Roughly one year after the federal election in September 2021, the German government’s plans to legalize cannabis for recreational use have further taken shape. German Minister of Health Karl Lauterbach has introduced a document on the key points of the planned legislative changes on Wednesday, 26 October 2022. According to this document, cultivation, distribution and taxation — as well as advertisement for recreational use — of cannabis will be specifically regulated.
EUR 4.30 instead of EUR 9.52 per gram: The reimbursable base price for medical cannabis cultivated in Germany has been almost cut in half whereas the base price for imported cannabis flowers remains unaffected. According to an arbitration ruling of 17 June 2022, a base price of EUR 4.30 (plus surcharges of 90% or 100%) per gram is reimbursable for cannabis flowers cultivated in Germany. Prior to the ruling, statutory health insurance funds reimbursed a base price of EUR 9.52 per gram plus varying surcharges for all cannabis flowers. This also applied to cannabis flowers cultivated in Germany and sold to pharmacies for a fixed price of only EUR 4.30 per gram.
On 8 July 2022, the German Health Ministry officially shared the second edition of a new bill referred to as the Act for Financial Stability of the Public Health Insurance (GKV-Finanzstabilisierungsgesetz). The bill is still subject to discussions with stakeholders and several rounds of congress hearings. If ultimately implemented, which is a likely scenario, pharma companies will face several painful cutbacks on the statutory reimbursement of prescription-only medicinal products.
As of 1 January 2022, Germany has set up a mandatory public lobbying register. Its broad scope covers – similar to the EU transparency register – every entity which regularly communicates with the German federal executive or legislative to represent and further its interests. As a result, every company with a public affairs department may fall under its scope. Such companies will need to complete their initial registration by 28 February 2022.
The Medical Device Coordination Group (MDCG), the expert panel of the EU Member States and the EU Commission, has released on 20 October 2021 two guidance documents which provide meaningful guidance (1) for manufacturers, importers and distributors of “legacy devices” on which MDR obligations they must comply with (guidance document 2021-25), and (2) on the obligations of parallel importers regarding the repackaging and relabeling of medical devices under Article 16 MDR/IVDR (guidance document 2021-26).