2009: Healthcare and decision-making in dementia
Consent to medical treatment
In Malta, there is no legislation that deals with the consent to treatment issue comprehensively.
The Constitution has no express reference to the duty of obtaining informed consent, but the notion can be found in the general context of this fundamental law.
Malta is expected to sign and ratify the Council of Europe Convention on Human Rights and Biomedicine in the near future, following which the relevant articles relating to informed consent and research will apply to Malta.
The Data Protection Act that makes provisions for the protection of the individuals against the violation of their privacy by processing of personal data and for matters connected defines "consent" as "any freely given specific and informed indication of the wishes of the data subject by which he signifies his agreement to personal data relating to him being processed.”
The "Patients' Charter of Rights and Responsibilities" issued by the Hospital Management Committee refers to informed consent to be given by a patient in hospital.
It states that hospitalized patients have the right to receive clear information concerning their medical condition, to make their own informed decision for treatment, to be well informed and completely free to accept, decline or withdraw any diagnostic or treatment procedure.
The "Patients’ Charter" issued by the Malta College of Family Doctors refers to the right of a patient to give or withhold their consent to medical or other care and treatment.
Consent to treatment in the case of incapacity
The "Patients' Charter of Rights and Responsibilities" states that “under certain circumstances (e.g. children, people with mental disability or dementia) parents or an appointed representative should be fully informed in order to take decisions on behalf of the patient.
If the person is declared by a Court sentence as incapacitated the tutor appointed is the person in charge of giving consent on his/her behalf.
The Mental Health Act (Act XVIII of 1976 and subsequent amendments) rules the compulsory admission for observation or for treatment of a patient in pursuance of an application for that purpose. This application must be made in the interest of the person’s own health or safety or with a view to the protection of other persons. The application shall be founded on the written recommendation of two medical practitioners.
Consent in case of emergency
The "Patients' Charter of Rights and Responsibilities" mentioned above, states that “Every hospital patient has the right to make his/her own decisions that have implications on his/her wellbeing, except in those emergencies when the patients lack decision making capacity and a need for treatment is urgent.”
In these exceptional cases the treatment can proceed without previous consent.
The right to refuse treatment
The "Patient Charter" issued by the Malta College of Family Doctors refers to the right of a patient to "give or withhold your consent to medical or other care and treatment". It also advises patients that they can choose whether or not they wish to take part in research or student training.
The right to withdraw consent
The "Patients' Charter of Rights and Responsibilities" issued by the Hospital Management Committee states that hospitalized patients have the right to withdraw consent to any diagnostic or treatment procedure.
Consent to the donation of organs and/or human tissue
In Malta there is no presumption of donator. The donator has to express the intention of donating and then a donator card is issued. 15% of the population have a donation card (Eurobarometer, 2007).
Consent to research
Malta is expected to sign and ratify the Council of Europe Convention on Human Rights and Biomedicine in the near future, following which the relevant articles relating to research will apply to Malta.
The Bioethics Consultative Committee issued Guidelines Relating to Consent of patients to medical intervention. These Guidelines request specifically that consent of patients to research is necessary and that research should not normally be carried out on those unable to express their consent.
The Data Protection Act (Act XXVI of 2001 and subsequent amendments) provides for the processing of data concerning research and statistics. Article 16 states that (1) Sensitive personal data may be processed for research and statistics purposes, provided that the processing is necessary as stipulated in article 9(e). (2) If the processing referred to in sub article (1) has been approved: (a) in the case of statistics, by the Commissioner himself; (b) in the case of research, by the Commissioner on the advice of a research ethics committee of an institution recognized by the Commissioner for the purposes of this paragraph; the provisions of sub article (1) shall be deemed to be satisfied. (3) Personal data may be provided to be used for the purposes referred to in sub-article (1), unless otherwise provided by applicable rules on secrecy and confidentiality.
The Data Protection Commissioner has asked the University of Malta to see that all research in Malta is undertaken in accordance with the data protection laws.
The "Patient Charter" issued by the Malta College of Family Doctors advises patients that they can choose whether or not they wish to take part in research or student training.
Consent to clinical trials
Following EU Accession, Malta has to adopt EU Directives as part of its own legislation. Three such directives concern the conduct of clinical trials in European countries – 2001/20/EC, 2003/94/EC and 2005/28/EC. These directives, and the respective guidelines explaining their implementation, have considerably changed the way clinical trials are conducted. While the participation of Malta in clinical trials is to be encouraged for various reasons, these have to be regulated according to the legislation set out by the European Union. In themselves, what these Directives strive to achieve are mainly the safety of the study subject and the protection of the investigators from serious consequences.
The legislation concerning clinical trials consists of Directive 2001/20/EC1 (transposed as Clinical Trials Regulations, 20042), Directive 2003/94/EC3 (transposed as Good Manufacturing Practice in Respect of Medicinal and Investigational Medicinal Products for Human Use Regulations, 20044) and Directive 2005/28/EC5 which come into force at the end of January 2006.
Article 6(3) of Directive 2001/20/EC1 and Regulation 7(2) of the Clinical Trials Regulations, 20042 list the points which the Health Ethics Committee should consider when assessing an initial clinical trial submission. The Ethics Committee shall consider among other elements: (g) the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent.
Advance directives and health care proxies
There is, as yet, no legislation governing advance directives and health care proxies in Malta but discussions are underway (Scerri, 2008; Mallia, 2009).
Access to information/diagnosis
The right to be informed
The "Patients' Charter of Rights and Responsibilities" issued by the Hospital Management Committee states that hospitalized patients have the right to receive clear information concerning their medical condition, to make own informed decision for treatment, to be well informed and completely free to accept, decline or withdraw any diagnostic or treatment procedure.
Access medical files
The "Patients' Charter of Rights and Responsibilities" states that the patient has the right to review the records pertaining to his/her medical care and to have the information explained or interpreted as necessary.
The right to designate another person to be informed on one’s behalf
In Malta, there is no legislation governing advance directives and the same is the case for the designation of another person to act or to be informed on one’s behalf in case of future incapacity.
The patient’s right to refuse information
The "Patients' Charter of Rights and Responsibilities" states that patients have the right not to be informed about their condition or for their condition not to be divulged to next of kin, if this is expressed in writing.
Confidentiality/disclosure of information to other people
The Data Protection Act makes provisions for the protection of individuals against the violation of their privacy by processing of personal data and for matters connected. Article 15 on processing concerning health and medical purposes states,
“Sensitive personal data may be processed for health and hospital care purposes, provided that it is necessary for:
(a) preventive medicine and the protection of public health;
(b) medical diagnosis;
(c) health care or treatment; or
(d) management of health and hospital care services.”
Provided that the data is processed by a health professional or other person subject to the obligation of professional secrecy.
The “Professional Secrecy Act” states that all professionals have the duty of respecting confidentiality. The disclosure of information to other people can be a criminal offence.
The patient’s privacy is to be respected when discussing his/her medical condition.
The patient has the right to expect that all personal details and records are treated as confidential.
Only in accidental or emergency cases the personal files can be disclosed.
End-of-life care and issues
The Malta Hospice Movement is the only provider of palliative care in Malta. The team provides home, hospital, and day care. Officially, there are no palliative care beds in Malta. The Malta Hospice Movement is home-care based. There are no inpatient services.
The Malta Hospice Movement has initiated talks with the state Department of Health to introduce palliative care formally into medical practice in Malta.
It is also in the process of extending its vision and policy to include end-of-life care in accordance with WHO policy and recommendations on the global level. It is hoped that the movement will expand and develop according to the needs of the Maltese people.
The Movement is also in dialogue with the faculty of medicine, as part of endeavors to include palliative care in the undergraduate curriculum.
The Malta Hospice Movement did not officially mark the publication of the Council of Europe report on palliative care (Recommendation Rec (2003) 24 of the Committee of Ministers to member states on the organization of palliative care). However, the movement brought the publication to the attention of the state health authorities and to the faculty of medicine in 2005.
The Malta Hospice Movement has not participated in any way in the Council of Europe discussions about euthanasia (the Marty Report).
Special leave for carers in paid employment (to care for a terminally ill person)
According to Triosi and Formosa (2006, p54) there are no formal measures granting special rights such as special leave.
At the current time, there are no initiatives in Malta seeking the legalisation of euthanasia or assisted suicide.
Assisted suicide and murder
Assisted suicide and murder are covered in the Criminal Code.
Article 211 of the Criminal Code states:
(1) Whosoever shall be guilty of wilful homicide shall be punished with imprisonment for life.
(2) A person shall be guilty of wilful homicide if, maliciously, with intent to kill another person or to put the life of such other person in manifest jeopardy, he or she causes the death of such other person.
Article 213 of the Criminal Code states that:
Whosoever shall prevail on any person to commit suicide or shall give him or her any assistance, shall, if the suicide takes place, be liable, on conviction, to imprisonment for a term not exceeding twelve years.
Non-assistance to a person in danger
Article 339, nº 1, j) of the Criminal Code states that a person is guilty of a contravention if “being in duty bound to take care of children, or of other persons incapable of taking care of themselves, neglects to take the necessary care of such children or persons”.
There is discretion of the Court in the application of punishments for contraventions.
Murder at the request of the victim
According to Article 213 of the Criminal Code murder at the request of victim is a crime that can be punished with imprisonment for a term not exceeding twelve years.
Eurobarometer (2007), Europeans and Organ Donation, accessed online on 6 October 2009: http://ec.europa.eu/health/ph_threats/human_substance/documents/ebs272d_en.pdf
Mallia, P. (2009), Treat me right: the usefulness of an advance directive, http://www.independent.com.mt/news2.asp?artid=93480
Scerri, C. (2008), Dementia: is it time for advanced directives? The Times of Malta Weekender, 18 October 2008, p6
Triosi, J and Formosa, M (2006), Supporting family carers of older people in Europe: the national background for Malta, Eurofamcare accessed online on 6 October 2009: http://books.google.com/books?id=PmYbwlZ26e8C&pg=PA54&lpg=PA54&dq=SPECIAL+LEAVE+FOR+CARERS+IN+PAY+EMPLOYMENT+IN+MALTA&source=bl&ots=kcHSvje5J5&sig=75djnjXq3MC2At7nhE_WboUH9bw&hl=pt
Last Updated: Wednesday 27 April 2011