https://doi.org/10.3233/PPL-170450","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121870512","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
Compulsory licensing: Procedural requirements under the TRIPS agreement 强制许可:TRIPS协议下的程序要求
Pharmaceuticals, policy and law Pub Date : 2016-10-10 DOI: 10.3233/PPL-160430
M. Desai
{"title":"Compulsory licensing: Procedural requirements under the TRIPS agreement","authors":"M. Desai","doi":"10.3233/PPL-160430","DOIUrl":"https://doi.org/10.3233/PPL-160430","url":null,"abstract":"Compulsory licenses of patents under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are often mistakenly viewed as a solution to problems relating to access to medicines in developing countries. Access requires a strong political commitment, a health system that contains multi-disciplined health professionals, and an adequate infrastructure to enable transportation of patients and equipment. The use of compulsory licenses should be a rare event considered only under extremely limited circumstances and not an instrument of industrial policy. If a government decides to issue a compulsory license, there are several technical and procedural requirements that must be satisfied under TRIPS. This paper explores those requirements and examines instances where courts have issued decisions relating to compulsory license requests or grants. It analyses the key provisions of TRIPS that are relevant to a government grant of a compulsory license without the authorization of the right holder. It also provides examples and analyses of previous grants of compulsory licenses that have been deficient in meeting on more more procedural requirements under TRIPS.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126954760","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: 6
Breaking New Ground: The WTO Agreement on Trade Facilitation: Potential and Perspectives for the Pharmaceutical Industry 开辟新天地:世贸组织贸易便利化协定:制药业的潜力和前景
Pharmaceuticals, policy and law Pub Date : 2016-10-09 DOI: 10.3233/PPL-160433
Nora Neufeld
{"title":"Breaking New Ground: The WTO Agreement on Trade Facilitation: Potential and Perspectives for the Pharmaceutical Industry","authors":"Nora Neufeld","doi":"10.3233/PPL-160433","DOIUrl":"https://doi.org/10.3233/PPL-160433","url":null,"abstract":"Recently adopted, the WTO Agreement on Trade Facilitation (TFA) adds fresh momentum to worldwide efforts to speed up the movement, release and clearance of goods across borders. With all required decisions having now been taken in Geneva, preparations are under way to ensure the Agreement’s expeditious entry into force. Once in operation, this ground-breaking treaty will significantly accelerate cross-border trade and reduce related costs. This article analyses the TFA from a pharmaceutical angle, highlighting provisions of particular interest to the industry. It will look at how the new Agreement is likely to impact trade in medical goods and where business stands to benefit. A final segment will review governments’ implementation plans and discuss the road ahead.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125578621","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
Editorial - The innovation and access to landscape 社论-景观的创新和通道
Pharmaceuticals, policy and law Pub Date : 2016-10-09 DOI: 10.3233/PPL-160427
J. Valverde, E. Pisani
{"title":"Editorial - The innovation and access to landscape","authors":"J. Valverde, E. Pisani","doi":"10.3233/PPL-160427","DOIUrl":"https://doi.org/10.3233/PPL-160427","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133780936","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
Chapter 6 - Clinical trials and off-label use of drugs 第六章-临床试验和超说明书用药
Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160422
Giovanni Maria Cavo
{"title":"Chapter 6 - Clinical trials and off-label use of drugs","authors":"Giovanni Maria Cavo","doi":"10.3233/PPL-160422","DOIUrl":"https://doi.org/10.3233/PPL-160422","url":null,"abstract":"The contribution aims to analyze a topic closely related to the subject of experimentation, in terms of protection of patients undergoing drug therapy: the use of off-label drugs, that is, in summary, the possibility to use a medicine for therapeutic indications not covered within the marketing authorisation (M.A.) of the drug. Moving from European discipline on medicines for human use, the analysis focuses on the peculiarities of the Italian legislation, representing in Europe an emblematic case of off-label rules. A particular focus is dedicated to the case of drugs Avastin R © and Lucentis R © , which in recent years has highlighted the limits of that national legislation, including the possible contrast with European regulations. In particular, the choice of legislator, recently upheld by the Italian Constitutional Court, to submit the possibility, as well as the definition of what are the minimum requirements of safety and efficacy for a drug “off-label” may be prescribed to patients, are the main issues on which we intend to stimulate reflection on the reader.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131175186","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
Chapter 8 - Scientific research and human reproduction: The prevalence of the embryo in the Italian legal system 第八章-科学研究与人类生殖:胚胎在意大利法律制度中的盛行
Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160425
B. Vitiello
{"title":"Chapter 8 - Scientific research and human reproduction: The prevalence of the embryo in the Italian legal system","authors":"B. Vitiello","doi":"10.3233/PPL-160425","DOIUrl":"https://doi.org/10.3233/PPL-160425","url":null,"abstract":"In 2004, in Italy, it appears, for the first time, a law that regulates limits and the methods on assisted reproduction techniques. One of the principles on which is based the already famous 40 law, and that will strongly affect its forecast, is the protection of the human embryo, accompanied, in the structure of the regulatory text, a related limitation of other interests that they found a weaker response from the legislature. It is easy to detect the valorization of the human embryo in several steps; its correlation with the needs of scientific research are included in this framework, and we will try to provide some observations on the following pages, also in the light of important judicial interventions.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124389677","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
Chapter 2 - Community intervention in the field of health and the European regulation of clinical trials on medicinal products for human use 第2章-共同体在卫生领域的干预和欧洲对人用医药产品临床试验的管理
Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160418
P. Angelis
{"title":"Chapter 2 - Community intervention in the field of health and the European regulation of clinical trials on medicinal products for human use","authors":"P. Angelis","doi":"10.3233/PPL-160418","DOIUrl":"https://doi.org/10.3233/PPL-160418","url":null,"abstract":"The European Union organisation, which was established to regulate the relations of economic nature, has expanded its scope, including among its objectives the protection of the citizen fundamental rights; this is a result of the evolving case-law of the Court of Justice pursuant to the information contained in the Charter of Nice and the Treaty of Lisbon. Only from the early 70’s health policies have begun to affect community entities, especially since carriers through which contribute to achieving the four main freedoms expressed in community legislation. On April 16th 2014 regulation No 536/2014 on clinical trials on medicinal products for human use was adopted by the European Parliament and the Council. As can be seen from reading the text, the target of the regulation is to ensure the robustness and reliability of data on clinical trials throughout the Union, while guaranteeing respect for the rights, safety, dignity and well-being of the subjects. The European regulation is at the heart of a contrast between two different wishes that the EU, the regulation seeks to combine: on one hand, the need for the EU to remain an attractive place to conduct clinical trials. And on the other hand, the need to ensure respect for the rights, safety, dignity and well-being of those involved in clinical trials.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130055311","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
Chapter 5 - Regulation and control of drugs: Between prescriptive appriopriateness and limitation of public spending towards the goal of deregulating the pharmaceutical market 第5章-管制和控制药物:在规范的适当性和限制公共开支之间，以实现解除对药品市场的管制
Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160421
C. Agnello
{"title":"Chapter 5 - Regulation and control of drugs: Between prescriptive appriopriateness and limitation of public spending towards the goal of deregulating the pharmaceutical market","authors":"C. Agnello","doi":"10.3233/PPL-160421","DOIUrl":"https://doi.org/10.3233/PPL-160421","url":null,"abstract":"This article allows toanalyze drug testing from the standpoint of prescriptive appropriateness, as a tool and a resource to implement a welfare state system, in which the NHS provides an equitable access to innovative pharmaceutical treatments that might cause clinical benefits. In pursuing these interests it is necessary to ensure the due interaction between the economic and the legal profile. This implies the need of analyzing and balancing risks and benefits of experimental treatments with the objective of lowering health care costs for state budgetary purposes. In this respect, both economic process trends and social dynamics will bedealt with, given their link with market globalization, as well as compensatory measures, tax reliefs and settlements designed to streamline and reduce public spending in this area.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"44 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125796828","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
Chapter 4 - Competence and role of ethics committees in clinical trials 第四章-伦理委员会在临床试验中的能力和作用
Pharmaceuticals, policy and law Pub Date : 2016-02-15 DOI: 10.3233/PPL-160420
Michele Buratin
{"title":"Chapter 4 - Competence and role of ethics committees in clinical trials","authors":"Michele Buratin","doi":"10.3233/PPL-160420","DOIUrl":"https://doi.org/10.3233/PPL-160420","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124352229","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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