ORGANIC HEALTH LAW. Law 67, Official Registry Supplement 423 of December 22, 2006. THE NATIONAL CONGRESS Considering: That numeral 20 of article 23 of the Political Constitution of the Republic consecrates health as a human right fundamental and the State recognizes and guarantees people the right to a quality of life that ensures health, food and nutrition, drinking water, environmental sanitation, ...; That Article 42 of the Political Constitution of the Republic provides that "The State shall guarantee the right to health, its promotion and protection, through the development of food security, the provision of drinking water and basic sanitation, the promotion of healthy family, work and community environments, and the possibility of permanent and uninterrupted access to health services, in accordance with the principles of equity, universality, solidarity, quality and efficiency. "; That the Health Code approved in 1971, contains outdated provisions regarding advances in health public, in human rights, in science and technology, to the health and disease situation of the population, between others; That the current Health Code has undergone multiple partial reforms that have made it a legal body dispersed and disintegrated; That before the current processes of reform of the State, of the health sector and of globalization, in which it is immersed in our country, legislation must prioritize the health interests of the population over commercial ones and economic; That Ecuador has ratified international conventions and treaties that determine important commitments of the country in different subjects such as human rights, sexual and reproductive rights, rights of children and adolescents, among others; That it is necessary to update normative concepts in health, through the promulgation of an organic law that guarantee supremacy over other laws in this matter; Y, In exercise of its constitutional and legal powers, it issues the following: ORGANIC HEALTH LAW PRELIMINARY TITLE CHAPTER I The right to health and its protection Art. 1.- The purpose of this Law is to regulate the actions that make it possible to realize the universal right to health enshrined in the Political Constitution of the Republic and the law. It is governed by the principles of equity, integrality, solidarity, universality, inalienability, indivisibility, participation, plurality, quality and efficiency; with a rights, intercultural, gender, generational and bioethical approach. Art. 2.- All members of the National Health System for the execution of activities related to the health, will be subject to the provisions of this Law, its regulations and the norms established by the authority national health Art. 3.- Health is the complete state of physical, mental and social well-being and not only the absence of conditions or diseases. It is an inalienable, indivisible, irrevocable and intransigible human right, whose protection and guarantee is the primary responsibility of the State; and, the result of a collective process of interaction where State, society, family and individuals converge for the construction of environments, environments and lifestyles healthy. CHAPTER II From the national health authority, its competences and responsibilities Art. 4.- The national health authority is the Ministry of Public Health, the entity to which the exercise corresponds. of the rectory functions in health; as well as the responsibility for the application, control and surveillance of the compliance with this Law; and, the norms that it dictates for its full validity will be obligatory. Art. 5.- The national health authority will create the necessary regulatory mechanisms so that the resources allocated to health from the public sector, non-governmental organizations and international organizations, whose beneficiary be the State or public sector institutions, focus on the implementation, monitoring and evaluation of policies, plans, programs and projects, in accordance with the requirements and conditions of population health. Art. 6.- It is the responsibility of the Ministry of Public Health: 1. Define and promulgate the national health policy based on the principles and approaches established in the article 1 of this Law, as well as to apply, control and monitor its compliance; 2. Exercise the rectory of the National Health System; 3. Design and implement comprehensive and quality care programs for people during all stages of life and according to their particular conditions; 4. Declare the mandatory immunization against certain diseases, in the terms and conditions that the national and local epidemiological reality requires; define the rules and the national basic scheme of immunizations; and, provide the population with the necessary elements to comply with it; 5. Regulate and monitor the application of technical standards for detection, prevention, comprehensive care and rehabilitation of communicable, noncommunicable, chronic degenerative diseases, disabilities and problems of public health declared priority, and determine the communicable diseases of mandatory notification, guaranteeing the confidentiality of the information; 6. Formulate and implement policies, programs and actions for the promotion, prevention and comprehensive care of sexual health and reproductive health according to the life cycle that allow the validity, respect and enjoyment of rights, both sexual as reproductive, and declare the obligation of their attention in the terms and conditions that reality national and local epidemiological requirements; 7. Establish prevention and comprehensive health care programs against violence in all its forms, with emphasis in vulnerable groups; 8. Regulate, control and monitor the donation, procurement, processing, storage, distribution, transfusion, use and quality of human blood, its components and derivatives, in public and private institutions and organizations, with and without for profit, authorized for it; 9. Regulate and control the functioning of banks of cells, tissues and blood; industrial blood products plants and apheresis, public and private establishments; and, promote the creation of these in their health services; 10. Issue policies and regulations to regulate and avoid the consumption of tobacco, alcoholic beverages and other substances that affect health; 11. Determine health alert areas, identify population groups at serious risk and request the declaration of the state of sanitary emergency, as a consequence of epidemics, disasters or others that put at serious risk the collective health; 12. Prepare the health plan for disaster risk management and its consequences, in coordination with the National Directorate of Civil Defense and other competent agencies; 13. Regulate, monitor and take measures to protect human health from risks and damages that may cause environmental conditions; 14. Regulate, monitor and control the application of biosafety standards, in coordination with other agencies competent; 15. Regulate, plan, execute, monitor and inform the population about health activities concerning the water, air and soil quality; and, promote healthy spaces and environments, in coordination with organizations sectional and other competent; 16. Regulate and monitor, in coordination with other competent bodies, safety regulations and conditions environmental conditions in which workers carry out their activities, for the prevention and control of diseases occupational and minimize occupational risks and accidents; 17. Regulate and monitor actions aimed at eliminating and controlling the proliferation of fauna harmful to health human; 18. Regulate and carry out sanitary control of production, import, distribution, storage, transport, marketing, dispensing and sale of processed foods, medicines and other products for use and consumption human; as well as the systems and procedures that guarantee its safety, safety and quality, through the Institute National of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez and other dependencies of the Ministry of Health Public; 19. Dictate, in coordination with other competent bodies, the policies and standards to ensure safety food and nutrition, including the prevention of disorders caused by deficiency of micro nutrients or alterations caused by eating disorders, with a life cycle approach and monitoring compliance with themselves; 20. Formulate policies and develop strategies and programs to ensure access and availability of quality medicines, at the lowest cost to the population, with emphasis on generic drug programs; 21. Regulate and control all forms of advertising and promotion that threaten health and induce behavior that affect it negatively; 22. Regulate, control or prohibit in necessary cases, in coordination with other competent bodies, production, importation, marketing, advertising and use of toxic or dangerous substances that constitute a health risk of people; 23. Regulate, monitor and control in coordination with other competent agencies, the production and marketing of products for animal and agricultural use and consumption that affect human health; 24. Regulate, monitor, control and authorize the operation of public and health facilities and services private, non-profit, and other subjects subject to sanitary control; 25. Regulate and execute the licensing and certification processes; and, establish the standards for the accreditation of health services; 26. Establish policies to develop, promote and enhance the practice of traditional, ancestral and alternative; as well as research, for its good practice; 27. Determine the professions, higher technical levels and auxiliary health who must register for their exercise; 28. Design in coordination with the Ministry of Education and Culture and other competent organizations, programs of health promotion and education, to be applied in state, private educational establishments, municipal and fiscomisionales; 29. Develop and promote strategies, plans and programs for information, education and social communication in health, in coordination with competent institutions and organizations; 30. To dictate, within its scope of competence, the sanitary norms for the operation of the premises and establishments public and private services for the population; 31. Regulate, control and monitor the donation and transplantation processes of organs, tissues and anatomical components humans and establish mechanisms that promote voluntary donation; as well as regulate, control and monitor the use of orthoses, prostheses and other synthetic implants in the human body; 32. Participate, in coordination with the competent national body, in research and development of science and health technology, safeguarding the validity of human rights, under bioethical principles; 33. Issue sanitary norms and regulations for the installation and operation of cemeteries, crypts, crematoriums, funeral homes, wake-up rooms and funeral homes; 34. Comply with and enforce this Law, regulations and other legal and technical provisions related to the health, as well as the international instruments of which Ecuador is a signatory. These actions will be carried out by the Ministry of Public Health, applying deconcentration principles and processes and decentralization; Y, 35. The others provided in the Political Constitution of the Republic and other laws. CHAPTER III Rights and duties of people and the State in relation to health Art. 7.- Every person, without discrimination for any reason, has the following rights in relation to health: a) Universal, equitable, permanent, timely and quality access to all health actions and services; b) Free access to public health programs and actions, giving preferential attention to health services public and private, to the vulnerable groups determined in the Political Constitution of the Republic; c) Living in a healthy, ecologically balanced and pollution-free environment; d) Respect for their dignity, autonomy, privacy and intimacy; to its culture, its practices and cultural uses; as well as your sexual and reproductive rights; e) Be timely informed about treatment alternatives, products and services in the processes related to your health, as well as uses, effects, costs and quality; to receive counseling and personal advice trained before and after the procedures established in the medical protocols. The members of the villages Indigenous people, if applicable, will be informed in their mother tongue; f) Have a unique medical history written in precise, understandable and complete terms; as well as the confidentiality regarding the information contained therein and to have your epicrisis delivered; g) Receive, by the health professional responsible for your care and empowered to prescribe, a prescription containing, in the first place, the generic name of the prescribed medication; h) Exercise the autonomy of their will through written consent and make decisions regarding their status health and diagnostic and treatment procedures, except in cases of urgency, emergency or risk for people's lives and for public health; i) Use, with opportunity and efficiency, in the competent instances, the actions to handle complaints and claims administrative or judicial that guarantee the fulfillment of their rights; as well as repair and compensation timely for the damages caused, in those cases that merit it; j) Be treated immediately with professional emergency services, supply of medicines and supplies necessary in cases of imminent risk to life, in any public or private health facility, without require prior financial commitment or administrative procedure; k) Participate individually or collectively in health activities and monitor compliance with actions in health and quality of services, through the formation of citizen oversight or other mechanisms of social participation; and, be informed about the prevention and mitigation measures of threats and situations of vulnerability that puts your life at risk; Y, l) Not be subject to tests, clinical trials, laboratory or research, without your knowledge and consent prior written; nor be subjected to diagnostic tests or exams, except when the law expressly determined or in case of emergency or urgency in danger of life. Art. 8.- Are individual and collective duties in relation to health: a) Comply with the prevention and control measures established by the health authorities; b) Provide timely and truthful information to health authorities, in the case of diseases declared by the national health authority as a mandatory notification and responsible for actions or omissions that put individual and collective health at risk; c) Comply with the treatment and recommendations made by health personnel for recovery or to avoid risks to your family or community environment; d) Participate individually and collectively in all health activities and monitor the quality of services by shaping citizen oversight and contributing to the development of healthy work-level environments, family and community; Y, e) Comply with the provisions of this Law and its regulations. Art. 9.- It is up to the State to guarantee the right to health of people, for which it has, among others, the following responsibilities: a) Establish, comply with and enforce State, social protection and health insurance policies to favor of all the inhabitants of the national territory; b) Establish public health programs and actions at no cost to the population; c) Prioritize public health over commercial and economic interests; d) Adopt the necessary measures to guarantee, in case of a sanitary emergency, the access and availability of supplies and medicines necessary to deal with it, using the mechanisms provided for in the agreements and treaties international and current legislation; e) Establish through the national health authority, the mechanisms that allow the person as the subject of rights, permanent and uninterrupted access, without obstacles of any kind to health actions and services of quality; f) Guarantee the population access and availability of quality medicines at low cost, with emphasis on generic drugs in the appropriate presentations, according to age and appropriate provision, at no cost to the treatment of HIV-AIDS and diseases such as hepatitis, dengue, tuberculosis, malaria and other communicable diseases that put at risk collective health; g) Promote the participation of society in the care of individual and collective health; and, establish mechanisms of oversight and accountability in the public and private institutions involved; h) Guarantee the fiscal allocation for health, in the terms indicated by the Political Constitution of the Republic, the timely delivery of resources and their distribution under the principle of equity; as well as human resources necessary to provide comprehensive quality care to individual and collective health; and, i) Guarantee the investment in infrastructure and equipment of health services that allows permanent access from the population to comprehensive, efficient, quality and timely care to respond adequately to the needs Epidemiological and community. BOOK I On health actions TITLE I CHAPTER I Common provisions Art. 10.- Those who are part of the National Health System will apply the policies, programs and standards of care comprehensive and quality, which include promotion, prevention, recovery, rehabilitation and palliative care of individual and collective health, subject to the principles and approaches established in the Article 1 of this Law. Art. 11.- The study programs of public, private, municipal and physical education establishments, in All its levels and modalities will include contents that promote knowledge of health duties and rights, healthy habits and lifestyles, promote self-care, gender equality, personal co-responsibility, family and community to protect health and the environment, and discourage and prevent harmful behavior. The national health authority, in coordination with the Ministry of Education and Culture, will monitor that public, private, municipal and fiscal institutions, as well as their staff, guarantee the care, protection, mental and physical health of its students. Art. 12.- Social communication in health will be aimed at developing habits and lifestyles in the population healthy, discourage harmful behaviors, promote gender equality, raise awareness about importance of self-care and citizen participation in health. The social media, in compliance with the provisions of the law, will allocate permanent spaces, without cost for the State, for the dissemination of educational and informative programs and messages in health addressed to the population, according to the productions that compulsorily, for this purpose, will elaborate and deliver the quarterly National Health Authority The national health authority will regulate and control the dissemination of programs or messages, to prevent their contents are harmful to the physical and psychological health of people, especially children and teenagers. Art. 13.- Health plans and programs for vulnerable groups indicated in the Political Constitution of the Republic, will incorporate the development of self-esteem, will promote the fulfillment of their rights and will be based on the recognition of their particular needs by members of the National Health System and society usually. Art. 14.- Those who are part of the National Health System will implement mental health plans and programs, with based on comprehensive care, privileging vulnerable groups, with a family and community focus, promoting social reintegration of people with mental illness. Art. 15.- The national health authority in coordination with other competent institutions and organizations social, will implement programs for timely prevention, diagnosis, treatment and recovery of growth and development disorders. CHAPTER II Of food and nutrition Art. 16.- The State shall establish an intersectoral policy of food and nutritional security, which provides for eliminate bad eating habits, respect and encourage traditional food knowledge and practices, as well as the use and consumption of products and food of each region and will guarantee people access permanent to healthy, varied, nutritious, safe and sufficient food. This policy will be specially oriented to prevent disorders caused by deficiencies of micro nutrients or alterations caused by eating disorders. Art. 17.- The national health authority, together with the members of the National Health System, will promote and promote breastfeeding during the first six months of the child's life, ensuring its prolongation Until two years old. It will guarantee access to safe breast milk or milk substitutes for children of mothers with HIV-AIDS. Art. 18.- The national health authority, in coordination with the sectional governments, the production chambers and university centers will develop information, education, communication and community participation activities aimed at knowledge of the nutritional value of food, its quality, sufficiency and safety, in accordance with the technical norms that the competent organism dictates for the effect and of the present Law. Art. 19.- The national health authority shall ensure the protection of health in the control of diseases by iodine deficiency, through the control and monitoring of salt iodization for human consumption. CHAPTER III Of sexual health and reproductive health Art. 20.- Sexual and reproductive health policies and programs will guarantee the access of men and women, including adolescents, to health actions and services that ensure gender equity, with a multicultural approach, and they will contribute to eradicating risk behaviors, violence, stigmatization and exploitation of sexuality. Art. 21.- The State recognizes maternal mortality, teenage pregnancy and abortion in risky conditions. as public health problems; and, guarantees access to public health services at no cost to users in accordance with the provisions of the Free Maternity and Child Care Law. Public health problems require comprehensive care, which includes the prevention of health situations. risk and encompass educational, health, social, psychological, ethical and moral solutions, privileging the right to life guaranteed by the Constitution. Art. 22.- The health services, public and private, have the obligation to attend as a priority the obstetric emergencies and provide safe blood when patients require it, without commitment requirement economic or prior administrative procedure. Art. 23.- Family planning programs and services will guarantee the right of men and women to decide freely, voluntarily, responsibly, autonomously, without coercion, violence or discrimination on the number of children who can procreate, maintain and educate, on equal terms, without the need for consent from third persons; as well as to access the information necessary for it. Art. 24.- Contraceptives imported by the national health authority will require the sanitary registration national in addition to the sanitary registry of the country of origin, as well as the quality control and product safety, prior to distribution. Art. 25.- The members of the National Health System will promote and respect knowledge and practices of indigenous and Afro-Ecuadorian peoples, of alternative medicines, in relation to pregnancy, childbirth, postpartum, as long as they do not compromise the life and physical and mental integrity of the person. Art. 26.- The members of the National Health System will implement prevention and health care actions comprehensive, sexual and reproductive, aimed at women and men, with emphasis on adolescents, at no cost to users in public institutions. Art. 27.- The Ministry of Education and Culture, in coordination with the national health authority, with the agency State specialized in gender and other competent, will develop educational policies and programs of implementation mandatory in educational establishments nationwide, for dissemination and guidance in health sexual and in order to prevent teenage pregnancy, HIV-AIDS and other sexually transmitted diseases, the promotion of responsible parenthood and maternity and eradication of sexual exploitation; and, will allocate resources Enough for it. The media must comply with the guidelines issued by the national health authority so that the disseminated content does not promote sexual violence, disrespect for sexuality and gender discrimination, by sexual orientation or any other. Art. 28.- Sectional governments, in coordination with the national health authority, will develop activities of promotion, prevention, education and community participation in sexual and reproductive health, in accordance with the rules she dictates, considering her local reality. Art. 29.- This Law, empowers public and private health services, to terminate a pregnancy, unique and exclusively in the cases provided for in article 447 of the Criminal Code. They cannot refuse to care for women with abortion in progress or inevitable, duly diagnosed by the professional responsible for the care. Art. 30.- The national health authority, with the members of the National Health System, shall promote and promote the family planning, with mutual responsibility and on equal terms. CHAPTER IV Of violence Art. 31.- The State recognizes violence as a public health problem. It is the responsibility of the national health authority, health services, sectional organizations, others competent bodies and society as a whole, contribute to the reduction of all types of violence, including gender, intrafamily, sexual and its impact on health. Art. 32.- In all cases of intrafamily and sexual violence, and its consequences, health care will be provided integral to the affected people. Health services personnel have the obligation to deal with cases of domestic and sexual violence. They must provide, among others, emergency contraception, perform the procedures and apply the schemes prophylactic and therapeutic necessary to detect and prevent the risk of contracting transmission infections sexual, especially HIV and hepatitis B, prior counseling and advice to the affected person, with their consent Informed expressed in writing. Art. 33.- The national health authority in coordination with the Fiscal Ministry and other competent bodies will implement actions to harmonize the standards of care and registration instruments of the different types of violence and sexual crimes, unifying them in a manual of procedures of mandatory application in the different health levels and in the National Health System. CHAPTER V Of accidents Art. 34.- The national health authority, in coordination with the National Land Transit and Transportation Council, the Ministry of Labor and Employment, other competent agencies, public and private, and sectional governments, promote and develop policies, programs and actions to prevent and reduce traffic accidents, labor, domestic, industrial and others; as well as for care, recovery, rehabilitation and reintegration social of the affected people. The State recognizes traffic accidents as a public health problem, as long as its consequences affect the physical and mental integrity of people. CHAPTER VI Of disasters Art. 35.- The national health authority shall collaborate with the sectional governments and with the competent agencies. to integrate the health component in risk management in emergencies and disasters into the respective current plan, to prevent, reduce and control the effects of disasters and natural and anthropic phenomena. Art. 36.- The members of the National Health System will implement, in collaboration with the competent agencies, a permanent and updated system of information, training and education in emergency risk management and disasters, with the participation of society as a whole. Art. 37.- All public and private institutions and establishments of any nature must have a emergency plan, mitigation and attention in case of disasters, in accordance with the plan formulated for this purpose. CHAPTER VII Of tobacco, alcoholic beverages, psychotropic drugs, narcotics and other substances that generate dependence Art. 38.- Be declared as a public health problem to the consumption of tobacco and the excessive consumption of alcoholic beverages, as well as the use of narcotic and psychotropic substances, outside the therapeutic field. It is the responsibility of the national health authority, in coordination with other competent bodies, to adopt measures to avoid the consumption of tobacco and alcoholic beverages, in all its forms, as well as providing the population of a healthy environment, to promote and support the abandonment of these habits harmful to human health, individual and collective The health services will carry out comprehensive care actions aimed at people affected by consumption and exposure to tobacco smoke, alcoholism, or the harmful use of psychotropic drugs, narcotics and others substances that generate dependence, oriented to their recovery, rehabilitation and social reintegration. SECTION I OF TOBACCO PRODUCT CONSUMPTION CONTROL Art. 39.- The national health authority in coordination with the Ministry of Education and Culture, universities, sectional governments and civil society will design and execute education and prevention plans and programs for tobacco consumption and its products. Art. 40.- The distribution or delivery of tobacco products, free of charge or onerous, to persons is prohibited. under 18 years; as well as its sale and consumption in educational, health and drug dispensing establishments. Article 41.- Advertising is prohibited, whether direct or indirect, promotion by any means, as well as sponsorship of cigarettes and other tobacco products, in educational, cultural or sporting events. Health authority National will monitor and control compliance with this provision. Art. 42.- Cigarette packs and containers of other tobacco products must clearly include, visible and understandable, the warning of its harmful nature to health, subject to the provisions of the Law Organic Consumer Defense. Art. 43.- In addition to the provisions of the Organic Law on Consumer Defense, smoking is prohibited in institutions public, educational and sports establishments, whether public or private, health services, workplaces, means of collective transport, cinemas and theater, auditoriums, elevators, warehouses and sites for the provision of fuel, factories or explosives tanks, places where there are products of easy combustion and other spaces defined in the corresponding regulations, issued by the national health authority. All establishments, public and private, will post visible warnings indicating the smoking ban. Art. 44.- The rights and obligations established in this Law do not exclude or oppose those contents. in legislation aimed at regulating the protection of human beings from exposure to tobacco smoke, from before its birth, of the environment and sustainable development and other laws related to the control of the consumption of tobacco. Art. 45.- Foreign tobacco companies that sell their products in Ecuador must count in the country with a legal representative with full powers to exercise rights and fulfill obligations arising from the application of this Law. SECTION II OF THE PREVENTION OF THE CONSUMPTION OF ALCOHOLIC BEVERAGES Art. 46.- The national health authority in coordination with the Ministry of Education and Culture, universities, sectional governments and civil society will design and execute education and prevention plans and programs for consumption of alcoholic beverages Art. 47.- The distribution or delivery of alcoholic beverages, free of charge or onerous, to persons is prohibited. under 18 years; as well as its sale and consumption in educational, health and drug dispensing establishments. Art. 48.- The advertising of alcoholic beverages for no reason shall be linked to health, sports success or Image of women as a sexual symbol. The national health authority will monitor and control compliance with this provision. Art. 49.- The containers of alcoholic beverages must include in a clear, visible and understandable way, the warning of its harmful nature to health; and, for the printing of the warning, the specifications provided in the corresponding regulation. Art. 50.- Except in the acts authorized by the competent authority, it is prohibited to consume alcoholic beverages and moderation, in public institutions, educational establishments, whether public or private, health services, workplaces, means of collective transport, cinemas and theater, and other spaces defined in the corresponding regulations issued by the national health authority. In these establishments they will be placed visible warnings indicating the prohibition of the consumption of alcoholic beverages. SECTION III ON THE USE AND CONSUMPTION OF PSYCHOTROPICS, STUPFACIENTS AND OTHER SUBSTANCES THAT GENERATE DEPENDENCE Art. 51.- The production, commercialization, distribution and consumption of narcotic and psychotropic drugs is prohibited and other addictive substances, except for therapeutic use and under medical prescription, which will be controlled by the national health authority, in accordance with the provisions of the relevant legislation. Title II Prevention and control of diseases CHAPTER I Immunizations Art. 52.- The national health authority shall provide the health facilities with biologicals and supplies for the immunopreventable diseases contemplated in the national basic vaccination scheme, in a timely manner and permanent, ensuring its quality and conservation, without cost to the end user. Art. 53.- It is the obligation of health services and other public and private institutions and establishments, immunize workers who are exposed to risks preventable by vaccination, in accordance with the regulations issued by the national health authority. Art. 54.- The State shall guarantee and timely transfer, through the competent agency, economic resources. sufficient for compliance with the actions of the Expanded Program on Immunizations, in accordance with noted in the law. Art. 55.- Biological products imported by the State through the Revolving Fund or government agreements to government, they do not require a national sanitary registry, being that of the country of origin and the verification of the product quality and safety before distribution and use. Art. 56.- Biologicals acquired under any title by public or private institutions, produced in the country or imported, will be subjected to the processes established by the national health authority for batch release in order to preserve its quality and safety. Art. 57.- Biological products imported by the Ministry of Public Health upon arrival in the country must pass to the Bank. National Vaccines, within a period not exceeding forty-eight hours, ensuring the maintenance of the chain of cold and the quality of the products, this being the responsibility of the customs authority and the sanitary authority national. Art. 58.- Public and private health institutions will administer, at no cost to the population, according to what establish the applicable regulation, the biological ones contemplated in the national basic vaccination scheme, when these have been supplied by the national health authority. Public and private institutions will report to the national health authority on people immunized Art. 59.- Parents, guardians or legal representatives of children and adolescents, educational entities, public and private institutions with captive population at risk, have the obligation and responsibility to monitor that the basic national vaccination scheme established by the National Health Authority Art. 60.- Public and private institutions for the administration and sale of biologicals must have the authorization of the national health authority and comply with the requirements established to guarantee a vaccine safe. CHAPTER II Of communicable diseases Art. 61.- Public and private institutions, health professionals and the general population will report in timely existence of suspected, probable, compatible and confirmed cases of diseases declared by the national health authority as a mandatory notification and those for international reporting. The institutions and health professionals, will guarantee the confidentiality of the information delivered and received. Art. 62.- The national health authority will elaborate the norms, protocols and procedures that must be compulsorily complied with and used for epidemiological surveillance and disease control Transmissible, emerging and reemerging mandatory notification, including those of sexual transmission. It will guarantee in its health services, care, access and availability of medicines, with emphasis on generics, screening and follow-up exams, for the diseases indicated in the preceding paragraph, which must also guarantee the national social security system. Art. 63.- The national health authority in coordination with other competent agencies will execute campaigns of information and education aimed at health personnel and the general population, to eradicate attitudes discriminatory against people affected by communicable diseases. Art. 64.- In cases of suspicion or diagnosis of the existence of communicable diseases, health personnel are forced to take biosecurity and other necessary measures to prevent the transmission and propagation of conformity with the provisions established by the national health authority. Art. 65.- Sectional governments must comply with the provisions issued by the national health authority to prevent the proliferation of vectors, the spread of communicable diseases and ensure the control of same. Art. 66.- Natural and legal persons, national and foreign, who are in Ecuadorian territory they must comply with the regulations that the government dictates and the measures that the national health authority dispose in accordance with the International Health Regulations, the international agreements signed and ratified by the country, in order to prevent and prevent the international spread of communicable diseases. Art. 67.- The State recognizes the transmission and transmission of HIV-AIDS as a public health problem. The national health authority will guarantee in its health services people living with HIV-AIDS care specialized, access and availability of antiretroviral drugs and for opportunistic diseases with emphasis on generic medications, as well as reagents for screening and follow-up exams. The responsibilities indicated in this article also correspond to the national social security system. Art. 68.- The corresponding contraception will be provided, with prior informed consent, to women carrying HIV and those living with AIDS. This includes emergency contraception when the case requires, in the judgment of the Professional responsible for care. CHAPTER III Of noncommunicable diseases Art. 69.- Comprehensive care and control of noncommunicable, chronic - degenerative, congenital diseases, Inherited and problems declared a priority for public health, will be carried out through action coordinated of all the members of the National Health System and of the participation of the population as a whole. It will include the investigation of its causes, magnitude and impact on health, epidemiological surveillance, promotion of healthy habits and lifestyles, prevention, recovery, rehabilitation, social reintegration of people affected and palliative care. The members of the National Health System will guarantee the availability and access to programs and medications for These diseases, with emphasis on generic drugs, prioritizing vulnerable groups. CHAPTER IV Of blood, its components and derivatives Art. 70.- The availability of safe blood and its components is declared a national priority. The State, through the national health authority, will take the necessary measures to guarantee availability and access to blood and safe components in sufficient quantities for those who need it, being mandatory their provision in public, private and autonomous institutions, in case of imminent risk to life, regardless of the ability to pay. The national health authority is obliged to promote voluntary and altruistic blood donation. Art. 71.- The national health authority shall issue the rules regarding the processes of donation, transfusion, use and monitoring of the quality of human blood with its components and derivatives, in order to guarantee access equitable, efficient, sufficient and safe, the preservation of donor health and maximum protection of donors recipients as well as health personnel. Art. 72.- The national health authority shall license, through the competent body, the blood services (blood cells, banks, deposits and transfusion services) and industrial plasma fractionation plants, public and private, according to current regulations. Art. 73.- Blood cells, banks, deposits and human blood transfusion services must maintain programs of internal and external quality management and control, as well as complying with the other standards and provisions that for the effect dictates the national health authority. Art. 74.- The commercialization, publicity of the same and the profit in the process of donation, obtaining, processing, distribution and use of blood, its derivatives and components, by natural persons or Legal, public or private. The institutions that carry out the processes indicated in the preceding paragraph can only recover corresponding to operating expenses of the procedures carried out; Any overcharges will be sanctioned. Art. 75.- The establishments authorized to collect blood units, prior to their use in transfusions, are required to perform tests to determine the blood group and factor and the presence of irregular antibodies, as well as serological antibodies for infection markers, determined in the regulations corresponding according to the local, regional and national epidemiological profile and technological advances. The separation of components will be carried out in compliance with the applicable technical standards in order to ensure the function therapeutic of the same. Art. 76.- The transfusion of blood and its components must be prescribed by a doctor, legally authorized to to practice the profession, practiced under his responsibility and supervision, in conditions that guarantee the safety of the procedure and in accordance with the provisions of the technical standards. Art. 77.- Acceptance or refusal for blood transfusion and its components must be made in writing by a party. of the potential recipient or through the person legally capable of exercising their representation, except for emergency or urgent cases. Art. 78.- Voluntary blood donation requires the express, voluntary and written authorization of the donor. Art. 79.- The export of plasma for industrial processing can only be done to processing plants accredited and provided that the derivatives obtained are recovered for national consumption. Art. 80.- The export of blood and its components is prohibited, unless express cases of donation originated for reasons Emergency and humanitarian as indicated in the previous article. TITLE III Transplants of organs, tissues and disposition of corpses CHAPTER I Of organ and tissue transplants Art. 81.- The commercialization of anatomical components of living or deceased persons is prohibited. No person can offer or receive directly or indirectly economic or other benefits, for the delivery or obtaining of organs and other anatomical components of living or deceased persons. Art. 82.- The donation of organs or other anatomical components of a living person, requires its express authorization, expressed freely and voluntarily. It can also be performed among people with histocompatibility antigens between donor and recipient, provided that The former expresses his desire to be a voluntary donor. The national health authority will promote campaigns for the voluntary donation of organs and tissues. Art. 83.- The use of organs or other anatomical components of a person with confirmed brain death of according to the relevant regulation, it will be carried out if in person the person expressed their consent, in the identity card of identity and / or citizenship or other legal document, or have the authorization of persons empowered by law. Art. 84.- The national health authority shall regulate, license and control the operation of health services. specialized, public and private, for the exercise of activities related to organ or other transplantation anatomical components It will also control the professional practice of those who carry out these activities. Art. 85.- The national health authority shall regulate the organization of tissue and cell banks, under the technical parameters and standards that are established for this purpose. The assignment of organs or other anatomical components must be done under national parameters and international, established by a national system created for this purpose. Art. 86.- Xenotransplants may only be performed when scientific and technological conditions are guaranteed. that ensure the quality of the procedure subject to bioethical principles, and will be subject to the authorization of the national health authority through the competent body. CHAPTER II Of the disposal and handling of corpses Art. 87.- The installation, construction and maintenance of cemeteries, crypts, crematoriums, morgues or sites of conservation of corpses, public and private entities may do, for which the norms established in this Law. Previously, the location and infrastructure to be used will be verified and that they do not constitute a health risk. They must have the environmental impact study and the corresponding environmental license. Cemeteries and crypts are the only authorized sites for burial of corpses and must comply with the regulations established by the national health authority and the corresponding municipality. Art. 88.- Once the autopsy is performed, the body must be treated, burned or cremated. No corpse may remain insecure or without cremation for more than seventy-two hours, except when by court order or not recognized or claimed by their relatives or rightful recipients, in which case you must guarantee its maintenance in the authorized sites and in adequate conservation conditions that do not compromise the integrity of the body or alter the possible evidence. Art. 89.- Unidentified or unclaimed corpses within thirty days after their death, will be delivered by way of donation to the faculties of Medical or Health Sciences legally established giving preference to state-owned companies, or they will be buried in accordance with the relevant provisions. From the unidentified bodies, prior to donation or burial, samples will be taken to obtain the genetic profile of the person. This information will be registered in a database of unidentified bodies. Art. 90.- The burial or cremation of a body may not be carried out without the medical certificate. To confirm the death and establish its possible causes, according to its diagnosis. This responsibility corresponds to cemeteries or crematoriums as appropriate. Art. 91.- Exhumation for legal purposes may be practiced at any time by order of competent authority. Art. 92.- The transfer of corpses, within the country, in the cases and conditions established in the regulations of this Law, as well as its entry into the national territory requires authorization from the national health authority, who will establish conservation and safety standards. Art. 93.- Necropsies must be performed under the responsibility of pathologists or forensic doctors, except in locations where these professionals do not exist, in which case they will be carried out in accordance with the provisions of the Code Criminal Procedure, at no cost to relatives or relatives in public institutions. Art. 94.- Necropsy is mandatory when: a) The cause of death is unknown; b) By sudden death; c) The Public Ministry so provides; d) In cases of health emergency; e) For public health reasons; Y, f) At the request and consent of the closest legal representative or relative up to the fourth degree of consanguinity and second affinity. BOOK II Environmental health and safety Common provision Art. 95.- The national health authority in coordination with the Ministry of Environment, will establish the basic norms for the preservation of the environment in matters related to human health, which will be compliance mandatory for all natural persons, public, private and community entities. The State through the competent agencies and the private sector is obliged to provide the population, adequate and truthful information regarding the environmental impact and its consequences for individual and collective health. UNIQUE TITLE CHAPTER I Water for human consumption Art. 96.- Water for human consumption is declared a national priority and of public utility. It is the obligation of the State, through the municipalities, to provide the population with quality drinking water, suitable for human consumption. Every natural or legal person has the obligation to protect the aquifers, sources and watersheds that serve for the supply of water for human consumption. It is prohibited to carry out activities of any kind, which put the sources of water collection at risk of contamination. The national health authority, in coordination with other competent bodies, they will take measures to prevent, control, mitigate, remedy and sanction the contamination of water sources for human consumption. In order to guarantee quality and safety, all water supplies for human consumption are subject to the surveillance of the national health authority, who is responsible for establishing the rules and regulations that allow ensure the protection of human health. CHAPTER II Of common, infectious, special wastes and of ionizing and non-ionizing radiation Art. 97.- The national health authority shall issue the rules for the management of all types of waste and waste that affect human health; rules that will be mandatory for natural and legal persons. Art. 98.- The national health authority, in coordination with public or private entities, shall promote programs and Information and education campaigns for waste and waste management. Art. 99.- The national health authority, in coordination with the municipalities of the country, will issue the regulations, norms and mandatory technical compliance procedures for the proper management of infectious wastes that generate establishments of health services, public or private, outpatient or inpatient, veterinary and aesthetic. Art. 100.- The collection, transport, treatment and final disposal of waste is the responsibility of the municipalities that they will perform it in accordance with the laws, regulations and ordinances that are issued for this purpose, with observance of Biosafety and control standards determined by the national health authority. The State will deliver the resources necessary for compliance with the provisions of this article. Art. 101.- The homes, educational establishments, health facilities and buildings in general, must have systems adequate sanitary disposal of excreta and sewage disposal. The educational establishments, public and private, will have the number of sanitary batteries that are available in the respective regulatory standard. The State shall deliver to the public establishments the resources necessary for compliance with the provisions of this article. Art. 102.- It is the responsibility of the State, through the municipalities of the country and in coordination with the respective public institutions, provide the population of sanitary, stormwater and other sewage disposal systems and sewage systems that do not affect individual, collective health and the environment; as well as sewage treatment systems. Art. 103.- Any person, natural or legal, is prohibited from discharging or depositing sewage and wastewater, without appropriate treatment, as provided in the corresponding regulations, in rivers, seas, canals, streams, lagoons, lakes and other similar sites. Its use is also prohibited in animal husbandry or agricultural activities. Infectious, special, toxic and hazardous health wastes must be treated technically prior to disposal. elimination and the final deposit will be made in the special sites established for the purpose by the municipalities from the country. The dispositions established for this purpose will be complied with for the disposal of household waste. The health authorities, in coordination with the municipalities, will be responsible for enforcing these provisions. Art. 104.- Every industrial, commercial or service establishment has the obligation to install systems of treatment of contaminated water and toxic waste that is produced as a result of its activities. The health authorities, in coordination with the municipalities, will be responsible for enforcing this provision. Art. 105.- Natural or legal persons who own facilities or buildings, public or private, located in coastal and insular areas, they will use sewage networks to dispose of wastewater and residuals product of the activities that develop; and, in cases that inevitably require eliminating them in the sea, should treat them beforehand, having to have environmental impact studies for the purpose; as well as use submarine emissaries that comply with the corresponding sanitary and environmental standards. Art. 106.- The lands through which sewage networks, aqueducts or pipes pass or pass, will be constituted obligatorily in servant lands, according to what is established by law. The health authorities, in coordination with the municipalities, will be responsible for enforcing this provision. Art. 107.- The national health authority, in coordination with other competent bodies, will dictate the rules for handling, transport, treatment and final disposal of special waste. Radioactive waste will be treated in accordance with the norms dictated by the competent body in the matter or accepted by means of agreements International Art. 108.- Corresponds to the national health authority, in coordination with the Ecuadorian Energy Commission Atomic and more competent bodies, monitor compliance with the established standards regarding radiation ionizing and non-ionizing. Art. 109.- No person shall be subjected to or exposed to ionizing and non-ionizing radiation beyond the doses or permissible limits, in accordance with the relevant standards. Diagnostic and therapeutic equipment using ionizing and non-ionizing radiation will be installed in technically appropriate buildings that meet health and safety requirements, established by the national health authority and the Ecuadorian Atomic Energy Commission; will be subject to rigorous maintenance and newspapers, having to have quality control certificates. Art. 110.- Importers of electronic articles and devices that emit non-ionizing radiation must ensure that they comply with current health regulations, are not prohibited in their country of origin or in other countries; and, bear the labeling of precautions and clear indications about their use. CHAPTER III Air quality and noise pollution Art. 111.- The national health authority, in coordination with the national environmental authority and other agencies competent, will dictate the technical standards to prevent and control all types of emanations that affect the systems respiratory, auditory and visual. All natural and legal persons must comply with said regulations. Art. 112.- Municipalities will develop programs and activities to monitor air quality, to prevent their pollution by emissions from fixed, mobile sources and natural phenomena. The results of monitoring will be reported periodically to the competent authorities in order to implement information systems and prevention aimed at the community. Art. 113.- All labor, productive, industrial, commercial, recreational and fun activity; as well as housing and other facilities and means of transport, must comply with the provisions of the respective rules and regulations on prevention and control, in order to avoid noise pollution, which affects human health. CHAPTER IV Pesticides and other chemicals Art. 114.- The national health authority, in coordination with the Ministry of Agriculture and Livestock and more competent bodies, will dictate and implement the regulations for the use and control of pesticides, fungicides and other chemical substances for domestic, agricultural and industrial use that affect human health. Art. 115.- National and international norms and regulations for the production, importation, export, marketing, use and handling of pesticides, fungicides and other chemical substances whose Inhalation, ingestion or contact may cause damage to people's health. Art. 116.- The production, importation, commercialization and use of pesticides, fungicides and other substances is prohibited. chemical, vetoed by national and international sanitary standards, as well as their acceptance and use as donations CHAPTER V Health and Safety at Work Art. 117.- The national health authority, in coordination with the Ministry of Labor and Employment and the Institute Ecuadorian Social Security, will establish health and safety at work standards to protect the health of Workers. Art. 118.- Employers will protect the health of their workers, providing them with sufficient information, equipment of protection, appropriate clothing, safe work environments, in order to prevent, reduce or eliminate risks, accidents and occurrence of occupational diseases. Art. 119.- Employers have the obligation to notify the competent authorities, accidents at work and occupational diseases, without prejudice to the actions taken by both the Ministry of Labor and Employment and the Ecuadorian Institute of Social Security. Art. 120.- The national health authority, in coordination with the Ministry of Labor and Employment and the Institute Ecuadorian Social Security, will monitor and control working conditions, so that they are not harmful or unhealthy during the periods of pregnancy and lactation of working women. Employers have the obligation to comply with the standards and adapt women's work activities pregnant and breastfeeding. Art. 121.- Public or private institutions whose personnel are exposed to ionizing radiation and emissions are not Ionizing agents are required to provide radiation care and control devices and safety conditions at work that prevent health risks. Failure to comply with this provision by employers, which causes harm to the health of the worker, will give place to apply the sanction determined by law. CHAPTER VI Control of harmful fauna and zooanthroposis Art. 122.- The national health authority will organize campaigns to eradicate the proliferation of vectors and others animals that represent individual and collective health risk. Natural and legal persons will collaborate with these campaigns. Art. 123.- It is the obligation of the owners of domestic animals to vaccinate them against rabies and other diseases that the national health authority declares that they can cause epidemics, as well as keeping them in conditions that are not constitute a risk to human health and environmental hygiene. Control and management of stray animals is the responsibility of the municipalities, in coordination with the health authorities Art. 124.- It is prohibited within the urban perimeter to install stables or farms to raise or house cattle, equine, bovine, goat, pig, as well as poultry and other species. Art. 125.- The slaughter, transport, industrialization and commercialization of dead animals or slaughtered who had suffered diseases harmful to human health. Art. 126.- The entry of animals into the country is subject to compliance with legal and regulatory provisions. issued by the corresponding authorities, international conventions and other laws that regulate the traffic of animals. The entry into the country of animals affected by diseases transmissible to the population or suspected of be, or that are carriers of pathogens whose dissemination may constitute a danger to the health of persons. Art. 127.- Every person shall proceed to the extermination of arthropods, rodents and other species harmful to health that there are in your home, other properties and annexes of your property or its use. It will also be the obligation of the national health authority to promote massive campaigns to make effective the fulfillment of this purpose. Art. 128.- Companies dedicated to the extermination or control of pests and vectors transmitting diseases such as Dengue, rabies and malaria, should obtain the respective permit issued by the national health authority to operate. All chemicals used by such companies must be approved by that authority. BOOK III Health surveillance and control Common provisions Art. 129.- Compliance with health surveillance and control regulations is mandatory for all institutions, public and private organizations and establishments that carry out production, import, export activities, storage, transport, distribution, marketing and sale of products for human use and consumption. The observance of health surveillance and control regulations also apply to public health services and private, non-profit, autonomous, community and private health and prepaid medicine companies. Art. 130.- The establishments subject to sanitary control for their operation must have the permit granted by the national health authority. The operating permit will be valid for one calendar year. Art. 131.- Compliance with the standards of good manufacturing, storage, distribution, dispensing practices and pharmacy, will be controlled and certified by the national health authority. Art. 132.- Health surveillance and control activities include those of quality control, safety and security. of processed products for human use and consumption, as well as verification of compliance with the requirements technical and sanitary in the establishments dedicated to the production, storage, distribution, marketing, import and export of the indicated products. Art. 133.- The national health authority may delegate to the municipalities, within its functions, the exercise of necessary actions for health control, who will perform them in accordance with the provisions and regulations issued by said authority. Art. 134.- The installation, transformation, expansion and transfer of industrial plants, food processors, Pharmaceutical establishments, biological production, processing of processed natural products for use medicinal, homeopathic production, pesticides, dental products, cosmetic companies and products hygienic, are subject to obtaining, prior to use, the permission granted by the national health authority. Art. 135.- It is the responsibility of the national health authority to authorize the importation of any product registered in the registry. health, including medical samples and those intended for internal consumption from free zones. The importation of products will not be authorized, even for promotional purposes, if they have not previously registered national health, except for the exceptions determined in this Law. Art. 136.- Raw materials for the preparation of products subject to sanitary registration do not require for their Import comply with this registration, provided they justify its use in such products. SINGLE TITLE CHAPTER I From the sanitary registry Art. 137.- Processed foods, food additives, medications in general, are subject to sanitary registration. nutraceutical products, biological products, natural processed medicinal products, homeopathic medicines and dental products; medical devices, biochemical and diagnostic reagents, hygienic products, pesticides for domestic and industrial use, manufactured in the national territory or abroad, for import, export, marketing, dispensing and sale, including those received by donation. Donations of products subject to sanitary registration will be subject to the authorization and requirements established in the regulation issued by the national health authority for this purpose. Art. 138.- The national health authority through its competent body, National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez, who will perform his duties in a decentralized manner, will grant, suspend, cancel or re-enroll the certificate of sanitary registration, prior to compliance with the procedures, requirements and deadlines indicated in this Law and its regulations, according to the guidelines and norms issued by the national health authority, which will set the payment of an amount for the registration and re-registration of said health registration certificate, whose values ​​will be destined for institutional development, which will include Priority is a national post-registration quality control and safety program. The national health authority shall exercise administrative, technical and financial control of the National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez and will annually evaluate the results of the management for relevant purposes The analytical technical report for the granting of the sanitary registry, as well as the quality control analyzes Post-registration must be prepared by the National Institute of Hygiene and Tropical Medicine, Dr. Leopoldo Izquieta Pérez, and by laboratories, universities and polytechnic schools, previously accredited by the competent body, in accordance with applicable regulations, procedures that are subject to payment of the amount established by the National Health Authority Art. 139.- The sanitary registry will be valid for five years, counted from the date of its concession. Everything change of the condition in which the product was approved in the sanitary registry must be obligatorily notified to the national health authority through the National Institute of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez and, will lead to the procedure indicated by the law and its regulations. For the process of sanitary registration, the patent of the products will not be considered as a requirement. The sanitary registration of medicines does not give the right of exclusivity in the use of the formula. Art. 140.- The importation, exportation, commercialization and sale of products processed for use are prohibited. and human consumption that do not comply with the prior obtaining of the sanitary registry, except for the exceptions provided in this Law. Art. 141.- The sanitary registry will be suspended or canceled by the national health authority through the Institute National of Hygiene and Tropical Medicine Dr. Leopoldo Izquieta Pérez, at any time if the product or its manufacturer does not comply with the requirements and conditions established in this Law and its regulations or when the product could cause damage to health, and the other sanctions indicated in this Law will be applied. In all cases, the owner of the registry or the responsible natural or legal person must fully compensate any damage that occurs to third parties, without prejudice to other legal actions that may take place. Art. 142.- The national health authority, through its competent bodies, will periodically carry out controls Post-registration of all products subject to sanitary registration by sampling for control analysis of quality and safety, whether in the places of manufacture, storage, transport, distribution or sale. Will perform further inspections to establishments. If I detect that any commercial or industrial entity will use a registration number health service not authorized for that product, the national health authority will suspend the marketing of the product or products products, notwithstanding the penalties of law. Art. 143.- Advertising and promotion of products subject to sanitary registration must conform to their true nature, composition, quality or origin, so as to avoid any misconception of its qualities or benefits, which will be controlled by the national health authority. Advertising by any means of medicines subject to prescription sale is prohibited. Art. 144.- The national health authority may authorize the importation of medicines, biological products, medical devices, biochemical and diagnostic reagents not registered in the health registry, in cases of health emergency or for people who require specialized treatments not available in the country, as well as for Human clinical research purposes, prior to compliance with the requirements established for this purpose. The medicines, biological products, medical devices, authorized biochemical and diagnostic reagents will be the specific to each situation. CHAPTER II Of food Art. 145.- It is the responsibility of the producers, retailers and other agents that intervene during the cycle production consumption, comply with the standards established in this Law and other provisions in force to ensure the Quality and safety of food for human consumption. Art. 146.- Regarding food, it is prohibited: a) The use of additives to disguise, mitigate or correct the technological deficiencies of production, handling or conservation and to fraudulently highlight its characteristics; b) The use, importation and commercialization of raw materials not suitable for human consumption; c) The inclusion of harmful substances that make them dangerous or potentially harmful to the health of consumers; d) The use of raw materials and products treated with ionizing radiation or that have been genetically modified in the development of formulas for infants and baby foods; e) Processing and handling in non-hygienic conditions; f) The use of packages that do not comply with the technical specifications approved for this purpose; g) The offer of a processed food with names, brands, graphics or labels that make false claims or that omit data in a way that confuses or misleads the consumer; h) The storage of raw materials or processed food in premises where harmful substances are found or dangerous; i) Any form of falsification, contamination, alteration or adulteration, or any procedure that produces the effect of making them harmful or dangerous to human health; Y, j) The display and sale of products whose shelf life has expired. Art. 147.- The national health authority, in coordination with the municipalities, will establish education programs for food producers, handlers and consumers, promoting hygiene, individual health and Collective and environmental protection. Art. 148.- The control of the sale of food and beverages on public roads will be carried out by the municipalities, in coordination with the national health authority and in accordance with the provisions of the Organic Regime Law Municipal. Art. 149.- The development, treatment, elaboration, production, application, handling, use, storage, transport, distribution, importation, marketing and sale of food for human consumption that are or contain genetically modified products, it will be carried out when demonstrated before the competent authority, through technical and scientifically advanced studies, their safety and security for consumers and the environment. To fulfill this purpose, the national health authority must coordinate with the public technical bodies and corresponding private. Art. 150.- The donation of foods containing genetically modified products, as well as their use, use and management in plans and programs and food aid plans, will be accepted if by technical procedures and scientifically advanced, demonstrate their safety and security before the national health authority. To fulfill this purpose, the national health authority will act in accordance with the universal principles in matters of public health and what is established in the second paragraph of the preceding article. Art. 151.- The packaging of products containing genetically modified foods, whether national or imported, must include, in a visible and understandable way on their labels, the indication of this condition, in addition to the other requirements established by the national health authority, in accordance with the law and the regulations that are issued for this purpose. Art. 152.- The national health authority, in coordination with the competent agencies, shall establish and implement an integrated national system to ensure food safety. CHAPTER III Of the medications Art. 153.- All medication must be sold in legally authorized establishments. For the sale to the public, a prescription issued by professionals authorized to do so is required, with the exception of over-the-counter medications, classified as such with strict adherence to updated pharmacological standards, in order to guarantee the safety of its use and consumption. Art. 154.- The State shall guarantee the access and availability of quality medicines and their rational use, prioritizing Public health interests over economic and commercial ones. Promote the production, importation, commercialization, dispensing and sale of generic medicines with emphasis in the essentials, in accordance with current regulations on the subject. Its use, prescription, dispensing and sale It is mandatory in public health institutions. Art. 155.- Medicines in general, including products containing new chemical entities that obtain National health registry and are not marketed for a period of one year, will be subject to cancellation of said Health Register. Art. 156.- The national health authority will authorize the importation of medicines in general, in the quantities necessary to obtain the sanitary requirement, in accordance with the provisions of the corresponding regulation. Art. 157.- The national health authority will guarantee the quality of medicines in general and develop Drug surveillance programs and studies of drug use, among others, to safeguard the safety of its use and consumption. In addition, it will periodically carry out post-registration controls and studies on the use of medicines to evaluate and control quality, safety and efficacy standards and punish those who sell products that do not meet such standards falsify or adulterate pharmaceutical products. Art. 158.- The development, production, handling, use, storage, transport, distribution, importation, marketing and sale of nutraceutical products, will be allowed when it is demonstrated technically and scientifically before the national health authority, its safety for the consumer and the environment. Health registration and control of these products will be subject to current regulations for medications. Art. 159.- It is the responsibility of the national health authority to fix, review and control the prices of medicines. of use and human consumption through the National Council for the Fixation and Review of Prices of Medicinal Products for Human Use, in accordance with the law. The commercialization of the aforementioned products is prohibited without fixing or reviewing prices. Art. 160.- For the purposes of setting and reviewing prices of medicines for human use and consumption, the expenses of Advertising and promotion will be regulated in accordance with current law and regulations, so that they do not affect access to medicines and consumer rights. Art. 161.- For the fixing and revision of prices of imported medicines, the price at the port of shipment (FOB) of the country of origin of the product, which may not be higher than the sales prices at distributor or wholesaler of the country of origin. Art. 162.- The retail prices must be printed on the packages so that they cannot be removed. It is forbidden to alter prices or place labels that modify them. Art. 163.- Pharmaceutical laboratories, pharmaceutical distributors, drug representation houses, medical devices, dental products, biochemical and diagnostic reagents, in sales made to Public institutions will deduct a percentage of not less than 15% of the sale price to the pharmacy. CHAPTER IV Of processed natural products for medicinal use Art. 164.- Processed natural products for medicinal use will be produced, stored, marketed and they will matter as long as they have a national sanitary registry, in accordance with the law and regulations corresponding and under the quality standards issued by the national health authority. CHAPTER V Of the pharmaceutical establishments Art. 165.- For legal and regulatory purposes, pharmaceutical establishments are pharmaceutical laboratories, drug representation houses, pharmaceutical distributors, pharmacies and first aid kits, which are located in The whole national territory. Art. 166.- Pharmacies must serve the public at least twelve hours a day, uninterrupted and must comply the shifts established by the national health authority. They necessarily require the operation of the technical direction and responsibility of a pharmaceutical chemist or pharmaceutical biochemist, who will provide specialized pharmaceutical care. The kits will be in charge of qualified and certified people for the handling of medications. Authorization for its operation it is transitory and revocable. The national health authority will implement pharmacies and institutional kits, properly equipped, in all its operating units according to the level of complexity. Art. 167.- The prescription issued by health professionals authorized by law to do so must contain obligatorily and first of all the generic name of the prescribed medication. Who sells will obligatorily inform the buyer about the existence of the generic medicine and its price. Illegible, altered or code prescriptions will not be accepted. Art. 168.- They are human health professionals authorized to prescribe medications, doctors, dentists and obstetricians Art. 169.- The sale of medicines to the retail public can only be carried out in establishments authorized for The effect. Art. 170.- Medicines, for sale, must meet the following requirements: a) Be duly identified and labeled, without alterations or amendments; b) Contain in their labels the national sanitary registration number, the retail price and the date of expiration; c) Not be expired; d) Not come from social service institutions, state social programs, donations or be samples doctors; e) Not have been clandestinely introduced to the country; f) Not be falsified or adulterated; Y, g) Not having elements placed on the labels that impede the visibility of product information, including those that contain prices. Art. 171.- The sale of medicines containing psychotropic substances and narcotic drugs that are not prohibited is prohibited. have a prescription issued by professionals authorized to prescribe them. When prescription and sale is required of medicines containing these substances, will be carried out in accordance with the standards issued by the health authority National and the Law on Narcotic and Psychotropic Substances. Art. 172.- In pharmacies and medicine cabinets, medical, obstetric, dental, and medical advice cannot be offered or applied. treatments, take samples or have clinical laboratories. Art. 173.- Every pharmaceutical establishment must have the technical responsibility of a chemical professional pharmacist or biochemical pharmacist, who may have one or more establishments under his technical responsibility Pharmacists, in accordance with the regulations. The regulation of application of this Law will regulate the related thing to this service, in the places where they do not exist enough professionals or pharmaceutical establishments. Art. 174.- Pharmacy retailers are prohibited from recommending the use of prescription medications. medical or change the prescribed active substance, without the written authorization of the prescriber. Art. 175.- Sixty days before the expiration date of medications, pharmacies and first aid kits will notify its suppliers, who have the obligation to withdraw these products and exchange them in accordance with what is established the corresponding regulation. Art. 176.- Expired medicines referred to in the previous article must be destroyed and disposed of by manufacturers or importers, compliant to the procedures established by the national health authority and under its supervision. CHAPTER VI Other establishments subject to sanitary control Art. 177.- It is the responsibility of the national health authority to issue regulations and control hygienic conditions. health facilities of public service facilities and other subjects under sanitary control, for granting or renewal of the operating permit. In the case of public and private educational establishments, it will monitor, control and periodically evaluate the infrastructure and sanitary hygienic conditions requirements necessary for its operation. Art. 178.- The establishments of production, storage, packaging or sale of natural products for use medicinal and homeopathic medicines, require for installation and operation of the permit granted by the National Health Authority Art. 179.- Representation houses and distributors of dental products, medical devices, reagents biochemical and diagnostic, for its operation must obtain permission from the national health authority. BOOK IV On health services and professions UNIQUE TITLE CHAPTER I Health services Art. 180.- The national health authority shall regulate, license and control the operation of the services of public and private health, with and without profit, autonomous, community and private health companies and Prepaid medicine and will grant your operating permit. It will regulate the licensing and accreditation processes. Regulate and control compliance with the regulations for the construction, expansion and operation of these establishments according to the typology, based on the resolution capacity, attention levels and complexity. Art. 181.- The national health authority shall regulate and monitor that public and private health services, with and Nonprofits, freelancers and private health and prepaid medicine companies, ensure timely care, efficient and of quality according to the approaches and principles defined in this Law. Art. 182.- The national health authority shall regulate and approve the rates of health services and those of the plans and programs of prepaid health and medical services companies, in accordance with the regulations Issue for the effect. Art. 183.- The contract for the provision of prepaid medicine services must be approved by the health authority national. It is the obligation of the prepaid medicine companies to obtain such approval and to record it in the contract respective. Art. 184.- It is the obligation of health services to display the rates that are visible to the public. They charge for their services, which must be approved by the national health authority. Art. 185.- Health services will function, in accordance with their field of competence, under the responsibility Technician of a health professional. Art. 186.- It is the obligation of all health services that have emergency rooms, receive and attend to emergency patients. It is forbidden to demand payment, commitment from the patient or related persons economic or administrative procedure, as a precondition for the person to be received, attended and stabilized in their Health. Once the patient has overcome the emergency, the private health facility may demand payment of services you received Art. 187.- The values ​​not recovered by the health service for the care of a patient in a state of emergency, whose inability to pay is duly verified, will be deducted from income tax in accordance with the provisions of the Internal Tax Regime Law. Art. 188.- The national health authority shall regulate and supervise that public and private health services apply the norms of prevention and control of nosocomial infections. CHAPTER II Of traditional and alternative medicines Art. 189.- The members of the National Health System will respect and promote the development of medicines traditional, will incorporate the intercultural approach in the policies, plans, programs, projects and models of health care, and will integrate the knowledge of traditional and alternative medicines in the processes of teaching - learning Art. 190.- The national health authority shall promote and promote the exchange of knowledge between the different agents of traditional medicines, will promote research processes of their diagnostic and therapeutic resources within the framework of the principles established in this Law, protecting the collective rights of indigenous peoples and Blacks or Afro-Ecuadorians. Art. 191.- The national health authority will implement regulation and control processes, to prevent practices of traditional medicines pay attention to people's health. Art. 192.- The members of the National Health System will respect and promote the development of medicines alternatives in the framework of comprehensive health care. Alternative medicines must be exercised by health professionals with degrees recognized and certified by CONESUP and registered with the national health authority. Alternative therapies require, for their exercise, the permission issued by the national health authority. CHAPTER III Of the health professions, related and their exercise Art. 193.- Health professions are those whose third or fourth level university education is directed specifically and fundamentally to provide professionals with knowledge, techniques and practices related to the individual and collective health and control of its conditioning factors. Art. 194.- To practice as a health professional, it is required to have obtained a third level university degree, conferred by one of the universities established and legally recognized in the country, or by one from abroad, revalidated and endorsed. In both cases, it must be registered with CONESUP and by the health authority national. Art. 195.- The titles of superior technical or technological level as well as those of auxiliaries in different branches of the health, for their authorization they must be registered in the respective instances and registered with the health authority national. Art. 196.- The national health authority will analyze the different aspects related to the formation of resources human health, taking into account national and local needs, in order to promote among the training institutions for human resources in health, reforms in training and training plans and programs. Art. 197.- For the qualification of the professional exercise and the corresponding registry, the health professionals they must carry out a year of practice in marginal rural or urban parishes, with remuneration, in accordance with the service model and in accordance with the corresponding regulations in the places designated by the authority national health, at the end of which the certification will be granted to prove compliance with the obligation that this article establishes. The national health authority in coordination with sectional organizations and grassroots organizations will control the allocation and compliance of the mandatory year by professionals who meet the year of rural health. The practice of rural practice in urban operating units of second and third level is prohibited. Art. 198.- The professionals and technicians of higher level who carry out activities related to health, are forced to limit their actions to the area assigned by the title. Art. 199.- The investigation and sanction of illegal practice, negligence, corresponds to the national health authority. impericia, imprudence and non-observance in the practice of health professions, without prejudice to the action of the ordinary justice Art. 200.- The professional who protects with the title or his signature the exercise of the health professions to Unauthorized persons, notwithstanding the provisions of this Law, will be sanctioned in accordance with the legislation applicable. Art. 201.- It is the responsibility of health professionals to provide quality care, with warmth and efficiency, in the scope of their competencies, seeking the greatest health benefit of their patients and the population, respecting Human rights and bioethical principles. It is your duty to demand basic conditions for compliance with the provisions of the preceding paragraph. Art. 202.- It constitutes an infraction in the exercise of the health professions, any individual and non-transferable act, not justified, that generates damage in the patient and is the result of: a) Failure to comply with the regulations; b) Impericia, in the performance of the health professional with total or partial lack of technical knowledge or experience; c) Recklessness, in the performance of the health professional with omission of care or due diligence; Y, d) Negligence, in the performance of the health professional with omission or unjustified delay in his obligation professional. Art. 203.- The health services will be civilly responsible for the actions of the professionals of the health that work in them. Art. 204.- The consent or authorization of the patient or the person who legally represents him, does not exempt responsibility to the professional or to the health service in those cases determined in article 202 of this Law. CHAPTER IV Health training Art. 205.- Create the health career for human resources of the National Health System, based on the criteria classification by levels of training and occupational structure, with the purpose of establishing their obligations and rights, as well as the incentives that guarantee equity, quality of care and service, the adequate and sufficient allocation of human resources in different areas of the country. The national health authority will promote and develop, within the health career, a national education plan permanent with a gender and multicultural approach, to improve productivity, quality of work performance and Promotion of your human resources. Art. 206.- The national health authority shall establish training plans and permanent evaluation of the professionals and human resources in health and will implement promotions and incentives. BOOK V ONLY TITLE Scientific research in health, genetics and information system in Health CHAPTER I Of scientific research in health Art. 207.- Scientific research in health as well as the use and Biotechnology development will be carried out oriented to national priorities and needs, subject to bioethical principles, with multicultural, rights and gender approaches, incorporating traditional medicines and alternatives. Art. 208.- The scientific technological research in health will be regulated and controlled by the health authority national, in coordination with the competent bodies, subject to bioethical and rights principles, prior informed and written consent, respecting confidentiality. CHAPTER II Of human genetics Art. 209.- The national health authority will regulate, license and control the operation of health services specialized, public and private, for the exercise of activities related to the research and development of Human genetics It will also control the professional practice of those who carry out these activities, which must necessarily have a specialty in the area of ​​genetics or related. Art. 210.- Tests of human identification, filiation and compatibility of antigens may only be done to: a) Transplants; b) Mutational studies; c) Genetic ligation; d) Predictive tests of genetic diseases. e) Tests to detect the genetic predisposition to a disease; f) Therapeutic purposes; Y, g) Others that are developed for genetic health purposes. These tests must have specialized genetic counseling and supervision, following procedures scientifically proven, with subjection and respect to bioethical principles. Art. 211.- Any form of discrimination of a person is prohibited because of their genetic heritage. It is mandatory to keep confidentiality regarding the individual genome of the person. Art. 212.- Genetic intervention is prohibited on germline cells and stem cells, for the purpose of Experimentation and profit. Interventions may be performed on the human genome, germline cells and stem cells only by predictive, preventive, diagnostic or therapeutic reasons, provided genetic counseling is available specialized, scientifically proven and safe procedures, with prior informed, express and written consent of the person and that is of social and eugenic benefit. Art. 213.- It will not be possible to patent genes or natural human cellular derivatives. Art. 214.- The cloning practices of human beings are prohibited, as well as the obtaining of human embryos with Experimentation purposes The national health authority shall endeavor and promote the integration and cooperative work of the centers of research and development of genetics. CHAPTER III Of the common information system Art. 215.- The national health authority with the participation of the members of the National Health System, implement the common information system in order to know the health situation, identify the risks to the people and the environment, dimension the available resources and the production of the services, to guide the political and managerial decisions and articulate citizen participation at all levels, among others. This system will incorporate multicultural, multi-ethnic, gender, regional and regional particularities. population, as well as the political - administrative division of the country. SIXTH BOOK Jurisdiction, competence, procedure, sanctions and definitions CHAPTER I Of jurisdiction and competence Art. 216.- Jurisdiction and administrative competence, in matters of health, arise from this Law. Art. 217.- They have jurisdiction to know, judge and impose the sanctions provided for in this Law and other regulations. in force, the following health authorities: a) The Minister of Public Health; b) The Director General of Health; c) The provincial directors of health; Y, d) Health commissioners. Art. 218.- Health commissioners must be doctors in jurisprudence or lawyers with a minimum experience of three years of professional practice. Art. 219.- The Minister of Public Health and the Director General of Health, have jurisdiction throughout the territory national. The provincial directors of health and the commissioners of health, have competence in the provincial scope. Art. 220.- The Public Force is obliged to collaborate with the health authorities to enforce the provisions of this Law, when its intervention is required. CHAPTER II Of the procedure Art. 221.- The health authorities indicated in the previous Chapter shall act ex officio, by complaint or report to Know and punish the infractions indicated in this Law. Complaints will be presented verbally or in writing. Art. 222.- The health authorities indicated in article 217, which do not adequately fulfill their obligation to know, judge and impose the sanctions provided for in this Law, will be sanctioned in accordance with the regulations corresponding and other regulations pertaining to the subject, without prejudice to administrative, civil and criminal actions to that place. Art. 223.- Public action is granted to report any violation of the provisions of this Law. Art. 224.- When acting ex officio or by means of a report or complaint, the corresponding health authority shall issue a initial car that will contain: a) The succinct relationship of the facts and the way they came to their knowledge; b) The order to cite the alleged offender, providing that you indicate address to deliver notifications, under prevention that will be judged in default in case of not appearing; c) The order to add to the file the report or complaint, if they exist, and to carry out the proceedings that are necessary to prove the violation; d) The indication of the day and time for the trial hearing to take place; Y, e) The appointment of the secretary who will act in the process. Art. 225.- It is appropriate to know and resolve the causes in the first instance: a) To the health commissioner, the infractions sanctioned in articles 241, 242, 243, 244 and 245 of this Law; b) To the provincial director of health, the infractions sanctioned in articles 246, 247, 248 and 256 of this Law; Y, c) To the Director General of Health, the infractions sanctioned in articles 249, 250, 251, 252, 254 and 255 of this Law. If the authority is not competent, the authority will be inhibited from knowing the cause and will forward it ex officio, to whom it may concern. Art. 226.- In case the infraction has evidence of criminal responsibility, the file will be sent to the competent authority Art. 227.- The summons with the initial order will be made personally to the offender, at his home or place of work; yes you will not be found, you will be cited through three ballots left at home or at work, on different days, laying down the reason for the citation. Art. 228.- At the trial hearing, the offender will be heard, who will intervene on his own or through his lawyer; I know they will receive the evidence they present and will be added to the process, which will be recorded in the minutes signed by the appearing, the corresponding health authority and the secretary. Art. 229.- If requested by either party or ex officio, in the same diligence, the cause will be opened for proof by the term of six days, in which all the requested tests will be performed. Art. 230.- If the cause has not been requested to be opened, the corresponding health authority shall proceed to issue the resolution within five days. Art. 231.- Upon expiration of the test term and all the procedures requested and ordered, the Corresponding health authority will issue its resolution within five days. Art. 232.- Of the resolutions of the health commissioner, it may be appealed to the provincial director of health; of which dictates the provincial director of health, before the Director General of Health; and, of those of this authority before the Minister Public Health, these decisions being second and final instance. The resolutions may be appealed within three days after being notified to the parties; the superior authority within eight days from the time that knowledge has to issue the corresponding resolution. Only the first instance resolutions may be appealed, the second instance resolutions will cause enforcement. Art. 233.- Once the resolution is enforced, the payment order will be issued, the same as if not paid by The taxpayer will be charged coercively by the Ministry of Public Health in accordance with the provisions of the Article 941 of the Code of Civil Procedure, in which it is granted to the State and its institutions, action and coercive jurisdiction at the national level. Art. 234.- The goods and products that are commissioned and can be used, will be delivered to the institutions of charity of the provincial jurisdiction where the offense was committed, in accordance with the regulations that the national health authority issues for that purpose. Art. 235.- Goods and products that cannot be used will be destroyed by the corresponding authority, leaving a record in the minutes to be signed jointly with the secretary, whose original will be sent to the authority Immediate superior for your knowledge. Art. 236.- In everything not provided for in this Law, it will act in accordance with the provisions of the Criminal and Civil Codes; and, of Criminal and Civil Procedure. CHAPTER III Of the sanctions Art. 237.- Health infractions will be sanctioned in accordance with the provisions contained in This Law and its regulations, without prejudice to the civil, administrative and criminal penalties that may apply. Art. 238.- In the concurrence of more than one violation of the provisions of this Law and its regulations, the person It will be judged for all the tasks. Art. 239.- The recidivism in the breach of this Law and its regulations, will be repressed with double the maximum of the penalty for each case, without prejudice to the civil or criminal penalties that may be applicable. Art. 240.- The infractions determined in this law will be sanctioned with: a) Fine; b) Suspension of the permit or license; c) Suspension of professional practice; d) Confiscation; Y, e) Partial, temporary or final closing of the corresponding establishment. CHAPTER IV Of the infractions Art. 241.- Will be sanctioned with a fine of a unified basic salary of the worker in general, the breach of provided in articles 32, 53, 61, 64, 74 second subsection, 101, 111 second subsection, 115, 120 subsection second, 122, 123, 167, 195, 198 and 202 literal a), of this Law. Art. 242.- It will be sanctioned with a fine of a unified basic salary of the worker in general and temporary closure or definitive establishment, the breach of the provisions of articles 40, 47, 58 subsection second, 97, 103 and 124 of this Law. Art. 243.- Will be sanctioned with a fine of five unified basic wages of the worker in general, the breach to the provisions of articles 50, 57, 60, 74 first paragraph, 90, 118, 163, 175, 184 and 202 literal b), of this Law. Art. 244.- It will be sanctioned with a fine of five unified basic salaries of the worker in general and temporary closure or definitive establishment, the breach of the provisions of articles 105, 109, 166, 169, 172, 174, 178, 194, 200 and 212 of this Law. Art. 245.- It will be sanctioned with a fine of five unified basic wages of the worker in general and forfeiture breach of the provisions of article 125 and first paragraph of article 153 of this Law. Art. 246.- It will be sanctioned with a fine of ten unified basic salaries of the worker in general, the breach of the provisions of the articles 12 second paragraph, 22, 29, 41, 48, 80, 110, 173 and 202 literal c), of this Law. Art. 247.- It will be sanctioned with a fine of ten unified basic salaries of the worker in general and temporary closure or definitive establishment, the breach of the provisions of articles 104, 116, 121, 143, 159 second subsection, 186 and 192 second and third subsections, of this Law. Art. 248.- It will be sanctioned with a fine of ten unified basic salaries of the worker in general, forfeiture and closure temporary or definitive establishment, the breach of the provisions of articles 42, 49, 137, 140, 141 first paragraph, 146, 164 and 170 of this Law. Art. 249.- Will be sanctioned with a fine of twenty unified basic salaries of the worker in general, the breach to the provisions of articles 27, second paragraph, 75, 162 and 202 literal d) of this Law. Art. 250.- It will be sanctioned with a fine of twenty unified basic salaries of the worker in general and closing temporary or definitive, the breach of the provisions of articles 149 and 183, second paragraph, of this Law. Art. 251.- It will be sanctioned with a fine of twenty unified basic salaries of the worker in general, forfeiture and temporary or definitive closure of the corresponding establishment, non-compliance with the provisions of the articles 150 and 151, of this Law. Art. 252.- It will be sanctioned with a fine of fifty unified basic salaries of the worker in general, the breach of the provisions of articles 81 and 82 first paragraph of this Law. Art. 253.- The violation of the provisions of articles 213 and 214, will be sanctioned with suspension of the exercise professional, fine of one hundred unified basic salaries of the worker in general and final closure of the establishment, without prejudice to the civil and criminal penalties that may be applicable. Art. 254.- Will be sanctioned with a fine of five unified basic salaries of the worker in general, the breach to the provisions of articles 130 and 134 of this Law. Art. 255.- It will be sanctioned with the suspension of the professional exercise for five years and temporary or definitive closure. of the corresponding establishment, the breach of the provisions of article 210 of this Law. Art. 256.- It will be sanctioned with temporary or definitive closing of the corresponding establishment, the breach to the provisions of article 185 of this Law. Art. 257.- The product of the fines that are collected for violations of the provisions of this Law and its regulations, it will be used in the respective jurisdiction where it is imposed, and must be used for care and improvement of the health services of the respective provincial direction. Art. 258.- For compliance with the provisions established in this Law, health authorities shall have free access to the places where they must fulfill their inspection and control functions, being able to do so require the intervention of the public force, if necessary. CHAPTER V Of the definitions Art. 259.- For the purposes of this Law, it is understood as: Accreditation of health services.- It is the voluntary process carried out regularly and regularly, of a character reserved, through which a health service, regardless of its level is evaluated by a technical agency qualified, according to a set of standards that describes the activities and structures that contribute in a way Direct to the desired results for patient-users, compliance with these standards seeks to achieve optimal level of quality of care taking into account available resources. Food additives.- They are substances or mixtures of substances of natural or artificial origin, which alone do not they consume directly as food, have or not nutritional value and are added in limits allowed during the production, handling, manufacturing, processing, treatment or preservation of food. Agents of traditional medicines.- They are those healers who intervene in different areas of health, whose denominations are particular to each of the nationalities and peoples, and their recognition comes from the own communities where they provide their services. The formal and temporary conditions and characteristics of your Training are typical of their ancestral tradition and culture. Food.- It is any natural or artificial product that ingested contributes to the organism of the human beings or of the animals, materials and energy necessary for the development of biological processes. It also includes substances and mixtures thereof that are ingested by habit or custom, whether or not they have value nutritious. Genetically modified foods.- Those that contain or are composed of genetically modified organisms modified or have been produced from them. Natural food.- It is one that is used as presented in nature without having undergone transformation in its characters or in their composition, being able to be subjected to prescribed processes for reasons of hygiene, or those necessary for the separation of inedible parts. Processed food.- It is all natural or artificial food material that for human consumption has been subjected to technological operations necessary for its transformation, modification and conservation, which is distributed and markets in containers labeled under a particular brand. The term processed food, extends to alcoholic and non-alcoholic beverages, table waters, condiments, spices and food additives. Pharmaceutical care.- It is patient care by the pharmaceutical chemist or pharmaceutical biochemist in the follow-up of therapeutic drug treatment, aimed at contributing to the doctor and other health professionals, in achieving the expected results and achieving the maximum therapeutic benefit. Blood banks.- They are health, technical, specialized and qualified services, responsible for carrying out the extraction, preparation, conservation, storage and supply of human blood, its components and derivatives. Tissue banks.- These are technical, specialized and qualified health services, whose mission is to guarantee the quality of the tissues from its obtaining to its clinical use. First aid kits.- These are pharmaceutical establishments authorized to sell to the public, only the list of medicines and other products determined by the national health authority; they will work in rural areas where There are no pharmacies and they must comply at all times with proper storage practices. Representative houses.- These are the pharmaceutical establishments authorized to carry out medical promotion, import and wholesale sale to third parties of the products made by their represented. They must meet good storage and distribution practices determined by the national health authority. They require for your operation of the technical management responsible for a professional pharmaceutical chemist or pharmaceutical biochemist. Production - consumption cycle.- These are the stages or phases involved in the production, handling, storage, transport, distribution, import, export, marketing, sale and consumption of products. Anatomical components.- They are the organs, tissues, cells, their derivatives and in general all parts of the organism human. Waste.- Are the waste or waste in any state of the matter, product of industrial activities, commercial and community; They are classified as common, infectious and special or dangerous. Common waste.- Are those that do not represent a risk to human, animal or environmental health. Hazardous waste.- Are those resulting from a process of production, transformation, recycling, use or consumption and that they have some compound with reactive, flammable, corrosive, infectious or toxic characteristics, which present a risk to human health, natural resources and the environment. Infectious wastes.- Are those that contain pathogenic germs and represent a health risk; are generated in human health establishments, veterinarians, morgues and others. Medical devices.- Are items, instruments, devices, devices or mechanical inventions, including their components, parts or accessories, manufactured, sold or recommended for use in diagnosis, curative treatment or palliative, prevention of an abnormal disease, disorder or physical condition or its symptoms, to replace or modify the anatomy or a physiological process or control it. They include amalgams, varnishes, sealants and more products similar dental Pharmaceutical distributors.- These are pharmaceutical establishments authorized to carry out import, export and wholesale of medicines in general for human use, pharmaceutical specialties, products for industry Pharmaceutical, medical-surgical auxiliaries, devices doctors, medical supplies, cosmetics and hygiene products. They must comply with good storage practices and distribution determined by the national health authority. They will work under representation and responsibility Technique of a pharmaceutical chemist or pharmaceutical biochemist. Donor.- It is the person from whom, during his life or after his death, anatomical components are extracted in good functional status, to transplant them into another person or use them for therapeutic or research purposes. Health emergency.- It is any situation of risk of health condition caused by natural disasters or by action of people, climatic phenomena, absence or precariousness of basic sanitation conditions that favor the increase in communicable diseases. It requires the special intervention of the State with resource mobilization human, financial or other, aimed at reducing the risk or mitigating the impact on the health of populations more vulnerable The health emergency must be declared by the President of the Republic as mandated by the Constitution Politics. Pharmacies.- They are authorized pharmaceutical establishments for the dispensing and sale of medicines for use and human consumption, pharmaceutical specialties, processed natural products for medicinal use, biological products, medical supplies and devices, cosmetics, dental products, as well as for the preparation and sale of formulas officinal and masterly. They must comply with good pharmacy practices. They require management to operate Technique and responsibility of a professional pharmaceutical chemist or pharmaceutical biochemist. Genetics.- It is the science that deals with reproduction, inheritance, variation in both normal and abnormal state or disease, and the set of phenomena and problems related to the offspring. Pharmaceutical laboratories.- Pharmaceutical establishments are authorized to produce or produce medicines in general, pharmaceutical, biological specialties for human or veterinary use; must meet good standards manufacturing practices determined by the national health authority; and, will be under the technical direction of Pharmaceutical chemists or pharmaceutical biochemists. Licensing of health services.- It is the mandatory procedure through which the authority National Health Service grants operating permission to public health service institutions or private, according to their resolution capacity, attention levels and complexity, after verifying compliance with the minimum essential requirements or standards. Food raw material.- It is the substance or mixture of substances, natural or artificial allowed by the authority National sanitary, which is used for the preparation of food and beverages. Medication.- It is any preparation or pharmaceutical form, whose composition formula expressed in units of the system international, it consists of a substance or mixture of substances, with constant weight, volume and percentages, Prepared in legally established pharmaceutical laboratories, packaged or labeled for distribution and marketed as effective for diagnosis, treatment, mitigation and prophylaxis of a disease, physical anomaly or symptom, or the restoration, correction or modification of the balance of the organic functions of beings Humans and animals. By extension this definition applies to the association of substances of dietary value, with therapeutic indications or specially prepared foods, which replace special diets. (KEEP GOING). Art. 259.- (CONTINUED) Over-the-counter medication.- It is the oral or topical medication that due to its composition and the pharmacological action of Its active ingredients are authorized to be sold or dispensed without optional prescription. Generic medicine.- It is the one that is registered and marketed with the International Common Denomination (INN) of the active principle, proposed by the World Health Organization; or in its absence, with a generic denomination conventional internationally recognized. These medications must maintain quality, safety and efficiency required for brand. Homeopathic medicine.- It is the pharmaceutical preparation obtained by homeopathic techniques, according to the rules described in the official pharmacopoeias accepted in the country, in order to prevent disease, relieve, cure, Treat and rehabilitate a patient. The containers, labels, labels and packaging are an integral part of the medicine, Because these guarantee their quality, stability and proper use. They must be prescribed by authorized professionals for the purpose and dispensed or expended in places authorized for that purpose. Alternative medicines.- They are the set of scientifically proven medicines, exercised by medical professionals, with a fourth level degree in the subject and recognized by the national health authority. Traditional medicines.- They are the set of ancestral knowledge and practices of nationalities, peoples, indigenous, mestizo and afro descendant communities that over time have constituted a specific knowledge, maintained and disseminated in a cultural context, of interrelation of natural, ethical, spiritual, mental elements, psychological and emotional and that is explained and works in that same cultural universe. Their practices correspond to knowledge, techniques and procedures of their worldview and are exercised by medicine healers traditional, recognized by their communities and registered by the national health authority. Necropsy or autopsy.- It is the technical procedure by which a corpse is observed and analyzed, external and internally to establish the causes of death of the person. New chemical entity.- It is the medicine, ingredient or active ingredient of human use or consumption that has never been used for any therapeutic indication worldwide. It will not be considered a new chemical entity among others, the new uses or second uses, nor the novelties or change of the following aspects: pharmaceutical forms, indications or second indications, new combinations of known chemical entities, formulations, forms of dosage, routes of administration, modifications of any kind that do not affect the mechanism of action, marketing and packaging conditions and in general, those that involve new presentations. Genetically modified organisms, GMO or LMO modified living organism.- Any living organism, with the exception of human beings, who have acquired a novel genetic combination, generated through the specific use of techniques of modern biotechnology. Operation permit.- It is the document granted by the national health authority to the subject establishments health control and surveillance that meet all the requirements for its operation, established in the corresponding regulations. Food processing plants.- These are establishments where selection, purification operations are carried out. and transformation of raw materials for food production, packaging and labeling. Processed natural product for medicinal use.- It is the finished and labeled medicinal product, whose ingredients assets are formed by any part of the natural resources for medicinal use or their combinations, as a drug raw, extract or in a recognized pharmaceutical form, which is used for therapeutic purposes It is not considered a processed natural product for medicinal use, if the natural resource for medicinal use is combined with Chemically defined active substances, including constituents of natural resources, isolated and chemically defined. Nutraceutical product.- Also called functional or bioactive compound, it is any similar product in appearance to a conventional food that has one or more intentional benefits, beyond providing nutrition adequate, such as a better state of health or a reduction in the risk of a given disease. Tobacco products.- It covers products prepared totally or partially using raw materials tobacco and intended to be smoked, sucked, inhaled, chewed or used as a snuff. Biochemical reagents.- These are all substances or products that are used with special machines or not, for react with liquids or organic matter and help in the diagnosis, monitoring, control and treatment of diseases of human beings. Receiver.- Is the person whose body implants anatomical components from himself, from another person or of another species. Sanitary registration.- It is the certification granted by the national sanitary authority, for the import, export and commercialization of the products of human use and consumption indicated in article 137 of this Law. This certification is granted when the quality, safety, efficacy and fitness requirements are met for consume and use these products in compliance with the procedures established in this Law and its regulations. Environmental health.- These are the knowledge that deal with the life forms, substances, forces and conditions of the environment of the human being that can exert harmful effects on their health and well-being, as well as the actions to prevent or reduce them, within the framework of the promotion and development of healthy environments. Reproductive health.- It is the general state of physical, mental and social well-being and not of mere absence of diseases or ailments, in all aspects related to the reproductive system, its functions and processes and implies the people's right to make decisions about it. Sexual health.- It is the general state of physical, mental and social well-being and not of mere absence of diseases or ailments, that allows the person in a free and responsible way to enjoy a full, pleasant, free sexual life of sexual abuse, coercion or harassment and sexually transmitted diseases. Environmental sanitation.- It is the set of activities dedicated to conditioning, controlling and protecting the environment in which the human being lives, in order to protect his health. Health services.- Are those that are intended to provide health, promotion, prevention, and health benefits. recovery and rehabilitation on an outpatient, home or internment basis, are classified according to the resolving capacity, attention levels and complexity. Alternative therapies.- Set of methods, techniques and systems used for prevention or treatment of diseases and are oriented to balance the organism in its physical, mental or spiritual aspects, and to establish a balance between the individual and the environment. Organ transplantation.- It is the replacement for therapeutic purposes of anatomical components in a person, by others equal and functional from the same recipient or from a living or dead donor. Violence.- It is any action, omission or intentional use of physical force or power, real or by threat, of a person, group or institution in order to harm another against their will, characterized by aggression against physical, sexual, psychological, symbolic or cultural integrity. GENERAL DISPOSITION FIRST.- Control services, inspections, authorizations, permits, licenses, registrations and others of similar nature provided by the national health authority, will satisfy the payment of rights in accordance with the respective regulations. SECOND.- The President of the Republic shall issue the general regulations for the application of this Law, in a maximum term of ninety days. THIRD.- Derogatory.- Repeal all the rules, general or special provisions that oppose this Law, in health matters. Repeal expressly: The Health Code, issued by Executive Decree No. 188, published in the Official Register No. 158 of 8 of February 1971 and all its reforms. Articles 8, 9, 10, 11 and Chapter VIII of the Law on Production, Importation, Marketing and Expenditure of Generic Medicines for Human Use, published in the Official Register No. 59 of April 17, 2000. Article 99 of the Law for the Promotion of Investment and Citizen Participation, published in the Supplement to Official Registry No. 144, of August 18, 2000. Article 11 of the Law of Organ and Tissue Transplants, published in the Official Registry No. 492 of July 27 of 1994. FOUR.- Make the following reforms: a) In Article 2 of the Law on Production, Importation, Marketing and Expenditure of Generic Drugs for Use Human, published in the Official Register No. 59 of April 17, 2000, replace the word: "... employ", by: "market ..."; b) Throughout the Law on Rights and Protection of the Patient, replace: "health centers", with: "health services"; c) In article 98 of the Civil Registry, Identification and Certification Law, following numeral 13, add the next: "14. Express authorization of the citizen to be a donor of organs or other anatomical components, in accordance with what is established in the article 83 of the Organic Health Law. "; d) Replace articles 1 and 2 of the Law on the Provision and Use of Blood and its Derivatives, published in the Official Registry No. 559 of November 7, 1986, by the following. "Art. 1.- The surveillance and control of the supply and use of blood and its derivatives in Ecuador will be responsibility of the national health authority. Organize in coordination with the Ecuadorian Red Cross, the national system of banks and blood deposits, in the cities and health services that require them, provided they have the technical conditions for this. The Ecuadorian Red Cross, the Ministry of Public Health, the Ecuadorian Institute of Social Security, the Forces Armadas and the Junta de Beneficencia de Guayaquil will continue to administer the banks and blood deposits attached to Your health services. Art. 2.- The export of blood and its derivatives is prohibited, except as indicated in article 79 of the Organic Law of Health and, e) Following the fifth subsection of Article 46 of the Organic Customs Law, include another subsection with the following text: "They are also exempted from verification at source: vaccines, biologicals, medicines and supplies imported by the Ministry of Public Health.". FIFTH.- All provincial capitals, without exception, will have at least a third level public hospital of attention, with the infrastructure, equipment, goods, supplies, budgets and adequate human resources, sufficient and permanent, empowered to solve the needs of the population, in accordance with reality local epidemiological SIXTH.- As provided in numeral 10 of article 35 of the Political Constitution of the Republic, it is prohibited the stoppage, for any reason or for some reason, of the public health service, under prevention of applying to responsible for the sanctions provided for in the laws that regulate the employment relationship and the Criminal Code. TRANSITIONAL PROVISION The regulations on health matters are in force, will continue to apply in everything that does not oppose the present Law, until when others are dictated. Dada, in the city of San Francisco de Quito, Metropolitan District, in the session hall of the National Congress of the Ecuador, on the fourteenth day of the month of December of the year two thousand and six.