Appendix 4.
Legal aspects in palliative care
General regulation framework
It is compulsory for the State to protect the dignity of is members and penalise anyone not respecting this. It is also compulsory for it to create the conditions to develop it and promote it, fostering
an equitable society where no person is marginalised, discriminated or segregated, and no person
is placed in a situation of lack of dignity. In these conditions, a society that seeks to procure death,
arguing respect for the patient’s will would be as immoral as a society that forbids it without providing any solution to the harm and injustice of its citizens9.
Different laws that affect the clinical relationship at the end of life have been referred to
throughout the different chapters of this guideline. Some of the laws that may affect the people
who intervene in the care of patients at the end of life are listed below:
International Standards
1. The Convention of Oviedo.
2. The Universal Declaration of Human Rights proclaimed by the General Assembly of the
United Nations, 10 December 1948.
3. Convention for the Protection of Human Rights and of Fundamental Freedoms, 4
November 1950.
4. European Social Charter, 18 October 1961.
5. International Covenant on Civil and Political Rights, and the International Covenant on
Economic, Social and Cultural Rights, 16 December 1966.
National Standards
1. Spanish Constitution.
2. Criminal Code (assistance to suicide, omission of the duty to help, coercions, homicide
by imprudence).
3. General Health Act (with Spanish acronym, LGS).
4. Law 41/2002, Basic Law regulating the patient’s autonomy and the rights and obligations
related to information and clinical documentation.
5. Law 16/2003, 28 May: Law of cohesion and quality of the National Health System.
6. Law 44/2003, 21 November: Organisation of health professions.
7. Laws enacted in different Autonomous Communities that contemplate Living Wills (LW)
or Preliminary Instructions (PI).
8. Deontological Codes.
9
Couceiro A. El enfermo terminal y las decisiones en torno al final de la vida. In: Couceiro A, editor. Ética en Cui- dados Paliativos.
Madrid: Editorial Triacastela; 2004. p. 426.
CLINICAL PRACTICE GUIDELINE FOR PALLIATIVE CARE
211
Euthanasia and assisted suicide
An important amendment was introduced into our criminal code in 1995 in connection with euthanasia and assisted suicide: section four of article 143, referring only to the active cooperation,
in other words, to actions and not to omissions. That is why passive collaboration, when carried
out after the serious and unequivocal request by a patient suffering a serious disease, which is
necessarily going to lead to his or her death, or which produces serious permanent suffering that
is difficult to support, is free from criminal responsibility. In other words, our code legalises what
is known as passive euthanasia and continues to penalise direct active euthanasia.
Spanish Criminal Code. Taken from Azucena Couceiro9
Article 143
Consequences
1. Any person inducing to suicide will be punished
with 4 to 8 years in prison.
2. A 2 to 5 year prison sentence will be imposed on
anyone cooperating in, with necessary actions,
the suicide of a person.
3. If the cooperation should reach the point of executing death, it will be punished with a 6 to 10
year prison sentence.
4. Anyone causing or actively cooperating in, with
necessary actions, in the death of another person, following a serious and express request of
this person, in the event that the victim suffers
a serious disease that would necessarily lead to
his or her death, or that would produce serious
permanent suffering difficult to support, will be
punished with a sentence that is one or two degrees less than those indicated in nos. 2 and 3 of
this article.
Penalised: Inducing suicide, simple cooperation and
cooperation that leads to executing the death.
Not punishable: Omissions of help or treatment that
are not subject to being qualified as cause or as
active cooperation, so long as two requirements intervene: objective —disease— and subjective —patient’s request—.
The Criminal Code:
1. De-categorises the so-called «passive and indirect» euthanasia, as it requires active and direct
behaviours.
2. Categorises «active» euthanasia, but in a very
reduced manner.
3. It reduces the sentence for consented homicide
with respect to the simple homicide of article 138.
In Recommendation 1418 of the Parliamentary Assembly of the Council of Europe, adopted on
25 June 1999: The Assembly calls upon member states to provide in domestic law the legal and
social protection against these specific dangers and fears which a terminally ill or dying person
may be faced with, and in particular against:
1. Dying exposed to unbearable symptoms (pain, dyspnoea, etc.).
2. Prolongation of the dying process of a terminally ill person against his or her will.
3. Dying alone and neglected.
4. Dying under the fear of being a social burden.
5. Limitation of self-sustaining treatment due to economic reasons.
6. Insufficient provision of funds and resources for adequate supportive care of the terminally ill or dying persons.
212
CLINICAL PRACTICE GUIDELINES IN THE NHS
Use of medications in different conditions of use to those authorised
In Spain, both Royal Decree 223/2004, whereby clinical trials on medications are regulated, and
Law 29/2006, on Guarantees and Rational Use of Medications, establish that a medication can
be used in different indications or conditions for use to those only approved within a clinical trial
or as compassionate use. Compassionate use is understood as the «use in isolated patients and
outside a clinical trial, of products in clinical research phase, or also the use of medications for
different indications or conditions for use to those authorised, when the physician, under his or her
exclusive responsibility, considers its use essential». To use a medication under compassionate
conditions for use the informed written consent of the patient or his or her legal representative is
required, as well as a clinical report where the physician justifies the need for this treatment, the
agreement of the director of the centre where the treatment is going to be applied and the authorisation of the Directorate General for Pharmacy and Health products for each specific case.
However, processing via the compassionate use channel is not always the most satisfactory
for certain situations, as often occurs in palliative care; therefore, as development to the Law on
Guarantees and Rational Use of Medication, the Spanish Medication Agency is currently developing a Ministerial Order to facilitate access to medications submitted to special conditions.
CLINICAL PRACTICE GUIDELINE FOR PALLIATIVE CARE
213