Between Consulting and Treatment: Telemedicine in Germany is still hampered by legal barriers

Written on 17 Mar 2017

Initial diagnosis and suitable therapy via video transmission – in the USA, Great Britain, or Switzerland patients have long since been spared tedious waiting times in the overcrowded waiting rooms of the doctor’s surgery. According to a study by Roland Berger, the market for telemedicine will grow worldwide from USD 14 billion in 2016 to USD 26 billion by the year 2020. A recent survey commissioned by the Techniker Krankenkasse revealed that one in every two patients has already communicated online with their doctor’s surgery, or could imagine doing so.

Germany, however, lags far behind – especially due to legal barriers. Nonetheless, with different business models, companies are also active within the country in the field of telemedicine.

Ban on Remote Treatment

In Germany there is a ban on remote treatment in accordance with Sec. 8 (4) of the Model Professional Code for Doctors (Musterberufsordnung der Ärzte – MBO-Ä). According to that provision, doctors are not permitted to treat patients by means of telemedicine applications, such as by video consultation, if they have not seen the patients at least once before in person and examined them. Additionally, advertisement of remote treatment is forbidden according to Sec. 9 of the Act on the Advertising of Medical Products (Heilmittelwerbegesetz – HWG). For initial treatment, sick notes and prescriptions, a visit to the doctor is therefore unavoidable.

Telemedicine services provided by a doctor are only lawful as a follow-up treatment after an initial, prior personal examination by the same doctor. To this effect, the E-Health Law, which came into effect on the 1st January 2016, includes video consultation in the catalogue of services of the statutory health insurance providers from July 2017 – though only if it is used supplementing an already commenced treatment and after prior, personal doctor-patient contact.

Remote consultation by doctors does not fall under the ban on remote treatment. Consultation in this sense is understood, for example, to include the recommendation of a particular remedy for an abstractly determined illness. As soon as an individual diagnosis is prepared or advice is given in relation to an individual case of illness, it is deemed to be treatment. In practice the distinction is rather difficult and the boundary between consultation and treatment will be quickly crossed.

Pilot Project in Baden-Württemberg

Admittedly, the MBO-Ä serves only as a guide to the safeguarding of a broadly uniform professional law of doctors across Germany. The legally binding adoption of the professional code is incumbent upon the individual Federal States. Thus, in August 2016 the Baden-Württemberg State Chamber of Medicine loosened the ban on remote treatment in a pioneering decision which is unique nationwide: in the course of a pilot project, doctors based there are now permitted to treat patients who they have not previously seen personally by means of video consultation.

Existing Business Models Between Consulting and Treatment

Despite the very restrictive legal framework compared with international standards, there are businesses active in this country in the highly-regulated field of telemedicine. For instance, the Munich-based start-up TeleClinic offers patients medical consultation by video or telephone call.

The decision on when the boundary of mere medical consultation, not covered by the ban on remote treatment, is crossed and personal treatment is instead required is entrusted by TeleClinic to its practising doctors. Patients pay a fixed fee per consultation, whilst the consultation is free for those insured by certain private und statutory health insurance providers.

Its competitor, Patientus, also offers medical consultation for patients over telephone and video calls. Unlike TeleClinic, the telemedical consultation is free in principle for the patients; where applicable a fee is incurred. Doctors, on the other hand, require an account for which they must pay a fee. Patientus has just been bought by Jameda, Germany’s biggest portal for doctor recommendations and the market leader in online doctor’s appointments.

For some time, however, international telemedicine providers have also been pushing into the German market. The British company DrEd advertises explicitly that its doctors can also issue prescriptions for a multitude of illnesses and thereby save the patient the trip to the doctor.

As every insured person in the EU has a free choice of doctor, German patients can also approach a British doctor via DrEd and be issued with prescriptions from that doctor. Prescriptions from other EU Member States must be recognised in every other EU Member State in accordance with Art. 11 of the Directive 2011/24/EU on the Application of Patients’ Rights in Cross-border Healthcare.

Initiatives Against Prescriptions from Online Surgeries

This business model has long been a thorn in the side of critics and was, inter alia, the impetus for the fourth Amending Act of the German Medicines Act (vierte Novelle des Arzneimittelgesetzes), which came into force on the 24th December 2016. According to this, pharmacies in Germany are not permitted to dispense prescription medication if it is clear that there has been no prior personal contact between the prescribing doctor and the respective patient. Prescriptions from online surgeries should be precluded thereby.

This ban may be circumvented, however, by the integration of European mail-order pharmacies. According to a decision of the Court of Justice of the European Union of October 2016, foreign pharmacies are, firstly, not required to comply with the local Pharmaceutical Price Ordinance (Arzneimittelpreisverordnung) when sending prescription medication to Germany. Secondly, the aforementioned limitations with regard to prescriptions do not apply to foreign mail-order pharmacies.

However, it remains doubtful whether the online surgeries can circumvent the ban on online prescriptions contained in the draft of the fourth Amending Act to the German Medicines Act by means of cooperation with foreign mail-order pharmacies in the long term. The Federal Ministry of Health has already submitted a draft bill in December 2016 on the “Act on the Prohibition of Mail-order Sales of Prescription Medication”. With this it wants to eliminate the discrimination produced by the aforementioned CJEU decision between EU mail-order pharmacies and those within Germany. There have already been several attempts to prohibit the mail-order pharmaceutical trade in the past – so far they have failed.

Liberalisation Through Market Pressure?

Due to the great potential of telemedicine, it is to be anticipated that new companies with a variety of offers and business models will push into the telemedicine market. Such a market growth will, in turn, reinforce the pressure on the legislator to adjust the legal regulation of telemedicine and to further liberalise.