No. 32722
THE PRESIDENT OF THE REPUBLIC
AND THE MINISTER OF HEALTH
In use of the powers conferred by articles 140 subsections 3) and 18) and 146 of the Political Constitution, second paragraph of Law No. 6227 of May 2, 1978 “General Law of Public Administration”: 1st, 2nd , 4th and 113 of Law No. 5395 of October 30, 1973 “General Health Law, Law No. 7739 of January 6, 1998 “Childhood and Adolescence Code” and Law No. 8111 of July 18, 2001 ” National Vaccination Law”.
_Considering:
1º-That in accordance with the provisions contained in article 2 of the General Health Law, it corresponds to the Ministry of Health to ensure the health of the population, for which it must define the national health policy and the regulation of all public activities and deprived of health.
2º-That the purpose of the National Vaccination Law is to guarantee availability of vaccines and free vaccines to the entire population, especially children, immigrants and sectors located below the poverty rate. Therefore,
DECREE:
Regulations to the National Vaccination Law
CHAPTER I
General disposition
Article 1 – For the purposes of this Regulation, it is defined as:
a) National Vaccine Bank: Storage and Distribution Area (Fridge Warehouse), belonging to the Costa Rican Social Security Fund.
b) Fund: Costa Rican Social Security Fund.
c) Commission: National Epidemiology and Vaccination Commission: hereinafter referred to as Commission.
d) Department of Pharmacotherapy of the CCSS as named in Law 8111: currently Department of Pharmacoepidemiology, belonging to the Directorate of Medicines and Therapeutics.
e) Official Basic Scheme: List of vaccines with their respective application periods that are recommended and must be received in a compulsory manner by the target populations that are defined by the Commission, whose review will be on an annual basis, with the power to modify, based on in the evidence, the national or subnational epidemiology and the processes of acquisition of the vaccines, when so warranted. This scheme will be free and compulsory access.
f) Special Schemes: List of vaccines with their respective application periods, which are optionally recommended for populations considered special for having some condition that is defined as risk by the Commission. As it is optional and does not represent an excessive risk for populations outside of those considered low risk, said vaccination is voluntary.
g) Epidemiology: Study of the relationships between the various factors that determine the frequency and distribution of diseases in the human population and in animals.
h) Vaccine-preventable disease : Disease preventable by vaccination.
i) Vaccine stability: Resistance to physical degradation (heat, freezing, light, etc.), of marketed vaccines, which makes them maintain their immunogenic properties until the expiration date if they are transported and stored according to the conditions recommended by the manufacturer.
j) Label: Any tag, brand, label or other descriptive graphic indication, written, printed, stencilled, marked, embossed or hollowed out, affixed to a container or appearing together with a container of a designated product.
k) Manufacturer: Any natural or legal person engaged in the business of manufacturing a designated product, either directly, or through an agent or a person controlled by him or her by virtue of a contract.
l) Expiration date: Date of useful life of the medication, until which the manufacturing laboratory is responsible for ensuring that the medication has maintained its quality. After this date, the adequate quality of the vaccine is not assured, so it must be discarded under appropriate conditions.
m) Risk groups: Population group characterized by having a certain age, sex, residence or disease condition in whose certain exposure preventable by vaccination determines a higher risk of morbidity, lethality or mortality compared to groups that do not share said characteristics despite that they may be exposed.
n) Law: National Vaccination Law No. 8111.
o) Ministry: Ministry of Health.
p) Vaccine: Suspension of live attenuated or inactivated microorganisms, or their fractions that are administered by different routes to the individual, in order to induce active protective immunity against the corresponding infectious disease.
Article 2º- They are subject to the provisions of this Regulation, the natural and legal persons that directly or indirectly are related or intervene with public and private health services, that carry out activities of prevention, surveillance and control of vaccine-preventable diseases.
Article 3 – The Ministry and the Fund are the institutions in charge of ensuring compliance with the immunization programs, both in relation to the official immunization scheme approved for the country and the vaccines defined by the Commission for risk groups.
Article 4 – The Ministry and the Fund, through their technical, regulatory and executive units, are responsible for ensuring that the family and the community in general are provided with objective, complete and consistent information on immunizations.
Article 5 – The material that contains information about the use of immunizations must indicate the risk that the unnecessary, inappropriate and indiscriminate use of these medications implies for the health of the person.
Article 6 – The Ministry and the Fund, through their administrative, technical-regulatory and executive dependencies, are responsible for the dissemination, advice and application of these Regulations.
Article 7 – It is the responsibility of the Ministry, with the advice of the Commission, to establish the provisions or actions for compliance with this Regulation at the level of public and private health services.
Article 8 – Any action or omission that contravenes the provisions of Law No. 8111 and these regulations, will be considered a violation of health and will be sanctioned as established by legal regulations.
Article 9 – The sanctions that the authorities may impose for violations of Law No. 8111 and of these regulations and those issued by the health authorities, must be in accordance with the current legal system.
CHAPTER II
From the National Commission of Epidemiology and Vaccination
Article 10.- Nature: Pursuant to article 4 of the National Vaccination Law, the National Epidemiology and Vaccination Commission is attached to the Ministry of Health, as a body with maximum decentralization and instrumental legal personality.
Article 11.- Functions: The Commission will have the functions contemplated in article 6 of Law 8111.
Article 12.- Composition of the National Vaccination Commission: The Commission will be made up of the members indicated in article 5 of Law 8111.
The presidency is in charge of the Minister of Health or his representative, they will carry out their positions ad honorem . They will meet ordinarily once a month and extraordinarily when necessary. The place and dates of the meetings will be at your discretion, you will schedule your activities under an annual operating plan. The Commission must submit a six-monthly report to the authorities of the Ministry and the Fund. The Commission may appoint ad hoc advisors for a certain period of time and for specific topics that are of interest to the Commission. These advisers will hold ad honorem positions . In the case of public employees, the permit must be managed by the president of the Commission to the corresponding headquarters.
The appointment of the representatives of both the Department of Pharmacotherapy of the Costa Rican Social Security Fund and the Costa Rican Association of Pediatrics, will be for a period of three years, with the possibility of being re-elected.
Article 13.-From the moment they assume their positions, they may be replaced by:
to. Abandon your duties.
b. When for reasons not justified in the opinion of the Commission, they do not attend three consecutive or four alternate sessions during a semester.
c. Incur responsibility for their fraudulent or illegal acts or operations.
d. When there is a conflict of interest.
Article 14.-In any case, the substitution due to resignation, justified removal, death or any other cause, will be made within thirty days after the event.
Article 15.- Sessions: The Commission will meet ordinarily once a month and extraordinarily whenever it deems it necessary. The sessions will be called by the president ex officio or at the request of five members, in writing and at least twenty-four hours in advance. In the absence of the President, the call will be made by the representative appointed by the President of the Commission.
Article 16.- Quorum: The quorum will be made up of five members and the agreements will be reached by an absolute majority of the members present, specifying when the agreements reached are final.
CHAPTER III
From the supply of selection vaccines, acquisition, storage and distribution
Article 17.- Selection of vaccines: The Commission is responsible for reviewing and updating the official basic schedule and the special immunization schedules, based on the epidemiological reality and current scientific-technical information. The analysis of schemes will be done continuously, for updating. In cases of special situations such as disasters or declared emergencies in which it is necessary to apply vaccines, the scheme that guarantees the coverage of the most vulnerable populations will be defined, in an extraordinary session of the Commission. The changes in the official scheme and the inclusion of new vaccines will be made by the Ministry and the Fund in a communication to all the care units and all the dependencies of the country’s health sector.
Article 18.-The Official List of Vaccines included in the universal basic public scheme of Costa Rica are the following:
1 Tuberculosis (BCG)
2 oral polio.
3 Diphtheria.
4 Pertussis.
5 Tetanus.
6 Haemophilus influenzae B.
7 Hepatitis B.
8 Measles.
9 Rubella.
10 mumps.
11 Chickenpox.
The Costa Rican Social Security Fund must take the necessary steps to include it in the Institution’s Supply Catalog and in the Official List of Medications (LOM).
(As amended by article 1 of executive decree No. 33564 of January 17, 2007)_
Article 19.- Acquisition of vaccines: The Fund is responsible for acquiring vaccines according to the official vaccine scheme and special schemes. It will do so in accordance with the regulations through international organizations: Revolving Fund administered by the Pan American Health Organization. The Fund will request from PAHO/Revolving Fund the product certification of vaccines that are registered as suppliers of the Fund. The Medicines Standards and Quality Laboratory of the Fund will verify the quality of the batches of vaccines that are imported to meet the country’s immunization needs.
Article 20.- In the event that the Revolving Fund / PAHO cannot supply the vaccines that are needed, or cannot offer any necessary vaccine either within the official scheme or within the special schemes, the Fund will purchase the vaccines following the regulations in force for the acquisition of medicines.
Article 21.- Storage of vaccines: The Fund will have a Cold Storage Warehouse in the Storage and Distribution Area with the internationally stipulated conditions that ensure the stability and quality of the vaccines. It will have trained personnel for its proper operation and management. The Fund must provide its units with the necessary equipment to maintain the useful life of the vaccines until the expiration date established by the manufacturing laboratory.
Article 22.- Distribution of vaccines: The Storage and Distribution Area must guarantee the timely and efficient distribution mechanism of the vaccines of the official scheme and special schemes. The mechanism for the distribution of the vaccines will be established, taking control of their distribution. The Storage and Distribution Area must have standards and procedures that comply with national and international recommendations for the handling, storage and distribution of vaccines both at the central level and during the process of transport and distribution to health facilities. Health
Article 23.- Donations: Donations made by public institutions, autonomous and semi-autonomous institutions, public and private companies, as well as
Article 24.- Treatment and final disposal of vaccination waste: The treatment and final disposal of waste will be done in accordance with Decree No. 30965-S of December 17, 2002 “Regulations on waste management infectious-contagious that are generated in establishments that provide health care and related” and to the policies and institutional regulations on Basic and Environmental Sanitation of the Bank.
CHAPTER IV
Of the application of vaccines and their registration
Article 25.- The administration of the vaccines corresponds to the technical personnel with adequate training in the application of injectables. It must be governed according to the guidelines issued by the Commission, based on scientific criteria and available international information.
Article 26.- The Fund will supervise the application of vaccines in its care centers in accordance with the regulations on the application of injectables.
Article 27.-The Ministry, through the Health Services Directorate, must authorize the centers or clinics established for the application of vaccines, taking responsibility for their supervision.
Article 28.-All health personnel who apply vaccines are required to write down the vaccines applied and the date on which they were applied on the patient’s vaccination card. In the event that the patient does not carry the vaccination card or does not have one, a new one must be given with the registration of the application.
Article 29.- It is mandatory both in the public and private sectors to register (manual or automated) the vaccines applied and the report of adverse reactions, through the channels and terms established for said purposes by current regulations. Serious adverse reactions, established in the vaccination regulations, must be investigated individually, according to the deadlines established for these cases.
Article 30.- The application of the vaccines will be registered in the information system created for this purpose and must follow the flow of information designed by the National Health Surveillance System, for its analysis and corresponding calculation of coverage, both at the local, regional and national. These coverages will be forwarded for analysis to the Commission for recommendations at the operational level.
CHAPTER V
Research
Article 31.- Research: The Commission must be informed about research in the field of immunizations carried out in the country by researchers, whether from the public or private sector. The Commission will not be related to the approval of the studies, which must follow the approval procedures before the National Health Research Council (CONIS), or the respective Institutional Ethical-Scientific Committees (CEC), in accordance with the provisions of the Executive Decree No. 31078-S of March 5, 2003 “Regulations for Research involving human beings.”
Article sheet
CHAPTER VI
vaccine fund
Article 32.-On the structure and procedures for the establishment and management of the Vaccine Fund:
1. The Budget Process of the Administrative Directorate of the Ministry will request the opening of a current account for the exclusive use of the Commission from the National Treasury. Additionally, the Technical Secretariat of the Budgetary Authority will be asked whether or not there is a budget ceiling.
2. The Commission must prepare an Annual Operating Plan and its respective budget so that the execution of the assigned resources is scheduled, according to the established deadlines.
3. During the process of preparing the Annual Operational Plan, the Commission will have the technical support of the Department of Health Development of the Ministry.
4. Both the POA and the budget must be sent to the Office of the Comptroller General of the Republic, through the established channels, for their respective approval so that the execution of the budget begins.
5. The Administrative Directorate of the Ministry would provide technical and professional personnel in administration, accounting and treasury for the adequate administrative management of the funds.
6. The funds contained in the National Vaccine Fund will be used to support:
6.1 Health promotion activities in the field of vaccination and vaccine-preventable diseases.
6.2 Health education activities in the field of vaccination and vaccine-preventable diseases.
6.3 Health research activities in the field of vaccination and vaccine-preventable diseases.
6.4 Purchase and acquisition of equipment intended to improve the management of the Vaccination Program.
6.5 Maintenance of equipment intended to improve the management of the Vaccination Program.
Article 33.- The Commission must request the Minister’s Office the inclusion of funds within the National Budget Law according to the projections of expenses based on the programming of activities and the foreseen needs.
Article 34.- For the purposes of article 15 subparagraph c) of Law 8111, the Commission must request the General Management of the Social Protection Board, that the date of the draw assigned to Vaccination be as close as possible to April 7 every year.
Article sheet
Article 35.-The Fund will allocate 2% of its surplus to the National Vaccination Fund, in