There has been much talk about Germany’s Digital Healthcare Act, but in reality the ground-breaking legislation is still in its infancy.
Ralf-Gordon Jahns told The Sidebar that while the legislation has been ratified in parliament, products have yet to be launched because the reimbursement framework mandated by the act is still under development.
Jahns said that the details of the act will not be decided until around February or March this year.
The act is aimed at digital therapeutics (DTx), which have been shown to have a beneficial effect against diseases or conditions in clinical trials.
It passed through Germany’s Bundestag in early November 2019 and requires digital app providers to prove to the country’s federal Institute of Drugs and Medical Devices (BfArM) that their technology can improve patient care.
These can be prescribed like drugs by doctors after approval by regulators, and Germany’s legislation follows the creation of a special approval pathway for this class of therapies from the US Food and Drug Administration (FDA).
“There will be an impact starting from next year (2020), maybe in the middle of next year, when the first applications are being passed to the authorities and then after that, doctors will start to prescribe (the apps),” Jahns told The Sidebar last month.
Despite the delays, the German authorities have been transparent about the sort of app that will be likely to make it through the process.
According to Jahns the main focus will initially be apps deemed to be “low risk” that could be eligible for a fast track to market.
These could be available for prescription as early as summer 2020, according to Jahns, who added that the government is being open in its discussion to encourage manufacturers to come forward.