El régimen jurídico del transporte de medicamentos termolábiles

Abstract

The land transportation of goods, a crucial component of the global supply chain, is subject to extensive regulation. However, the current universal regulation in transporting thermolabile medications creates legal uncertainty for the parties involved. This research aims to study the actual performance of the agents in the logistics, distribution, and transportation of thermolabile medications. It also delves into the legal regime applicable to this type of transportation, with the goal of proposing a regulatory harmonization that specifies the responsibilities of each party involved. Before addressing the specific problems of transporting thermolabile medicines, the entire supply chain has been analyzed, identifying the barriers and opportunities to improve the supply chain of these medicines. The study also analyzes the absence of uniform criteria in land transport legislation and the need for a clear regulatory framework. The research advocates for harmonizing the rules to ensure legal certainty and define clear responsibilities for all parties involved in the supply chain. Therefore, the purpose of this research is twofold: first, to identify through the experience of the transporters what the usual practice of transporting medicines is and what the shortcomings are perceived a priori, and second, the analysis of the responsibility for each of the subjects involved in the drug distribution chain, especially in transportation, to analyze the necessity or not to establish a clear and concise harmonization of legal texts on this matter at its various legal levels. Additionally, aiming to develop more efficient strategies for transporting thermolabile medications and addressing the current problem, the research proposes to visualize the current trend in the matter and project possible future scenarios with the help of Artificial Intelligence. This innovative approach offers improvements for the effective control in the supply chain of the thermolabile medication, as well as for the security of land transport of goods in general, both in road safety, and in security regarding loss and deterioration of the merchandise. The results of this research were identified, as well as the development of the aspects that generate the greatest controversies in the sector. A proposal for improvement for the effective and safe exercise of the activity of land transportation of thermolabile medications was included. In this sense, the research goes beyond merely synthesizing the reasoning and legal bases studied since it proposes guidelines for the development of future legislation, opening new avenues of exploration for the study of the regulation of the distribution and transportation of thermolabile medications. Keywords: Thermolabile medications, Supply chain, Medication distribution, Medication logistics operations, Land transportation of goods, Legal security in the transportation of medications, Responsibility in the transportation of thermolabile medications.

Date of Award	12 Nov 2024
Original language	Spanish
Supervisor	Mª Isabel Martinez Jimenez (Director)