Medicinal cannabis in Germany - Business Report

3 Confidential 4.7 The Cannabis Agency at the BfArM .................................................................................... 47 4.8 Monitoring by the BfArM ..........................................................................................................47 4.8.1 Initial evaluation of the data from the monitoring survey...................................................49 5. Stakeholders in the Cannabis market ........................................................................... 52 5.1 The Federal Institute for Drugs and Medical Devices (BfArM) ..................................................53 5.2 The Cannabis Agency at the BfArM ...........................................................................................54 5.3 The Federal Opium Agency at the BfArM (BOpSt).....................................................................55 5.4 The Federal Joint Committee (G-BA) .........................................................................................56 5.5 The Federal Office of Consumer Protection and Food Safety (BVL) ..........................................57 5.6 The State Authorities of the regions for Health Protection with regard to Medicinal Products and Medical Devices............................................................................................................................59 5.7 The German Hemp Association (DHV).......................................................................................60 5.8 The German Pharmaceutical Industry Association (BPI) ...........................................................61 5.9 The association of Cannabis supplying pharmacies (VCA) .........................................................62 5.10 The International Association for Cannabinoid Drugs (IACM) and the Association for Cannabis as Medicine (ACM) ...............................................................................................................................62 5.11 Leafly Germany GmbH ............................................................................................................63 6. Payers and Cannabis reimbursement............................................................................ 64 6.1 Reimbursement of Cannabis costs by the SHI funds (Section 31 Para. 6 SGB V) .......................65 6.2 Reimbursement of Cannabis costs by the private health insurance (PHI) companies...............67 6.3 Changes due to the GSAV (Law on Safety in the Supply of Medicines) .....................................67 6.4 Future regulatory instruments by the payers............................................................................68 6.4.1 Discount contracts according to § 130a SGB V ....................................................................69 6.4.2 Fixed amounts according to § 35 SGB V ..............................................................................70 6.4.3 IV contracts under Section 140a of the Social Code, Book V (cross-sector contracts).........71 6.4.4 Model projects according to § 63 and 64 SGB V ..................................................................72 6.4.5 Drug Directives according to § 92 SGB V .............................................................................72 6.4.6 Modifications of the legal framework .................................................................................73 7. Cannabis products ........................................................................................................ 73 7.1 Prescription drugs with Cannabis ....................................................................................... 75 7.1.1 Cannabis flowers .................................................................................................................76 7.1.2 Cannabis extracts ................................................................................................................78 7.1.3 Cannabis oils........................................................................................................................78 7.1.4 Dronabinol...........................................................................................................................79 7.2 Finished medicinal products containing Cannabinoids ......................................................... 80 7.2.1 Sativex® (Nabiximols) ..........................................................................................................81 7.2.2 Canemes® (Nabilone) ..........................................................................................................81