JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following Law:

I

Of all the hellbent who have endeavoured to fulfil the public powers since the very emergency of the contemporary administration, there may not have been any so repeatedly rehearsed or with as much frustrated contumacy as the health reform.

It is, in fact, an easily verifiable historical data that the public responses to the challenge that at every moment has brought attention to the problems of health of the community have always been to the lag of the evolution of the needs without ever achieving them, so that it has become a constant among us the inadaptation of the sanitary structures to the needs of each epoch.

It is known that the first trial of updating public intervention techniques in the health problems of the community was created by the draft Health Code of 1822, whose approval was thwarted by the disputes about the scientific accuracy of the technical means of action in which it was intended to be supported. With this failure, the consolidation of a well-resourced and flexible executive body, accommodated in terms of its organization to the new management techniques that try to make its way in Spain in the first years of the last century, has to wait until the adoption of the Law of 28 November 1855, which establishes the Directorate General of Health, created very few years before. This law will extend its validity during a very long time, although not in reason of its excellencies, but because of the impossibility of reaching an agreement on a new text of the Health Law, the formulation of which has been issued with reiteration during the last few years. of the last century and the first of the present, without getting definitive approval. Given the impossibility of moving forward a new law, the following reform is established by Royal Decree, in particular by the one of 12 January 1904, which approves the General Instruction of Health, a rule that, despite having remained in force in part until very close dates, only if it altered the device of the public organization to the service of the Health. It is, therefore, the organizational scheme of 1855 (changing the name of the Directorate General of Health for the General Inspection of Health) that transcends the century that saw it born and settles in our system with a firmness. amazing.

The Law of 1944, although innovative at some extremes, assumed the structural plant received, which does not alter, but will perpetuate. The organizational scheme is, in fact, the same as 1855, based on a General Directorate of Health, recited, as the supreme organ. The idea of the content of public responsibilities in this sector is also decimononic: The Public Administration is satisfied with those health problems that may affect the community as a whole, it is the responsibility of the public administration. developing a preventive action, in short. The care function, the problem of the attention to the problems of the individual health, are left to the margin.

the stagnation of the specific public organization at the service of the Health will not mean, however, a lack of attention to all new problems, but the rupture of the unitary character of this organization, which is fragmented in various subsystems which are ordered separately, in response to their own principles and objectives, irrespective of a unit address. In fact, traditional preventive functions will be added to new ones, relating to the environment, food, sanitation, occupational risks, etc., which will bring new public structures to their service. The care functions grow and disperse equally. The traditional ones concerned only the prevention or assistance of certain diseases of particular social importance (tuberculosis, mental illnesses, etc.). These traditional care services are assumed with their own responsibility by different Public Administrations (State, Diputations) that operate without any union nexus in the formulation of the respective health policies. None of them is directed, however, to the attention of the individual individual, if the disease he suffers is not one of the singularized by its transcendence. The dogma that endures is the decimononic of the individual's self-sufficiency to address his health problems. When this dogma goes bankrupt in the eyes of the growth of a system of foresight aimed at the workers, this system also creates its own sanitary structures that are set aside from the general organization, and function according to policies and impulses developed with separation, although explained by new needs and advances both in the field of health and disease and in the new criteria that are imposed by social coverage and health care.

It can be said without hyperbole that the need for a reform of the system that exceeds the state of affairs described has been clear to all those who have had responsibilities in the health sector, since the following day. to the approval of the Law of Bases of 1944. It would prove a summary inquiry of the archives of the Administration; where successive attempts of reform can be found which, however, have not seen any other light than that of the offices of the Ministries.

In the face of the impossibility or lack of conviction in the need to organize a health system to integrate so many scattered structures, the idea has been established that, keeping the various health structures separate public, coordination could be the answer to the needs of rationalisation of the system. The essay is old. It is intended to be implemented first in the field of local administrations with the Health Coordination Law of 11 June 1934. Then, more generally and also in the field of central services, with the Law of Hospitals of 21 July 1962, and by the creation of a very extensive number of Interministerial Commissions, which flow as a real flood, In the end the problem of coordinating the coordinating bodies.

In 1942, in the year 1942, by Law of December 14, the Mandatory Health Insurance is constituted, under the National Institute of Forecasting. This system of health risk coverage, reached through a quota linked to work, has been greatly developed as a result of the gradual process of economic expansion that has arisen in our country since 1950, but especially in the sixties and early seventies. The compulsory sickness insurance, since its creation and subsequent restructuring by Decree 2065/1974 of 30 May-which approves the recast text of the General Law on Social Security, in which the current legislation is crystallized Social Security system-until today, has been assuming a greater number of pathologies within its framework of benefits and, at the same time, has been a system that has progressively gone by including greater number of people and collectives within its scheme Health Insurance. At present, this health system of social security is very evolved, being autonomous manager of a sanitary structure spread throughout the national territory, constituting the most important health network of our country.

Although with the creation, already in very recent times, of a Ministry of Health, it has been possible to improve some of the problems received, it is no less true that a plurality of functioning health systems have been maintained in The European Commission has also been able to take the necessary steps to ensure that the European Commission is able to do so. However, it has been possible to maintain a reasonably efficient level of our health which can certainly be improved and made more profitable and effective if the establishment of a new unitary system adapted to the new rules is strongly encouraged. needs.

II

To the needs of reform to which it has just been mentioned, never completed in depth, they have come to join, in order to definitively support the formulation of the present General Law of Health, two reasons of maximum weight, come from our Constitution, which makes the reform of the system no longer possible. The first is the recognition in Article 43 and in Article 49 of our basic normative text of the right of all citizens to the protection of health, which, in order to be effective, requires the public authorities to adopt the appropriate measures to satisfy it. The second, with greater incidence still in the organizational plan, is the institutionalization, based on the provisions of Title VIII of our Constitution, of Autonomous Communities throughout the territory of the State, to which they have recognized its Statute of a broad competence in the field of health.

The law responds to the first constitutional requirement alluded to, recognizing the right to obtain the benefits of the health system to all citizens and foreigners resident in Spain, although, for reasons of economic crisis which is not to be stressed, does not generalise the right to obtain such benefits free of charge but programme its gradual application, so that it is possible to observe the evolutionary process of costs prudently, In the first phase of the reform, it is not necessarily linked to the reform measures which, in the first phase, Further rationalization that you introduce into the Administration can be expected to be the opposite.

The incidence of the establishment of the Autonomous Communities in our health organization has a major importance. If it is not necessary to make available to them, through the processes of transfers of services, a sufficient sanitary device to meet the sanitary needs of the resident population in their respective jurisdictions. Traditional organisational difficulties can be increased. instead of being resolved. If the Autonomous Communities were to receive only a few specific health services, and not complete organic blocks, the transfer of services would result in the incorporation of a new public administration into the already complex fabric of public entities with responsibility for the sector.

This effect is, however, in addition to a stimulus to anticipate reform, perfectly avoidable. The State, pursuant to Article 149.1.16 of the Constitution, in which this Law is supported, must lay down the principles and substantive criteria for conferring on the new health system certain characteristics. General and common. which are the foundation of health services throughout the territory of the State.

III

The guideline on which the entire reform proposed by the present bill is proposed is the creation of a National Health System. In establishing this, all the organizational experiences compared to the same model have been well-attended, separating themselves from them in order to establish the necessary consequences derived from the peculiarities of our tradition. and our political organization.

The axis of the model that the Law adopts are the Autonomous Communities, sufficiently endowed and with the necessary territorial perspective, so that the benefits of autonomy are not determined by the needs of efficiency in management. The National Health System is conceived as well as the set of health services of the Autonomous Communities conveniently coordinated. The principle of integration for health services in each Autonomous Community inspires Article 50 of the Law: " In each Autonomous Community, a Health Service shall be constituted by all the centers, services and establishments of the Community, Diputaciones, Ayquestas and any other intra-Community territorial administrations, which shall be managed as set out in the following Articles under the responsibility of the respective Autonomous Community ".

The generalization of this organizational model is basic, and the State enjoys, in order to implement it, the powers granted to it by Article 149.1.16 of the Constitution. The effective integration of health services is essential, not only because it is a principle of reform in which the effectiveness of the right to health is at stake, which the Constitution recognises citizens, but also because it is It is desirable to ensure that living conditions are equalised, to impose the coordination of public actions, to maintain the functioning of public services on uniform minimum standards and, finally, to achieve effective health planning. improve both services and their capabilities.

The health services are, therefore, under the responsibility of the Autonomous Communities and under the powers of management, in the basic, and the coordination of the State. The creation of the respective Health Services of the Autonomous Communities is, however, gradual. The Law of the Law of the Autonomous Communities prevents the progressive adoption of the structures and the pace of application of their forecasts to the progress of the processes of transfers of services to the Autonomous Communities.

The concentration of services and their integration at the political and administrative level of the Autonomous Communities, which replace the Local Corporations in some of their traditional responsibilities, precisely in those that experience has proven that the municipal level, in general, is not the most appropriate for its management, this does not mean, however, the correlative acceptance of a strong centralization of services at that level. To avoid this, two types of forecasts are articulated: The first refers to the structure of health services; the second, to the agencies responsible for their management.

As for the first, the Law establishes that the Health Areas will be the basic pieces of the Health Services of the Autonomous Communities; areas organized according to the indicated integral conception of the Health, so that it is possible to offer all the benefits of the health system from them. The areas are distributed, in a concentrated way, in demarcated territorial demarcations, taking into account factors of various kinds, but above all, responding to the idea of the proximity of the services to the users and the management decentralized and participatory.

Secondly, without prejudice to the fact that the Project has the organization of the Health Services under the exclusive responsibility of the Autonomous Communities, ordering even the integration in those centers and establishments that were previously managed separately by the Local Corporations, the slight centralizing effect that could result from this measure is compensated by granting to the Local Corporations a effective right to participate in the control and management of the Health Areas, which is concrete in the incorporation of representatives of the In the main collegiate bodies of the Area.

It must be added, finally, that the integration of services that the Law postulates, when it is accomplished precisely and in principle at the level constituted by the Autonomous Communities, can be produced without any stridency and overcoming difficulties which would undoubtedly be opposed to the same effort if the integrative effect were to be pursued within the State Administration. Indeed, many services with health responsibilities that operate in a way that is not currently integrated within the State Administration have already been transferred, or will be, to the Autonomous Communities in the future. This is an excellent historical opportunity to overcome the previous organizational deficiencies, integrating all the services into a single organization. The Law takes good note of this opportunity and imposes the basic organizational criteria that have been mentioned, preventing the Autonomous Communities from reproducing a model that has already been proven inconvenient, or even introducing a larger model. complexity, by the path of the craft, on the received system.

IV

The implementation of the reform that the Law establishes has, by force, to be gradual, to be harmonized with the successive assumption of responsibilities by the Autonomous Communities, and to adapt to the budgetary resources available in the which concerns the granting of the benefits of the system to all citizens. This explains the extent to which the transitional arrangements have been designed.

That extension is not minor in the case of the final provisions, though for a different reason. These provisions contain various mandates to the Government to develop the provisions of the General Law on Health and Authorizations to the Government to cover up much of the very dispersed and abundant health legislation. in force. In this way, the new healthcare system will begin its journey with renewed and updated legislation, where the most relevant content of the regulation of the health sector must be duly specified.

PRELIMINARY TITLE

The right to health protection

ONLY CHAPTER

Item one.

1. The purpose of this Law is the general regulation of all actions that make it possible to make effective the right to health protection recognized in Article 43 and consistent with the Constitution.

2. They are the holders of the right to health protection and health care for all Spaniards and foreign citizens who have established their residence in the national territory.

3. Non-resident foreigners in Spain, as well as Spaniards outside the national territory, shall be guaranteed such a right in the form that international laws and conventions establish.

4. For the exercise of the rights established by this Law, the persons referred to in paragraph 2 of this Article are entitled, both on the administrative and judicial routes.

Item two.

1. This Law shall have the status of a basic rule within the meaning of Article 149.1.16 of the Constitution and shall apply to the entire territory of the State, except for Articles 31 (1) (b) and (c) and 57 to 69, which shall constitute the right to supletory in those Autonomous Communities which have laid down rules applicable to the matter referred to in those provisions.

2. The Autonomous Communities may lay down detailed rules for the development and supplementary of this Law in the exercise of the powers conferred upon them by the corresponding Statutes of Autonomy.

TITLE FIRST

From the health system

CHAPTER FIRST

From general principles

Article three.

1. The means and actions of the health system shall be primarily geared towards the promotion of health and the prevention of diseases.

2. Public health care will be extended to the entire Spanish population. Access and health benefits shall be carried out under conditions of effective equality.

3. The health policy will be geared towards overcoming territorial and social imbalances.

Article four.

1. Both the State and the Autonomous Communities and the other competent public administrations shall organise and develop all the health actions referred to in this Title within an integral conception of the health system.

2. The Autonomous Communities will create their Health Services within the framework of this Law and their respective Statutes of Autonomy.

Article five.

1. The Public Health Services shall be organized in such a way that it is possible to articulate the community participation through the corresponding territorial Corporations in the formulation of the health policy and in the control of its execution.

2. The effects of such participation shall be understood as business and trade union organisations. The representation of each of these organisations shall be determined on the basis of proportionality criteria, as set out in Title III of the Organic Law on Freedom of Association.

Article six.

The actions of the Sanitary Public Administrations will be oriented:

1. To the promotion of health.

2. To promote individual, family and social interest in health through the proper health education of the population.

3. To ensure that the development of health actions is aimed at the prevention of diseases and not only the cure of diseases.

4. To ensure healthcare in all cases of loss of health.

5. To promote the actions necessary for the functional rehabilitation and social reinsertion of the patient.

Item seven.

Health services, as well as administrative, economic and other services that are accurate for the functioning of the Health System, will adapt their organization and function to the principles of effectiveness, speed, economy and flexibility.

Article eight.

1. It is considered as a fundamental activity of the health system to carry out the epidemiological studies necessary to better target the prevention of health risks, as well as health planning and assessment, should be based on an organised system of health information, surveillance and epidemiological action.

2. In addition, it is considered the basic activity of the health system that can have an impact on the own field of Public Health Veterinary in relation to the control of hygiene, technology and food research, as well as prevention and the fight against zoonoses and the techniques necessary for the avoidance of risks in humans due to animal life or disease.

Article nine.

Public authorities must inform users of the services of the public health system, or linked to it, of their rights and duties.

Article ten.

All have the following rights with respect to different public health administrations:

1. Respect for their personality, human dignity and intimacy, without being discriminated against for reasons of race, social, sex, moral, economic, ideological, political or union.

2. Information about the health services that you can access and the requirements for your use.

3. To the confidentiality of all information related to their process and with their stay in public and private health institutions that collaborate with the public system.

4. To be warned if the prognosis, diagnostic and therapeutic procedures applied to it can be used according to a teaching or research project, which, in no case, may pose additional danger to your health. In any case it will be essential to have the patient's prior written authorisation and acceptance by the doctor and the Directorate of the appropriate Sanitary Centre.

5. To be understood in understandable terms, to him and to his or her family members, complete and continuous, verbal and written information about their process, including diagnosis, prognosis and treatment alternatives.

6. To the free choice between the options presented to him by the medical officer of his case, the prior written consent of the user is necessary for the realization of any intervention, except in the following cases:

a) When non-intervention poses a risk to public health.

b) When you are not able to make decisions, in which case, the right will be for your family members or people to the lawman.

(c) Where the urgency does not allow delays in order to cause irreversible injury or danger of death.

7. To be assigned a doctor, whose name will be released to you, who will be your primary partner with the care team. In case of absence, another team member will assume such responsibility.

8. To be issued with a certificate of health status, when your requirement is established by a statutory or statutory provision.

9. To refuse treatment, except in the cases referred to in paragraph 6; for this purpose, to request the voluntary discharge, in the terms referred to in paragraph 4 of the following Article.

10. To participate, through the community institutions, in the health activities, in the terms established in this Law and in the provisions that develop it.

11. A written record of the entire process. At the end of the user's stay in a hospital institution, the patient, family member or person to the legal person will receive their High Report.

12. To use the means of complaint and proposal for suggestions within the time limits. In one case or another it shall receive a written reply within the time limits to be laid down.

13. To choose the physician and other health professionals entitled under the conditions mentioned in this Law, in the provisions that are dictated for their development and in those that regulate the health care work in the Health Centers.

14. To obtain the medicines and medical devices deemed necessary to promote, maintain or restore their health, in the terms that are regulated by the State Administration.

15. Respecting the particular economic regime of each health service, the rights referred to in paragraphs 1, 3, 4, 5, 6, 7, 9 and 11 of this Article shall also be exercised in respect of private health services.

Item eleven.

It will be citizens ' obligations to the institutions and agencies of the healthcare system:

1. Comply with general health requirements common to the entire population, as well as specific health requirements determined by the Health Services.

2. Care for facilities and collaborate in maintaining the habitability of Sanitary Lnstitutions.

3. To be responsible for the proper use of the benefits offered by the health system, in particular as regards the use of services, procedures for low employment or permanent incapacity and therapeutic and social.

4. Sign the high voluntary document in the cases of non-acceptance of the treatment. If this is not the case, the Directorate of the corresponding Health Centre, on a proposal from the optional case-manager, will be able to discharge the discharge.

Article twelve.

The public authorities will guide their health spending policies in order to correct health inequalities and guarantee equal access to Public Health Services throughout the Spanish territory as provided in the Articles 9.2 and 158.1 of the Constitution.

Article thirteen.

The government will approve the precise rules to avoid professional intrusive and malpractice.

Article fourteen.

The public authorities will proceed, through the corresponding normative development, to the application of the faculty of choice of physician in the primary care of the Health Area. In the population centres of more than 250,000 people will be able to choose from the city as a whole.

Article fifteen.

1. Once the possibilities for the diagnosis and treatment of primary care are exceeded, the users of the National Health System are entitled, within the framework of their Health Area, to be cared for in the specialized hospital services.

2. The Ministry of Health and Consumer Affairs will provide credit services, which will be accessible to all users of the National Health System once the possibilities for diagnosis and treatment of the specialized services of the The Autonomous Community where they reside.

Article sixteen.

The rules for the use of health services will be the same for all, regardless of the condition in which they are accessed. As a result, users without the right to attend Health Services, as well as those provided for in Article 80, will be able to access health services with the consideration of private patients, according to the following criteria:

1. As far as primary care is concerned, the same rules on allocation of equipment and free choice will apply to them as to the rest of the users.

2. Admission to hospital facilities will be carried out through the hospital admission unit, through a single waiting list, so there will be no differentiated access and hospitalization system according to the patient's condition.

3. The billing for the care of these patients will be carried out by the respective, administrations of the Centers, based on the actual costs. This income will have the status of the Health Services. In no case will this income be directly reversed in those who are involved in the care of these patients.

Article seventeen.

Public administrations obliged to provide health services to the public will not pay to the public the expenses that may be caused by the use of health services other than those that correspond to them the provisions laid down in this Law, in the provisions to be laid down for their development and in the rules adopted by the Autonomous Communities in the exercise of their powers.

CHAPTER II

Health system health actions

Article eighteen.

The Public Administrations, through their Health Services and the Competent Bodies in each case, will develop the following actions:

1. Systematic adoption of actions for health education as an essential element for the improvement of individual and community health.

2. Comprehensive primary health care, including, in addition to curative and rehabilitating actions, that tend to health promotion and the prevention of individual and community disease.

3. Specialist healthcare, which includes home care, hospitalization and rehabilitation.

4. The delivery of the precise therapeutic products.

5. Programs for care for higher-risk population groups and specific programs for protection against risk factors, as well as programs to prevent deficiencies, both congenital and acquired.

6. The promotion and improvement of sanitation, water supply, disposal and treatment of liquid and solid waste; the promotion and improvement of sanitation and air control systems, with special attention to pollution atmospheric; health surveillance and environmental health adequacy in all areas of life, including housing.

7. Guidance programmes in the field of family planning and the provision of the relevant services.

8. Promoting and improving mental health.

9. The protection, promotion and improvement of occupational health.

10. Health control and prevention of health risks arising from food products, including the improvement of their nutritional qualities.

11. The sanitary control of pharmaceutical products, other products and elements of therapeutic, diagnostic and auxiliary use and of those others that, affecting the human organism, may pose a risk to the health of the people.

12. Promotion and improvement of public health veterinary activities, especially in the areas of food hygiene, in slaughterhouses and industries of their competence, and in the functional harmonisation that requires the prevention and control of zoonoses.

13. The dissemination of general and specific epidemiological information to encourage detailed knowledge of health problems.

14. The improvement and adequacy of the needs of staff training in the service of the health organisation.

15. The promotion of scientific research in the specific field of health problems.

16. Monitoring and improving the quality of healthcare at all levels.

Article nineteen.

1. The public authorities shall pay particular attention to environmental health, which must be considered in the health programmes.

2. The health authorities shall propose or participate with other Departments in the preparation and implementation of the legislation on:

a) Air quality.

b) Waters.

c) Food and food industries.

d) Solid and liquid organic waste.

e) The soil and subsoil.

f) The different forms of energy.

g) Collective transport.

h) Toxic and dangerous substances.

i) Housing and urbanism.

j) School and sports media.

k) The working environment.

l) Places, premises and public recreation facilities.

m) Any other aspect of the health-related environment.

CHAPTER III

Of Mental Health

Article twenty.

On the basis of the full integration of mental health actions in the general health system and the total equalization of the mental illness to other people who care resources at the outpatient level and partial hospitalization and home care systems, which reduce the need for hospitalization as much as possible.

1. Attention to the mental health problems of the population will be carried out at the community level, enhancing the care resources at the outpatient level and the systems of partial hospitalization and home care, which will reduce as much as possible the need for hospitalization.

Those problems concerning child psychiatry and psychogeriatrics will be considered in a special way.

2. The hospitalization of patients by processes that will require it will be performed in the psychiatric units of the general hospitals.

3. The rehabilitation and social rehabilitation services needed for adequate comprehensive care of the mental illness problems will be developed, seeking the necessary coordination with the social services.

4. The mental health and psychiatric care services of the general health system will also cover, in coordination with social services, the primary prevention aspects and the attention to the psychosocial problems that accompany the loss of overall health.

CHAPTER IV

From occupational health

Item twenty-one.

1. Health action in the field of occupational health shall cover the following

:

a) To promote in general the integral health of the worker.

b) Act on health aspects of the prevention of occupational risks.

(c) The working conditions and environmental conditions that may be harmful or unhealthy during pregnancy and breastfeeding periods of the working woman shall be monitored, in order to accommodate their employment, if necessary, to a compatible work during the periods referred to.

d) Determine and prevent the factors of work microclimate as soon as they can cause harmful effects on the health of workers.

e) To monitor workers ' health to detect early and individualize risk and deterioration factors that may affect the health of workers.

f) Develop a map of occupational health risks to workers ' health with the competent labour authorities. To this end, the companies have an obligation to communicate to the relevant health authorities the substances used in the production cycle. In addition, a health information system is established to allow for epidemiological control and the recording of morbidity and mortality due to professional pathology.

g) Promote the information, training and participation of workers and employers in terms of health plans, programmes and actions in the field of occupational health.

2. The actions listed in the previous paragraph shall be developed from the Health Areas referred to in Chapter III of Title III of this Law.

3. The exercise of the powers listed in this Article shall be carried out under the direction of the health authorities, who shall act in close coordination with the labour authorities and with the participation, inspection and control bodies. of the working conditions and safety and hygiene in business.

Article 22.

Employers and workers through their representative organizations will participate in the planning, programming, organization and management of work related health management at the various levels territorial.

CHAPTER V

From public intervention in relation to collective individual health

Article twenty-three.

In order to achieve the objectives that are developed in this chapter, the Sanitary Administrations, in accordance with their competencies, will create the Registers and develop the necessary information analysis for the knowledge of the different situations in which actions may be derived from the health authority.

Article 24.

Public and private activities that, directly or indirectly, could have negative consequences for health, will be submitted by the competent bodies to preventive administrative constraints, according to the basic State regulations.

Article 25.

1. The requirement of health authorizations, as well as the obligation to submit to the register for health reasons to the companies or products, shall be established regulatively, taking as a basis the provisions of this Law.

2. Prohibitions and minimum requirements for the use and traffic of goods shall also be laid down where they pose a risk or harm to health.

3. Where the activity carried out has an exceptional and negative impact on the health of the public, the public authorities, through its competent bodies, may decree the relevant administrative action, with the object of remove that. Health intervention will have no more objective than eliminating the risks to collective health and will cease as soon as those are excluded.

Article twenty-six.

1. In the event that there is or is reasonably suspected imminent and extraordinary risk to health, the health authorities shall take the preventive measures they consider relevant, such as the seizure or detention of products, suspension of the exercise of activities, closures of undertakings or their facilities, intervention of material and personal means and any other measures considered to be justified.

2. The duration of the measures referred to in the preceding paragraph, which shall be fixed for each case, without prejudice to successive extensions agreed upon by reasoned resolutions, shall not exceed what is required by the situation of imminent and extraordinary risk. which justified them.

Article twenty-seven.

The Public Administrations, in the field of their competences, will carry out a control of advertising and commercial propaganda to meet the criteria of truthfulness in relation to health and to limit everything that may be detrimental to the same.

Article twenty-eight.

All preventive measures contained in this chapter should address the following principles:

a) Preference for voluntary collaboration with health authorities.

(b) No mandatory measures may be ordered which entail a risk to life.

(c) Health limitations shall be proportionate to the purposes that are pursued in each case.

(d) The measures that are less detrimental to the principle of the free movement of persons and property, the freedom of enterprise and any other rights affected shall be used.

Article twenty-nine.

1. Health centres and establishments, whatever their level and category or holder, shall require prior administrative authorisation for their installation and operation, as well as for modifications to their structure and arrangements. initial can be set.

2. The prior administrative authorisation shall also relate to the establishment, accreditation and registration of the establishment. The general bases on qualification, registration and authorization will be established by Royal Decree.

3. Where the defence of the health of the population so requires, the competent Sanitary Administrations may establish temporary and exceptional arrangements for the operation of health facilities.

Article thirty.

1. All health centres and establishments, as well as promotional and publicity activities, shall be subject to inspection and control by the competent Sanitary Administrations.

2. The centres referred to in Article 66 of this Law shall also be subject to the assessment of their activities and operation, without prejudice to Articles 67, 88 and 89. In any case, the conditions to be established shall be similar to those laid down for public centres.

Article thirty-one.

1. Personnel serving the Public Administrations who carry out the inspection duties, when exercising such functions and crediting if they need their identity, shall be authorised to:

(a) enter freely and without prior notification, at any time, in any Center or establishment subject to this Law,

b) proceed with the testing, investigations, or examinations necessary to check compliance with this Law and the rules that are required for its development,

c) take or take samples, in order to check compliance with the provisions of this Law and the provisions for its development, and

d) perform as many actions as are accurate, in order to fulfill the inspection functions they develop.

2. As a result of the inspection and control measures, the competent health authorities may order the temporary suspension, prohibition of the activities and final closure of the centres and establishments, for the purpose of health collective or non-compliance with the requirements for their installation and operation.

CHAPTER VI

Of violations and penalties

Article thirty-two.

1. Infringements in the field of health shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to the civil, criminal or other responsibilities which may be held.

2. In cases where infringements may be a criminal offence, the Administration shall pass the fault of the fault to the competent jurisdiction and shall refrain from following the sanctioning procedure while the judicial authority does not give judgment. firm.

If the existence of a crime has not been estimated, the Administration will continue the sanctioning file based on the facts that the courts have considered proven.

The administrative measures that would have been taken to safeguard the health and safety of persons shall be maintained as long as the judicial authority decides on them.

Article thirty-three.

In no case will a double sanction be imposed for the same facts and according to the same protected public interests, even if the other responsibilities that are deducted from other facts or infractions must be demanded concurrent.

Article thirty-four.

The infractions are described as mild, severe and very serious, taking into account the health risk criteria, the amount of the possible benefit obtained, the degree of intentionality, the severity of the health and social changes produced, generalization of the violation and recidivism.

Article thirty-five.

The following are listed as health violations:

A) Minor infractions.

1. The simple irregularities in the observation of the current health regulations, without direct relevance to public health.

2. The one committed for simple negligence, provided that the health risk or alteration produced is of little entity.

3. Those which, by reason of the criteria referred to in this Article, deserve the rating of minor or do not carry out their qualification as serious or very serious faults.

B) Serious infractions.

1. Those who expressly receive such qualification in the special rules applicable in each case.

2. Intakes for lack of controls and precautions that may be required for the activity, service or installation concerned.

3. Those that are concurrent with other minor health violations, or have served to facilitate or cover them.

4. Failure to comply with the specific requirements of health authorities, provided they occur for the first time.

5. The resistance to providing data, providing information or collaborating with health authorities or their agents.

6. Ins which, by reason of the elements referred to in this article, merit the qualification of serious or do not carry out their qualification as minor or very serious faults.

7. The recidivism in the commission of minor infractions in the last three months.

C) Very severe infractions.

1. Those who expressly receive such qualification in the special rules applicable in each case.

2. Those that are realized in a conscious and deliberate manner, as long as serious damage occurs.

3. Those that are concurrent with other serious health violations, or have served to facilitate or cover up their commission.

4. The repeated non-compliance with the specific requirements of the health authorities.

5. The absolute refusal to provide information or to provide collaboration with the control and inspection services.

6. The resistance, coercion, threat, retaliation, contempt or any other form of pressure exerted on the health authorities or their agents.

7. The number of which, by reason of the elements referred to in this article and their degree of concurrency, merit the rating of very serious or does not carry out their qualification as minor or serious faults.

8. The recidivism in the commission of serious faults in the last five years.

Article thirty-six.

1. Infringements in the field of health shall be punishable by fines according to the following graduation:

a) Minor infractions, up to 500,000 pesetas.

(b) Serious infractions, from 500,001 to 2,500,000 pesetas, and may exceed that amount until the value of the products or services covered by the infringement is reached.

c) Very serious infractions, from 2,500,001 to 100,000,000 pesetas, and may exceed that amount until the value of the products or services that have been the subject of the infringement has been increased.

2. In addition, in the case of very serious infringements, the Council of Ministers or the Councils of Government of the Autonomous Communities may agree to the temporary closure of the establishment, installation or service for a maximum period of five years. In such a case, the provisions of Article 57.4 of Law 8/1980 of 10 March on the adoption of the Staff Regulations shall apply.

3. The amounts mentioned above should be reviewed and updated regularly by the Government, by Royal Decree, taking into account the variation in the price indices for consumption.

Article thirty-seven.

The closure or closure of establishments, facilities or services that do not have prior authorizations or health records, or the suspension of their operation until such time, shall not be of a sanction. the defects are remedied or the requirements for health, hygiene or safety reasons are met.

TITLE II

From the competencies of the Public Administrations

CHAPTER FIRST

From the competencies of the State

Article thirty-eight.

1. External health and international health relationships and agreements are the exclusive competence of the State.

2. External health activities are all carried out in the field of surveillance and control of the possible health risks arising from the importation, exportation or transit of goods and international passenger traffic.

3. The Ministry of Health and Consumer Affairs shall collaborate with other departments to facilitate the coordination of external health inspection or control activities with those other departments which may be related, in order to simplify and speed up traffic, and always in accordance with international conventions.

4. The activities and functions of external health shall be regulated by Royal Decree, on the proposal of the competent departments.

Article thirty-nine.

Through international health relations and agreements, Spain will collaborate with other countries and international organizations: In epidemiological control; in the fight against communicable diseases; in the conservation of a In the case of the Commission, the Commission has been in a position to take the necessary steps to ensure that the Commission is in a position to take the necessary steps to ensure that the health. It will pay particular attention to cooperation with the nations with which it has the greatest ties for historical, cultural, geographical and relations reasons in other areas, as well as for the actions of health cooperation which are aimed at development of the peoples. In the exercise of these functions, the health authorities shall act in collaboration with the Ministry of Foreign Affairs.

Article forty.

The State Administration, without prejudice to the competencies of the Autonomous Communities, will develop the following actions:

1. The determination, in general terms, of the methods of analysis and measurement and of the technical requirements and minimum conditions for the health control of the environment.

2. The determination of the health requirements of the technical-health regulations of food, services or products directly or indirectly related to human use and consumption.

3. The general health record of food and of the industries, establishments or facilities that produce, produce or import them, which shall collect the authorisations and communications of the Autonomous Communities in accordance with their powers.

4. Authorisation by means of regulations and positive lists of additives, denatants, macromolecular material for the manufacture of packaging and packaging, food components for special schemes, detergents and disinfectants used in the food industry.

5. Regulation, authorisation and registration or approval, as appropriate, of medicinal products for human and veterinary use and of other medical devices and articles and of those which, when affecting the human being, may pose a risk to health of the people. In the case of medicinal products, products or articles intended for external trade or the use or consumption of which may affect public safety, the State Administration shall exercise the powers of inspection and quality control.

6. Regulation and authorisation of the activities of natural or legal persons engaged in the preparation, manufacture and manufacture of the products referred to in the preceding number, as well as the determination of minimum requirements (a) to be observed by persons and warehouses dedicated to their wholesale distribution and the authorization of those who carry out their activities in more than one Autonomous Community. When the activities referred to in this paragraph refer to the medicinal products, products or articles referred to in the last subparagraph of the previous paragraph, the State Administration shall exercise the powers of inspection and control of quality.

7. The general determination of the minimum technical conditions and requirements for the approval and approval of the facilities and equipment of the centres and services.

8. Regulation on accreditation, approval, authorisation and registration of centres or services, in accordance with the provisions of the legislation on organ extraction and transplantation.

9. The General Catalogue and Register of health centres, services and establishments which shall collect the decisions, communications and authorisations of the Autonomous Communities, in accordance with their powers.

10. The approval of post-graduate training programs, the improvement and specialization of the health personnel, for the purposes of regulating the conditions for obtaining academic qualifications.

11. The general approval of the health services ' jobs, in order to ensure equal opportunities and the free movement of health professionals and workers.

12. Surveillance and epidemiological analysis services and zoonoses, as well as the coordination of the competent services of the different Sanitary Public Administrations, in the processes or situations that present a risk to the health of the National or international incidence and interest.

13. The establishment of health information systems and the performance of statistics, in the general interest of each unit.

14. The coordination of actions aimed at preventing or pursuing all forms of fraud, abuse, corruption or diversion of health services or services from the public sector where reasons of general interest so advise.

15. The elaboration of general reports on public health and health care.

16. The establishment of means and systems of relationship that guarantee the reciprocal information and communication between the State Health Administration and that of the Autonomous Communities in the matters covered by this Law.

CHAPTER II

From the competencies of the Autonomous Communities

Article forty-one.

1. The Autonomous Communities shall exercise the powers assumed in their Statutes and which the State transfers to them or, where appropriate, delegates them.

2. The decisions and public actions provided for in this Law which are not expressly reserved for the State shall be construed as being attributed to the Autonomous Communities.

CHAPTER III

From the competencies of Local Corporations

Article forty-two.

1. The rules of the Autonomous Communities, having regard to the organization of their respective health services, shall take into account the responsibilities and responsibilities of the provinces, municipalities and other territorial administrations. intra-community, in accordance with the provisions of the Statutes of Autonomy, the Law of Local Regime and this Law.

2. Local Corporations will participate in the management bodies of the Health Areas.

3. However, the Councils, without prejudice to the powers of the other Public Administrations, shall have the following minimum responsibilities in relation to the obligation to comply with the health rules and plans:

(a) Health control of the environment: Air pollution, water supply, wastewater treatment, urban and industrial waste.

b) Health control of industries, activities and services, transport, noise and vibration.

c) Health control of buildings and places of housing and human coexistence, especially of food centers, hairdressers, saunas and personal hygiene centers, hotels and residential centers, schools, camps tourism and sports and recreational physical activity areas.

(d) Health control of the distribution and supply of food, beverages and other products, directly or indirectly related to human use or consumption, as well as the means of their transport.

e) Health control of cemeteries and mortuary health police.

4. For the development of the functions related to the previous paragraph, the Ayculos shall obtain the technical support of the personnel and means of the Health Areas in whose demarcation they are understood.

5. The health staff of the Health Services of the Autonomous Communities which provides support to the Councils in the cases referred to in paragraph 3 shall have the consideration, for these purposes, of staff at the service thereof, with their the consequences of the system of personal and property rights and resources.

CHAPTER IV

From High Inspection

Article forty-three.

1. The State shall exercise the High Inspection as a function of guarantee and verification of compliance with the State and Autonomous Communities in the field of health, in accordance with the provisions of the Constitution and the laws.

2. These are activities of the High Inspectorate:

(a) Monitor the adequacy between the health plans and programs of the Autonomous Communities and the general objectives established by the State.

(b) Assess the fulfilment of common objectives and objectives and identify any generic or structural difficulties or deficiencies that impede the achievement or distortion of the functioning of a coherent, harmonious and solidarity.

c) Monitor the destination and use of the State's own funds and grants allocated to the Autonomous Communities that have a particular destination or purpose.

d) Check that the funds corresponding to the Health Services of the Autonomous Communities are used in accordance with the general principles of this Law.

e) Oversee the provision for health purposes of centres, services or establishments of the State transferred for that purpose, without prejudice to the rearrangements that may be agreed by the corresponding Autonomous Communities and, where applicable, the other public administrations.

(f) Verify the non-existence of any discrimination in the systems of administration and provision of health services, as well as in the systems or procedures for the selection and provision of their posts

g) To monitor that the exercise of powers in the field of health is in line with the criteria for the democratic participation of all stakeholders. To this end, the provisions of Article 5.2 of this Law shall be provided.

3. The duties of High Inspection shall be exercised by the competent authorities of the State in the field of health. Officials of the State Administration exercising the High Inspectorate shall enjoy the consideration of public authority for all intents and purposes, and may, in their actions, obtain from the authorities of the State and the organs of the Community. Autonomous and other Public Administrations the collaboration necessary for the performance of the functions that are legally entrusted to them.

4. When, as a result of the exercise of the duties of the High Inspection Office, breaches are found by the Autonomous Community, the health authorities of the State shall warn the Autonomous Community of non-compliance by means of the Government.

5. If, once such a warning has been issued, the situation of non-compliance persists, the Government, in accordance with the provisions of the Constitution, shall formally require the competent authority of the Autonomous Community to adopt the precise measures.

6. Decisions taken by the State Administration in the exercise of its High Inspection powers shall always be communicated to the highest body responsible for the Health Service of each Autonomous Community.

TITLE III

From the structure of the public healthcare system

CHAPTER FIRST

From the general public health system organization

Article forty-four.

1. All public structures and services to the health service will integrate the National Health System.

2. The National Health System is the set of Health Services of the State Administration and the Health Services of the Autonomous Communities in the terms established in this Law.

Article forty-five.

The National Health System integrates all the functions and health benefits that, according to the provisions of this Law, are the responsibility of the public authorities for the due respect of the right to protection. of health.

Article forty-six.

These are fundamental characteristics of the National Health System:

a) The extent of their services to the entire population.

b) The right organization to deliver comprehensive health care, understanding both health promotion and disease prevention and healing and rehabilitation.

c) Coordination and, where appropriate, the integration of all public health resources into a single device.

d) The financing of the obligations arising from this Law shall be made by means of public administrations, contributions and fees for the provision of certain services.

e) The delivery of comprehensive health care by ensuring high quality levels that are properly evaluated and monitored.

Article forty-seven.

1. The Interterritorial Council of the National Health System will be created, which will be composed of a representative of each of the Autonomous Communities and equal numbers of members of the State Administration.

2. The Interterritorial Council of the National Health System will be the permanent organ of communication and information of the different Health Services, among them and with the State Administration, and will coordinate, among other aspects, the basic lines of procurement policy, procurement of pharmaceutical, healthcare and other goods and services, as well as the basic principles of personnel policy.

3. The Interterritorial Council of the National Health System will also exercise the functions of planning that this Law attributes to it.

You will also exercise the functions that can be entrusted to you for the proper coordination of health services.

4. He will be President of the Interterritorial Council of the National Health System, the Minister of Health and Consumer Affairs.

5. For the purposes set out in Article 5.2 of this Law, an Advisory Committee is set up with the Interterritorial Council of the National Health System referred to in the preceding paragraphs, integrated by representatives of the more representative business and trade union organisations.

Article forty-eight.

The State and the Autonomous Communities may set up commissions and technical committees, conclude agreements and develop the joint programs that are required for the most effective and cost-effectiveness of the Health Services.

CHAPTER II

From the Health Services of the Autonomous Communities

Article forty-nine.

The Autonomous Communities shall organize their Health Services in accordance with the basic principles of this Law.

Article fifty.

1. In each Autonomous Community, a Health Service shall be constituted by all the centres, departments and establishments of the Community itself, Diputations, Councils and any other intra-Community territorial administrations, which will be managed, as set out in the following articles, under the responsibility of the respective Autonomous Community.

2. Notwithstanding the integrated nature of the Service, each Territorial Administration may maintain the ownership of the centres and establishments dependent on it, at the entry into force of this Law, although, in any case, with functional to the Health Service of each Autonomous Community.

Article fifty-one.

1. The Health Services created in the Autonomous Communities will be planned with criteria for the rationalization of the resources, according to the health needs of each territory. The basis of the planning will be the division of the entire territory into geographical demarcations, in order to implement the general principles and basic health care that are set forth in this Law.

2. The territorial management of the Services will be the responsibility of the Autonomous Communities and will be based on the application of an integrated concept of health care.

3. Intra-Community territorial administrations may not create or establish new health centres or services, but in accordance with the health plans of each Autonomous Community and subject to prior authorisation.

Article fifty-two.

The Autonomous Communities, in the exercise of the powers assumed in their Statutes, shall have regard to the management and control bodies of their respective Health Services, without prejudice to what is established in this Law.

Article fifty-three.

1. The Autonomous Communities shall adjust the exercise of their health powers to criteria for the democratic participation of all stakeholders, as well as trade union representatives and business organisations.

2. In order to articulate the participation in the area of the Autonomous Communities, the Health Council of the Autonomous Community will be established. In each area, the Autonomous Community shall also constitute bodies for participation in health services.

3. In territorial areas other than those referred to in the previous paragraph, the Autonomous Community shall ensure effective participation.

Article fifty-four.

Each Autonomous Community will develop a Health Plan that will include all the necessary health actions to meet the objectives of its Health Services.

The Health Plan of each Autonomous Community, which will be in accordance with the general coordination criteria approved by the Government, should encompass the set of plans of the different Health Areas.

Article fifty-five.

1. Within its sphere of competence, the corresponding Autonomous Communities shall regulate the organization, functions, assignment of personal and material means of each of the Health Services, within the framework of the provisions of Chapter VI of this title.

2. Local Corporations, which, at the entry into force of this Law, will be developing hospital services, will participate in the management of these services, raising a proposal for the definition of objectives and objectives, as well as annual budgets. They will also raise the proposed Autonomous Community to the appointment of the Director of the Hospital Center.

CHAPTER III

From Health Areas

Article fifty-six.

1. The Autonomous Communities shall delimit and constitute in their territory demarcations called Areas of Health, having regard to this effect the basic principles that in this Law are established, in order to organize a coordinated sanitary system integral.

2. The Health Areas are the fundamental structures of the sanitary system, responsible for the unitary management of the centers and establishments of the Health Service of the Autonomous Community in its territorial demarcation and the benefits health and health programs to be developed by them.

In any case, the Health Areas should develop the following activities:

(a) In the field of primary health care, by means of teamwork, the individual, the family and the community will be addressed; developing, through programs, functions of health promotion, prevention, healing and rehabilitation, through both their basic and primary care support teams.

b) In the level of specialized care, to be performed in the hospitals and centers of specialties functionally dependent of those, the attention will be given to the health problems more complex and will develop other functions of the hospitals.

3. The Health Areas will be run by an organ of its own, where the Local Corporations will have to participate in them located with a representation of not less than 40 per 100, within the guidelines and general health programs established by the Autonomous Community.

4. The Health Areas will be demarcated taking into account geographical, socioeconomic, demographic, labor, epidemiological, cultural, climatological and endowal factors and means of communication, as well as the health facilities of the Area. Although they may vary the territorial extent and the population contingent in them, they must be delimited in such a way that the objectives set out in this Law can be met from them.

5. As a general rule, and without prejudice to the exceptions to which the factors expressed in the previous paragraph have been taken, the Health Area shall extend its action to a population of not less than 200,000 inhabitants and not more than 250,000. The Autonomous Communities of the Balearic Islands and the Canary Islands and the cities of Ceuta and Melilla are exempted from the previous rule, which may accommodate their specific characteristics. In any case, each province shall have at least one Area.

Article fifty-seven.

The Health Areas will have at least the following organs:

1. Participation: The Area Health Council.

2. Address: The Area Address Board.

3. Management: The Area Manager.

Article fifty-eight.

1. The Area Health Councils are collegiate bodies of community participation for the consultation and monitoring of the management, in accordance with the provisions of article 5.2 of this Law.

2. The Area Health Councils will consist of:

(a) The representation of citizens through the Local Corporations included in their demarcation, which will be 50 per 100 of its members.

b) The most representative trade union organisations, in a proportion of not less than 25 per 100, through qualified healthcare professionals.

c) Health Administration of the Health Area.

3. They will be the functions of the Health Council:

a) Verify the adequacy of the actions in the Health Area to the standards and guidelines of health and economic policy.

b) Orienting the health guidelines of the Area, to which effect they may raise motions and reports to the governing bodies.

c) Propose measures to be developed in the Health Area to study the health problems specific to it, as well as its priorities.

d) Promote community participation in the Health Ark.

e) Know and report the project's blueprint for the Area Health Plan and its annual adaptations.

f) Know and report the annual Health Area Memory.

4. In order to comply with the provisions of the above paragraphs, the Area Health Councils may set up sectoral participation bodies.

Article fifty-nine.

1. The Board of Directors of the Health Area is responsible for formulating the guidelines in health policy and controlling the management of the area, within the general rules and programs established by the autonomic administration.

2. The Governing Board shall consist of the representation of the Autonomous Community, which shall be 60 per 100 of the members of the Autonomous Community, and the representatives of the Local Corporations, elected by those who have such a condition in the Council of Health.

3. These will be the functions of the Governing Board:

a) The proposed appointment and termination of the Health Area manager.

b) The approval of the project of the Area Health Plan, within the standards, guidelines and general programs established by the Autonomous Community.

c) Approval of the Health Area Annual Memory.

d) The establishment of the general coordination criteria in the Health Area.

e) Approval of the Health Area's specific priorities.

f) The approval of the preliminary draft and the annual adjustments to the Area Health Plan.

g) The elaboration of the Regulation of the Board of Directors and of the Health Council of the Area, within the general guidelines established by the Autonomous Community.

Article sixty.

1. The Health Area Manager will be appointed and terminated by the Directorate of the Health Service of the Autonomous Community, on a proposal from the Board of Directors of the Area.

2. The Health Area Manager is the management organ of the same. It may, upon convocation, assist with a voice, but without a vote, to the meetings of the Governing Board.

3. The Health Area Manager will be in charge of the implementation of the guidelines established by the Board of Directors, of the Health Plan of the Area and of the norms corresponding to the Autonomous Administration and the State. It will also present the Health Plan's preliminary projects and annual adaptations and the Health Area Annual Report.

Article sixty-one.

In each Health Area the maximum integration of the information relative to each patient must be sought, so the principle of single-health history for each patient must be maintained, at least within the limits of each individual patient. Care institution. It shall be available to the sick and to the doctors who are directly involved in the diagnosis and treatment of the patient, as well as for the purposes of medical inspection or scientific purposes, and must be fully guaranteed. the right of the patient to his personal and family intimacy and the duty to keep the secret for who, by virtue of his or her competences, has access to the medical history. The public authorities shall take the necessary measures to ensure such rights and duties.

Article sixty-two.

1. In order to achieve maximum operability and effectiveness in the operation of services at the primary level, the Health Areas will be divided into basic health zones.

2. In the delimitation of the basic areas, account must be taken of:

a) The maximum distances from the most remote population groups of services and the normal time to invest in their journey using the ordinary means.

b) The degree of concentration or dispersion of the population.

c) The epidemiological characteristics of the area.

d) The health facilities and resources in the area.

Article sixty-three.

The basic health zone is the territorial framework of primary health care where health centers, integrated primary care centers, develop health activities.

The Health Centers will develop in an integrated way and through teamwork all activities aimed at the promotion, prevention, healing and rehabilitation of health, both individual and collective, of the inhabitants of the basic area, to whose effect they shall be equipped with the personal and material means necessary for the fulfilment of that function.

As a means of technical support for the development of preventive activity, there will be a Health Laboratory responsible for making the determinations of hygienic and sanitary analysis of the environment, food hygiene and zoonoses.

Article sixty-four.

The Health Center will have the following functions:

a) Shelter the physical structure of personal care services and consultations corresponding to the population in which it is located.

b) To shelter the precise material resources for the realization of the complementary explorations that can be arranged in the area.

c) Serve as a meeting center between the community and healthcare professionals.

d) Facilitate the teamwork of healthcare professionals in the area.

e) Improve the administrative organization of health care in your area of influence.

Article sixty-five.

1. Each Health Area shall be linked or at least have a general hospital, with the services to advise the population to attend, the structure of the hospital and the health problems.

2. The hospital is the establishment responsible for both clinical detention and specialized and complementary assistance that requires its area of influence.

3. In any case, appropriate measures will be put in place to ensure the interrelationship between different levels of care.

Article sixty-six.

1. The creation of an integrated network of public sector hospitals will be part of the health policy of all public administrations.

The general hospitals in the private sector that request it will be linked to the National Health System, according to a defined protocol, provided that due to its technical characteristics they are approved, when the This is justified and if the public sector's financial resources allow it to be available.

2. The protocols will be subject to periodic review.

3. The linked private sector will retain ownership of centres and establishments that are dependent on it, as well as ownership of the employment relationships of staff who provide their services.

Article sixty-seven.

1. The link to the public network of the hospitals referred to in the previous article shall be carried out by means of a unique agreement.

2. The Convention shall establish reciprocal rights and obligations in respect of duration, extension, temporary suspension, final termination of the Convention, economic regime, number of hospital beds and other conditions for the provision of assistance. In accordance with the provisions to be adopted for the development of this Law. The working day arrangements for the hospitals referred to in this paragraph shall be the same as that of public hospitals of similar nature in the relevant territorial area.

3. In each Convention established in accordance with the above, it will be ensured that the health care provided by private hospitals to the users of the Health System is imparted in conditions of gratuitousness, Health activities of that hospital may not be of a lucrative nature.

The recovery of any amount to the sick in the form of non-sanitary care, whatever the nature of these, may be established if they are previously authorized by the corresponding Health Administration. concept and the amount that it is intended to charge.

4. The following shall be the cause of denunciation of the Convention by the competent Health Administration:

a) Pay attention to the Convention in violation of the principle of gratuitousness.

b) Establish non-medical supplementary services without authorisation or receive unauthorised amounts for them.

(c) Infringement of the rules relating to the day and time of hospital staff as set out in paragraph 2.

d) Infringement of the employment law of Social or Tax Security in a serious manner.

e) Lesion the rights set forth in Articles 16, 18, 20 and 22 of the Constitution when determined by Judgment.

(f) Other than any other obligations arising out of the obligations set out in this Law.

5. Private hospitals linked to the National Health System will be subject to the same sanitary, administrative and economic inspections and controls as public hospitals, applying homogeneous criteria. and previously watered.

Article sixty-eight.

The hospital centers will develop, in addition to the strictly health care tasks, health promotion, disease prevention and research and teaching functions, according to the programs of each Health Area, in order to complement their activities with those developed by the primary care network.

Article sixty-nine.

1. Public Health Services will tend towards the autonomy and democratic control of its management, implementing a participatory direction for objectives.

2. The assessment of the quality of the care provided should be a continuous process that will inform all the activities of the health personnel and the health services of the National Health System.

The health administration will establish health quality assessment systems that are heard by scientific health societies.

Doctors and other professional graduates from the centre should be involved in the bodies responsible for assessing the quality of care.

3. All the hospitals must make it possible or to provide the external quality control units with the performance of their tasks. They will also establish appropriate mechanisms to provide a high level of quality of care.

CHAPTER IV

From general health coordination

Article seventy.

1. The State and the Autonomous Communities shall approve health plans in the field of their respective competences, in which the investments and health actions to be developed, annually or pluriannual shall be provided.

2. The General Health Coordination shall include:

(a) The general establishment of basic and common minimum rates or criteria for assessing the needs of health personnel, centres or services, the definitive inventory of institutional and personnel resources health and national health maps.

(b) The determination of common minimum objectives or objectives in the field of prevention, protection, promotion and health care.

c) The framework of actions and priorities to achieve a coherent, harmonious and supportive healthcare system.

d) The general establishment of basic and common minimum criteria for the assessment of the effectiveness and performance of health programmes, centres or services.

3. The Government shall establish the general health coordination criteria in accordance with the provisions of the Autonomous Communities and the advice and collaboration of trade unions and business organisations.

4. The general coordination criteria approved by the State shall be forwarded to the Autonomous Communities to be taken into account by the Autonomous Communities in the formulation of their health plans and annual budgets. The State shall communicate. also to the Autonomous Communities the progress and forecasts of its new budget that can be used for the financing of health plans of those.

Article seventy-one.

1. The State and the Autonomous Communities may establish joint health plans. When these joint plans involve all the Autonomous Communities, they will be formulated within the Interterritorial Council of the National Health System.

2. The joint plans, once formulated, shall be carried out by the Department of Health of the State Administration and by the competent authority of the Autonomous Communities, for the purpose of obtaining their approval by the legislative bodies. in accordance with the provisions of Article 18 of the Organic Law for the Financing of Autonomous Communities.

Article seventy-two.

The Autonomous Communities may lay down plans for their jurisdiction in which a financial contribution from the State is proposed for its implementation, in accordance with the provisions of Article 158.1 of the Constitution.

Article seventy-three.

1. General health coordination shall be carried out by the State, by means of means and systems of relationship to facilitate reciprocal information, technical homogeneity in certain aspects and the joint action of the Public Health Administrations. in the exercise of their respective competences, in such a way as to achieve the integration of partial acts into the globality of the National Health System.

2. As a development of the plans or the exercise of their ordinary competences, the State and the Autonomous Communities may develop health programmes and project actions on the different sectors or problems of interest to the health.

Article seventy-four.

1. The Integrated Health Plan, which must take into account the general health coordination criteria developed by the Government in accordance with the provisions of Article 70, will include in a single document the State plans, the plans of the Autonomous Communities and joint plans. It will also link the allocations to be made by the different Public Administrations and the sources of their funding.

2. The Integrated Health Plan shall have the term of validity specified therein.

Article seventy-five.

1. For the purpose of making up the Integrated Health Plan, the Autonomous Communities shall forward the projects of plans approved by the competent bodies of the same, in accordance with the provisions of the previous articles.

2. Once the adequacy of the Health Plans of the Autonomous Communities has been verified to the general coordination criteria, the Health Department of the State Administration will draw up the Integrated Health Plan, which will contain the specifications set out in Article 74 of this Law.

Article seventy-six.

1. The Integrated Health Plan will be definitively understood once it has knowledge of the Interterritorial Council of the National Health System, which will be able to make the observations and recommendations it deems pertinent. The Government will be responsible for the final approval of the Plan.

2. The incorporation of the different state and regional health plans into the Integrated Health Plan implies the correlative obligation to include in the budgets of the successive years the forecasts necessary for its financing, without prejudice to the adjustments required by the budgetary situation.

Article seventy-seven.

1. The State and the Autonomous Communities may make adjustments and adjustments that are required by the assessment of circumstances or by the dysfunctions observed in the execution of their respective plans.

2. The modifications referred to will be notified to the Department of Health of the State Administration for referral to the Interterritorial Council of the National Health System.

3. Each year, the Autonomous Communities shall inform the Department of Health of the State Administration of the degree of implementation of their respective plans. The Department will forward this information to the Interterritorial Council of the National Health System, along with the level of implementation of the state plans.

CHAPTER V

From Financing

Article seventy-eight.

The State, Autonomous Communities, Local Corporations and Social Security Budgets will provide the necessary items to meet the health needs of all the institutions and institutions that are dependent on the Public administrations and for the development of their competencies.

Article seventy-nine.

1. The financing of the assistance provided will be carried out by:

a) Social Quotations.

b) State transfers, covering:

Participation in the contribution of that to the sustainability of Social Security.

Compensation for the extension of health care from Social Security to those without economic resources.

The compensation for the integration, if any, of the hospitals of the Local Corporations in the National Health System.

c) Fees for the provision of certain services.

d) By contributions from the Autonomous Communities and Local Corporations.

2. Participation in the financing of the services of the Local Corporations to be assumed by the Autonomous Communities will take effect, on the one hand, by the Local Corporations themselves and, on the other, by the National Fund of Cooperation with Local Corporations.

Local Corporations will also have to establish in their budgets the precise consignations to meet the health responsibilities attributed to them by the Law.

Article eighty.

The government will regulate the system of financing the health care coverage of the Social Security system for people not included in it, which, if they are people without economic resources, will be in all case from state transfers.

Article eighty-one.

The generalization of the right to health protection and health care which implies the approval of the care and benefits of the public health system shall be carried out by means of an allocation of financial resources. the population to be taken into account in each Autonomous Community as well as the health investments to be made to correct the territorial health inequalities, in accordance with the provisions of Article 12.

Article eighty-two.

The financing of the services transferred to the Autonomous Communities will be carried out through the General Budget of the State or Social Security, as appropriate.

In the case of those Autonomous Communities that have powers to assume the functions of the health care of the Social Security, the financing of these transferred services will be carried out according to the criterion of protected population. However, before the allocation is made, the budgetary expenditure necessary for the attention of the State's common services and those relating to special centres which, as a result of their nature, must be managed must be determined in the first place. centralized form.

The deviation, positive or negative, between the percentage of the healthcare expenditure at the initial moment and the percentage of the protected population will be cancelled over the course of ten years at the rate of 10 per 100 per year.

The Autonomous Communities shall annually draw up the preliminary draft general budget of the health care expenditure of the Social Security of the transferred services.

This preliminary draft will be forwarded to the competent authorities of the State Administration for integration and adaptation to the available resources of the Social Security System, then presenting it to the General Cortes for its approval.

The initial appropriations shall be overall integrated in the budget for each financial year which are authorised in favour of the Autonomous Community and shall be limited. However, the budget settled at the end of the transferred services shall be affected in the appropriate proportion, on the basis of the protected population criterion, to the budgetary deviation, either positive or negative, in the case of services not transferred, deduced the expenditure corresponding to the common services of the State and those relating in proportion to special centres. The commitments of expenditure to be acquired by a higher amount must be financed from resources provided by the Autonomous Community itself, unless it comes from binding provisions which are generally binding for the whole of the Community. the territory of the State, the fulfilment of which implies an effective increase in expenditure.

The compensation between Autonomous Communities for service provision will be made on the basis of payment by process and, failing that, by the tariffs established with other criteria.

Article eighty-three.

Income from healthcare in the case of special compulsory insurance and in all cases, whether insured or not, in which a third party is required to pay, shall have the condition of income of the Health Service concerned. The costs inherent in the provision of such services shall not be financed by the revenue from the Social Security. In no case will these revenues be able to reverse those who have intervened in the care of these patients.

For these purposes, the Public Administrations which would have served the users in such cases would be entitled to claim the cost of the services provided from the third party.

CHAPTER VI

From Staff

Article eighty-four.

1. The staff of the Social Security regulated in the Legal Staff Regulations of Social Security, in the Staff Regulations entitled and Auxiliary of the Social Security Clinic, in the Staff Regulations of the Non-Sanitary Staff Service of the Sanitary Institutions of Social Security, the staff of the Management Entities who assume the non-transferable services and those who perform their work in the Health Services of the Autonomous Communities, will be governed by the Under the Staff Regulations-Framework to be adopted by the Government under development of this Law, all without prejudice to the provisions of Article 87 of this Law.

2. This Statute-Framework shall contain the basic rules applicable to the classification, selection, provision of jobs and situations, rights, duties, disciplinary arrangements, incompatibilities and the remuneration system, stability in employment and its professional status. In the development of such basic rules, the completion of the functions of each of those mentioned in the preceding paragraph shall be established in their respective Statutes, which shall be maintained as such.

3. The rules of the Autonomous Communities in the field of personnel shall be in accordance with the provisions of that Framework. The selection of staff and their management and administration shall be carried out by the administrations responsible for the services to which the various personnel are attached.

4. In the Autonomous Communities with their own official language, in the process of selection of staff and the provision of jobs of the Public Health Administration, the knowledge of both official languages will be taken into account personal information, in the terms of Article 19 of Law 30/1984.

Article eighty-five.

1. Officials at the service of the various Public Administrations, for the purposes of exercising their health powers, shall be governed by Law 30/1984 of 2 August and the remainder of the legislation in force in the field of civil servants.

2. Similarly, the Autonomous Communities may, in the exercise of their powers, lay down rules for the development of the basic legislation of the statutory system of such officials.

Article eighty-six.

The exercise of the work of the health personnel must be organized in such a way that the assessment of the state of health of the population is stimulated and the needs of the disease repair care are diminished.

Article eighty-seven.

Human resources belonging to the Area Services shall be considered as assigned to that management unit, ensuring the continuing training and further training of the health personnel assigned to the Area.

Staff may be changed from the health organization's imperative needs, with respect to all labor and economic conditions within the Health Area.

TITLE IV

From private health activities

CHAPTER FIRST

From the free exercise of health professions

Article eighty-eight.

The right to free exercise of the health professions is recognized, in accordance with the provisions of Articles 35 and 36 of the Constitution.

CHAPTER II

Of Healthcare Entities

Article eighty-nine.

The freedom of enterprise in the healthcare sector is recognized, in accordance with Article 38 of the Constitution.

Article ninety.

1. Public Health Administrations, within the scope of their respective competences, may establish concerts for the provision of health services with means other than them.

To this end, the various public administrations will take into account, on a prior basis, the optimal use of their own health resources.

2. For the purposes of establishing a concert, the Public Administrations shall give priority, where there are similar conditions of effectiveness, quality and costs, to the establishments, centres and health services of which the public authorities are which are non-profit.

3. Public Health Administrations may not agree with third parties on the provision of health care, where this may contradict the health, social and economic objectives set out in the relevant health plans.

4. Public administrations within the scope of their powers shall lay down the minimum, basic and common requirements and conditions applicable to the concerts referred to in the preceding paragraphs. Economic conditions shall be established on the basis of effective, pre-established and revised cost modules by the Administration.

5. Health centres which can be agreed by the Sanitary Public Administrations must be approved in advance by those institutions, in accordance with a protocol defined by the competent authority, which may be reviewed. periodically.

6. In every concert that is established, in addition to the rights and obligations of the parties, it will be assured that the health care and all kinds that are provided to the users affected by the concert will be the same for all without others differences than the health care inherent in the nature of the various health processes, and that no additional services will be established in respect of those in public health facilities that are dependent on the administration Concerned public.

Article ninety-one.

1. Health centres and establishments, whether or not they are owned by the various public authorities, may, on a non-periodic basis, receive financial or other benefits or aid from public funds for the purposes of qualified health activities of high social interest.

2. In no case shall the funds referred to in the previous paragraph be applied to the financing of the ordinary activities of the centre or establishment to which they have been granted.

3. The granting of such aid and its acceptance by the institution holding the centre or health establishment shall be subject to the inspections and checks necessary to verify that the public funds have been applied for the implementation of the aid. activity for which they were granted and that their application has been technically and economically managed correctly.

4. The Government will issue a Royal Decree to determine minimum conditions and minimum, basic and common requirements, which are required for a health activity to be qualified as a high social interest, and to be supported economically with funds. public.

Article ninety-two.

1. The Health Administration shall facilitate the free activity of the Associations of Health Users, Non-profit Entities and Health Care Cooperatives, in accordance with the applicable legislation, promoting their coordinated action. with the public health system.

2. They shall not benefit from the benefits to which such recognition shall be given by the Associations or Entities in which one of these circumstances is present:

a) Include as partners with profit-making legal persons.

b) To receive grants or grants from companies or groups of companies that supply goods or products to consumers or users.

c) Conduct commercial or non-informational advertising of services.

d) To engage in activities other than the defense of the interests of consumers or users, without prejudice to the benefits that must be provided to their partners by the cooperative entities.

e) Act with manifest recklessness, judicially appreciated.

Article ninety-three.

The hospitals and private sector establishments in the National Health System will not be linked, nor will they be able to establish concerts with private health centers, when in some of their owners or in some of their workers are present in the circumstances that on incompatibilities of the public and private sector establishes the legislation on incompatibilities of the staff to the service of the Public Administrations.

Article ninety-four.

1. Private hospitals linked in the public offering will be subject to the same health, administrative and administrative inspections and controls as public hospitals.

2. The Public Administration shall carry out inspection duties on health, administrative and economic aspects relating to each patient taken on behalf of the Public Administration in the private centres.

TITLE V

Of Pharmaceuticals

ONLY CHAPTER

Article ninety-five.

1. It is for the State Health Administration to assess the health suitability of medicinal products and other medical devices and articles, both to authorise their circulation and use and to monitor their quality.

2. Prior authorisation shall be required for the movement and use of medicinal products and medical devices which are treated as such. For other medical devices and articles, it may be necessary to require individual prior authorisation or compliance with type-approval conditions.

The circulation of unauthorised or approved medicinal products or medical devices, with the administrative and criminal responsibilities to which they may occur, shall not be prescribed and prohibited.

3. Only safe and effective medicinal products with due quality and purity and prepared by a sufficient capacity shall be authorised.

4. The authorisation procedure shall ensure that the guarantees of efficacy, tolerance, purity, stability and information that mark the legislation on medicinal products and other relevant provisions are satisfied. In particular, controlled clinical trials shall be required.

5. All qualified persons providing their services in the Public Health and Research and Technological Development Services have the right to participate and the duty to collaborate in the evaluation and control of medicines and products. health.

Article ninety-six.

1. The authorisation of medicinal products and other medical devices shall be temporary and, exhausted, shall be revalidated. The holder shall notify each year of his intention to keep them on the market so that the authorisation is not extinguished.

2. The health authority may suspend or revoke it for serious public health reasons.

Article ninety-seven.

The State Health Administration, in accordance with the international treaties of which Spain is a party, will grant the medicines a Spanish official name adapted to the international denominations of the World Health Organization, which will be in the public domain and will identify it appropriately in the information referred to them and in their packaging, packaging and labels.

Trade marks may not be confused with the official Spanish denominations or international common names.

Article ninety-eight.

1. The Government will codify the quality standards for compulsory medicines in Spain.

2. The National Form shall contain the guidelines according to which they shall be prepared, provided that they are subject to recognized action and indication substances, by pharmacists in their pharmacy offices.

Article ninety-nine.

Importers, manufacturers and healthcare professionals have an obligation to report adverse effects caused by medicinal products and other medical devices, where a danger to life or health of the health patients.

Article 1.

1. The State Administration shall require the prior authorisation of natural or legal persons engaged in the import, manufacture, manufacture, distribution or export of medicinal products and other medical devices and their laboratories and establishments. This license must be revalidated periodically.

2. The State Administration shall lay down rules for the manufacture, manufacture, transport and storage.

3. Manufacturers and wholesalers shall have a sufficiently qualified Technical, Pharmaceutical or Higher Director in accordance with the pharmaceutical directives of the European Economic Community.

Article one hundred one.

1. The licence of medicinal products and other medical devices and of the entities referred to in Article 96 shall bear the fees necessary to cover the costs of their assessment and control. In order to avoid speculative applications for licenses, modifications and periodic revalidation, the Administration may require bail before its admission to processing.

2. In determining the amount of the fees and sureties, objective rules shall be taken into account in order to stimulate the marketing of medicinal products and special medical devices, in order to give market access to small and medium-sized enterprises, by reasons for industrial policy, or to promote employment.

Article one hundred two.

1. Advertising of medicinal products and other medical devices addressed to professionals shall be subject to the conditions of their licence and may be subject to a prior authorisation

.

2. Advertising of medicinal products and medical devices • addressed to the public will require their special qualification and prior authorisation of messages by the health authority.

Article one hundred three.

1. The custody, preservation and dispensing of medicinal products shall be:

a) To legally authorized pharmacy offices.

b) To the pharmacy services of the hospitals, the Health Centers and the Primary Care structures of the National Health System for their application within those institutions or for those requiring a particular monitoring, monitoring and control of the multidisciplinary health care team.

2. Pharmacy offices open to the public are considered to be health facilities for the purposes set out in Title IV of this Law.

3. Pharmacy offices will be subject to health planning in terms of the special legislation on medicines and pharmacies.

4. Only pharmacists will be able to own and hold pharmacy offices open to the public.

TITLE VI

From teaching and research

CHAPTER FIRST

From teaching in the National Health System

Article one hundred four.

1. The entire healthcare structure of the healthcare system should be available to be used for pre-graduate teaching. post-graduate and continuous professionals.

2. In order to achieve greater adequacy in the training of the human resources needed for the functioning of the health system, the permanent collaboration between the Department of Health and the corresponding Departments will be established in In order to ensure that all the training provided by health professionals can be integrated into the service structures of the health system, it is particularly important to ensure that health professionals are trained.

3. The public authorities responsible for education and health shall establish the arrangements for concerts between the universities and the health institutions in which university education is to be provided, in order to ensure teaching Practice of Medicine and Nursing and other teachings that would require it.

The general bases of the Regime of Concert will provide, as required in article 149.1.30 of the Constitution.

4. The universities will have to count, at least, with a Hospital and three Primary Care Centers, or with a university function for the exercise of teaching and research, arranged according to the development of the previous.

5. These university centres or university functions will have to be programmed, in terms of teaching and research, in a coordinated way by the university and health authorities, within the framework of their competences. For these purposes, the participation of the universities in their governing bodies should be envisaged.

6. The Public Administrations responsible for education and health will promote the permanent review of the teaching in the field of health for the best adaptation of the professional knowledge to the needs of the Spanish society. In addition, these Departments will promote interdisciplinary training in Health Sciences and the continuous updating of knowledge.

CHAPTER II

From fostering research

Article one hundred five.

1. In the framework of the care planning and teaching of the Public Administrations, the system of concert between the universities and the health institutions may establish the linkage of certain care places of the institution Health with teaching places of the University Teachers ' Corps. The places thus linked will be provided through a contest, in which the candidates who meet the requirements mentioned in the Organic Law 11/1983, of the University Reformation, which accredit, in addition, the possession of the title of Specialist who is appropriate and the requirements which, in terms of his/her care qualification, are determined to be regulated. The competitions shall be resolved, as appropriate, in the form referred to in Title V of the Law on University Reform and its provisions of development, with the following particularities:

(a) The Government, on a proposal from the Ministries of Education and Science and Health and Consumer Affairs, will regulate the Commissions responsible for resolving the competitions, which in any case will have five members, of which the President and a Vocal will be appointed by the University of Teachers belonging to the university faculty of the area of knowledge to which the square corresponds. The three remaining Vocals will be appointed by the University, one appointed by the Council of Universities, by means of a drawing of teachers belonging to the university faculty of the respective area of knowledge, occupying square health care in any health institution: the other two, after designation of the relevant health institution.

b) In the first test of the competitions, the Commissions must assess the merits and academic and research history and the candidates ' own care work, in the form that is regulated.

(c) The Government may establish, for certain places, the conduct of practical tests.

2. The concerts may also establish a number of associate teachers ' places to be covered by care staff who are providing services at the agreed health institution. This number shall not be taken into account for the purposes of the percentage referred to in Article 33.3 of the Law on University Reform. These Associate Teachers will be governed by the provisions of the Law on University Reform and its development provisions, with the peculiarities that they will regulate in terms of the temporary regime of their contracts. The Statutes of the University will have to collect specific formulas to regulate the participation of these teachers in the governing bodies of the University.

3. The concerts may also provide for the existence of a number of Adjutant places in the universities ' templates, which must be covered by public competition among professionals in the areas of health who are in possession of the title. "Specialist", without applying the prerequisites to be hired and the forecasts regarding the title of Doctor mentioned in article 34.3 of the Law of University Reform.

4. The various titles of Specialist Doctors and Teachers will be able to access the conditions that will be established in the framework of the care and teaching needs. The concert regime must guarantee the University Assistant and the Teachers the fulfilment of the above requirements.

CHAPTER II

From fostering research

Article cent six.

1. Research activities will have to be promoted throughout the health system as a key element in the health system's progress.

2. Research in biomedicine and in health sciences will be developed mainly in the light of national research policy and national health policy.

Research in health sciences has to contribute to the promotion of the health of the population. This research should especially consider the socio-sanitary reality, the causes and mechanisms that determine it, the ways and means of preventive and curative intervention and the rigorous evaluation of the effectiveness, effectiveness and efficiency of the interventions.

Article one hundred seven.

1. In order to programme, stimulate, develop, coordinate, manage, finance and evaluate research, the Departments of Health of the State and of the Autonomous Communities may set up the research bodies they consider appropriate. agreement with the Spanish scientific policy.

2. Research and allocation programmes should be coordinated to the same public resources of any source, in order to achieve the maximum productivity of investments.

3. Research bodies shall have the capacity to establish their priority programmes and to establish research units. Their autonomy shall be guaranteed and funding may be provided in accordance with the general health and research criteria.

Article one hundred eight.

In the priority areas and objectives, specific resource training programs will be developed to cover the respective needs. The dedication to the research of those involved in information, assistance, teaching and administration will be regulated.

Article one hundred nine.

In the funding of research, the following criteria will be taken into account:

(a) Establishment of a minimum annual research budget, consisting of 1 per 100 of the overall health budgets, which will be progressively achieved from the enactment of this Law.

b) Health and economic assessment of investments in research.

Article one hundred ten.

It is up to the State Health Administration to assess the safety, efficacy and efficiency of health and healthcare relevant technologies.

TITLE VII

From The "Carlos III" Health Institute

ONLY CHAPTER

Article one hundred and eleven.

1. The "Carlos III" Health Institute, as a scientific-technical support organ of the Department of Health of the State Administration and the various Health Services of the Autonomous Communities, is constituted.

2. The Institute of Health "Carlos III" will have the nature of the Autonomous Body of the State Administration, attached to the Ministry of Health and Consumer Affairs.

Article one hundred twelve.

1. The structure, organization and operating system of the "Carlos III" Health Institute will be regulated by Royal Decree. In any case, it will have a Board of Directors whose President will be the Minister of Health and Consumer Affairs.

2. The Institute of Health "Carlos III" will develop its functions in coordination with the Interterritorial Health Council referred to in Article 47 of this Law and in collaboration with other Public Administrations. Such functions shall be:

a) Specialist training of staff in the health and health management service.

b) Microbiology, virology and immunology.

c) Food, metabolism and nutrition.

d) Control of medicines and medical devices.

e) Environmental health.

0 Control of biological products.

g) Food control of food.

h) Health control of potentially hazardous chemicals.

i) Epidemiology and information systems.

j) Control of infectious and immunological diseases.

k) Control of chronic diseases.

l) Clinical research.

m) Research on genetics and human reproduction.

n) Social and economic sciences applied to health.

n) Promotion and coordination of biomedical and health research activities within the framework of the Law on the Promotion and General Coordination of Scientific and Technical Research.

o) Health education of the population.

p) Other interest rates for the National Health System that are assigned to you.

Article cent thirteen.

The Health Institute "Carlos III", as well as the organs responsible for the health of the Autonomous Communities, may propose to the Ministry of Health and Consumption the designation as national reference aid units those who reach the health level of research and teaching that is regulated to access such a condition.

The Ministry of Health and Consumer Affairs shall dictate the rules governing the granting of the accreditation of national reference units, the access to such units of system users and the applicable economic regime.

Additional disposition first.

1. In the cases of the Autonomous Community of the Basque Country and of the Community of Navarra, the financing of the State's health care shall be governed, as soon as it affects their respective concert or contract systems, establish, respectively, their Statute of Autonomy and the Law of Reintegration and Improvement of the Fuero.

2. In the case of the Autonomous Community of the Basque Country, by way of derogation from Article 82, the financing of the health care of the social security to be transferred shall be that laid down in the conventions referred to in the Fifth transitional provision of the Autonomous Statute of the Basque Country.

Additional provision second.

The government will adopt the basic minimum and common criteria for health information. In order to develop the above, agreements with the Autonomous Communities may be established.

Additional provision third.

It will be regulated, with the economic and budgetary flexibility required by the commercial nature of its operations, the organ responsible for the management of the drug deposits, as provided for in the treaties. international, foreign and urgent medicine not authorized in Spain, strategic deposit for emergencies and catastrophes, acquisitions for international cooperation programs and supplies of vaccines and others that are needed in the exercise of the functions of the State Administration.

Additional provision fourth.

The distribution and dispensing of medicinal products and animal health products shall be regulated by their corresponding legislation.

Additional provision fifth.

In the National Health System, for the purposes set out in Article 10 (14) and Article 18.4, new drugs and more effective or less expensive medical devices will be financed with public funds. available. In all or part of the public funding, or subject to special conditions, the medicinal products and medical devices already available, the indications of which are symptomatic, the efficacy of which is not proven or those indicated for conditions whenever there is a better or equal and less expensive therapeutic alternative for them.

Additional provision sixth.

1. The health centres of social security shall be integrated into the Health Service only in cases where the Autonomous Community has assumed responsibility for the health care of the Social Security, in accordance with its Staff Regulations. In the remaining cases, the health network of Social Security shall coordinate with the Health Service of the Autonomous Community.

2. The coordination of the health centres of social security with the Health Services of the Autonomous Communities which have not assumed responsibility for the health care of the Social Security shall be carried out by a Commission composed of representatives of the State Administration and the Autonomous Community, whose President shall be appointed by the State in the manner that it is determined to regulate.

Additional provision seventh.

The health centers and establishments that form part of the unique patrimony of Social Security will continue to be qualified in the name of the General Treasury, without prejudice to their functional affiliation to the various administrations. Public Health.

Additional provision octave.

1. For the purposes of applying Chapter VI of Title III of this Law, the health and non-health personnel of the Social Security shall be understood to refer to the fourth transitional provision of the Law on Measures for the Reform of the Public Function.

2. As for the official staff at the service of the Social Security regulated in the transitional provision third of the Law of Measures for the Reform of the Civil Service will be in the provisions of this norm.

Additional provision ninth.

1. The Government shall approve by Royal Decree, within six months of the entry into force of this Law, the procedure and time limits for the formation of the Integrated Health Plans.

2. For the formation of the first Integrated Health Plan, the Department of Health of the State Administration shall inform the Autonomous Communities of the general coordination criteria and other circumstances to which the Article 70 of this Law within the maximum period of eighteen months from the entry into force of this Law.

Additional provision tenth.

The appointment as technical directors of foreign nationals, referred to in Article 100.3, will only be authorized when the international treaties signed by Spain and the Spanish have been established. of which those are nationals.

First transient disposition.

1. The local corporations that currently have health services and establishments that carry out actions that under this Law are assigned to the Health Services of the Autonomous Communities, will establish by mutual agreement with the governments of the Autonomous Communities a process of transferring them.

2. Notwithstanding the foregoing, the functional affiliation referred to in Article 50.2 of this Law shall be produced on the same date as the Health Services of the Autonomous Communities. From this moment on, the Autonomous Communities will finance with their own budgets the effective cost of the establishments and services that are attached to their Health Services.

3. Local Corporations and Autonomous Communities may establish arrangements for the financing of new investments and for the conservation, improvement and replacement of establishments.

4. In any event, until the definitive system of financing of the Autonomous Communities comes into force, the Local Corporations will contribute to the financing of the Health Services of those in an amount equal to that allocated in their budgets, which shall be updated annually for the financing of establishments operating in the same way. For these purposes, the quantities which may be obtained from concerts with the National Institute of Health shall not be considered.

5. The amounts corresponding to the concerts referred to in the preceding paragraph shall be allocated directly to the Autonomous Communities when the functional ademat of the establishments is produced in accordance with the provisions laid down in paragraph 2 of this Article. the present transitional provision.

Second transient disposition.

The Government, taking into account the extraterritorial character of the maritime work, will determine in due course the timely coordination of the health services managed by the Social Institute of the Navy with the various Health Services.

Transient Disposition third.

1. The National Institute of Health will continue to subsidize and exercise the functions it has attributed, as long as the process of transfers to the Autonomous Communities with competence in the field has not been completed.

2. The Autonomous Communities shall agree on the creation, organization and operation of their Health Services within the maximum period of twelve months, from the moment the process of transfers of services is completed. corresponds to its statutory powers.

3. In cases where the Autonomous Communities do not have sufficient powers in relation to Health to fully adapt the functioning of their Health Services to the provisions of this Law, the State shall conclude with those agreements. and conventions for the gradual implementation of the provisions of the same and to achieve an integrated functioning of health services.

Fourth transient disposition.

The possible transfers to be made in the field of health care management of Social Security in favour of the Autonomous Communities, which may assume such management, should be accommodated in accordance with the principles laid down in the this Act.

Transient disposition fifth.

The extent of public health assistance referred to in Articles 3.2 and 20 of this Law shall be made progressively.

First repeal provision.

Any provisions of equal or lower rank are repealed in contradiction with the provisions of this Law.

The Government, within twelve months of the publication of this Law, will publish a Table of Vigences and Derogations.

Repeal provision second.

Any provisions that, upon the entry into force of this Law, regulate the structure and functioning of health institutions and bodies, for the purposes of proceeding with their reorganization and adaptation to the provisions of this Law.

First disposition first.

In order to achieve the objectives of pre-graduate training, post-graduate training and health specialisation, the Government, within eighteen months of the publication of the present, is indicated in Title VI. Law, regulate, clarify and harmonise the following legal texts:

-The third basis of the Law of 25 November 1944, on the National School of Health.

-The second paragraph of the first article of Law 37/1962, of July 21, on hospitals as centers of training and specialization.

-The Law of 20 July 1955, Royal Decree 2015/1978 of 15 July, and Royal Decree 3303/1978 of 29 December 1978 on specialties of the medical profession.

-Law 24/1982 of June 16 on specialized health practices and teaching.

-Royal Decree 127/1984, of 11 January, which regulates specialized medical training and obtaining the degree of specialist physician.

The above provisions, as well as those relating to the training and specialisation of the health professions, will be duly updated.

Final disposition second.

Until public health coverage systems are not integrated into the National Health System, the government within eighteen months of the publication of this Law will proceed to the harmonisation and recasting of:

1. Health care in the social security system, in cases of maternity, common or occupational disease and accidents, whether or not they are a work referred to in Article 20.1.a) of the General Law on Social Security of 30 May 1974, and concordant provisions, both of the General Regime and of Special Regimes, including those regulated by specific laws: Agrarian, Sea Workers and Civil Servants of the State and in the service of the Administration of Justice and the members of the Armed Forces referred to in Article 195 of Law 85/1978 of 28 December.

2. Pharmaceutical medical assistance to officials and employees of the Local Administration.

3. The health care of the National Health referred to in the Law of 25 November 1944; the second subparagraph of Article 2 (a) of Decree-Law No 13/1972 of 29 December 1972 and the provisions of the Law of 29 December 1972; including psychiatric care, communicable diseases and the general benefit of the State.

4. The general and beneficial health care of the Provincial and Ayalqual Diputations referred to in bases 23 and 24 of the Law of 25 November 1944, the Law of Local Regime and concordant provisions.

5. The health care provided to the prison inmates referred to in Articles 3 and 4. of Law 1/1979 of 26 September, and concordant provisions.

6. Health care for civilians and military maimed as a result of actions of war or defense of public order and citizen security.

Third end disposition.

1. The Government, through Royal Decree, on a joint proposal from the Ministries concerned, will have:

(a) Participation in the National Health System of the National Institute of Toxicology, Forensic Medicine, Medical Services of the Civil Registry and Penitentiary Health.

b) The participation and collaboration of the Military Hospitals and Health Services of the Armed Forces in the National Health System, and its harmonization with the provisions of Articles 195 and 196 of Law 85/1978, for ensure, within their scope, their support for the National Health System.

c) Full integration into the National Health System of Clinical or University Hospitals and the peculiarities derived from their teaching, training and research functions.

d) Participation in the National Health System of Customs Laboratories and control of exports and imports.

The Administration of the State and the Autonomous Communities, in the field of their competencies, will have the participation in the National Health System of the Agrarian and Livestock Research Laboratories and, in general, of any other centres and services which may contribute to the general purposes and interests of the protection of health.

2. The Government, by means of a Royal Decree, on a joint proposal from the Ministries concerned, will have the centres, services and health facilities of the Accidents, Mutualities and Public or private non-profit institutions, may be subject to integration into the National Health System, provided that they meet the minimum conditions and requirements.

Final disposition fourth.

The Government, by means of Royal Decree agreed within the maximum period of eighteen months, counted from the entry into force of this Law, shall establish in general the minimum technical requirements for the approval and approval of the facilities and equipment of the centres and services.

Final disposition fifth.

In order to achieve the objectives of this Law and in compliance with the current distribution of powers, the Government shall, within the maximum period of eighteen months from the date of its publication, recast, regularise, clarify and harmonise, in accordance with current epidemiological, technical and scientific knowledge, with. the health and social needs of the population and the requirements of the health system, the following provisions:

1. Law 45/1978 of 7 October-third paragraph of its additional provision-on family planning and guidance.

2. Law 13/1982 of 7 April-Article 9 and concordant-on family planning and guidance, genetic advice, prenatal and perinatal care, early detection and diagnosis of subnormal and disability.

3. Law of 12 July 1941 on child and maternal health.

4. Law 39/1979 of 30 November 1979, fifth paragraph, second paragraph, on the prohibition of the advertising of alcoholic beverages.

5. Law 22/1980 of 24 April on compulsory and recommended vaccinations.

6. Royal Decree 2838/1977 of 15 October 1977 on the planning, implementation and control of activities related to school health.

7. The bases 4. ª, 6. ª, 7. ª, 9. ª, 10, 11, 12, 13, 14 and 15 of the Law of 25 November 1944 on infectious diseases, disinfection and disinterment, health statistics, tuberculosis, rheumatism, heart disease, malaria, trachoma, diseases sexual, leprosy, dermatosis, cancer, maternal and child health, mental hygiene and psychiatric care.

8. The third and next base 25-the Law of 25 November 1944 and Law 13/1980 of 31 March-Article 9 (1) and additional provision on hygiene and health inspection of physical education and sport.

9. The Law of 14 April 1955 and the Law of 26 December 1958 on psychiatric and anti-tuberculosis assistance as soon as they continue to be in force in accordance with the Additional Provision 5, 2 of Decree-Law 13/1972 of 29 December.

10. Bases 17 and 26 of the Law of 25 November 1944 on transmissible food hygiene zoonoses.

Final disposition sixth.

The Government is authorised to adopt by Royal Decree a single text on the protection of workers ' health, clarifying, regulating and harmonizing the existing rules, in accordance with the following principles:

1. The permissible levels and values of occupational exposure to harmful agents shall be fixed in order to prevent damage to physical, mental and social health, in particular by the prevention of harmful effects in the short term. as of the harmful effects for reproductive function and the risks of mutagenesis, carcinogenesis and teratogenesis.

2. Modalities for the determination and updating of the permissible levels or values of the harmfulness factors of chemical, physical, biological and psychological origin shall be laid down.

Final disposition seventh.

The Rules of Procedure of the Interterritorial Council of the National Health System shall be approved by the National Health System and communicated to the administrations represented in the National Health System.

Final disposition octave.

The Government, by means of Royal Decree, will adopt the necessary measures for the joint action of several Public Administrations for the purposes of external health and in order to be able to recognize validity and effectiveness for the same purposes certain inspections at source or other specific controls which are deemed sufficient, carried out by the technical services of the Autonomous Communities or other public administrations.

Final disposition ninth.

The Government is authorized to adapt the structure and functions of the Agencies and Entities attached to the Ministry of Health and Consumer Affairs and, among them, the National Institute of Health to the principles established in the present Law, as well as to regulate the organization and regime and to develop the competencies of the state autonomous organizations that in this Law are created.

Final disposition tenth.

For the purposes of this Law, health officials of the Social Security Management Entities are considered to be those included in the Health Corps and Escalations of the Staff Regulations of the extinct National Institute of Foresight, of Medical Advisors of the Extinct Labor Mutualism and of the Medical Inspectors Scale of the Social Institute of the Navy.

Final disposition eleventh.

The Government is authorized to merge or integrate the Public Administrations and Social Security Management Bodies and Officials, in order to facilitate the management of the staff and to approve the systems. (a) the legal basis for the employment relationship, without prejudice to the powers conferred on the Government by Article 26.4 of the Law on Measures for the Reform of the Civil Service.

Final disposition twelfth.

The Government will determine the conditions and the system of functioning of the health services, in relation to the compliance with the competences assigned to the Social Security in the field of invalids, disability temporary work and temporary invalidity.

Final disposition thirteenth.

They are attached to the "Carlos III" Health Institute:

a) The National Food and Nutrition Center.

b) The National Center for Microbiology, Virology and Health Immunology.

c) The National Center for Pharmacobiology.

d) The National Environmental Health Center.

e) The School of National Health and the School of Hospital Management.

f) The Health Care Complex of the King's Hospital.

Final disposition fourteenth.

The Government is authorised to amend the health protection mechanisms of the different existing public schemes, accommodating them to the principles set out in this Law.

15th end disposition.

For the better use of human resources, the staff referred to in Articles 84 and 85 of this Law may hold jobs in the Sanitary Administrations of the State or the Communities without distinction. Autonomous, without prejudice to the requirements of certification and other requirements in relation to the employment of the different administrations.

Therefore,

I command all Spaniards, individuals and authorities, to keep and keep this Law.

Palacio de la Zarzuela, Madrid, 25 April 1986.

JOHN CARLOS R.

The President of the Government,

FELIPE GONZÁLEZ MARQUEZ