{"title":"Cross-border healthcare and recognition of medical prescriptions issued in another Member State","authors":"Francisco Miguel Bombillar Sáenz","doi":"10.3233/PPL-170445","DOIUrl":"https://doi.org/10.3233/PPL-170445","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"566 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":"114913699","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":"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}
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.
{"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}
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.
{"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}
{"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}
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.
{"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}
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.
{"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}
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.
{"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}
{"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}
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