[Opioid substitution therapy for opioid use disorder and legal framework in Germany]

Opioid use disorder (OUD) is a chronic, relapsing condition associated with high morbidity and mortality, primarily due to respiratory depression and overdose. In Germany, approximately 160,000 people are affected by opioid dependence, with significant variation across regions. Opioid Agonist therapy (OAT), also known as opioid agonist treatment (OAT), is the internationally recognized first-line therapy for OUD. It involves the medically supervised administration of long-acting opioid agonists such as methadone, levomethadone, buprenorphine, or - under strict conditions - diacetylmorphine (heroin) and aims to stabilize physical and mental health, reduce illicit opioid use, and support social reintegration.The legal framework for OAT in Germany is defined by the Narcotic Drugs Act (BtMG), the Narcotic Drugs Prescription Ordinance (BtMVV) and guidelines issued by the Federal Medical Association and the Joint Federal Committee (GBA). These regulations stipulate the qualifications required for prescribers, conditions for supervised daily dosing, and criteria for take-home prescriptions. Psychosocial support is strongly recommended. OAT has proven effective in reducing mortality, improving quality of life, and lowering the prevalence of infectious diseases among people with OUD. Special regulations apply to substitution with diacetylmorphine, which is reserved for patients with severe treatment-resistant opioid dependence. Despite clear benefits and legal clarity, access to OAT is unevenly distributed in Germany, with rural areas facing significant gaps in care. Expanding provider capacity and increasing the flexibility of treatment delivery remain key priorities to ensure comprehensive and equitable care for individuals affected by OUD.