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A hard pill to swallow: Belgian Court of Cassation provides clarity on patient informed consent

Setting the stage

Since long, discussions in Belgium have been ongoing as to who needs to prove that a patient was sufficiently informed about his/her treatment and its potential complications. With its 18 June 2020 judgment, the Belgian Court of Cassation has finally put this ambiguity to bed.

Article 8 of the Belgian law of 22 August 2002 concerning the rights of the patient (“Law on the rights of patients”) holds that healthcare professionals (“HCPs”) must obtain prior informed consent from their patient for every medical intervention. The information obligation enshrined in this provision serves to inform patients of all essential aspects of their treatment, and in practice mostly boils down to informing patients of the risks connected with such treatment.1  

As the Law on the rights of patients does not provide who bears the burden of proof for such informed consent, it was traditionally argued that the more general civil law rules on burden of proof should apply. A combined reading of Articles 870 of the Judicial Code and 1315 of the Civil Code would then indicate that the party which alleges something, needs to prove such allegation.2  This seemingly obvious matter led to a number of diverging decisions from the Court of Cassation.

Evolving case law

The Court of Cassation initially placed the burden of proof on the claimant, which is generally the patient alleging the HCP did not fulfil his information obligation.3  The patient should thus demonstrate both the existence of an information obligation, as well as that no (sufficient) information was provided. 

In June 2015, however, the Court of Cassation suddenly changed course, and held that it is up to the party which has an information obligation to prove that he/she fulfilled this information obligation, rather than to the ‘receiving’ party, who otherwise would need to deliver a negative proof that the information was not provided (correctly).4  At stake was the legal obligation of an attorney to inform his client on his right to legal aid should he consider that the conditions for legal aid are fulfilled. As the judgment was written in general terms, the principles enshrined in it were thought to also apply to the medical sphere. 

The Court of Cassation nonetheless gradually returned to its initial approach, and decided in a decision of 11 January 2019 that it was up to the patient to deliver the negative proof that no information was and should have been provided. As this case did not concern the information obligation of HCPs based on Article 8 of the Law of the rights of patients (but rather a specific information obligation of a nurse), scholars continued to argue that this judgment would not apply to a patient-HCP relationship.

In a recent decision of 18 June 2020, the Court indicated that this line of reasoning also holds true with respect to the general information obligation of HCPs. The Court thereby invalidated a decision of the Antwerp Court of Appeal, which much in the same wording as the Court of Cassation case of 25 June 2015, placed the burden of proof on the HCP. Endorsing its traditional approach, the Court held that the Antwerp Court of Appeal violated the general civil law rules on the burden of proof, which require that the patient who alleges that the health practitioner has not fulfilled its information obligation, must prove such allegation.  

Negative burden of proof  

When a patient thus claims to have suffered damage due to an HCP’s failure to provide certain information, he/she should not only demonstrate that the HCP should have provided such information, but also that such HCP didn’t do so.

While vesting the burden of proof on HCPs would indeed entail the danger that the HCP would attempt to safeguard his/her position by systematically requiring patients to ‘sign away their life’5, it is clear that patients will have a hard time delivering such negative burden of proof. 

Case law indicates that a negative ‘proof’ should not be held to the same level of scrutiny as a positive event, and that such proof could be delivered by all means of law, including by witnesses and presumptions.6  As such, the fact that no follow up appointment was planned, in addition to the fact that the general practitioner was not informed about the importance of aftercare, could be a clear presumption that no or insufficient information was provided to the patient.7  In the same vein, if the consultation or the surgery report, now accessible to patients online or through a patient app, does not make any mention of potential intervention risks, a patient suffering damage after a medical intervention, could argue that it was not sufficiently informed by the HCP.  

This article was co-authored by Irem Guzel.


  1. Art. 8 §2 of the Law of 22 of August 2002 concerning the rights of the patient.
  2. Art. 1315 of the Civil Code and Art. 870 of the Judicial Code.
  3. An example: Cass. 16 December 2004.
  5. Tack S. and Balthazar T., Patiëntenrechten. Informed consent in de zorgsector: recente evoluties in CABG, Brussel, De Boeck & Larcier, 2007, 79.
  6. Cass. 16th of December 2004; Luik 30 april 1998, T.Gez. 1998-99, 139, noot T. Vansweevelt.
  7. C. Lemmens, “Het pleit dan toch niet beslecht. De implicaties van het arrest van het Hof van Cassatie van 25 juni 2015 op de bewijslast van de geïnformeerde patiënt”, T. Gez. 2014-2015, (352) 356 and S. Lierman, “Het pleit beslecht: de patiënt draagt de bewijslast van de informatiemiskenning door de arts” (noot Cass. 16 december 2004), T.Gez. 2004-05, 307.

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