The rights of the patients and informed consent

Patients' rights in particular right to information during treatment

Article 8, §1 of the Patient Rights Act stipulates that the patient has the right to be informed and prior and free consent to any intervention by the healthcare practitioner, including the doctor.

Failure to comply with the obligation to provide information constitutes a violation of the general standard of care, being an error on the basis of which the doctor can be held liable for the damage suffered.

David Teniers: the village doctor

General

1. Any medical treatment, procedure, examination or any other intervention is a violation of the right of any person to their physical integrity. Moreover, everyone has the right to make certain personal decisions.

This has prompted the legislator to create the right to informed consent.

2. Prior to each treatment, procedure, etc., the doctor must inform the patient (orally / in writing) about all the risks, side effects, aftercare, possible alternatives and financial consequences that are relevant to the patient. Even rare risks should be communicated if they are known by the doctor.

Only after communication of this information can the patient consent or refuse with full knowledge of the facts and the physician has fulfilled his obligation to provide information.

Failure to provide information - Burden of proof

3. In the absence of adequate information, the doctor can be held liable for the damage suffered, such as permanent / temporary incapacity for work, personal incapacity, household incapacity,….

However, in order to be compensated for the aforementioned damage, the patient must demonstrate that he or she was not informed or was insufficiently informed, which is not a simple assignment in the case of a mere verbal statement or a statement by way of a brochure.

4. After all, the Supreme Court has decided that the patient does bear the burden of proof, in contrast to what applies in France. This may raise your eyebrows somewhat… After all, how do you prove that you have not been informed?

Fortunately, the courts and tribunals (sometimes) recognize this and judge the heavy burden of proof flexibly. For example, non-compliance with the obligation to provide information can be inferred from suspicions arising from the circumstances of the case. For example, the absence of any mention in the medical file regarding the personal contact prior to the operation, nor the duration thereof, can provide relevant indications in order to ease the burden of proof on the patient. In 2018 (January 22), the Court of Appeal Antwerp had placed the burden of proof on the nurse (involved a patient falling off the examination table and the various versions of what the patient should do - nurse claimed he had told patient to remain seated while lowering the table). However, the Court of Cassation has recently broken (HvC 11.1.2019, Journal health law 2019, p. 314).

5. A signed informed consent form is the most appropriate means for the physician to avoid later discussions about the information provided or not.

After all, upon signing, the patient declares to have been informed of all risks, side effects, ..., so that afterwards it can no longer be stated that they have not been properly informed.

The patient should therefore be very careful not to just sign such a form.

Information absence - Causal link

6. If it appears that the patient, after being duly informed, would have refused the planned intervention / treatment, the causal link between the error and the damage is established.

7. However, there is no causal link if the patient claims to have had the procedure / treatment performed after having been informed. This means that the patient is in no way entitled to any compensation.

8. In view of all this, it is no sinecure for a patient to receive compensation when the right to information has been violated. Moreover, this inadequate remedy of the right to informed consent may be found to be contrary to the right to physical integrity and human dignity.

In France, attempts are made to compensate for this by compensating the damage suffered because of the unpreparedness for the risk realized. The patient then no longer has to demonstrate that he would have refused the procedure if he had been informed. This damage can then be of a moral or material nature, but the compensation must be substantial. Otherwise, this would result in the right to informed consent losing all meaning.

Fund for Medical Accidents (FMO)

9. The FMO is available to people who believe they have suffered damage as a result of healthcare.

This institution compensates damage in a limited number of cases, more specifically:

• Medical accident without liability where the damage is sufficiently serious;
• In the event of no or insufficient coverage of the liability of the care provider by an insurer;
• In case of a dispute of liability insofar as the damage is sufficiently serious;
• In the event of an inadequate proposal for cover from the insurer of the liable healthcare provider;

The purpose of the FMO is to reimburse the patient in a simple, free and fast way. That is why the procedure is kept as accessible as possible. It is sufficient for the patient to send a registered letter to the FMO with a request for advice.

10. In the case of a mere violation of informed consent, the patient cannot appeal to the FMO. Only if the violation is accompanied by a specific damage resulting from the intervention or treatment can this fund be called upon.

Decision

11. As a patient, you must ensure that you are properly informed, this means that you communicate all relevant information (profession, hobbies, previous experiences, ...) to your doctor so that he can assess which risks are / can be of great importance to you.

Do you receive a brochure? Read it and discuss it again with your doctor afterwards. Such a brochure is impersonal and, in my opinion, suffices to be able to speak of informed consent. Send a friendly email to your doctor confirming the exchanged information.

Are you getting a form pushed under the nose? Read the fine print before signing! As already explained, it may state that you confirm that you have been sufficiently informed and that you agree with the proposed treatment / procedure, which then means that you are not entitled to compensation when the risks are realized.