Medicinal cannabis in Germany - Business Report

165 Confidential __________________________________________________________________________________ Bionorica has tried to obtain a generic approval for Dronabinol from the BfArM. The BfArM has not yet issued these. Bionorica is undertaking clinical trials to eventually obtain generic approval for Dronabinol. With the availability of generic Dronabinol, the price per milligram will also continue to fall. 10.5 Finished Cannabis medicinal products The so-called price moratorium is an effective legal regulatory instrument, whereby certain price increases of pharmaceutical companies cannot be unilaterally charged to health insurance companies and other cost units. The legal basis for this is Section 130a (3a) of Book Five of the Social Security Code. According to this, health insurance companies and other cost units have been entitled to a price reduction since August 1, 2010, in the amount by which a manufacturer increases the sales price of a drug above the price level of August 1, 2009. In principle, the regulation applies to all drugs that are reimbursable in the SHI system. This does not apply to those drugs for which a fixed amount deter- mined by the German Federal Association of Health Insurance Funds (Spitzenverband Bund der Krank- enkassen) already applies and for which drugs are reimbursed. The regulation also does not apply to new drugs whose pricing is based on the Law on the Reorgan- isation of the Pharmaceutical Market (AMNOG). With the Act to Strengthen the Supply of Medicines in the SHI System (AMVSG), the price morato- rium will now be continued until 31 December 2022 in connection with further measures in the phar- maceutical sector, as it has proven its worth in curbing the rising expenditure trend in the pharmaceu- tical sector and otherwise a significant increase in pharmaceutical expenditure and above-average price development could have been expected again when the price moratorium expires. ▪ Canemes® will try to maintain its high price level; however, the number of reimports is increasing. ▪ Sativex® will maintain its price level, there are no re-imports, which speaks for a consistent international pricing policy. ▪ Cash registers will demand discounts and manufacturers will face open house tenders. ▪ Epidyolex® will initially release its price ( OD ). What will be agreed as the reimbursement price after the AMNOG procedure is completed remains an open question. ▪ CannEpil® will try to achieve its U.K. price also in Germany. ▪ New finished pharmaceuticals entering the market will certainly come onto the market with high prices.