Resolution to require the National Government to establish compulsory licenses and other measures to guarantee free and affordable access to pharmaceutical products and medical technologies in the Declaration of Sanitary Emergency due to the Coronavirus pandemic (COVID-19) and other variations, as well as biosafety protocols and instruments for health personnel, postgraduates and students of the Public Health System.
CONSIDERING
That article 3 of the Constitution of the Republic of Ecuador establishes as primary duties of the State to guarantee without any discrimination the effective enjoyment of the rights established in the Constitution and in international instruments, in particular education, health, food, social security and water for its inhabitants;
That, the Constitution of the Republic of Ecuador establishes in its article 359 that “The national health system will include the institutions, programs, policies, resources, actions and actors in health; it will cover all dimensions of the right to health; it will guarantee promotion, prevention, recovery and rehabilitation at all levels; and will promote citizen participation and social control.”;
That, the Constitution of the Republic of Ecuador establishes in its article 359 that “The national health system will include the institutions, programs, policies, resources, actions and actors in health; it will cover all dimensions of the right to health; it will guarantee promotion, prevention, recovery and rehabilitation at all levels; and will promote citizen participation and social control.”;
That, according to article 363 of the Constitution of the Republic, in its article 363 literal 7, the State will be responsible for guaranteeing “(…) the availability and access to quality, safe and effective medicines, regulate their commercialization and promote production and the use of generic drugs that respond to the epidemiological needs of the population. In access to medicines, the interests of public health will prevail over economic and commercial interests.”;
That, the Supreme Charter of Ecuador states in its article 421 that: “The application of international commercial instruments shall not directly or indirectly impair the right to health, access to medicines, supplies, services, or scientific and technological advances.”;
That, article 85 of the Organic Code of Social Economy of Knowledge, Creativity and Innovation establishes that the acquisition and exercise of intellectual property rights, as well as their weighting with other rights, will ensure the effective enjoyment of fundamental rights;
That article 90 of the Organic Code of Social Economy of Knowledge, Creativity and Innovation establishes a typology of goods based on intellectual property rights;
That article 91 of the Organic Code of Social Economy of Knowledge, Creativity and Innovation determines that the goods that guarantee fundamental rights and that are protected by intellectual property rights are in the public interest and will enjoy a type of protection that allows satisfy basic needs of society;
That articles 91, 314, 315, 316, 319, 509 and 510 of the articles of the Organic Code of Social Economy of Knowledge, Creativity and Innovation, empower State entities to take measures to guarantee the right to health and other fundamental rights when it comes to technologies patented or protected by other modalities related to intellectual property;
That, on March 11, 2020, due to the alarming levels of expansion and severity of the outbreak of the so-called Coronavirus after a 13-fold increase in the number of cases outside China and the number of those affected tripling with more than 4,000 people dead, the World Health Organization has declared a global pandemic by COVID-19;
That, according to the WHO, the Coronavirus constitutes an extensive family of viruses that can cause diseases in both humans and animals. Coronaviruses have so far been known to cause respiratory infections that can range from the common cold to more serious illnesses such as Middle East syndrome (MERS) and severe acute respiratory syndrome (SARS). However, this new Coronavirus called COVID-19, which presents syndromes similar to those previously exposed, to date is already found in more than 140 countries, confirming more than 180,000 confirmed cases and already exceeding 8,000 deaths worldwide;
That, on March 13, 2020, the National Emergency Operations Committee for the coordination of emergencies was activated, said body has issued several resolutions focused on safeguarding the health and public safety of all Ecuadorians, in addition this body has reported to the date that there are 199 confirmed cases, 3 deaths and an active epidemiological fence of 575 citizens;
That, the National Government, through Agreement of the Ministry of Public Health No. 00126-2020 declared the State of Health Emergency in all establishments of the National Health System, in laboratory services, epidemiology and control units, ambulances air, medical and paramedical services, hospitalization and external consultation for the imminent possibility of the effects caused by the coronavirus COVID-19, and to prevent a possible massive contagion in the Ecuadorian population;
That, in the aforementioned Agreement of the Ministry of Public Health, it was established: (i) ”… Provide that health establishments belonging to the Comprehensive Public Health Network, during the validity of this declaration, proceed to prioritize economic resources , of human talent; and, other measures deemed necessary to face the present declaration of emergency. ” (ii) ”… Summon the highest representatives of the institutions that are part of the Comprehensive Public Health Network and the Complementary Private Network, to form the technical response table against COVID-19, chaired by the Vice Minister of Governance and Health Surveillance. ” (iii) “… Provide that the Public Comprehensive Health Network, the Complementary Private Network and other private health establishments, maintain and update the notification to the National Health Authority, about patients who present symptoms or conditions and who have received care related to COVID-19, through the computer system available for this purpose. “(iv)” … Provide that health providers, both the Comprehensive Public Health Network, the Complementary Private Network and other establishments of private health, guarantee timely and effective medical care and the availability of resources for the diagnosis and comprehensive treatment of users or patients related to COVID-19. ”(v) “… The Comprehensive Public Health Network will contract, directly or through invitations, the works, fungible and non-fungible goods, or services that are strictly required to overcome this emergency situation, in accordance with the provisions of the Article 57 of the Organic Law of the National System of Public Procurement. ” (vi) “… The National Health Authority will inform the Migration Control Authority about the preventive measures against COVID-19 that it must take into consideration with respect to citizens entering and leaving Ecuadorian territory, to proceed in accordance with a situation international health alert. ” (vi) “… The National Sanitary Authority will periodically issue the sanitary guidelines and measures to prevent the transmission of COVID-19 for mass influx events so that the competent authorities proceed with the due regulations and controls of these.” (vii) “… The National Health Authority in its capacity as the competent authority in matters of Public Health and clinical management of patients will update and issue the protocols, technical standards and other instruments applicable to the care of this emergency.” (viii) “… The National Health Authority reiterates the need to prohibit the export of individual protection medical devices in order to guarantee their supply in the National Health System.” (ix) “… The National Agency for Sanitary Regulation, Control and Surveillance (ARCSA) is ordered to update the regulations regarding the national production of medicines and medical devices necessary for emergency care and which, in turn, prioritize attention to ongoing regulatory processes. “;
That, through Executive Decree No. 1017 dated March 16, 2020, the President of the Republic, attorney Lenin Moreno Garcés, decreed a state of emergency throughout the national territory due to public calamity, for confirmed coronavirus cases and the declaration of a COVID-19 pandemic by the World Health Organization;
That, within the principles of the Organic Code of the Social Economy of Knowledge, Creativity and Innovation established in article 4, it is established: “1. Knowledge constitutes a good of public interest, its access will be free and will have no more restrictions than those established in this Code, the Constitution, international treaties and the Law and, its distribution will be carried out in a fair, equitable and democratic way; “, This principle seeks to guarantee, among others, the right to public health, over the interests and economic rights of large pharmaceutical companies;
That, to date, adequate vaccines, medications, diagnoses, devices, supplies, equipment and technologies for the treatment of coronavirus (COVID-19) and other variations have not been developed, nor is there any certainty about the technologies adequate that could be useful for its treatment, it is necessary that the National Government take the measures to guarantee public health focused on the prevention, diagnosis and treatment of this pandemic;
That the availability of vaccines, medications, diagnoses, devices, supplies, equipment and technologies that may arise for the treatment of the coronavirus (COVID-19) and other variations may be threatened by the monopolies of the regulations related to the rights of patents and other forms of protection of industrial property, which could affect the right to public health, and therefore aggravate the current situation of the pandemic;
That, in addition to this problem through various public complaints from postgraduates and students of health sciences, as well as Health professionals through which their vulnerability to contagion with the Coronavirus (COVID-19) is evidenced by not have the necessary bio-security protocols and instrumentation for patient care within the public health system;
DECIDES
Article 1.- Demand the President of the Republic and the Minister of Public Health of Ecuador, that within the declaration of a State of Health Emergency, include the administrative and technical mechanisms for the establishment of compulsory patent licenses, access to test data and access to other technologies for the availability of vaccines, drugs, diagnoses, devices, supplies, and other useful means for the surveillance, prevention, detection, diagnosis, and treatment of people infected with the Coronavirus (COVID-19) and other variations in order to guarantee the right to health through its free access or at an affordable costs.
Article 2.- Require the Minister of Public Health of Ecuador that within the declaration of State of Health Emergency also provide for non-commercial public use or the compulsory license of patents, as well as access to test data for pharmaceutical products for the production, import or massive use in Ecuador of vaccines, drugs, diagnoses, devices, supplies, and other useful technologies for the surveillance, prevention, detection, diagnosis, and treatment of people infected with the Coronavirus (COVID-19) and others variations, in coordination with the competent technical organizations.
Likewise, the Ministry of Public Health must take the necessary measures to guarantee technology and inventions that are pending of a resolution in patent examination procedures.
Article 3.- Urge the Minister of Public Health of Ecuador to take administrative and technical measures to guarantee the availability and access to vaccines, drugs, devices, supplies, and other useful technologies for surveillance, prevention, detection, diagnosis and treatment of people infected with the Coronavirus (COVID-19), free of charge or at an affordable costs and to avoid speculation in prices and shortages in coordination with the relevant public entities.
Likewise, the pertinent measures must be taken to facilitate imports and the commercialization of products that serve to face the Covid-19 pandemic, such as simplification of imports and accelerated procedure of the corresponding sanitary registry.
Article 4.- Require the Minister of Public Health to provide all bio-securities to postgraduates, students and all health personnel who are doing internships or offering their contingency in the diagnosis and treatment of people exposed to the Coronavirus (COVID-19), in coordination with the corresponding public entities.
Article 5.- Urge the Ministry of Public Health of Ecuador to request the World Observatory for Health Research and Development of the World Health Organization (WHO) to collect information on the costs of research and development directly associated with vaccines, drugs, diagnostics, devices, supplies, and other useful technologies for COVID-19 surveillance, prevention, detection, diagnosis, and treatment, including investments made by public sector institutions, private sector institutions, and charities.
Article 6.- Require the Ministry of Public Health and the Ministry of Economy and Finance to allocate the necessary public resources to the entire Public Health System in order to face the health emergency caused by the Coronavirus (Covid-19).
Article 7.- Request to the Assembly of the Higher Education System of Ecuador, the constitution of a roundtable of experts and researchers to provide technical advice on the decisions of the competent authorities regarding the coronavirus pandemic (COVID-19).
Article 8.- Request the Ministry of Economy and Public Finance to report to this legislative roundtable on the resources destined to the pre-constitutional allocation of Science, Technology and Innovation established in article 298 of the Constitution of the Republic during the last three years.
Article 9.- Notify this Resolution, through the Secretary of the Permanent Specialized Commission for Education, Culture and Science and Technology, to the Presidency of the Republic, Ministry of Public Health, Secretary of Higher Education, Science, Technology and Innovation and to the National Service of Intellectual Rights.
Quito, March 20, 2020.
Jimmy Candell Soto
PRESIDENT
Raysa Vargas Secaira
REPORTING SECRETARIAT