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.

EXPLANATORY STATEMENT

The importance of patients ' rights as a basic axis of clinical-care relations is evident in the interest shown by almost all organizations. international competition in the field. Since the end of the Second World War, organizations such as the United Nations, UNESCO or the World Health Organization, or, more recently, the European Union or the Council of Europe, among many others, have pushed forward statements or, in some cases They have enacted legal rules on generic or specific aspects related to this issue. In this sense, it is necessary to mention the transcendence of the Universal Declaration of Human Rights, of the year 1948, which has been the binding point of reference for all constitutional texts subsequently promulgated or, in the most In addition to a number of international declarations on the promotion of patients 'rights in Europe, the Declaration on the promotion of patients' rights in Europe, promoted in 1994 by the World Health Organisation's Regional Office for Europe, more or less scope and influence that have been addressed to these issues.

The special relevance of the Council of Europe Convention for the protection of human rights and the dignity of the human being in relation to the applications of biology and medicine (Convention on the rights of man and biomedicine), signed on 4 April 1997, which entered into force in the Kingdom of Spain on 1 January 2000. This Convention is a capital initiative: in fact, unlike the various international declarations that have preceded it, it is the first international instrument legally binding on the countries that subscribe to it. Its special value lies in the fact that it establishes a common framework for the protection of human rights and human dignity in the application of biology and medicine. The Convention explicitly deals with the need to recognise the rights of patients, including the right to information, the informed consent and the privacy of the information relating to the patient. the health of the people, pursuing the scope of harmonization of the laws of the various countries in these matters; in this sense, it is absolutely appropriate to take into account the Convention at the time of addressing the challenge of regulating issues so important.

It must be said, however, that the regulation of the right to health protection, as enshrined in Article 43 of the 1978 Constitution, from the point of view of the issues most closely linked to the condition of In the case of human rights, the rights of users of health services, that is to say, the plasmation of rights relating to clinical information and the individual autonomy of patients in relation to their health, has been the subject of a regulation. State of the Union, through Law 14/1986 of 25 April, General of Health.

the other hand, this Law, although basically its focus on the establishment and management of the health system from an organizational point of view, devotes to this issue a number of forecasts, among which the the will to humanize health services. It thus maintains the utmost respect for the dignity of the individual and individual freedom, on the one hand, and, on the other, declares that the health organization must make it possible to guarantee health as an inalienable right of the population through the structure of the National Health System, which must be ensured in conditions of scrupulous respect for the personal privacy and individual freedom of the user, guaranteeing the confidentiality of the information related to the health services provided and without any discrimination.

On the basis of these premises, this Law completes the provisions of the General Health Law as general principles. In this sense, it reinforces and gives special treatment to the right to autonomy of the patient. In particular, special mention is made of the regulation on prior instructions which, in accordance with the criteria laid down in the Oviedo Convention, provides for the wishes of the patient previously expressed in the area of consent. reported. In addition, the Law deals in depth with everything related to the clinical documentation generated in the care centers, emphasizing especially the consideration and the realization of the rights of the users in this aspect.

In September 1997, in the development of a collaboration agreement between the General Council of the Judiciary and the Ministry of Health and Consumer Affairs, a joint seminar on information and clinical documentation took place, in which the main regulatory and judicial aspects in the field were discussed. At the same time, a group of experts was set up to whom it was commissioned to draw up guidelines for the future development of this topic. This group endorsed an opinion on 26 November 1997, which has been taken into account in the elaboration of the fundamental principles of this Law.

The attention given to these matters in their day by the General Health Law marked a significant step forward, as they reflect, among others, Articles 9, 10 and 61. However, the right to information, as the right of the citizen when it demands health care, has been the subject of several clarifications and enlargements in recent years by laws and regulations of different kinds and rank, which the need for reform and updating of the legislation contained in the General Health Law. Thus, the Organic Law 15/1999, of 13 December, of Protection of Personal Data, qualifies the data relating to the health of the citizens as specially protected data, establishing a uniquely rigorous regime for their obtaining, custody and eventual disposal.

This defence of confidentiality had already been defended by Community Directive 95/46 of 24 October, in which, in addition to the defence of the rights and freedoms of European citizens, in particular its This study is based on the results of the study, which has been carried out by the European Commission in the field of research and development, in particular in the field of health and safety at work. which, where they are included in law-range rules, may justify a reasoned exception to the rights of the patient. A Community conception of the right to health is thus manifested, in which, together with the singular interest of each individual, as a recipient par excellence of health information, others also appear

agents and legal goods referring to public health, which must be considered, with the necessary relevance, in an advanced democratic society. In this respect, the Council of Europe, in its Recommendation of 13 February 1997 on the protection of medical data, after stating that they should be collected and processed with the consent of the affected person, indicates that the information may be to be restricted if a law so provides and is a necessary measure for reasons of general interest.

All these circumstances advise an adaptation of the General Health Law with the aim of clarifying the legal situation and the rights and obligations of healthcare professionals, citizens and institutions. health. It is a question of offering the same guarantees in the field of information and clinical documentation to all citizens of the State, thereby strengthening the right to health protection that the Constitution recognizes.

CHAPTER I

General principles

Article 1. Scope of application.

This Law aims to regulate the rights and obligations of patients, users and professionals, as well as healthcare, public and private health centers and services, in the field of patient and patient autonomy. information and clinical documentation.

Article 2. Basic principles.

1. The dignity of the human person, respect for the autonomy of their will and their privacy will guide all the activity aimed at obtaining, using, archiving, guarding and transmitting the information and the clinical documentation.

2. Any action in the field of health requires, as a general rule, the prior consent of patients or users. Consent, which must be obtained after the patient receives adequate information, will be made in writing in the assumptions provided for in the Act.

3. The patient or user has the right to freely decide, after receiving the appropriate information, among the available clinical options.

4. Every patient or user has the right to refuse treatment, except in the cases determined in the Law. Their refusal to treatment will be written in writing.

5. Patients or users have a duty to provide data on their physical condition or on their health in a fair and true manner, as well as to cooperate in obtaining them, especially when they are necessary for reasons of public interest or for reasons of public interest. of health care.

6. Every professional involved in the care activity is obliged not only to the correct delivery of his/her techniques, but to the fulfillment of the duties of information and clinical documentation, and to the respect of the free and the free decisions voluntarily by the patient.

7. The person who prepares or has access to the information and the clinical documentation is required to keep the reservation due.

Article 3. The legal definitions.

For the purposes of this Law, it is understood by:

Healthcare Center: the organized group of professionals, facilities and technical means that perform activities and provide services to take care of the health of patients and users.

Medical certificate: the written declaration of a physician who attests to the health of a person at a certain time.

Informed consent: the free, voluntary and conscious compliance of a patient, manifested in the full use of his or her faculties after receiving the appropriate information, to take place a performance affecting his/her health.

Clinical documentation: the support of any type or class that contains a set of data and information of a care nature.

Clinical history: the set of documents containing the data, assessments and information of any kind on the situation and the clinical evolution of a patient throughout the care process.

Clinical information: any data, whatever form, class or type, that allows to acquire or expand knowledge about the physical state and health of a person, or how to preserve, care for, improve or recover it.

High-medical report: the document issued by the responsible physician in a healthcare facility at the end of each patient's care process, which specifies the patient's data, a summary of his or her clinical history, the activity Care provided, diagnosis and therapeutic recommendations.

Intervention in the field of health: all actions performed for preventive, diagnostic, therapeutic, rehabilitation or research purposes.

Free choice: the right of the patient or user to opt, freely and voluntarily, between two or more care alternatives, among several physicians or among care centers, in the terms and conditions they establish the competent health services, in each case.

Responsible doctor: the professional who is responsible for coordinating the information and health care of the patient or the user, with the character of the main interlocutor of the patient in everything related to his or her attention and information during the care process, without prejudice to the obligations of other professionals involved in the care actions.

Patient: the person who requires healthcare and is subject to professional care for the maintenance or recovery of their health.

Healthcare: the health care unit with its own organization, equipped with the technical resources and the qualified personnel to carry out health activities.

User: the person who uses health education and health promotion, disease prevention, and health information services.

CHAPTER II

The right of health information

Article 4. The right to care information.

1. Patients have the right to know, for any action in the field of their health, all the information available on it, saving the assumptions excepted by the Law. In addition, everyone has the right to respect his will not to be informed. The information, which as a general rule will be provided verbally, in the clinical history, includes at least the purpose and nature of each intervention, its risks and its consequences.

2. The clinical information is part of all the care actions, will be true, will be communicated

to the patient in an understandable and appropriate way to your needs and help you make decisions according to your own free will.

3. The doctor responsible for the patient guarantees the right to the information. Professionals who care for you during the care process or apply a specific technique or procedure will also be responsible for informing you.

Article 5. Holder of the right to care information.

1. The holder of the right to information is the patient. Persons linked to it shall also be informed, for family reasons or in fact, to the extent that the patient expressly or tacitly permits.

2. The patient will be informed, even in the event of incapacity, in an appropriate way to his or her possibilities of understanding, fulfilling the duty to inform his legal representative as well.

3. When the patient, according to the criterion of the physician who assists him, lacks the capacity to understand the information because of his physical or mental state, the information will be brought to the attention of the persons linked to him for reasons of family or done.

4. The right to patient health information may be limited by the proven existence of a state of therapeutic need. Therapeutic need shall mean the ability of the physician to act professionally without informing the patient before, when, for objective reasons, knowledge of his/her own situation may seriously impair his/her health.

If this is the case, the physician will leave a reasoned record of the circumstances in the medical history and will communicate his/her decision to the patients linked to the patient for family reasons or in fact.

Article 6. Right to epidemiological information.

Citizens have the right to know the health problems of the community when they pose a risk to public health or to their individual health, and the right to have this information spread in real terms, understandable and appropriate for the protection of health, in accordance with the provisions of the Law.

CHAPTER III

Right to Privacy

Article 7. The right to privacy.

1. Any person has the right to respect the confidential nature of the data relating to his health, and that no one can access them without prior authorization under the law.

2. Health centres shall take appropriate measures to ensure the rights referred to in the previous paragraph and shall, where appropriate, draw up the rules and procedures to ensure legal access to the data of the Member States. patients.

CHAPTER IV

Respect for patient autonomy

Article 8. Informed consent.

1. Any action in the field of the health of a patient requires the free and voluntary consent of the patient, once the information provided for in Article 4 has been received, and has assessed the case's own options.

2. Consent will be verbal as a rule.

However, it will be provided in writing in the following cases: surgical intervention, invasive diagnostic and therapeutic procedures and, in general, application of procedures involving risks or disadvantages of foreseeable negative impact on the health of the patient.

3. The written consent of the patient will be necessary for each of the actions specified in the previous point of this article, leaving the possibility of incorporating anexes and other general data, and will have information sufficient on the application procedure and on its risks.

4. Every patient or user has the right to be warned about the possibility of using the prognostic, diagnostic and therapeutic procedures applied to them in a teaching or research project, which in no case can behave at risk. additional for your health.

5. The patient may freely revoke written consent at any time.

Article 9. Limits of informed consent and consent by representation.

1. The patient's resignation to receive information is limited by the interest of the patient's own health, third parties, the community and the therapeutic requirements of the case. When the patient expressly expresses his or her wish not to be informed, his will be respected by stating his complete resignation, without prejudice to obtaining his prior consent for the intervention.

2. The physicians may carry out the necessary clinical interventions in favor of the patient's health, without the need for their consent, in the following cases:

(a) When there is a risk to public health due to health reasons established by the Law. In any event, once the relevant measures have been taken, in accordance with the provisions of the Organic Law 3/1986, they shall be notified to the judicial authority within a maximum of 24 hours provided that they have the mandatory detention of persons.

(b) Where there is an immediate serious risk to the physical or mental integrity of the patient and it is not possible to obtain his/her authorisation, in consultation, where circumstances permit, to his or her family members or to persons linked to made to him.

3. Consent shall be granted per representation in the following cases:

(a) When the patient is not able to make decisions, at the discretion of the physician responsible for the care, or his physical or mental condition does not allow him to take care of his situation. If the patient has no legal representative, consent will be provided by persons linked to him for family reasons or in fact.

b) When the patient is legally incapacitated.

c) When the minor patient is not able to be able to understand the scope of the intervention. In this case, consent will be given by the child's legal representative after hearing his or her opinion if he is twelve years old.

When it comes to minors who are neither incapable nor incapacitated, but emancipated or with sixteen years of age, consent is not to be provided by representation. However, in the event of a serious risk, according to the criterion of the optional, the parents will be informed and their opinion will be taken into account in order to make the corresponding decision.

4. The voluntary termination of pregnancy, the practice of clinical trials and the practice of assisted human reproduction techniques are governed by the general principle of the age of majority and by the special provisions of the application.

5. The provision of consent by representation shall be appropriate to the circumstances and proportionate to the needs to be met, always in favour of the patient and with respect to his personal dignity. The patient will participate as much as possible in decision-making throughout the health process.

Article 10. Conditions of information and written consent.

1. The optional shall provide the patient with the following basic information before obtaining written consent:

a) The relevant or important consequences that the intervention originates with security.

b) Risks related to the patient's personal or professional circumstances.

c) Likely risks under normal conditions, in accordance with the experience and state of science or directly related to the type of intervention.

d) The contraindications.

2. In each case, the responsible physician should weigh the more doubtful the outcome of a more necessary intervention, the prior written consent of the patient.

Article 11. Previous instructions.

1. By the document of previous instructions, a person of age, capable and free, expresses his will in advance, so that it may be fulfilled at the moment when he comes to situations in which circumstances he is not able to express them. personally, on the care and treatment of your health or, once the death has arrived, on the fate of your body or the organs of your body. The document's grantor may also designate a representative to serve as his or her partner with the physician or health team to ensure compliance with the previous instructions.

2. Each health service shall regulate the appropriate procedure so that, where appropriate, compliance with the prior instructions of each person is ensured, which shall be recorded in writing.

3. Prior instructions contrary to the legal order, the "lex artis", or those which do not correspond to the alleged fact that the person concerned has provided for at the time of their application, shall not be applied. In the patient's clinical history, the records related to these forecasts will be substantiated.

4. Prior instructions may be freely revoked at any time, with written record.

5. In order to ensure the effectiveness throughout the national territory of the previous instructions expressed by the patients and formalised in accordance with the provisions of the legislation of the respective Autonomous Communities, it will be established in the Ministry of Health and Consumer Affairs the National Register of prior instructions that will be governed by the rules that are regulated, with the agreement of the Interterritorial Council of the National Health System.

Article 12. Information in the National Health System.

1. In addition to the rights recognized in the above articles, patients and users of the National Health System will be entitled to receive information about the available services and care units, their quality and the requirements of the access to them.

2. Health services shall have in the health centres and services a guide or a letter of the services specifying the rights and obligations of the users, the benefits available, the assistance characteristics of the centre or the service, and their personnel, facilities and technical resources.

All users will be provided with information about the participation guides and suggestions and complaints.

3. Each health service shall regulate procedures and systems to ensure effective compliance with the provisions of this Article.

Article 13. Right to information for the choice of physician and center.

Users and patients of the National Health System, both in primary and specialized care, will have the right to the corresponding prior information to choose a physician, and also center, according to the terms and conditions to be established by the competent health services.

CHAPTER V

Clinical history

Article 14. Definition and file of the medical history.

1. The clinical history includes all the documents related to the care processes of each patient, with the identification of the physicians and other professionals who have intervened in them, in order to obtain the maximum Possible integration of the clinical documentation of each patient, at least, in the field of each center.

2. Each center will archive the medical records of its patients, whatever the paper, audiovisual, computer or other support they contain, so that they are guaranteed their safety, their correct conservation and the recovery of the information.

3. Health administrations shall establish mechanisms to ensure the authenticity of the content of the clinical history and the changes in the clinical history, as well as the possibility of its future reproduction.

4. The Autonomous Communities shall adopt the necessary provisions to enable health centres to take appropriate technical and organisational measures to archive and protect medical records and to prevent their destruction or loss of life. accidental.

Article 15. Contents of the clinical history of each patient.

1. The clinical history will incorporate the information that is considered transcendental for the truthful and updated knowledge of the patient's health status. Every patient or user has the right to be aware, in writing or in the most appropriate technical support, of the information obtained in all their care processes, carried out by the health service in the field of primary care as specialized care.

2. The main purpose of the medical history will be to facilitate health care, with all the data that, under medical criteria, allow the true and up-to-date knowledge of the state of health.

The minimum content of the medical history will be as follows:

a) The documentation relating to the clinicostatistical sheet.

b) The authorization to enter.

c) The urgency report.

d) Anamnesis and physical exploration.

e) Evolution.

f) Medical orders.

g) The interquery sheet.

h) Reports of complementary scans.

i) Informed consent.

j) The anesthesia report.

k) The operating room report or delivery report.

l) The pathological anatomy report.

m) The evolution and planning of nursing care.

n) The therapeutic nursing application.

n) The constant graph.

o) The high clinical report.

Paragraphs (b), (c), (i), (j), (k), (l), (n) and (o) shall only be required in the completion of the clinical history in the case of hospitalization processes or so shall be available.

3. The completion of the clinical history, in the aspects related to the direct assistance to the patient, will be the responsibility of the professionals involved in it.

4. The clinical history will be carried out with criteria of unity and integration, in each care institution at least, to facilitate the best and most timely knowledge by the faculty of the data of a particular patient in each process. assistance.

Article 16. Uses of the medical history.

1. The clinical history is an instrument aimed primarily at ensuring adequate assistance to the patient. Care professionals in the center who perform the diagnosis or treatment of the patient have access to the clinical history of the patient as a fundamental instrument for their proper care.

2. Each centre shall establish the methods that enable access to the clinical history of each patient by the professionals who assist him at all times.

3. Access to medical history for judicial, epidemiological, public health, research or teaching purposes is governed by the provisions of the Organic Law 15/1999, the Protection of Personal Data, and Law 14/1986, General de Health and other implementing rules in each case. Access to the medical history for these purposes requires the preservation of the patient's personal identification data, separated from those of a clinical-care character, so that as a general rule anonymity is assured, except that the patient's own personal identification patient has given his consent not to separate them. Except for the cases of investigation by the judicial authority in which it is considered essential to unify the identification data with the clinical-care, in which the judges and courts will be available in the corresponding process. Access to data and documents in medical history is strictly limited to the specific purposes of each case.

4. The management and management staff of the healthcare facilities can only access the data in the medical history related to their own functions.

5. Duly accredited health personnel who perform inspection, evaluation, accreditation and planning functions have access to the medical records in the performance of their quality assurance functions, the respect for the rights of the patient or any other obligation of the centre in relation to patients and users or the health administration itself.

6. Personnel who access the data in the medical history in the exercise of their duties are subject to the duty of secrecy.

7. The Autonomous Communities shall regulate the procedure so that access to the medical history and its use is recorded.

Article 17. The preservation of the clinical documentation.

1. Healthcare facilities have an obligation to keep the clinical documentation in a condition that ensures their correct maintenance and safety, although not necessarily in the original support, for the due care of the patient during the appropriate time for each case and at least five years from the date of discharge of each care process.

2. The clinical documentation shall also be kept for judicial purposes in accordance with the legislation in force. It shall also be retained where there are epidemiological, research or organisational and operational reasons for the National Health System. Their treatment will be done in such a way as to avoid the identification of the affected persons as far as possible.

3. Healthcare professionals have a duty to cooperate in the creation and maintenance of an orderly and sequential clinical documentation of the patients ' care process.

4. The management of the medical history by the centers with hospitalized patients, or by those who tend to a sufficient number of patients under any other care modality, according to the criteria of the health services, will be carried out through the unit of admission and clinical documentation, in charge of integrating into a single archive the medical records. The custody of such medical records will be under the responsibility of the health center management.

5. Healthcare professionals who develop their activity individually are responsible for the management and custody of the care documentation they generate.

6. The technical safety measures established by the legislation regulating the conservation of files containing personal data and, in general, by the Organic Law 15/1999, are applicable to the clinical documentation. Protection of Personal Data.

Article 18. Access rights to the medical history.

1. The patient has the right of access, with the reservations mentioned in paragraph 3 of this article, to the documentation of the medical history and to obtain copies of the data contained in it. Health centres shall regulate the procedure to ensure compliance with these rights.

2. The patient's right of access to medical history can also be exercised by duly accredited representation.

3. The right to access the patient to the documentation of the medical history cannot be exercised to the detriment of the right of third parties to the confidentiality of the data contained in it collected in the therapeutic interest of the patient, nor in prejudice to the right of the professionals involved in their preparation, who may oppose the right of access to the reservation of their subjective annotations.

4. Healthcare facilities and individual exercise facilities will only facilitate access to history

patients who are deceased to the persons linked to him, for family reasons or in fact, unless the deceased has expressly prohibited him and so is accredited. In any case, the access of a third party to the clinical history motivated by a risk to their health shall be limited to the relevant data. Information shall not be provided which affects the privacy of the deceased or the subjective annotations of the professionals, nor does it harm third parties.

Article 19. Rights related to the custody of medical history.

The patient has the right to have health centers establish a mechanism of active and diligent custody of the medical records. Such custody shall permit the collection, integration, recovery and communication of the information subject to the principle of confidentiality in accordance with Article 16 of this Law.

CHAPTER VI

High report and other clinical documentation

Article 20. High report.

Any patient, family member or person linked to him, if any, will have the right to receive from the health center or service, after the care process has been completed, a discharge report with the minimum contents that determines the Article 3. The characteristics, requirements and conditions of the discharge reports shall be determined by the autonomic health authorities.

Article 21. The patient's discharge.

1. In case of not accepting the prescribed treatment, the patient or user will be proposed to sign the high volunteer. If you do not sign it, the address of the health centre, on a proposal from the responsible doctor, may provide the high force in the conditions regulated by the Law.

The fact that we do not accept the prescribed treatment will not give rise to the high force when there are alternative treatments, even if they are palliative, provided that they are provided by the health center and the patient agrees to receive them. These circumstances will be duly documented.

2. In the event that the patient does not accept discharge, the management of the centre, after checking the relevant clinical report, will hear the patient and, if it persists in his refusal, put it to the judge's knowledge to confirm or revoke the decision.

Article 22. Issuing medical certificates.

Every patient or user has the right to be provided with the certificates of their health status. These will be free of charge when it is established by a statutory or statutory provision.

Article 23. Professional technical, statistical and administrative reporting obligations.

Health professionals, in addition to the obligations identified in the field of clinical information, have the duty to complete the protocols, records, reports, statistics and other administrative or administrative documentation, which are related to the clinical processes in which they are involved, and those requiring the competent health centres or services and the health authorities, including those related to medical research and information epidemiological.

Additional disposition first. Character of basic legislation.

This Law has the basic condition, in accordance with the provisions of Article 149.1.1. and 16. of the Constitution.

The State and the Autonomous Communities shall, in the field of their respective competences, adopt the measures necessary for the effectiveness of this Law.

Additional provision second. Extra application.

The rules of this Law regarding the provision of care information, the information for the exercise of the freedom of choice of physician and center, the informed consent of the patient and the clinical documentation, will be applicable In the case of medical research projects, in the processes of organ extraction and transplantation, in the application of assisted human reproduction techniques and in those that lack special regulation.

Additional provision third. Coordination of medical records.

The Ministry of Health and Consumer Affairs, in coordination and with the collaboration of the Autonomous Communities competent in the field, will promote, with the participation of all stakeholders, the implementation of a system of compatibility that, attended to the evolution and availability of the technical resources, and the diversity of systems and types of medical records, make it possible to use them by the care centers of Spain that care for the same patient, in avoidance of the care In several centers, they undergo explorations and procedures of unnecessary repetition.

Additional provision fourth. Needs associated with disability.

The State and the Autonomous Communities, within the scope of their respective competences, will dictate the precise provisions to guarantee patients or users with special needs, associated with disability, rights in terms of autonomy, information and clinical documentation regulated in this Law.

Additional provision fifth. Information and documentation on medicines and medical devices.

Information, documentation and advertising relating to medicinal products and medical devices, as well as the arrangements for prescriptions and corresponding prescription orders, shall be governed by their specific rules, without prejudice to the application of the rules laid down in this Law in respect of the prescription and use of medicinal products or medical devices during care processes.

Additional provision sixth. Sanctioning regime.

The infringements of the provisions of this Law are subject to the sanctioning regime provided for in Chapter VI of Title I of Law 14/1986, General of Health, without prejudice to civil or criminal liability and to the professional or statutory liability in law.

Single transient arrangement. High report.

The discharge report shall be governed by the provisions of the Order of the Ministry of Health of 6 September 1984, as long as the provisions of Article 20 of this Law are not legally developed.

Single repeal provision. General derogation and specific precepts.

The provisions of equal or lower rank which are contrary to the provisions of this Law and, in particular, paragraphs 5, 6, 8, 9 and 11 of Article 10, Article 11 (4) and Article 61 of the Law shall be repealed. 14/1986, General of Health.

Single end disposition. Entry into force.

This Law shall enter into force within six months of the day following that of its publication in the "Official Gazette of the State".

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

Madrid, 14 November 2002.

JOHN CARLOS R.

The President of the Government,

JOSÉ MARÍA AZNAR LÓPEZ