Licensing requirements in the field of medical health care

1.

• 1904 BGB medical measures According to § 1904 para. 1, the consent of the guardian to an examination of the state of health, a medical treatment or a medical intervention is only effective with the approval of the guardianship court if there is a justified risk that the person under guardianship will die or suffer serious and prolonged damage to his or her health as a result of the measure. Without the authorisation, the measure may only be carried out if there is a risk associated with the postponement, i.e. significant health disadvantages would be likely without immediate action. According to § 1904 para. 2 applies para. 1 also applies to the consent of an authorised representative, which is only effective if given in writing and which is defined in para. 1 sentence 1 must include the measures referred to above.
• 1904 thus regulates special cases of the doctor-patient relationship in the event that the patient himself is incapable of giving consent and the guardian takes his place. In the event of the guardian’s incapacity, the guardianship court may also exceptionally consent to a measure or appoint a substitute guardian, § 1846.

The prerequisite is the guardian’s authority to give consent. The scope of duties must therefore include a description of the consent to the above measures. “Health care” or “personal care” or care for a particular treatment are quite sufficient. However, the guardian is only authorised to declare consent in place of the person concerned if the latter is unable to give consent himself. Due to the highly personal nature of consent to measures affecting physical integrity, a reservation of consent is not permissible.

The consent of the guardian is directed only to the medical measure and not to the treatment contract in other respects.

1.1. The consent

Paragraph 1 also applies to the consent of an authorised representative. It is only effective if the power of attorney is granted in writing and expressly covers the measures specified in subsection (1) sentence 1. It is important for the legal representative to know in which cases his power of representation begins. In the case of any health care measures, the natural capacity of the person concerned to consent must be taken into account. This means that if, after being informed by the doctor, the person concerned is able to form an opinion about the reason, nature, significance, consequences, anticipated risks and/or alternative treatment options and consequences of the intended intervention or examination and to declare his or her natural will, his or her decision is binding. If the person concerned has the capacity to make an informed decision, there is no need for the guardian to assume any additional responsibility. However, if the person being cared for must be regarded as incapable of giving consent in this sense, the consent of the guardian/authorised representative is required.

In the event of a substitution, the latter then has the duty to inform himself about

– nature, – purpose and – duration of treatment,

– the methods to be used in the course of treatment,

– alternative types of treatment,

– possible pain and discomfort,

– possible risks, side effects and

– The patient must be informed about the expected advantages of the treatment, critically examine and weigh them up, and then make his or her decision.

The legal representative must satisfy himself personally of the capacity to consent and must act accordingly. He must not follow the wishes and ideas of third parties (e.g. doctors, nursing service managers, home managers) unchecked and thus run the risk of no longer making the welfare of the person being cared for the exclusive subject of his decisions. The legal validity of the consent of the patient concerned is therefore independent of his legal capacity, as well as of the arrangement of a legal guardianship or even a consent reservation, since it depends only on the natural insight and control capacity. If the patient has the necessary capacity of understanding and control, i.e. if he or she is able to recognise the consequences and implications of the medical measure, medical intervention, examination or treatment for his or her body, profession and happiness in life and to declare his or her will in this respect, his or her consent or refusal is binding. Amelung takes a more differentiated view of the concept of incapacity to consent, which is based on the fact that the person concerned, because of being a minor, having a mental handicap or being mentally ill, is unable to grasp – what value or rank the goods and interests affected by the decision to consent have for him; – what facts are at stake in the decision; – what consequences and risks result from the decision to consent; – what means there are for achieving the aims sought by consent which are possibly less onerous.

The power of representation of the guardian/authorised representative therefore only begins when the person being cared for or the person granting the power of attorney is incapable of giving consent. Physicians in particular are therefore advised to check in each individual case, despite the existence of a legal guardianship with the task of health care, whether their patient is not able to consent to the specific measure himself and is also in agreement with the measure in question. The doctor is at most relieved by the authorisation of the guardianship court to the extent that, in the event of incapacity to consent, his actions would be justified in accordance with medical practice.

If there are doubts as to whether the patient is capable of giving consent, the decision of the guardian entrusted with the task of health care is decisive; for the unlawfulness of a medical intervention is only excluded by the consent of a patient capable of giving consent. The consent of the patient who is not capable of giving consent beyond doubt is not sufficient. Moreover, the lack of approval by the guardianship court cannot be made up, since the curative measure cannot be reversed. For the vast majority of outpatient and inpatient measures and medical consultations, the guardianship court is not required to give its consent, since in the vast majority of cases these are likely to be purely routine matters of the medical duty of care. The legislator intended to preserve the right of self-determination of the person concerned as far as possible. Schwab’s assumption that the provision is to be explained by a distrust of uncontrolled interaction between caregiver and physician cannot be dismissed out of hand .

The prerequisite for any consent is the information provided by the attending physician. It must contain information about the dangers of the medical intervention, about possible permanent or temporary side effects that cannot be excluded with certainty. Even if the patient is only owed a general picture of the severity and direction of the risk spectrum, the caregiver’s explanation may differ because he needs information that is necessary for his decision. For on the basis of this information the guardian has fulfilled his duty to discuss under § 1901 para. 3 sentence 3. Since the person being cared for is allowed to shape his or her life according to his or her wishes and ideas within the scope of his or her abilities, the caregiver cannot simply disregard the person’s wishes. Only nonsensical ideas of the person being cared for remain out of consideration.

If the guardian does not obtain permission from the guardianship court in contravention of section 1904, it is disputed whether the medical measure is lawful if the doctor has complied with his duty to inform the patient and has obtained the necessary consent. According to one view, this is an internal authorisation, the absence of which does not affect the legality of the measures. Accordingly, the lack of authorisation concerns only the breach of duty of the guardian’s failure to act. According to another and probably correct view, the legitimacy of medical action depends on the existence of authorization by the guardianship court. This is already clear from the unambiguous wording in §§ 1904, 1905, 1906 “requires approval” or “only permissible with approval…”. This is because the approval requirement is not only directed at the caregiver, but also at the treating physicians. You will, of course, need to satisfy yourself that the responsible caregiver is acting appropriately.

The decisions between caregiver and cared-for may well be competing. According to one view, there is a so-called “formal dual competence” externally. However, there is no double responsibility, since the consent to a medical intervention depends on the capacity of the person concerned. In the absence of this, the guardian is only competent to give the consent that requires approval. In terms of substantive law, the declarations and decisions of the patient who has the capacity to consent take precedence, i.e. the decision of the patient who has the capacity to consent is not only binding for the guardian, but also for the attending physicians. The decision-making framework is the “subjective value system” of the consenting guardian and not an outwardly reasonable value system of third parties or the general public. The “autonomy” of the decision of will is to be respected as long as no pathological or illness-related change of the person concerned is recognizable. It should be noted that, in the opinion of the Federal Constitutional Court, the mentally ill are also to be granted “a right to illness” in principle.

The following case constellations come into consideration:

– Caregiver and cared for consent in unison to the required action. This makes it unnecessary to determine the concrete capacity of the person under guardianship to give consent.

– Both refuse to consent to the particular action.

This decision is also binding if the person concerned is capable of giving consent. In the event that the doctor came to the opposite conclusion, he would be advised, should he consider the refusal of the guardian to be irresponsible, to apply to the guardianship court for a restriction of the scope of the guardian’s duties. – The patient consents, the guardian does not: The doctor must examine the patient’s concrete capacity to consent. If he deems the person to be capable of giving consent, his decision shall apply. For the future, it should be considered whether the restriction of the scope of duties of the guardian should be suggested to the court. If the doctor deems the patient incapable of giving consent, a negative decision by the guardian is nevertheless binding. On the other hand, the guardian has to fear criminal and civil law consequences as well as reproaches on the part of the guardianship court if the guardian has remained unprovided for and has suffered damage as a result. – The guardian consents, the patient does not: if the patient can no longer express his or her will, the guardian’s consent is sufficient. If the person in care is capable of giving consent, his or her decision applies. In the reverse case, that of the guardian. If the person under care resists the treatment/measure, the capacity to consent must be examined precisely with regard to the coercive nature of the measure to be carried out. Under certain circumstances, it may also be necessary to consider to what extent the scope of the guardian’s duties would have to be restricted in individual cases if the guardian does not discuss the intended measure with the person concerned or does so inadequately.

1.2. The health hazard

The guardian or authorised representative requires the approval of the guardianship court for risky medical measures if there is a justified risk that the patient could die or suffer serious and prolonged damage to his or her health. Further, in decisions regarding the termination of life-sustaining measures. The law does not contain any decision-making aids for the question of the degree of dangerousness. According to Wiebach, the justified danger is only when there is a 20% probability of harm occurring, which is why the usual treatment with psychotropic drugs should not be subject to approval. According to Dose, there must be a serious and concrete expectation of consequences of damage on the basis of the individual case. The drawing up of any lists is also problematic. Also criteria of § 226 STGB – loss of sight in one or both eyes, – loss of hearing – loss of the ability to speak – loss of the ability to reproduce – loss or uselessness of an important member of the body – considerable permanent disfigurement – infirmity – paralysis – mental illness or handicap as a yardstick is unsuitable, since this list cannot be exhaustive.
In the case of “prolonged damage to health”, the duration of a year or more is generally to be assumed. Shorter periods may be considered for exceptional pain. This is especially true for treatment with psychotropic drugs. Particularly in the treatment of mentally ill patients with highly potent neuroleptics and their use in the geronto-psychiatric field (especially in the administration of haloperidol), special medical caution is required, since these drugs are associated with considerable side effects or not inconsiderable impairments and long-term consequences for the affected person. The following measures are eligible under § 1904: – examination of the state of health, regardless of whether it is associated with a physical intervention; – curative treatment, it is aimed at the restoration of health, alleviation of the disease or consequences of the disease, as well as the prevention of disease and its aggravation; – medical interventions, they fall in principle under the concept of curative treatment, but in the case of cosmetic surgery or abortion need not be medically indicated. Failure to act, on the other hand, does not fall under § 1904. Not every action falls under § 1904, but only a risky one. Here there must be a justified danger to life or health. The risk must therefore exceed the average risk of medical treatments. The wording “serious and concrete expectation of a health risk” in the official explanatory memorandum suggests the exceptional nature of the provision. It is decisive that for the question of the need for approval it does not depend on whether the measure is necessary or not with regard to the severity of the illness; this is only relevant for the approval of the guardianship court.

Abortion The question of the guardian’s consent to an abortion in the case of his or her guardian who is incapable of giving consent is not regulated. Therefore, the general principles apply, taking into account the other requirements of impunity under § 218 a StGB. Therefore, the guardian can consent to an abortion, even one that is not medically indicated, in the case of his or her guardian who is incapable of giving consent. This is highly controversial because a pregnant woman who is incapable of giving consent cannot effectively request an abortion, and a proxy cannot answer the question of how the pregnant woman herself views her situation. This inevitably leads to conflicts that can only be resolved legally.

Organ donation Since the organ donation does not benefit the person being cared for, the consent of the caregiver is ruled out with regard to the welfare of the person being cared for.

Testing of medicinal products and medical devices Pursuant to Section 40 para. 2 No. 2 AMG, the guardian cannot consent to clinical trials of medicinal products on behalf of the person concerned. A distinction must be made between this and the therapeutic experiment in patients incapable of giving consent according to § 41 AMG. The guardian can consent to this if he has been sufficiently informed. However, the clinical trial may only be carried out if the use of the medicinal product to be tested is indicated, according to the findings of medical science, to save the life of the subject, to restore his health or to alleviate his suffering. According to §§ 17, 18 MPG, the same applies to the use of medical devices such as instruments, apparatus, devices, substances, preparations and other objects intended for treatment.

Euthanasia Active euthanasia is the shortening of life at the patient’s request; it is punishable by law. Passive euthanasia is the omission or termination of life-sustaining measures. Indirect euthanasia is the medically prescribed pain-relieving or consciousness-attenuating medication of a terminally ill person with the unintended but unavoidable shortening of life. A distinction must be made between assisted suicide as support for the dying process insofar as it has progressed irreversibly; it is in principle exempt from punishment. Passive and indirect euthanasia are exempt from punishment if, in accordance with the patient’s real or presumed wishes, medical technology is not exhausted in order not to violate the patient’s right to die with dignity. If a corresponding living will exists, the consent of the guardian is superfluous. If there is no decision by the person concerned, the decision to end life-sustaining measures cannot be transferred to the guardian. Such cases are problematic when there is no decision on the part of the person concerned and the question of discontinuing feeding arises. It goes without saying that no third party can starve the person concerned.

As already explained at the outset, the guardian of the person concerned who is incapable of giving consent must initially decide for himself or herself whether or not to give consent to medical measures. He has to make his balancing of interests according to the values of the person under care, his wishes, as well as the balancing of interests, taking into account all risks and the balancing of possibly occurring or already recognizable serious side effects, as well as in the case of a lack of healing success. In the latter case, measures are neither subject to consent nor to approval if a lasting improvement or even cure is obviously not likely to be achieved, but on the other hand there is a considerable risk of serious side effects from the treatment. A treatment success would therefore not be outweighed. The guardian may therefore only consent to medical treatment if there are reasonable prospects of concrete success or chances of recovery and the risks do not outweigh the chances of a significant improvement in the state of health or chances of recovery.

1.3. Procedure

Before the decision of the guardianship court, the person under guardianship must be heard in person, section 68 subs. 1 FGG and to obtain an expert opinion from an expert who is not to be the same person as the executing physician, section 68 d subs. 2 in conjunction with. § 68 a sentences 3 and 4FGG. The hearing of the person under guardianship can be omitted if considerable disadvantages for the health of the person under guardianship are to be feared from this, section 68 subs. 2 FGG. The court must also hear the relatives, § 68 a FGG. If the person under guardianship cannot be heard at all because of his illness, a guardian ad litem is to be appointed, § 67 FGG. The decision is to be made known to the person under guardianship, § 69 a para. 1 FGG and becomes effective upon notice to the guardian, section 69 a subs. 3 FGG. The judge is functionally responsible, § 14 No. 4 RPflG.

by Dr. Johannes Fiala

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About the author

Dr. Johannes Fiala
PhD, MBA, MM

Dr. Johannes Fiala has been working for more than 25 years as a lawyer and attorney with his own law firm in Munich. He is intensively involved in real estate, financial law, tax and insurance law. The numerous stages of his professional career enable him to provide his clients with comprehensive advice and to act as a lawyer in the event of disputes.
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