Law on Donation and Transplantation of Anatomical Organs in Human Beings

For the purposes of this Law, the following terms are understood to mean:

• 1)

  CADAVER: The integrated remains of a human being in which death has occurred.

• 2)

  CELL: The morphological and functional unit of living matter.

• 3)

  DERIVATIVES OR ANATOMICAL MATERIALS: Refers to cells and other elements of the human body derived from the action of organs or tissues.

• 4)

  DISPOSITION: The act or set of acts relating to the obtaining, preservation, preparation, utilization, supply and final disposition of organs, tissues and cells.

• 5)

  DONATION: A voluntary and gratuitous act to cede organs, tissues and other materials or anatomical derivatives, in accordance with this Law.

• 6)

  SPECIAL DISPOSITION: Disposition relating to cadavers of unknown or named persons not claimed by their relatives, perfect fetuses and embryos for experimentation and teaching and where applicable, transplants;

• 7)

  DONOR: The human being from whom, during his or her life or after his or her death, whether by his or her will or that of his or her relatives, organs, tissues, derivatives or anatomical materials are extracted for the purpose of utilization for transplant in other human beings, or for therapeutic objectives.

• 8)

  POST MORTEM DONATION: Donation that proceeds from a deceased donor;

• 9)

  RESEARCH AND TEACHING: Are the acts conducted in educational scientific institutions, where organs, tissues, derivatives or anatomical materials, products and human cadavers are utilized, including embryos and fetuses for the purpose of teaching or the search for knowledge that cannot be obtained by other methods.

• 10)

  DEATH: There is clinical death when the absence of all vital signs is produced or, in other words, total absence of life 11) BRAIN DEATH OR CEREBRAL DEATH: Absolute and irreversible loss of all encephalic functions of the brain stem. Legally, brain death is evidenced by means of a declaration subscribed by three (3) or more attending physicians following transplant protocols. 12) ORGAN: A morphological entity composed of the grouping of different tissues that concur in the performance of the same function. 13) RECIPIENT: Is the human being in whose body organs, tissues, derivatives or any other anatomical material can be implanted by means of surgical procedures. 14) BLOOD: Hematopoietic cells. 15) HUMAN BEING: All individuals of the human species. 16) TISSUE: A morphological entity composed of the grouping of cells of the same nature and with the same function. 17) TRANSPLANT: The substitution or implantation, for therapeutic purposes, of organs, tissues, derivatives or anatomical material of others, proceeding from a human donor, living or deceased.

The extractions and placements of organs, tissues, derivatives or any other anatomical material of human beings and its utilization for therapeutic purposes, can only be carried out by qualified medical personnel in authorized hospital centers, which must have appropriate facilities, equipment and qualified personnel. The extraction and transplant proceeds when, by means of analysis and certification by the laboratory, it is determined that the elements to be transplanted retain the viability factors that guarantee the therapeutic effects and clinical safety sought.

Surgical interventions for transplants may only be performed once the usual therapeutic methods, with timely decision, have been exhausted and there is no other solution to restore health to patients.

The physicians in charge of performing surgical interventions for transplants must inform donors and recipients clearly and precisely about the risks implied by the surgical interventions, as well as their moral and health consequences, evolution and resulting limitations; once this requirement is fulfilled, in the test of donation between living persons, the expression of the will of the recipient must be heard, or in his case that of his legal representatives and the personal will of the donor. In the case of a post mortem donation, the donor must express his will during his lifetime and the general or specific destination of his donation. In the case of donors and recipients who are minors, the respective authorization of their parents or legal representatives must be obtained. Without prejudice to the authorization of their relatives in accordance with this Law. Of the information relating to the donation, whether this decision of both parties or of the post mortem donor, as well as other conditions of the donation, there must be a record in a notarial instrument or any other unavoidable document, in accordance with what is established in the regulations of this Law. In the case of post-mortem donations, the donor during his lifetime must be given an identification, which he must carry with his personal documentation, issued under security norms that make it inviolable, precise and inalienable and that can be verified with the document cited in the preceding paragraph. Donations of human semen and ova must always be anonymous.

Any transplant operation of organs, tissues, derivatives or anatomical materials that involves payment to the donor or any other onerous condition is classified as trafficking in organs and is subject to the sanctions determined by this Law and criminal legislation. Such sanctions must be applied to donors, recipients, promoters, medical and administrative professionals of hospital establishments and any other person who, knowingly, participates directly or indirectly in it. The Secretariat of State in the Office of Health and the Public Ministry must remain informed on those common matters related to their respective functions and attributions, relating to this Law.

Any remuneration or compensation for organs, tissues, derivatives or anatomical materials remunerated for therapeutic purposes is prohibited. Those who mediate with the purpose of profit in obtaining anatomical organs for therapeutic purposes must be sanctioned with imprisonment of ten (10) to twenty (20) years.

Health professionals and others who participate in the extraction of organs from a donor, living or deceased, knowing that they have been or will be subject to a commercial transaction must be sanctioned with imprisonment of ten (10) to twenty (20) years. Equal punishment applies to whoever performs the transplant under these conditions. CHAPTER II OF TRANSPLANTS

The obtaining of organs from a living donor, for its subsequent grafting or implantation in another person, may be carried out if the following requirements are met:

• 1)

  That the donor be of legal age, unless otherwise authorized in accordance with this Law;

• 2)

  That the donor enjoys full mental faculties and has been previously informed of the consequences of his decision, being informed of the foreseeable consequences of a somatic, psychic and psychological nature, and the possible repercussions that the donation may have on his personal, family and professional life, as well as the benefits that the recipient is expected to achieve with the transplant;

• 3)

  That the donor grants his consent in an express, free and conscious manner, which must be manifested in writing before the public authority that is determined by regulation, prior to the explanations of the physician who is to perform the extraction, such physician also being obligated to sign the document of cession of the organ. In no case may the extraction be performed without the prior signature of this document. For the purposes of this Law, no type of organ can be obtained from persons who, due to mental deficiency or for any other reason, cannot grant express, free and conscious consent;

• 4)

  That the extracted organ be transplanted to a determined person or intended for Organ Banks, in accordance with Article 16 of this Law, with the purpose of substantially improving his life expectancy or living conditions, guaranteeing the anonymity of the recipient, when applicable; and,

• 5)

  The physicians in charge of the transplant operation must sufficiently inform the donor and recipient of the risk implied by the operation and its consequences, so that they may base their informed consent. The act of donation of organs, tissues, derivatives or anatomical materials is always revocable until the moment of the surgical intervention. The donation does not generate rights against the donor. The total transplant of unique or vital organs among living persons, or of pieces or anatomical materials whose separation may cause the death or total or permanent incapacity of the donor is prohibited.

Organs, tissues, derivatives or anatomical materials may be extracted from cadavers for the purpose of transplant to other persons or for research or teaching purposes, in the following cases:

• 1)

  When brain death or cerebral death is certified.

• 2)

  When the identity is verified and the will of the post mortem donor is verified or in the absence of it, the authorization of at least two (2) of his relatives in the first degree of consanguinity or one of them, if there are no more;

• 3)

  When the Public Ministry issues its forensic opinion; and,

• 4)

  In the special case, relating to cadavers of unknown, unnamed or unclaimed persons by their relatives or persons with whom they have permanently cohabited since their death, as well as in the case of fetuses and embryos of like origin and for the purposes of transplant, experimentation and teaching.

In case of violent death, accidental death or suicide and when physicians certify regarding the cause of death, in accordance with the Law, the extraction of organs, tissues, derivatives or anatomical materials for therapeutic purposes may be practiced without delay, provided that the requirements demanded in the preceding articles for donations are met. The Director of the institute or hospital center must gather, within forty-eight (48) hours following, a report to the forensic medical service of the locality, detailing the personal data of the deceased, date and time of admission and detailed relation of the conditions presented by the deceased upon being admitted to the care facility, the injuries presented, the evolution of the case, the date and time of death, diagnosis of the cause of death, name of the physicians who verified it, the thamatological operations and the enumeration and macroscopic description of the organs, tissues derivatives or anatomical materials removed for the purposes of transplant.

The extraction of organs, tissues derivatives or anatomical materials from the cadaver must be performed, preferably, by the physicians who make up the transplant team. An act must be drawn up in which the organs, tissues derivatives or anatomical materials that are extracted, the destination that will be given to them, the name of the deceased, age, marital status, date and time of death and its circumstances are recorded.

The extraction of organs, tissues derivatives or anatomical materials from the cadaver shall be performed in such a manner that the dignity of the deceased person is respected and unnecessary mutilations are avoided.

The person responsible for the medical unit in which the transplant is to be performed can only give his approval if the following requirements are met:

• 1)

  The recipient be fully conscious of the type of intervention that is to be performed, knowing the possible risks and the foreseeable advantages that, both physically and psychologically, may derive from the transplant;

• 2)

  The recipient be informed that, in the precise cases, the necessary immunological studies of histocompatibility or others that are appropriate have been performed between donor and future recipient, conducted by a laboratory accredited by the Secretariat of State in the Office of Health; and,

• 3)

  The recipient express in writing his consent for the performance of the transplant when it is an adult legally responsible for his acts, or by his legal representatives, parents or guardians, in the case of patients with mental deficit or minors.

Organs, tissues derivatives or anatomical materials that are obtained in accordance with the present Law and can be preserved shall only be deposited in Organ Banks, duly authorized by the Secretariat of State in the Office of Health. CHAPTER III ORGANIC AND ADMINISTRATIVE FRAMEWORK

It is the responsibility of the Secretariat of State in the Office of Health to establish the provisions of this Law, in this regard it must: authorize, certify, regulate and oversee the functioning of any center that performs operations or activities related to this Law. This Secretariat must establish, within the framework of the organization and supervisory and monitoring attributions established by the Health Code, a unit of Medical Superintendency, which has the following responsibilities and attributions:

• 1)

  Ensure compliance with this Law, its regulations and particular provisions issued by the Secretariat of State in the Office of Health;

• 2)

  Supervise and inspect the authorized establishments for the performance of transplant operations;

• 3)

  Supervise the clinical and scientific laboratories that conduct research and experimentation in relation to cloning, stem cells, human insemination and any other scientific activity related to transplants or utilization of human tissues;

• 4)

  Intervene in accordance with Law, before the administrative bodies and the Public Ministry in relation to irregular acts resulting from its interventions or of which it has knowledge by other means;

• 5)

  Qualify and recommend, for application by the Secretariat of State in the Office of Health, the administrative sanctions determined by this Law or other applicable provisions;

• 6)

  Study and propose to the Secretariat of State in the Office of Health, for its approval and application of technical norms, promotion programs, warnings, procedures, scientific research, inter-institutional agreements and any other provision related to the purposes of this Law;

• 7)

  Maintain the following Registers:

  • a)

    Register of Authorizations of the Secretariat of State in the Office of Health for establishments authorized to perform transplants of organs, tissues, derivatives or anatomical materials;

  • b)

    Register of Potential Donors and Awaiting Recipients;

  • c)

    Register of Transplant Operations Performed; and, d) Any other register determined by the Secretariat of State in the Office of Health, in relation to the provisions of this Law.

• 8)

  Be informed of the movements of cadavers handled by the Judicial Morgue intended for experimentation, teaching or transplant; and,

• 9)

  Others that the Secretariat of State in the Office of Health determines, in relation to the objectives of this Law.

The non-compliance with administrative provisions of this Law shall be sanctioned by the Secretary of State in the Ministry of Health, in the following manner:

• 1)

  Formal admonition;

• 2)

  Cancellation of administrative rights;

• 3)

  Administrative seizure;

• 4)

  Reparation of damages caused; and,

• 5)

  Fines, which shall be applied taking into consideration the damage caused, the illicitly obtained profit, or the economic capacity of the violator. In the case of infractions committed by public servants, sanctions of temporary or permanent suspension from the performance of their duties and other administrative sanctions determined by Law shall be applied. The framework of administrative sanctions indicated in this Article shall be applied without prejudice to other administrative, civil, and criminal responsibilities that correspond. The regulations for the application of sanctions shall be determined by the Regulation of this Law.

Health workers who have legally proven participation in trafficking of organs, tissues, derivatives, or anatomical materials in transplants outside of what is provided in this Law shall be administratively suspended from the exercise of their profession or trade, without prejudice to other administrative, civil, or criminal responsibility. The facilities in which illegal trafficking of organs, tissues, and derivatives, or anatomical materials occurs, or where such transplants are carried out shall have their administrative authorizations to operate suspended.

The installation and operation of Banks of public or private Organs, Tissues, Derivatives, or anatomical Materials must be authorized by the Secretary of State in the Ministry of Health and supervised by the Medical Superintendency.

As of the effective date of this Law, information on the benefits of organ donation and on the obligations and rights that it establishes must be mandatorily included in the related subjects of basic and secondary education study programs. The Secretary of State in the Ministry of Health shall request free space from media outlets for the dissemination of campaigns aimed at promoting, at least every six (6) months per year, the culture of organ donation and to inform about the requirements it establishes. CHAPTER IV FINAL PROVISIONS

The General Regulation of this Law shall be issued by the Secretary of State in the Ministry of Health, within a term of three (3) months counted from the effective date of this Law.

To repeal Decree No. 131 of November 11, 1982, containing the LAW ON TRANSPLANT AND EXTRACTION OF HUMAN ORGANS AND TISSUES.

This Decree shall enter into force as of the day of its publication in the Official Gazette "La Gaceta". Given in the city of Tegucigalpa, municipality of the Central District, in the Session Room of the National Congress, on the sixteenth day of the month of January of two thousand fourteen. MAURICIO OLIVA HERRERA PRESIDENT, BY THE LAW GLÁDIS AURORA LÓPEZ CALDERÓN SECRETARY ÁNGEL DARIO BANEGAS LEIVA SECRETARY Forwarded to the Executive Branch on March 28, 2014. Therefore: Let it be executed. Tegucigalpa, M.D.C., April 10, 2014. JUAN ORLANDO HERNÁNDEZ ALVARADO PRESIDENT OF THE REPUBLIC THE SECRETARY OF STATE IN THE MINISTRY OF HEALTH EDNA VOLANY BATRES CRUZ Executive Branch EXECUTIVE DECREE NUMBER PCM-009-2014 THE PRESIDENT OF THE REPUBLIC IN COUNCIL OF MINISTERS, WHEREAS: In accordance with what the Constitution of the Republic establishes, the Constitutional President of the Republic has under his charge the general administration of the State. WHEREAS: That by constitutional and legal mandate, education is an essential function of the State and it is the duty thereof to provide all Hondurans with the benefits of education. WHEREAS: That it is fundamental to form, train, and educate with high quality standards our human resources with the firm purpose of converting Honduras into a highly competitive country with the rest of the nations of the world. WHEREAS: That the Constitution of the Republic and the Fundamental Law of Education guarantee the human right to education, recognize the student as the holder of that right and principal actor, and establish that the primary purpose of education is the maximum development of his or her potential and personality. WHEREAS: That compliance with the Fundamental Law of Education and with all else linked to the national educational field that derives from it is mandatory and requires organizational transformation and integration of the National System of Education, as well as the definition and execution of effective policies and programs, in a decentralized manner, based on results. WHEREAS: That efficient coordination of the educational activity of the different public and private, national and foreign organisms and institutions is also necessary, in their respective areas of competence, that has direct or indirect impact on the development of educational activities, in order to sustainably raise its level of quality and equity. WHEREAS: That it is an attribution of the President of the Republic to organize, direct, orient, and promote education