Decree No. 7-2021 by which Executive Decree Number PCM-032-2017 relating to the Health Regulatory Agency (ARSA) is reformed
Congreso Nacional
- Decree: 7-2021
- Published: June 12, 2021
- Issuing body: Congreso Nacional
- Gazette: 35,626
- Category: Health
Summary
This decree establishes the Health Regulation Agency (ARSA) as an official institution with power to supervise, control, and authorize health products, services, and establishments in Honduras. ARSA can now issue licenses, permits, and health registrations, establish quality standards, and enforce penalties, benefiting the population by ensuring that health products and services meet quality and safety standards.
Considerations
Whereas Article 59 of the Constitution of the Republic of Honduras establishes that: "The human person is the supreme purpose of society" and it is the function of the State to promote and facilitate access to public services related to health in order to improve sanitary conditions and the quality of life of persons.
Whereas the Constitution of the Republic in its Article 145 establishes that: "The Right to Health Protection is recognized. It is the duty of all to participate in the promotion and preservation of personal and community health. The State shall preserve an adequate environment to protect the health of persons".
Whereas Article 3, first paragraph of the General Law of Public Administration, reformed by Decree No. 266-2013 published in the Official Journal "La Gaceta" dated January 23, 2014, states that: "The creation, modification or suppression of the Bodies of Public Administration including the Decentralized and Deconcentrated Institutions can only be done after prior definition of the public purpose to be satisfied when its economic and administrative feasibility is accredited, considering the cost of its operation, specialized performance or the projected savings".
Whereas Article 4 of the aforementioned Law establishes the following: "The creation, modification, or suspension of the Secretariats of State or of the Deconcentrated Bodies or Entities can only be done by the President of the Republic in State Secretaries Council".
Whereas the reformed Article 45 of the General Law of Public Administration establishes that deconcentrated bodies or entities shall be created, modified, merged or suppressed by Decree of the President of the Republic in State Secretaries Council and their heads shall be responsible for their management before the centralized administration body upon which they depend.
Whereas by Executive Decree Number PCM-061-2013, published in the Official Journal "La Gaceta" dated January 29, 2014, Articles 67, 68 and 69 of the Regulation of Organization, Operation and Competencies of the Executive Branch were reformed, granting the Secretariat of State in the Office of Health a new organizational structure with the definition of substantive functions that are proper to it in matters of sectoral leadership, regulation, surveillance of the normative framework, health surveillance, financing modulation, assurance guarantee and harmonization of service provision, as well as the definition of scope concerning the function of health assurance and health service provision of its hierarchically dependent units.
Whereas the performance of the function of regulation and surveillance of the normative framework is a very specific field of action characterized by a high level of complexity and diversity both technical and scientific, which requires having a specialized institution that improves the management of sanitary regulation, oversight, control and surveillance, therefore, in order to respond efficiently to the requirements previously stated, it is necessary the design and implementation of a new model of organization and administration.
Whereas by Executive Decree Number PCM-032-2017, published in the Official Journal "La Gaceta" dated May 19, 2017, reformed by Executive Decree Number PCM-013-2020, published in the Official Journal "La Gaceta" dated September 3, 2020, the Health Regulatory Agency (ARSA) was created as a Deconcentrated Entity of the Secretariat of State in the Office of Health (SESAL) attached to the Sectoral Cabinet for Development and Social Inclusion, with functional, technical, financial, administrative and national security independence, with legal personality, responsible for the supervision, review, verification, control, surveillance and oversight of compliance with legal, technical and administrative regulations of establishments, providers, products and services of sanitary interest and those that carry out activities or engage in conduct that affects or may affect the health of the population; and for the regulation, granting, renewal, modification, suspension or cancellation of registrations, permits, licenses, certifications and other sanitary authorizations, with competence at the national level.
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
Ratify the creation of the HEALTH REGULATORY AGENCY (ARSA), created by Executive Decree Number PCM-032-2017, published in the Official Gazette "La Gaceta" on May 19, 2017, amended by Executive Decree Number PCM-013-2020, published in the Official Gazette "La Gaceta" on September 3, 2020, as a Decentralized Entity of the Secretariat of State in the Office of Health (SESAL), with functional, technical, financial, administrative and national security independence, with its own legal personality, which is the entity responsible for supervision, review, verification, control, surveillance and oversight of compliance with the legal, technical and administrative regulations of establishments, suppliers, products and services of sanitary interest and those that carry out activities or practice conduct that affects or may affect the health of the population; and for the regulation, granting, renewal, modification, suspension or cancellation of registrations, permits, licenses, certifications and other sanitary authorizations. The Health Regulatory Agency (ARSA) has competence at the national level and is domiciled in the Municipality of the Central District.
The Health Regulatory Agency (ARSA) is headed by a Commissioner President, who is the highest authority and legal representative of the institution, responsible for defining and executing administrative and operational policies, strategies, plans and programs, in accordance with the State's economic, fiscal and tax policy, for meeting the institutional goals and results established by Law and by the Presidency of the Republic. The Health Regulatory Agency (ARSA) also has two Deputy Commissioners. The Commissioner President and the Deputy Commissioners shall be appointed by the President of the Republic for a period of five (5) years and may only be removed from their positions for legal or natural impossibility, when their actions conflict with the nature of the functions of the Health Regulatory Agency (ARSA).
To be Commissioner President or Deputy Commissioner of the Health Regulatory Agency (ARSA), the following is required:
- 1)
To be Honduran, over thirty (30) years of age;
- 2)
To be in the enjoyment of civil and political rights;
- 3)
To be a university professional of recognized capacity and ethical fitness;
- 4)
To have no debts or pending accounts with the State; and,
- 5)
Proven experience of at least five (5) years in the field of health regulation.
The relations between the Health Regulatory Agency and its respective personnel are governed by labor regulations that shall be approved by the highest authority of the institution for this purpose. Such regulations must contain as minimum standards the subsystems for adequate Human Talent administration. The personnel of the Health Regulatory Agency (ARSA) must be technical and highly qualified, subject also to the certification of their fitness through the performance of trustworthiness tests. The remuneration of the personnel of the Health Regulatory Agency (ARSA) must correspond to the responsibility of the positions and the positional structure within the institution, for which purpose the Agency is authorized to approve its own salary scale.
The Commissioner President holds all the powers corresponding to Administrators and Higher Decision Bodies, specifically with respect to its functioning, development and operation, exercising therefore all the powers of administration and direction related to the competencies of the Health Regulatory Agency (ARSA), as well as the exercise of the other powers conferred by applicable Laws and International Agreements.
The Organic Structure of the Health Regulatory Agency (ARSA) shall be established in the Regulations that the Agency shall issue within ninety (90) calendar days from the publication of this Decree in the Official Gazette of the Republic "La Gaceta".
The Health Regulatory Agency (ARSA) has the following attributions and competencies:
- 1)
To regulate, supervise, review, verify, control, monitor and oversee compliance with the regulatory framework of products, services and establishments of sanitary interest, including matters related to pharmacovigilance and technovigilance, with the exception of those corresponding to health service provider establishments, as well as those corresponding to the areas of environmental health, occupational health and health personnel;
- 2)
To develop, update and approve the regulatory framework that governs establishments, services and products of sanitary interest;
- 3)
To grant, renew, modify, suspend or cancel sanitary licenses of establishments, including hospitality and recreation services, as well as other certifications and sanitary authorizations that it issues. This attribution may be delegated to other official authorities with territorial competence, always exercising oversight and control;
- 4)
To grant, renew, modify, suspend or cancel registrations and other sanitary authorizations of products of sanitary interest, including the oversight of Clinical Trials, the products to be used therein and its scientific ethics committee;
- 5)
To establish mechanisms to guarantee the quality of services and products on the market that may affect the health of the population;
- 6)
To monitor, evaluate, supervise and provide technical follow-up to the authorization processes of establishments and services of sanitary interest;
- 7)
To establish mechanisms of transparency and accountability for the exercise of its functions;
- 8)
To approve and execute the Strategic Plan and Annual Operational Plans of the Agency in accordance with national regulations;
- 9)
To design and propose strategies and instruments to execute policies, plans and projects within the framework of its functions;
- 10)
To apply sanctions in accordance with the provisions of current legislation and the Regulations issued by the higher decision body of the Agency;
- 11)
To approve recovery fees for the provision of services; and,
- 12)
To exercise the other functions assigned to it within the scope of its competence.
It is ratified that the functions of the General Directorate of Standardization and the General Directorate of Surveillance of the Regulatory Framework that, at that time, were dependent on the Sub-secretariat of Regulation of the Secretariat of State in the Office of Health (SESAL), created by Executive Decree Number PCM-061-2013 published in the Official Gazette of the Republic "La Gaceta" of January 29, 2014, which reforms Articles 67, 68 and 69 of the Regulations of Organization, Functioning and Competencies of the Executive Branch, related to formulating and updating the sanitary regulatory framework; as well as interpreting, applying, monitoring, overseeing and controlling compliance with the legal, technical and administrative regulations that guarantee compliance with the quality standards established for suppliers of goods and services of sanitary interest or for those that carry out activities or practice conduct that affects or may affect the health of the population, respectively, shall be assumed by the Health Regulatory Agency (ARSA).
It is ratified that the Health Regulatory Agency (ARSA) assumes the functions that, at that time, corresponded to the Unit for Verification of Sanitary Regulations attached to the Department of Surveillance of the Regulatory Framework and the Regulation Area of the Unit of Laboratory Services, attached to the Department of Integrated Health Service Networks of the Health Regions, in accordance with the provisions of the Organization and Functions Manual of the Health Regions, numeral 7.2 with the exception of function 6 and numeral 8.3.2 respectively. Laboratory services shall continue to operate in the facilities where they currently function, until the Health Regulatory Agency (ARSA) has its own infrastructure.
The Patrimony of the Health Regulatory Agency (ARSA) is constituted by: 1) One hundred percent (100%) of the net income generated by services proper to the Health Regulatory Agency (ARSA) from the provision of services of any kind; and, 2) Inheritances, bequests and donations from other public or private sources, national or foreign.
The public servants who, as of the date of entry into force of this Decree, work for the Health Regulatory Agency (ARSA), shall retain their seniority and other acquired labor rights, in accordance with their contracting modality.
The Health Regulatory Agency (ARSA) is ordered to issue the pertinent regulatory provisions within a period of three (3) months counted from the date of entry into force of this Decree.
The actions provided for in this Law and others that may arise from it shall be addressed in the Court of Administrative Law.
For the resolution of matters not expressly provided for in this Law, the general principles of administrative procedure shall be applied subsidiarily, International Agreements that Honduras has signed, in their absence, the rules of the Civil Procedural Code and other branches of law that may be applicable according to their nature and purposes.
This Decree enters into force as of the date of its publication in the Official Gazette "La Gaceta". Done in the city of Tegucigalpa, municipality of the Central District, in the Session held by the National Congress in a Virtual manner, on the tenth day of the month of February 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., March 4, 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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