Introduction

Companies that offer and advertise teeth aligner treatment to the public are flooding the German market. One key aspect of the business model of such companies is the limitation of in-person contact between patients and dentists or orthodontists, which enables them to offer low treatment prices (eg, under €2,000). This limitation is mostly ensured by mere distance treatment control – for example, via tele-dentistry (eg, telephone, videophone or requiring the patient to upload photos of their teeth via apps) and replacing a dentist's or orthodontist's examination of the patient with patient self-examination. Often, providers of such teeth aligner treatment directly advertise that in-person dentist or orthodontist appointments are unnecessary and that treatment control is ensured by distance treatment via tele-dentistry. Considering the strict German regulations on advertising of distance treatment under the Act on Advertising in the Healthcare Sector (HWG), advertising for distance treatment control may be problematic.

Legal starting point

Originally, Section 9 of the HWG provided for a general prohibition of advertising for distance treatment. Thereafter, advertising for the diagnosis or treatment of diseases, ailments, bodily injury or disease symptoms which was not based on an in-person examination of the person to be treated (ie, distance treatment) was inadmissible. Violations of this prohibition led to administrative fines of up to €50,000.

This prohibition referred only to the advertising of distance treatment, not to distance treatment itself. Distance treatment was permitted subject to general provisions (eg, the Professional Codes for Dentists), but advertising therefor was not – to some extent, a contradictory result.

However, the German legislature has acknowledged the rise in digitalisation and the need for practical solutions. Consequently, it amended Section 9 of the HWG by the Digital Supply Act (9 December 2019). While the original wording of Section 9 of the HWG remained unchanged, the German legislature introduced, as well as potential fines, an exception to Section 9 of the HWG – namely, that:

Sentence 1 of 9 HWG [the original Section 9 of the HWG] shall not apply to the advertising of distance treatment using communication media if, according to generally accepted professional standards, personal medical contact with the person to be treated is not required.

Admissibility of respective advertising

Given the wording of the amended Section 9 of the HWG, the admissibility of advertising for distance treatment control in connection with teeth aligner treatment – for example, advertising that dentist or orthodontist appointments are unnecessary given that treatment control is solely undertaken by distance treatment via tele-dentistry – depends on whether personal medical contact with the (potential) patient (ie, an in-person examination by a dentist or orthodontist) is required according to the generally accepted professional standard.

The German jurisdiction understands the generally accepted professional standard as the state of scientific knowledge and medical experience that is required to achieve the treatment objective and that has been proven in practice.

In this context, providers of teeth aligner treatment often argue that distance treatment control via tele-dentistry (ie, audio, video or photos) meets the generally accepted professional standard and is sufficient to control the treatment, since:

  • teeth aligners are produced based on imprints, followed by a dentist or orthodontist appointment that involves the dentist or orthodontist carrying out a 3D intraoral scan, combined with a computer calculation of tooth movement. The dentist or orthodontist can easily monitor the tooth movement process (it has been said that this can be done even better via patient self-examination than via dentist or orthodontist examination);
  • the dentist or orthodontist can easily require the patient to make an in-person appointment, if necessary; and
  • the treatment bears no significant risks, so an in-person examination is unnecessary.

From a medical standpoint, it must be stressed that teeth aligner treatment is complex. Each such treatment is an intervention in the stomatognathic system as an anatomical totality of the dental, oral and jaw system with all of its different components and structures and their biomechanical, functional relationships and neuromuscular interactions. Regardless of whether the associated objective is of a mere aesthetic nature or whether it is for primarily medical or dental purposes, the use of an aligner leads to multiple changes in the tooth positions in the jaw and directly affects the temporomandibular joints, the periodontium and the facial muscular system, especially of the tongue and lips.

Therefore, the argument that the generally accepted professional standard does not require an in-person examination is at least strongly questionable. It must be assumed that the opposite is the case: due to the risks and the specific circumstances of each patient, distance treatment control in connection with teeth aligner treatment should be carried out only in exceptional circumstances. This applies to advertising therefor.

Other providers focus on a legal perspective to justify the advertising of distance treatment control in connection with aligner treatment. According to such providers, treatment control must be seen as part of the whole teeth aligner treatment, the key point of which is not the teeth movement (including the control thereof), but the imprint, followed by a dentist or orthodontist appointment that involves the dentist or orthodontist carrying out a 3D intraoral scan, the diagnosis and the creation of a treatment plan. Therefore, the use of the teeth aligner and the control thereof remain a mere appendage. The treatment as a whole includes at least one in-person examination by a dentist or orthodontist – namely, a dentist or orthodontist appointment following an imprint during which the dentist or orthodontist performs a 3D intraoral scan. Since the treatment that is the subject of the advertisement contains such personal medical contact (ie, an initial personal examination by a dentist or orthodontist), Section 9 of the HWG does not apply.

However, considering the wording of Section 9 of the HWG, this argument seems unconvincing. In light of the HWG, teeth aligner treatment cannot be seen as a whole, since diagnosis and treatment are to be distinguished (Section 9(1) of the HWG states "diagnosis or treatment of diseases"). Therefore, Section 9 of the HWG requires a more specific view. Even if it is assumed that the treatment starts with the creation of the treatment plan followed by the teeth movement and its control, the following must be noted:

  • treatment plans in such business models are created by dentists or orthodontists who have not personally examined the patients; and
  • the following teeth movement and the control thereof does not involve a personal examination.

Since respective companies advertise exactly this, it is undoubtable that Section 9 of the HWG applies in this context.

Comment

Advertising for distance treatment control in connection with teeth aligner treatment is problematic. It is not generally prohibited under the HWG. However, whether a specific ad is admissible must be assessed on a case-by-case basis. Consequently, companies providing such treatment are recommended to check with local lawyers and medical experts, if necessary.