Law for more safety in the supply of medicines (Gesetz für mehr Sicherheit in der Arzneimittelversorgung, „GSAV“) came into force on Aug 16th 2019
"Patients must be able to rely on the fact that medicines help them and that they do not harm them. Therefore, we are strengthening the competences of the federal government" said Jens Spahn, Federal Minister of Health on 6th of June 2019, when the Bundestag passed the law.
The law is intended to increase protection against counterfeit medicines.
What will change for medicinal cannabis?
Adjustments have also been made regarding the treatment with cannabis that will allow an easier process of changing the type or dosage of medicine. If the public health insurance has granted cost coverage for the treatment with cannabis, the physicians will now be allowed to change the cannabis variety or the dosage without prior re-approval of the public health insurance..
It is also ruled that the top associations of pharmacies and public health insurances are obligated to negotiate fixed pharmacy surcharges for the supply of substances and preparations of substances in accordance with the German Medicines Act (AMG). It is intended that this will result in a price reduction of medical cannabis. Until now, the pharmacy selling price is calculated based on the pharmacy purchase price plus a pharmacy surcharge (90 t0 100%), which reflects the work in the pharmacy.
Cannabis flowers preparations (formula magistralis) cause a lot of work in the pharmacy. In particular, the identity testing by thin-layer chromatography (TLC), which is supposed to take around 90 minutes, is difficult for small pharmacies to perform alongside customer interaction.
[Frankfurt, August 19th 2019]
Cansativa became a member of the German Association of the Pharmaceutical Industry ["Bundesverband der Pharmazeutischen Industrie (BPI)"]
Cansativa is looking forward to working together with the members of the BPI to strive for an open and professional dialogue within politics and the pharmaceutical cannabis industry.
What does that mean? Cansativa stands for a proactive engagement in the action fields of the BPI, including i.a. the participation in political discussion of industry standards.
By joining the BPI, Cansativa is committed to promote the interests of its clients and international industry partners. Cannabis products have received an official right to existence with the change in the law in medicine. From responsible manufacturing to the delivery to the patient, Cansativa will support the cornerstones of this innovative industry.
We expect a successful cooperation with the BPI, which is constantly working on the clarification and improvement of industry standards. Cansativa played an active role in the preparation of an elaborated statement to the draft monograph of cannabis extracts.
[Frankfurt, July 15th 2019]
CANNABIS - ABC - A like Apothekenbetriebsordnung
Public pharmacies fall within the scope of the Apothekenbetriebsordnung (short ApBetrO). It was created in the 1980s in accordance with § 21 ApoG and sets requirements for the operation of pharmacies. The aim of ApBetrO is to ensure that the population is properly supplied with medicinal products and medical devices requiring the use of pharmacies.
As with other medicines, the handling of cannabis flowers in pharmacies must be carried out in compliance with the ApBetrO guidelines. The inspection obligations of pharmacies depend on the regulatory classification of cannabis flowers. Since the state authorities are entrusted with the monitoring of obligations of pharmaceutical law, the classification is not regulated uniformly throughout Germany. For the handling of cannabis flowers this means that, depending on the federal state, the requirements for the duties in the pharmacy business can diverge. The Federal Government already commented on the differences in January 2019. In case of ambiguities, the responsible drug authority should be contacted.
CANNABIS - ABC - B like bioavailability
Bioavailability describes the degree and speed at which the active pharmaceutical ingredient (API) of a drug is released and absorbed. It therefore indicates the proportion that is metabolized in the organism. The active ingredient must be present at the site of action in the correct dosage. Bioavailability depends in particular on the form of consumption. For the intake of cannabis flowers, the application with a vaporizer is advantageous in order to absorb the main substances THC and CBD.
When properly applied with a vaporizer, the bioavailability of ingredients such as THC from cannabis flowers is relatively high at about 29-40 %. Smoking cannabis flowers, however, is not recommended for several reasons. As with the use of a vaporizer, the APIs are quickly released during smoking. However, the effect and bioavailability of THC is uneven over time. The bioavailability of THC is subject to large intra- and interindividual fluctuations with 2-56 %. The probably decisive disadvantage compared to the vaporizer is the damage to the respiratory tract caused by the addition of tobacco and the burning of plant material at high temperatures.
[Frankfurt, August 14th, 2019]