Fundamental right to proper functioning of public health services and provision of medication not on official listDerecho fundamental al buen funcionamiento de los servicios públicos de salud y suministro de medicamento no incluido en la LOM

“I.- The petitioner claims a violation of her fundamental rights, in particular her right to health, due to the refusal of the authorities of the Costa Rican Social Security Fund to provide the medication prescribed by her treating physician for the treatment of her illness, trastuzumab, despite having been diagnosed with breast cancer. In her opinion, the foregoing is improper and injures the Right of the Constitution.” “…III.- CONSTITUTIONAL PRINCIPLES OF EFFICACY, EFFICIENCY, SIMPLICITY, AND SPEED OF ADMINISTRATIVE ORGANIZATION AND FUNCTION. The Political Constitution, in its organic part, includes or sets forth certain guiding principles of administrative function and organization, which as such must orient, direct, and condition all public administrations in their daily work. Among such principles, efficacy, efficiency, simplicity, and speed stand out (articles –all of the Political Constitution– 140, subsection 8, insofar as it imposes on the Executive Branch the duty to “Monitor the proper functioning of administrative services and dependencies,” 139, subsection 4, to the extent that it incorporates the concept of the “proper conduct of the Government,” and 191 by including the principle of “efficiency of the administration”). These constitutional principles have been developed by infra-constitutional regulations; thus, the General Public Administration Act (Ley General de la Administración Pública) includes them in articles 4, 225, paragraph 1, and 269, paragraph 1, and mandates that they must orient and nourish all administrative organization and function. Efficacy as a principle assumes that administrative organization and function must be designed and conceived to guarantee the attainment of the objectives, purposes, and goals proposed and assigned by the legal system itself, with which it must be linked to planning and to evaluation or accountability (article 11, paragraph 2, of the Political Constitution). Efficiency implies obtaining the best results with the greatest savings in costs or the rational use of human, material, technological, and financial resources. Simplicity demands that administrative structures and their competences be easily understood and comprehended, without convoluted procedures that delay the satisfaction of the public interests involved. For its part, speed obligates public administrations to fulfill their objectives and purposes of satisfying public interests, through the various mechanisms, in the most expeditious, rapid, and accurate manner possible to avoid undue delays. This set of principles imposes permanent demands, responsibilities, and duties on all public entities that cannot be declined transiently or singularly.

IV.- CONSTITUTIONAL GUIDING PRINCIPLES OF PUBLIC SERVICES. All public services provided by public administrations –including assistance or social services– are governed by a series of principles that must be observed and respected, at all times and without any exception, by the public officials in charge of their management and provision. Such principles constitute a legal obligation of an irrefutable nature imposed on any administrative entity or body by their direct and immediate normative efficacy, since the block or parameter of legality (article 11 of the Political Constitution) to which they must conform in their actions is composed, among other elements, of the general principles of administrative law (article 6 of the General Public Administration Act). It must not be lost from perspective that the General Principles of Law have the rank of the norm they interpret, integrate, or delimit, with which they can assume a constitutional rank if the precept with respect to which they fulfill such functions also has that hierarchy. As we shall see in the subsequent recital (considerando), our fundamental text includes as a fundamental right of persons the right to the proper functioning of public services; consequently, the principles that inform public services insofar as they make such right effective have a constitutional rank. Article 4 of the General Public Administration Act clearly provides that “The activity of public entities shall be subject in its entirety to the fundamental principles of public service, to ensure its continuity, its efficiency, its adaptation to any change in the legal regime or in the social need they satisfy, and equality in the treatment of the recipients or beneficiaries.” Continuity assumes that the provision of services must not be interrupted; various legal mechanisms of the administrative system seek to ensure this principle, such as the prohibition of strike and stoppage in essential public services, the theory of unforeseeability (teoría de la imprevisión) to face economic disruptions that may suspend or paralyze public services, the unattachable nature of dominical assets destined for the provision of a public service, etc. Any action –by action or omission– of officials or lack of foresight by them in the rational organization of resources that tends to interrupt a public service is openly anti-juridical. Regularity implies that the public service must be provided or performed subject to certain rules, norms, or pre-established conditions. Continuity must not be confused with regularity; the first concept assumes it must function without interruptions and the second with adherence to the norms that make up the legal system. Adaptation to any change in the legal regime or to the needs imposed by the socioeconomic context means that administrative entities and bodies must have the capacity for foresight and, above all, for programming or planning to face the new demands and challenges imposed, whether by the increase in the volume of demand for the public service or by technological changes. No entity, body, or public official can adduce reasons of budgetary or financial lack, absence of equipment, lack of technological renewal thereof, excess or saturation of demand in the public service to cease providing it continuously and regularly. Equality or universality in access demands that all inhabitants have the right to demand, receive, and use the public service under equal conditions and in conformity with the norms that govern them; consequently, all those who are in the same situation can demand identical advantages. One of the guiding principles of public service that is not stated in article 4 of the General Public Administration Act is its obligatoriness, since it would be useless to affirm that they must be continuous, regular, uniform, and general if the provider subject does not have the obligation to provide it. The public administration providing the public service cannot choose its clientele or users; it must provide it to anyone who requires it.

V.- FUNDAMENTAL RIGHT TO THE PROPER FUNCTIONING OF PUBLIC SERVICES. Our political constitution implicitly includes the fundamental right of the administered to the proper and efficient functioning of public services, that is, that they be provided with high quality standards, which has as its necessary corollary the obligation of public administrations to provide them continuously, regularly, speedily, efficaciously, and efficiently. This last obligation arises from the systematic relationship of various constitutional precepts, such as 140, subsection 8, which imposes on the Executive Branch the duty to “Monitor the proper functioning of administrative services and dependencies,” 139, subsection 4), insofar as it incorporates the concept of the “proper conduct of the Government,” and 191 to the extent that it incorporates the principle of “efficiency of the administration.” This atypical or unnamed individual guarantee is accentuated in the case of essential public services of an assistance nature such as those of social security and, especially, when we have patients who due to the pathology or clinical syndrome presented, in the specific case breast cancer, require immediate attention without any type of undue delay to guarantee their rights to life and health.

VI.- FUNDAMENTAL RIGHT TO HEALTH. The right to life recognized in article 21 of the Constitution is the cornerstone upon which the rest of the fundamental rights of the inhabitants of the republic rest. Likewise, in that article of the political charter the right to health finds its basis, since life is inconceivable if minimum conditions for an adequate and harmonious psychic, physical, and environmental equilibrium are not guaranteed to the human person. Evidently, any delay by the hospitals, clinics, and other health care units of the Costa Rican Social Security Fund (Caja Costarricense del Seguro Social) can negatively impact the preservation of the health and life of its users. Public entities, bodies, and officials owe themselves to the users with a clear and unequivocal vocation of service, since that has been the reason for their creation and existence.

VII.- EFFICIENCY, EFFICACY, CONTINUITY, REGULARITY, AND ADAPTATION IN PUBLIC HEALTH SERVICES. The public bodies and entities that provide public health services have the imperative and non-deferrable obligation to adapt them to the particular and specific needs of their users or patients and, above all, of those who demand immediate and urgent medical attention, without the lack of human and material resources being legally valid arguments to exempt them from fulfilling such obligation. From this perspective, the services of the clinics and hospitals of the Costa Rican Social Security Fund are under the duty to adopt and implement the organizational changes, to contract the medical or auxiliary personnel, and to acquire the materials and technical equipment that are required to provide efficient, efficacious, and rapid services. The heads of the Clinics and Hospitals cannot invoke, to justify deficient and precarious care of patients, the problem of “waiting lists” for surgical interventions and the application of certain specialized exams or the lack of financial, human, and technical resources, since it is a constitutional imperative that public health services be provided efficiently, efficaciously, continuously, regularly, and speedily. The heads of the Costa Rican Social Security Fund and the Directors of the Hospitals and Clinics that belong to it are under the duty and, consequently, are personally responsible –in the terms of article 199 et seq. of the General Public Administration Act–, for adopting and implementing all administrative and organizational measures and provisions to put a definitive end to the delayed provision –which, on occasions, becomes omitted due to its consequences– of health services, a situation that constitutes, by all lights, an unequivocal lack of service that may give rise to the patrimonial administrative liability of that entity for the anti-juridical injuries caused to the administered or users (articles 190 et seq. of the General Public Administration Act).

VIII.- SPECIFIC CASE. The protected party is a patient of the Oncology Service of Hospital San Juan de Dios and is a carrier of a cancer; in that nosocomio she received chemotherapy. Likewise, her treating physician prescribed the use of Trastuzumab to the petitioner with the purpose of improving her health conditions (folio 55). In that order of ideas, authorization was requested from the Central Pharmacotherapy Committee (Comité Central de Farmacoterapia) of the Costa Rican Social Security Fund to provide the tutelada with Trastuzumab. However, that body in session No. 2007-21 of May 30, 2007, considered that the promotora’s request does not meet the established technical criteria to authorize the use of trastuzumab, since other treatment options have not been exhausted (folios 42 to 44). On the matter, in judgment No. 2006-05024 of 10:49 hours of April 7, 2006, the Constitutional Chamber (Sala Constitucional) ordered regarding a similar matter:

“(…) II.- Object of the appeal: In the specific case the accionante accuses the authorities of the Costa Rican Social Security Fund of injury to her right to health, since they have refused to provide her with the medication trastuzumab, which was recommended by her treating physician at Hospital Calderón Guardia in radiotherapy, Dr. Ronald Badilla.

III.- Regarding the patient's informed consent in scientific research: The topic of informed consent is one of the most important within scientific research, since thousands of persons have been violated, intimidated, or coerced by being subjected against their will to scientific research projects. The international community, protected by human rights, such as the inviolability of human life, liberty, dignity, the prohibition of cruel and degrading treatment, has expressly permitted the scientific community to conduct scientific research with human beings within a legal framework that does not in any way impair the life, health, and self-determination of the subject participating in it. Within the legal framework that supports scientific research we find the Nuremberg Code, the Helsinki Declaration (Declaración de Helsinki) of the World Medical Association, International Ethical Guidelines and Declarations for Biomedical Research and Experimentation on Human Beings, the Universal Declaration of Human Rights, the Lisbon Declaration (Declaración de Lisboa) of the World Medical Association on the Rights of the Patient, the International Covenant on Civil and Political Rights, the American Declaration of the Rights and Duties of Man, the American Convention on Human Rights, the Political Constitution, the Civil Code, the General Health Act (Ley General de Salud), and the Regulation for Clinical Research in the Assistance Services of the Costa Rican Social Security Fund (Reglamento para la Investigación Clínica en los Servicios Asistenciales de la Caja Costarricense del Seguro Social), among others. One of the essential prerequisites within scientific research is the patient's consent, which must be granted freely, clearly, spontaneously, voluntarily, and consciously, once the physician has informed the patient of the nature of the intervention with its risks and benefits. The physician who does not inform the patient, or who does not obtain the patient's suitable consent, is assuming the direct or indirect risks or consequences of the unconsented medical act. For its part, the Regulation for Biomedical Research in the Assistance Services of the Costa Rican Social Security Fund (Reglamento para la Investigación Biomédica en los Servicios Asistenciales de la Caja Costarricense de Seguro Social) defines informed consent as the formal procedure to apply the principle of autonomy. It must meet at least three elements: voluntariness, information, and comprehension. Voluntariness implies that subjects can freely decide whether they want to participate in a study, without persuasion (i.e., when one induces to “freely accept” attitudes, values, intentions, or actions), manipulation (i.e., intentional and effective influence to alter real options or their perception of choice), or coercion (i.e., when certain informational elements are exaggerated in order to obtain consent). The voluntary nature of consent may be undermined when it is requested by persons in a position of authority or of great influence over the research subject and when a “sufficient” time is not given for the subject to reflect, consult, and decide. The information must be understandable and must include the objective of the study and its procedure, the potential benefits and risks, the possible discomforts derived from participation, and the possibility of withdrawing from the study at any time without this giving rise to prejudice. In this context, the comprehension of the information is basic, which depends not only on it, but also on the competence of the recipient, that is, on their capacity to understand. Having been informed about all aspects of the study that are relevant so that the person can make the decision to participate or not. This process must be duly documented in a written, signed, and dated form. Therefore, prior to making their decision, they must be explained the nature, duration, and purpose of the same, the method and the ways through which it will be carried out, all the inconveniences and risks that may arise, and the effects on their health or person that may derive from their participation in the experiment. Consequently, the physician must ensure that the patient freely makes the decision to participate in the research project.

IV.- Regarding medical liability: The International Ethical Guidelines and Declarations for Biomedical Research and Experimentation on Human Beings indicate that during the research process the patient will be informed by the research team, who must transmit the information to the patient depending on the maturity, intelligence, education, and rationality of the potential participant, in order to ensure that the participant has satisfactorily understood the information. Furthermore, they must be informed of the risks derived from the research. It provides that in all cases of biomedical research conducted on human beings, the investigator must obtain the informed consent of the person who will presumably participate in the research; in the case of a person not capable of giving informed consent, the investigator must obtain proxy consent from a duly authorized representative.

Guideline # 2 provides that before requesting a person's consent for their participation in research, the investigator must provide them with the following information, in a language that person is capable of understanding: 1. That each person is invited to be a participant in research, and the objectives and methods of the research; 2. The expected duration of the person's participation; 3. The benefits that could reasonably be expected in favor of the participant or other persons, as a result of the research; 4. Any foreseeable risk or discomfort that may affect the person, associated with their participation in the research; any other procedure or treatment that could be as advantageous for the participant as the procedure or treatment under test; 5. The extent to which the confidentiality of the files identifying the participant will be maintained; 6. The degree of responsibility that may fall upon the investigator in terms of providing medical care to the participant; 7. That free therapy will be offered in case of specific-type injuries related to the research; 8. Whether the participant or their family or dependents will be indemnified in case of disability or death as a result of such injuries, and 9. That the person is free to refuse to participate and will have the freedom to withdraw from the research at any time without sanction or loss of benefits to which they would otherwise be entitled.

Likewise, Guideline # 3 enumerates the obligations of investigators regarding informed consent: 1. Communicate to the potential participant all the information necessary to grant duly informed consent; 2. Give the potential participant a full opportunity to ask questions, and encourage them to do so; 3. Exclude the possibility of unjustified deception, undue influence, or intimidation; 4. Procure consent only after the potential participant has sufficient knowledge of the pertinent facts and the consequences of their participation, and has had sufficient opportunity to consider their participation; 5. As a general rule, obtain from each potential participant a signed form as proof of their informed consent, and 6. Renew the informed consent of each participant if important changes occur in the conditions or procedures of the research.

Similarly, it is established that investigators or sponsors who do not comply with the established norms may be sanctioned. The sanctions may consist of fines or the suspension of their privilege to receive funding to conduct research, to use experimental therapies, or to practice medicine. The possibility of denying the publication of the results of research conducted unethically may also be considered, as stipulated in the Helsinki Declaration, as well as refusing to accept unethically obtained data presented in an application for registration of a medication.

For its part, article 22 of the Regulation for Clinical Research in the Assistance Services of the Costa Rican Social Security Fund, regarding the suspension of research, mentions that they will be ordered in protection of patients, or when investigators incur serious breaches of their obligations or when circumstances arise that affect the services of the CCSS. They must be preceded by a hearing and will be ordered by the Executive Directorate of the CENDEISSS, with a ruling from the COIBI-CCSS. The Sub-Area of Bioethics in Research of the CENDEISSS will instruct the procedure. In serious and urgent cases the director of the assistance center may, with reasons given, suspend the research and must immediately inform the Sub-Area of Bioethics in Research of the CENDEISSS. Article 27 indicates that serious breaches of this Regulation, by officials of the Fund (Caja), shall be deemed a serious offense punishable by disciplinary action, without prejudice to potential civil or criminal liabilities. The following are considered serious breaches: 1. The approval and execution of Phase I and Phase II clinical trials in the assistance services of the Fund. 2. Conducting research in the assistance services of the Fund without the recommendation of a CLOBI or the COIBÍ- CCSS, as applicable. 3. Conducting research in the assistance services of the Fund without the approval of the medical director of the assistance center. 4. Legal impediment due to undisclosed conflict of interest. 5. Receiving gifts from any individual, company, or institution interested in a particular research. 6. The inclusion of persons in research without obtaining informed consent approved by a CLOBI or by the COIBI- CCSS. 7. False testimony in the sworn declaration of the funding source. 8. The non-signing of a contract for those investigations that require it, as dictated by this Regulation. 9. The non-signing of a policy for those investigations that require it. 10. Falsification of data in the proposal, design, execution, registration, supervision, or review of research or its results, including acts of omission or commission. 11. Whoever, using their position in public office, uses health or social protocols or files of patients or users of the Fund, to locate, recruit, or contact subjects for experimentation in the application of medications, drugs, substances, devices, or techniques, or other health projects that signify economic benefit to them, their spouses or cohabitants, or their relatives by consanguinity or affinity up to the second degree inclusive. 12. Whoever opposes the control and follow-up of research protocols as determined in this Regulation. Likewise, article 28 establishes that the sponsor and/or investigator who: 1. Commits any of the serious offenses established in the previous article shall be disqualified for 10 years from conducting research in the Fund. 2. Offers gifts and/or exerts coercion on the members of the COIBI-CCSS or CLOBI. 3. Incurs anomalies in the proper development of the protocol that was approved or if any other act contrary to the provisions of this Regulation is proven that could put the research participants at risk.

V.- Analysis of the specific case: From the report issued by the respondent authorities –which is taken as given under oath with the consequences, including penal, provided for in article 44 of the Law governing this Jurisdiction– and the evidence provided for the resolution of the matter, it has been duly accredited that the appellant (recurrente) Cintia Natalia Solano Cantillo is a twenty-six-year-old patient who presented cancer of the left breast, for which a breast-conserving surgery was performed and she later received adjuvant chemotherapy and radiotherapy. That the tumor presents overexpression of Her-2 which makes it have a high risk of recurrence of the disease. On February first, two thousand six, Dr. Ronald Badilla González of the Oncology Service of Hospital Dr. Rafael Ángel Calderón Guardia presented a Standardized Request (Petición Estandarizada) to process a medication not included in the LOM for chronic treatment, for patient Cintia Natalia Solano Cantillano, with a request for trastuzumab before the Central Pharmacotherapy Committee. That trastuzumab is a medication that is currently in phase III of experimentation and therefore has no official indication for its use. By means of official letter CCF 280-02-06 of February twenty-one, two thousand six, the Central Pharmacotherapy Committee communicated to the Local Pharmacotherapy Committee that “as a result of the technical-scientific analysis carried out regarding the analyzed case, it is requested that the case be reassessed and that treatment with an LOM medication be sought, since the requested drug has no official indication for use in this condition and as specifically instructed by the Medical Management (Gerencia Médica), in the CCSS it is not permissible to use medications outside of official indications - circular 22375 of June nine, two thousand five. From the above, the Chamber concludes that the medication requested by the appellant given the recommendation of her treating physician, namely, trastuzumab, is not on the Official List of Medications (Lista Oficial de Medicamentos, LOM) authorized by the CCSS, given that the requested drug has no official indication for use in the patient's conditions, so in accordance with the guidelines of the Medical Management, in the CCSS it is not permissible to use medications outside of official indications, given that it is in phase III of research. Notwithstanding the above, the Chamber considers that the patient suffers from breast cancer, with a high rate of recurrence, and that the treating physician considers that the medication trastuzumab would benefit the patient in accordance with the clinical picture she presents. Already in other similar cases this Chamber has ordered that the criterion of the treating physician be respected, by virtue of the fact that the physician knows with greater precision the patient's conditions, and the convenience of the treatment to be provided.

Hence, in accordance with the report rendered by Luis Paulino Hernández Castañeda, Director General, William Hernández Rojas, Head of the Oncology Service, and Ronald Badilla González, Assistant Physician Specialist in Oncology, the need to provide the claimant with the drug trastuzumab is clear, which in the judgment of the physicians has an official indication for the treatment of metastatic breast cancer that overexpresses Her-2, given that it improves the disease-free period and decreases the patient’s risk of mortality from breast cancer. Consequently, and given that in this matter the oncologist in charge of the appellant’s case does not hesitate to prescribe the drug trastuzumab, Alberto Sáenz Pacheco, in his capacity as Executive President of the Caja Costarricense del Seguro Social, and Luis Paulino Hernández Castañeda, in his capacity as Director General of the Hospital Dr. Rafael Ángel Calderón Guardia, or whomever exercises those positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent and pursuant to Considerandos III and IV of this resolution, with the drug trastuzumab that she requires to adequately treat her condition, under the strict responsibility of the treating physician Dr. Ronald Badilla and the Oncology Committee of the Hospital Dr. Rafael Ángel Calderón Guardia, and in strict adherence to the legal framework governing it. Consequently, Alberto Sáenz Pacheco, in his capacity as Executive President of the Caja Costarricense del Seguro Social, and Luis Paulino Hernández Castañeda, in his capacity as Director General of the Hospital Dr. Rafael Ángel Calderón Guardia, or whomever exercises those positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent and pursuant to Considerandos III and IV of this resolution, with the drug trastuzumab that she requires to adequately treat her condition, under the strict responsibility of the treating physician Dr. Ronald Badilla and the Oncology Committee of the Hospital Dr. Rafael Ángel Calderón Guardia, and in strict adherence to the legal framework governing it. (…)” Considerations that are applicable to the specific case, in which it has been established that the protected person’s treating physician prescribed the drug to her, due to her personal conditions. From this perspective, it is evident that the situation challenged in this jurisdictional recourse (recurso jurisdiccional) is unjustified and violates the Right of the Constitution. Accordingly, the proper course is to grant the recourse (recurso), but not without first warning the respondents, based on the provisions of Article 50 of the Ley de la Jurisdicción Constitucional, that they must not in future engage in the acts or omissions that gave merit to the acceptance of this matter.

IX. Magistrate Cruz Castro issues a dissenting vote and declares the amparo without merit with its consequences.”

<b>“I.-</b> The petitioner claims the violation of her fundamental rights, in particular her right to health, due to the refusal of the authorities of the Caja Costarricense de Seguro Social to supply the medication prescribed by her treating physician for the treatment of her illness, trastuzumab, despite having been diagnosed with breast cancer.

Likewise, Guideline # 3 lists among the obligations of researchers regarding informed consent (consentimiento informado): 1. Communicate to the prospective participant all necessary information so that they may grant a duly informed consent; 2. Give the prospective participant a full opportunity to ask questions, and encourage them to do so; 3. Exclude the possibility of unjustified deception, undue influence, or intimidation; 4. Seek consent only after the prospective participant has sufficient knowledge of the pertinent facts and the consequences of their participation, and has had sufficient opportunity to consider their participation; 5. As a general rule, obtain from each prospective participant a signed form as proof of their informed consent, and 6. Renew the informed consent of each participant if significant changes occur in the conditions or procedures of the research.

Similarly, it is established that researchers or sponsors that do not comply with the established norms may be sanctioned. The sanctions may consist of fines or the suspension of their privilege to receive funding to conduct research, to use experimental therapies, or to practice medicine. The possibility of denying publication of the results of research conducted in an unethical manner may also be considered, as stipulated in the Declaration of Helsinki, as well as refusing to accept data obtained unethically and submitted in an application for drug registration.

For its part, Article 22 of the Reglamento para la Investigación Clínica en los Servicios Asistenciales de la Caja Costarricense de Seguro Social, regarding the suspension of research, mentions that it will be ordered for the protection of patients, or when researchers incur serious breaches of their obligations, or when circumstances arise that affect the services of the CCSS. They shall be preceded by a hearing and ordered by the Executive Directorate of the CENDEISSS, with a ruling from the COIBI-CCSS. The Subárea de Bioética en Investigación of the CENDEISSS shall instruct the procedure. In serious and urgent cases, the Director of the healthcare center may, with reasons stated, suspend the research and must immediately inform the Subárea de Bioética en Investigación of the CENDEISSS. Article 27 states that serious breaches of this Reglamento, on the part of Caja officials, shall be deemed a serious offense punishable by disciplinary action, without prejudice to any potential civil or criminal liabilities. The following are framed as serious breaches: 1. The approval and execution of Phase I and Phase II clinical trials in the Caja’s healthcare services. 2. Conducting research in the Caja’s healthcare services without the recommendation of a CLOBI or the COIBÍ- CCSS, as the case may be. 3. Conducting research in the Caja’s healthcare services without the approval of the medical director of the healthcare center. 4. Legal impediment due to undisclosed conflict of interest. 5. Receiving gifts from any individual, company, or institution interested in a particular research. 6. The inclusion of persons in research without obtaining an informed consent approved by a CLOBI or by the COIBI- CCSS. 7. False testimony in the sworn declaration of the funding source. 8. The failure to sign a contract for those research projects that require it, according to the dictates of this Reglamento. 9. The failure to take out an insurance policy for those research projects that require it. 10. Falsification of data in the proposal, design, execution, recording, supervision, or review of research or its results, including acts of omission or commission. 11. Whoever, taking advantage of their position in public function, uses health or social protocols or records of Caja patients or users, to locate, recruit, or contact subjects for experimentation for the application of medications, drugs, substances, devices, or techniques, or other health projects that mean economic benefit for them, their spouses or common-law partners, or their relatives by consanguinity or affinity up to the second degree inclusive. 12. Whoever opposes the control and follow-up of research protocols as determined in this Reglamento. Likewise, Article 28 establishes that the sponsor and/or researcher shall be disqualified for 10 years from conducting research at the Caja if they: 1. Incur any of the serious faults established in the previous article. 2. Offer gifts and/or exert coercion on the members of the COIBI-CCSS or CLOBI. 3. Incur anomalies in the proper development of the protocol that was approved or if any other act contrary to what is established in this Reglamento is proven that could put research participants at risk.

**V.-** Analysis of the specific case: From the report rendered by the respondent authorities—which is taken as given under oath with the consequences, including criminal ones, provided for in Article 44 of the Law governing this Jurisdiction—and the evidence provided for the resolution of the matter, it has been duly accredited that the petitioner Cintia Natalia Solano Cantillo is a twenty-six-year-old patient who presented with left breast cancer, for which she underwent breast-conserving surgery and then received adjuvant chemotherapy and radiotherapy. That the tumor presents overexpression of Her-2 which means she has a high risk of recurrence of the disease. On February first, two thousand six, Dr. Ronald Badilla González of the Oncology Service of the Hospital Dr. Rafael Ángel Calderón Guardia submitted a Standardized Petition to process a medication not included in the LOM for chronic treatment, for the patient Cintia Natalia Solano Cantillano, with a request for trastuzumab before the Comité Central de Farmacoterapia. That trastuzumab is a medication that is currently in phase III of experimentation and therefore has no official indication for its use. By official letter CCF 280-02-06 of February twenty-first, two thousand six, the Comité Central de Farmacoterapia informed the Comité Local de Farmacoterapia that “as a result of the scientific-technical analysis carried out regarding the case analyzed, it is requested that the case be reassessed and that treatment with a LOM medication be sought, since the requested drug has no official indication for use in this condition and as specifically instructed by the Gerencia Médica, in the CCSS it is not permissible to use medications outside of official indications – circular 22375 of June ninth, two thousand five. From the foregoing, the Chamber concludes that the medication requested by the petitioner upon the recommendation of her treating physician, namely, trastuzumab, is not on the Lista Oficial de Medicamentos authorized by the CCSS, given that the requested drug has no official indication for use under the patient's conditions, and therefore, in accordance with the guidelines of the Gerencia Médica, it is not permissible to use medications outside of official indications in the CCSS, since it is in phase III of research. Notwithstanding the foregoing, the Chamber considers that the patient suffers from breast cancer, with a high rate of recurrence, and that the treating physician considers that the medication trastuzumab would benefit the patient in accordance with her clinical condition. Already in other similar cases, this Chamber has ordered that the criterion of the treating physician be respected, given that they know the patient's conditions more precisely and the convenience of the treatment to be provided. Hence, in accordance with the report rendered by Luis Paulino Hernández Castañeda, Director General, William Hernández Rojas, Head of the Oncology Service, and Ronald Badilla González, Assistant Physician Specialist in Oncology, it is clear that there is a need to provide the petitioner with the medication trastuzumab, which in the opinion of the physicians has an official indication for the treatment of metastatic breast cancer that overexpresses Her-2, and that it improves the disease-free period and reduces the risk of mortality from breast cancer for the patient. Consequently, and given that in this matter the oncologist in charge of the petitioner's case does not hesitate to prescribe the medication trastuzumab, Alberto Sáenz Pacheco, in his capacity as Executive President of the Caja Costarricense del Seguro Social, and Luis Paulino Hernández Castañeda, in his capacity as Director General of the Hospital Dr. Rafael Ángel Calderón Guardia, or whoever holds these positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent; and in compliance with the provisions in Considerando III and Considerando IV of this resolution; the medication trastuzumab that she requires to adequately attend to her ailment, under the strict responsibility of the treating physician Dr. Ronald Badilla and the Oncology Committee of the Hospital Dr. Rafael Ángel Calderón Guardia, and in strict adherence to the legal framework that governs it. Consequently, Alberto Sáenz Pacheco, in his capacity as Executive President of the Caja Costarricense del Seguro Social, and Luis Paulino Hernández Castañeda, in his capacity as Director General of the Hospital Dr. Rafael Ángel Calderón Guardia, or whoever holds these positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent; and in compliance with the provisions in Considerando III and Considerando IV of this resolution; the medication trastuzumab that she requires to adequately attend to her ailment, under the strict responsibility of the treating physician Dr. Ronald Badilla and the Oncology Committee of the Hospital Dr. Rafael Ángel Calderón Guardia, and in strict adherence to the legal framework that governs it. (…)” Considerations that are applicable to the specific case, in which it is taken as accredited that the treating physician of the protected party prescribed the drug to her, due to her personal conditions. From this perspective, it is evident that the situation challenged in this jurisdictional appeal is unjustified and violates the Right of the Constitution. Consequently, the appropriate course is to grant the appeal, not without first warning the respondents, based on the provisions of Article 50 of the Ley de la Jurisdicción Constitucional, that they must not incur in the future in the acts or omissions that gave merit to the granting of this matter.

**IX.** Magistrate Cruz Castro dissents and declares the amparo without merit with its consequences.” In its opinion, the foregoing is improper and violates the right established in the Constitution." **"...III.- CONSTITUTIONAL PRINCIPLES OF EFFICACY, EFFICIENCY, SIMPLICITY, AND CELERITY OF ADMINISTRATIVE ORGANIZATION AND FUNCTION.** The Political Constitution, in its organic part, enshrines or enunciates certain guiding principles of administrative function and organization, which as such must guide, direct, and condition all public administrations in their daily work. Prominent among such principles are efficacy, efficiency, simplicity, and celerity (articles –all of the Political Constitution– 140, subsection 8, insofar as it imposes upon the Executive Branch the duty to "Oversee the proper functioning of administrative services and dependencies," 139, subsection 4, to the extent it incorporates the concept of "good governance," and 191 by enshrining the principle of "administrative efficiency"). These constitutional principles have been developed by infra-constitutional regulations; thus, the General Law of Public Administration enshrines them in articles 4, 225, paragraph 1, and 269, paragraph 1, and mandates that they must guide and nourish all administrative organization and function. Efficacy as a principle assumes that the administrative organization and function must be designed and conceived to guarantee the achievement of the objectives, ends, and goals proposed and assigned by the legal system itself, and must therefore be linked to planning, evaluation, and accountability (article 11, paragraph 2, of the Political Constitution). Efficiency implies obtaining the best results with the greatest cost savings or the rational use of human, material, technological, and financial resources. Simplicity demands that administrative structures and their competencies be easily understood and comprehended, without convoluted procedures that delay the satisfaction of the public interests at stake. For its part, celerity obliges public administrations to fulfill their objectives and goals of satisfying public interests, through the various mechanisms, in the most expeditious, rapid, and accurate way possible to avoid undue delays. This set of principles imposes permanent demands, responsibilities, and duties on all public entities that they cannot decline on a transitory or singular basis.

**IV.- CONSTITUTIONAL PRINCIPLES GOVERNING PUBLIC SERVICES.** All public services provided by public administrations –including welfare or social services– are governed by a series of principles that must be observed and respected, at all times and without any exception, by the public officials responsible for their management and provision. Such principles constitute a legal obligation of a non-waivable nature imposed on any administrative entity or body by their direct and immediate normative efficacy, since the block or parameter of legality (article 11 of the Political Constitution) to which they must adjust their actions is composed, among other elements, of the general principles of administrative law (article 6 of the General Law of Public Administration). One must not lose sight of the fact that the General Principles of Law have the rank of the norm they interpret, integrate, or delimit, and can thus assume a constitutional rank if the precept for which they fulfill such functions also has that hierarchy. As we will see in the subsequent recital (considerando), our fundamental text enshrines the proper functioning of public services as a fundamental right of individuals; consequently, the principles that inform public services, insofar as they give effect to that right, have a constitutional rank. Article 4 of the General Law of Public Administration clearly provides that "The activity of public entities shall be subject in its entirety to the fundamental principles of public service, to ensure its continuity, its efficiency, its adaptation to any change in the legal regime or in the social need they satisfy, and equality in the treatment of recipients or beneficiaries." Continuity implies that the provision of services must not be interrupted; various legal mechanisms of the administrative system seek to ensure this principle, such as the prohibition of strikes and work stoppages in essential public services, the theory of unforeseeability to deal with economic disruptions that may suspend or paralyze public services, the unseizable nature of public domain assets destined for the provision of a public service, etc. Any action –by action or omission– by officials, or lack of foresight by them in the rational organization of resources that tends to interrupt a public service, is openly unlawful. Regularity implies that the public service must be provided or carried out subject to certain pre-established rules, norms, or conditions. Continuity should not be confused with regularity; the first concept implies that it must function without interruptions, and the second implies adherence to the norms that make up the legal system. Adaptation to any change in the legal regime or to the needs imposed by the socioeconomic context means that administrative entities and bodies must have the capacity for foresight and, above all, for programming or planning to face the new demands and challenges imposed, whether by the increase in the volume of demand for the public service or by technological changes. No entity, body, or public official may assert reasons of budget or financial scarcity, lack of equipment, lack of technological renewal thereof, or excess or saturation of demand for the public service to cease providing it continuously and regularly. Equality or universality in access demands that all inhabitants have the right to demand, receive, and use the public service under equal conditions and in accordance with the norms that govern them; consequently, all those who find themselves in the same situation can demand identical advantages. One of the guiding principles of public service not enunciated in article 4 of the General Law of Public Administration is its mandatory nature, since it would be useless to assert that they must be continuous, regular, uniform, and general if the providing entity does not have the obligation to provide it. The public administration providing the public service cannot choose its clientele or users; it must provide it to anyone who requires it.

**V.- FUNDAMENTAL RIGHT TO THE PROPER FUNCTIONING OF PUBLIC SERVICES.** Our political constitution implicitly enshrines the fundamental right of those administered to the proper and efficient functioning of public services, that is, that they be provided with high quality standards, which has as its necessary corollary the obligation of public administrations to provide them in a continuous, regular, expeditious, efficacious, and efficient manner. This latter obligation derives from the systematic relationship of several constitutional precepts, such as 140, subsection 8, which imposes upon the Executive Branch the duty to "Oversee the proper functioning of administrative services and dependencies," 139, subsection 4, insofar as it incorporates the concept of "good governance," and 191, to the extent it incorporates the principle of "administrative efficiency." This atypical or unnamed individual guarantee is accentuated in the case of essential public services of a welfare nature, such as social security services, and, especially, when we have patients who, due to the pathology or clinical syndrome presented—in the specific case, breast cancer—require immediate attention without any type of undue delay to guarantee their rights to life and health.

**VI.- FUNDAMENTAL RIGHT TO HEALTH.** The right to life recognized in article 21 of the Constitution is the cornerstone upon which the rest of the fundamental rights of the inhabitants of the republic rest. Likewise, the right to health finds its basis in that article of the political charter, since life is inconceivable if the human person is not guaranteed minimum conditions for an adequate and harmonious psychic, physical, and environmental equilibrium. Evidently, any delay by the hospitals, clinics, and other healthcare units of the Caja Costarricense del Seguro Social can negatively impact the preservation of the health and life of its users. Public entities, bodies, and officials owe themselves to users with a clear and unequivocal vocation of service, since that has been the reason for their creation and existence.

**VII.- EFFICIENCY, EFFICACY, CONTINUITY, REGULARITY AND ADAPTATION IN PUBLIC HEALTH SERVICES.** The public bodies and entities that provide public health services have the imperative and non-deferrable obligation to adapt them to the particular and specific needs of their users or patients, and above all, of those who demand immediate and urgent medical attention, without the lack of human and material resources being legally valid arguments to exempt them from fulfilling such obligation. From this perspective, the services of the clinics and hospitals of the Caja Costarricense de Seguro Social are under a duty to adopt and implement the organizational changes, to contract the medical or auxiliary personnel, and to acquire the materials and technical equipment required to provide efficient, efficacious, and rapid services. The heads of Clinics and Hospitals cannot invoke, to justify deficient and precarious patient care, the problem of "waiting lists" for surgical interventions and the application of certain specialized exams or the lack of financial, human, and technical resources, since *it is a constitutional imperative that public health services be provided efficiently, efficaciously, continuously, regularly, and expeditiously*. The heads of the Caja Costarricense de Seguro Social and the Directors of its Hospitals and Clinics are under a duty and, consequently, are personally responsible—under the terms of article 199 et seq. of the General Law of Public Administration—for adopting and implementing all administrative and organizational measures and provisions to definitively put an end to the tardy provision—which, at times, becomes negligent (omisa) due to its consequences—of health services, a situation that constitutes, by all accounts, an unequivocal lack of service that may give rise to the patrimonial administrative liability of that entity for the unlawful harms caused to those administered or users (articles 190 et seq. of the General Law of Public Administration).

**VIII.- SPECIFIC CASE.** The amparo petitioner is a patient of the Oncology Service of the Hospital San Juan de Dios and is a carrier of a cancer; she received chemotherapy at that hospital. Likewise, her treating physician prescribed her the use of Trastuzumab for the purpose of improving her health condition (folio 55). In that vein, the Central Pharmacotherapy Committee of the Caja Costarricense de Seguro Social was requested to authorize providing the petitioner with Trastuzumab. However, that body, in session No. 2007-21 of May 30, 2007, considered that the petitioner's request does not meet the established technical criteria for authorizing the use of trastuzumab, as other treatment options have not been exhausted (folios 42 a 44). In this regard, in judgment No. 2006-05024 of 10:49 a.m. on April 7, 2006, the Constitutional Chamber resolved, concerning a similar matter:

*"(...) II.- Purpose of the appeal: In the specific case, the plaintiff accuses the authorities of the Caja Costarricense del Seguro Social of harming her right to health, since they have refused to supply her the medication trastuzumab, which was recommended by her treating physician at the Hospital Calderón Guardia in radiotherapy, Dr. Ronald Badilla.* *III.- Regarding the informed consent of the patient in scientific research: The topic of informed consent is one of the most important within scientific research, since thousands of people have been violated, intimidated, or coerced by being subjected against their will to scientific research projects. The international community, protected by human rights, such as the inviolability of human life, freedom, dignity, and the prohibition of cruel and degrading treatment, has expressly allowed the scientific community to conduct scientific research with human beings within a legal framework that does not in any way undermine the life, health, and self-determination of the subject participating in it. Within the legal framework supporting scientific research, we find the Nuremberg Code, the Helsinki Declaration of the World Medical Association, the International Ethical Guidelines and Declarations for Biomedical Research and Experimentation on Human Beings, the Universal Declaration of Human Rights, the Lisbon Declaration of the World Medical Association on the Rights of the Patient, the International Covenant on Civil and Political Rights, the American Declaration of the Rights and Duties of Man, the American Convention on Human Rights, the Political Constitution, the Civil Code, the General Health Law, and the Regulation for Clinical Research in the Healthcare Services of the Caja Costarricense del Seguro Social, among others. One of the essential prerequisites within scientific research is the patient's consent, which must be given freely, clearly, spontaneously, voluntarily, and consciously, once the physician has informed them of the nature of the intervention with its risks and benefits. The physician who does not inform the patient, or who fails to obtain the patient's suitable consent, is assuming the direct or indirect risks or consequences of the non-consented medical act. For its part, the Regulation for Biomedical Research in the Healthcare Services of the Caja Costarricense de Seguro Social defines informed consent as the formal procedure to apply the principle of autonomy. It must meet at least three elements: voluntariness, information, and comprehension. Voluntariness implies that subjects can freely decide whether they wish to participate in a study, without persuasion (i.e., inducing someone to 'freely accept' attitudes, values, intentions, or actions), manipulation (i.e., intentional and effective influence to alter real options or their perception of choice), or coercion (i.e., exaggerating certain informational elements to obtain consent). The voluntary nature of consent may be violated when it is requested by persons in a position of authority or great influence over the research subject and when sufficient time is not given for the subject to reflect, consult, and decide. The information must be understandable and must include the objective of the study and its procedure, potential benefits and risks, possible discomforts derived from participation, and the possibility of withdrawing from the study at any time without this leading to prejudice. In this context, understanding the information is basic, which depends not only on the information itself but also on the competence of the recipient, that is, their capacity to understand. Having been informed about all aspects of the study relevant for the person to decide to participate or not. This process must be duly documented in a written, signed, and dated form. Therefore, before making a decision, the nature, duration, and purpose of the study must be explained, as well as the method and ways by which it will be carried out, all the inconveniences and risks that may arise, and the effects on their health or person that may derive from their participation in the experiment. Consequently, the physician must ensure that the patient freely decides to participate in the research project.* *IV.- Regarding medical liability: The International Ethical Guidelines and Declarations for Biomedical Research and Experimentation on Human Beings state that during the research process, the patient will be informed by the research team, who must transmit the information to the patient depending on the maturity, intelligence, education, and rationality of the potential participant, in order to ensure that the participant has satisfactorily understood the information. Furthermore, the risks derived from the research must be indicated to them. It provides that in all cases of biomedical research carried out on human beings, the investigator must obtain the informed consent of the person who will presumably participate in the research; in the case of a person incapable of giving informed consent, the investigator must obtain proxy consent from a duly authorized representative.* *Guideline # 2 states that before requesting an individual's consent for participation in research, the investigator must provide them with the following information, in a language that person is capable of understanding: 1. That each person is invited to be a participant in research, and the objectives and methods of the research; 2. The expected duration of the individual's participation; 3. The benefits that might reasonably be expected for the participant or for other persons, as a result of the research; 4. Any foreseeable risk or discomfort that may affect the individual, associated with their participation in the research; any other procedure or treatment that could be as advantageous for the participant as the procedure or treatment being tested; 5. The extent to which the confidentiality of records identifying the participant will be maintained; 6. The degree of responsibility that the investigator may bear for providing medical care to the participant; 7. That free therapy will be offered in case of specific types of research-related injuries; 8. Whether the participant or their family or dependents will be compensated in case of disability or death as a result of such injuries; and 9. That the person is free to refuse to participate and will have the freedom to withdraw from the research at any time without sanction or loss of benefits to which they would otherwise be entitled.* *Likewise, Guideline # 3 lists among the obligations of investigators regarding informed consent: 1. To communicate to the potential participant all the information necessary for duly informed consent; 2. To give the potential participant a full opportunity to ask questions, and encourage them to do so; 3. To exclude the possibility of unjustified deception, undue influence, or intimidation; 4. To seek consent only after the potential participant has sufficient knowledge of the relevant facts and the consequences of their participation, and has had sufficient opportunity to consider their participation; 5. As a general rule, to obtain from each potential participant a signed form as evidence of their informed consent; and 6. To renew the informed consent of each participant if significant changes occur in the conditions or procedures of the research.* *Similarly, it is established that investigators or sponsors who do not comply with the established norms may be sanctioned. The sanctions may consist of fines or the suspension of their privilege to receive funding for research, to use experimental therapies, or to practice medicine. The possibility of denying the publication of the results of research conducted unethically may also be considered, as stipulated in the Helsinki Declaration, as well as refusing to accept data obtained unethically and submitted in an application for drug registration.* *For its part, article 22 of the Regulation for Clinical Research in the Healthcare Services of the Caja Costarricense de Seguro Social, regarding the suspension of research, mentions that suspensions will be ordered in protection of patients, or when investigators incur serious breaches of their obligations, or when circumstances arise that affect the services of the CCSS. They must be preceded by a hearing and will be ordered by the Executive Directorate of CENDEISSS, with the opinion of COIBI-CCSS. The Subarea of Bioethics in Research of CENDEISSS will conduct the procedure. In serious and urgent cases, the director of the healthcare center may, with reasons, suspend the research and must immediately inform the Subarea of Bioethics in Research of CENDEISSS. Article 27 indicates that serious breaches of this Regulation by Caja officials shall be considered serious misconduct punishable by disciplinary action, without prejudice to potential civil or criminal liabilities. The following are framed as serious breaches: 1. The approval and execution of Phase I and Phase II clinical trials in the Caja's healthcare services. 2. Conducting research in the Caja's healthcare services without the recommendation of a CLOBI or the COIBÍ- CCSS, as the case may be. 3. Conducting research in the Caja's healthcare services without the approval of the medical director of the healthcare center. 4. Legal impediment due to an undisclosed conflict of interest. 5. Receiving gifts from any individual, company, or institution interested in a particular research project. 6. The inclusion of persons in research without obtaining informed consent approved by a CLOBI or by the COIBI-CCSS. 7. False testimony in the sworn statement regarding the source of funding. 8. The failure to sign a contract for those research projects that require it, as dictated by this Regulation. 9. The failure to subscribe to an insurance policy for those research projects that require it. 10. Falsification of data in the proposal, design, execution, recording, supervision, or review of research or its results, including acts of omission or commission. 11. Whoever, taking advantage of their public office, uses health or social protocols or files of patients or users of the Caja to locate, recruit, or contact subjects for experimentation for the application of medications, drugs, substances, devices, or techniques, or other health projects that yield economic benefit to them, their spouses or cohabitants, or their relatives by consanguinity or affinity up to the second degree inclusive. 12. Whoever opposes the control and follow-up of research protocols as determined in this Regulation. Likewise, article 28 establishes that a sponsor and/or investigator shall be disbarred for 10 years from conducting research at the Caja who: 1. Commits any of the serious misconduct established in the preceding article. 2. Offers gifts and/or exerts coercion on members of COIBI-CCSS or CLOBI. 3. Incurs anomalies in the proper course of the protocol that was approved, or if any other act contrary to the provisions of this Regulation is verified that could put research participants at risk.* *V.- Analysis of the specific case: From the report rendered by the respondent authorities –which is taken as given under oath with the consequences, including criminal ones, provided for in article 44 of the Law governing this Jurisdiction– and the evidence provided for the resolution of the matter, it has been duly accredited that the petitioner Cintia Natalia Solano Cantillo is a twenty-six-year-old patient who presented with left breast cancer, for which she underwent conservative breast surgery and then received adjuvant chemotherapy and radiotherapy. That the tumor presents overexpression of Her-2, which means she has a high risk of disease recurrence. On February first, two thousand six, Dr. Ronald Badilla González of the Oncology Service of the Hospital Dr. Rafael Ángel Calderón Guardia submitted a Standardized Petition to process a medication not included in the LOM for chronic treatment, for patient Cintia Natalia Solano Cantillano, with a request for trastuzumab before the Central Pharmacotherapy Committee. That trastuzumab is a medication that is currently in phase III of experimentation and therefore has no official indication for its use.*" By official communication CCF 280-02-06 of February twenty-first, two thousand six, the Central Pharmacotherapy Committee (Comité Central de Farmacoterapia) informs the Local Pharmacotherapy Committee (Comité Local de Farmacoterapia) that "as a result of the scientific-technical analysis carried out regarding the case under review, it is requested that the case be reassessed and that treatment with the medication LOM be attempted, since the requested drug has no official indication for use in this condition and, as specifically instructed by the Medical Management, within the CCSS it is not permissible to use medications outside of their official indications—circular 22375 of June ninth, two thousand five. From the foregoing, the Chamber concludes that the medication requested by the appellant, given the recommendation of her attending physician, namely trastuzumab, is not on the Official List of Medications authorized by the CCSS, given that the requested drug has no official indication for use in the patient's conditions, and therefore, in accordance with the Medical Management guidelines, within the CCSS it is not permissible to use medications outside of their official indications, as it is in phase III of investigation. Notwithstanding the foregoing, the Chamber values that the patient suffers from breast cancer, with a high rate of recurrence, and that the attending physician considers that the medication trastuzumab would benefit the patient in accordance with the clinical picture she presents. In other similar cases, this Chamber has ordered that the attending physician's criterion be respected, by virtue of the fact that the physician knows the patient's conditions with greater precision, and the suitability of the treatment to be provided. Hence, in accordance with the report issued by Luis Paulino Hernández Castañeda, General Director, William Hernández Rojas, Head of the Oncology Service, and Ronald Badilla González, Assistant Physician Specialist in Oncology, the need to provide the claimant with the medication trastuzumab is clear, which, in the opinion of the physicians, has an official indication for the treatment of metastatic breast cancer that overexpresses Her-2, and that it improves the disease-free period and reduces the risk of mortality from breast cancer for the patient. Consequently, and given that in this matter the oncologist in charge of the appellant's case does not hesitate to prescribe the medication trastuzumab, Alberto Sáenz Pacheco, in his capacity as Executive President of the Costa Rican Social Security Fund (Caja Costarricense del Seguro Social), and Luis Paulino Hernández Castañeda, in his capacity as General Director of the Dr. Rafael Ángel Calderón Guardia Hospital, or whomever occupies those positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent and in accordance with the provisions set forth in Considerandos III and IV of this resolution, the medication trastuzumab that she requires to adequately address her ailment, this under the strict responsibility of the attending physician Dr. Ronald Badilla and the Oncology Committee (Comité de Oncología) of the Dr. Rafael Ángel Calderón Guardia Hospital, and in strict adherence to the legal framework governing it. Consequently, Alberto Sáenz Pacheco, in his capacity as Executive President of the Costa Rican Social Security Fund (Caja Costarricense del Seguro Social), and Luis Paulino Hernández Castañeda, in his capacity as General Director of the Dr. Rafael Ángel Calderón Guardia Hospital, or whomever occupies those positions in their stead, are ordered to immediately issue the orders within their scope of authority and competence, so that Cintia Natalia Solano Cantillo is immediately provided, in accordance with informed consent and in accordance with the provisions set forth in Considerandos III and IV of this resolution, the medication trastuzumab that she requires to adequately address her ailment, this under the strict responsibility of the attending physician Dr. Ronald Badilla and the Oncology Committee (Comité de Oncología) of the Dr. Rafael Ángel Calderón Guardia Hospital, and in strict adherence to the legal framework governing it. (…)" Considerations which are applicable to the specific case, in which it is deemed proven that the attending physician of the protected party prescribed the drug to her, due to her personal conditions. From this perspective, it is evident that the situation challenged in this jurisdictional remedy (recurso) is unjustified and violates the Right of the Constitution. Consequently, the appropriate course is to declare the remedy (recurso) granted, not without first warning the respondents, based on the provisions of Article 50 of the Law of Constitutional Jurisdiction (Ley de la Jurisdicción Constitucional), that they must not incur in the future in the acts or omissions that gave merit to the acceptance of this matter.

IX. Magistrate Cruz Castro issues a dissenting vote and declares the amparo (amparo) without merit with its consequences."

“I.- La recurrente reclama la violación de sus derechos fundamentales, en particular de su derecho a la salud, por la negativa de las autoridades de la Caja Costarricense de Seguro Social de suministrar el medicamento prescrito por su médico tratante para el tratamiento de su enfermedad, trastuzumab, a pesar de haberse diagnosticado un cáncer de mama. En su criterio, lo anterior es indebido y lesiona el Derecho de la Constitución.” “…III.- PRINCIPIOS CONSTITUCIONALES DE EFICACIA, EFICIENCIA, SIMPLICIDAD Y CELERIDAD DE LA ORGANIZACIÓN Y FUNCIÓN ADMINISTRATIVAS. La Constitución Política, en su parte orgánica, recoge o enuncia algunos principios rectores de la función y organización administrativas, que como tales deben orientar, dirigir y condicionar a todas las administraciones públicas en su cotidiano quehacer. Dentro de tales principios destacan la eficacia, eficiencia, simplicidad y celeridad (artículos –todos de la Constitución Política- 140, inciso 8, en cuanto le impone al Poder Ejecutivo el deber de “Vigilar el buen funcionamiento de los servicios y dependencias administrativas”, el 139, inciso 4, en la medida que incorpora el concepto de “buena marcha del Gobierno” y el 191 al recoger el principio de “eficiencia de la administración”). Estos principios de orden constitucional, han sido desarrollados por la normativa infraconstitucional, así, la Ley General de la Administración Pública los recoge en los artículos 4°, 225, párrafo 1°, y 269, párrafo 1°, y manda que deben orientar y nutrir toda organización y función administrativa. La eficacia como principio supone que la organización y función administrativa deben estar diseñadas y concebidas para garantizar la obtención de los objetivos, fines y metas propuestos y asignados por el propio ordenamiento jurídico, con lo que debe ser ligada a la planificación y a la evaluación o rendición de cuentas (artículo 11, párrafo 2°, de la Constitución Política). La eficiencia, implica obtener los mejores resultados con el mayor ahorro de costos o el uso racional de los recursos humanos, materiales, tecnológicos y financieros. La simplicidad demanda que las estructuras administrativas y sus competencias sean de fácil comprensión y entendimiento, sin procedimientos alambicados que retarden la satisfacción de los intereses públicos empeñados. Por su parte, la celeridad obliga a las administraciones públicas cumplir con sus objetivos y fines de satisfacción de los intereses públicos, a través de los diversos mecanismos, de la forma más expedita, rápida y acertada posible para evitar retardos indebidos. Este conjunto de principios le impone exigencias, responsabilidades y deberes permanentes a todos los entes públicos que no pueden declinar de forma transitoria o singular.

IV.- PRINCIPIOS CONSTITUCIONALES RECTORES DE LOS SERVICIOS PUBLICOS. Todos los servicios públicos prestados por las administraciones públicas –incluidos los asistenciales o sociales- están regidos por una serie de principios que deben ser observados y respetados, en todo momento y sin excepción alguna, por los funcionarios públicos encargados de su gestión y prestación. Tales principios constituyen una obligación jurídica de carácter indeclinable impuesta a cualquier ente u órgano administrativo por su eficacia normativa directa e inmediata, toda vez que el bloque o parámetro de legalidad (artículo 11 de la Constitución Política) al que deben ajustarse en sus actuaciones está integrado, entre otros elementos, por los principios generales del derecho administrativo (artículo 6° de la Ley General de la Administración Pública). No debe perderse de perspectiva que los Principios Generales del Derecho, tienen el rango de la norma que interpretan, integran o delimitan, con lo que pueden asumir un rango constitucional si el precepto respecto del cual cumplen tales funciones tiene también esa jerarquía. Como veremos en el considerando subsiguiente nuestro texto fundamental recoge como derecho fundamental de las personas el del buen funcionamiento de los servicios públicos, consecuentemente los principios que informan los servicios públicos en cuanto hacen efectivo tal derecho tienen un rango constitucional. El ordinal 4° de la Ley General de la Administración Pública dispone claramente que “La actividad de los entes públicos deberá estar sujeta en su conjunto a los principios fundamentales del servicio público, para asegurar su continuidad, su eficiencia, su adaptación a todo cambio en el régimen legal o en la necesidad social que satisfacen y la igualdad en el trato de los destinatarios o beneficiarios”. La continuidad supone que la prestación de los servicios no se debe interrumpir, diversos mecanismos jurídicos del ordenamiento administrativo pretenden asegurar este principio, tales como la prohibición de la huelga y de paro en los servicios públicos esenciales, la teoría de la imprevisión para hacerle frente a los trastornos económicos que pueden suspender o paralizar los servicios públicos, el carácter inembargable de los bienes dominicales destinados a la prestación de un servicio público, etc.. Cualquier actuación –por acción u omisión- de los funcionarios o imprevisión de éstos en la organización racional de los recursos que propenda a interrumpir un servicio público es abiertamente antijurídica. La regularidad implica que el servicio público debe prestarse o realizarse con sujeción a ciertas reglas, normas o condiciones preestablecidas. No debe confundirse la continuidad con la regularidad, el primer concepto supone que debe funcionar sin interrupciones y el segundo con apego a las normas que integran el ordenamiento jurídico. La adaptación a todo cambio en el régimen legal o a las necesidades impuestas por el contexto socioeconómico significa que los entes y órganos administrativos deben tener capacidad de previsión y, sobre todo, de programación o planificación para hacerle frente a las nuevas exigencias y retos impuestos, ya sea por el aumento en el volumen de la demanda del servicio público o bien por los cambios tecnológicos. Ningún ente, órgano o funcionario público pueden aducir razones de carencia presupuestaria o financiera, ausencia de equipos, falta de renovación tecnológica de éstos, exceso o saturación de la demanda en el servicio público para dejar de prestarlo de forma continua y regular. La igualdad o universalidad en el acceso demanda que todos los habitantes tienen derecho a exigir, recibir y usar el servicio público en igualdad de condiciones y de conformidad con las normas que los rigen, consecuentemente, todos los que se encuentran en una misma situación pueden exigir idénticas ventajas. Uno de los principios rectores del servicio público que no se encuentra enunciado en el artículo 4° de la Ley General de la Administración Pública lo constituye el de su obligatoriedad, puesto que, de nada serviría afirmar que deben ser continuos, regulares, uniformes y generales si el sujeto prestador no tiene la obligación de prestarlo. La administración pública prestadora del servicio público no puede escoger su clientela o usuarios, debe brindárselo a cualquiera que se lo requiera.

V.- DERECHO FUNDAMENTAL AL BUEN FUNCIONAMIENTO DE LOS SERVICIOS PUBLICOS. Nuestra constitución política recoge, implícitamente, el derecho fundamental de los administrados al buen y eficiente funcionamiento de los servicios públicos, esto es, que sean prestados con elevados estándares de calidad, el cual tiene como correlato necesario la obligación de las administraciones públicas de prestarlos de forma continua, regular, célere, eficaz y eficiente. Esta última obligación se desprende de la relación sistemática de varios preceptos constitucionales, tales como el 140, inciso 8, el cual le impone al Poder Ejecutivo el deber de “Vigilar el buen funcionamiento de los servicios y dependencias administrativas”, el 139, inciso 4), en cuanto incorpora el concepto de “buena marcha del Gobierno” y el 191 en la medida que incorpora el principio de “eficiencia de la administración”. Esa garantía individual atípica o innominada se acentúa en tratándose de servicios públicos esenciales de carácter asistencial como los de la seguridad social y, en especial, cuando tenemos pacientes que por la patología o síndrome clínico presentado, en el caso concreto un cáncer de mama, requieren de una atención inmediata sin ningún tipo de dilación indebida para garantizarles sus derechos a la vida y a la salud.

VI.- DERECHO FUNDAMENTAL A LA SALUD. El derecho a la vida reconocido en el numeral 21 de la Constitución es la piedra angular sobre la cual descansan el resto de los derechos fundamentales de los habitantes de la república. De igual forma, en ese ordinal de la carta política encuentra asidero el derecho a la salud, puesto que, la vida resulta inconcebible si no se le garantizan a la persona humana condiciones mínimas para un adecuado y armónico equilibrio psíquico, físico y ambiental. Evidentemente, cualquier retardo de los hospitales, clínicas y demás unidades de atención sanitaria de la Caja Costarricense del Seguro Social puede repercutir negativamente en la preservación de la salud y la vida de sus usuarios. Los entes, órganos y funcionarios públicos se deben a los usuarios con una clara e inequívoca vocación de servicio, puesto que, esa ha sido la razón de su creación y existencia.

VII.- EFICIENCIA, EFICACIA, CONTINUIDAD, REGULARIDAD Y ADAPTACIÓN EN LOS SERVICIOS PUBLICOS DE SALUD. Los órganos y entes públicos que prestan servicios de salud pública tienen la obligación imperativa e impostergable de adaptarlos a las necesidades particulares y específicas de sus usuarios o pacientes y, sobre todo, de aquellos que demandan una atención médica inmediata y urgente, sin que la carencia de recursos humanos y materiales sean argumentos jurídicamente válidos para eximirlos del cumplimiento de tal obligación. Desde esta perspectiva, los servicios de las clínicas y hospitales de la Caja Costarricense de Seguro Social están en el deber de adoptar e implementar los cambios organizacionales, de contratar el personal médico o auxiliar y de adquirir los materiales y equipo técnico que sean requeridos para brindar prestaciones eficientes, eficaces y rápidas. Los jerarcas de las Clínicas y Hospitales no pueden invocar, para justificar una atención deficiente y precaria de los pacientes, el problema de las “listas de espera” para las intervenciones quirúrgicas y aplicación de ciertos exámenes especializados o de la carencia de recursos financieros, humanos y técnicos, puesto que, es un imperativo constitucional que los servicios de salud pública sean prestados de forma eficiente, eficaz, continua, regular y célere. Los jerarcas de la Caja Costarricense de Seguro Social y los Directores de Hospitales y Clínicas que les pertenecen están en el deber y, por consiguiente son los personalmente responsables -en los términos del artículo 199 y siguientes de la Ley General de la Administración Pública-, de adoptar e implementar todas las providencias y medidas administrativas y organizacionales para poner coto definitivo a la prestación tardía –la cual, en ocasiones, deviene en omisa por sus consecuencias- de los servicios de salud, situación que constituye, a todas luces, una inequívoca falta de servicio que puede dar lugar a la responsabilidad administrativa patrimonial de esa entidad por las lesiones antijurídicas provocadas a los administrados o usuarios (artículos 190 y siguientes de la Ley General de la Administración Pública).

VIII.- CASO CONCRETO. La amparada es paciente del Servicio de Oncología del Hospital San Juan de Dios y es portadora de un cáncer; en ese nosocomio recibió quimioterapia. Asimismo, su médico tratante prescribió a la recurrente el uso de Trastuzumab con el propósito de mejorar sus condiciones de salud (folio 55). En ese orden de ideas, se solicitó al Comité Central de Farmacoterapia de la Caja Costarricense de Seguro Social la autorización para proporcionarle a la tutelada el Trastuzumab. Sin embargo, ese órgano en la sesión N°2007-21 de 30 de mayo de 2007, estimó que la petición de la promovente no reúne los criterios técnicos establecidos para autorizar el uso del trastuzumab, pues no se han agotado otras opciones de tratamiento (folios 42 a 44). Sobre el particular, en la sentencia N°2006-05024 de las 10:49 horas del 7 de abril de 2006, la Sala Constitucional dispuso respecto de un asunto similar:

“(…) II.- Objeto del recurso: En el caso concreto acusa la accionante lesión a su derecho a la salud por parte de las autoridades de la Caja Costarricense del Seguro Social, ya que, se han negado a suministrarle el medicamento trastuzumab, el cuál fue recomendado por su médico tratante del Hospital Calderón Guardia en radioterapia, Dr. Ronald Badilla.

III.- Con relación al consentimiento informado del paciente en investigación científica: El tema del consentimiento informado es uno de los más importantes dentro de la investigación científica, ya que, miles de personas han sido violentadas, intimidadas o coaccionadas al ser sometidas contra su voluntad a proyectos de investigación científica. La comunidad internacional amparada en los derechos humanos, tales como, la inviolabilidad de la vida humana, la libertad, la dignidad, la prohibición de tratos crueles y degradantes ha permitido expresamente a la comunidad científica realizar investigación científica con seres humanos dentro de un marco jurídico que no menoscabe en forma alguna la vida, la salud y la autodeterminación del sujeto que participa en el mismo. Dentro del marco jurídico que respalda la investigación científica encontramos el Código de Nuremberg, la Declaración de Helsinki de la Asociación Médica Mundial, Declaraciones y Pautas Éticas Internacionales para la Investigación y Experimentación Biomédica en Seres Humanos, la Declaración Universal de Derechos Humanos, la Declaración de Lisboa de la Asociación Médica Mundial sobre los Derechos del Paciente, el Pacto Internacional de Derechos Civiles y Políticos, el Pacto Internacional de Derechos Civiles y Políticos, la Declaración Americana de los Derechos y Deberes del Hombre, la Convención Americana Sobre Derechos Humanos, la Constitución Política, el Código Civil, la Ley General de Salud, y el Reglamento para la Investigación Clínica en los Servicios Asistenciales de la Caja Costarricense del Seguro Social, entre otros. Uno de los presupuestos esenciales dentro de la investigación científica es el consentimiento del paciente, el cuál debe ser otorgado de forma libre, clara, espontánea, voluntaria y consciente, una vez que el médico le haya informado la naturaleza de la intervención con sus riesgos y beneficios. El médico que no informa al paciente, o bien, cuando no obtiene el consentimiento idóneo del paciente, está asumiendo los riesgos o consecuencias directas o indirectas del acto médico no consentido. Por su parte el Reglamento para la Investigacion Biomédica en los Servicios Asistenciales de la Caja Costarricense de Seguro Social define el consentimiento informado como el procedimiento formal para aplicar el principio de autonomía. Debe reunir por lo menos tres elementos: voluntariedad, información y comprensión. La voluntariedad implica que los sujetos puedan decidir libremente si quieren participar en un estudio, sin que haya persuasión (es decir, cuando se induce a “aceptar libremente” actitudes, valores, intenciones o acciones), manipulación (es decir, influencia intencionada y efectiva para alterar las opciones reales o su percepción de elección) ni coerción (es decir cuando se exageran ciertos elementos informativos con el fin de obtener el consentimiento). El carácter voluntario del consentimiento puede resultar vulnerado cuando es solicitado por personas en posición de autoridad o de gran influencia sobre el sujeto de la investigación y cuando no se da un tiempo “suficiente” para que el sujeto pueda reflexionar, consultar y decidir. La información debe ser comprensible y debe incluir el objetivo del estudio y su procedimiento, los beneficios y riesgos potenciales, las posibles incomodidades derivadas de la participación y la posibilidad de retirarse del estudio en cualquier momento sin que ello dé lugar a perjuicio. En este contexto es básica la comprensión de la información, que no sólo depende de ésta, sino también de la competencia de quien la recibe, es decir, de su capacidad para comprender. El haber sido informado sobre todos los aspectos del estudio que son relevantes para que la persona pueda tomar la decisión de participar o no. Este proceso debe quedar debidamente documentado en un formulario escrito, firmado y fechado. Por lo que previo a tomar su decisión se le debe explicar la naturaleza, duración y propósito del mismo, el método y las formas mediante las cuales se llevará a cabo, todos los inconvenientes y riesgos que pueden presentarse, y los efectos sobre su salud o persona que puedan derivarse de su participación en el experimento. En consecuencia, el médico debe asegurarse que el paciente tome libremente la decisión de participar en el proyecto de investigación.

IV.- Con relación a la responsabilidad médica: Las Declaraciones y Pautas Éticas Internacionales para la Investigación y investigación el paciente será informando, por el equipo de investigación, los cuales deben transmitir la información al paciente dependiendo de la madurez, inteligencia, instrucción y racionalidad del posible participante, a fin de asegurarse que el participante ha entendido satisfactoriamente la información. Además se le deben indicar los riesgos derivados de la investigación. Dispone que en todos los casos de investigación biomédica realizada en seres humanos, el investigador debe obtener el consentimiento informado de quien presumiblemente participará en la investigación; en el caso de una persona que no sea capaz de dar un consentimiento informado, el investigador debe obtener el consentimiento por poder de un representante debidamente autorizado.

La Pauta # 2 dispone que antes de solicitar el consentimiento de una persona para su participación en una investigación, el investigador debe proporcionarle la siguiente información, en un lenguaje que esa persona sea capaz de entender: 1.Que se invita a cada persona a ser participante de una investigación, y los objetivos y métodos de la investigación; 2. La duración prevista de la participación de la persona; 3. Los beneficios que razonablemente podrían preverse a favor del participante o de otras personas, como resultado de la investigación; 4. Todo riesgo o molestia previsible que pueda afectar a la persona, asociado con su participación en la investigación; todo otro procedimiento o tratamiento que pudiese ser tan ventajoso para el participante como el procedimiento a tratamiento que se somete a prueba; 5. La medida en que se mantendrá la confidencialidad de los archivos en los que se identifique al participante; 6. El grado de responsabilidad que pueda caberle al investigador en cuanto a proporcionar atención médica al participante; 7. Que se ofrecerá terapia gratuita en caso de lesiones de tipo específico relacionadas con la investigación; 8. Si se indemnizará al participante o a su familia o a personas dependientes del mismo en caso de invalidez o muerte como resultado de dichas lesiones, y 9. Que la persona es libre de negarse a participar y tendrá la libertad de retirarse de la investigación en cualquier momento sin sanción o pérdida de beneficios a los cuales en otras circunstancias tendría derecho.

Asimismo, la Pauta # 3 enumera dentro de las obligaciones de los investigadores con respecto al consentimiento informado: 1.Comunicar al posible participante toda la información necesaria para que otorgue un consentimiento debidamente informado; 2. Dar al posible participante una oportunidad plena de hacer preguntas, y estimularlo a que lo haga; 3. Excluir la posibilidad de un engaño injustificado, de una influencia indebida o de intimidación; 4. Procurar el consentimiento sólo después de que el posible participante tenga un conocimiento suficiente de los hechos pertinentes y de las consecuencias de su participación, y haya tenido suficiente oportunidad de considerar su participación; 5. Como regla general, obtener de cada posible participante un formulario firmado como prueba de su consentimiento informado, y 6. Renovar el consentimiento informado de cada participante si ocurren cambios importantes de las condiciones o procedimientos de la investigación.

De igual forma, se establece que los investigadores o patrocinadores que no cumplan las normas dispuestas podrán ser sancionados. Las sanciones pueden consistir en multas o la suspensión de su privilegio de recibir financiamiento para realizar investigación, para usar terapias experimentales o para practicar la medicina. También se puede considerar la posibilidad de negar la publicación de los resultados de una investigación realizada en forma poco ética, según se estipula en la Declaración de Helsinki, así como negarse a aceptar datos obtenidos en forma poco ética y presentados en una solicitud de registro de un medicamento.

Por su parte el artículo 22 del Reglamento para la Investigación Clínica en los Servicios Asistenciales de la Caja Costarricense de Seguro Social, en cuanto a la suspensión de las investigaciones, menciona que serán dispuestas en protección de los pacientes, o cuando los investigadores incurran en incumplimientos graves de sus obligaciones o cuando surjan circunstancias que afecten los servicios de la CCSS. Deberán precederse de una audiencia y las dispondrá la Dirección Ejecutiva del CENDEISSS, con dictamen del COIBI-CCSS. La Subárea de Bioética en Investigación del CENDEISSS instruirá el procedimiento. En casos graves y urgentes el Director del centro asistencial podrá, razonadamente, suspender la investigación y deberá informar inmediatamente a la Subárea de Bioética en Investigación del CENDEISSS. El artículo 27º indica que los incumplimientos graves a este Reglamento, por parte de los funcionarios de la Caja, se reputarán falta grave sancionable disciplinariamente, sin perjuicio de eventuales responsabilidades civiles o penales. Se enmarca como incumplimientos graves los siguientes: 1. La aprobación y ejecución de ensayos clínicos Fase I y Fase II en los servicios asistenciales de la Caja. 2. La realización de una investigación en los servicios asistenciales de la Caja sin contar con la recomendación de un CLOBI o del COIBÍ- CCSS, según sea el caso. 3. La realización de una investigación en los servicios asistenciales de la Caja sin contar con la aprobación del director médico del centro asistencial. 4. Impedimento legal por conflicto de interés no manifiesto. 5. Recibir dádivas por parte de cualquier individuo, compañía o institución interesada en una investigación en particular. 6. La inclusión de personas en una investigación sin la obtención de un consentimiento informado aprobado por un CLOBI o por el COIBI- CCSS. 7. Falso testimonio en la declaración jurada de la fuente de financiamiento. 8. La no suscripción de un contrato para aquellas investigaciones que así lo requieran, según dicta este Reglamento. 9. La no suscripción de una póliza para aquellas investigaciones que así lo requieran. 10. Falsificación de datos en la propuesta, diseño, ejecución, registro, supervisión o revisión de una investigación o de los resultados de la misma, incluyendo actos de omisión o comisión. 11. Quien valiéndose de su cargo en la función pública utilice protocolos o expedientes de salud o sociales de pacientes o usuarios de la Caja, para ubicar, reclutar o contactar sujetos para la experimentación para la aplicación de medicamentos, fármacos, sustancias, dispositivos o técnicas, u otros proyectos de salud que les signifique beneficio económico a ellos, sus cónyuges o convivientes, o sus parientes por consanguinidad o afinidad hasta segundo grado inclusive. 12. Quien se oponga al control y seguimiento de los protocolos de investigación según lo determinado en este Reglamento. Asimismo el artículo 28 establece que se inhabilitará por 10 años para realizar investigación en la Caja al patrocinador y/o investigador que: 1. Incurra en alguna de las faltas graves establecidas en el artículo anterior. 2. Ofrezca dádivas y/o ejerza coerción a los miembros del COIBI-CCSS o CLOBI. 3. Incurra en anomalías en el buen desarrollo del protocolo que fue aprobado o si se comprobara algún otro acto contrario a lo establecido en este Reglamento que pudiera poner en riesgo a los participantes de la investigación.

V.- Análisis del caso concreto: Del informe rendido por las autoridades recurridas -que se tiene por dado bajo fe de juramento con las consecuencias, incluso penales, previstas en el artículo 44 de la Ley que rige esta Jurisdicción- y la prueba aportada para la resolución del asunto ha sido debidamente acreditado que la recurrente Cintia Natalia Solano Cantillo es paciente de veintiséis años de edad la cuál presentó cáncer de mama izquierda, por lo que se le practicó una cirugía conservadora de mama y luego recibió quimioterapia y radioterapia adyuvantes. Que el tumor presenta sobreexpresión de Her-2 lo cuál hace que tenga alto riesgo de recurrencia a la enfermedad. El primero de febrero del dos mil seis el Dr. Ronald Badilla González del Servicio de Oncología del Hospital Dr. Rafael Ángel Calderón Guardia presenta Petición Estandarizada para gestionar un medicamento no incluido en la LOM para tratamiento crónico, para la paciente Cintia Natalia Solano Cantillano, con solicitud de trastuzumab ante el Comité Central de Farmacoterapia. Que el trastuzumab es un medicamento que se encuentra al día en fase III de experimentación por lo que no tiene indicación oficial para su uso. Mediante oficio CCF 280-02-06 del veintiuno de febrero del dos mil seis el Comité Central de Farmacoterapia comunica al Comité Local de Farmacoterapia que “como resultado del análisis científico técnico realizado respecto del caso analizado se solicita que se revalore y el caso y se procure brindar tratamiento con medicamento LOM, pues el fármaco solicitado no tiene indicación oficial para uso en esta condición y tal como está específicamente instruido por la Gerencia Médica, en la CCSS no es permisible utilizar medicamentos fuera de las indicaciones oficiales -circular 22375 del nueve de junio del dos mil cinco. De lo anterior, la Sala concluye que el medicamento solicitado por la recurrente dada la recomendación de su médico tratante, a saber, trastuzumab, no se encuentra dentro de la Lista Oficial de Medicamentos autorizados por la CCSS, siendo que, el fármaco solicitado no tiene indicación oficial para uso en las condiciones de la paciente, por lo que de conformidad con los lineamientos de la Gerencia Médica, en la CCSS no es permisible utilizar medicamentos fuera de las indicaciones oficiales, dado que se encuentra en la fase III de investigación. No obstante lo anterior, la Sala valora que la paciente sufre de un cáncer de mama, con un alto índice de reincidencia, siendo que, el médico tratante considera que el medicamento trastuzumab beneficiaría a la paciente de conformidad con el cuadro clínico que presenta. Ya en otros casos similares esta Sala ha dispuesto respetar el criterio del médico tratante, en virtud de que éste conoce con mayor precisión las condiciones de la paciente, y la conveniencia del tratamiento a suministrar. De ahí que, de conformidad con el informe rendido por Luis Paulino Hernández Castañeda, Director General, William Hernández Rojas, Jefe del Servicio de Oncología y Ronald Badilla González, Médico Asistente Especialista en Oncología queda claro la necesidad de otorgarle a la accionante el medicamente trastuzumab, el cuál a criterio de los galenos tiene indicación oficial para el tratamiento del cáncer de mama metastásico que sobre período libre de enfermedad y disminución del riesgo de mortalidad por cáncer de mama de la paciente. En consecuencia, y dado que en este asunto el oncólogo a cargo del caso de la recurrente no duda en prescribir el medicamento trastuzumab, se ordena a Alberto Sáenz Pacheco en su condición de Presidente Ejecutivo de la Caja Costarricense del Seguro Social y a Luis Paulino Hernández Castañeda en su condición de Director General del Hospital Dr. Rafael Ángel Calderón Guardia o a quienes en sus lugares ejerzan dichos cargos, que procedan de inmediato a girar las órdenes que están dentro del ámbito de atribuciones y de su competencia, para que de forma inmediata se entregue a Cintia Natalia Solano Cantillo, de acuerdo al consentimiento informado; y de conformidad con lo dispuesto en los considerandos III y IV de ésta resolución; el medicamento trastuzumab que requiere para atender adecuadamente su padecimiento, ello bajo la estricta responsabilidad del médico tratante Dr. Ronald Badilla y del Comité de Oncología del Hospital Dr. Rafael Ángel Calderón Guardia, y en estricto apego al marco jurídico que la regula. En consecuencia, se ordena a Alberto Sáenz Pacheco en su condición de Presidente Ejecutivo de la Caja Costarricense del Seguro Social y a Luis Paulino Hernández Castañeda en su condición de Director General del Hospital Dr. Rafael Ángel Calderón Guardia o a quienes en sus lugares ejerzan dichos cargos, que procedan de inmediato a girar las órdenes que están dentro del ámbito de atribuciones y de su competencia, para que de forma inmediata se entregue a Cintia Natalia Solano Cantillo, de acuerdo al consentimiento informado; y de conformidad con lo dispuesto en los considerandos III y IV de ésta resolución; el medicamento trastuzumab que requiere para atender adecuadamente su padecimiento, ello bajo la estricta responsabilidad del médico tratante Dr. Ronald Badilla y del Comité de Oncología del Hospital Dr. Rafael Ángel Calderón Guardia, y en estricto apego al marco jurídico que la regula. (…)” Consideraciones que son aplicables al caso concreto, en el que se tiene por acreditado que el médico tratante de la amparada le prescribió el fármaco, debido a sus condiciones personales. Bajo esta perspectiva, es evidente que la situación impugnada en este recurso jurisdiccional es injustificada y viola el Derecho de la Constitución. Consecuentemente, lo procedente es declarar con lugar el recurso, no sin antes advertir a los recurridos, con fundamento en lo dispuesto por el artículo 50 de la Ley de la Jurisdicción Constitucional, que no debe incurrir a futuro en los actos u omisiones que dieron mérito a la acogida de este asunto.

IX. El Magistrado Cruz Castro salva el voto y declara sin lugar el amparo con sus consecuencias.”