The National Regulatory Authority in Mexico (COFEPRIS) has published on its website its actions to deal with the health emergency derived from COVID-19; among them: measures in relation to clinical trials, technical guidelines for clinical trials protocols related to the therapeutic use of convalescent plasma, regulatory flexibility in import and export processes for all health supplies, and provisions for the acquisition and manufacture of ventilators.
In the event that the available resources (such as ventilators or ICU beds) are not sufficient to meet all the needs of the population in the COVID-19 pandemic, we must proceed ethically. Since we cannot do everything that we should do, what is the most ethical path of action? Responsible action calls for health authorities to establish criteria for the priority-setting decisions that may be necessary.
Ethics and COVID-19: resource allocation and priority-setting
Governments, international agencies and health systems have an obligation to ensure, to the best of their ability, adequate provision of health care for all. However, this may not be possible during a pandemic, when health resources are likely to be limited. Setting priorities and rationing resources in this context means making tragic choices, but these tragic choices can be ethically justified. This is why we have ethics. This document answers a number of questions about the ethics of setting priorities for the allocation of resources during times of scarcity, and provides a high-level ethical framework that can be used to guide decision-making.
WHO has issued a Medical Product Alert on 31 March 2020 regarding falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
The website with updated information on INVIMA’s action on COVID-19 as well as supply of medicines and medical devices in Colombia is available at https://www.invima.gov.co/coronavirus-covid-19
This guidance aims to provide general consideration to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during COVID-19 pandemic.
We invite you to participate in a virtual seminar to discuss this publication and an upcoming one with a template of standard operating procedures for ethics review in emergency situations. In preparation for the seminar, we invite you to send your questions about these topics to bioethics@paho.org.
In its web page, the National Regulatory Authority of Argentina (ANMAT) keeps information, recommendations of the Ministry of Health and actions on COVID-19 prevention: https://www.argentina.gob.ar/salud/coronavirus-COVID-19
Further information is available in its original language (Spanish):
Medidas y recomendaciones con el objeto de preservar las actividades de los estudios de farmacología clínica (EFC) protegiendo la seguridad y bienestar de los participantes del estudio.
Se exceptúa temporalmentede la intervención de ANMAT el ingreso al país en calidad de importación de barbijos, tapa bocas y guantes de examinación, en el marco de la Emergencia Sanitaria en relación al COVID-19
ANMAT aclara a la comunidad que hasta el momento no existe evidencia científica que indique una influencia en la transmisión y evolución de la enfermedad por coronavirus (Covid-19) de las terapias basadas en medicamentos antihipertensivos *(inhibidores de la ECA y sartanes).
