Special Law for Guaranteeing Care for Serious Adverse Events from COVID-19 Vaccine Administration
Congreso Nacional
- Decree: 193-2020
- Published: February 3, 2021
- Issuing body: Congreso Nacional
- Gazette: 35,505
- Category: Health
Summary
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.
Considerations
Whereas the Constitution of the Republic establishes that the human person is the supreme purpose of society and the State, consequently, all have the obligation to respect and protect it, and likewise recognizes the right to protection of the health 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 vulnerable groups.
Whereas on January 30, 2020, the World Health Organization (WHO), through the Emergency Committee declared the outbreak of the new Coronavirus, which causes COVID-19 disease, as a public health emergency of international importance; having affected to date the world population in general and Honduras in particular, resulting in a high rate of mortality and morbidity, having been decreed "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 Gazette "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. For this reason, for the control of the Pandemic, it is considered that the introduction of the COVID-19 vaccine is an additional intervention, to which a high degree of priority must be assigned 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 vaccine access 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 COVID-19 vaccine manufacturers, that the beneficiary country enter into with each of them, once the vaccine is acquired, an Agreement for Exemption of Liability and grant 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 Gazette "La Gaceta" on December 7, 2020, Edition No. 35,452, the Law for Free Vaccine for All Against COVID-19 was approved, through which free and universal access to the vaccine against the SAR-COV-2 virus that produces COVID-19 disease is guaranteed, however, the same requires modifications in order to expand the capacity for action of the Secretary of State in the Office of Health in the process of vaccine acquisition and application, authorizing it to be able to subscribe to agreements for the exclusion of liability of manufacturers and suppliers, as well as the establishment of indemnification processes in the event of adverse effects that could occur in the Honduran population due to the application of the COVID-19 vaccine.
Whereas in the related Vaccine Law it was approved because this is a recently emerged disease and was not contemplated in the current Vaccine Law, given the novelty of the COVID-19 vaccine despite rigorous studies having been conducted on it, however with its application it can 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 within 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 serious adverse events attributed to the application of the vaccine against COVID-19, which are treated in public institutions.
The purpose of this Law is to establish a GUARANTEE OF CARE FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE VACCINE AGAINST COVID-19 AND WHERE APPLICABLE FOR NO-FAULT COMPENSATION, 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 of this no-fault compensation 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 must ensure that those persons for whom the vaccine is contraindicated do not receive it, in accordance with the technical operational guidelines for COVID-19 vaccination issued by the Secretariat of State in the Office of Health (SESAL).
This Law is of public order, applicable throughout national territory, and mandatory in establishments providing public health services. CHAPTER II OF THE CARE UNIT FOR THE PERSON VACCINATED AGAINST COVID-19
There is hereby created the Care Unit for the Person Vaccinated Against COVID-19, under the subordination of the General Directorate of Surveillance of the Regulatory Framework dependent on the Secretariat of State in the Office of Health (SESAL), which shall have national coverage through the Departmental Health Regions, with the following powers:
- a)
To 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)
To request from the Pharmacovigilance Department of the Secretariat of State in the Office of Health (SESAL) the investigation and complete documentation related to the serious adverse event;
- c)
To follow up expeditiously on the case file until it is completed with proper documentation; and,
- d)
Those others established in the Regulation. CHAPTER III OF THE VACCINATION DOSE REGISTRATION CARD AGAINST COVID-19
For purposes of the application of the COVID-19 vaccine, the Vaccination Dose Registration Card against COVID-19 must be implemented, which shall be available in digital and physical form, which shall be delivered to the vaccinated person, in which the following shall be 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)
Landline/mobile phone 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, other);
- m)
Name of Manufacturer/lot number/expiration date; and, n) Name of the vaccinator. CHAPTER IV OF THE CLAIM PROCEDURE FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE VACCINE AGAINST COVID-19
The claim procedure for serious adverse events attributed to the application of the vaccine against COVID-19 is subject to what is established in this Law and its Regulation. For purposes of this Law, serious adverse event shall be understood as that which leads to any 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 Care Unit for the Person Vaccinated Against COVID-19 or, in its absence, a duly authorized representative. The deadline for the claim shall expire within sixty (60) business days after the vaccine is applied.
The investigation related to a serious adverse event shall be conducted in accordance with the guidelines established by the Secretariat of State in the Office of Health (SESAL). CHAPTER V OF NO-FAULT COMPENSATION
No-fault compensation proceeds when it is confirmed through epidemiological investigation, clinical analyses, and any other expert examination that may be necessary to determine 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 shall proceed for the manufacturer of the COVID-19 vaccine that has been applied in national territory when as a result of the application of that vaccine the person presents a serious adverse event and the person or a duly authorized representative has filed a claim or lawsuit before the jurisdiction of the manufacturer and has obtained a favorable judgment. The claimant, their legal representatives, or their heirs may only make use of one of the compensation mechanisms regulated in this Article and the preceding one. CHAPTER VII OF THE FUND FOR NO-FAULT COMPENSATION AND INDEMNIFICATION TO THE MANUFACTURER
There is hereby created a Special Fund to cover no-fault compensation to the person affected with a serious adverse event by the application of the COVID-19 vaccine and indemnifications to manufacturers resulting from claims or lawsuits presented before the corresponding instances, in relation to serious adverse events caused by the application of COVID-19 vaccines, said fund must be incorporated into the General Provisions of the General Budget of Income and Expenses of the Republic for each Fiscal Year, assigned to the Secretariat of State in the Office of Health (SESAL).
The Special Fund referred to in the preceding Article cannot be allocated for other purposes, therefore no budgetary modifications that affect said Fund shall be made; furthermore, they may not be subject to attachments decreed by any Civil Court, Administrative Contentious Court, or Labor Court, nor by any other court at the national level, since the Fund is exclusive for payment of no-fault compensation to the person affected with a serious adverse event by the application of the COVID-19 vaccine and indemnifications to vaccine manufacturers.
The State may agree with persons who will be compensated on a no-fault basis to make partial payments until the total amount to be compensated is covered, when it cannot be made in a single payment. FINAL PROVISIONS
Due to the complexity of epidemiological investigations involved in no-fault compensation claims 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 Vaccination Law of the Republic of Honduras. Failure to comply with this provision shall be subject to sanctions as established by Article 45 of the Vaccination Law of the Republic of Honduras.
Any person who commits falsification of the COVID-19 Vaccination Dose Registry Card, for any purpose, shall incur the penalties provided in the applicable provisions contained in the current Penal Code.
The Executive Branch, through the Secretariat of State in the Ministry of Health (SESAL), must issue the respective Regulations to this Law within a maximum period of one hundred twenty (120) business days following its promulgation.
To reform Articles 2, 6, 7, and 9 of the FREE VACCINATION LAW FOR ALL 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 read as follows:
The Secretariat of State in the Ministry of Health (SESAL) is authorized to proceed with the acquisition of vaccines against the SARS-COV-2 virus that produces COVID-19 disease, through the Revolving Fund for Vaccines of the Pan American Health Organization PAHO/WHO, and to ensure its availability in sufficient quantities for the entire population, in accordance with the provisions of the Vaccination 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 Scheme through the Expanded Program on Immunization (EPI). The Secretariat of State in the Ministry of Health is likewise authorized to proceed, exceptionally and only this one time, to acquire directly, without intermediaries and without subjection to the provisions established in the State Contracting Law, to carry out the actions and management pertinent to the acquisition of COVID-19 vaccines, utilizing already established mechanisms, ensuring transparency in the purchase. In order to ensure transparency in the acquisition or purchase of COVID-19 vaccines referred to in the previous paragraph, the Secretariat of State in the Ministry of Health may have, during the acquisition process, the accompaniment as an observer of the Court of Accounts or, failing that, must request the corresponding technical opinion from it.
The Secretariat of State in the Ministry of Health and the Honduran Social Security Institute (IHSS) must ensure that the acquisition of vaccines against the SARS-COV-2 virus that produces COVID-19 disease shall be carried out under the observance of transparent mechanisms and with manufacturers of vaccines approved by international organisms, and must ensure the quality of the vaccines and that they are obtained at the most just price.
The pharmaceutical company contracted by the Secretariat of State in the Ministry of Health and the Honduran Social Security Institute (IHSS) for the acquisition of vaccines against the SARS-COV-2 virus that produces COVID-19 disease must guarantee that it is part of the initiatives led by the World Health Organization (WHO), whereby vaccines and supplies acquired by the Secretariat of State in the Ministry of Health and the Honduran Social Security Institute (IHSS) are exempted 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 lot release certificate issued by the Regulatory Authority of Origin.
The Executive Branch ratifies the National Consultative Council on Immunizations as an advisory and consultative body, established in Title II, Chapter III, Article 11 of the Vaccination 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 Secretariat of State in the Ministry of Health to subscribe, in representation and benefit of the Honduran people, 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 other means.
This Decree enters 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 Virtual manner, on the Twenty-first day of the month of January of Two Thousand Twenty-one. MARIO ALONSO PÉREZ LÓPEZ PRESIDENT JOSÉ TOMÁS ZAMBRANO MOLINA SECRETARY ROSSEL RENÁN INESTROZA MARTÍNEZ SECRETARY To the Executive Branch. Therefore: Let it be executed. Tegucigalpa, M.D.C., February 3, 2021. JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE SECRETARY OF STATE IN THE MINISTRY OF HEALTH ALBA CONSUELO FLORES
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