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April 29, 2021In force

Decreto-No.17-2021

Congreso Nacional

  • Decree: 17-2021
  • Published: April 29, 2021
  • Issuing body: Congreso Nacional
  • Gazette: 35,586
  • Category: Health

Summary

AIThis summary was generated by AI and may contain errors. Always verify against the original law text below. Not legal advice. Learn how we use AI

This law protects manufacturers, distributors, and healthcare providers from lawsuits over damages caused by COVID-19 vaccines and medical treatments during the health emergency, except in cases of serious intentional negligence. It creates a state fund to compensate people who suffer serious adverse effects, being the only available compensation.

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 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 State Secretariat of Health (SESAL), by constitutional provision, to coordinate all public activities of the centralized and decentralized organisms of such sector, through a National Health Plan, in which priority shall be given to the most vulnerable groups.

Whereas as a result of the COVID-19 Pandemic, the Government of the Republic of Honduras declared a STATE OF HEALTH EMERGENCY, through 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 national territory, until December 31, 2021, with the purpose of strengthening surveillance, prevention, control and guarantee of care actions 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 world and national health, given the magnitude and significance of the disease. Therefore, for Pandemic control it is considered that the introduction of the vaccine against COVID-19 is an additional intervention, to which a high degree of priority should be assigned by Government authorities, the scientific community, cooperating organizations and the general population.

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 VACCINE AGAINST COVID-19, IN SUCH CASE, FOR COMPENSATION WITHOUT FAULT" in Decree No. 193-2020, dated January 21, 2021 and published in the Official Gazette "La Gaceta" on February 3, 2021, Edition No. 35,505, given 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 such person 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 extracontractual 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 product 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 power of the National Congress: To create, decree, interpret, reform and repeal laws.

Articles

Article 1.-

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 situation of public order and is part of the circumstances that have given rise to the declaration of the SANITARY 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.

Article 2.-

For the purposes of this Law, the use of Medical Treatment Products during the Sanitary 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 drugs, or other devices to treat, diagnose, cure, prevent, or mitigate damages or the threat of damages in the Sanitary Emergency State that arose from the COVID-19 Pandemic.

Article 3.-

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 lawsuits and judicial, administrative, or any other nature complaints, and shall be exempt from any civil, criminal, or administrative/commercial responsibility or obligation to indemnify that arises from 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 Sanitary 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 lawsuits and judicial, administrative, or any other nature complaints, and shall be exempt from any civil, criminal, or administrative/commercial responsibility or obligation to indemnify.

Article 4.-

The protection referred to in the preceding 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 the 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, transport, storage, formulation, packaging, commercialization, promotion, sale, purchase, donation, dispensation, prescription, administration, licensing, commercialization, or use of such Products for Medical Treatments to address the COVID-19 pandemic.

Article 5.-

This protection shall not apply 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 deterioration of a bodily function, or that causes permanent damage to a bodily 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 regard to a known or obvious risk that is so great that it makes it highly probable that the damage is greater than the benefit.

Article 6.-

The administration or use of any Product for Medical Treatments to address the COVID-19 pandemic requires formal registration and/or authorization by means of a resolution issued by the Sanitary Regulatory Agency (ARSA) and the State Secretariat of the Health Department (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 State Secretariat of the Health Department (SESAL).

Article 7.-

Reform 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 Amendment to the SPECIAL LAW FOR THE GUARANTEE OF CARE FOR SERIOUS ADVERSE EVENTS ATTRIBUTED TO THE APPLICATION OR USE OF THE VACCINE AGAINST COVID-19, AND IN ITS CASE, FOR COMPENSATION WITHOUT FAULT and which shall hereafter read as follows: "ARTICLE 13. A Special Fund is hereby created... Furthermore, said fund shall serve for indemnifications 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 Sanitary 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 TREATMENT PRODUCTS FOR THE COMBAT OF THE SANITARY EMERGENCY AS A CONSEQUENCE OF COVID-19 BY NATURAL AND LEGAL PERSONS NATIONAL OR FOREIGN, by administrative resolution or judgment rendered in 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 State Secretariat of the Health Department (SESAL)."

Article 8.-

The Special Fund referred to in the preceding Article may not be allocated for other purposes, therefore it shall not be possible to make budgetary modifications that affect said Fund; likewise, it may not be subject to attachment ordered by any Civil Court, Administrative Contentious 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 Products for Medical Treatments to address the COVID-19 pandemic in establishments that provide health services.

Article 9.-

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 Sanitary 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 VACCINE AGAINST COVID-19, AND IN ITS CASE, 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.

Article 10.-

Notwithstanding the provisions of Article 5 of this Law, indemnification through the fund for compensation without fault and indemnification to the manufacturer created by means of 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 drugs, or other devices to treat, diagnose, cure, prevent, or mitigate damages or the threat of damages in the Sanitary Emergency State that arose from the COVID-19 Pandemic.

Article 11.-

This Decree shall enter into force as of the date 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 Power Therefore: Let it be executed. Tegucigalpa, M.D.C., April 29, 2021 JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE STATE SECRETARY IN THE OFFICE OF HEALTH ALBA CONSUELO FLORES

Notes

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