Libro II Título II. De las acciones de recuperacion y rehabilitacion de la salud

For the purposes of this Code, it is considered:

a)Health recovery, the set of general medical services, dental services and specialized services provided to the individual, the family and society with the purpose of restoring health.

b)Health rehabilitation, the set of actions aimed at restoring persons' capacities to carry out their normal activities and to be able to participate actively with their community.

The Ministry of Health, in coordination with the other institutions of the Sector, shall formulate a policy regulating the growth and development of health infrastructure, in order to guarantee optimal utilization of health resources by the State, thereby avoiding unnecessary duplication of resources and efforts.

The Ministry of Health, in coordination with the Guatemalan Institute of Social Security, private institutions and other non-governmental and community organizations, shall organize their services on the basis of levels of care; these being understood as a set of different appropriate technologies for the resolution of specific groups of health problems of varying complexity, in order to guarantee access and coverage to all inhabitants who request care from the health services network that is established.

To guarantee the population's access to the different health establishments, the Ministry of Health shall create and standardize a referral and counter-referral network for patient care in accordance with the established levels of care.

Third-level national hospitals, both those of the Ministry of Health and those of the Guatemalan Institute of Social Security, shall become national reference hospitals, to treat only cases of high specialty which by their nature require technologies of high complexity. General care of the patients they currently cover shall gradually be deconcentrated to regional and local peripheral hospitals.

For the treatment of high-specialty cases, the Ministry of Health and the other institutions comprising the sector shall propose and put into practice models for the joint provision of services, in order to increase their coverage and reduce costs.

Within the framework of the established policy for the development of health infrastructure, the Ministry of Health and the Guatemalan Institute of Social Security and other institutions that make up the Sector shall implement a plan for the shared use of their health establishments, on the basis of the health model defined by the Ministry of Health and in accordance with the level of care.

It is the responsibility of the Ministry of Health to authorize and supervise the operation of public and private health care establishments, in accordance with the norms that are established.

Every hospital, whether public or private, shall have a Bioethics Committee, which shall assist the patient, the family and the treating physician, within the legal framework, in making the most appropriate decisions.

The installation, construction, expansion, modification and relocation of public and private health-care establishments, of whatever type they may be, shall be authorized by the Ministry of Public Health, in accordance with the corresponding regulations.

Every public or private health service shall hold the quality accreditation certificate, which shall be issued by the Ministry of Health.

The State through the Sector shall incorporate, regulate and strengthen alternative systems, such as homeopathy, natural medicine, traditional medicine, therapeutic measures and others for health care, establishing mechanisms for their authorization, evaluation and control,

The provisions in this field are oriented toward the regulation and sanitary surveillance of the production, importation, exportation and commercialization of these products. Likewise toward the conformity assessment, sanitary register and registration of the products covered in this chapter and of the different establishments that produce and commercialize them.

For the purposes of this Code and its regulations, the following products are covered:

a)Medicinal or pharmaceutical product;

b)Cosmetics, personal and household hygiene products;

c)Narcotics, psychotropics and their precursors;

d)Phyto- and zootherapeutic products and similar products;

e)Pesticides for domestic use;

f)Dressing material;

g)Laboratory reagents for diagnostic use;

h)Dental materials, products and equipment.

For purposes of the application of this Code, the products contemplated in Article 163 of this chapter are defined as follows:

a)Medicine or pharmaceutical product: Any simple or compound substance, natural or synthetic, or mixture thereof, intended for persons and having the property of preventing, diagnosing, treating, alleviating or curing diseases or symptoms associated therewith.

b)Cosmetics, personal hygiene products, household products and pesticides:

Cosmetic: Any preparation intended to be applied externally to the human body for purposes of beautification, modification of its physical appearance or preservation of the normal physicochemical conditions of the skin and its appendages (hair and nails).

Personal hygiene products: They are all those products used for the hygiene of persons, among which are found dentifrices, mouthwashes or buccal rinses, deodorants, antiperspirants, products for shaving the beard and after shaving, talcs, condoms, sanitary towels, tampons, disposable diapers, solid and liquid toilet soaps, toothpastes, solutions and aerosols for buccal washing.

Household hygiene products: They are all those products used in household hygiene, considering within these soaps and detergents, ambient deodorants, antiseptics and disinfectants for water, cleaning products for furniture, floors and kitchen equipment.

c)Narcotic drugs and psychotropics: They are substances that affect organic and psychic health, that may create addiction and that are considered as such internationally. The term narcotic drug may be applied to substances that belong to different pharmacological categories (analgesics, narcotics, central nervous system stimulants, hallucinogens, and others)…

Chemical Precursors: Substances that may be used in the manufacture of narcotic drugs and psychotropics or of substances of similar effects, which incorporate their molecular structure into the final product in such a way that they are fundamental to such processes.

d)Phyto- and zootherapeutic and similar products: Any preparation based on plants, algae, fungi, tissues of animal origin having a defined pharmaceutical form, to which therapeutic purposes are attributed and whose use is safe.

e)Domestic-use pesticides: Any substance intended to be applied in the environment of dwellings, buildings and public and private installations, industries, private gardens, transport vehicles, on persons and domestic animals, and in public health programs, with the object of combating organisms capable of producing damage to the health of persons, to flora or to objects or of transmitting diseases to human beings.

f)Curative material: They are all those products used in medical and dental practice to effect cures; within these may be mentioned: cotton, gauzes, adhesive plasters, medical-surgical adhesive tapes, suture threads, and all those others contemplated within the respective regulation.

g)Laboratory reagents for diagnosis: Chemical enzymatic, natural or synthetic substances used for qualitative and quantitative determinations of biological samples, and culture media used for purposes of in vitro diagnosis,

h)Dental materials, products and equipment: Products intended for their use in persons and having the property of preventing, diagnosing, treating, alleviating or curing buccal diseases.

i)Falsified medicines and falsified pharmaceutical products: They are products fraudulently produced, manufactured, fabricated, packed, conditioned or labeled with respect to their identity, brand or origin, to make them appear to be original products, which represent a grave risk to the health and life of persons.

j)Adulterated medicine: Condition in which the content or nature of an original medicine is altered in its previously authorized specifications, with the addition or elimination of an inert or foreign element of any nature. This includes those that have been prepared, handled, packed, conditioned or stored in clandestine or unauthorized establishments.

k)Medical devices and medical-surgical material: is any instrument, apparatus, implement, machine, artifact, material implant or other similar or related article, used alone or in combination, including the accessories and software necessary for its correct application, proposed by the manufacturer for its use with human beings for: diagnosis, prevention, monitoring, treatment or relief of a disease; diagnosis, prevention, monitoring, treatment or relief of an injury; investigation, replacement or support of the anatomical structure or of a physiological process, support and sustainment of life, birth control, disinfection of medical devices, in vitro examination of samples derived from the human body, and which does not fulfill its intended basic action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its functions by such means.

l)Falsified medical devices and medical-surgical material; Any instrument, apparatus, implement, machine, artifact, implant, material or other similar or related article, used alone or in combination, including the accessories and software for its use with human beings pursuant to the definition of the preceding subparagraph, fraudulently produced, manufactured, fabricated, packed, conditioned, wrapped or labeled with respect to its identity or brand to make them appear to be original products.

The Ministry of Health shall maintain control and surveillance over the action of these products, according to the risk to the health of the inhabitants in accordance with what the respective regulation establishes.

All advertising, promotion or propaganda made concerning products covered in this chapter must be governed by ethical criteria, must provide the user with reliable, accurate, balanced and up-to-date information, so that the user may apply his or her judgment and take the option most in keeping with his or her interests.

It is the set of specifications for the product to be registered, which shall serve as a reference for controlling the same when it is being marketed. The registration shall have a duration of five years, provided that it maintains the characteristics of the reference sample and complies with quality and safety standards. Otherwise, the sanctions established by this Code shall apply. The registration shall be carried out under the responsibility of a university professional in the field, in accordance with what the corresponding regulation establishes.

It is the process by which a product becomes registered before the responsible institution designated by the Ministry of Health, leaving a record of the company and of the responsible professional. The regulation shall establish the necessary requirements for such purpose, as well as the analyses to be performed in accordance with risk criteria.

All products of this chapter, prior to their commercialization and in accordance with the provisions of the respective regulation, shall have:

a)Mandatory registration with the Ministry of Health:

I.Phyto- and zootherapeutic products and similar products;

II.Dressing material and others;

III.Cosmetics, personal and household hygiene products;

IV.Dental materials, products and equipment;

V.Laboratory reagents for diagnosis;

b)Reference sanitary register:

I.Medicine or pharmaceutical product;

II.Narcotics and Psychotropics;

III.Pesticides for domestic use.

For the products covered by this chapter, manufacturers and importers shall be directly liable for their safety and quality. In the event that the products do not comply with such characteristics and cause damage to health and the environment, those liable shall be sanctioned in accordance with what this law specifies.

The Ministry of Health shall establish safe and agile mechanisms to monitor and control the quality and safety of the products covered in the present title, and to comply with this requirement shall issue the corresponding document in the shortest possible time, in accordance with the time limit set in the respective regulation.

The Ministry of Health shall establish a national medicines program that allows for the operationalization of medicines policies, including the selection, quality, supply, production, commercialization and rational use thereof, promoting social participation, with the primordial aim of the population's access to quality medicines. It shall likewise designate the offices responsible for these functions.

The Ministry of Health shall regulate the supply, prescription, promotion and appropriate use of medicines, according to the levels of health care and tiers of complexity established in the health care model.

Any medicine found on the market may be subjected to evaluation that ensures its levels of quality, efficacy and safety, in accordance with the standard established in the reference sanitary register. The corresponding regulation shall establish the procedures to be applied.

In the international agreements or treaties signed by Guatemala concerning medicines, aspects of legislation, strengthening, safety, quality and efficacy thereof and reciprocal treatment for Guatemalan products and imported products shall be contemplated, through harmonized procedures approved by the Ministry of Health.

Entities that produce and distribute medicines shall guarantee that they are manufactured in accordance with good manufacturing, laboratory and storage practices, as well as those established in the respective regulation.

The substitution of prescriptions prescribed by health professionals in exchange for an economic or material benefit to the owners or employees of the establishment is prohibited. The sanctions imposed for this offense shall be applied both to the person who receives the benefit and to the person who grants it, in accordance with the book of sanctions of this Code.

Any act related to narcotics, psychotropics and their precursors may only be carried out for therapeutic or industrial purposes, with prior authorization from the Ministry of Health, in coordination with other institutions, according to their jurisdiction. Control shall be exercised in accordance with the Political Constitution and other laws of the Republic, this Code, and other regulations and decisions issued by the Ministry of Health and with the norms established in the treaties, conventions and international agreements ratified by Guatemala.

Surveillance of the production, manufacture and importation, commercialization and distribution of narcotic drugs, psychotropics and their precursors corresponds to the Ministry of Health, in accordance with national legislation and international treaties in force.

The cultivation and harvesting of the opium poppy (Papaver somniferum), coca (Erythroxilon coca), hemp and marijuana (Cannabis indica and Cannabis sativa), poppy and of others determined by law are prohibited and subject to destruction by the competent authority. Likewise, trafficking in and use of seeds and phytogenetic material with germination capacity of the aforementioned plants, their resins and oils, is prohibited.

Personal consumption of narcotics and psychotropics shall be permitted only when carried out for therapeutic purposes and under medical prescription and supervision; the prescription thereof shall be subject to the corresponding regulations. Its prescription shall be restricted to the professional legally authorized for that purpose.

Pharmaceutical establishments are the laboratories for the production and quality control of pharmaceutical and similar products, droguerías, distributors, pharmacies, dental depots and medicine sales outlets. Their classification and definition shall be detailed in the respective regulation according to the type of operation carried out.

They are spaces of any kind, whether fitted out or not, intended for: production, manufacture, fabrication, packing, conditioning, storage, labeling, distribution, commercialization, supply, sale or dispensing of any type of medicine, pharmaceutical product or medical devices or medical surgical material, without due authorization from the Ministry of Public Health and Social Assistance.

All establishments referred to in the preceding article require, for their installation and operation, the sanitary license granted by the Ministry of Health through the corresponding department, which shall be issued within the established time limit and in accordance with the rules established by the regulation. The sanitary license shall be valid for five (5) years, the establishment remaining subject to control during this period. In case of non-compliance with the corresponding sanitary laws or regulations, it shall become subject to the sanction established by this Code.

Pharmaceutical establishments shall be under the technical direction of a university professional of the field, with the exceptions contemplated in the respective regulation remaining applicable; said professional shall ensure the supervision mechanisms of the establishments under his or her charge, and shall answer jointly with the owner, representative or manufacturer for the identity, purity and good condition of the products that are manufactured, transformed, prepared, imported, exported, analyzed, stored, distributed or dispensed, as corresponds to the nature of the establishment.

Any of the persons referred to in the preceding article shall be liable when they engage in the commission of acts sanctioned by criminal, civil or administrative laws.

The Ministry of Health shall formulate the policies, norms and procedures for the donation of medicines, which shall address the unmet needs of the population in this area, quality standards and effective communication between donors and the health authorities of the country.

All donations of medicines must be based on the expressed needs and be consistent with the morbidity of the country. The donated medicines or their generic equivalents must be approved in the donor country and in the recipient country for clinical use.

All donated medicines must come from a reliable source and comply with national standards or, failing that, with internationally recognized quality standards. Donations must be first-choice medicines.

The Ministry of Health, jointly with other institutions that make up the Sector, shall promote the establishment of centers and services for physical, psychological, social and occupational rehabilitation, as well as programs to prevent disability.

The Ministry of Health, through its competent organs, shall provide, by itself or through actions coordinated with other institutions, for the physical and mental rehabilitation of persons who present a diminution of their physical, intellectual and mental capacities as a consequence of disabling, congenital or acquired conditions.

Minors in a special situation are considered to be those who, lacking adequate protection, suffer or are exposed to suffering deviations or disorders in their development or in their physical or mental state, and also those who are in situations of abandonment or danger in accordance with special laws.

The Ministry of Health, in coordination with other institutions of the sector and of non-governmental organizations, shall provide protection, assistance and rehabilitation to minors of special conduct and assistance shall be sought from the competent tribunals in the compliance with and processing of the measures decreed by them. Likewise, it shall develop actions aimed at suppressing or reducing the causes that interfere with the normal physical, mental and social development of minors and of persons who due to their social condition are affected in their personal development.

Only those who hold the corresponding degree or the respective incorporation from the Universidad de San Carlos de Guatemala, and are active members of the professional college, may practice the health-related professions, in the case of university professions. The Ministry of Health shall keep a register of such professionals.

Those who prove their training in institutions authorized or created by the Ministry of Health, and the Ministry of Public Education, the Universities of the country and the Guatemalan Institute of Social Security shall be recognized and shall be registered to practice the technical, intermediate and auxiliary degrees.

The Ministry of Health shall regulate the practice of physiotherapists, massage therapists, operators of beauty and personal hygiene salons, manicurists, pedicurists, kinesiologists, midwives, acupuncturists, chiropractors, naturopaths, homeopaths, and others who carry out activities involving direct care to persons.

Public and private health laboratories are those that practice and analyze human or animal specimens, for the diagnosis, monitoring, treatment and prevention of disease for purposes of medical and public health research, certification of persons' health statuses and judicial proceedings, classified as follows;

a)Pathological anatomy laboratories, those that perform examinations on tissues of human origin directed at diagnosis or research to determine structural changes by means of tissues obtained by surgery, biopsy or necropsy, encompassing macroscopic and microscopic pathology changes.

b)Clinical laboratories, those that perform examinations directed at diagnosis or research in the fields of biochemistry, biophysics, hematology, immunology, parasitology, virology, bacteriology, mycology, coprology, urology, cytology, radioisotopes and others in samples of human origin.

c)Forensic laboratories, those that, through the application of anatomo-pathological, histopathological, chemical, toxicological and other technical methods, perform examinations for matters related to judicial investigations.

The Ministry of Health shall be responsible for approving the operation of public and private health laboratories, in accordance with the requirements established in the respective regulation.

The Ministry of Health, in coordination with the Guatemalan Social Security Institute and non-governmental organizations, shall adapt the network of public and private laboratories nationwide, based on profiles of increasing complexity, linking it to the network of health establishments, thus favoring, through this organization, access by the user population to the different types of services that are required.

The direction of every health laboratory shall be in charge of a professional specialist in the subject matter, an active member of the professional association, as established in the respective regulation.

The owner of the laboratory that fails to comply with the provisions governing its operation shall be jointly and severally liable with the Director thereof for any damage or harm caused.

Blood Banks and Transfusion Medicine Services are centers where the appropriate procedures are performed for the utilization of human blood for therapeutic and research use.

The establishment and operation of Transfusion Medicine services and blood banks are regulated by the respective law.

Failure to observe the provisions contemplated in the present law shall be sanctioned in accordance with what is stipulated in the respective book of sanctions.

The disposition of organs and tissues is regulated by the respective law.

Failure to observe the provisions contemplated in the present law shall be sanctioned in accordance with what is stipulated in the respective book of sanctions.

It is mandatory to comply with the provisions issued by the Ministry of Energy and Mines, through the competent authority, concerning directly and indirectly ionizing radiation, for the purpose of preventing accidents caused by radiation.

The Ministry of Health shall be in charge of medical surveillance and pre-occupational and occupational examinations, which comprise the clinical and laboratory examinations of persons who in the future, by reason of their work, may be exposed to ionizing radiation. The Ministry of Energy and Mines, through its competent department, shall be in charge of radiological surveillance. Every person exposed to ionizing radiation shall be monitored by a personal dosimetry system in accordance with the opinion of the competent authority.

Any person who engages in activities of importation, exportation, manufacture, storage, transportation, marketing, supply, maintenance, installation, operation, irradiation of food and other products; produces, uses, handles, applies or works in other activities related to radioactive sources or ionizing radiation-generating equipment; for medical, industrial research, commercial or defense purposes, may only do so with the authorization of the Ministry of Energy and Mines and, when applicable, with the Ministry of Health.

No person, by reason of occupation, nor the population in general, shall be subjected to the risk of exposure to ionizing and non-ionizing radiation exceeding the dose limits established internationally and those set at the national level by the Ministry of Energy and Mines through its competent department.

The institutions or establishments in which workers handle radioactive substances, or in which radioactive sources and ionizing radiation-generating equipment are operated, shall be responsible for ensuring that, in the establishment under their charge, precautionary and protective measures for personnel are taken, providing personnel with protective equipment and means, periodic health monitoring, as well as continuous training in ionizing radiation safety and hygiene. The institutions and persons involved in the handling of radioisotopes and ionizing radiation must hold the respective license, in which the requirements to be met by the facilities, radioactive sources and ionizing radiation-generating equipment shall be specified.

Importers of radioactive articles and electronic devices, such as fluoroscopes, microwave devices, or goods for commerce and industry, such as laser or microwave communication devices, shall guarantee that such goods meet the requirements so that the emitted radiation is within existing standards and complies with what is established in the country. The Ministry of Health is obligated to inform of the risks to health posed by the use of such articles.

Persons who trade in or distribute the goods referred to in the preceding article shall ensure that such goods are not prohibited in the country of origin and bear labeling with indications in Spanish on the type of radiation they emit, with the corresponding hazard warnings.

The activities of importation, manufacture, commercialization and supply, including in the form of donation from a national or foreign institution, shall require authorization from the Ministry of Health, as well as compliance with the requirements that it may establish to safeguard the health of persons.

The importation, commercialization and supply, including in the form of a donation from a national or foreign entity or institution, of the goods cited in this section is prohibited when it is prohibited in the country of origin, they are in a poor state of preservation, have an operating defect or lack adequate labeling indicating their nature, their characteristics, and are not accompanied by the manufacturer with instructions in Spanish for their correct use and to avoid the risks they may involve.

The Ministry of Health, through its corresponding offices, shall verify that equipment and supplies have the manufacturer's quality guarantee, that there is local supply of spare parts, maintenance and the written warning in Spanish of the risks they pose, where applicable.