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Unofficial SIF translation:

Final Version, Dated December 4, 2009

Decree No.

The Legislative Assembly of the Republic of El Salvador

Considering:

I. That the first part of Article 65 of the Constitution of the Republic establishes “health of the inhabitants of the Republic constitute a public good. The State and the people are required to look out for its preservation and reestablishment;”

II. That Article 66 of the Constitution of the Republic establishes “the State will give free assistance to sick people who lack resources, and to the population in general, when prevention and treatment constitutes an efficient means of preventing the spread of a transmittable disease. In such cases, everyone is required to avail him/herself of said treatment;” and

III. That it is vitally important to establish legal mechanisms which guarantee the supply, availability, distribution, preservation, prescription and application of vaccines and serums, in order to protect the population from the diseases that are prevented through these means.

Therefore,

Through the use of its constitutional powers and at the initiative of the Pediatric Association of El Salvador and the Salvadoran Association of Infectious Diseases

Vaccination Law Chapter I Objective and Scope of Application

Objective Article 1 – The objective of the present law is to regulate and promote mechanisms that guarantee the acquisition of vaccines, serums and biological agents, the supply, availability, distribution, preservation prescription and application of the same, in an ongoing manner to the whole population, taking into account vulnerable age groups, in order to prevent infectious diseases that affect the population’s health.

Scope and Application 2

Unofficial SIF translation: Article 2 – The dispositions contained in the present law are applicable to natural or juridical persons, public entities, private or incorporated, irrespective of their race, creed or religion.

When the present laws, refers to autonomous institutions, it is understood that the Salvadoran Institute of Social Security is included, that would be referred to as the SISS.

Chapter II Program Management, Free Acquisition of the Vaccine

Program Management Article 3. The Ministry of Public Health and Social Assistance, hereinafter referred to as MSPAS, through the National Program of Immunization, referred to as PAI, will control the monitoring, supervision and evaluation of everything related to vaccines and immunizations.

Obligatory Nature Article 4 – Vaccinations against diseases are compulsory when the National Program of Vaccinations and Immunizations of El Salvador deems it necessary.

The supply and application of the vaccinations included in the National Program of Vaccinations and Immunizations will be ongoing and without discrimination or regard of economic means. In the case of vaccinations for special purposes directed to specific risk groups, the National Program of Vaccinations and Immunizations of El Salvador will define the same.

The National Program of Vaccinations and Immunizations of El Salvador ought to develop an official list of serums and vaccines. The list can be revised and updated periodically, in accord with the frequent technological changes in this field.

Guarantee of Access and Free Supply Article 5 – When a Salvadoran Social Security Institute (ISSS) user requests a vaccine, it should be supplied without regard to the type of affiliation he/she may have.

Private entities ought to guarantee that the vaccines are free of charge when they are provided by the Ministry of Health and Social Assistance (MSPAS).

Medical professionals will participate fully in providing this service, whenever such provision may be requested by the governing entity.

Provision through MSPAS 3

Unofficial SIF translation: Article 6 – Every establishment of public, corporate or private health ought to be legally authorized by the competent authority to perform its function, and thus may obtain vaccines through the MSPAS, which will issue the requirements and necessary procedures in order to comply with the cold chain and the preservation of vaccines.

Chapter III Immunization Practice

The Advisory Committee Article 7 – A National Advisory Committee for Immunization Practices is to be created, hereinafter designated CAPI, as an organization attached to MSPAS, made up of representatives of the following institutions: a. Ministry of Public Health and Social Assistance b. Salvadoran Social Security Institute c. Higher Council of Public Health d. Salvadoran Association of Infectious Diseases e. The Medical College of El Salvador f. Pediatric Association of El Salvador g. Salvadoran Association of Allergy, Asthma and Clinical Immunology h. Salvadoran Gynecology Association i. National Association of Salvadoran Nurses j. Salvadoran Association of Neonatology k. Salvadoran Association of Internal Medicine

Because it is the Coordinator and Governing Authority, the MSPS will have two representatives.

Designation and Requirements Article 8 – The Director or the President of the institutions, will designate the members that will form the CAPI. In the case of the above-mentioned associations mentioned in article 7, the representatives to be designated will be elected from within its membership, in accordance with their statutes. In any case, the members should fill the following prerequisites:

a. Physician specialized in the fields related to the vaccine and immunization program, preferably in a teaching or research field.

b. For the non-medical associations, its representative should be a professional in the health sector, with a specialization in the fields of immunization or public health.

The MSPAS representatives should be part the Director of Infectious Diseases and the Coordinator of the Expanded Program of Immunizations of the 4

Unofficial SIF translation: pediatric physicians that are permanent staff of the Benjamin Bloom National Hospital.

Period of Operation Article 9 – All members will be selected for a period of two years, may be reelected and exercise their functions free of charge.

Committee members may be removed when they cease to be active association members or public servants.

Quorum Article 10 – A quorum will be established at one-half plus one, and decisions will be taken by simple majority except in cases dealing with modification of the National Vaccination Framework or removal of one or the more members, which will require the vote of seven Committee members. Each one of the twelve members will have the right to participate and vote.

Functions Article 11 – The functions of CAPI are as follows:

1. Provide the National Vaccination Framework to MSPAS; 2. Support MSPAS and all the institutions requesting assistance in the field of vaccination; 3. Revise and update the immunization program, in accordance with analysis of epidemiological information; 4. Propose actions for vigilance of illnesses preventable by vaccine; 5. Suggest rules and standards for immunization practices; 6. Propose the use of new vaccines or their retirement, as well as their incorporation in The Salvadoran National Program of Vaccinations and Immunizations (PAI); 7. Collaborate in the development rules for technicians prior to the development of vaccination campaigns; 8. Suggest investigations that permit the strengthening of PAI; 9. Collaborate with MSPAS in the development of training in the field of vaccination; 10. Collaborate in forming relationships between the public, corporate and private sector and entities that create health resources, for the purpose of achieving strategic analysis; 11. Clinically analyze special cases of adverse reactions to vaccines and suspect cases of diseases preventable by vaccine, and propose solutions with respect to them; 12. Advise MSPAS with regard to the selection of applicable strains, preservatives and vaccines; 13. Perform evaluations of PAI activities at the national level, if considered necessary; 5

Unofficial SIF translation: 14. Collaborate in authorizing investigations that permit strengthening the program; 15. Participate in formulation of proposed legislation, regulations and technical norms that ensure the sustainability and effectiveness of the program; 16. Collaborate in order to guarantee that vaccines supplied and applied by the State are done free of charge; 17. Collaborate to determine the priority of sectors or age groups of the population that ought to be vaccinated; and 18. Evaluate outbreaks of infectious diseases preventable by vaccine.

Chapter IV Distribution and Use of Vaccines

Distribution Article 12 – MSPAS is the institution authorized to buy and distribute vaccines free of charge included in the national vaccination framework, for the entire health network, including that of private practice. Such action is without prejudice to private practice to this end.

It is absolutely prohibited to sell vaccines supplied free of charge by MSPAS.

In any event, it is prohibited to import vaccines that are not certified by the World Health Organization (WHO), nor registered by the competent authority. Excluded from this prohibition are vaccines that may be part of a clinical trial done in country, provided the competent authority duly authorizes such studies.

Transportation and Mobilization Article 13 – MSPAS will establish the technical requirements for the preservation, distribution and use of vaccines within the temperatures appropriate to guarantee their immunization potency, and from their manufacture and importation until the time they are administered to users.

Transportation for mobilization of vaccines will be authorized by MSPAS.

Oversight and Control Article 14 – The Salvadoran National Program of Vaccinations and Immunizations, hereinafter referred to as PAI, will have the responsibility of seeing to it that the public and private entities authorized to exercise vaccination procedures have adequate systems of storage, distribution and control that guarantee the quality and stability of vaccinations, for which they ought to maintain a good control over the expiration date, and that guarantee to the national population the required prophylactic immunological effect. 6

Unofficial SIF translation: Chapter V System of Information and Registry

Vaccination Carnet Article 15 – Every vaccine user will be issued a respective vaccination carnet that will have characteristics established by MSPAS.

Mandatory Nature Article 16 – All users are required to present the vaccination carnet when they enter the education system, public or private, from preschool to higher education, at the moment of matriculation at the education center.

Educational institutions will have a period of thirty days in order to inform the Health Unit corresponding to their geographical areas of the number of students who do not have a carnet, so that their vaccination status can be determined and the vaccinations corresponding to their age can be administered and the respective carnet issued.

Likewise, for the issuance of a residence or national identity card, foreigners ought to present their vaccination carnet, together with the application and documentation that is to be presented to the competent authority. If the person does not have it, he/she should go to the Health Unit of the geographical area corresponding to the place of residence, so that it may be determined what vaccinations had been administered, and if they have not been administered, those that are lacking be administered according to age, and the respective carnet issued.

Notification of Cases Article 17 – Persons or entities, public or private, providing health services are obliged to give notification of confirmed or suspected illnesses preventable by vaccination in order to facilitate investigation and establishment of means of control.

Adverse Results Article 18 – Persons or entities, public or private, providing health services are obliged to give notification of local adverse events attributable to immunizations.

Chapter VI Finance

Provision of Funds Article 19 –A national vaccination fund shall be created whose financial source will come from the Ministry of the Treasury, with a permanently assigned Line Item with a specific destination; funds from the ISSS budget; 7

Unofficial SIF translation: and all donations of whatever nature received by MSPAS for vaccinations and related activities.

The initial amount will be determined based on the budget established by MSPAS within its budgetary structure, in which resources designed to ensure PAI’s functioning will be established.

The amount will be determined in accordance with the needs established in the annual work plan, which ought to be developed jointly among the different actors, ensuring at a minimum participation of the Salvadoran Institute of Social Security and MSPAS, and presented as a coordinated program in June of each year.

The resources assigned ought to completely cover the amount necessary to acquire the vaccines and defray the administrative costs, equipment and supplies PAI requires without detrimental effect on other budgetary areas of MSPAS.

Acquisition of Vaccines Article 20 – The acquisition of vaccines will be done in conformity with national norms or with those indicated in cooperation agreements signed and ratified by our country with International Organizations such as: The Rotating Fund of the Panamerican Health Organization.

If the required vaccine cannot be supplied by international entities or if a necessary vaccine cannot be obtained either within the official framework or within special frameworks, PAI will buy the vaccines following MSPAS procedures for the acquisition of goods.

Donations Article 21 – Donations to MSPAS of vaccines or other supplies for use in vaccination made by public or private, national or international institutions will be channeled through the head of PAI.

Chapter VII Preferential Handling of Vaccines

Tax Exemption Article 22 – Vaccines and supplies acquired by MSPAS in coordination with ISSS for PAI will be exempt from all revenue charges, be it tax, rent, customs duty or special contribution, state or municipal, and a written request from the head of the Ministry of Public Health and Social Assistance is all that is necessary for release from customs.

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Unofficial SIF translation: Release Article 23 – PAI’s vaccines acquired by MSPAS or ISSS ought to enter into MSPAS or ISSS installations, according to who acquires them, in a period no greater than twenty-four hours after their arrival at whatever customs house, with care exercised to maintain the cold chain in an optimum manner.

Chapter VIII Violations and Penalties

Violations Article 24 – Violations of the present law will be punished with a fine equivalent to one to ten current minimum monthly urban wages, or special dismissal of exercise of function if the offender were to be a public employee or special dismissal from the profession if the offender were to be a health professional.

Violations of the present law are: a) For PAI members, refusal to provide service, except in case of force majeure or fortuitously; b) Impede vaccination activities foreseen in the present law, its regulations and relevant technical norms; c) Non-compliance with technical norms, guidelines and regulatory provisions issued as the basis for the present law; d) Hinder the smooth functioning of the program; e) Provide vaccination services without being duly authorized by the Council for Public Health (C.S.S.P.); f) Divert the program’s resources for use in other areas of activity; g) Retain or delay release from customs or delay transport of vaccines belonging to MSPAS; h) Charge for items included in the national framework of vaccination and supplied free of charge by the program, but not for the service; i) Sell or obtain any benefit for the delivery of vaccines for vaccination campaigns included in the national framework and distributed free of charge by MSPAS; j) Deliver information required by the program outside the established deadlines; k) Impede the process of obtaining the vaccination carnet, in those cases the present law establishes; l) Issue false vaccination carnets or ones that indicate receipt of a vaccination that has not been applied; and m) Failure to report within MSPAS-established time periods persons who, at the time of entry into educational institutions, do not present up-to-date vaccination carnets.

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Unofficial SIF translation: Repeat Offenses Article 25 – Repetition of offenses in the above article augments the fine to double the amount.

Penalties Article 26 – Fines imposed in accord with the present law will be paid by the person found guilty, and will go to the Special Activities Fund of MSPAS, in order to finance activities related to those provided for in the present law.

In the case of dismissal of exercise or function, these could be imposed for a three-month to two-year period, in accordance with the gravity of the violation.

Chapter IX Competent Authority

Competent Authority Article 27 – The competent authority for the imposition of the penalties referred to in the above articles will be MSPAS, through the Vice Ministry of Sectoral Policies and the Oversight Committees in the case where the offenders are health professionals, for violations of the dispositions of the present law, its Regulations and Technical Norms.

Levels of Authority Article 28 – The Vice Ministry of Sectoral Policies will be competent to determine in the First Instance the above-mentioned violations, and in the Second Instance will correspond to the Branch Head of Public Health and Social Assistance. In the case of health-related professionals, determination in the First Instance will be by the respective Oversight Committee, and in the Second Instance by the Superior Public Health Council.

Chapter X Procedure

Procedure Article 29 – The penalties established by the present law will be substantiated in a summary manner.

Denunciations Article 30 – All persons have the right to denounce whatever violation of those contemplated in this law, as well as the remaining related norms. The denunciation will be made to the competent health authority.

In case the person making the denunciation cannot do it directly to the Vice Ministry, this denunciation can be made at whatever health establishment of 10

Unofficial SIF translation: the National Public Network, from where it will be remitted to the Vice Ministry or to the corresponding Oversight Committee.

The officials or technical employees of the Ministry who, by virtue of their duties, witness or would have knowledge of a violation of what the present law contemplates or its related norms, are obliged to make it known immediately to the competent health authority; if they themselves were not. If not doing so, or if not initiating the process, they may be penalized, according to the procedures established by pertinent legislation.

Save proof to the contrary, an official or employee will be presumed to have witnessed or have knowledge of a violation by the official or employee, when such were committed in the same section or organization in which the official or employee works. It will constitute valid proof of knowledge if it can be proven that another person had already denounced the deed to him/her, or notified him/her of the same, having elapsed one work-day without the official or employee for his/her part having given notice of such deed to the corresponding authority or not having initiated notification.

The denunciation may be presented either verbally or in writing. A denunciation made in writing ought to be signed by the person making the denunciation or by another person at his/her request, if the person would not know how or could not do it; and it will be immediately ratified before the health authority competent to receive it.

If the denunciation were to be verbally made, it will be recorded in an act, in the form of a declaration, where it will be stipulated what the denouncer affirms, in respect to the deed and the offender being denounced, in this instance, the denouncer ought to sign the act; if he/she could or would be able to.

The health authority that would receive a verbal or written denunciation will verify the identity of the person making the denunciation by means respective documents.

Contents of the Denunciation Article 31 – The written denunciation ought to contain, insofar as possible: a. Description of the circumstances of the deed, specifying place, time and method of perpetration; b. Names of the offender or offenders and other participants, as well as those of persons who can give information regarding the act or who could have knowledge of its perpetration; and c. All the facts and additional circumstances that could lead to proving the act being denounced.

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Unofficial SIF translation: Documentation Article 32 – The competent authority will execute an official document stating that a process has been initiated upon acknowledgment of a violation of the present law or its related norms, having been made aware of it through an official or public employee, memorandum or technical judgment, or by whatever means of social communication.

Right to a Hearing Article 33 – A procedure having been initiated, the Vice Ministry of Sectoral Policies or the corresponding Oversight Committee ought to grant to the alleged offender a hearing to be scheduled within a period of three days, counting from the day following that of the notification, for him/her to appear and formally present his/her defense.

Defense and Default Article 34 – The health professional who is officially notified is obligated to appear personally or by an empowered official to conduct his/her defense, and ought to designate at the time the defense is made effective the precise location where notifications, citations and other legal procedural communications will be received.

In case that the above-cited designation is not made, notification may be made in conformity with common law norms.

Non-attendance will be considered a presumption of guilt, provided no just cause for non-attendance can be proved. He/she will be declared in contempt, and the process will continue to conclusion. If later on, more citations or notifications are made outside the area of jurisdiction declared in contempt, the resolution that imposes the penalty, and the judgment would be declared definitive.

In any case, the person denounced can retake his/her defense at any point in the proceedings, suspending the contempt of court, but by doing so the proceedings are not turned back.

Evidentiary Period Article 35 – With the declaration of defense on the part of an alleged offender or his/her legal representative, or without it, in the case of non-appearance, an evidentiary procedure will be opened for a period of eight working days.

In said term, evidence given in the denunciation will be gathered, along with that of reports and those of the Vice Ministry or those the corresponding Oversight Committee had at the time proceedings were initiated. Equally, the alleged offender or his/her legal representative could furnish evidence.

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Unofficial SIF translation: When during the legal period the alleged offender or his/her legal representative make no opposition or confesses having committed the violation, the evidentiary period may be eliminated and the proceedings brought to resolution.

Definitive Decision Article 36 – The evidentiary period having been concluded, in those cases where such has taken place, and evidence that may have been offered, solicited or ordered has been received, the Vice Ministry of Intersectoral Policy or the Oversight Committee will pronounce the corresponding definitive decision within the period of three days, to be founded on the pertinent evidence and dispositions.

Enforcement Article 37 – The decision that imposes whatever of the penalties established in the present law will be declared final and enforceable, when not appealed within the time granted for such a recourse, and when having been appealed, the penalty were to be confirmed in the recourse interposed.

The guilty party will have eight workdays to make payment of the fine at the General Directorate of the Treasury of the Ministry of Finance, counting from the date that it is declared enforceable.

The certificate of the decision that imposes the fine and that causes its enforcement, will be subject to executive power, with the Attorney General of the Republic the initiator of action corresponding to its payment.

In case of dismissal from professional functions, this will be communicated to the corresponding authorities for the pertinent legal effects.

Admissible Recourse Art. 38 – An appeal recourse to the Ministry of the definitive sentences given by the Vice Ministry will be admitted, within a term of three days beginning from the next day of the notification of the final resolution. In the case of the Oversight Committees the term will be the same as that of the Higher Public Health Council.

Chapter XI Recourse to Appeal

Appeal Article 39 – If the offender does not agree with the verdict pronounced by the Vice Ministry of Sectoral Policy or the corresponding Oversight Committee, he/she will be able to avail him/herself, within the deadline of three days counting from the day following notification, of the resource of appeal to the 13

Unofficial SIF translation: Ministry of Public Health and Social Assistance or to the Higher Public Health Council, as may be the case.

The appeal application should be presented to the Vice Ministry of Sectoral Policy or to the corresponding Oversight Committee, who will, immediately and without any procedures, remit it to the Ministry of Health or the Higher Public Health Council, as appropriate.

The written appeal should include the reasons of fact and law for which the petitioner believes he/she has been aggrieved, and the points which the request is to resolve.

The Vice Ministry of Sectoral Policy or the corresponding Oversight Committee will accept the appeal request in both its effects, and will subpoena the petitioner so that he/she may appear before the Ministry of Public Health and Social Assistance or the Higher Public Health Council, as may be the case, to avail him/herself of his/her rights, and will remit the original records of the case to the above-mentioned Ministry or Council, being able nevertheless, before remitting them, certify the passages considered relevant, in order to facilitate the performance of its functions.

Manner of Procedure Article 40 – The head of the Ministry or his designate, the Higher Public Health Council, as the case may be, will order the petitioner to be subpoenaed so that in the period of three days he/she make use of his/her right.

Abandonment Article 41 – In the case of non-attendance by the interested party, the recourse will be declared forfeited, and the appealed decision will be confirmed.

Opening for Investigation Article 42 – If necessary or if requested on the part of the appealing party, an investigation will be opened for a period of eight days, during which the head of the Ministry or his/her designate, the Higher Public Health Council, as the case may be, will order the carrying out of necessary measures in order to determine the responsibility of the offender, and the latter will be able to bring forward points of evidence for acquittal, that would be admitted, if they were to be pertinent.

Resolution of Recourse Article 43 – The evidentiary term having expired, the head of the Ministry or his/her designate the Higher Public Health Council, as the case may be, will resolve the matter in three days, modifying or confirming the appealed 14

Unofficial SIF translation: decision, which in no case can aggravate the situation of the person making the appeal.

Decisions Article 44 – Verdicts that resolve the intervention of recourse [to appeal] and the decisions that are not subject to appeal under the specified terms, will be taken as definitive and executed.

Suspension Article 45 – When the imposed sanction is suspension of professional activity or of the performance of his/her duties, the offender will remain able to exercise his/her activities upon completion of the term of the imposed penalty, when it is shown that the corresponding violation has been corrected.

Chapter XII Final Dispositions

Special Activity Funds Article 46 – Funds received from fines ought to enter the Account of the Directorate General of the Treasury, Special Activities Fund, Sub-account: Ministry of Public Health and Social Assistance.

Regulation Article 47 – The Executive Body of the Public Health and Social Assistance Branch will issue the regulations, technical health norms and the manuals of organization and function, in order to achieve the proper application of the present law.

Annulment Article 48 – To be annulled are Articles 146 and 147 of the Health Code, promulgated by Decree Law Number 955, dated April 28, 1988, published in the Diario Oficial Number 86, Volume Number 299 of May 11, 1988.

Legal Effect Article 49 – The present law will enter in force eight days after its publication in the Diario Oficial.

DONE IN THE BLUE HALL OF THE LEGISLATIVE PALACE: San Salvador, on the ______day of the month of ______in the year two thousand nine.