Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Prescription of Cannabis - Regulatory environment and current situation in Germany in comparison with the Netherlands and the USA ***
Dr. Jasmin Fahnenstich (Abschlußjahr: 2010)
Language: English
For thousands of years, cannabis was used for medicinal purposes and was very popular as recently as nearly hundred years ago. In consequence of the UN Conventions of narcotic drugs and psychotropic substances in the last century, the participating member states such as Germany, the Netherlands and the USA, committed themselves to implement the resolutions and to transition into national law. Among others, the cultivation, trade and possession of cannabis became illegal by prosecution and cannabis was listed in schedules of drugs and substances which were completely banned. The protection of public health affected by cannabis consumption and the prevention of cannabis trade were in the foreground and therefore the use of cannabis was only allowed for scientific purposes.
After the discovery of the endocannabinoid system in the 1990ies, the demand for reliable cannabis research and for acceptation of cannabis having a medicinal value increased.
Until now, only a few proprietary medicinal products which can be obtained by prescription, like one cannabis extract or products containing the main active substance of cannabis (e.g. dronabinol) were approved for limited indications and only in a few countries. The costs of the legal cannabis-based medicinal products are higher than the costs for medicinal cannabis which is extremely rare and difficult to obtain for a patient. Moreover, reimbursement if at all is only given on a case-by-case basis and as a consequence most patients buy their "medicine" at the illicit market taking the risk of buying an adulterated product and facing additional prosecution.
The protection of public health and the concurrently treatment of patients and their supply with approved cannabis and cannabis products which are safe, efficacious and of high quality is of current legal and regulatory challenge in most countries. Especially the requirement of being conform to the existing resolutions of the conventions is of outstanding concern and the creation of an appropriate legal framework on international and national level of great importance.
The present master thesis gives an overview of the current legal and regulatory framework concerning the prescription of cannabis and presents the tendency of its development in the three countries: Germany, the Netherlands and the USA.
The implementation of the resolutions passed by the UN Conventions led to varying national laws regarding controlled substances and of special concern cannabis. In Germany, cannabis cannot be marketed and not prescribed and can only be used for scientific and other purposes of public health with an exceptional licence. By now, 37 patients hold an exceptional licence which gives them the opportunity to use medicinal cannabis supervised by a physician. Great difficulty in creating a legal framework to support cannabis and cannabis products using patients exists and only small steps are taken concerning the rescheduling. In the Netherlands, Dutch patients have the ability to obtain medicinal cannabis more easily than German patients and purchase their medicine at the pharmacy due to a narcotic prescription of a physician. In the USA, only in 14 states it is possible to obtain a physicians recommendation in order to gain cannabis at dispensaries. Medicinal cannabis programs develop on a state-by-state basis out of compassion for patients need but always in conflict with federal law which is quite prohibitive compared with the more patient orientated permissive state law of some states. In this way, an upcoming referendum in California is of great interest and might serve as a sign because of the possibility to create the most liberal law worldwide.
After the discovery of the endocannabinoid system in the 1990ies, the demand for reliable cannabis research and for acceptation of cannabis having a medicinal value increased.
Until now, only a few proprietary medicinal products which can be obtained by prescription, like one cannabis extract or products containing the main active substance of cannabis (e.g. dronabinol) were approved for limited indications and only in a few countries. The costs of the legal cannabis-based medicinal products are higher than the costs for medicinal cannabis which is extremely rare and difficult to obtain for a patient. Moreover, reimbursement if at all is only given on a case-by-case basis and as a consequence most patients buy their "medicine" at the illicit market taking the risk of buying an adulterated product and facing additional prosecution.
The protection of public health and the concurrently treatment of patients and their supply with approved cannabis and cannabis products which are safe, efficacious and of high quality is of current legal and regulatory challenge in most countries. Especially the requirement of being conform to the existing resolutions of the conventions is of outstanding concern and the creation of an appropriate legal framework on international and national level of great importance.
The present master thesis gives an overview of the current legal and regulatory framework concerning the prescription of cannabis and presents the tendency of its development in the three countries: Germany, the Netherlands and the USA.
The implementation of the resolutions passed by the UN Conventions led to varying national laws regarding controlled substances and of special concern cannabis. In Germany, cannabis cannot be marketed and not prescribed and can only be used for scientific and other purposes of public health with an exceptional licence. By now, 37 patients hold an exceptional licence which gives them the opportunity to use medicinal cannabis supervised by a physician. Great difficulty in creating a legal framework to support cannabis and cannabis products using patients exists and only small steps are taken concerning the rescheduling. In the Netherlands, Dutch patients have the ability to obtain medicinal cannabis more easily than German patients and purchase their medicine at the pharmacy due to a narcotic prescription of a physician. In the USA, only in 14 states it is possible to obtain a physicians recommendation in order to gain cannabis at dispensaries. Medicinal cannabis programs develop on a state-by-state basis out of compassion for patients need but always in conflict with federal law which is quite prohibitive compared with the more patient orientated permissive state law of some states. In this way, an upcoming referendum in California is of great interest and might serve as a sign because of the possibility to create the most liberal law worldwide.
Until now, all efforts that have been made to achieve rescheduling of cannabis on an international level failed.
In conclusion, the prescription of cannabis is still a great issue and the challenge is to find a way between prohibitive approach and the use in therapy and research. Therefore profound scientific research is of great importance to show the efficacy of cannabis in treating a lot of medical conditions with the purpose of possible rescheduling, reappraisal and approval.
Pages: 76