by Micha on 27/11/2014 | Uncategorized

Hurdles facing natural Cannabis as a medicine

Many EU countries have now approved Sativex, although its indications in Germany are very restricted. It is a similar story for Dronabinol (Marinol), with health insurance companies generally refusing to reimburse the cost for this THC-Pharm active substance. Since Dronabinol is far more expensive than the already over-priced medicinal cannabis flowers available in Germany, for German patients Dronabinol is often not a viable alternative to the weed they have grown themselves or obtained on the black market.


The German ‘special way’ is a lazy compromise

Hurdles facing natural Cannabis as a medicine

Many EU countries have now approved Sativex, although its indications in Germany are very restricted. It is a similar story for Dronabinol (Marinol), with health insurance companies generally refusing to reimburse the cost for this THC-Pharm active substance. Since Dronabinol is far more expensive than the already over-priced medicinal cannabis flowers available in Germany, for German patients Dronabinol is often not a viable alternative to the weed they have grown themselves or obtained on the black market. Just under three hundred cannabis patients living in Germany have a certificate of exemption for the import of Dutch medicinal flowers produced by Bedrocan. In the Netherlands, these flowers cost patients between six and seven euros depending on which pharmacy they use. In Germany, the same medicine costs 15-20 euros per gram, a cost which the health insurance companies will of course not reimburse because it is not an approved drug in Germany, but simply has a certificate of exemption. Furthermore, German politicians, with the exception of the Sativex approval, have not shown themselves willing to compromise voluntarily. All the rights available to cannabis patients have had to be tested in court over the past ten years. The courts will be kept busy with people growing cannabis for personal use too, as it’s clear that the Federal Opium Agency intends to appeal against Günter Weiglein and two other patients. As a result, the people affected can scarcely afford their medicine any more, and cannot grow their own despite the positive judgement in the summer. While the cost of medicinal flowers are now not being paid, many patients are also complaining about supply difficulties. For example the Bediol variety, which has a high CBD content, will not be available to patients in Germany before the end of the year at the earliest. Germany does not have a cannabis agency either, something which countries with a cannabis programme really should establish. While there are administrative regulations in place for cannabis patients, there is no standard procedure for obtaining a certificate of exemption for medicinal cannabis flowers. Basically, the route for potential patients is rather drawn-out and rocky, but it certainly can be done. This brief overview is intended to serve as a summary of the current situation and answer the most pressing questions which cropped up repeatedly at the first Berlin Patients’ Meeting.

By prescription: Dronabinol & Co

Hurdles facing natural Cannabis as a medicine

Doctors of any specialism may prescribe Dronabinol (‘Marinol’), Nabilon and Nabiximols (‘Sativex’) as a prescription anaesthetic. In principle, cannabis-based medications can be prescribed for all ailments if the doctor and the patient expect a successful treatment outcome.

No anaesthetic prescription is required for the active ingredient Cannabidiol (CBD). CBD is sold as an active substance by the Frankfurt-based company THC-Pharm and can be given with a simple prescription. However the health insurance companies will not pick up the cost of this either, and it is questionable whether they will do so in the future.

Hurdles facing natural Cannabis as a medicine

It is the same for other cannabis medications too: with the exception of Sativex for MS patients, reimbursement is the exception rather than the rule. With Dronabinol in particular, for which there are officially three recognised indications (loss of appetite due to HIV, MS and cancer), the health insurance companies like to argue for ‘Off-Label Use’ when it comes to reimbursing costs for patients in pain who do not show any of the three indications. Many doctors are fearful of prescribing cannabis-based drugs under a public health service prescription because the health insurance company would first have to make the payment and subsequently recover it from the doctor.

A doctor in Potsdam who saved a tongue cancer patient’s life with Dronabinol once had to pay back 70,000 euros to the health insurance company before winning a case against the health insurance company that dragged on for several years. This uncertainty surrounding public health service prescriptions, which can cost doctors a lot of money, also scares a lot of doctors away from prescribing cannabis-based drugs. To find a doctor who is prepared to prescribe a cannabis-based drug and make the decision easier for him, it is better to ask for a private health insurance prescription. This means that you are personally responsible for the costs and can also ask the public health insurance company for reimbursement.

Prepared drugs or flowers – the main thing is that it’s untreatable

Hurdles facing natural Cannabis as a medicine

Over the years, many patients have noted that the natural product helps more in their individual case than the extracted medication. The first patients had to go to court to obtain an import permit, but there is now a prescribed procedure for issuing such permits. Patients need to apply for a certificate of exemption under § 3 clause 2 of the Narcotics Act.

Sadly, hardly any doctors have yet got to grips with this bureaucratic hurdle. Mention cannabis to a GP, and the patient will generally be thought of as a bit mad. It is not easy to find a doctor who is even aware of cannabis as an alternative form of medicinal treatment, never mind one who understands how easy it is to prescribe Dronabinol, Nabilon or Sativex. It can be prescribed straight off for certain symptoms, but for diagnoses such as chronic pain or epilepsy, the patient needs to be untreatable. Untreatable means that the use of traditional drugs has proven to be ineffective or to have a poor effect. The patient also needs to keep a three-month record as to why conventional medicine is not sufficiently effective. As documentation, the doctor and the patient must then compile a record of the frequency of pain or attacks. If the patient is untreatable, the doctor may also prescribe cannabis-based drugs for indications other than those officially referred to.

Application for a certificate of exemption for medical cannabis flowers from the Netherlands

Even many doctors who have already worked with Dronabinol or Sativex are unaware of the aforementioned “certificate of exemption under § 3 clause 2 of the Narcotics Act for the obtaining of cannabis flowers for use in the context of medically supervised and supported self-treatment”. Supporting a patient in the application process is also completely new territory for doctors and is frightening to them.

Potential patients should give the doctor a print-out of the application. This article from the ‘Ärzteblatt’ German medical magazine may also be helpful “Das therapeutische Potenzial von Cannabis und Cannabinoiden“ [The therapeutic potential of cannabis and cannabinoids.] An article from a medical journal generally has more of an impact than an evangelical patient trying to convert a doctor.

When can cannabis help as a medicine?

Regarding the use of cannabis, a distinction is made in the case of illnesses for which

  • cannabis as a medicine has been well researched;
  • there are existing certificates of exemption for these specific diagnoses;
  • plausible applications can be demonstrated for which only empirical values existed to-date.

For some ailments, THC or CBD in combination is effective while in other applications only one of these two active ingredients will influence the prognosis. Dr Franjo Grotenhermen, Chairman of the Working Group on Cannabis as a Medicine (ACM), cites the following diagnoses: spasticity, impaired movement, pain conditions, loss of appetite and weight loss, nausea and vomiting, glaucoma, epilepsy, withdrawal symptoms, asthma, Alzheimer’s disease, depression, inflammations, allergies, itchiness and ADHD/ADS. The ACM magazine and the ACM website constantly publish the latest contributions on the most up-to-date research into cannabinoid medications.

What diagnoses justify a certificate of exemption?

Hurdles facing natural Cannabis as a medicineThe majority of patients granted a certificate of exemption are suffering from: chronic pain, multiple sclerosis, Tourette’s syndrome, depression as well as ADHD and epilepsy. Certificates of exemption for Crohn’s disease or glaucoma remain relatively rare. A list of all the diagnoses which have to-date supported an import permit for Bedrocan cannabis can be found in the Alternative Drugs Report published by akzept e.V.

As with prescribing cannabis drugs, a certificate of exemption for medicinal cannabis flowers is in principle an option for many ailments. As evidence, the relevant scientific literature needs to include reference to effectivity, or data needs to be presented which documents successful healing for the individual. An “improvement in subjective condition” may also represent a medicinal benefit if it can be substantiated with documentation. It is often difficult to produce evidence for rare or poorly researched ailments. In this case, a consultant and a specialist in cannabinoid medicine should work on the application together because the approving authority requires a risk/benefit assessment for the use of cannabis. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) must be in a position to understand, based on the documentation, why cannabis is the only medicine in the absence of suitable and available alternative therapies which has a positive impact on the individual prognosis.

All the relevant information for patients, doctors and pharmacists with respect to the application and prescribing the cannabis medications Dronabinol, Nabilon and Sativex can be found in the “Guidance on applying for a certificate of exemption from the Federal Opium agency for the medicinal use of cannabis” (“Anleitung zur Beantragung einer Ausnahmegenehmigung zur medizinischen Verwendung von Cannabis bei der Bundesopiumstelle”) by Dr Franjo Grotenhermen.

Summary

Depending on the indication, it is moderately difficult to obtain prepared cannabis drugs on prescription. When it comes to the plant version it becomes complex but not irresolvable. Germany must supply patients with cannabis whether it wants to or not because some patients have gone to court to obtain it. Import is expensive because transport to and sale in Germany costs between 9 and 14 euros per gram – ultimately more than the flower itself. The German government has for years been refusing to allow the medicine to be produced domestically because it does not want to establish a cannabis agency. After all, a cannabis agency would mean regulation, and most importantly the standardisation of natural cannabis medication. In Germany, the country with the most powerful pharmaceutics lobby in the EU, this is not politically desirable. This is why the import model and bureaucratic monster known as the “Certificate of exemption under § 3 clause 2 of the Narcotics Act” was established. It is a way of protecting against lawsuits from more patients and at the same time creating enormous hurdles which many ill people cannot get over on their own. For the moment, at least.

Comment Section

Post a comment

android

Your blog provided us valuable information to work on. You have done a marvellous job.

01/04/2016

Leave a Comment

Please enter a name
Oops, looks like you forgot something?
Read More