In brief
In Germany, the digitalization of the healthcare market is a hot topic. “Digital health” is prominently featured in the coalition agreement of the newly elected German federal government. At the same time, there is still skepticism within the medical community on whether quality standards might fall victim to these rapid developments. Now, the German Federal Civil Court has addressed some of those concerns. In its December 2021 ruling (I ZR 146/20), the court has ruled that advertisement for comprehensive tele-treatment of patients (Fernbehandlung) violates applicable law.
Contents
Background
In May 2018, the German Medical Assembly agreed on a crucial change of the (Model) Professional Code for Physicians in Germany ((Muster) Berufsordnung der Ärzte (MBO-Ä)). While treating patients exclusively remotely (meaning without any physical contact between physician and patient during the entire treatment) used to be forbidden under the MBO-Ä, the new version of Sec. 7 para 4 MBO-Ä now states:
It is permissible in individual cases for medical consultation or treatment to be provided exclusively via communications media where it is medically justifiable and where the necessary medical care is ensured…
As a reaction to this change in medical professional law, in December 2019, the German legislator aligned drug advertisement law accordingly. Under the original wording of Sec. 9 German Advertising of Medicines Act (Heilmittelwerbegesetz (HWG)), advertisement for a diagnosis or treatment of diseases that is not based on personal perception of the person to be treated was generally forbidden. In its new version, Sec. 9 HWG now contains a second sentence, which clarifies that advertisement of remote treatment via communication media (tele-treatment) will be allowed, “if, according to generally accepted professional standards, personal medical contact with the person to be treated is not required.”
These changes in medical professional law and drug advertisement law have opened the gates for implementing tele-treatments on a larger scale. Video consultation has been implemented by more and more physicians. Additionally, the COVID-19 pandemic has accelerated the transition to the “digital doctor.” At the same time, there is still uncertainty regarding several legal aspects of tele-treatment. Consequently, the German Federal Civil Court’s recent decision about advertisement for tele-medicine has the potential to influence the tele-medicine market significantly.
Facts of the case
In 2019, a private health insurance fund promoted a “digital doctor’s appointment” on its website. According to the advertisement, diagnosis, treatment recommendations and even sick notes should all be available via an app, in this case provided by Swiss doctors. In other words, the entire medical treatment was supposed to be conducted without any physical contact between patient and physician. The District Court Munich saw this as a clear violation of the then still applicable old version of Sec. 9 HWG. The Higher Regional Court Munich later agreed with this opinion despite the new wording of Sec. 9 HWG, which came into force before the verdict. The courts argued that even if the tele-treatment itself might be permissible under medical professional law, advertising it can still be forbidden if done too broadly.
Judgment of the German Federal Civil Court
When the German Federal Civil Court had to decide on the case in December 2021, it ultimately upheld the opinion of the lower courts: An advertisement for tele-treatment, if it is done as comprehensively as in the case of the private health insurance fund, violates Sec. 9 HWG and is therefore not permitted. While the full verdict is not yet available, the main reasons for the court’s decision can be derived from the press release.
The German Federal Civil Court points out that according to Sec. 9 HWG, advertisement of tele-treatment is only permissible if no personal contact between patient and physician is required according to generally accepted professional standards. The court further clarifies that those standards are not only based on the applicable medical professional law. Rather, they are determined by the ever-evolving medical progress. As those standards might change going forward, the court argues that promoting a comprehensive tele-treatment without any physical contact with the physician during the course of the whole treatment process cannot take into account the applicable medical standards sufficiently. Therefore, an advertisement as broad as the one subject to the court’s ruling violates Sec. 9 HWG and is forbidden.
Consequences
When advertising tele-treatment, meticulous care should be taken not to choose wording that could be too comprehensive or too broad. Any company that wants to engage in tele-treatment and respective advertising will have to carefully draft and adapt promotion claims, taking into account the status and development of medical standards.
For further information, or to discuss potential options for advertising tele-medicine, feel free to contact us.
