Home Affairs Committee - Drugs: Breaking the CycleWritten evidence submitted by Tjalling Erkelens (DP 075)

1. Brief Introduction of the Submitter

Tjalling Erkelens (1956) is co-owner and CEO of Bedrocan Beheer BV. Since 2003 Bedrocan BV (subsidiary of Bedrocan Beheer BV, established in 1984 as a horticultural company) is licensed and contracted by the Dutch government for the production of medicinal cannabis in four different varieties to be provided to patients upon prescription.

In cooperation with Dutch universities in Wageningen and Leiden Bedrocan BV is involved in the scientific development of cannabis as a medicine. Furthermore the company recently established a pharmaceutical company under the name Bedromedical BV whose main aim is to take herbal cannabis through the drug approval process.

If the Committee has more questions for us, I’ll be glad to provide more information upon your request. Our scientific staff, Mrs Lisette Wijnkoop (pharmacist, head of processing) and Dr Arno Hazekamp (PhD, head of Research & Development) will be able to submit more detailed technical information upon your request.

2. Executive Summary

(a)Over the last decade the amount of scientific evidence of the efficacy of cannabis as a medicine to fight symptoms of certain debilitating diseases has increased very significantly.

(b)More and more European countries have decided to legalise and regulate the use of cannabis as medicine.

(c)In The Netherlands the biggest Health Insurance company, Achmea, lately decided to reimburse the full cost of prescription cannabis for clients suffering from diseases for which the use of cannabis is recommended by the Dutch government.

(d)Cannabis of standardised pharmaceutical quality has been available for export through the Dutch government since 2003. Germany, Italy and Finland are using this source to provide medicinal cannabis to their patients.

(e)Illegal producers and traders of cannabis often use medical reasons to justify their actions, thus blurring the emerging scientific evidence that cannabis is a good alternative to combat certain symptoms like pain and spasms in debilitating diseases like Multiples Scleroses, Cancer, Tourette Syndrome, HIV/Aids and Glaucoma.

(f)A clear separation between the medicinal use of cannabis and other use will contribute to an improvement of health and/or quality of life for certain groups of patients in the UK and would be cost effectiveness to the legal system with regard to prosecution of illegal production and sales of cannabis.

3. Preamble

This document will focus on the effects of the UK’s policy to not allow the use of cannabis as a means to treat certain conditions and symptoms of serious diseases. More specifically I will focus on two of the considerations in the Home Affairs Select Committee’s Call for written evidence:

The extent to which public health considerations should play a leading role in developing drugs policy.

The comparative harm end-cost of legal and illegal drugs.

Although certain extracts and pure compounds of the plant species Cannabis Sativa L. are allowed for medicinal use in the UK, there is still a very strong demand amongst patients for standardised herbal material from this plant species, as they claim that derived or synthesised compounds are less, or even, not effective compared to herbal cannabis. This demand is not just confined to the UK, but occurs worldwide.1

4. The Drug-substance: Cannabis Flos (Dried Female Flowers of the Species Cannabis Sativa L)

Cannabis Sativa L is just a single plant species of which many varieties are known. Originally there were two main (feno) types of cannabis, named Sativa and Indica. The main differences between these two types is found in their appearance (resp tall, open structured plants, narrow leaves and short bushy plants, broad leaves). More differentiation is found in the chemical structure of these cannabis varieties. The cannabis plant contains over 100 known unique compounds that are known as cannabinoids. Many of these cannabinoids have been identified over the last decade. The most important ones are Tetrahydrocannabinol (THC), Cannabidiol (CBD) and Cannabinol (CBN) a degradation product of THC. THC is the substance that is known for its psychotropic effect, for which it has become the most popular recreational drug worldwide. However, cannabinoids are found in the plant material in an acidic form that changes only after heating these substances. Some terpenes that are found in cannabis, such as Myrcene and Beta Caryophyllene are quite often generally available in other plant species too and are also known for some of their therapeutic effects such as relaxing (Myrcene) and anti-inflammatory (Beta Caryophyllene).2

The constituents mentioned above are most abundant in the female flowers of the plant species, making these flower-buds (cannabis flos) the most wanted part of the plant for both recreational and medicinal use.

5. Administration of the Drug-substance

Cannabis flos (constituents) can be administered via inhalation and/or by digestion. The most popular way is via inhalation because of the quick onset of effects (only a few minutes). The digestive way takes more time (approximately 1–1.5 hours) to become effective. In both cases the substance needs to be heated up to a temperature of at least 200 degrees C to change the less effective acidic cannabinoids into the regular cannabinoids (decarboxylation). This is the main reason why smoking cannabis has become the most popular way of using the substance. However, exactly the same effect can be achieved by vaporizing (using a vaporizer) the volatile compounds of the plant matter instead of combusting the substance.3

6. Current Legal Use of Cannabis as Medicine Worldwide

Using cannabis as a medicine, in full compliance with the UN Single Convention on Narcotic Drugs of 1961, is now officially allowed in six countries:

Canada.

The Netherlands.

Germany.

Italy.

Finland.

Israel.

Three of these countries (Canada, The Netherlands and Israel) also allow production of cannabis to be sold to patients under very strict requirements. Germany, Italy and Finland import cannabis from The Netherlands through the Dutch Office of Medicinal Cannabis (an official government agency as defined by the UN treaties). In these countries cannabis is prescribed for patients by a doctor, on prescription through the regular pharmaceutical system.

Although until recently, medicinal cannabis was not reimbursed on a regular basis in The Netherlands, an increase in the annual number of prescriptions has been noted since 2006.4 Doctors in The Netherlands are free to prescribe cannabis for any condition, however the Office of Medicinal Cannabis specifically recommends use of the drug for patients suffering from Multiple Scleroses (spasms and pain), HIV/Aids (wasting syndrome), Tourette syndrome (tics and spasms), Cancer (nausea and vomiting related to chemotherapy and pain), Glaucoma (lowering eyeball pressure) and Neuropathic pain.5

Since January 1st 2012 the biggest Dutch Health insurance company, Achmea (4.7 million clients, 29% market share), has started to reimburse medicinal cannabis for 100 % of all their clients that have a prescription from their doctor to fight symptoms of one of the diseases for which the use of cannabis is recommended by the Dutch government.

In Canada patients have to obtain a license from the government on the basis of a so-called “recommendation” from a doctor, to either grow cannabis for themselves or obtain it from the government.

In Israel people have access to medicinal cannabis the same way as in Canada, however the government is not producing or providing cannabis (products) to patients. This is done by a number of government licensed growers.

The Swiss government has allowed the use of cannabis and cannabis derived products as medicine since 1 July 2011.

The government of the Czech Republic is preparing a change of law that will allow the use of cannabis as medicine under strict conditions in the near future.6

7. Regulatory and Pharmaceutical Compliance

The main reasons to not legalise cannabis for medicinal purposes are often found in regulatory and pharmaceutical hurdles. Leakage to illicit markets, lack of standardised cannabis and lack of scientific proof are often mentioned in this regard. However lack of scientific proof of efficacy of natural cannabinoids is no longer a valid argument since the cannabis extract Sativex (GW Pharmaceuticals) has become a registered medicine in the UK and other European countries as well as in Canada. Beyond that, the number of positive clinical studies with cannabis and cannabinoids has increased rapidly over the last decade.7 8

In The Netherlands our company (Bedrocan BV) has been producing cannabis flos for the Dutch government since 2003. We now produce four standardised varieties which are made available to patients on a doctor’s prescription through pharmacies. These varieties are all standardised for their content of THC, CBD, CBN and moisture. Since last year we have also been able to detect and quantify the terpene content of cannabis.9 Within a few years our varieties will also be standardised for the most abundant terpenes in each variety. During the nine years that cannabis has been legally available as medicine in The Netherlands, not a single case of abuse by patients has been reported.

8. Hiding Behind Patients

Discussions about regulation and/or legalisation of cannabis are nowadays seriously polluted by confusing medicinal and so-called recreational use. This basically started in the United States in the mid nineties, when the state of California legalised use and growth of cannabis for medicinal purposes. The state of California failed to embed cannabis into the regular medical and pharmaceutical system at the time. This triggered the rise of a newly created system of home growers and cannabis outlets, organised by non-professionals that claimed to be professional, supported by a group of medical doctors that were only interested in earning money by selling so-called recommendations to people that were looking for access to cannabis (with or without medical reasons).

This system started to spread around the world from the beginning of the 21st century. Many illicit growers and traders did see (and still do) the medical use of cannabis as a mean to earn huge amounts of money, more or less legally. While more scientific data was being gathered that supported the efficacy of cannabis, these people started to promote cannabis as a panacea, blurring the entire scientific discussion about the medical value of cannabis and making governments (understandably) very hesitant about allowing this substance in its raw form to become legal. However, now scientific evidence about the efficacy of cannabis for treatment of certain serious conditions is piling up, it is, at the least, very peculiar that many governments, including the UK’s, still refuse to even touch the subject.

9. Solving Problems by Clear Separation, Legalisation and Regulation

Clear separation of medicinal and non-medicinal use of cannabis, by rescheduling and regulating cannabis for medicinal purposes, will definitely help to solve urgent matters of public health and several legal and emotional problems in this field.

It is our experience over the last decade that many patients suffering from serious diseases only find relief from cannabis and some of them are even willing to go to jail for it. Our company has been approached by several patients living in the UK with requests for access to our products. In several cases they even came to Holland to obtain a prescription for medicinal cannabis from a local doctor to see whether it works for them. And in a number of cases it does work. If no legal alternative is available to these people, they either turn to the illicit market or start growing cannabis themselves. However in both cases, the finished product is not controlled in any way, so patients basically don’t know what they are getting. Products from the illicit market are often contaminated with residues of pesticides and fungicides or other dangerous substances, such as led dust or milled glass. This is to get more weight into the product or give it a more attractive appearance. These products can have a seriously negative effect on the already vulnerable condition of patients. Legalising and regulating the use and production of medicinal cannabis will contribute very significantly to the wellbeing of many patients who at present depend on the illicit market.

Regardless of the question whether cannabis should be entirely legal or not, once legal and illegal use and production are clearly separated, the legal system will be able to operate much more effectively against illicit use and production. Importantly, producers will not be able to “hide behind patients” anymore, by stating in court that they grow and sell cannabis for medicinal purposes.

All in all a clear policy aiming for separation between medicinal and recreational use will have a positive effect on the financial burden (policing, judiciary, NHS) on the UK government that goes along with the current policy of full prohibition of all use of cannabis.

January 2012

1 IACM survey among almost 1000 patients World wide. http://www.cannabis-med.org/meeting/Bonn2011/abstractbook.pdf page 42

2 Beta-caryophyllene is a dietary cannabinoid. http://www.pnas.org/content/105/26/9099.short

3 D I Abrams, Vaporization as a smokeless cannabis delivery system: a pilot study. Clinical Pharmacology & Therapeutics (2007). http://www.nature.com/clpt/journal/v82/n5/abs/6100200a.html

4 Stichting Farmaceutische Kengetallen. http://www.sfk.nl/publicaties/farmacie_in_cijfers/2011/2011-20.html (only available in Dutch.)

5 www.cannabisbureau.nl/en

6 http://www.vlada.cz/assets/ppov/protidrogova-politika/Press_release_medical_cannabis-in-CR_08122011.pdf

7 Journal of Ethnopharmacology 105 (2006) 1–25.
http://www.doctordeluca.com/Library/WOD/WPS3-MedMj/CannabinoidsMedMetaAnalysis06.pdf

8 Cannabinoids 2010;5 (special issue):1-21 http://www.cannabis-med.org/data/pdf/en_2010_01_special.pdf

9 J.T. Fischedick: Metabolic fingerprinting of< i> Cannabis sativa</i> L, cannabinoids and terpenoids for chemotaxonomic and drug standardisation purposes. http://www.sciencedirect.com/science/article/pii/S003194221000381X

Prepared 8th December 2012