Special Law on the Regulation of the Use of Vaccines and Medical Treatments for Combat Against Covid-19
Congreso Nacional
- Decree: 17-2021
- Published: April 29, 2021
- Issuing body: Congreso Nacional
- Gazette: 35,586
- Category: Health
Summary
This law protects manufacturers, distributors, and healthcare providers from lawsuits and liability for injuries caused by COVID-19 vaccines and medications during the health emergency. Affected citizens can only receive compensation through a special state fund, except in cases of serious intentional negligence.
Considerations
Whereas the Constitution of the Republic establishes that the human person is the supreme end of society and the State, consequently, all have the obligation to respect and protect it, and it 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 such purpose it corresponds to the Secretary of State in the Office of Health (SESAL), by constitutional provision, to coordinate all public activities of the centralized and decentralized organisms of said sector, through a National Health Plan, in which priority shall be given to the most needy groups.
Whereas as a result of the COVID-19 Pandemic, the Government of the Republic of Honduras declared a STATE OF HEALTH EMERGENCY, by Executive Decree Number PCM-005-2020 published in the Official Gazette "La Gaceta" on February 10, 2020, Edition No. 35,171, modified by Executive Decrees Numbers: PCM-016-2020, PCM-023-2020 and PCM-146-2020, throughout the entire national territory, until December 31, 2021, for the purpose of strengthening surveillance, prevention, control and guarantee of care for persons in the event of the probable appearance of COVID-19 infection.
Whereas the control of the COVID-19 Pandemic constitutes a priority of global and national health, given the magnitude and importance of the disease. Therefore, 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 should be assigned by Government authorities, the scientific community, cooperating organizations and the population in general.
Whereas in order to combat the pandemic, the Government of the Republic of Honduras created the "SPECIAL LAW FOR THE GUARANTEE OF CARE FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE COVID-19 VACCINE, IN SUCH CASE, FOR COMPENSATION WITHOUT FAULT" by Decree No. 193-2020, dated January 21, 2021 and published in the Official Gazette "La Gaceta" on February 3, 2021, Edition No. 35,505, due to the need to establish other mechanisms that strengthen the acquisition of vaccines pre-qualified by the World Health Organization (WHO) or approved by other globally recognized regulatory agencies; however, said Law limited the scope of indemnification only to the manufacturer of a COVID-19 vaccine, when the application resulted in a serious adverse event for a person, and it obtained a favorable resolution of a claim filed in the jurisdiction of the manufacturer.
Whereas it is of utmost importance to establish a legal regime applicable to the non-contractual responsibilities of persons and entities that operate in the public health sector in the context of the State of Health Emergency derived from the COVID-19 Pandemic, which result in serious adverse events or threat of harm to the citizens of the Republic of Honduras as a result of the use of Medical Treatments or with their development, administration, or use within the context of the State of Health Emergency that arose from the COVID-19 Pandemic.
Whereas in accordance with Article 205 Attribution 1) of the Constitution of the Republic, it is the authority of the National Congress: To create, decree, interpret, reform and repeal laws.
Articles
The State of Honduras reaffirms and declares that the COVID-19 Pandemic resulting from the transmission of the SARS-CoV-2 virus or any mutant virus thereof constitutes a matter of public order and is part of the circumstances that have given rise to the declaration of the HEALTH EMERGENCY STATE, as established in Executive Decree Number PCM-005-2020 published in the Official Gazette "La Gaceta" on February 10, 2020, Edition No. 35,171, modified by Executive Decrees Numbers: PCM-016-2020, PCM-023-2020 and PCM-146-2020.
For purposes of this Law, the use of Medical Treatment Products during the Health Emergency State as a consequence of the COVID-19 Pandemic consists of the development, administration and use of certain Products for Medical Treatments to address the COVID-19 pandemic, including vaccines, antivirals, biological products, diagnostic products, other pharmaceutical drugs or other devices to treat, diagnose, cure, prevent or mitigate damages or the threat of damages in the Health Emergency State that arose from the COVID-19 Pandemic.
Natural or legal persons, national or foreign, who provide health services, who manufacture and develop medications or other medical treatment products against COVID-19, shall not be subject to legal claims and lawsuits, administrative or any other nature and shall be exempt from any civil, criminal or administrative/commercial liability or obligation to indemnify that arises or derives from the development, administration or use of any Product for Medical Treatments in exceptional situations of public health or within the context of the Health Emergency State that arose from the COVID-19 Pandemic. The manufacturer, the holder of the authorization, distributor and/or logistical operator of the Product for Medical Treatments to address the COVID-19 pandemic, whether national or foreign, shall likewise not be subject to legal claims and lawsuits, administrative or any other nature and shall be exempt from any civil, criminal or administrative/commercial liability or obligation to indemnify.
The protection referred to in the previous Article is applicable to any claim that has a direct or indirect causal relationship with the administration or use of any Product for Medical Treatments to address the COVID-19 pandemic. For purposes of this Law, the development, administration or use of a Product for Medical Treatments to address the COVID-19 pandemic shall include the design, development, testing or clinical research, manufacturing, labeling, distribution, transportation, storage, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescription, administration, licensing, commercialization or use of such Products for Medical Treatments to address the COVID-19 pandemic.
This protection is not applicable to claims or lawsuits for death or for a physical injury that endangers life, or that causes or requires a medical or surgical intervention in order to prevent permanent impairment of a body function, or that causes permanent damage to a body structure, which is demonstrated directly to have been caused by an action or omission carried out: (
- i)
intentionally to achieve an unlawful purpose; (
- ii)
knowingly without legal or factual justification; and, (
- iii)
without taking into account a known or obvious risk that is so great that it makes it highly probable that the damage is greater than the benefit.
The administration or use of any Product for Medical Treatments to address the COVID-19 pandemic requires formal registration and/or authorization by resolution issued by the Health Regulatory Agency (ARSA) and the Ministry of Health (SESAL), when required by applicable legislation, which shall determine the manner of use and application of the treatment. It is prohibited to use, apply and prescribe a Product for Medical Treatments to address the COVID-19 pandemic for treatments not authorized by the Ministry of Health (SESAL).
Amend Article No. 13 of Legislative Decree No. 193-2020 dated January 21, 2021 and published in the Official Gazette "La Gaceta" dated February 3, 2021, Edition No. 35,505, containing the Reform to the 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 COMPENSATION WITHOUT FAULT, and which shall henceforth read as follows: "ARTICLE 13. A Special Fund is created... Likewise, said fund shall serve for indemnification of damages resulting from the development, administration or use of a Product for Medical Treatments to address the COVID-19 pandemic in the context of the Health Emergency State that arose from the COVID-19 pandemic, as defined in the SPECIAL LAW FOR THE REGULATION OF THE USE OF VACCINES AND MEDICAL TREATMENTS FOR COMBATING THE HEALTH EMERGENCY AS A CONSEQUENCE OF COVID-19 BY NATURAL AND LEGAL PERSONS NATIONAL OR FOREIGN, by administrative resolution or sentence handed down by the courts of national jurisdiction. This fund shall be incorporated into the General Provisions of the General Budget of Income and Expenses of the Republic for each Fiscal Year, allocating it to the Ministry of Health (SESAL)."
The Special Fund referred to in the previous Article may not be allocated to other purposes, so it shall not be possible to make budgetary modifications that affect said Fund; likewise, it cannot be the subject of attachment ordered by any Civil Court, Administrative Litigation Court or Labor Court, nor by any other court or tribunal at the national level, since the Fund is exclusively for the payment of indemnifications derived from the Products for Medical Treatments to address the COVID-19 pandemic, in establishments that provide health services.
Claims arising from damages resulting from the development, administration or use of a Product for Medical Treatments to address the COVID-19 pandemic in the context of the Health Emergency State that arose from the COVID-19 pandemic shall follow the procedure established in articles 8, 9, 10 and 16 of the 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 COMPENSATION WITHOUT FAULT, Legislative Decree No. 193-2020 dated January 21, 2021 and published in the Official Gazette "La Gaceta", Edition No. 35,505 dated February 3, 2021.
Without prejudice to the provisions of Article 5 of this Law, the indemnification through the fund for compensation without fault and indemnification to the manufacturer created by Legislative Decree No. 193-2020 shall be the sole and exclusive indemnification for any claim for damages that are related to or result from the development, administration or use of Products for Medical Treatments to address the COVID-19 pandemic, including vaccines, antivirals, biological products, diagnostic products, other pharmaceutical drugs or other devices to treat, diagnose, cure, prevent or mitigate damages or the threat of damages in the Health Emergency State that arose from the COVID-19 Pandemic.
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 Virtual manner, on the twenty-ninth day of the month of April 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., April 29, 2021 JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE SECRETARY OF STATE IN THE OFFICE OF HEALTH ALBA CONSUELO FLORES
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