Establishing healthy pharmaceutical regulations on statutory exclusivity: Lessons from the experience in the European Union, Canada, South Korea, Australia, and the United States

2018 ◽  
Vol 14 (4) ◽  
pp. 167-174 ◽  
Author(s):  
Kyung-Bok Son
Keyword(s):  
United States ◽  
European Union ◽  
International Trade ◽  
South Korea ◽  
Trade Agreements ◽  
The United States ◽  
The European Union ◽  
Middle Income ◽  
International Trade Agreements ◽  
Middle Income Countries

Abstracts Objectives Recent international trade agreements require member countries a prolonged statutory exclusivity for biologics, and domestic legislation guarantees various forms of exclusivity for specific drugs, indications, or studies. This study notes prolonged exclusivity provisions for biologics in the United States and international trade agreements. We aim to review various exclusivity systems, including chemical entities, in selected high-income countries and to suggest implications for establishing the system specifically relevant for biologics in low- and middle-income countries. Methods We conducted a review of a comprehensive range of literature to develop the framework. Then, a comparative legal analysis was conducted to analyze the deviations among the systems in the European Union, Canada, South Korea, Australia, and the United States. Results There is constructive ambiguity in international trade agreements, specifically for provisions regarding biologics. Furthermore, the selected countries operate different statutory exclusivity systems in terms of eligibility for statutory exclusivity, specific measures for exclusivity, and other elements of exclusivity. In addition, market exclusivity, which is distinguished from data exclusivity, is not available in Korea and Australia. There are also various forms of statutory exclusivity for specific drugs, indications, or studies requested by the marketing authority. Conclusions Given constructive ambiguities in international agreements and variations in the manner of implementations of the systems in selected countries, statutory exclusivity for biologics could be established with cautions to mediate the harms. In this study, we suggest several solutions and alternatives for low- and middle-income countries.

Energy reform will hit investor confidence in Mexico

2021 ◽  
Keyword(s):  
United States ◽  
International Trade ◽  
Trade Agreements ◽  
The United States ◽  
Energy Prices ◽  
Content Type ◽  
Investor Confidence ◽  
International Trade Agreements ◽  
The Government ◽  
Energy Reform

Significance The government will appeal the rulings, which follow action by renewables firms. With constitutional battles over energy investments already unfolding, the future of Mexico’s energy framework has been thrown into turmoil. Impacts Increasing energy prices will probably push inflation above Banxico’s upper target limit of 4%. AMLO’s apparent disregard for international trade agreements will strain relations with the United States. AMLO’s pro-austerity fiscal stance could take a toll on his popularity.

scholarly journals COVID-19 Therapeutics for Low- and Middle-Income Countries: A Review of Candidate Agents with Potential for Near-Term Use and Impact

2021 ◽  
Author(s):  
Daniel Maxwell ◽  
Kelly C. Sanders ◽  
Oliver Sabot ◽  
Ahmad Hachem ◽  
Alejandro Llanos-Cuentas ◽  
...  
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
Middle Income ◽  
Middle Income Countries ◽  
Negative Results ◽  
Clinical Trial Registries ◽  
Oral Agents ◽  
Near Term ◽  
Low And Middle Income

Low- and middle-income countries (LMICs) face significant challenges in the control of COVID-19, given limited resources, especially for inpatient care. In a parallel effort to that for vaccines, the identification of therapeutics that have near-term potential to be available and easily administered is critical. Using the United States, European Union, and WHO clinical trial registries, we reviewed COVID-19 therapeutic agents currently under investigation. The search was limited to oral or potentially oral agents, with at least a putative anti-SARS-CoV-2 virus mechanism and with at least five registered trials. The search yielded 1,001, 203, and 1,128 trials, in the United States, European Union, and WHO trial registers, respectively. These trials covered 13 oral or potentially oral repurposed agents that are currently used as antimicrobials and immunomodulatory therapeutics with established safety profiles. The available evidence regarding proposed mechanism of actions, potential limitations, and trial status is summarized. The results of the search demonstrate few published studies of high quality, a low proportion of trials completed, and the vast majority with negative results. These findings reflect limited investment in COVID-19 therapeutics development compared with vaccines. We also identified the need for better coordination of trials of accessible agents and their combinations in LMICs. To prevent COVID-19 from becoming a neglected tropical disease, there is critical need for rapid and coordinated effort in the evaluation and deployment of those agents found to be efficacious.

scholarly journals El tema laboral en las negociaciones de los TLC: Lecciones de las experiencias de Colombia frente a los TLC con los Estados Unidos y la Unión Europea

2016 ◽  
pp. 205-244
Author(s):  
Daniel Hawkins
Keyword(s):  
United States ◽  
European Union ◽  
Free Trade ◽  
Social Impact ◽  
Action Plan ◽  
Free Trade Agreements ◽  
Trade Agreements ◽  
The United States ◽  
Labor Rights ◽  
The European Union

Los dos tratados de libre comercio firmados por Colombia con los Estados Unidos (2012) y Perú y la Unión Europea (2013) no solo marcaron el eje central de la política de apertura e integración económica de los gobiernos de Álvaro Uribe y Juan Manuel Santos, sino también pusieron a prueba la capacidad del Gobierno estadounidense y las instituciones de la Unión Europea para asegurar que sus políticas comerciales hacia países del Sur, como Colombia, pudieran mejorar las precarias condiciones laborales de gran parte de la población trabajadora y la capacidad estatal para proteger y garantizar los derechos laborales fundamentales y demás derechos sociales. Este artículo analiza las diferencias en ambos modelos de negociar temas laborales y compara el grado de impactos sociales positivos que ambos TLC han traído a Colombia varios años después de su implementación.Palabras clave: Tratados de libre comercio, acuerdos laborales paralelos, derechos laborales fundamentales, plan de acción laboral, Resolución 2628. Abstract The Labor Issue in FTA Negotiations: Lessons from Colombia’s Experiences with FTAs with the United States and the European Union Free Trade Agreements (FTAs) signed by Colombia with the United States (2012) and Peru and the European Union (2013) not only marked the central axis of the economic liberalization and integration policy of Alvaro Uribe and Juan Manuel Santos governments, but they also put to test the ability of the US government and the EU institutions to ensure that their commercial policies with countries of the South, such as Colombia, would improve the precarious working conditions of a considerable part of the working population. Furthermore, they also challenge the capacity of the Colombian state to protect and guarantee fundamental labor rights and other social rights. This article examines the differences between both models of negotiating labor issues and compares the degree to which both FTAs have actually brought about positive social impact in Colombia a few years after their formal implementation.Key words: Free Trade Agreements, Parallel Labor Agreements, Fundamental Labor Rights, Labor Action Plan, Resolution 2628.

Fishing Downstream Revisited: A Multi-country Analysis of Antidumping Patterns

2018 ◽  
Vol 18 (2) ◽  
pp. 20170096 ◽  
Author(s):  
Maxwell T. Andersen ◽  
Robert M. Feinberg
Keyword(s):  
United States ◽  
European Union ◽  
Statistical Estimation ◽  
Descriptive Analysis ◽  
Trade Agreements ◽  
The United States ◽  
Trade Barriers ◽  
The European Union ◽  
The Us ◽  
Country Analysis

A long-held view in international trade policy analysis is that import protection flows downstream. The descriptive analysis of Feinberg and Kaplan 1993, looking at trends in upstream and downstream antidumping and countervailing-duty cases since the US Trade Agreements Act of 1979. It covers the period from 1980 to 2015 for the five leading users of temporary trade barriers (TTBs): Argentina, Brazil, the European Union, India, and the United States. We examine evidence for two broad sectors which have dominated the use of TTBs: metals and chemicals. Both via descriptive trend analysis and simple statistical estimation, we find suggestive evidence in support of cascading trade protection, though more so for the developing countries studied.

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