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Act Of Donation And Transplantation Of Organs, Tissues And Cells

Original Language Title: Ley Orgánica de Donación y Trasplante de Organos, Tejidos y Células

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Year II -- Quito, Friday, March 4, 2011 -- No. 398

ING. HUGO ENRIQUE DEL POZO BARREZUETA

DIRECTOR

Quito: Avenida 12 de Octubre N 16-114 y Pasaje Nicolás Jiménez Dirección: Telf. 2901-629 -- Offices and sales: Telf. 2234-540 Distr ibution (Storeroom): 2430-110 -- M anosca Nº 201 and Av. 10 de Agosto. 10 de Agosto -- Telf. 2527-107 Annual subscription: US$ 400 + VAT -- Printed in National Editor 1,150 copies -- 40 pages -- Value US$ 1.25 + VAT

SUMMARY:

Pags.

NATIONAL ASSEMBLY

LAW:

-Organic Law on Donation and Transplantation of Organ, Tej and Cells ....................

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DECREE:

668 Reform the Procurement Regulation

of Vehicles for State Institutions, issued by Executive Decree 519, published in the Official Register 315 of November 8, 2010 .....

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EXECUTIVE FUNCTION

AGREES:

NATIONAL SECRETARY OF PUBLIC ADMINISTRATION:

601 Author izase the journey and declare in commission

of services abroad to the eco nomist Wilson Pastor Morr is, M inister of Natural Resources Non-Renewables ......

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602 Author izase the trip and declare in commi-sion of services abroad to Mr. Freddy Ehlers Zur ita, M inistro de Tur ismo ...................................................

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603 Author izase the trip and declare in commission of services abroad to Dr. Domingo Paredes Castill or, Secre-tar io Nacional del Agua ..............................

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Pags.

604 Leave no effect to Agreement 531 of December 2, 2010 .......................................

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M CULT URA:

016 2011 Delegate to Mrs. Deputy Minister of Cul-tura, the competence to exercise in

representation of this Mystery M, Chair of the National Permanent Commission on Civic Commemorations

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M JUSTICE, HUMAN RIGHTS AND CULT:

0251 Order the registration of the status of the religious entity called " Centro Comunitar io Pastoral Alianza de Cr istö Runakuna Yachana Wasi-Kkarawai ", with either house or in the canton Quito, province of Pichincha ..................................................

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0252 Delegate to the Deputy Minister of Justice, Human Rights and Cults, all of the obligations and duties of the Direc-tora/National Director of Social Rehabili .......................................................

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RESOLUTIONS:

M ENVIRONMENT MYSTERY:

541 Approve the Am-biental Ex-Post Impact Study and the Am-biental Management Plan of the Industr al Chaide and Chaide Plant, located in the Ruminahui canton, Pichincha Province, and grant the environmental licen-cia to the same company, for the execution of this project .......................

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Administration of Mr. Ec. Rafael Correa Delgado Constitutional President of the Repub lica

2 -- Official Registration No. 398 -- Friday, March 4, 2011

Pags.

GOVERNING BOARD OF THE

ECUADORIAN INSTITUTE OF SOCIAL SECURITY:

C.D. 346 Reform the IESS Organic Fun-International Regulation ............................................ 21

ECUADORIAN INSTITUTE OF

PROPERTY INTELE CTUAL:

004-2011 DNPI-IEPI Delegate temporarily goes-r ias atr ibutions, to lawyer Kar ina

Guerrero Flores, Deputy Regional Director of the IEPI in Guayaquil ................................

28

008-2011 DNDAYDC-IEPI Delegate temporarily var ias faculties to lawyer Kar ina

Guerrero Flores, Deputy Regional Director of the IEPI in Guayaquil ................................

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COTOPAXI PROVINCIAL ADDRESS INTERNAL REVENUE SERVICE:

PCO-SPRRDRI11-0001 Assignate to Serversas Maria Gabr iela Atiaga Romero, Paola

Marylin Pérez Cedeno and Veronica de las Mercedes Barba Carr asco, atr ibutions de la Dirección Regional .............................

30

PCO-SPRRDRRI11-0002 Assignate atr ibutions to server M iryam Noemi Alban Moyano,

in the Mana ..................................................

31

MUNICIPAL ORDINANCES:

03 CCP Autonomous Municipal Government of the Canton Paute: Regulating the integral handling of solid waste ..................

31

-Canton Baba Municipal Decentralized Autonomous Government: That defines the Government's designation of the Descentra-li zado Municipal Government of the Canton Baba ............

39

NATIONAL ASSEMBLY

Office No. SAN-2011-0154 Quito, February 12, 2011 Mr. Engineer Hugo del Pozo Barrezueta Director of the Official Register Cuidad Of My Consideration: The National Assembly, in accordance with the privileges conferred upon it by the Constitution of the Republic of Ecuador and the Organic Law of the Function

Legislative, discussed and approved the project of ORGANIC LAW OF DONATION AND TRANSPLANTATION OF ORGANS, TISSUES AND CELLS. In session on 14 February 2011, the plenary session of the National Assembly met and gave a statement on the partial objection presented by the Constitutional President of the Republic. As explained above; and, as provided for in Article 138 of the Constitution of the Republic of Ecuador and Article 64 of the Organic Law of the Legislative Function, it accompanied the text of the ORGANIC LAW OF DONATION AND TRANSPLANTATION OF ORGANS, TISSUES AND CELLS, so that it can be published in the Official Register. Intently, f.) Dr Andrés Segovia S., Secretary General.

NATIONAL ASSEMBLY

THE PLENO

Considering:

What, the first paragraph of article 32 of the Constitution of the Republic establishes that health is a right that must be guaranteed by the State; That, the second paragraph of article 32 of the Constitution of the Republic expresses that the provision of health services shall be governed, among others, by the principles of precaution and bioethics; That, Article 50 of the Constitution of the Republic guarantees to every person suffering a catastrophic or high complexity illness the right to an attention " Special and free, in a timely and preferential manner; that, the numeral second of Article 66 of the Constitution of the Republic recognizes and guarantees to persons the right to a dignified life, which ensures their health; that, literal (a) of article 66 of the Constitution of the Republic guarantees the right to personal integrity that includes the physical, mental, moral and sexual integrity; that, the literal d) of article 66 of the Constitution of the Republic prohibits the use of genetic material and scientific experimentation that attack human rights; Article 84 of the Constitution of the Republic establishes the obligation of the National Assembly to adapt, formally and materially, the laws and other legal norms to the rights provided for in the Constitution and those necessary to guarantee the dignity of the human being; that, the second paragraph of Article 133 of the Constitution of the Republic provides that the laws governing the exercise of constitutional rights and guarantees shall be organic;

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That, in accordance with the provisions of Article 361 of the Constitution of the Republic, the State shall exercise the rectory of the national health system through the national health authority; that Article 358 of the Constitution of the Republic establishes that the national health system shall have the purpose of developing, protecting and recovering the capacities and potentialities for a healthy and integral life, both individual and collective, and shall recognize social and cultural diversity; Among others, it will guide the principles of bioethics and sufficiency; that, the numeral 1 of article 363 of the Constitution of the Republic states the responsibility of the State to formulate public policies that guarantee the promotion, prevention, cure, rehabilitation and comprehensive health care and to promote healthy practices in the fields of the family, labor and community; that, the number 3 of article 385 of the Constitution of the Republic establishes that it is the objective of the national system of science, technology, innovation and ancestral knowledge to develop technologies and innovations that improve the quality of life and contribute to the realization of good living; that, the American Declaration of the Rights and Duties of Man establishes the right to the preservation of health and welfare, stating that every person has the right to be preserved by health and social measures concerning food, clothing, housing and medical care, corresponding to the level that the public and community resources permit; that, in 1997, the General Conference of the United Nations Educational, Scientific and Cultural Organization (UNESCO), in its 298va. meeting, approved the Universal Declaration on Human Genome and Human Rights, which was adopted by the General Assembly of the United Nations in 1998; which, in 1999, the General Conference of UNESCO, in its 308va. meeting, endorsed the guidelines for the implementation of the Universal Declaration on Human Genome and Human Rights approved by the Intergovernmental Committee on Bioethics; Que, the Pan American Health Organization/World Health Organization (PAHO/WHO), at the Third Latin American Meeting of Law, Bioethics and Human Genome, held in the city of Santiago, Chile in 2001, issued the Ibero-Latin American Declaration on Law, Bioethics and Human Genome; That, the 63rd World Health Assembly reviewed the WHO's Guiding Principles on Transplanting human tissues, cells, tissues and organs, inviting the Member States to adopt the recommended resolution; whereas, the UNESCO General Conference, held on 19 October 2005, adopted the Universal Declaration on Bioethics and Human Rights, the principles of which are based on respect for the life and dignity of persons

and its fundamental freedoms, with fundamental recognition of the inter-relationship between ethics and human rights; and, which said Declaration recognizes that the identity of a person includes biological, psychological, educational, affective, cultural and spiritual; that, one of the main objectives of the Universal Declaration on Bioethics and Rights is to provide a universal framework of principles and procedures that serve as a guide to States in the formulation of legislation, policy or other instruments in the field of bioethics; while determining that any preventive, diagnostic and therapeutic medical intervention will only be carried out with prior free and informed consent of the person concerned, based on adequate information; Genetic Data, held on 16 October 2003, recognises that genetic information is part of the overall medical data collection, and that the content of genetic information is closely linked to the context and depends on the circumstances of each case; recognising, likewise, that human genetic data is unique because of its sensitive data and that the States and institutions must apply rigorous confidentiality requirements to all medical data; that the Organic Health Law, published in the Supplement to the Official Register No. 423 of 22 December 2006, regulates the Organ transplants, tissue and disposal of corpses; and, In use of the privileges conferred upon it by the Constitution of the Republic and the Law, it states the following: ORGANIC DONATION AND TRANSPLANTATION LAW

OF ORGANS, TISSUES AND CELLS

PRELIMINARY TITLE

Of the object and scope of application

Ar t. 1.-Object.- This Law guarantees the right to health in the field of transplants, through the regulation of activities related to the collection and clinical use of organs, tissues and human cells, in addition to products derived from them, including the promotion, donation, extraction, preparation, storage, transport, distribution and transplantation. This law aims to promote the transplanting activity in the country, as well as to consolidate the National Integrated Donation and Transplant System that strengthens the public system and acts under the State's rectory, through the National Health Authority, guaranteeing the fulfillment of the rights enshrined in the Constitution of the Republic and in strict observance with the constant provisions in the international treaties and instruments in force on the human genome, genetic data and bioethics. Art. 2.-Scope of application.- The provisions of this Law are mandatory for the entire National Health System on issues related to the donation and transplantation process.

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This standard includes new practices or techniques that the National Health Authority recognizes as linked to the implantation of organs or tissues in human beings.

Art. 3.-Responsibility of the National Sanitar Authority.- It is for the National Health Authority, in the exercise of its rectory, to issue public policies related to the donation and transplantation of organs, tissues and cells, according to the following responsibilities: a) Create and develop the Integrated National System of

Donation and Transplants;

b) Generate the appropriate mechanisms for the mandatory detection and reporting, to the National Health Authority, of potential donors in both brain and heart deaths, as determined by the respective regulations;

c) Ensuring access to transplants for Ecuadorian citizens, and for foreign nationals residing in the country, who require it and meet the technical and/or medical criteria to undergo them;

d) To develop the transplanting activity, especially the implementation of heterologous banks of hematopoietic progenitors, tissue banks as well as transplant units in the hospitals of the National Health System, mainly in the public system;

e) Develop new techniques for transplantation, which are approved by international organizations to which the country is located;

f) Develop and strengthen the training of personnel who are part of the National Integrated Donation and Transplant System;

g) Implement actions aimed at increasing the number of organ, tissue and cell donors throughout the National Health System; and,

h) Ensuring the resources needed to implement the policy and the National Integrated Donation and Transplant System of organs, tissues and cells throughout the country.

TITLE I

From the Incios Pr, Rights, and Generalities

FIRST CHAPTER

From the Inciples Pr

Art. 4.-Pr incites.- In addition to those established in the Constitution of the Republic and the existing international treaties on the subject, this Law is governed by the following principles: a) Altruism.-It is human behavior that reflects a

attitude of voluntary service, manifesting concern or disinterested attention on the other;

b) Volunteering.-Human attitude that manifests, freely and

potestatively, the intention to participate in a donation process;

c) Gratuity.-It will not be possible to offer or to perceive economically or economically valuable compensation for the donation of organs and/or human tissues, by the donor or any other natural or legal person;

d) Solidarity.-It is one of the principles of philosophy

social and political that determines a relationship between human beings, derived from justice, based on equality, that seeks the good of others;

e) Transparency.-All processes related to the

donation and transplantation of organs and/or human tissues will be carried out with transparency, so that they allow and promote knowledge, contents, and foundations for the realization of these processes;

f) Interculturality. -The consideration and guarantee of

respect for diversity that in relation to the health and integrity of the person have the members of the collectives, communes, communities, peoples and nationalities; as well as, the dialogue between the knowledge on human health among the cultures; and,

g) Bioethics.-the moral, interdisciplinary and ethical examination

of the dimensions of human behavior in the area of life sciences and health, examined in the light of moral values and principles.

CHAPTER SECOND

Donor and recipient rights

Ar t. 5.-Rights.- In addition to those established in the Constitution of the Republic and the international treaties in force on the subject, donors and recipients will enjoy, within the process of donation, the following rights: a) To be informed truthful, timely and previously about

the consequences of the decision to participate in a donation and/or transplant procedure;

b) To express explicitly and in writing your

consent to participate in a donation and/or transplant procedure, whether as a donor or recipient;

c) A that information that relates to your identity, that

may affect your rights in any way, is not disclosed and your confidential nature is respected;

d) That all data to be determined or obtained,

product of the procedure of donation and/or transplantation, are protected and precautionary in their confidentiality by those who own them;

e) To receive, timely and free of charge, all

facilties to protect their health, ensuring accurate assistance for their restoration, without prejudice to the place where the donation and/or transplantation process takes place;

f) To the guarantee that the anatomical components,

from a donation prior to their use, comply with all legal and technical requirements in each of the stages of the process;

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g) To ensure that the State guarantees the necessary resources to

ensure a specialized place for the treatment of the patient and the person's accommodation in their care, maintaining appropriate conditions for a favorable and satisfactory evolution; and,

h) To receive the necessary medication in free, timely and permanent form by the State for the maintenance of the transplanted organ under the highest standards that guarantee its quality and effectiveness.

THIRD CHAPTER

Generalities

Pr Section Image

Common Provisions

Ar t. 6.-Organ, tej and cells.- The organs, tissues and cells, regardless of the place of their ablation or removal, once obtained according to the rules of this Law, are the responsibility of the National Health Authority, including its proper use. Art. 7.-Delivery of Information.- All the actors of the National Integrated Donation and Transplant System are obliged to provide regularly the information regarding the frequency, processes and results in the short and medium term to the regulatory body defined by the National Health Authority. The National Health Authority is obliged to carry out the respective periodic checks, at least once a year. Art. 8.-preferential treatment.- Everyone, who has received a transplant organ, will have preferential treatment in medical care in order to preserve the transplanted organ and improve its quality of life. Similarly, any person who has received a transplanted organ has not recovered his/her functional, organic and/or work abilities, will be considered as a person with disabilities, so that he/she can obtain the relevant legal benefits.

The same treatment shall be granted to all or all living donors who, for the purpose of the donation, have suffered an alteration that means a decrease or disability in their organic and health functions which, duly certified by a qualified medical institution, at least partially incapacitate them for the activities it carried out before the donation.

Art. 9.-Exceptions.- The provisions of this Law shall not apply to cases of human blood, its differentiated components, sperm and eggs. The medical activities in which these elements or parts of the human body are used, will be regulated by international provisions, health laws, and more legal bodies.

Second Section

Confidentiality

Art. 10.-Data protection and confidentiality.- The National Health Authority, through the designated regulatory body, shall take the necessary measures to ensure that the information generated from the process of

donation and transplantation, becomes anonymous, in order to ensure that the donor and the recipient are not identifiable. Consequently, it is the duty of the National Health Authority: a) Adopt measures to ensure the security of the

data and the imposibilityof its unauthorized disclosure, as well as to establish safeguards to prevent additions, deletions or modifications of data in the tokens or registers of the donors;

b) Establish procedures to address possible discrepancies in the data; and,

c) Reglamenting that the Banks of Tissue and Cells retain the necessary data for a minimum of thirty years, to ensure their tracing in all phases. The data will be archived in physical and electronic support.

Art. 11.-Prohibition of the disclosure of information.- no case shall information be provided or disclosed to permit the identification of the donor and/or the recipient of the organs, tissues or cells, except in the case of a requirement of the judicial function, within the scope of its jurisdiction, or by action of habeas data, whose audience shall be reserved. The official who divulges the information considered as confidential by this law shall be immediately removed without prejudice to the actions which may be initiated against him. Art. 12.-Identity of the donor and/or recipient.- The donor or the donor may not know the identity of the recipient or the recipient, or the donor, with the exception of the living donors. Art. 13.-Adoption of preventive measures.- The duty of confidentiality shall not prevent the adoption of preventive measures when suspected of the existence of risks to the individual or collective health, in the terms provided for in the Constitution of the Republic, the international treaties and instruments in force, this Law and other laws in force that govern public health in the country. Art. 14.-Prohibition of compensation.- No financial or other compensation may be received for the donation of organs, tissues and/or human cells in favour of the donor or other person.

Third Section

Of The Integrated National Donation and Transplant System

Art.15.-Integrated National Donation and Transplant System.- The Integrated National Donation and Transplant System is created as part of the National Health System that will act under the National Health Authority's rectory. The system shall be coordinated by the body designated for this purpose by the National Health Authority and shall be responsible for implementing public policies in this field. It will comprise the institutions, programs, policies, resources, actions and actors related to the transplantation of organs, tissues and human cells.

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The development of the System will be based on the technical analysis of the potentialities and capacities of the institutions of the National Public Health System, in order to promote its specialization and strengthening. Art. 16.-Integrants of the National Integrated Donation and Transplant System.- All institutions, entities and/or professionals, which are part of the National Integrated Donation and Transplant System, must have the respective accreditation issued by the National Health Authority. They are part of the National Integrated Donation and Transplant System: a) Hospitals and institutions of the National System of

Health;

b) The general clinical laboratories of the health network and the special laboratories of genetics;

c) The tissue banks and heterologous banks of hematopoietic progenitors, accredited by the National Health Authority;

d) Medical professionals or specialized medical teams in transplants;

e) Scientific research centers that develop organ, tissue and/or cell transplantation activities;

The country's airport system, within the scope of its competence;

g) The judicial function, within the scope of its competence; and,

h)

autonomous autonomous governments of the provinces

district and municipal, within the scope of their respective competences.

The Armed Forces, the National Police, air, land, and river transport companies; and other institutions, will be entities of logistical and operational support in the transplantation processes and will comply with the provisions of this Law and its regulations. Art. 17.-Optimisation of units of high completeness.- The National Health Authority, through the appropriate mechanisms, will create and/or strengthen units of high complexity in the public system, in order to generate the sufficient and necessary capacities to develop the transplanting activity in the country, the same ones that will be part of the National Integrated Donation and Transplantation System, being responsible for the supervision, monitoring and evaluation in the pre-transplant, transplant and post-transplant phases. Art. 18.-Staff training.- The National Health Authority will prioritize the training of health personnel and ensure sufficient and necessary human resources for this purpose. Art. 19.-Author and Accreditation.- Transplants of organs, tissues and cells can only be performed in hospitals and health institutions that have the authorization of the National Health Authority.

The accreditation will be granted by the entity or agency designated by the National Health Authority. The requirements for accreditation shall be determined in the regulation to be issued for the purpose. The National Health Authority shall suspend or withdraw the authorisation and/or accreditation of the transplant programmes of the health establishments which do not carry out these procedures, in accordance with the relevant regulation, immediately and after the relevant inspection. Art. 20.-The National Health Authority be jointly and severally liable for any damages arising from the accreditation of establishments and professionals who have not complied with the requirements laid down in this Law and its regulations. The institutions in which the transplanting activity develops and their teams of professionals shall be jointly and severally liable for any violation of the provisions of this Law and its regulations. Art. 21.-Preparation of the human resource.- The institutions of higher education, in coordination with the National Health Authority, will ensure the preparation of the professional human resource and the transplant teams, through processes of training and permanent education. Until the national higher education institutions offer advanced and specialized postgraduate studies in this field, the corresponding preparation will be carried out through cooperation agreements with educational institutions in other countries. Art. 22.-Professional Accreditation.- The medical acts referred to the donation and transplantation process referred to in this Law can only be performed by health professionals accredited, for this purpose, by the National Health Authority and recognized by the Secretariat of Higher Education Science, Technology and Innovation. Art. 23.-Integration of transplant teams.- The transplant teams will be formed for each type of transplant. Professionals will be able to participate in transplant teams for which the Health Authority has granted their accreditation, but they will not be able to participate in two or more simultaneous transplants. Foreign professionals will be able to carry out their activities in the country, as long as they meet the requirements laid down in this Law and in the Organic Law of Higher Education. Professionals belonging to transplant teams may not be part of the regulatory body. Art. 24.-Of the remuneration.- The professionals who are part of the National Integrated Donation and Transplant System will receive a remuneration according to the activity carried out, which guarantees their permanent dedication to the System. Art. 25.-The National Single Wait L ist.- The organs, tissues and/or cells will be distributed respecting the National Single Wait List; and, in specific cases, on the basis of the technical scales adopted for each organ and tissue in particular.

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The National Single Wait List will be set according to the parameters defined in accordance with the regulation that, for each organ and/or fabric, establishes the competent authority. The National Health Authority shall administer this database and assign the anatomical components with respect to universal and constitutional principles and criteria, in particular the best interests of girls and boys and the conditions of double infringements. It is recognized the right of the Ecuadorian residents abroad, who require a transplant, to be incorporated in the National Single Wait List according to the regulations that are dictated to the effect and in accordance with the international conventions regarding the matter that the Ecuadorian state subscribes. Art. 26.-Assignments of anatomical components.- The National Health Authority, according to technical scales, will design the operating mechanisms for the allocation of the anatomical components from a donation.

Art. 27.-Reference obligator ia.- Every doctor who diagnoses a disease susceptible to being treated by a transplant, has the obligation to notify the patient and refer to the corresponding health units.

TITLE II

Of Organ and Tej Donation and Tej

FIRST CHAPTER

Of The Donation

Art. 28.-Donor identification system.- The National Health Authority will develop a system for identifying potential donors. This system will be mandatory in all the institutions that are part of the National Health System.

Art. 29.-Donation.- Ecuadorians, Ecuadorians and foreign legal residents in the country, over the age of eighteen, will become donors, unless they have expressed their willingness to the contrary in one of the following ways:

a) Manifesting their refusal to grant organs, tissues or cells from their body for later implantation in living human beings or for study or research purposes; or,

b) By restricting, in a specific way, their affirmative will to donate to certain organs, tissues and/or cells.

Art. 30.-Expression of Will.- The manifestation, restriction or conditioning of the will for the donation of anatomical components will be recorded in the citizenship card in the case of the Ecuadorian citizens and in any other document of identification in the case of the foreigners legally resident in the country. The refusal of persons to be donors shall not create any discrimination and shall not be publicly used by any authority, person or means of communication.

Art. 31.-Registration of the demonstration of will.- It is the obligation of the Directorate General of Civil Registry, Identification and Cedulation of the Republic to consult and collect from persons over eighteen years of age, who are present before that body, the manifestation of their will with respect to the quality of organ donors and to register it in the respective identification document. Art. 32.-Author of donation of organs, tej and cells of deceased minors.- When the diagnosis of death of Ecuadorians, Ecuadorians or foreign residents legally resident in the country, under eighteen years of age and not emancipated, is verified, only their parents and in the absence of these their legal representatives will be able to authorize, exclusively, the donation of their organs, tissues and/or cells specifying the scope of the same. In the absence of the persons mentioned in the previous paragraph, the judges of the competent children and adolescents may intervene to authorize the donation. Art. 33.-Requirements of the donation in life.- Any person may donate their anatomical components in life, provided that the following requirements are met: a) That the donor or the donor is older, in enjoyment of

full mental faculties, with a health status appropriate to the procedure and there is biological, morphological and functional compatibility with the recipient or the recipient;

b) That the recipient has a parentage, up to the fourth

degree of consanguinity, with the donor or the donor, or is a partner in free union; and, being the case, the compatibility between the donor and the recipient has been proven through the corresponding medical tests. The same rule will apply for adoption fili cases;

c) That the donor and/or recipient have been

previously informed of the possible consequences of their decision and grant their written and notarized consent, in a free, conscious and voluntary manner. Such consent shall be annexed to the respective medical records;

d) That the recipient is a person determined in

prior form, according to the regulation to this Law;

e) That the removal of parts or tissues or removal of

organs does not involve the risk of permanent functional incapacity for the donor;

f) That there are no indications of illegal tourism practices

for transplantation or organ trafficking; and, g) In the case of cross-donation, the identity

of the recipient or the recipient will not be recorded and will be codified by the Health Authority. National.

Art. 34.-Restr tion of donation in life.- The removal of organs from living donors will be limited to situations in which the success of the transplant is anticipated.

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Art. 35.-Express Consent.- The donation of organs, tissues and/or cells of living donor, for transplantation purposes, will require the declaration of the informed consent of the donor, granted to a notary public. This declaration will be incorporated into the corresponding psychiatric report on the normality of their mental faculties. To this end, it will be necessary to have the reasoned report of the Ethics Committee of the transplant hospital.

Art. 36.-State of health.- The state of physical and mental health of the donor or donor must be certified by a physician, other than those who are to carry out the extraction and transplantation. This professional must inform the patient about the risks inherent in the intervention, the foreseeable consequences of a somatic or psychological order, the repercussions he may have on his personal, family or professional life and the expected benefits.

Art. 37.-Transfer document.- The transfer document, where the conformity with the donation is recorded, will be signed by the donor, the doctor who has to carry out the extraction and the other assistants. Any of them may object, in express form, to the donation in case of doubt regarding the suitability of the consent of the donor, which shall be notified immediately to the regulatory body.

Between the signing of the transfer document of the organ and the removal of the organ, subject to the authorization of the National Health Authority, at least twenty-four hours must elapse. Art. 38.-Revocator of consent.- The informed consent of the living donor cannot be replaced or supplemented. However, it may be revoked, in verbal form, until the moment of the surgical intervention, while the donor or the donor retains the capacity to express his will. This recall shall not generate any obligation of any kind or give rise to any damages.

Art. 39.-Prohibition of expressing consent for daughters and children under age or represented alive.- Parents or legal representatives may not grant consent to donate in life, for the purposes of transplantation or other such operation, the organs or tissues of their daughters or children under age or represented. Except for this prohibition, cases of bone marrow donation, which may be authorized exclusively by the parents, are subject to the conditions and limitations laid down in this Law and its regulations.

Art. 40.-Transplants to foreign donors of living donors.- The institutions accredited for the performance of transplants will be prevented from performing surgical acts of donation and/or implantation of organs and tissues to foreign patients who are not legal residents in the Republic of Ecuador.

In the particular case of the foreign patient who is declared in zero code, he will have the same treatment as the national patients. Art. 41.-Donation.- death of a person may be available to all or part of its organs, tissues and/or cells, in accordance with the provisions of Article 29 of this Law.

Art. 42.-Violent death.- In case of violent death of a person, the extraction indicated in the previous article can only be performed when it does not interfere with the final results of the autopsy, being necessary for the realization of the ablation of the organs and tissues the prior notification to the prosecutor in turn. Art. 43.-Xenotransplantation.- The xene-transplant procedures are permitted according to the regulations established in the regulation to this Law.

CHAPTER SECOND

Of the selection, donation, and extraction

Art. 44.-Selection of organs, tej and cells.- The activities related to the selection, evaluation and procurement of organs, tissues and cells shall be carried out by ensuring that these procedures are carried out in accordance with the requirements that the National Health Authority will establish for the purpose. Art. 45.-Ablation procedure.- The removal of organs, tissues and/or cells from a corpse will be performed by accredited professionals. The ablation of organs, tissues or cells will be performed in strict adherence to the protocols issued by the National Health Authority. Art. 46.-Conditions and Conditions for Ablation.- The procurement of deceased donor organs may be performed in all institutions with intensive care units and by personnel duly accredited by the National Health Authority, in accordance with the regulations that dictate to the effect. Art. 47.-anatomical components that can be ablation.- The National Health Authority, according to technical and scientific criteria, will describe in the respective regulations the anatomical components that can be ablation. Art. 48.-Bank of tej and/or cells.- The National Health Authority, in the exercise of its rectory, shall establish, authorize and regulate the operation of tissue bank, non-embryonic or fetal progenitors, hematopoietic and non-embryonic or fetal cells. The obligations of the latter shall be laid down in the rules governing the effect. Art. 49.-Access to the banks of tej and/or cells.- The accredited public and private institutions, which carry out tissue and/or cell implantation, to have access to them, will be registered in a database and their delivery will be carried out according to the corresponding regulation. Art. 50.-Conditions of the tej banks and/or cells.- The tissue and/or cell banks shall ensure that all procedures associated with their procurement, processing, transport, storage and distribution are documented in the procedures and comply with the international regulations and requirements established by the National Health Authority. Art. 51.-Staff of the tej banks and/or cells.- All staff of the tissue banks and/or cells involved in the various activities related to the

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obtaining, processing, preserving, storing, and distributing cells and tissues must be accredited for the exercise of their activities. Their profile, functions and responsibilities shall be as provided for in the respective regulations. Art. 52.-Hematopoietic cells.- with progenitor cells, non-embryonic or fetal, hematopoietic stem cells from the bone marrow, peripheral blood and cord umbili cal for the treatment of pathologies may be performed in the country, the efficacy of which has been proven and duly authorized by the National Health Authority. Art. 53.-Stem cells.- The National Health Authority shall monitor and regulate the use, investigation and application of adult stem cells, coming from blood, umbilical cord of the newborn, bone marrow, or any other adult anatomical component from which it is obtained. The application of embryonic and fetal stem cells is excluded. Any new therapy with adult, non-embryonic and fetal stem cells, which is to be applied in the country, must be approved by the National Health Authority and be accepted by the world health agencies from which the Ecuadorian State is a party.

The manipulation of stem cells for research purposes shall be permitted as long as the following requirements are met: (a) Exist the express authority of the authority

competent;

b) Do not exist for profit;

c) Exist the informed consent of the donor and the recipient;

d) Do not involve embryonic and fetal stem cells; and,

e) Other than the respective regulations. Art. 54.-Author.- It will be possible to carry out research with tissue engineering, prior to the authorization of the National Health Authority and the sponsorship of recognized research centers. Art. 55.-Prohibition.- activity involving the use of human tissues and cells that is not regulated in this Law and its regulations is prohibited.

TITLE III

OF THE REGULATORY AUTHORITY

Ar t. 56.-Regulatory Author.- The National Health Authority, in the exercise of its rectory, through the entity or agency designated for the purpose, will regulate, regulate and control the transplanting activity in the Republic of Ecuador. The functions and powers for its operation shall be those laid down in the Regulation to this Law. Art. 57.-Function.- The entity or agency designated by the National Health Authority, which is responsible for implementing the public policy of donation and transplantation, shall be assigned to that Authority and shall enjoy technical autonomy,

administrative and financial. It will be subject to the provisions of this Law and its regulations, ensuring compliance and promoting international cooperation agreements.

Art. 58.-Control of the activity of insurance companies and companies paid for health and prepaid medicine.- The National Health Authority shall regulate and control insurance companies and private health and prepaid medical companies as regards the supply of organs, tissues and/or cells.

The insurance companies and the private health and medical companies are obliged, in the framework of the policies defined by the National Health Authority and this law, to comply with the commitments committed for transplants to be established in the respective contracts or policies, as well as to cover the total amounts of the transplant and the medical complications that may be presented. In the event of non-compliance, these companies will be administratively and civilly responsible. Without prejudice to criminal actions that may be initiated against their administrators and/or legal representatives.

Art. 59.-Education and information campaigns.- The National Health Authority, through its competent authorities, will carry out, coordinate and implement education and information campaigns to promote a solidarity awareness among the population, in order to promote the culture of donation and to explain objectively the benefits of transplants.

Art. 60.-Education campaigns in the National Education System.- The National Education Authority in coordination with the National Health Authority, will incorporate into the national education system plans and programs the theme corresponding to the importance and need of organ donation, tissues and/or cells for transplantation.

Art. 61.-Dissemination to medical units and health professionals.- The National Health Authority will plan, implement and coordinate internal campaigns and training related to the transplantation of organs, tissues and/or cells, for the benefit of medical units and health professionals. Art. 62.-Advertising and Promotion.- The State will guarantee through the corresponding instances, dissemination and promotion, through national information campaigns in the mass media aimed at directing the population towards a culture of donation and transplantation of organs, tissues and/or cells, as well as to inform the right of the population not to be a donor.

TITLE IV

of Administrative Procedure, Bans, and Sanctions

FIRST CHAPTER

Of Administrative Acts

Ar t. 63.-Administrative Acts.- For the implementation of this Law, the National Health Authority shall be governed by the provisions of the Statute of the Administrative Legal Regime of the Executive Function, including the

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impeachment, administrative resources, deadlines to resolve, and the effects of administrative silence. Art. 64.-Regulatory acts.- The normative acts of the entity or agency designated by the National Health Authority shall be issued in accordance with the provisions of the Statute of the Administrative Legal Regime of the Executive Function. The initiative for their issue must be accompanied by the necessary studies and reports to justify their legitimacy and opportunity. Art. 65.-Impeachment of normative acts.- Persons who are directly affected by the provisions of the normative acts, issued in accordance with the provisions of the previous article of this Law, may request their repeal or reform in administrative headquarters, without prejudice to their right to challenge them judicially.

CHAPTER SECOND

Of administrative competence and procedure

Ar t. 66.-Administrative jurisdiction.- The entity or agency designated by the National Health Authority shall have the administrative competence to know, implement and implement the provisions provided for in this Law and to administer administrative penalties for the violations provided for in this Law at the national level. Art. 67.-Exercise of Competition.- The administrative competence of the designated entity or agency shall be subject to the rules established for competition in the Statute of the Administrative Legal Regime of the Executive Function. Art. 68.-Administrative Procedure.- For the purpose of the provisions of this Law, including the application of sanctions, the designated entity or agency shall apply the common administrative procedure established in the Statute of the Administrative Legal Regime of the Executive Function. Art. 69.-Responsibility of the health authorities.- The health authorities, responsible for the application of this Law, who do not comply adequately with their obligation, shall be subject to the administrative, civil and criminal actions to which they may take place.

THIRD CHAPTER

The administrative sanctions and violations regime

Pr imera section

Of the preventive measures and inspection activities

Ar t. 70.-Verification of compliance.- The National Health Authority shall be responsible for verifying compliance with this Law and its regulations by carrying out the inspections and requests for information that it considers relevant. Art. 71.-Preventive measures.- If actions or omissions that could cause harm are verified or

constitute a danger to the health of the persons, as a consequence of the activities related to this Law, the National Health Authority shall establish the preventive measures to be adopted, in accordance with the corresponding regulation.

Second Section

Of administrative violations and penalties

Ar t. 72.-Sanctions.- The administrative violations determined in this Law shall be sanctioned by the National Health Authority with: a) Multa;

b) Suspension of the permit or li cency and accreditation; c) Temporary suspension or definition of the authorization or

accreditation to perform transplant activities;

d) Temporary suspension or definition of the professional exercise; and,

e) Partial, temporary or defined closure of the corresponding establishment.

Art. 73.-Sanctions on the market.- Without prejudice to the civil and criminal penalties to which it may occur, it shall be sanctioned by: a) Fine of fifty basic unified remuneration

of the private worker, who places organs, tissues, cells and/or anatomical components on the market. In the event that they come from living persons, the fine will be one hundred unified basic wages of the private worker; and,

b) Multa of fifty unified basic wages

of the private worker, who provides and/or provides to another with a profit motive, one or more of the organs to be used for transplantation purposes;

Organ donation can only be made free of charge. It is therefore prohibited and shall be null and void and shall have no legal value, the act or contract which, for consideration or for any other type of compensation, contains the promise of delivery of one or more organs for transplantation. Art. 74.-Sanction for the misuse of information.- Without prejudice to the civil and criminal sanctions to be taken, it will be sanctioned with a fine of 100 unified basic remuneration of the private worker, who, using privileged information, favors a recipient for the transplantation of organs, tissues and/or cells, ignoring the National Single Wait List. Art. 75.-Sanction for performing tur ism for transplants- Without prejudice to the civil and criminal penalties to which there is a place, who or those who encourage or participate in activities related to tourism for organ transplantation, in accordance with the provisions of the Pan American Health Organization, will be punished with a fine of one hundred unified basic salaries of the private worker. Art. 76.-Sanction for the conduct of transplant procedures without author ization.- Without prejudice to the

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civil and criminal penalties to be imposed, public or private health facilities in which procedures are performed or have been performed, without the authorization and accreditation issued by the National Health Authority, shall be punishable by a fine of two hundred unified basic remuneration of the private worker and temporary or final closure of the establishment. Art. 77.-Penalties for lack of notification.- Without prejudice to the civil and criminal penalties to which there is a place, the maximum authority of the institution of health, which having knowledge of the commission of the offence established in the previous article has not been notified to the National Health Authority, shall be punished with a fine of fifty unified basic remuneration of the private worker.

In the case of a health professional, you will be suspended for five years, and if you are involved in any other activity, any other activity that is related to the activities covered by this Law will be suspended.

If it is a public institution, its highest authority will be removed, prior to the corresponding administrative summary, respecting due process. Art. 78.-Acting of the health professionals.- Without prejudice to the civil and criminal penalties to which there is a place, the health professional who has carried out any of the procedures referred to in this Law without the proper authorization of the National Health Authority shall be punished with: (a) Temporary suspension of the professional year up to and including

five years; and,

b) A final suspension of the professional exercise, in the event of a recidivism.

Art. 79.-I respect the National Single Wait L.- Without prejudice to the civil and criminal penalties to which there is a place, the institution and/or health professional who violate the provisions of this Law with respect to the order established in the National Single Wait List shall be punished as follows: a) Temporary closure of the institution for up to five

years; and, b) Suspension of the authorization or accreditation of the health professional or the

to carry out transplant activities for up to five years.

In both cases, a fine of twenty unified basic remuneration of the private worker will be applied; and, in the event of a recidivism, the definitive closure of the institution will be imposed or the definitive suspension will be imposed on the authorization or accreditation of the health care professional to carry out transplant activities. Art. 80.-Incompliance in br indar facilties para el transpor te.- Without prejudice to the administrative, civil and criminal sanctions to which there may be, whoever fails to comply with the provisions of the Third General Disposition of this Law

will be punished with a fine of one hundred unified basic remuneration of the private worker.

Art. 81.-Lack of payment of fines.- The failure to pay the fines, applied in accordance with this Law, will make its collection payable by coactive, constituting sufficient executive title the authenticated testimony of the final conviction.

Art. 82.-Reoffending.- The recidivism in the breach of this Law and its regulations will be repressed with the double of the maximum sanction established for the case of the fines, with closing definiti goes for the case of establishments and the definitive suspension goes from the professional exercise for the case of health professionals.

Art. 83.-Destination of the fines.- The total value of the fines applied by the National Health Authority will be deposited in the National Treasury Account and will be used to strengthen the processes of donation and transplantation of organs, tissues and cells throughout the national territory, as well as to the processes of control of the activities provided for in this Law.

Art. 84.-Prescription of administrative actions.- Administrative actions shall be prescribed within three (3) years from the date of their commission.

DEFINITIONS

For the interpretation of the rules contained in this Law, the following definitions will be used: Ablation.- Separation or surgical removal of a part of the body; amputation.

Storage.- It is the maintenance of tissues and/or cells in controlled and appropriate conditions up to their distribution.

Alogenic.- It is the transplant between individuals of the same genetically different species.

Application.- It is any activity that involves the use of cells and/or tissues in a human receptor and/or in extra body applications (the activities of implanting, infusing, grafting, applying, or transplanting are included).

Allocation of organs, tej and/or cells.- It is the procedure whereby, in compliance with the principles of bioethics, the waiting les and their regulations, the Health Authority determines the beneficiary of the organs, tissues and/or cells

Self-graft or single-personnel transplantation.- It is the replacement in a person of anatomical components by others coming from their own organism.

Bank of Tej idos.- It is the technical health unit, specialized and authorized, which obtains, processes, stores and preserves tissues and/or cells for further implantation or use for therapeutic and research purposes, under rules that guarantee the quality from obtaining to the clinical use. Autologous Bank.- It is the technical, specialized, and cali health unit that preserves tissues and cells of the same person.

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alogical Bank.- It is the technical, specialized, and cali health unit that preserves tissues and cells obtained from various donors and used for different receptors;

Cell.- It is the anatomical, functional, and genetic unit of living beings. For purposes of this Law, cells are understood to be the set of individual cells that are not bound together by any form of connective tissue.

Stem cells.- They are those cells that are simultaneously endowed with the capacity of autorenovation (i.e., to produce more stem cells) and to originate committed daughter cells in certain development routes, which will eventually become differentiated in specialized cell types.

Code Zero.- It is the medical condition in which the patient's life is in imminent danger and depends on a transplant of extreme urgency, considering with strict priority in the waiting li. anatomical components.- They are the organs, tissues and/or cells, and in general, all the parts that make up the human organism. Quarantine.- The waiting condition for the extracted tissue or cells, prior to implantation, while making a decision on their acceptance or rejection. Distr ibution.- The transport and delivery of organs, tissues and/or cells destined for implantation in the human being. Donation.- It is the fact of donating tissues and/or human cells destined to be applied in the human being.

Donor.- It is any living or dead human source of organs, tissues and/or cells in good functional condition, to transplant them into another person or to use them for therapeutic or research purposes.

Live donor.- A living donor is considered to be a person who, in compliance with the requirements laid down in this Law and its regulations, makes the donation in life of cells, tissues or organs or part thereof, the function of which is compatible with life and can be compensated by its organism in an adequate and safe manner.

Donal Donor.- The deceased person is considered to be a donor to the deceased person from whom it is intended to extract organs, tissues and/or cells which, in compliance with the requirements laid down in this Law and its regulations, would not have been expressly expressed by his opposition.

Serious adverse effect.- Any adverse event related to the obtaining, evaluation, processing, storage and distribution of anatomical components that may lead to the transmission of a disease, to the death of the patient, or to states that endanger their lives, disabilities or disabilities or that may result in hospitalization, or disease, or may prolong it.

Transplant Equipment.- Interdisciplinary group of professionals with academic training and certified experience in the different processes related to the procurement of organs, ablation and/or transplants of tissues and cells, called by the National Health Authority. National Single Wait List.- It is the orderly registration of patients with pathologies susceptible to transplantation, managed directly and exclusively by the National Health Authority, which are waiting for an organ, tissue and/or corresponding cells and that has met the established requirements, in accordance with the corresponding regulations. Death.- For purposes of this Law, it is the " permanent cessation of the function of the organism as a whole. This definition implies that the maintenance by artificial means of the cardiovascular and ventilation function is reduced to the functioning of independent "subsystems" and that the function of the organism "as a whole" has been lost; considering that the brain is responsible for the function of the organism as a whole "is considered that" brain death " is equivalent to death. Brain Death.- Irreversible cessation of brain functions, even in the presence of cardio-vascular and artificial ventilation, certified according to the protocol that the National Health Authority rules. Organ.- A differentiated and vital part of the human body formed by different tissues, which maintains its structure, vascularization and capacity to develop physiological functions with a level of important autonomy. Preservation.- The use of physical and chemical agents, or other means during the obtaining, processing and maintenance of organs and/or tissues, in order to delay the biological or physical deterioration thereof. Attorney General's Office.- It is the set of activities related to the detection, identification, evaluation and maintenance of a potential donor, with the diagnosis and certification of death, obtaining the consent of the family or of attorney in the case of children and adolescents or of persons who cannot express their will according to the law; coordination with the equipment of ablation, conditioning and maintenance of the organs, tissues and cells in conditions of viabili ty for its implant. As well as the assignment, search and location of receivers. Protocols.- They are the documents that define the technical and administrative procedures and procedures of the transplantation process and in which all the data and information that must be met by the responsible for the different phases of the transplants. Receiver.- It is the person in whose body anatomical components are implanted from another human organism or another species. Tej gone.- All constituent parts of the human body formed by cells joined by some type of connective tissue.

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Organ Trafficking.- It is the extraction or procurement, transportation, transfer, cover-up, and/or receipt of anatomical components of living or deceased persons for the purpose of obtaining or extracting their organs, tissues or cells for transplantation purposes; by a threat, use of force or other forms of coercion, plagiarism, fraud, abuse of power, or the delivery and receipt of payments or benefits.

Transplant.- It is the replacement, for therapeutic purposes, of anatomical components in a person, by other equals and functional, coming from the same recipient, from a living or a cadaveric donor.

Trazabili dad.- Ability to locate and identify tissues or cells during any stage, from obtaining, through processing, evaluation and storage, to their distribution to the recipient or their disesteem or elimination, including the ability to identify the donor, tissue and cell bank, facilities that receive, process or store the organs, tissues or cells, the receptors and any products and material that comes into contact with those tissues or cells and which may affect the quality and safety of the cells. Transplantation ism.- It is the transfer of organs, donors, transplant recipients outside their original jurisdictional borders, directed to perform a transplant in Ecuador, without having the category of immigrant in the country.

Validation.- It is the documentary evidence that proves, with a high level of guarantee, that a certain process, equipment or part of a team or environmental condition ends up producing, in a consistent and reproducible manner, a certain product that meets the specifications, qualities and attributes that had been predetermined. A process is validated with a view to testing its effectiveness for a given use.

Xenotransplantation.- It is the transplantation of organs, tissues, or cells from one species to another. That is, the use of organs, tissues or animal cells for implantation in the human being.

GENERAL PROVISIONS

FIRST.- Transplants of organs, tissues and cells will be considered as current and non-experimental technique practices and will be subject to the technical and legal procedures of quality control to be established by the National Health Authority.

SECOND.- It is the obligation of the National Health Authority to strengthen public health services, so that they may develop procedures for the transplantation of organs, tissues and cells at the national level.

THIRD.- Air, land, sea and river transport companies must provide all the facilties to transport the human equipment, organ, tissue, cell or anatomical component that is necessary to perform a transplant procedure.

TRANSIENT provisions

FIRST.- The President of the Republic, within ninety days of the validity of this Law, will issue the Regulation that believes or ratifies the

regulatory body for transplantation of organs, tissues and cells of the Republic of Ecuador. Meanwhile, the National Organ Transplantation Agency, created through Executive Decree No. 2302, published in the Official Register No. 516 of 18 February 2002, will continue to fulfill its functions and duties. SECOND.- The President of the Republic, within ninety days of the validity of this Law, will issue all the relevant regulations for its proper implementation. THIRD.- Once this Law has been enacted, the Directorate General of Civil Registry, Identification and Cedulation in coordination with the National Health Authority, will implement within a period not greater than 360 days, the necessary mechanisms for the application of the provisions of Article 30 of this Law. FOURTH.- The National Health Authority, once enacted this Law and in coordination with related entities, in the course of the subsequent year of the promulgation, will carry out a national information and educational campaign regarding the content of this Law, as well as, of awareness of organ donation and the mechanisms of access to the services; after the year that is referred to in this provision, the provisions of article 29 of the law will be made effective.

REFORMATTER PROVISIONS

FIRST.- Replace the numeral 14 of Article 98 of the General Law of Civil Registration Identification and Cedulation, added by Law No. 67, published in the Supplement to the Official Register No. 423 of 22 December 2006, by the following: "14o.-Manifestation, restriction or conditioning of the will for the donation of organs, tissues or cells of the citizen, in accordance with the provisions of the Organic Law of Donation And Transplantation of Organs, Tissues and Cells." SECOND.- Replace the numbered article, which is contained in the Chapter added by Law 2005-2, promulgated in the Official Register No. 45 of June 23, 2005, by the following: " Article ... (1) Who wilfully violate the obligations or violate the prohibitions provided for in Articles 11, 19, 58, 69, 74, 76, 77, 78 and 79 of the Organic Law on Donation and Transplantation of Organs, Tissues and Cells; who falsifies or adulterates a protocol of donation and transplantation, a document defined in the same Law, shall be repressed with a minor imprisonment of three (3) to six (6) years. In the event of non-compliance with or failure to comply with the obligations or prohibitions referred to above, where it relates to legal institutions or persons, the criminal liability of the institution or legal representative of the legal person shall be presumed. Who, in dolously trade or trafficking with organs, tissues, body substances or any anatomical material from human corpses will be

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repressed with an extraordinary minor seclusion of nine (9) to twelve (12) years. The same penalty will be imposed for those who select, extract, evaluate, prepare, obtain, store, transport, assign, distribute, or transplant dolously.

The penalty will be of extraordinary imprisonment of twelve (12) to sixteen (16) years, if the activities referred to in the previous paragraph are performed with organs, tissues, bodily substances or any anatomical material that comes from living persons.

A maximum of twelve (12) to sixteen years of imprisonment will be imposed on people who extract or transplant any human anatomical component into medical centers not accredited by the National Health Authority.

If the anatomical components extracted or transplanted dolously, come from children, girls or adolescents or persons with disabilities, the penalty will be of special imprisonment of sixteen (16) to twenty-five (25) years. " THIRD.- Agreguese, following the article numbered, added in the chapter added by Law 2005-2, added in the chapter added by Law 2005-2, promulgated in the Official Register No. 45 of June 23, 2005, the following article: " Art. ... (2).-Who transfers organs, donors, recipients or health professionals specialized in transplants, outside their original jurisdictional borders, in order to perform one or more transplants in the Republic of Ecuador, without having the category of immigrant in the country or with the corresponding permissions of the National Health Authority, will be repressed with the penalty of extraordinary imprisonment of twelve (12) to sixteen (16) years. ¨

REPEAL provisions

FIRST.- Repeal the Law of Transplantation of Organs And Fabrics, Law No. 58, published in the Official Register No., 492 of 27 July 1994. SECOND.- Derogase Article 82 of the Organic Health Law, Law No. 67, published in the Supplement to the Official Register No. 432 of 22 December 2006. THIRD.- Derogase Article 83 of the Organic Health Law, Law No. 67, published in the Supplement to the Official Register No. 432 of 22 December 2006. FOURTH.- Derogase article 252 of the Organic Health Law, Law No. 67, published in the Supplement to the Official Register No. 432 of 22 December 2006. QUINTA.- I expressly repealed all those rules that are contrary to this Law. Article final.- This Law shall enter into force from the date of its publication in the Official Register and signed at the headquarters of the National Assembly, located in the Metropolitan District of Quito, province of Pichincha, on the fourteenth day of February of two thousand eleven. f) FERNANDO CORDERO CAVE President f) DR. ANDRES SEGOVIA S. Secretary-General.

CERTIFIED that the National Assembly discussed and approved the ORGANIC LAW ON ORGAN, TISSUE AND CELL DONATION AND TRANSPLANTATION, in the first debate on 28 October 2010, in the second debate on 4 and 6 January 2011, and gave a statement on the partial objection of the President of the Republic on 14 February 2011. Quito, 21 February 2011. f.) Dr Andrés Segovia S., Secretary General.

Nº 668

Rafael Correa Delgado CONSTITUTIONAL PRESIDENT OF LA

REPUBLIC

Considering:

That article 288 of the Constitution of the Republic of Ecuador states that, in matters of public procurement, national products and services will be prioritized and that the criteria of environmental responsibility must be observed; that Article 18 of the Law on Industrial Development, in accordance with the rules of the Law on the Promotion of Automotive Industry, establishes that the National Government, the institutions of law public and private with a social or public purpose and all others who enjoy some state benefit, provincial, municipal, or who participate in public funds, will compulsorily supply themselves with products from the national industry; that in accordance with article 10 of the Organic Law of the National System of Public Procurement, the Executive Director of the National Institute of Public Procurement has among its powers the authorization of imports of goods and services by the State, in the field of public procurement; 519, published in the Official Registry 315 of 8 November 2010, the Regulation on the Acquisition of Vehicles for State Institutions was issued, to which it is necessary to make adjustments aimed at strengthening national production; and, In use of the privileges conferred by Articles 147, numerals 5 and 13 of the Constitution of the Republic of Ecuador and 11 letters a), b) and f) of the Statute of the Administrative Legal Regime of the Executive Function, it issues the following: REFORM OF THE REGULATION OF ACQUISITION OF VEHICLES FOR STATE INSTITUTIONS, EXECUTIVE DECREE 519, PUBLIC OFFICIAL REGISTER 315 OF 8 NOVEMBER 2010.