Source: Franjo Grotenhermen
Last update: 29 October 2008
Cannabis is listed in annex I of the Betäubungsmittelgesetz (narcotics law) of substances that cannot be prescribed and marketed. Substances listed in annex I are cannabis, mescaline, heroine, LSD (Lysergic acid diethylamide), methoxyamphetamine, PCP (phencyclidine), psilocybine, among others.
Substances listed in annex I can only be used for "scientific and other purposes of public interest." On the basis of this wording of the narcotics law, some patients have received an exemption for the medical use of cannabis by the BfArM (Federal Institute for Pharmaceuticals and Medical Products), an institution of the Federal Health Ministry. The first exemption was granted in August 2007 to an MS patient.
The cannabinoids nabilone and dronabinol are listed in annex III of the Betäubungsmittelgesetz of substances that can be prescribed on a special prescription for narcotics. Since 1983 nabilone, a synthetic derivative of THC, and since 1998 the cannabis compound dronabinol, which is the international non-proprietary name for the natural (-)-trans-delta-9-tetrahydrocannabinol (delta-9-THC), is listed in annex III.
Nabilone and dronabinol do not possess drug approval in Germany, so that health insurances are usually not allowed and obligated to pay for a treatment.
There are several rulings that have heavily influenced the possibilities to use cannabis or cannabinoids for medicinal purposes in Germany.
Federal Constitutional Court
In December 1999, eight patients had registered complaints before the Federal Constitutional Court and demanded permission for the medical use of otherwise illegal cannabis. The court did not accept the complaints for decision and pointed out in a decision of 20 January 2000 (File number: 2 BvR 2382/99) that the applicants had not exhausted all available legal avenues. They could previously made application to the BfArM (Federal Institute for Pharmaceuticals and Medical Products). The German Narcotics Law allows the use of narcotics listed in annex I only for "scientific and other purposes of public interest". In their statement the judges of the Federal Constitutional Court wrote: "The medical supply of the population serves a public purpose that may justify an approval in individual cases."
Federal Administrative Court
Following the decision of the Federal Constitutional Court of 20 January 2000, many patients submitted applications for a permission to treat their illness with cannabis, which were defeated by the BfArM (Federal Institute for Pharmaceuticals and Medical Products) on the grounds that the treatment of a single patient did not represent a scientific or other purpose of public interest. A number of patients then sued the BfArM before the Administrative Courts.
In a ruling of 19 May 2005 that was made public in November 2005, the Federal Administrative Court indicated that the BfArM cannot globally deny applications for the medical use of cannabis (File number: BVerwG 3 C 17.04). The ruling pertained to the case of an advocate suffering from multiple sclerosis.
In its ruling, the Federal Administrative Court wrote: "The medical supply of the population is not a global act referred to a mass of undifferentiated subjects. Rather, it always results from the supply of single individuals that have a need thereof." The Federal Administrative Court emphasised the high value of the right to life and physical integrity based on the constitution (Grundgesetz). "The right to physical integrity cannot only be impaired when governmental organs themselves create an assault, or when their actions cause pain. The protective boundary of the constitution rather is also reached if the government takes actions that inhibit that illnesses are cured or alleviated, and if physical suffering is continued and adhered without affliction as a result."
Physicians are not currently allowed to prescribe cannabis. However, that would "not prevent them from looking after and following a patient medicinally, who on the basis of a permission according to § 3 of the Narcotics Law uses such means him- or herself in the course of a pain therapy." With regard to the argument, patients could be prescribed dronabinol (THC) by a physician even if this drug is expensive and is not always paid by health insurance, the Federal Administrative Court wrote: "The reference to a medical drug that is neither readily available nor affordable by normal citizens is no alternative to achieve the public interest in the use of cannabis to combat illness."
Higher Regional Court of Karlsruhe
A ruling of the Higher Regional Court of Karlsruhe of 24 June 2004 represents the highest court decision concerning the illegal use of cannabis for medicinal purposes (File number: 3 Ss 187/03). The ruling pertained to the case of a multiple sclerosis sufferer, who was accused of illegal possession of cannabis and acquitted by two lower courts. Since the prosecutor did not appeal the ruling of the Karlsruhe Higher Regional Court, there is no ruling of the highest German court (Federal Constitutional Court) on this issue.
In their ruling the judges highlighted the prerequisites for a legal use of otherwise illegal cannabis justified by a state of emergency:
- The defendant has to suffer from a severe medical condition.
- This medical condition or its symptoms cannot or not sufficiently be treated by available therapeutic possibilities.
- The use of cannabis products is indeed alleviating the symptoms.
Federal Social Court
In a ruling of 4 April 2006 the Federal Social Court (File number: B 1 KR 7/05 R) implemented a jurisdiction of the Federal Constitutional Court of 6 December 2005. Accordingly, in the case of life-threatening or usually fatal disease the health insurances have to pay for a treatment that is not generally accepted in Germany if no alternative treatment options exist and "if there is not too far a prospect of positive influence of the disease process." In the concrete case a medical drug against cancer caused severe side-effects in a patient, so that the physicians administered a drug that was approved in Canada.
On 27 March 2007 this ruling was implemented by the Federal Social Court to dronabinol (File number: B 1 KR 30/06 R). The court dismissed the action of a patient suffering from pain due to spinal cord injury against his health insurance, which refused to pay for his treatment with the cannabinoid. The judges stated that dronabinol is not approved in Germany and that the plaintiff did not suffer from a life-threatening or usually fatal disease.
The possession of cannabis even for medical uses is illegal in Germany. However, the possession of small amounts of cannabis (depending on the Land usually not more than between 6 and 10 grams of cannabis) usually results in an abandonment of a criminal procedure due to "low guilt" (German Narcotics Law). A second offender may be convicted to pay a fine, especially if the prosecutor and judge have got the impression that the offender is a regular user of cannabis.
The possession of more than 7.5 grams of THC is a felony, which results in a prison sentence of not less than 1 year. First offenders usually get the prison sentence on probation. The amount of THC present in the seized cannabis can only be determined after chemical analysis. For example, 100 grams of marijuana with a THC concentration of 10 per cent contain 10 grams THC.
If prosecutor and judge are convinced that the accused uses cannabis for medicinal purposes, a criminal procedure due to "low guilt" is often abandoned with the possession of higher amounts of cannabis than 6 to 7 grams. In some cases medical users received an abandonment of a criminal procedure with amounts of more than 50 grams of cannabis or had to pay a fine lower than usually expected for a recreational user. A second offender will usually be convicted even if he uses cannabis for medical reasons. In recent years several patients had to serve a prison sentence of usually 6 to 12 months due to a felony (possession of more than 7.5 grams of THC).
In the year 2003, the first patient accused for the possession of cannabis was acquitted on the grounds of a state of emergency by the local court of Mannheim. Since the prosecutor appealed the ruling, it had to be confirmed by the regional court and finally was reappraised by the Higher Regional Court of Karlsruhe on 24 June 2004 (File number: 3 Ss 187/03), resulting in a final acquittal in 2005. Since then several other patients have been acquitted due to a state of emergency by other courts (less than 10).
In 2007 first patients received a formal approval from the BfArM (Federal Institute for Pharmaceuticals and Medical Products) to use a cannabis extract, following a ruling of the Federal Administrative Court of 19 May 2005. Applications for an import of cannabis from Dutch pharmacies or for a cultivation for personal use were all rejected by the BfArM. The cannabis extract is manufactured by the two companies that also manufacture dronabinol in Germany (THC Pharm, Bionorica Ethics). The cannabis extract is not covered by the health insurances; the price is about the half of that of dronabinol. So far, about 20 patients have received an exemption from the BfArM to use a cannabis extract.
Dronabinol that is available in German pharmacies may be imported from the US as Marinol® or prepared in the pharmacies from dronabinol supplied by two German companies (THC Pharm, Bionorica Ethics). Marinol® is available as capsules (containing 2.5, 5, or 10 mg dronabinol). From the raw dronabinol supplied by the two companies, pharmacies can prepare capsules and solutions (oily or alcoholic). Alcoholic solutions of dronabinol cannot only be used orally but also be inhaled by using a vaporizer. One milligram of dronabinol from the two German companies costs about 0.80 EUR to the patient resulting in monthly costs of about 250 to 500 EUR (with daily doses of 10 to 20 mg). One milligram of Marinol® costs about 3 to 5 EUR depending on packaging size.
According to a report by the WHO (World Health Organization) about 7.5 kg of dronabinol are delivered by German pharmacies per year.