German Court to Rule on Terminal Patient's Fight for Unapproved Drug
German Court to Rule on Terminal Patient's Fight for Unapproved Drug
Karlsruhe rules on medication cost coverage - German Court to Rule on Terminal Patient's Fight for Unapproved Drug
A young man with Duchenne muscular dystrophy has taken his fight for an unapproved drug to Germany's highest court. The Federal Constitutional Court will deliver its verdict on Wednesday at 9:30 AM, deciding whether insurers must cover treatments not fully authorised for terminally ill patients. The case centres on Translarna, a medication his health insurer has repeatedly refused to fund.
The plaintiff, born in 2004, lost the ability to walk in 2015. His legal battle has already seen conflicting rulings from lower courts, leaving the final decision to the Constitutional Court.
The dispute began when AOK Rheinland-Pfalz/Saarland, the young man's health insurer, declined to pay for Translarna. The drug is EU-approved for Duchenne muscular dystrophy—but only for patients who can still walk. An attempt to extend its approval to non-ambulatory patients failed, with regulators citing insufficient evidence of benefit.
The Rhineland-Palatinate State Social Court initially sided with the plaintiff, ordering the insurer to provide the medication. Judges ruled there was 'indication-based, plausible evidence' of a possible positive effect on his disease progression. However, the Federal Social Court in Kassel later overturned this decision. It argued that drug safety must come first, even in fatal conditions, and that unauthorised treatments cannot be mandated. The Constitutional Court now faces an appeal against the Kassel ruling. Its decision will determine whether patients with terminal illnesses can access unapproved drugs when no other options remain.
The verdict will set a precedent for how insurers handle requests for experimental or off-label treatments in severe cases. If the court rules in the plaintiff's favour, it could open the door for others in similar situations to seek unapproved medications. The outcome will also clarify the balance between patient rights and regulatory safeguards in Germany's healthcare system.