18 May 2022
The “Law for the Protection of Electronic Patient Data in the Telematics Infrastructure (Patient Data Protection Act, PDSG)” entered into force on 20 October 2020, establishing the legal basis for introducing electronic prescriptions for medicinal products subject to prescription. The PDSG governs digital prescriptions of pharmacy-only medicines, which are stored in the secure telematics infrastructure (TI) and can be filled at the pharmacy using an app or a printed code. The digital alternative is intended to replace the roughly 500 million paper prescriptions (Form 16) written each year. Originally scheduled for 1 January 2022, the launch of the mandatory e-prescriptions had to be postponed indefinitely: According to the Federal Ministry of Health, the necessary technology for the nationwide rollout is not yet widely available.
Testing of the electronic prescriptions started in summer 2021, moving from the initial focus on the Berlin/Brandenburg region to all of Germany on 1 December 2021. Gematik GmbH, a company established by the umbrella organisation of the German healthcare system, is in charge of the trial and rollout process. The Federal Ministry of Health announced that the trial phase has been prolonged indefinitely. The basic requirements for a mandatory introduction are technical availability as defined in § 360(1) SGB V and the fulfilment of quality criteria. As soon as these requirements are satisfied, the systems will be changed to electronic prescriptions.
At present, surgeries, pharmacies, hospitals and software providers still have to gain more experience to be able to safely switch to the digital system. The process remains at a trial stage where all operators are asked to actively participate and contribute. By early December 2021, a mere 42 e-prescriptions had been written. The system now is planned to be rolled out in stages, while the detailed procedure remains to be determined. It is uncertain when the legal obligation will come into effect, also in view of the acute and continuing pandemic situation.
Besides the e-prescription, other necessary healthcare products and services such as remedies, assistive devices or home nursing care gradually will become available for electronic prescription. At the end of 2019, the Digital Healthcare Act (DVG) established the basis for prescribing digital healthcare applications that will be reimbursed by the statutory health insurance providers. The current plan is for these app prescriptions to become fully electronic and available in the TI by 1 January 2023.
It will be interesting to see when the e-prescription digitalisation project will become binding. Considering the assessment of the previous trial phases and the unmet basic requirements under § 360(1) SGB V, it seems unlikely that electronic prescriptions will become standard in the healthcare structure before the end of the year.
Authors: Leoni König, Dr. Daniel Tietjen