Medicinal cannabis in Germany - Business Report

170 Confidential __________________________________________________________________________________ 11.2 Relevant factors influencing future market development Only the most important and most probable influencing factors according to the assessment of market experts are listed here. • 7/2019 GSAV simplifies reimbursement and at the same time reduces the amount of the pre- scription surcharge in pharmacies, saving amount approx. 25 million euros • Q2-2019, The BfArM has announced the awards of the Cannabis tender for the suppliers Aphria, Aurora and Demecan, thus starting local Cannabis production • 2019 several new suppliers from Israel, Canada, etc. enter the German market • 2020 the health insurance companies will try to limit the costs for Cannabis flowers with dis- count contracts • 2021 the health insurance companies will try to enforce fixed prices in the Cannabis market • 2021 Cannabis from German production is available on the market and is comparatively ex- pensive • 2022 The Federal Joint Committee will evaluate the legally stipulated concomitant survey and re-regulate Cannabis prescription and reimbursement • 2023 Corresponding legal adjustments will be made by the Federal Government 11.3 Defined Daily Dose (DDD) in the Cannabis market The defined daily dose = DDD is often used as a measure for a prescribed drug quantity, especially in comparisons. Compared to other measures, such as sales or turnover, the DDD measures the con- sumption of a drug directly based on a previously defined quantity of active ingredient. In addition, DDD has become established as a measurement for cross-national analyses. DDD is based on the amount of an active substance typically used for the main indication in adults (Nordic Counsel on Med- icines 1985, WHO Collaborating Centre for Drug Statistics Methodology 2018a and 2018b). It is im- portant to note here that DDD does not necessarily reflect the recommended or actually prescribed daily dose of a drug but is primarily a technical unit of measurement and comparison. For the considerations in this business report we have tried to use DDD values. However, DDD val- ues are only available for finished drugs such as Canemes® or Sativex®. The situation is much more difficult for Cannabis flowers and oils. There is in fact no reliable DDD information here, because de- pending on the relation of THC to CBD different amounts are required to achieve the desired thera- peutic effect. In the following we have compiled the available data for the different Cannabis prod- ucts/active substances.