Healthcare and Life Sciences

Obligatory E-Prescription of Pharmaceuticals in Germany: New approach in the Draft Act to Accelerate Digitalisation in the Healthcare Sector

While electronic prescriptions (“e-prescriptions”) were introduced back in 2022, their obligatory use across Germany has thus far failed on account of their technical requirements and due to data protection concerns. On 30 August 2023, the German Federal Cabinet approved a draft Act to Accelerate Digitalisation in the Healthcare Sector (Gesetz zur Beschleunigung der Digitalisierung des Gesundheitswesen, “DigiG”). The bill stipulates that the e-prescription be developed further and set as the binding standard in pharmaceutical supply from 1 January 2024. The electronic health card and electronic patient record app will make it much easier for insured persons to use e-prescriptions – at long last establishing a workable e-prescription format in the German healthcare system.

How e-prescriptions will work from 1 January 2024

Physicians will issue an e-prescription digitally, signing it electronically with their health professional card (Heilberufsausweis). It will then be stored and encrypted in the telematics infrastructure, where pharmacies can access it later. On the technical side, medical practices need an electronic health professional card, a link to the telematics infrastructure with a corresponding connector, and a practice management system that meets e-prescription requirements.

Patients receive an access code (known as an e-prescription token) that they then give the pharmacy for the prescription to be filled. Pharmacies are obliged to fill e-prescriptions. There are various technical ways of sending the token to the patients and of having the prescription filled by the pharmacy:

  • The e-prescription app is available as a digital solution.
  • The token can also be printed out on paper and given to the pharmacy as before.
  • Since 1 July 2023 it has also been possible to have the e-prescription filled using the electronic health card, which needs to be inserted into a corresponding reader at the pharmacy.
  •  A new option will be available from 1 January 2024: health insurance funds will be able to include a function in their electronic patient record apps enabling e-prescriptions to be received and filled.

Integrating e-prescriptions into the electronic patient record

With regards to integrating e-prescriptions into the electronic patient record, the current bill provides for more than merely showing an e-prescription on the app’s user interface. Unless the patient objects, further data will be sent to the electronic patient record, including the drugs dispensed, their batch number, and their dosage (“dispenser information”). So here as well, legislators have gone for an opt-out procedure that reverses the previous concept based on patient consent.

In future, data transfer will form one of the pillars of a digitally supported medication process. Together with further information on allergies, intolerances, pregnancies etc., the data will be made available to medical practices (unless the patient objects) and taken into account when prescribing drugs. For effective therapy, the interplay of e-prescription and electronic patient record promises added value in avoiding double prescriptions and improving drug safety, as physicians can better judge interactions with drugs already prescribed or with existing conditions.

E-prescriptions only for Rx drugs to date

It is likely that e-prescriptions will cover all medicinal products in future. Currently, only Rx drugs fall under the scope of e-prescriptions, but this scope is to be gradually expanded. Section 360 Social Security Code, Book V (Sozialgesetzbuch (SGB) Fünftes Buch, “SGB V”) is the main statutory provision on e-prescriptions and sets deadlines for this expansion. As the obligatory roll-out of the e-prescription has been delayed, however, the deadlines will be revised yet again and the section amended in line with the bill. The following overview shows the schedule for extending e-prescriptions to other benefits:

Conclusion and outlook

E-prescriptions will simplify how prescriptions are issued, sent and filled in everyday practice. But online pharmacies and pharmacy platforms that deliver medicines from established pharmacies directly to patients’ homes are also likely to benefit. Thus far, e-prescriptions have played barely any practical role in this regard. For this reason, they have not yet made a tangible contribution to modernising the provision of pharmaceuticals in line with customer needs. It is to be hoped that the bill will be passed in the near future and that using e-prescriptions will become obligatory as of 1 January 2024.

As well as amending the rules on e-prescriptions, the DigiG is also expected to include a legal update for DiGAs. You can find more details in our article: Update Planned for Digital Health Applications – Federal Government's Digital Act.