2009: Healthcare and decision-making in dementia
Consent to medical treatment
According to the Human Rights Ombudsman of the Republic of Slovenia, a doctor may only carry out a medical intervention on the basis of the patient’s free consent following an explanation. However, there are exceptions where consent is not required. For example, article 51 (3) (Right to Health Care) of the Constitution states:
“ No one may be compelled to undergo medical treatment except in cases provided by law.”
In August 2008 the Law on Mental Health was passed. This law permits referral and acceptance for treatment in a psychiatric hospital on the following conditions: with the consent of the patient (article 36-38), without the consent of the patient subject to a decision by a court of law (article 40-52) and without the consent of the patient in urgent cases (article 53-67).
Articles 19 to 25 of the Act on Patients Rights of 2008 address the issue of informed consent (hence covering both prior information and subsequent consent). It is forbidden to administer any treatment or healthcare to a person with disposing capacity unless he/she has given free and wilful consent after having received appropriate information. In some cases (depending on the type of proposed treatment) written consent may be required.
Consent is also covered by article 47 of the Law on Medical Practice which states that the patient or his/her guardian must consent to every medical practice (Trontelj and Korošec, 2003).
Consent for people unable to express their will
If a person lacks the capacity to consent the doctor can provide non-essential medical treatment provided that he/she does not or could not know that the patient or his/her authorised representative is opposed to the treatment. This would also be the case if the doctor considered treatment to be in the best interests of the patient but was unable to obtain consent within a reasonable amount of time (article 29 of the Act on Patients Rights) (Žnidaršič Skubic, 2008).
Article 37 of the Act on Patients Rights covers consent in the case of incapacity. If the patient’s inability to consent is linked to his/her mental health condition, a legal representative must consent on his/her behalf. If the patient does not have a legal representative, steps must be taken to have one appointed. Meanwhile, the right to consent or refuse treatment on his/her behalf is granted to the following people (provided that they are of legal age and have full disposing capacity) in the following order: 1. spouse or partner (in case of civil union), 2. children or adopted children, 3. parents or foster parents, 4. brothers or sisters, 5. grandparents, 6. grandchildren. These people cannot refuse emergency treatment. If they refuse consent, the doctor can decide on the patient’s behalf, based on all opinions received and based on his/her assessment of the patient’s best interests (Žnidaršič Skubic, 2008).
Patients may appoint a person to consent or refuse treatment on their behalf in the event that they are one day unable to do so themselves (art. 32-34 of the Act on Patients Rights). This advance appointment must be made in writing whilst the person has full disposing capacity. Similarly, the patient can exclude in advance someone who would normally have the right to consent or refuse consent on his/her behalf. Such information is recorded on the patient’s health card or in his/her medical file (Žnidaršič Skubic, 2008)
Consent in case of emergeny
According to article 28 of the Act on Patients Rights, emergency medical treatment can be administered to a person lacking capacity without his/her consent (Žnidaršič Skubic, 2008).
The right to refuse treatment or withdraw consent
According to article 31 of the Act on Patients Rights, patients with full disposing capacity can refuse treatment or withdraw consent at any time. However, the doctor must try to persuade the patient to accept treatment if he/she considers that the decision is not in the patient’s best interests and could threaten the life of the patient or of other people. The doctor may even consult the patient’s family or recommend that the patient seeks a second opinion (Žnidaršič Skubic, 2008).
Consent to innovative treatment
Article 3 of the Code of Medical Deontology of Slovenia states that doctors should only use therapeutic methods that have a scientific basis and have been accepted by the profession. It is further stated in article 14 that whilst they are free to select their methods and ways of healing, they must follow the latest achievements in medical science (Premik, undated).
Consent to the donation of organs and/or human tissue
The Law on Transplantation of Parts of Human Body for Therapeutic Purposes addresses the issue of organ transplantation. The removal of organs would be considered unlawful if the deceased person or close relations had refused this at the time of the removal. The Penal Code (article 191) addresses the issue of the removal of body parts, the implantation of such parts, the removal of such parts before legal confirmation of death or without having obtained prior consent of the donor or recipient and if dealing in body parts for money occurred (Trontelj and Korošec, 2003).
Consent to participation in scientific research and clinical trials
According to the EFGCP (2008), the regulations applying to clinical trials on investigational medicinal products are:
- Drug Act (Official gazette, No. 31/06) and Bylaw on Clinical Trials (Official gazette, No. 54/06), which is the Slovenian Directive on Clinical Drug Testing based on Directive 2001/20/EC.
- The Code of Medical Deontology of Slovenia
- The Oviedo Convention.
Articles 47-50 of the Slovenian Code of Medical Deontology also contain provisions on the ethical conduct of biomedical research on human subjects (Trontelj and Korošec, 2003).
Advance directives and health care proxies
The legal status of advance directives in Slovenia
As explained in the next sub-section, it is possible the patient to appoint (in advance of incapacity) a person to consent to or refuse treatment on one’s behalf and also to state which person or people should not have such a right.
Article 34 of the Act on Patients Rights permits a person with full disposing capacity to state in writing his/her will regarding the rejection of treatment should he/she ever be incapable of expressing his/her will on this issue (i.e. an advance directive).
Conditions surrounding the writing, validity and registering of an advance directive
There is a special form for recording future wishes regarding the acceptance or refusal of treatment. In this form, it must be stated that the person making the advance directive has full disposing capacity and is of legal age. It must be signed by the person making the advance directive and contain details of his/her doctor and authorised health representative. An advance directive is valid for five years from the date of signature. Details of the patient’s wishes are added to his/her medical card or main medical file.
Obligation to comply with instructions contained in an advance directive
Depending on the person’s situation/condition at the time that the treatment is proposed, these wishes will be considered either binding or merely advisory.
A patient’s previously expressed wishes would be considered binding if:
“he/she should suffer from grave illness, which given the ability of modern medicine would lead to death in a short period of time in spite of medical treatment or medical care, or for which treatment or care would not lead to an improvement in health or the alleviation of his/her suffering but rather only to the prolonging of his/her life.”
A patient’s previously expressed wishes would be considered by the doctor and guide him/her in deciding on a course of action if:
the patient’s life “would be prolonged by medical treatment or car, but he/she would end up being in a state where, due to the graveness of his/her disability, he/she would lose physical and metal ability to take care of himself/herself.” (Žnidaršič Skubic, 2008)
Previously expressed wishes might not be considered if there are reasonable grounds to believe that the patient would have retracted his/her wishes.
Amending, renewing and cancelling advance directives
An advance directive can be withdrawn by the patient at any time. The withdrawal must be in writing. It is not clear whether the patient has to have full disposing capacity to do this.
Access to information/diagnosis
The right to be informed
Article 20 of the Act on Patients Rights states covers the necessity for patients to be informed of their medical condition, the likely course and consequences of their condition, the purpose, type and manner of treatment, the likelihood of success and the likely outcome of proposed treatments. This is part of the process of obtaining informed consent. Such information must be provided in a way that is adapted to the patient’s ability to understand and should be presented in a timely, considerate and comprehensive manner (Žnidaršič Skubic, 2008).
Access to medical records
Patients have the right to access their medical file and take notes on the condition that a doctor or health care worker is present. People who have the right to decide on the patient’s behalf may also have access to the medical file insofar as this relates to a decision they need to make. This includes people who have been given written authorization by a patient with full disposing capacity provided that they also have full disposing capacity and are of legal age (art. 41-42 of the Act on Patients Rights). Patients can also name people who should not be granted access to their medical file.
Article 42 of the Act on Patients Rights grants certain people the right to access a patient’s file after his/her death. This includes the patient’s spouse, cohabiting partner, same sex partner, children or adoptive children or if the patient does not have such relatives, then his/her parents. However, if any of the above-mentioned people want to be granted post-mortem access to the medical files covering the period leading up to the patient’s death in which he/she lacked full disposing capacity, they must demonstrate legal grounds for this (Žnidaršič Skubic, 2008).
The right to appoint another person to be informed on one’s behalf
As mentioned in the section on consent, patients may appoint a person to consent or refuse treatment on their behalf in the event that they are one day unable to do so themselves. This advance appointment must be made in writing whilst the person has full disposing capacity. Similarly, the patient can exclude in advance someone who would normally have the right to consent or refuse consent on his/her behalf. Such information is recorded on the patient’s health card or in his/her medical file (Žnidaršič Skubic, 2008).
The doctor’s right to withhold information
Article 22 of the Act on Patients Rights authorises doctors to withhold information from patients about patients’ state of health if they consider that such information could result in serious harm to a patient’s health. The reason for withholding information must be recorded in the patient’s medical file. However, the right to withhold information does not apply if patient has full disposing capacity and expressly requests such information. The issue of withholding information from patients is also addressed in the Code of Medical Deontology which states that providing information to a patient who is deeply stressed or suffering from other psychological conditions is not recommended if doing so would be likely to have a negative impact on treatment. The doctor must, however, notify the patient’s relatives (Žnidaršič Skubic, 2008).
The patient’s right to refuse information
Patients have the right to refuse information about their state of health unless the lack of such information would pose a serious health risk to other people. The decision not to be informed must be recorded in the patient’s medical file in accordance with article 22 of the Act on Patients Rights (Žnidaršič Skubic, 2008).
Confidentiality/disclosure of information to other people
The Law on Medical Activity stipulates that medical information about patients must be kept in accordance with a special law but this special law has not yet been passed. Consequently, the Law on Medical Records (Official Gazette of the Socialist Federal Republic of Yugoslavia, No. 22/78 and 18/88) is still in force. This law requires that information about patients with mental disorders be kept in a separate record (Human Rights Ombudsman, 2007).
The protection of personal data is guaranteed by article 38 of the Constitution and by the Personal Data Protection Act which gives people the right to be informed about any personal data collected and to legal protection against the misuse of such personal data. Misuse of personal data is punishable under article 154 of the Penal Code by up to 2 years’ imprisonment (Trontelj and Korošec, 2003).
Article 153 of the Penal Code deals with the unlawful disclosure of secrets. Prosecution is initiated subject to a private action. It states:
(1) Whoever unlawfully discloses a secret which he/she has become party to in his/her position as counsel for the defence, doctor, priest, social worker or psychologist or by way of performing any other profession shall be punished by a fine or sentenced to imprisonment for not more than one year.
(2) No penalty shall be imposed on persons who commit such acts from the preceding paragraph where the disclosure of a secret is made for the general good or for some other person's benefit, and where the good or benefit therein is greater than that of withholding the secret.
End-of-life care and issues
According to the European Association for Palliative Care (2005), there are currently no initiatives in Slovenia seeking the legalisation of euthanasia or assisted suicide.
Article 131 of the Penal Code deals with solicitation to and assistance in suicide:
(1) Whoever intentionally solicits another person to kill him/herself or assists him/her in doing so, resulting in that person indeed committing suicide, shall be sentenced to imprisonment for not less than six months and not more than five years.
(2) Whoever commits the offence under the preceding paragraph against a minor above fourteen years of age or against a person whose ability to understand the meaning of his/her act or to control his/her conduct was substantially diminished shall be sentenced to imprisonment of not less than one and not more than ten years.
(3) In the event of the offence under the first paragraph of the present article being committed against a minor under fourteen years of age or against a person who was not capable of understanding the meaning of his/her act or of controlling his/her conduct shall be punished according to the prescription for murder.
(4) Whoever treats his subordinate or a person depending on him in a cruel or inhumane manner resulting in this person's suicide, shall be sentenced to imprisonment for not less than six months and not more than five years.
(5) Whoever, under particularly mitigating circumstances, assists another person to commit suicide, and if that person indeed commits suicide, shall be sentenced to imprisonment for not more than three years.
(6) If, relating to a criminal offence under the above paragraphs, the suicide has only been attempted, the Court may reduce the punishment of the perpetrator.
Non-assistance to a person in danger
According to Žnidaršič Skubic (2008), “if the doctor were to fail to administer medical treatment resulting in harm or even death, he/she would be liable for dereliction of assistance.” Article 140 of the Penal Code states:
Whoever fails to render aid to another person in a life-threatening situation, even though s/he could have done so without danger to him/herself or to any third person, shall be sentenced to imprisonment for not more than one year.
Article 127 of the Penal Code, which deals with murder, states:
(1) Whoever takes the life of another human being shall be sentenced to imprisonment for not less than five years.
(3) If the offence under the first paragraph of the present article has been committed in especially mitigating circumstances, the perpetrator shall be sentenced to imprisonment for not less than six months and not more than five years.
EFGCP (2008), The EFGCP report on the procedure for the ethical review of protocols for clinical research projects in Europe: Slovenia, accessed online on 6 October 2009: http://www.efgcp.be/Downloads/EFGCPReportFiles/Flow%20Chart%20Slovenia%20(revised)%2008-03-01.pdf
European Association for Palliative Care (2005), Report on palliative care in Slovenia, http://www.eapcnet.org/download/forPolicy/Slovenia.pdf
Human Rights Ombudsman of the Republic of Slovenia, Treatment of people with mental disorders: http://www.varuh-rs.si/index.php?id=475&L=6#c709 (accessed on 12 March 2007)
Žnidaršič Skubic, V. (2008), Patients Rights in the EU – Slovenia: European Ethical-legal Papers, N°16, Leuven
Premik (undated), Alternative medicine in Slovenia: some social-medical views, Internet article accessed online on 6 October 2009: http://animus.mf.uni-lj.si/~socmed/Cl7.doc
Trontelj, J and Korošec, D (2003), National regulations on ethics and research in Slovenia, European Commission/Science and Society, Brussels
Last Updated: Wednesday 27 April 2011