Special Law for the Guarantee of Care for Serious Adverse Events Attributed to the Application or Use of the Covid-19 Vaccine and Where Applicable for No-Fault Compensation Chapter I Purpose of the Law, Scope, and Field of Application
Congreso Nacional
- Decree: 193-2020
- Published: February 3, 2021
- Issuing body: Congreso Nacional
- Gazette: 35,505
- Category: Health
Summary
This law creates a system to care for and compensate people who suffer serious adverse events (life-threatening, hospitalization, or disability) from COVID-19 vaccines applied in Honduras. It establishes a special state fund to pay no-fault compensation without proving liability, and allows the government to sign indemnification agreements with vaccine manufacturers.
Considerations
Whereas the Constitution of the Republic establishes that the human person is the supreme end of society and the State, and consequently, all have the obligation to respect and protect it, and likewise recognizes the right to health protection of the Honduran population, as well as the duty of all in the promotion and preservation of personal and community health and for this purpose it corresponds to the Secretary of State in the Office of Health, by constitutional provision, to coordinate all public activities of the centralized and decentralized agencies of said sector, through a National Health Plan, in which priority shall be given to the most needy groups.
Whereas on January 30, 2020, the World Health Organization (WHO), through the Emergency Committee declared the outbreak of the new Coronavirus, which causes the disease COVID-19, as a public health emergency of international importance; having affected as of that date the world population in general and Honduras in particular, resulting in high mortality and morbidity rates, having declared a "STATE OF HUMANITARIAN AND SANITARY EMERGENCY" through Executive Decree Number PCM-005-2020 dated February 10, 2020 and its amendments, which was extended to December 31, 2021, through Executive Decree Number PCM-146-2020 and published in the Official Newspaper "La Gaceta" dated December 29, 2020, Edition No. 35,472.
Whereas the control of the COVID-19 Pandemic constitutes a priority of world and national health, given the magnitude and significance of the disease. Therefore, for the control of the Pandemic it is considered that the introduction of the vaccine against COVID-19 is an additional intervention, which must be assigned a high degree of priority by Government authorities, the scientific community, cooperating organizations and the population in general.
Whereas in the context of the COVID-19 pandemic, Honduras has been incorporated by GAVI-CEPI-WHO in the list of ninety-two (92) eligible countries for the GAVI-COVAX-AMC initiative, a mechanism for access to the vaccine for low and lower-middle income countries, having been notified and ratified by GAVI as one of the countries that will receive benefits from this initiative such as: Access to donation of a portion of the vaccine, differentiated pricing for several years, financial support for introduction and technical assistance.
Whereas it is a requirement of the COVAX Mechanism, at the request of the manufacturers of the COVID-19 vaccine, that the beneficiary country execute with each of them once the vaccine is acquired, an Agreement of Exemption of Liability and grant to the supplier an indemnification for damages and losses related to the use and administration of the vaccine or derived therefrom.
Whereas through Decree No. 162-2020, published in the Official Newspaper "La Gaceta" on December 7, 2020, Edition No. 35,452, the Free Vaccine Law for All Against COVID-19 was approved, through which free and universal access to the vaccine against the virus SAR-COV-2 that produces the disease COVID-19 is guaranteed, however, it requires modifications in order to expand the capacity of action of the Secretary of State in the Office of Health in the process of acquisition and application of vaccines, authorizing it to execute agreements for the exclusion of liability of manufacturers and suppliers, as well as the establishment of indemnification processes upon the occurrence of adverse events that could occur in the Honduran population due to the application of the vaccine against COVID-19.
Whereas the related Vaccines Law was approved because this is a recently emerged disease and was not contemplated in the current Vaccines Law, given the novelty of the COVID-19 vaccine despite rigorous studies having been conducted on it, nevertheless with its application it may at a given moment cause adverse events to the person to whom the vaccine is applied, as occurs with any other vaccine or medication, therefore the need arises to create a mechanism that guarantees a no-fault compensation, which is fair and equitable for the Honduran population.
Whereas other mechanisms should be sought that strengthen the acquisition of vaccines precertified by the World Health Organization or approved by other recognized world Regulatory Agencies, such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), etc., which must be acquired with due transparency.
Whereas in accordance with Article 205 Attribution 1) of the Constitution of the Republic, it is the power of the National Congress to: Create, decree, interpret, reform and repeal laws.
Articles
To reaffirm the commitment of the State of Honduras for the protection of the health of the population and to provide all the means at its disposal to address the emergency generated by the COVID-19 pandemic, as well as the immunization of the population through the application and/or use of the vaccine and to monitor the serious adverse events attributed to the application of the vaccine against COVID-19, which are treated in public institutions.
The present Law has as its object to establish a GUARANTEE FOR CARE FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE VACCINE AGAINST COVID-19 AND WHERE APPROPRIATE FOR COMPENSATION WITHOUT FAULT, for the person vaccinated against COVID-19 in national territory, in establishments providing public health services, with the exceptions established in the respective Regulation.
The obligation for compensation without fault is excepted in the case of serious adverse events that are not a direct consequence of the application of the vaccine against COVID-19, or that, at the moment of providing medical information prior to the application of the vaccine, the person has omitted relevant information from their clinical history.
For purposes of the preceding Article, prior to the application of the vaccine against COVID-19, the health personnel who will apply the vaccine shall ensure that those persons for whom the vaccine is contraindicated do not receive it, in accordance with the technical and operational guidelines for COVID-19 vaccination issued by the State Secretariat of Health (SESAL).
The present Law is of public order, applicable throughout the national territory, and mandatory compliance in establishments providing public health services. CHAPTER II OF THE UNIT FOR CARE OF THE PERSON VACCINATED AGAINST COVID-19
The Unit for Care of the Person Vaccinated against COVID-19 is created, under the subordination of the General Directorate of Regulatory Framework Surveillance dependent on the State Secretariat of Health (SESAL), which shall have national coverage through the Departmental Health Regions, with the following powers:
- a)
Receive claims presented by the interested party in relation to serious adverse events supposedly attributed to the application of the vaccine against COVID-19;
- b)
Request from the Pharmacovigilance Department of the State Secretariat of Health (SESAL) the investigation and complete documentation related to the serious adverse event;
- c)
Follow up expeditiously on the file until it is completed with proper documentation; and,
- d)
Those other powers established in the Regulation. CHAPTER III OF THE RECORD CARD FOR COVID-19 VACCINATION DOSE REGISTRATION
For purposes of the application of the COVID-19 vaccine, the Record Card for COVID-19 Vaccination Dose Registration must be implemented, which shall be available in digital and physical form, which shall be delivered to the vaccinated person, in which the following is recorded:
- a)
Full name of the citizen;
- b)
Identity number;
- c)
Passport number;
- d)
Date of birth (day, month, year);
- e)
Sex (Female/Male);
- f)
Profession/occupation;
- g)
Workplace;
- h)
Residential address;
- i)
Fixed telephone/mobile number;
- j)
Name of the Health Establishment where the vaccine was applied;
- k)
Date of application (day, month, year);
- l)
Dose number (First, Second Dose, others);
- m)
Name of Manufacturer/lot number/expiration date; and, n) Name of the vaccinator. CHAPTER IV OF THE PROCEDURE FOR CLAIMS FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE VACCINE AGAINST COVID-19
The procedure for claims for serious adverse events attributed to the application of the vaccine against COVID-19 is subject to what is established in the present Law and its Regulation. For purposes of the present Law, a serious adverse event shall be understood as that which leads to one of the following situations:
- a)
That puts the life of the vaccinated person at risk;
- b)
Requires hospitalization; and,
- c)
That generates disability and/or death.
The person who has been vaccinated against COVID-19 and who presents serious adverse events may present the respective claim before the Unit for Care of the Person Vaccinated against COVID-19 or failing that, a duly authorized representative. The deadline for filing the claim shall lapse within sixty (60) business days after the vaccine was applied.
The investigation related to a serious adverse event shall be conducted in accordance with the guidelines established by the State Secretariat of Health (SESAL). CHAPTER V OF COMPENSATION WITHOUT FAULT
Compensation without fault proceeds when it is confirmed through epidemiological investigation, clinical analyses, and any other facultative examination that may be necessary, to determine the serious adverse events derived from the application or use of the vaccine, in accordance with what is established in the Regulation. CHAPTER VI OF INDEMNIFICATION TO THE MANUFACTURER
Indemnification to the manufacturer of the COVID-19 vaccine that has been applied in national territory shall proceed when, as a result of the application of that vaccine, the person presents a serious adverse event and this person or a duly authorized representative has filed a claim or lawsuit before the manufacturer's jurisdiction and has obtained a favorable judgment. The claimant, their legal representatives, or their heirs may only use one of the compensation mechanisms regulated in this Article and the preceding one. CHAPTER VII OF THE FUND FOR COMPENSATION WITHOUT FAULT AND INDEMNIFICATION TO THE MANUFACTURER
A Special Fund is created to cover compensation without fault to the person affected with a serious adverse event from the application of the COVID-19 vaccine and indemnifications to manufacturers resulting from claims or lawsuits filed before the corresponding instances, in relation to serious adverse events caused by the application of the COVID-19 vaccines. Said fund shall be incorporated into the General Provisions of the General Budget of Income and Expenses of the Republic for each Fiscal Year, allocated to the State Secretariat of Health (SESAL).
The Special Fund referred to in the preceding Article cannot be allocated for other purposes, therefore no budget modifications that affect said Fund may be made; likewise they cannot be subject to attachments decreed by any Civil, Administrative Contentious, or Labor Court, nor by any other court at the national level, since the Fund is exclusive for payment of compensation without fault to the person affected with a serious adverse event from the application of the COVID-19 vaccine and indemnifications to vaccine manufacturers.
The State may agree with the persons who will be compensated without fault to make partial payments until the total compensation amount is covered, when it cannot be made in a single payment. FINAL PROVISIONS
Due to the complexity of the epidemiological investigations entailed by claims for no-fault compensation for serious adverse events associated with the application of the COVID-19 vaccine, a term of three hundred (300) business days is established for the issuance of the corresponding report and the admissibility or inadmissibility of the claim.
All public and private establishments, without exception, have the obligation to immediately notify the corresponding Health Region of the occurrence of serious adverse events allegedly attributed to the COVID-19 vaccine, as established by Article 24 of the Vaccine Law of the Republic of Honduras. Non-compliance with this provision shall be subject to sanctions as established by Article 45 of the Vaccine Law of the Republic of Honduras.
Any person who incurs in the falsification of the COVID-19 Vaccination Dose Registry Carnet, for any purpose, shall incur the penalties provided in the applicable provisions contained in the current Penal Code.
The Executive Branch, through the State Secretary of the Health Department (SESAL), must issue the respective Regulation to this Law within a maximum period of one hundred twenty (120) business days after its promulgation.
To reform articles 2, 6, 7 and 9 of the FREE VACCINE LAW FOR EVERYONE AGAINST COVID-19, contained in Decree No.162-2020, dated December 3, 2020 and published in the Official Gazette "La Gaceta", Edition No.35,452, dated December 7, 2020, which shall be read as follows:
The State Secretary of the Health Department (SESAL) is authorized to proceed with the acquisition of vaccines against the SARS-COV-2 virus that produces the COVID-19 disease, through the Revolving Fund for Vaccines of the Pan American Health Organization PAHO/WHO, and to ensure its availability in sufficient quantity for the entire population, in accordance with what is established in the Vaccine Law of the Republic of Honduras, contained in Decree No.288-2013 dated January 13, 2014, published in the Official Gazette "La Gaceta" dated March 26, 2014, in Edition No.33,389, and to incorporate it into the National Vaccination Schedule through the Expanded Program on Immunization (EPI). Likewise, the State Secretary of the Health Department is authorized to proceed, exceptionally for this sole occasion, to acquire directly, without intermediaries and without being subject to the provisions established in the State Contracting Law, to carry out the pertinent actions and management for the acquisition of vaccines against COVID-19, using already established mechanisms, ensuring transparency in the purchase. In order to promote transparency in the acquisition or purchase of COVID-19 vaccines referred to in the preceding paragraph, the State Secretary of the Health Department may have, during the acquisition process, the accompaniment as an observer of the Superior Court of Accounts or, failing that, must request the corresponding technical opinion from it.
The State Secretary of the Health Department and the Honduran Social Security Institute (IHSS) must guarantee that the acquisition of vaccines against the SARS-COV-2 virus that produces the COVID-19 disease shall be carried out under the observance of transparent mechanisms and with manufacturers of vaccines that are approved by international organizations, ensuring the quality of the vaccines and that they are obtained at the fairest price.
The pharmaceutical company contracted by the State Secretary of the Health Department and the Honduran Social Security Institute (IHSS) for the acquisition of vaccines against the SARS-COV-2 virus that produces the COVID-19 disease must guarantee that it is part of the initiatives led by the World Health Organization (WHO), thereby exempting the vaccines and supplies acquired by the State Secretary of the Health Department and the Honduran Social Security Institute (IHSS) from any process of regulation, supervision and control of COVID-19 vaccines, and in this case must request from the Health Regulatory Agency (ARSA) the summarized protocols of production and control, as well as the quality control certificate from the producing laboratory and the batch release certificate issued by the Regulatory Authority of Origin.
The Executive Branch ratifies the National Advisory Council on Immunization as an advisory and consultative body, established in Title II, Chapter III, Article 11 of the Vaccine Law of the Republic of Honduras dated January 13, 2014, published in the Official Gazette "La Gaceta" dated March 26, 2014 in Edition No.33,389".
To authorize the Executive Branch through the State Secretary of the Health Department to, in representation and benefit of the Honduran people, subscribe with the manufacturers and suppliers of the COVID-19 vaccine, one or more Indemnification Agreements, this being a requirement for its acquisition through the COVAX Mechanism or others.
This Decree shall enter into force as of the day of its publication in the Official Gazette "La Gaceta". Given in the City of Tegucigalpa, municipality of the Central District, in the Session held by the National Congress in a Virtual manner, on the Twenty-first day of the month of January in Two Thousand Twenty-one. MARIO ALONSO PÉREZ LÓPEZ PRESIDENT JOSÉ TOMÁS ZAMBRANO MOLINA SECRETARY ROSSEL RENÁN INESTROZA MARTÍNEZ SECRETARY To the Executive Branch. Therefore: Execute. Tegucigalpa, M.D.C., February 3, 2021. JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE STATE SECRETARY OF THE HEALTH DEPARTMENT ALBA CONSUELO FLORES
Related laws
- Special Law for Guaranteeing Care for Serious Adverse Events from COVID-19 Vaccine Administration — This law creates a protection system for people vaccinated against COVID-19 who suffer serious adverse events. It establishes a care unit to receive complaints, a special fund to compensate without proving fault, and authorizes the State to sign indemnification agreements with vaccine manufacturers. It benefits Honduran citizens vaccinated in public institutions who experience serious complications. (Decree 193-2020, 2021)
- Decreto Legislativo No. 193-2020 — Ley Especial para la Garantía de la Atención por Eventos Adversos Graves Atribuidos a la Aplicación o Uso de la Vacuna contra el COVID-19 y en su Caso para la Compensación sin Culpa (Decree 193-2020, 2021)
- Special Law on Economic Reactivation Through Support for Microenterprises — This law helps small and medium-sized business owners access credit again by allowing banks to refinance debts of up to US$25,000 without penalizing their credit history. The State contributes 100 million lempiras annually (2013-2017) to guarantee funds to support these loans and facilitate access to formal financing. (Decree 155-2012, 2013)
- Executive Decree PCM-059-2016 through which Article 4 of Legislative Decree Number 155-2012 is reformed regarding the Special Law on Economic Reactivation — This decree authorizes the government to transfer 40 million lempiras in 2016 and 100 million in 2017 from the Solidarity Fund to the Social Housing Guarantee Fund (FOGAVIS), managed by CONFIANZA. The money guarantees loans so that low-income people can access homeownership or improve their homes through assisted self-construction.
- Law of the System of Reciprocal Guarantee Funds for the Promotion of MSMEs, Social Housing and Professional Technical Education — This law creates a system of reciprocal guarantee funds that acts as a guarantor so that small and medium-sized businesses, social housing, and technical education can more easily access bank credit. The funds are administered by specialized companies that charge commissions and guarantee loans, allowing more entrepreneurs to obtain financing with fewer obstacles. (Decree 205-2011, 2011)