Vaccine Law of the Republic of Honduras

The purpose of this Law is to establish the regulatory framework applicable to the organization and functioning of the National Vaccination Scheme as an instrument for prevention and health protection through the application of safe, effective, quality vaccines that are easy to distribute and accessible to the national and foreign population of the country. Vaccination is determined as a priority action of the State. All persons residing in national territory have the right to receive free and equal treatment and cannot in this process be discriminated against for any reason. The provisions contained in this Law are of public order, applicable throughout national territory, and mandatory in public and private health care and social security facilities.

It is mandatory for all inhabitants of the Republic to submit to immunization against those diseases preventable by vaccines that the State Department of Health determines. All vaccines contemplated within the National Vaccination Scheme and those required for extraordinary vaccination shall be considered a national strategic asset.

For purposes of this Law and its application, the phases and terms used have the meaning expressed below:

• 1)

  CCNI: National Consultative Council on Immunizations.

• 2)

  Donation: The act by which a natural or legal person, national or foreign, transfers in a simple, pure and irrevocable manner goods or resources to the State Department of Health, for use in the services provided by this State Department.

• 3)

  EPV: Disease Preventable by Vaccine: One that we can prevent through vaccination, after receiving the required number of doses, according to the type of vaccine.

• 4)

  National Vaccination Scheme: Basic chart of vaccines, according to type, number of doses and age, that must be applied to different population groups subject to vaccination, that allow them to reach the necessary level of immunity against diseases preventable by vaccines in the Republic of Honduras.

• 5)

  ESAVI: Event Supposedly Attributed to Vaccination and Immunization: An unfavorable occurrence temporally associated with vaccination, which may or may not be caused by the vaccine.

• 6)

  Immunization: The action of conferring immunity through the administration of antigens or specific antibodies.

• 7)

  Immunobiological: Product used for immunization, includes vaccines, toxoids and preparations containing antibodies of human or animal origin such as toxoplasmosis and antitoxins.

• 8)

  Immunity: State of resistance generally associated with the presence of antibodies or cells that have a specific action against the microorganism causing an infectious disease.

• 9)

  Vaccination supplies: Vaccines, auto-retractable syringes, safety boxes and others such as cotton and distilled water, required for vaccination.

• 10)

  Concentration modality: Vaccination services conducted at State Centers, Work Centers and open population groups.

• 11)

  PAI: Extended Immunization Program.

• 12)

  Cold chain or network: Logistical system that comprises personnel, equipment and procedures for storing, transporting and maintaining vaccines at appropriate temperatures, from their place of manufacture until the moment they are applied to the population.

• 13)

  Vaccine Health Registration: Instrument through which the General Directorate of Health Regulation grants authorization for the use, distribution and commercialization of vaccines in the country.

• 14)

  Social Security: Honduran Social Security Institute (IHSS).

• 15)

  Vaccination: The act of administering any vaccine, regardless of whether the recipient becomes adequately immunized.

The State Department of Health is responsible for defining vaccination policies for all inhabitants throughout national territory, and in that regard has the following attributions:

• 1)

  Determine and update the National Vaccination Scheme as the basic chart of vaccines that must be applied to population groups to achieve the level of immunity against diseases preventable by vaccination;

• 2)

  Define through the Extended Immunization Program (PAI), the norms and procedures to achieve control, elimination and eradication of diseases preventable by vaccination;

• 3)

  Establish in conformity with the provisions of this Law, the guidelines for the provision of vaccination services, as well as the characteristics;

• 4)

  Adopt necessary measures to ensure the availability of vaccines and other vaccination supplies in sufficient quantity and with due timeliness throughout national territory;

• 5)

  Establish measures and regulations to ensure the appropriate technical handling of vaccines, regarding their quality, efficacy, storage, source of supply, transport, storage and other conditions that prevent their deterioration;

• 6)

  Permanently integrate with other competent authorities, budgetary provisions for the effective implementation of the Extended Immunization Program (PAI);

• 7)

  Coordinate national vaccination drives, campaigns and operations, both ordinary and extraordinary;

• 8)

  Supervise vaccination activities throughout national territory;

• 9)

  Evaluate biannually the results obtained from the implementation of the Extended Immunization Program (PAI) and specific vaccination actions, as well as propose measures aimed at achieving greater effectiveness in successive activities;

• 10)

  Define through the Extended Immunization Program (PAI), the technical standards for transport, handling and preservation for each of the vaccines contained in the National Vaccination Scheme, as well as monitor compliance and sanction non-compliance;

• 11)

  Disseminate national vaccination drives, campaigns and operations, ordinary and extraordinary, to the entire population, in a manner consistent with its geographic, ethical and cultural reality, the benefits of vaccination, as well as expected reactions and actions to prevent or mitigate them;

• 12)

  Operate a system of scientific information and research in the field of vaccines; as well as a system of information and health promotion to inform citizens about the benefits and vaccination obligations;

• 13)

  Establish regulations on customs control of vaccines for persons entering the country; and,

• 14)

  Any other attributions that correspond to it in conformity with legislation on the matter and those indicated in this Law.

The State Department of Health, with the support of corresponding authorities, must develop permanent educational communication campaigns, in order to inform the general population about the benefits of vaccines and the risk represented by the lack of timely vaccination.

The National Vaccination Scheme must be integrated by those vaccines that the State Department of Health through the Extended Immunization Program (PAI) determines as priorities according to technical criteria for effective control of diseases preventable by vaccination in the population.

The National Vaccination Scheme must include for each vaccine the following data:

• 1)

  Age group or risk group determined as objective;

• 2)

  Indications;

• 3)

  Mode of administration;

• 4)

  Scheme (number of doses), and,

• 5)

  Dose.

The National Vaccination Scheme must be evaluated periodically by the State Department of Health through the Extended Immunization Program (PAI). The Scheme must be updated each time said Program issues a recommendation in any of the following senses:

• 1)

  Suppress any vaccine;

• 2)

  Eliminate or substitute a vaccine among those included for another that has proven to be safer or more effective; or,

• 3)

  Incorporate new vaccines.

The State Department of Health through the Extended Immunization Program (PAI) must annually review the National Vaccination Scheme and shall disseminate it nationwide using available media.

Vaccines of the National Vaccination Scheme must be available in all public health care and social security service facilities for their application during all business days of the year, without prejudice to being able to conduct specific vaccination drives, campaigns or operations, including Vaccination Days or Weeks.

The National Consultative Council on Immunizations (CCNI) is established as a consultative or advisory body on immunization policies, must function with a permanent, autonomous, multidisciplinary and intersectoral character for consultation, where immunization policies to be followed are discussed and recommended, in that sense promoting and supporting actions for prevention, control, elimination and eradication in national territory of diseases that can be prevented through the administration of vaccines. For its composition, consideration must be given to representatives from Scientific Societies, Professional Associations and Universities, who perform their duties ad honorem, must meet ordinarily on a quarterly basis and extraordinarily when necessary; must present a biannual report of their activities to the State Department of Health.

The National Consultative Council on Immunizations has the attributions and responsibilities defined in the Regulation of this Law.

The right of all persons to receive free of charge in the public health and social security system the vaccines contained in the National Vaccination Scheme is recognized. Those who freely choose vaccination in private facilities are responsible for the costs this generates, as well as any side effects produced by the vaccines received. Residents in national territory are co-responsible with the State for maintaining their vaccination status updated and must take the corresponding measures to allow vaccines corresponding to their age to be applied. Persons legally responsible for minors under eighteen (18) years of age are obligated to take all necessary measures for them to receive the respective vaccines.

It is the obligation of the State Department of Health to establish mechanisms aimed at guaranteeing vaccination in places where persons reside or are regularly located, such as:

• 1)

  Family homes, group homes, orphanages, daycare centers and kindergartens;

• 2)

  Schools, colleges, universities, shelters, boarding schools and nursing homes;

• 3)

  Factories, companies and government and private institutions;

• 4)

  Any center of deprivation of liberty, whether provisional temporary or permanent; and,

• 5)

  Centers for care of psychiatric patients, among others. Persons responsible for such institutions must provide all facilities and cooperation in the development of vaccination activities and control of preventable diseases.

Prior to the administration of a vaccine, information must be provided to persons or their legal representatives regarding the nature, purpose, benefits and, where applicable, risks of the corresponding vaccine.

Every pregnant woman must be vaccinated in accordance with what the State Department in charge of Health determines, for the purpose of preventing risks to which she and the unborn child may be exposed.

Every child must be vaccinated in accordance with what is provided by the State Department in charge of Health for legal substances are responsible for compliance with this obligation. Equal responsibility falls upon whoever lodges or has under their care minors under eighteen (18) years of age for the purpose of educating them, protecting them, or employing them.

It is mandatory that every minor under eighteen (18) years of age who enters as a student to public or private educational institutions, prior to their enrollment present the corresponding vaccination card for verification. The directors of such establishments are responsible for compliance with this measure. The minor who has not received complete vaccinations must be referred to the nearest public health facility in order to complete them. The failure to present the vaccination card shall not be an impediment to the acceptance of the minor in the educational center; however, it must subsequently be presented to comply with verification.

Every employer must request from the worker the vaccination card established by the State Department in charge of Health as a prerequisite prior to incorporation or hiring for work. Employers are responsible for compliance with the worker's vaccination.

Every national or foreign person who enters the country must present the vaccination certificate determined by the State Department in charge of Health, in compliance with what is established in the International Health Regulations.

A person must not be vaccinated when there is a medical contraindication to a particular vaccine.

The person or institution that attends to or has knowledge of a suspected case of a disease preventable by vaccination must report it immediately to the State Department in charge of Health, to the nearest health institution.

All establishments providing public health assistance and social security services as well as private ones and their personnel are obligated to participate in epidemiological surveillance actions of diseases preventable by vaccination. For such purpose, they must make the respective notifications systematically and promptly directly to the Department of Health Surveillance at the departmental level and from this level to the Expanded Program on Immunization (EPI) and to the Health Surveillance Directorate of the State Department in charge of Health in accordance with the guidelines it establishes for this purpose.

All establishments providing public health assistance and social security services as well as private ones and their personnel must report and register the presence of events supposedly attributed to vaccination. Likewise, corresponding case and field studies must be conducted and the diagnosis and immediate treatment established, as well as the pertinent control measures.

The State Department in charge of Health must define the guidelines for the establishment and operation of a Vaccination Information System of the Expanded Program on Immunization (EPI); this must be standardized, complete, timely, verifiable and include the actions of vaccine application in the country.

All health personnel that perform a vaccination activity must register it in accordance with the norms established by the State Department in charge of Health. The health personnel that applies the vaccines must make the corresponding notation in the Vaccination Information System of the Expanded Program on Immunization (EPI), which will subsequently feed into the Health Information System in its vaccines component and must also register it in the vaccination card of the vaccinated person.

The State Department in charge of Health must order through the Expanded Program on Immunization (EPI), the application of vaccines in an extraordinary manner in the following cases:

• 1)

  When persons have not been vaccinated in accordance with the National Vaccination Schedule;

• 2)

  In the event of epidemic outbreaks;

• 3)

  In the event of danger of importation of communicable diseases to national territory;

• 4)

  In the event of a natural disaster;

• 5)

  In the event of the appearance of a new infectious agent or the reappearance of one that was considered controlled or eradicated; and,

• 6)

  When required in accordance with applicable international provisions. Extraordinary vaccination is mandatory for all residents in national territory and its application is free of charge.

In the event of epidemics and epidemiological situations associated with diseases preventable by vaccination, the State Department in charge of Health through its divisions must implement the respective prevention and control actions. All professionals, technicians, and health personnel in national territory shall be available to the State Department in charge of Health to collaborate and comply with the established strategies.

The vaccination card at the national level is mandatory throughout the health sector, a free, unique, and non-transferable document through which the record and control of vaccines that have been applied to a person is maintained. The State Department in charge of Health through the Expanded Program on Immunization (EPI), prior to the opinion of the National Advisory Council on Immunization must determine the unique format of the card, which must be used in all health establishments at the national level.

When a person who does not have a vaccination card is vaccinated, the health personnel is obligated to deliver it to them and inscribe in it the general data of the user, assigning them a number corresponding to their identity card. The card must be presented each time the person is vaccinated, regardless of the place where they receive the service. The card remains in the possession of the person to whom it belongs and in the case of minors under eighteen (18) years of age, it is in the custody of those who exercise legal representation.

All public and private educational establishments at the preschool, primary, secondary, and higher levels must require students to present their vaccination card. The student who for any reason does not have it shall be referred to the nearest public health facility in order to obtain it. The lack of presentation of the vaccination card shall not be an impediment to the acceptance of the student. Educational establishments must also record the vaccination status of enrolled students, which shall be available upon request by the State Secretary in the Ministry of Health.

Public and private establishments that have minors under eighteen (18) years of age in their care must request the vaccination card. The coordinators, directors, and administrators of these establishments are responsible for compliance with this provision.

The vaccination card has full validity for institutions before which vaccination must be proven. The verification of vaccination must be required by the competent authorities in the following cases:

• 1)

  For health personnel;

• 2)

  For admission to pre-basic, basic, secondary, and higher public or private education, as well as for daycare centers and kindergartens;

• 3)

  When epidemiological conditions so require; and,

• 4)

  In other cases where, in the opinion of the health authorities, it is necessary to verify vaccination status.

In cases of loss of the vaccination card, a new one must be provided to the person, in which the doses of vaccine previously received must be transcribed. This transcription must be carried out exclusively by personnel of the public health system, based on data found in the vaccination records of the health facility. Only in the case of the BCG vaccine shall the post-vaccination scar be valid as proof. In the absence of data supporting the doses previously received, the application of vaccines from the National Vaccination Schedule must be initiated in accordance with the person's age.

Vaccines may be administered by physicians, nurses, nursing assistants, and in general by any trained person under supervision who is competent to administer the vaccine, knows the indications and contraindications of the vaccine, and can recognize any immediate reaction.

Health personnel in the public system are administratively obligated to participate in vaccination campaigns, drives, and operations when the health and epidemiological authorities of the country so require and determine. If institutional health personnel is insufficient, exceptional support for national vaccination campaigns may be requested from personnel of other governmental or private institutions, or temporary personnel may be exceptionally hired, who must act under the guidelines issued by the State Secretary in the Ministry of Health.

The State Secretary in the Ministry of Health must establish guidelines and coordinate actions to provide continuous training to personnel responsible for vaccination activities at different operational levels in accordance with Program standards.

Public health service establishments, social security, and private facilities in the country must guarantee the proper functioning of an exclusive cold chain or cold storage network for vaccines in all health units and collection or distribution centers. For this purpose, establishments must have equipment and personnel trained in the procedures for storage, preservation, distribution, control, and transport of vaccines. Likewise, they must subject the following elements of the cold chain or cold storage network to strict surveillance:

• 1)

  Refrigeration equipment, including cold chambers, refrigerators, freezers, and thermoses;

• 2)

  Temperature recording and control of cold chain equipment;

• 3)

  Transport; and,

• 4)

  Recording and control of vaccines.

It is the responsibility of the State Secretary in the Ministry of Health, through its departments and Directorates constituted in accordance with the Law, to regulate, supervise, and control the vaccines that are registered, distributed, and commercialized in the country, which must comply with the corresponding health requirements. The General Directorate of Health Regulation is responsible for compliance with legal, technical, and administrative standards and has within its powers the authority to control establishments, institutions, or companies that provide vaccination services through the concentration modality. Establishments, institutions, or companies must request prior health authorization from the corresponding regional office before providing vaccination services.

The remaining supplies for vaccination are equally subject to health control in order to safeguard safety in the administration of vaccines.

Exempt from health registration processes are all vaccines and supplies acquired by the Expanded Program of Immunizations (PAI) through the Revolving Fund for Vaccines of the Pan American Health Organization PAHO/WHO, in which case the General Directorate of Health Regulation must request from the corresponding agencies the abbreviated production and control protocols, as well as the Certificate of Quality Control from the producing laboratory and the Certificate of Batch Release issued by the Regulatory Authority of Origin.

The State Secretary in the Ministry of Health shall be assigned annually in the General Budget of Income and Expenses of the Republic a specific and sufficient budget allocation to execute vaccination actions in compliance with this Law. All donations to the State made for this purpose must also be transferred to this allocation. The budget must be used to acquire vaccines, syringes, safety boxes, equipment, materials, and related accessories of the cold chain, and refrigerated vehicles. The budget must be increased based on the increase in the target population, the costs of acquisitions necessary for vaccination, and cannot be reduced or affected by budget cuts or reviews, nor transferred under any circumstance to other programs or actions within or outside the State Secretary in the Ministry of Health.

All purchases of vaccines, syringes, safety boxes, equipment, materials, cold chain accessories, and refrigerated vehicles acquired by the State Secretary in the Ministry of Health for the Expanded Program of Immunizations (PAI) must be made through the mechanism of the OPS Revolving Fund for vaccines. This guarantees timely supply, accessible prices, and quality vaccines pre-qualified by the World Health Organization (WHO), which will allow protection of the entire vaccinated population against vaccine-preventable diseases, being in this regard exempt from public bidding processes as well as from all kinds of fiscal taxes without exception.

Any donation of vaccines to the State Secretary in the Ministry of Health must comply with the standards and procedures governing the donation of resources in accordance with the laws of the country, health policies, needs, and priorities, guaranteeing that it is carried out correctly and in accordance with the criteria, technical specifications, and requirements for better use, so as to ensure an impact on the improvement of living conditions, health, and quality of life of the Honduran population.

The following conduct shall be considered violations of the provisions of this Law:

• 1)

  Obstructing vaccination actions provided for in this Law;

• 2)

  Failure to comply with technical standards, guidelines, and regulatory provisions issued on the basis of this Law;

• 3)

  Charging the population for the application of vaccines included in the National Vaccination Schedule in public health service establishments and social security;

• 4)

  Selling or obtaining any benefit from the delivery of vaccines intended for vaccination actions under the charge of the public health and social security system;

• 5)

  Issuing false vaccination cards or those indicating that a vaccine has been received that was not administered; and,

• 6)

  Others that imply the non-compliance with any of the obligations provided for in this Law. The violations contemplated in this Article must be sanctioned administratively by the State Secretary in the Ministry of Health in accordance with the provisions determined by the Regulation of this Law and other applicable laws, all without prejudice to other administrative, civil, or criminal responsibilities that in accordance with the Law may correspond.

Everything provided for in this Law shall be fully regulated by the provisions of this Law and the regulatory provisions applicable to the subject matter of this law.

The Executive Branch through the Ministry of Health shall issue, no later than one hundred twenty (120) days following the promulgation of this Law, the respective regulation of this Law.

This Law shall come 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 Hall of the National Congress, on the thirteenth day of the month of January of two thousand fourteen. MAURICIO OLIVAHERRERA PRESIDENT BY THE LAW GLADIS AURORA LOPEZ CALDERON SECRETARY ÁNGEL DARIO BANEGAS LEIVA SECRETARY FORWARD TO THE EXECUTIVE BRANCH ON DATE MARCH 3, 2014. Therefore: Execute. Tegucigalpa, M.D.C., March 18, 2014. JUAN ORLANDO HERNANDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE SECRETARY OF STATE IN THE MINISTRY OF HEALTH EDNA YOLANI BATRES