Help only as an exception: hemp-based medicines

We present the situation in 2012 around hemp-based medicines, which have been allowed for almost a year, and highlight some of the new legal regulations. There will hardly be a broad prescription, but exceptions are possible in individual cases. It's been a long time, but some may still remember the lost hemp initiative. On the same voting weekend, the revised narcotics law was approved. Since then, heroin addicts have been allowed to be treated with hard drugs under state supervision. As far as cannabis is concerned, the law has - apart from more repression for users - also created the possibility of authorizing hemp-based medicines.

(The 8th edition of the legal aid brochure Shit happens covers the general new regulations and can be ordered from us. This article is now an extension/concretization of the previous small section on hemp as medicine). When, on the occasion of the voting campaign on the revision of the Narcotics Law, it was a matter of presenting good reasons for an acceptance, the Federal Council explicitly wrote in its voting recommendations: “Today, the medical use of cannabis is prohibited. The amendment to the Narcotics Law creates the possibility of authorizing hemp-based medicines.” So what has become of the promise and what is the situation of sick fellow human beings who want to use cannabis to alleviate their suffering?

Anyone who had thought at the time that they would soon be able to obtain cannabis flowers from pharmacies at the expense of their health insurance was soon disappointed. As the introduction of the new regulations approached, it became clear that medicine from hemp would remain the exception.

Since July 1, 2011, the revised law has been in effect, allowing three uses for cannabis:

1. For research purposes, such as the development of a drug. This requires the approval of the responsible cantonal ethics committee as well as a release (notification) from Swissmedic and an exemption permit from the Federal Office of Public Health (FOPH).
2. As a conventional drug, which is registered with Swissmedic.
3. As a limited medical use for the indications known today; which also requires an exceptional authorization from the FOPH.

The first two points state that, with the necessary permits, it is permissible to conduct research with cannabis and to register it as a medicine for certain medical conditions. It could then be prescribed by a doctor like other “normal” medicines and obtained, for example, on prescription.

It is possible that the pharmaceutical industry, which is always looking for new lucrative markets, will soon become more interested in hemp and develop drugs that can be prescribed like other medicines. However, since the most important market for pharmaceuticals, the U.S., already has “medical marijuana” laws in sixteen states and hemp is allowed for medical purposes without lengthy bureaucratic processes, this may seem too unprofitable to pharmaceutical manufacturers, who have a strong international focus and prefer monopolies. The large investments for research and approval procedures are only made if the pharmaceutical companies expect a corresponding return. At present, there is only one product on the international drug market containing THC that is not synthetic but is extracted from hemp. This drug, known as Sativex, is manufactured in the UK and is expected to be approved in Switzerland next year (2013). However, its use will be limited to neuropathic pain in patients with multiple sclerosis.

In the third area of application, a drug is not approved in general, but is approved on an exceptional basis for a limited period of time for the treatment of a seriously ill patient (so-called magistral drug). This limited medical use is so far the only area of practical relevance in Switzerland and it is worth taking a closer look at the provision or its implementation.

To come straight to the point, smoking pot will never be allowed in Switzerland for medical reasons under the regulations currently in force. Although synthetic THC may be administered as an inhalation solution under certain conditions and can be consumed with the help of a vaporizer, smoking is not a medically accepted form of application according to the FOPH. This also applies to the ingestion of THC via food. Furthermore, no one can decide for herself or himself that she or he wants to ingest THC for medical reasons. A physician must determine that a patient could be helped with THC therapy and submit a corresponding application to the FOPH.

Such applications were already made before the revision of the Narcotics Law, but not for drugs containing THC from hemp, but for those with synthetic THC. Most often the product dronabinol, also known as Marinol, is prescribed. It contains 2.5 % THC and could be obtained in Switzerland in two pharmacies so far.

With the revision of the law, it has become possible to obtain exceptional licenses for drugs containing natural THC. This spring, the pharmacist Manfred Fankhauser from Langnau i. E. succeeded in obtaining such a permit for a preparation with 5% THC. He has had experience with THC as a drug for several years and has already successfully treated several hundred patients with the synthetic version of the active ingredient. As soon as the first medical application for treatment with the natural hemp preparation of the Emmental pharmacist is approved by the FOPH, a patient may be helped with natural THC for the first time in more than 60 years.

THC can help with many medical problems. What some stoners are aware of, however, has to be proven in expensive and elaborate studies for medical use. Often, anecdotal reports from stoners give researchers the impetus to investigate the efficacy of THC more closely. In the future, drugs containing natural THC will probably be used like those containing synthetic THC.

Dronabinol, for example, is used today in Switzerland for the following symptoms, among others:

• Nausea and vomiting
• Loss of appetite and emaciation
• Anorexia and weight loss
• Spasticity, muscle cramps and hardening
• Pain conditions
• Asthma, glaucoma, epilepsy, sleep disorders and anxiety.
• Movement disorders

Patients with these symptoms have, for example, multiple sclerosis, cancer, AIDS, Alzheimer's disease, hepatitis C, anorexia and other severe diseases. In Switzerland, almost half of the exceptional requests concern patients with multiple sclerosis.

Since the FOPH bases its granting of exemptions on published scientific evidence and is not bound to specific indications, THC could eventually be used in more than just symptom control. Its great potential will have an impact on many conventional forms of treatment as more research is conducted, which must also be recognized by more medically conservative circles. For example, the National Cancer Institute in the U.S. recently recognized that THC kills tumor cells and thus fights cancer without harmful side effects to healthy cells. Cannabis may also play a greater role in the treatment of AIDS in the future: Researchers at the Mount Sinai School of Medicine in New York have found that cannabinoids inhibit the replication of HI viruses in late stages of AIDS.

Since cannabis still seems to be a spectre for many politicians and the FOPH, the whole chain of activities leading to the final product “hemp-based medicine” and having something to do with its distribution to patients is subject to authorization. This includes the cultivation of hemp, the production of the medicine, the treatment of the patient as well as the trade with hemp medicine or its distribution.

If a treating physician submits an application to the FOPH for the treatment of his patient with THC based on his diagnosis, he must:

• Confirm in writing that he accepts responsibility for the consequences of his prescription
• Provide the patient's name, address, age, and written informed consent.
• disclose the medications used so far
• declare the intended dosage and intended duration of treatment
• prepare an interim report on treatment every six months and a final report for the FOPH
• Describe the logistics process for dispensing the drug; in this process, the physician himself, a pharmacy, or a hospital can only dispense the hemp-based drug directly to the patient
• indicate how the therapy will be financed, since it is not necessarily covered by basic insurance.

If the drug is then to be dispensed by a pharmacy, it requires an operating license for controlled substances in accordance with Article 11 of the Narcotics Control Ordinance. This authorization is also required if a pharmacy itself wants to produce a medicine from the prohibited cannabis, such as a hemp tincture.

As mentioned, the cultivation of hemp intended for the production of medicines is also regulated by law. Basically, according to the Narcotics Control Ordinance, the “grower” needs the already mentioned operating license or must act on behalf of an authorized company. Furthermore, an application for a cultivation permit must be submitted by the hemp producer.

If the producer himself or herself does not have an operating license, an application must be submitted to the FOPH, in which:

• sufficient protection against theft is demonstrated
• a written contract with an approved establishment must be presented
• precise information on the type and quantity of cultivation is provided
• it is guaranteed that the entire cultivation quantity will be delivered to the client.

The bureaucratic effort will deter most potential producers of medicinal hemp to produce legally and there is unlikely to be a revival of hemp fields in Switzerland. Probably a few companies specializing in the cultivation of medicinal plants will decide the market among themselves.

The costs incurred due to the various licensing requirements mean that a drug that has cleared all the hurdles to then be exceptionally approved for treatment will not be cheap. Currently, the cost of medication for treatment with synthetic THC ranges from 5 to 35 francs, depending on the daily dose. For hemp tincture produced in Switzerland, Manfred Fankhauser predicts typical daily costs of 10 to 15 francs.

If one considers that by the side effects and the abuse of commercial medicines, which can be bought often without prescription, hundreds of humans are killed in Switzerland each year and uncounted health damages, the described regulations seem grotesque. This is probably necessary, since exemption permits can also be issued for harder drugs. However, the question arises whether it makes sense to treat cannabis like heroin or LSD. The judiciary has learned to treat drugs differently with regard to narcotics consumption and trafficking. It is to be hoped that those involved in health care will also learn this in their field. However, as long as cannabis remains prohibited under the international narcotics conventions to which Switzerland is a signatory, no relaxation can be expected.

Since, for example, the production of a hemp tincture is technically relatively simple, the costs for treatment with hemp-based medications are not necessarily covered by health insurance companies and the bureaucratic hurdles for obtaining exemption permits are relatively high, it can be assumed that hemp medications are produced by patients themselves and that there is also a black market for them. Numerous recipes and experience reports can be found on the Internet. Good examples of production methods for hemp oils and tinctures can be found in English at http://phoenixtears.ca or in German at www.cannabis-med.org. However, anyone who has a serious illness and believes that cannabis could help should play it safe and first check with their doctor whether an exemption could be obtained.