La regulación del uso de medicamentos en condiciones especiales en Costa Rica
- Arias Mora, Freddy
- Belén Andreu Martínez Director
- Eduardo Javier Osuna Carrillo-Albornoz Director
Defence university: Universidad de Murcia
Fecha de defensa: 20 October 2022
- Julio César Galán Cortés Chair
- María Dolores Pérez Cárceles Secretary
- Massimo Niola Committee member
Type: Thesis
Abstract
The supply of medicines to treat, prevent or alleviate a disease is an act of risk. In addition, all medications have side effects that vary based on many factors. Therefore, each prescription requires a proper analysis of the balance between possible risks and expected benefits. This balance is made specifically for each specific patient; however, it is possible to make general assessments regarding the safety and efficacy of the products based on scientific research. Each country has regulatory bodies that analyze the risk for the population and give authorization to market medicines. The authorization is granted based on clinical studies supporting the medicines’ safety and efficacy and the quality of the product through laboratory tests. The authorization, health registration, or marketing permission details the form of use of a medicine, which includes pathologies for which it can be used, dose, contraindications, adverse effects, and route of administration, among others. Once marketing permission is granted for a specific treatment, it should not be used to treat another disease for which it was approved, as it represents a risk to the health and life of patients since there is not enough evidence to guarantee that it will not negatively affect the patient by giving it a different use for which it was investigated and approved. However, there is no approved treatment for many diseases or specific patients. These patients have compromised their health and lives by not having a treatment that helps them improve their quality of life. The use of already known drugs, but in indications for which it was not approved or using investigational treatments, is usually the last hope of many people today. As this phenomenon became more common, it was called drug supply under special conditions, which included using drugs without health registration, use in unapproved indications, and compassionate use. This research aims to analyze the legal regime for the use of medicines in special conditions in Costa Rica. In addition, it studies the role of each actor involved and establishes the professional responsibility associated with using medications in these conditions. The research is based mainly on analyzing documentation issued by organizations related to the subject, with a legal approach and unique detail in pharmaceutical technical aspects. The terms of use without registration, use off-label, and compassionate use of medicines are analyzed from the approach of the concept accepted by the doctrine, examples of clinical practice, and court cases. This allows contrasting how medicines are used and how they are regulated in different countries. A special mention is made to the case of COVID-19, given that the lack of treatments to treat the virus generated tremendous pressure to use experimental, off-label, unregistered, or compassionate use drugs to treat sick people. It was determined that, in Costa Rica, there are regulations that regulate some aspects related to medicines; however, they are not explicit regarding special uses, do not clarify terminology, and are limited to a greater extent to the use of medicines without health registration. This scenario has generated inconsistencies and confusion within health institutions and professionals. In other words, there is still a legal vacuum that makes it impossible to manage the use of medicines in special conditions properly.