Healthcare and decision-making in dementia
There are currently two laws in Spain governing health care and decision making: 1. the Basic Law 41/2002 on the Autonomy of the Patient and the Rights and Obligations with regard to Information and Clinical Documentation (the “Patients’ Rights Law”), which entered into force on 16 May 2003  , 2. the Convention on Human Rights and Biomedicine, Oviedo, April 1997 (ratified by Spain on 23 July 1999). The Patients’ Rights Law incorporates all the principles of the Convention on Human Rights and Biomedicine.
The Law 41/2002 is the basic legislation as established in article 149.1.1 and article 16 of the Constitution. The State and the autonomous regions are responsible for taking the necessary measures to ensure the effectiveness of this law.
This Law contains additional conditions and further provisions governing medical research projects. It is stated, “The norms of this law relative to welfare information, information on freedom of choice of doctor and centre, the informed consent of the patient and medical records, will also be applicable in the case of medical research, the processes of extracting and transplanting organs, human assisted reproduction and in other areas which lack special regulation”.
The Law 41/2002 has also repealed important articles of the former General Health Law, as stipulated in the Unique Repealing Disposition: “Dispositions of equal or low status that are opposed to the provisions contained in the present law are repealed, namely, paragraphs 5, 6, 8, 9 and 11 of article 10, paragraph 4 of article 11, and article 61 of the General Health Law 14/1986”.
Consent to medical treatment
In the context of the Patients’ Rights Law (41/2002) two possibilities are envisaged:
- When incapacity has not been declared (i.e. when there has been no declaration of judicial incapacity),
- When incapacity has been declared (i.e. there has been a court ruling and guardianship measures established),
When the patient is unable to make decisions in the opinion of the treating doctor, or his/her physical or mental state does not permit him/her to manage his/her situation, but he/she does not have a legal representative, consent must be given by a relative or someone tied to him/her for de facto reasons.
According to article 9, paragraph 3, for patients who have been declared legally incapacitated, consent must be granted by a legal representative.
It is stated in article 8 that consent should be given orally but there are certain exceptions for which written consent is necessary. These include surgical interventions, invasive diagnostic and therapeutic procedures, and in general, procedures involving risk or having a known or predictable negative impact on the patient’s health.
According to article 9, paragraph 2, physicians may carry out clinical interventions which are essential for the patient’s health without the patient’s consent if there is a risk to public health which has been established by law. Once measures have been initiated in accordance with Law 3/1986, the judicial authorities must be informed within 24 hours in order to arrange for compulsory internment.
Consent from incapacitated people who have been interned
In the case of people who have been involuntarily interned due to mental illness and who do not have the control over their revenue, the doctor must be vigilant of the tutors who are authorized to manage the income of the person who has been interned. However, the doctor must ensure that he/she does not recommend unnecessarily burdensome or dangerous examinations or treatment. He/she must also ensure that the patient does not run any unnecessary risk.
Consent in case of emergency
Consent is not needed in case of emergency or in situations involving a serious and immediate risk to a person’s physical or psychological integrity if it is impossible to obtain the consent of the patient, of his/her relatives or of people tied to him/her for de facto reasons (article 9, paragraph 2 of the Patients’ Rights Law, 41/2002).
The right to refuse consent
Refusal of consent is addressed in article 2, paragraphs 3 and 4 of the Patients’ Rights Law (41/2002). Patients have the right to decide freely, after having received the appropriate information, between the clinical options available (art. 2, par. 3). Such refusal must, however, be made in writing (art. 2, par. 4).
The right to withdraw consent
Under the Patients Rights Law (41/2002), patients are free to withdraw consent or refuse treatment at any time but this must be recorded in writing (article 8, paragraph 5).
Consent to the donation of organs and/or human tissue
Articles 19 and 20 of the Convention on Human Rights and Biomedicine (Oviedo, 1997) address the issue of consent to the donation of organs and human tissue and are applicable in Spain. The relevant provisions are as follows:
Article 19 – General rule
- Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.
- The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body.
Article 20 – Protection of persons not able to consent to organ removal
- No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.
- Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided the following conditions are met: I. there is no compatible donor available who has the capacity to consent;
- II. the recipient is a brother or sister of the donor;
- III. the donation must have the potential to be life-saving for the recipient;
- IV. the authorisation provided for under paragraphs 2 and 3 of Article 6 has been given specifically and in writing, in accordance with the law and with the approval of the competent body;
- V. the potential donor concerned does not object.
The Convention on Human Rights and Biomedicine also applies in the case of research, particularly articles 5 and 6 which cover informed consent, and article 17, which specifically addresses the protection of people who are unable to consent to research:
Consent to clinical trials
Article 9, paragraph 4 of the Patients’ Rights Law (41/2002) covers consent to participation in clinical trials (amongst other things).
The legal status of advance directives in Spain
Advance directives have been legal in Spain since 14 November 2002. The Patients’ Rights Law (41/2002), which is applicable throughout the whole of Spain, permits people to state their wishes with regard to medical treatment whilst they still have the capacity to do so. Article 11 also covers the possibility to express wishes concerning the disposal of the person’s body and organs after death, and the appointment of a representative with responsibility to ensure that healthcare professionals comply with the person’s previously expressed wishes.
Conditions surrounding the writing, validity and registering of an advance directive
In order to write a valid advance directive, a person must be at least 18 years of age, free from pressure and have the necessary capacity to do so. In Spain, everyone is presumed to have capacity unless proven otherwise by means of a legal procedure and declared by a court.
The document can be formalized by a notary but there is no mention of this in the law. Consequently, it seems that this is not necessary. If the document is nevertheless signed in the presence of a notary, the notary must confirm that the person has the necessary capacity to sign such a document.
In most of the autonomous communities advance directives are made either in the presence of a notary or privately with witnesses. These witnesses should be named in the document and should also sign the document. It is presumed that by signing the document they are also confirming that the person writing the advance directive has the capacity to do so. Two out of the three witnesses should not be family members or have any economic/business relationship with the person making the advance directive. In some autonomous communities, where very few advance directives are made, it is possible to just sign the document in front of a health care professional or the person who is in charge of the advance directives registry.
Several autonomous regions have advance directive registries so people writing advance directives should ensure that they follow the formal procedure of the region in which they reside. Legislation is pending to create a national register for advance directives. This was foreseen in the Patients’ Rights Law (41/2002) in which it was stated, “For the purpose of ensuring the effectiveness throughout the national territory of advance directives, expressed by patients and formalized in accordance with the respective laws of the autonomous regions, the Ministry of Health and Consumer Protection will create a national registry of advance directives which will be governed by the regulations previously determined by the Inter-territorial Council of the national health system.”
The Law stipulates that every health service should set up a suitable procedure to ensure compliance with a person’s previously expressed wishes (which should always be in writing). In order to be considered valid:
- advance directives should not contain instructions which are against the law;
- advance directives should not contain instructions which are contrary to “lex artis” or good medical practice;
- the actual circumstances or situation must correspond to that/those previously envisaged
Advance directives are not limited to a set period of time.
What an advance directive can cover
The Basic Law 41/2002 does not specify what an advance directive can or cannot cover. It can therefore be presumed that it could cover:
- The treatment of medical conditions;
- The treatment of a psychiatric condition;
- Care and welfare decisions;
- Basic care;
- Life-supporting treatment; and
- Life-saving treatment.
As stated earlier, an advance directive may be used to appoint a representative who will be consulted by the doctor and healthcare professionals, when appropriate, in order to ensure that the person’s previously expressed wishes are respected.
Obligation to comply with instructions contained in an advance directive
With regard to the refusal of life-supporting and life-saving treatment, some lawyers point out that doctors are faced with the conflicting duty of complying with the patient’s request and fulfilling their own obligation to preserve life and maintain health. However, the law states that doctors can only ignore instructions contained in an advance directive if the instructions are against the law, contrary to good medical practice or do not correspond to the situation previously envisaged. If a doctor fails to comply with instructions contained in an advance directive and cannot comply with the previously expressed wishes, he/she must state why the patient’s instructions were ignored.
Amending, renewing and cancelling advance directives
Advance directives can be amended, renewed or cancelled at any time provided that the person has the necessary capacity to do so. This must be done in writing. Some people involve a notary when modifying or cancelling an advance directive. However, a person with incapacity cannot revoke an advance directive. In such cases, to the best of our understanding, the legal representative (i.e. the tutor) can try to revoke the advance directiver with the prior approval of the public prosecutor and the approval of the relevant guardianship court. If a person made several advance directives, the most recent one would be the one considered valid.
Access to information/diagnosis
The right to be informed
The Patients Rights Law contains detailed information on the obligation to provide information to patients. As a general rule, such information must be given orally (previously it had to also be given in written form). Health information to be provided is divided into two categories: 1. health care information and 2. epidemiological information.
1. According to article 4, patients have the right to know, for any intervention linked to their health, all available information, unless otherwise stated by law. Moreover, everyone has the right for his/her wish not to be informed to be respected. Information, that as a general rule is provided orally but included in the medical files, should at least cover the purpose and nature of each intervention, as well as its risks and its consequences.
2. According to article 6, citizens have the right to know about the health problems of the community when there is a risk to public health or their individual health. This information must be disseminated using the correct terms and in a way that is understandable and suited to the protection of health in accordance with the law.
The information must be honest and adapted to the particular needs of the person so as to help them make the necessary decisions freely. People with partial incapacity or under guardianship should also be informed in a way that is adapted to their ability to understand. In such cases, their legal representative must also be informed.
Access medical files
Patients (or their duly accredited representatives) are entitled to access and receive a copy of their medical records at any time provided that this would not be prejudicial to the rights of a third party. This is regulated in articles 16, 17 and 18 of the Patients Rights Law.
It is stated in article 16 that a medical record is intended primarily to ensure that appropriate care is provided to the patient. Health care professionals and centres responsible for the diagnosis or treatment of the patient must have access to medical records which are essential for the provision of the appropriate care. Other provisions of article 16 include:
Every centre will set up a procedure to ensure that professionals have at all times the possibility to access the case history of each of their patients.
Access to the case history for legal or epidemiological ends, for public health, or for research or teaching, is governed by the provisions of the Organic Law 15/1999, of the Protection of Information of Personal Character, and in the Law 14/1986 of General Health, and other norms applicable in each case. Access to the case history for these purposes requires that information permitting the personal identification of the patient be separated from those of a clinical or welfare character, so that as a general rule the anonymity of the patient is maintained, unless the patient has given his/her consent not to keep them separate. Another exception is the possible situation in which it is necessary to combine personal information with clinical or care information for a legal or court process. Access to the information and documents contained in the case history shall be strictly limited to the specific purposes for which it was obtained.
Administrative and management staff of healthcare centres shall only have access to the information in a case history that is related to their specific functions.
Properly accredited healthcare personnel who exercise the functions of examination, evaluation, accreditation and planning shall have access to case histories in the fulfilment of their functions of cross-checking the quality of the assistance provided, the respect of the rights of the patient or any other obligation of the centre regarding the patients and users or the healthcare administration.
Personnel who gain access to information in the case history of a patient in the exercise of his/her functions are bound to secrecy.
The autonomous regions will regulate the procedure so as to ensure regularity in access to and the use of the clinical data.
Article 17 deals with the conservation of medical files.
Healthcare centres are obliged to preserve medical files in such a way as to guarantee their correct maintenance and safety, even those not necessarily in the original format, in order to be able to provide due assistance to the patient for a period of time adapted to each case and for a minimum of five years from the date of discharge of every period of care.
Medical files will also be kept for legal purposes in accordance with current legislation and when there are epidemiological reasons for investigation or for the organization and functioning of the National Health System. They will be handled in such a way as to prevent the possible identification of the affected persons.
Under article 18, the right to access medical files is not applicable if it would be detrimental to third parties. Healthcare providers may refuse to grant patients access to the subjective comments that the former made.
The right to designate another person to be informed on one’s behalf
The patient is entitled to permit other people to receive information. This is stated in article 5, paragraph 1 of the Patients’ Right Law which identifies the patient as the person who has the right to have the information. People who are related to him/her or linked for de facto reasons may also be informed provided that the patient has given explicit or implied consent.
The doctor’s right to withhold information
The withholding of health information, known as the “therapeutic exception” is covered by article 5 of the Patients Rights Law. Therapeutic exception refers to the doctor’s right to act without the prior consent of the patient, when there is reason to believe that the knowledge of his/her condition could seriously damage his/her health. In such cases, the necessary information shall be provided to the patient’s relatives or to people who are related to him/her for de facto reasons.
The patient’s right to refuse information
Under the Patients Rights Law, patients have the right not to be informed. This is also covered in article 10, paragraph 2 of the Convention on Human Rights and Biomedicine (Oviedo, 1997) which states that every person shall be entitled to receive information about their health but that the wish not to be informed must be respected.
Confidentiality/disclosure of information to other people
The patient has the right to expect health centres to establish mechanisms to enable careful medical records to be kept. This is stated in articles 7 and 19 of the Patients’ Rights Law (41/2002). The latter governs access to medical records by healthcare professionals and centres. However, it does not cover the right to privacy or the protection of the patient’s private life. The right to privacy is covered by Title X of the Spanish Criminal Code and the Organic Law 1/1982 of 5 May on the civil protection of the right to honour, to personal and family privacy and to protection of one’s own image. However, according to a study carried out by Pérez-Cárceles et al. (2005), 95.1% of doctors provided information to a patient’s family and of those who did so, 35.3% did not obtain prior consent.
The processing of personal data is covered by the Organic Law of 15/1999, relating to the protection of personal data. This law regulates how personal data should be processed and who can do this.
According to article 18 of the Patients’ Rights Law (41/2002), the medical records of a patient can be accessed by his/her relatives or by people linked for de facto reasons after the death of the patient unless the patient clearly expressed that such access was contrary to his/her will. In any case, access to the medical file by a third party, on the grounds of a presumed health risk, is limited to the relevant data. Information must not be provided which would affect the patient’s privacy, contain subjective professional comments or be harmful to third parties.
The Patients’ Rights Law (41/2002) covers the right to refuse interventions or treatments, which are not compulsory, provided that palliative care services exist. In case of disagreement, judges have to decide on the matter.
In the case of indirect euthanasia, understood as the application of medication to relieve pain but which may also hasten death, a debate has developed about the necessity to develop new concepts and revisit old ones, thereby adapting to new social demands, with terms such as palliative care.
Prior to 1978, euthanasia in its various forms was considered under the Penal Code as murder or incitement to commit suicide.
Although such a crime may be considered comparable to murder, mitigating circumstances (such as being motivated by pity, compassion or mercy etc.) may result in a lower penalty than would normally be the case for alleged murder.
Since 1978, associations in favour of euthanasia have been pushing for specific legislation relating to euthanasia. During this period, issues such as the autonomy of the patient, human dignity and the prohibition of inhuman or degrading treatment has profoundly changed the ideology of the pro-euthanasia movement.
Nevertheless, whilst a debate has started in all social domains, the spotlight will undoubtedly be in the field of bioethics. As a result of these discussions proposals have been made for the legalization of euthanasia.
Article 27 of the Spanish Code of Deontology, which was written by the Spanish Medical Association, states:
The doctor has a duty to try to cure or improve the condition of the patient whenever possible. If not possible, he/she is obliged to take the appropriate measures to promote the well-being of the patient. If there is a possible risk of shortening the patient’s life despite administering the correct dose of medication, the doctor should inform the closest relative of the patient and check whether they find this appropriate.
The doctor shall not undertake or pursue diagnostic or therapeutic treatment that is without hope, useless or futile. He/she must take into account the explicit will of the patient to refuse life prolonging the treatment and to die with dignity. When the patients’ condition makes it impossible for him/her to take decisions, the doctor shall take into consideration and assess the previously expressed wishes of the patient and the opinion of other relevant people.
The doctor will never deliberately provoke the death of any patient, not even in case of express request on the part of the latter.
Asociacion de Familiares de Enfermos de Alzheimer de Navarra, Proceso Sobre Incapacitacion Tutor (leaflet)
Asociacion de Familiares de Enfermos de Alzheimer de Navarra, Ezintasuna Deklaratzeko Auzibidea, Tutorea (leaflet in Basque)
Derecho a morir dignamente, D.M.D., España (Right to die with dignity, Spain) – EN/ES
José Nuñez Centaño, speech on the psychiatric care reform in Spain (made at the Lawnet conference on 11 May 1999 in Luxembourg)
Nuñez Olarte, Juan M. and Guillén, D.G. (2001), Cultural issues and ethical dilemmas in palliative and end-of-life care in Spain, Cancer Control, Vol.8, No.1, 46-54
Pérez-Cárceles, MD, Pereñiguez, JE, Osuna, E and Luna, A (2005), Balancing confidentiality and the information provided to families of patients in primary care. Journal of Medical Ethics , Vol. 31, 531-535
 State Official Bulletin, BOE no. 274, 15 November 2002, 40126-40132
Last Updated: mercredi 27 avril 2011