28 August 2019 - Authored by:Eda Zhuleku
The new Law for More Safety in the Supply of Pharmaceuticals in Germany (Gesetz für mehr Sicherheit in der Arzneimittelversorgung- GSAV) which has been in force since 16 August amends the law regarding the prescription and sale of medical cannabis in Germany.
Since 10 March 2017, it has been possible for medical cannabis to be prescribed at the expense of Statutory Health Insurance companies in Germany. However, this requires the prior approval of the statutory health insurance companies, which pose hurdles for physicians as well as patients. To date approximately two thirds of the applications were approved by the health insurance funds, whereas in the remaining cases they were rejected or the health insurance companies asked for further information. The GSAV facilitates access to medical cannabis for those patients who are already on prescription or who have been hospitalised. Furthermore, the legislator reinforces the necessity of an agreement between the participating organisations for a surcharge for the sale of cannabis, since as of the present date no agreement on the topic has been reached.
The amendments to the Social Code V (SVB V) aim to improve the current status quo as follows:
- Once approval has been granted by the health insurance company, no further application to the health insurance company will be necessary in the event of an adjustment to the dosage or a change in the type of cannabis extracts according to Sec. 31 Para 6 SGB V. This will act as an administrative relief for prescribing physicians and statutory health insurance companies.
- In case of a prescription in the course of a treatment following hospitalisation, the statutory health insurance shall approve reimbursement within 3 days of receipt of the application. This shortened approval period has so far only applied to specialised outpatient palliative care and is shorter than the standard approval period of three weeks.
The law also intends to facilitate an early agreement between the German Association of Pharmacists and the Association of Statutory Health Insurance Funds regarding the surcharge for the sale of cannabis. Sec. 129 Para 5 lit. d) SGB V will require the parties to reach an agreement by no later than 6 months after its coming into force. Otherwise an arbitration board will decide on the pharmacy surcharge.
The amendments will enable patients to switch smoothly between cannabis products without having to wait for approval and will also contribute to better cross-sectorial (inpatient-outpatient sector) care of patients. The agreement regarding the surcharge for the sale in pharmacies will also create clarity about the surcharge.
This post has been co-authored by Ruby Klett.