Nº 8111
THE LEGISLATIVE ASSEMBLY
OF THE REPUBLIC OF COSTA RICA
Decrees:
NATIONAL VACCINATION LAW
Article 1-Object. This Law regulates the selection, acquisition and availability of vaccines throughout the national territory, in order to allow the State to ensure the health of the population, in compliance with the constitutional obligations of the General Health Law, No. 5395, of October 30, 1973 and the Code of Childhood and Adolescence, Law No. 7739, of January 6, 1998.
Article 2-Gratuity and effective access. The compulsory and free vaccinations are guaranteed to the entire population , as well as effective access to vaccination, especially for children, immigrants and sectors located below the poverty rate.
Article 3-Obligation. In accordance with this Law, vaccinations against diseases are mandatory when deemed necessary by the National Vaccination and Epidemiology Commission, which is created by this Law, in coordination with the Ministry of Health and the Costa Rican Social Security Fund. .
The approved vaccines must be supplied and applied to the population, without economic reasons or lack of supply in the health services provided by state institutions being able to be alleged.
These approved vaccines refer to the official basic scheme that is applied to the entire population, and to vaccines for special schemes aimed at specific risk groups.
The National Vaccination and Epidemiology Commission must prepare an official list of vaccines, which will be included in the Regulations of this Law. The list may be reviewed and analyzed periodically, taking into account the frequent technological changes in this field.
Article 4 – Creation and legal nature of the National Commission for Vaccination and Epidemiology. Create the National Commission for Vaccination and Epidemiology, attached to the Ministry of Health, as a body with maximum decentralization and instrumental legal personality.
Article 5-Integration of the commission. The Commission will be made up of the following members:
a) The Minister of Health or his representative, who will chair it.
b ) The Head of the Health Surveillance Unit of the Ministry of Health.
c) A representative of the Costa Rican Association of Pediatrics.
d) A representative of the Department of Child and Adolescent Health , of the Costa Rican Social Security Fund.
e) A representative of the Department of Infectology, of the Costa Rican Social Security Fund.
f) A representative of the National Children’s Hospital.
g) A representative of Pharmacotherapy, of the Costa Rican Social Security Fund.
The members of this Commission will perform their duties ad honorem; They will meet ordinarily once a month, and extraordinarily, when necessary. It will be at your discretion to designate the place and dates of the meetings. The Commission must submit a six-monthly report to the country’s health authorities.
Article 6-Functions. The Commission will have the following basic functions and objectives:
a) Guarantee compulsory and free vaccines and effective access to them by the entire population.
b) Formulate the general political and strategic guidelines on vaccination, applicable in the health sector.
c) Approve the manuals, educational materials and immunization standards.
d) Ordinary coordinate the national vaccination programs and, extraordinarily, with the National Commission for Risk Prevention and Emergency Attention, when there is an emergency declared by this Commission.
e) Define, together with the country’s health sector authorities , the schedules and vaccines referred to in Article 3 of this Law.
f) Monitor the quality and expiration of the vaccines, to guarantee the required effects.
g) Manage the National Vaccine Fund.
h) Keep a record of cases of infectious diseases, including the epidemiological survey to detect sources of infection.
i) Coordinate, with the health sector authorities, national vaccination campaigns, taking advantage of the capacity to use resources that the current administrative structure allows.
j) Create the National Bank of Vaccines.
k) Any other functions established in this Law.
Article 7-Control and surveillance. The National Vaccination and Epidemiology Commission will be responsible for ensuring that both the Costa Rican Social Security Fund and the Ministry of Health, through their respective units, have adequate storage, distribution and control systems that guarantee the quality and stability of the vaccines. vaccines, so they must have a good control of the date of expiration or expiration, which guarantees the national population the required prophylactic and immunological effects.
Article 8-Quality and research. The National Vaccine Commission, in coordination with the Pan American Health Organization (PAHO), will promote studies to analyze the problems of control of communicable diseases and the alternatives that allow improving the quality and availability of biological products, as well as favoring the introduction research, new technologies and the development of new biological products.
The Commission will collaborate with PAHO to help consolidate a regional vaccine system. If it is the case, it will attend the Regional Vaccine Quality Control Network, the program and the certification guide for vaccine producers, in charge of PAHO.
Article 9º-National Bank of Vaccines. The National Vaccination and Epidemiology Commission will create, attached to the Costa Rican Social Security Fund, the National Vaccine Bank , where the vaccines will be stored and guarded.
Article 10.- Health personnel. All health centers, clinics, hospitals, dispensaries, services, establishments and health sector personnel will collaborate as necessary to achieve the objectives of prophylaxis of contagious diseases, statistical epidemiological analysis of infectivity situations, morbidity and mortality, case control, epidemiological surveillance, bacteriological diagnosis, treatment and other health measures. As this Law is of public interest, it will also be mandatory for public and private health centers to directly notify the National Vaccination and Epidemiology Commission or one of its representatives of cases of infectious diseases, including the epidemiological survey, to detect contagious sources.
The medical personnel and the sanitary auxiliary of the health sector are obligated, administratively, to participate in the vaccination programs, when the sanitary and epidemiological authorities of the country require and determine it. If institutional health
personnel are insufficient, private personnel may be hired, exceptionally, for national vaccination campaigns, under the guidelines of the medical and health authorities.
Article 11.-Target population, conditions and authorization. The Commission, together with the authorities of the Ministry of Health and the Costa Rican Social Security Fund, will determine the sectors of the population that must be vaccinated; In addition, it will decide whether vaccination is mandatory or optional and will establish the conditions under which the vaccines must be supplied, in accordance with the programs established for this purpose. The personnel supplying them must be duly authorized by the Commission.
Article 12.- Official health card for boys and girls. The official health card for boys and girls is established as the ideal instrument for registration, control and application of vaccines for children under seven years of age. This card will be mandatory for the purposes of disease prevention and immunization against them. It may be of complementary use for attention in health services and for the annual registration of schools.
Article 13.-National vaccination day. As part of the World Health Day celebrations, April 7 of each year is declared National Vaccination Day, especially aimed at immunizing children under seven years of age.
Article
14.- Vaccination campaigns. The health authorities will develop permanent educational campaigns, in order to inform the population about the risk that the lack of timely vaccination against possible preventable diseases represents.
Section 15.-Financing. Create the National Vaccination Fund, whose objective will be to provide economic and financial resources to the National Vaccination and Epidemiology Commission. The sources of financing will be:
a) The State may allocate, annually, in the National Budget Law, what is assignable to the Ministry of Health and the Costa Rican Social Security Fund, items that guarantee the provision of the necessary resources and enough to comply with the National Vaccination Plan. Both institutions, to the extent of their possibilities, will include in their respective budget plans, the amounts necessary to acquire the vaccines and defray the administrative expenses generated by the vaccination programs.
b) In addition to the obligations that the law imposes in this matter, when there is a surplus in the Costa Rican Social Security Fund, two percent (2%) of the Health Insurance surplus will be allocated to the National Vaccination Fund . For these purposes, the surpluses of the Disability, Old Age and Death Regime of the Fund will not be taken into account.
c) The Social Protection Board of San José must allocate all the resources collected in an annual drawing of the national lottery, which will be called Contributing to public health. The Board, before delivering the money resulting from the draw, must deduct, in its favor, the operating and administrative expenses generated by the draw.
d) The transfer of funds or vaccines that the National Commission for Risk Prevention and Emergency Care carries out when, due to some event of public calamity or national emergency, it is required to vaccinate the entire population or groups.
e) Donations made by pharmaceutical companies, health research companies and distributors, installed in Costa Rica or directly from the parent company.
f) Donations made for this purpose by international organizations, the Revolving Fund for Vaccines of the Pan American Health Organization (PAHO), the World Health Organization (WHO) and non-governmental or bilateral cooperation agencies.
Article 16.- Exemption from all kinds of taxes. The importation or local purchase of vaccines, as well as the purchase and maintenance necessary for the cold chain, transportation and materials destined for the vaccination programs of the Ministry of Health or of the Costa Rican Social Security Fund. The Ministry of Health, in coordination with the Costa Rican Social Security Fund, will define within the National Vaccination and Epidemiology Commission, the list of vaccines entitled to the described exemption and will submit it to the Executive Power so that it prepares the decree correspondent.
Likewise, vaccination campaigns that are disclosed in the mass media are exempt from all types of taxes.
When the vaccines must be acquired by virtue of a declaration of national emergency, they must be coordinated with the National Commission for Risk Prevention and Emergency Attention, to apply the exemptions ordered in the National Emergency Law, No. 4374, of August 14, 1969, and its reforms.
The present exemptions will be governed, in the supplementary, by the Regulatory Law of all current exemptions, their derogation and their exceptions, No. 7293, of March 31, 1992.
Article 17.- Regulations. Following a report from the National Vaccination and Epidemiology Commission, the Ministry of Health, together with the Costa Rican Social Security Fund, will draw up the regulations for the purchase, storage, distribution, prescription, dispensing and control of the administration of vaccines, without prejudice administrative procedures of this Ministry and the Fund. This proposed regulation will pass to the Executive Branch so that, in the exercise of its powers, it may issue the respective decree.
Article 18.- Repeals. This Law repeals all current legal provisions contrary to it. It does not repeal Section I of Chapter III of the General Health Law, No. 5395, of October 30, 1973, nor any other general rule on vaccination established by that regulatory body.
Article 19.-Public interest. This Law is of public interest.
Transitory I.- Within six months from the enactment of this Law, the Commission will focus on designing and planning the creation of the National Bank of Vaccines referred to in article 9 of this Law.
Transitory II.- The National Vaccination Day will be celebrated from the year following the enactment of this Law.
It applies as of its publication.