Biomedicine Convention

Facts

Signatures
Ratfications
Purpose & Object
Patient Rights
Additional Protocols

 



Article

Contents

Comment

Article 5

“An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.
The person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.
The person concerned may freely withdraw consent at any time”

This article contains the right of the patient to give his free and informed consent before a medical examination or a medical treatment.

The right to give consent implies the right to refuse treatment.

The patient has the right to withdraw his consent as long as the medical intervention has not yet been applied.

Article 5 which is general and covers very different situations does not require any particular form. The latter will largely depend on the nature of the intervention. It is agreed that express consent would be inappropriate as regards many routine medical acts. The consent is therefore often implicit (or non-verbal) as long as the patient is sufficiently informed.

Article 8

“When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned”

This article provides for an exception to the general rule of article 5: when the consent of the patient cannot be obtained in an emergency situation (e.g. after a severe car accident the patient is unconscious and his will is not known). Article 8 provides that in such a case his or her consent may be presumed for any medically necessary intervention which cannot be delayed. Even in emergency situations, however, healthcare professionals must make every reasonable effort to determine what the patient would want (see also article 9 of the Convention).

Article 9

“The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his of her wishes shall be taken into account”

So called ‘previously expressed wishes’ (in common language often referred to as “living wills”) may be either positive (expressing the wish to an intervention) or negative (expressing the refusal of an intervention). In both cases previously expressed wishes are not legally binding: they have to be taken into account but not necessarily to be respected or followed. For example when the wishes were expressed a long time before the intervention and science has since progressed; there may be grounds for not heeding the patient’s opinion.
This article covers not only the emergencies referred to in article 8 but also situations where individuals have foreseen that they might be unable to give their valid consent, e.g. in the event of a progressive disease such as senile dementia.

Article 10 §1

“Everyone has the right to respect for private life in relation to information about his or health”

In terms of patient rights article 10 §1 implies the following rights:

  1. the right to confidentiality
  2. the right to a medical file that is safely kept
  3. the right to access the medical file
  4. the right to copy (parts of ) the medical file

Article 10 § 2, first sentence

“Everyone is entitled to know any information collected about his or health”.

A patient has a right to know all information collected about his/her health status and its prognosis.
This right exists independently of the right to receive information prior to give informed consent

Article 10 §3

“In exceptional cases, restrictions may be placed by law on the exercise of the rights in § 2 in the interests of the patient”

 Exceptionally a doctor may withhold information from the patient for therapeutic reasons (this is called the “therapeutic exception” or “therapeutic necessity”).

Article 10 §2, second sentence

“However, the wishes of individuals not to be so informed shall be observed”

The ‘right to know’ is not an obligation; therefore a patient has a right not to know his/her health status

Article 10 §3

“In exceptional cases, restrictions may be placed by law on the exercise of the rights in § 2 in the interests of the patient”

The right not to know is not an absolute one and a law may provide that a doctor informs a patient against his wish not to know in case his ignorance would seriously harm him. For example, the knowledge that they have a predisposition to a disease might be the only way to enable them to take potentially effective (preventive) measures.
According to article 26 §1 of the Convention a law may provide for the possibility to inform a patient against his wish not to know to protect the interests of a third party, e.g. his/her partner

Article 23

“The parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice”

This article covers not only infringements which have already begun and are ongoing but also the threat of an infringement.

Article 24

“The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law”

Compensation conditions and procedures are prescribed by national law. In many cases, this establishes a system of individual liability based either on fault or on the notion of risk or strict liability. In other cases, the law may provide for a collective system of compensation irrespective of individual liability (no fault compensation as in Denmark and Sweden).

Article 25

“Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention”

The domestic law must pay special attention to the content and importance of the provision to be complied with, the seriousness of the offence and the extent of its possible repercussions for the individual and for society.

According to article 33 (1) of the Convention it is ‘open for signature’ by the Member States of the Council of Europe, the non-member states which have participated in its elaboration, and by the European Community. The latter has not signed the Convention.