Pharmaceutical and Cosmetic System Law
rokhsana esfandiyari
Articles in Press, Accepted Manuscript, Available Online from 19 January 2025
Abstract
This article examines the state of pharmaceutical regulations in the developing world by constructing international indices derived from World Health Organization data. The past two decades have been marked by profound changes in the pharmaceutical sector, including a complete overhaul of intellectual ...
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This article examines the state of pharmaceutical regulations in the developing world by constructing international indices derived from World Health Organization data. The past two decades have been marked by profound changes in the pharmaceutical sector, including a complete overhaul of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active pharmaceutical ingredient suppliers in China and India. Although drug ownership laws have been regulated and implemented globally, we surprisingly have little information about how national market entry standards and the regulation of pharmaceutical products have changed.
Pharmaceutical and Cosmetic System Law
Shahriar eslamitabar
Volume 2, Issue 2 , February 2025, , Pages 157-173
Abstract
Background and Objective: economic access to medicine and treatment is one of the most important dimensions of the right to health, which is considered one of the goals of national development in addition to international human rights. Achieving this important goal is possible by using correct and specific ...
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Background and Objective: economic access to medicine and treatment is one of the most important dimensions of the right to health, which is considered one of the goals of national development in addition to international human rights. Achieving this important goal is possible by using correct and specific strategies such as pricing and compensation of costs through insurance.Methods: First, the literature of the article was reviewed using e-books, and articles, then the qualitative data was analyzed through content analysis and a practical model was presented.Results: Price control is done in two ways, direct and indirect. Determining the price and correcting it, it is the direct type, and compensation of costs through insurance is considered the indirect type. As the first control step, pricing strategies are followed based on two basic principles: 1- Value-based pricing, which is related to drug effects and drug cost, and includes the same requirements. 2- Price Classification based on the type and nature of the drug, including generic, under patent and imported.Conclusion: Since Iran has recently abandoned the Cost Plus method (determining the prices based on a percentage more than the total cost), it is necessary to constantly regulated the prices according to the current conditions, needs and the existence of similar drugs, but This action dose not seems correct in any situation and the necessary considerations regarding single-prescription drugs have not been taken into account. While advanced countries such as France and England include all drugs in the insurance coverage list based on their medicinal nature without special requirements and prerequisites, the budget of countries such as Iran does not allow such a thing.
Pharmaceutical and Cosmetic System Law
Abbas Kebriaeezadeh; Vahideh Montazeri Najafabadi; Roya Ayazi-Nasrabadi
Volume 1, Issue 1 , June 2024, , Pages 99-113
Abstract
Background and Objective: According to the right to health, one of the most basic human rights, all individual have the right to essential medicines. These medicines should be available to those in need at the appropriate time and at a reasonable cost.Methods: This article has been written using both ...
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Background and Objective: According to the right to health, one of the most basic human rights, all individual have the right to essential medicines. These medicines should be available to those in need at the appropriate time and at a reasonable cost.Methods: This article has been written using both printed books and e-books, as well as articles and documents, and employes a comparative-analytical for examination.Results: From the perspective of the World Health Organization, access to essential medicines, regard asfunamental right and key indicator of the right to health. This issue is particulary significant for som countries, especially that are poor and less developed, due to concern about affordability. Because of the vital importance of these medicine, the World Health Organization publishes a list of essential medicine every two years, according to based on minimum needs.Conclusion: Although the Islamic Republic of Iran has taken serious measures to address the pharmaceutical needs of its citizens by regulating price and the drug market, especially through the import of drugs and the implementation of the generic plan, serious work has not been done regarding the preparation of the list of essential medicines. However, considering the rejection of this need and reaching the relative self-sufficiency in the country, through the comprehensive generic plan, adjusting the internal list according to the World Health Organization’s list does not seem necessary. Each country has its own independent list of essential medicines based on its production capacity and needs.
