In other words, a treatment may begin only after the patient has given his or her informed consent to it. In this way, the physical integrity of the patient is protected. If the patient refuses the treatment, this must of course be respected also.
“The patient has the right to make an informed and voluntary decision in advance about every intervention involving a healthcare practitioner.
This consent is given explicitly unless it can be reasonably inferred from the patient’s conduct after the healthcare practitioner has informed the patient adequately.”
Despite this statutory rule, informed consent has been a source of controversy and debate for a long time. Each time, the question arises as to who must produce proof of the violation of the right to informed consent. Is the healthcare provider the one who must prove that he or she has informed the patient (adequately)? Or is the patient the one who must prove that he or she was not informed adequately or at all?
In a very recent judgment (dated 31 March 2022), the Court of Cassation ruled (again) on the allocation of the burden of proof in disputes about patients’ informed consent. The fact that the Court of Cassation ruled on this issue once again can only be applauded in the context the pursuit of legal certainty for everyone. But is the verdict of Belgium’s highest court also favourable in practice? In the following sections, we will answer this question.
The Court of Cassation’s verdict
In its judgment of 31 March 2022, the Court of Cassation held that the burden of proof in disputes about informed consent lies with the patient. Concretely, this means that the patient must prove that the healthcare provider should have effectively given him or her the information and that the healthcare provider failed to do this.
With this decision, the Court of Cassation upholds its judgment of 15 December 2004, in which it laid down the general principle concerning the issue, and the judgments of 11 January 2019 and 18 June 2020, among others. A consensus on this can thus be expected to be found in the case-law in the future.
Accordingly, the Court of Cassation repeats the general rule that the one seeking compensation for the harm he or she suffered must be able to prove the existence of the fault,
the harm, and the causal link between them. Since it cannot be denied that the burden of proof, which lies with the patient, is a heavy one, the Court indicated already in 2004 that the judge ruling on the merits may well conclude that evidence of a negative fact does not have to be produced with the same level of stringency as that of an affirmative fact. This conclusion is still valid today.
The effects in practice
What can be expected of the patient then? Since the patient bears the burden of proof, the patient must be able to demonstrate in the first place that the healthcare provider performed an intervention or treatment without the patient having been informed adequately about it beforehand and/or without having obtained his or her informed and voluntary consent to it (the alleged fault). In addition, the patient must prove that he or she had actually suffered harm from the fact that the healthcare provider violated his or her right to informed consent. Finally, the patient must also be able to demonstrate that he or she would not have consented to the intervention by the healthcare provider if he or she had gained knowledge of certain information and risks beforehand. In practice, two different tests can be used in this situation:
- the objective test: would a reasonable person who was informed correctly have chosen or not chosen the treatment in question?
- the subjective test: would the patient have consented to the intervention if he or she had been correctly informed?
Only if the patient succeeds in proving the fault, the harm, and the causal link will the healthcare provider be found liable for the harm that the patient had suffered and will he or she then be ordered to effectively indemnify the patient for the harm.
Despite the fact that this rule places a heavy burden on the patients, this judgment can improve the relationship between healthcare provider and patient. For example, it was found in the past that in practice, some healthcare providers were used to documenting information that, according to them, was necessary. During the consultation, the healthcare provider would then be able to refer to the documentation that was communicated to the patient and he or she would often let the patient sign an impersonal consent form without having a thorough discussion with the patient about it.
By not allocating the burden of proof to the healthcare provider, healthcare providers cannot place too much importance on the use of impersonal consent forms, which would replace the conversation between the healthcare provider and the patient.
Obviously, we know that a patient’s written consent (and in some instances, even required by law) can also offer certain advantages to both the patient and the healthcare provider. In this way, the patient can read the form at his or her convenience after seeing the doctor and can consider the various treatment options again. Besides, the document can serve as a guideline for the doctor’s discussion with the patient.
Nevertheless, every healthcare provider should have a qualitative discussion with the patient before a treatment or an intervention. The intended purpose of the informed consent process is namely to put at every patient’s disposal all the information that he or she needs to make a decision. So, not every patient should be treated the same way.
The Court of Cassation judgment of 31 March 2022 seems to have put to rest the debate about the burden of proof in informed consent. The burden of proof lies with the patient, but it is the healthcare provider’s job to inform his or her patients correctly about the treatment or intervention that awaits them.
 T. Vansweevelt and F. Dewallens (eds.), Handboek Gezondheidsrecht Volume II: Rechten van patiënten: van embryo tot lijk, 414-415.