German Tax No.: 38/108/04462
VAT No.: DE313501847
German Tax No.: 38/108/04462
VAT No.: DE313501847
The difficulties that German patients have already faced in obtaining a drug that is now legal in their own country for medical use (and even for recreational purposes across an open border in Holland) are legion. While to a certain extent, German patients are in the same boat as patients elsewhere and their problems, in fact, there are still huge access issues that remain. For starters, the drug is much more expensive here, so those without health insurance approval face bills of about $3,000 per month. Why the eye-watering price? All medical grade cannabis is still imported, although increasingly this is now just via other EU countries, not just from Canada.
“One of the reasons we organized the national German Patient Roundtable is to give patients a voice in all of this supply and demand discussion and to help BfArM and others formulate workable solutions for all,” responded Philip Cenedella IV when reached for a response by CIJ. Cenedella, an American expat and the organizer of the Roundtable, a nationally focussed, umbrella group that is kicking off its campaign this year, spoke for many who are far from court and boardrooms where the decisions are being made.
“While there are very talented firms who will now take up this discussion with the government and reissue a response for the tender, what we continue to see on the ground is that patients simply do not have the access granted them in the law which was passed over a year ago,” Cenedella says, with more than a note of frustration. “We again are calling on all government officials, industry executives and patient advocates to band together to immediately establish workable protocols that directly help the patients.”
Indeed, despite the frustration and delay, if not new costs and opportunities that this decision creates, one thing is very clear on the ground here. The current status quo is unacceptable. That alone should also put pressure on the powers that be to remedy the situation as quickly as possible. And via several routes, including widening import quotas or even issuing new licenses as a new solution to domestic cultivation is implemented.
“Patients are not being served and do not have access to a medicine that has been proven to improve lives,” says Cenedella. “Our simple request is for BfArM to finally invite patients into their discussions, to work with patients to formulate workable cultivation and distribution solutions, and we humbly request that this happen now before they go down another dead-end road, ending in another court defeat, and resulting in even more delays to the patients that are still lacking the care afforded them by the German Federal Court’s decision of 2017.”
For more info:
BY MICHAEL KNODT ON
Bureaucratic hurdles and an unexpectedly high demand for medical cannabis in Germany have created a bottleneck that’s plagued cannabis patients and producers alike. It would seem as though working with the United States could alleviate some of the pressure, but the federal government in Germany has avoided working with the country’s producers for fear of violating the United Nations Single Convention on Narcotic Drugs.
Until Germany can develop a robust cannabis cultivation industry, its patients will continue to receive their medicine sporadically from Canada or the Netherlands. While 18 varieties of cannabis are supposed to be available, patients are lucky to find four strains at their local pharmacy — a significant issue when German doctors are required to prescribe a specific strain for patients. If that strain’s not available, the prescription is worthless.
Once the Israeli government has defined their guidelines for cannabis export, their medical cannabis will find its way into German pharmacies to help alleviate the recent bottlenecks. Israel is expected to develop a cannabis export system in the next couple of years.
Cannabis farmers in the U.S. West Coast, Nevada, Colorado, and Alaska might welcome the opportunity to expand into international markets, and patients in Germany could benefit from the new, highly effective selection of U.S. cannabis strains. But the United Nations Single Convention on Narcotic Drugs labels cannabis on par with cocaine and opium — therein lies the problem for Germany doing business with U.S. cannabis producers.
The Single Convention on Narcotics and Drugs of 1961 is still the foundation of worldwide drug legislation. It includes the coca, opium poppy, cannabis, the opium plant’s raw materials, opiates, heroin, and some synthetic opioids such as methadone. The Convention on Psychotropic Substances of Feb. 21, 1971 extended the list of controlled substances to include psychotropic substances such as amphetamines, barbiturates, and LSD and came into force on Aug. 16, 1976.
Only the medical use of narcotics for pain relief is excluded from the Convention but has to be enacted in compliance with the measures deemed necessary by the United Nations (UN). Member nations must report their produced, exported, stored, and used narcotics to the Narcotic Control Council.
A State Must Purchase All Medical Cannabis Crops
Article 23 of the Single Convention states:
A Party that permits the cultivation of the opium poppy for the production of opium shall establish, if it has not already done so, and maintain, one or more government agencies (hereafter in this article referred to as the Agency) to carry out the functions required under this article.
Article 23 (2) (d) says: “All cultivators of the opium poppy shall be required to deliver their total crops of opium to the Agency. As soon as possible, but not later than four months after the end of the harvest.”
According to Articles 26 and 28 of the Single Convention, the same control system applies to coca and cannabis. Health Canada is in violation of Article 23, paragraph 2d for allowing producers to sell directly to patients. Unlike the Office of Medical Cannabis (OMC) in the Netherlands, the Canadian agency does not purchase and sell the licensed producers’ crops.
The establishment of such an agency is independent of whether government institutions or licensed private providers take over the cultivation. Such agencies only exist in the few states where opium, coca, and cannabis are grown legally: The Turkish Grain Board (for Opium in Turkey), Health Canada’s Office of Controlled Substances, the National Institute on Drug Abuse in the U.S., the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, the Austrian Agency for Health and Food Safety, the Office of Medicinal Cannabis in the Netherlands, the Czech State Agency for Medical Cannabis, and the Medical Cannabis Unit in Israel.
The U.S. government would have to recognize the medical benefits of cannabis and remove the drug from Schedule 1 of the narcotics act before the NIDA could offer medical cannabis for export to the German BfArM.
Ways Around the Single Convention
It is almost impossible for a member of the United Nations to legalize cannabis without coming into conflict with the international community. Uruguay, Bolivia, and Canada have already had to deal with the issue and have each taken different approaches to reconciling new national policy with existing international agreements.
Out and Back In
In 2009, the Bolivian government proposed deleting some provisions regarding the coca leaf, but the proposal was rejected by the other member nations. On June 29, 2011, Bolivia withdrew from the Single Convention through Jan. 1, 2012 and rejoined with an objection to Article 50 on Jan. 10, 2012.
Bolivia stated that it would allow the cultivation, trade, and consumption of coca leaves in its country. Within one year, 15 contracting nations filed an objection, well short of the one-third quorum required to reject Bolivia’s objection. Bolivia was reclassified as a contracting party on Jan. 11, 2013.
Ignore the Issue
Uruguay was reprimanded shortly before the legalization of cannabis by the UN Drug Administration’s International Narcotic Control Board (INCB). The former INCB-president Raymond Yans accused Uruguay’s then-president Jose Mujica of having an “attitude of a pirate” because his government legalized cannabis. Mujica fiercely resisted the allegations repeatedly made against his country and publicly responded to the criticism of the former INCB chairman:
“Tell the old man to stop lying. We can meet whenever he wants in Uruguay. […]. He sits in a comfortable position on the International stage and believes he can tell nonsense.”
Despite the dramatic exchanges, the international community has not sanctioned Uruguay for being the first country in the world to legalize cannabis. Incidentally, a similar complaint was addressed to the United States after the legalization ballots in Colorado and Washington State. In November 2012, Yans stated the legalization of the cultivation and possession of cannabis in Colorado and Washington violated the treaty and asked the U.S. government to restore conformity with the single convention.
Recreational cannabis is legal in eight states and the District of Columbia, and the international community is far from sanctioning the U.S. However, ignoring the treaty also means missing out on access to the international market and the opportunity to take part in international research efforts.
Don’t Comply, Justify
At the 59th meeting of the United Nations Commission on Narcotic Drugs in March 2016, Undersecretary for Health of Canada Hilary Geller expressed Canada’s interest in international cooperation and made it clear, “the Government remains committed to strong international cooperation to combat the world drug problem and wherever possible, will seek to align its objectives for a new marijuana regime with the objectives of the international drug control framework and the spirit of the Conventions.”
Canada is the first to take the position of “non-compliance.” With Geller’s announcement, Canada has laid the foundation for an ongoing debate on how to regulate cannabis at the national level without violating international legal obligations.
Even if the 1961 Single Convention could be amended, that would involve a complex, years-long process.
Canada could set a precedent in July 2018, by forcing the U.N. to rethink the position of cannabis for the first time since 1961. The aim of the process would be to give all member nations the opportunity to regulate recreational and medical cannabis in the future. Legislation in international agreements is never set in stone, it can be changed any time the democratic will of the member nations demands it.
Michael Knodt is an expert on cannabis politics and cannabis culture across Europe. Born in North Germany, Michael has been living in Berlin since 1990. He initially studied history and journalism before receiving his certification as a carpenter. Since then, Michael has made regular visits to countries where cannabis is cultivated, such as Jamaica and Morocco. He has worked as a freelancer for Weedmaps, Vice Magazine Germany, Sensi Seeds and numerous German-language cannabis magazines since 2004. From 2005 to 2013, Michael was the Editor-in-Chief of Germanys biggest cannabis periodical. He also is the face and presenter of the most popular program on cannabis prohibition and just launched a new channel called “DerMicha.” Aside from his journalistic work, Michael is a cannabis patient, activist, sought-after speaker on conferences and congresses, and a father of two.
The current regulation in Germany made it difficult for German companies to apply to get a license for Cannabis cultivation.
** And that is why the process is now held up in litigation in the German court system. One of the unsuccessful bidders has sued over the requirements and the entire application process is on hold, with any potential awards being made in Q1 or Q2 2018 at the earliest.
What is the most popular model for cannabis cultivation in Germany, so far?
The cultivation in Germany is currently not legal, done outdoors and indoors and hidden from sight and smell as best as possible.
There is no legal German cultivation currently allowed, even for patients with valid medical approvals.
There is small cultivation being done as part of R+D projects in Universities and Scientific companies.
Regarding joint ventures: How do foreign cannabis companies usually work together with German companies?
In various ways, based on their business objectives and strategy. Three examples are:
Canopy Growth Corporation purchased a German firm Medcann, which became Spektrum Germany. They are considered by many to be the premier cannabis firm in Germany today.
Maricann of Canada purchased a former cargo facility in Dresden for 3€ million and is ramping up their European operations, adding staff, and building out their new European headquarters.
An international firm is currently in discussions with a German startup, to establish a joint venture partnership which will make news around the world. This partnership should be made public in early 2018 and will be ground-breaking.
To cover the demand of medical cannabis Germany is importing from other countries. Supply is coming especially from Canada. Which other countries might be relevant cannabis suppliers in the future?
Canada and The Netherlands are currently the only authorized countries to import into Germany. Supplies are seriously constrained and with Canada becoming a legal recreational country in July 2018, the supply bottlenecks are expected to be exacerbated well into 2019.
Tilray has announced plans to establish a cultivation facility in Portugal to supply the German, and European market in the future.
The governments of Greece, Israel, South Africa, Australia, Chile, Uruguay, and others are currently working with private sector companies to establish their own cultivation and export capabilities.
Germany, with twice the population of California, is a key market for any serious player in the global cannabis industry.
What is your personal opinion about the current German regulation. What will be the next major steps?
Regulation and taxation is always better than the illegality and violence of the black market. Always.
Thank God for the German court system which has brought legalized medical marijuana to the people, if it were up to the politicians, we would still be waiting.
Now the intelligent implementation of recreational laws need to be established to legalize the plant which has been used for thousands of years.
Reducing opioid deaths, helping certain people with their medical conditions, and enabling super-straight people to enjoy jazz music are just some of the benefits of a world where ganja is regulated, safe, and profitable.
The flower of cannabis will always have a place in the market, but in the next years we will see an increase in other forms of cannabis that are more easily consumed….edibles, oils, salves and the like. As a result, GMP (Good Manufacturing Process) certification is going to become very important for those wanting to establish a quality product in the German and European markets.
And if we look at the European Cannabis market. Which major market trends do you identify?
1- Everyone seems to be focusing on cultivation, but this segment is expected to become a commodity item in the near term. Companies may want to look at establishing a product line including “finished products with GMP certification” to become a leading force in this market.
2- At some point the insurance companies are going to become true partners in providing cannabis therapies to the German pharmacies. This will happen as a result of cost-savings and health-benefits realized vs. the current pharmaceuticals offered to patients.
3- In the words of Peter Tosh:
The Berlin Peace Accords (attached) calls for an end to the 80 year World War On Cannabis, and we agree. Legal, regulated, safe and non-violent recreational marijuana markets have already been established in the US and Uruguay, with Canada and others joining the party in 2018.
Pharmaceutical companies don’t like it, Beer companies don’t like it (although the owners of Corona beer just invested $250 million in Canopy Growth’s cannabis business last month) and some short-sighted politicians don’t like it. But “We the People…” have made our opinions known and the calls for a rational, legal, safe and non-violent cannabis market is just a few moments away here in the center of Europe.
These are historic times, Germany is leading the world in many ways, 2018 will be an interesting year.
October 31, 2017
As many Americans start the day making plans for Halloween 2017, the folks here in Germany have the day off of work to celebrate the 500-year Anniversary of Martin Luther’s project to reform German society. Surprisingly, the newspapers today also announced Chancellor Angela Merkel’s intentions, along with her new coalition partners called the “Jamaican coalition” to consider legalizing marijuana.
Seems an unintended benefit of the AFD’s victories in the last elections, is the CDU ruling party is now more receptive to working with those with divergent views in order to maintain their leadership position.
Could this really be the start of the Reformation of the 20th century drug laws in Germany and beyond?
Has the work of the DHV in Berlin and their partners finally started to pay dividends?
Was the signing of the BERLIN PEACE ACCORDS http://www.berlinpeaceaccords.de , which begins with “We the people of the Year 2017 do…
Hereby declare that it is our inalienable basic human right to have the freedom to grow, medicate and enjoy the plant we call Cannabis, without any governmental limitations.
We demand our plant has no more regulations or limitations than a tomato plant…..” really have been the precursor to this historic moment?
Good questions, time will tell, but for sure our collective efforts as cannabis business executives are starting to pay dividends.
The month of October had started off with over 350 doctors, scientists, investors and industry professionals waking up in view of the massive Cologne Cathedral, which is truly an amazing sight to see in person! The International Association for Cannabinoid Medicines’ (IACM) CANNABINOID CONFERENCE was held in downtown Cologne bringing together experts from Canada, Australia, Germany, and from throughout the world. Their website is http://www.cannabis-med.org and three take-aways were:
The idea that “Marijuana has no medicinal value” was pretty much, fully debunked 😊
The breath and quantity of existing “clinical trials” on our plant is amazing.
Meeting Josh Stanley, whose company has arguably helped more medical marijuana patients than anyone, was a privilege. CW Hemp’s team continues to lead the industry in many ways,…and additionally they are simply very cool people.
Later in the month, the folks from the regulatory and compliance organization ASTM came to Berlin for a 2-day intensive session for their new “Technical Committee D37 on Cannabis” section. You know we are becoming a real industry when 2 days is spent talking only about compliance related issues. Half the group was from Germany, including executives from the first licensed marijuana testing facility located within Germany, scientists from the University of Berlin currently working on marijuana clinical trials, and a few of the leading homegrown companies on the front lines including ABCann Germany, MH Hemp, Pedanois, and two guys who reminded me of what a young Ed Rosenthal would be like. 😊
So as November 2017 begins, many of us will meet in Berlin this weekend for the first annual DHV Convention. Their website is https://hanfverband.de and they are unequivocally the leading organization for marijuana reform in Germany today. This convention will probably confirm these four truths of the marijuana landscape in Germany today:
Canadian firms are kicking butt!
They understand the requirement of GMP certification, their government is supportive of providing qualified companies an export license for their THC-based products, and their executives are damn smart.
German firms are coming of age, are intelligent and committed.
The first DHV convention will be highlighting the work of patient advocates, industry professionals, knowledgeable physicians and forward-looking politicians involved in building this new industry within the German borders.
The European, South American, African, Israeli and Australian firms are all actively making plans to succeed.
Governments, investors, and executives from throughout the world are looking at Germany and making their plans to enter the European market with its 750+ million potential customers. They are forming strategic partnerships, investing in commercial facilities, and making Europe a priority for 2018.
The USA is an abysmal no-show in the game.
America started the war on Marihuana last century, and somehow tries to keep the war alive today. Scientist, Stoners and Society have evolved quite a bit since the 1930s. The Germans have taken note, changed course in their direction, and their people will be better off as a result.
Maybe now it’s time for President Trump get religion and start his own Marijuana Reformation project?
– Philip J. Cenedella
Sativex and Bedrocan are now available in many European countries, and several have infrastructure in place to supply patients with medicinal cannabis. So which countries are moving with the times, and which are dragging their heels? Where are medicinal and recreational users most (and least) free to utilize their drug of choice? Let’s take a look at the facts.
While there is plenty of accurate, up-to-date information online about medicinal cannabis in Europe, finding one reliable source to tell you everything you need to know can be an all-but-impossible task. So we’ve collated hundreds of online resources – news reports, analysis by governments and NGOs, and patient perspectives – in order to create a complete overview of the status of medicinal cannabis in Europe.
We have striven for clarity and accuracy in all respects, but we recognise the fact that legislative waters can at times be murky and misinterpretations can be made. Added to this, legislation is changing rapidly, so we’ll be adding updates every three months or more if necessary. Thus, we welcome any comments, feedback, or corrections – and your input will help us to make this a truly interactive resource that will continue to be relevant for many years to come!
Medicinal Cannabis Legality & Availability In Europe
The Situation With Medicinal Cannabis In Europe – A Complete Overview
This map shows the general state of medicinal cannabis legality and availability in Europe. All countries that have passed medicinal cannabis laws, that have approved whole-plant cannabis or cannabis-based drugs, or that make cannabis/cannabis-based drugs available in some form are marked green.
At first glance, the situation looks relatively good in the majority of European nations. However, we need a little more analysis to really get a clear picture, as medicinal cannabis laws and praxis vary wildly between countries.
Some countries that have passed laws supposedly allowing for the provision of medicinal cannabis do not actually permit anyone to use it; other countries do prescribe certain cannabis derivatives or synthetic cannabinoids, but do not allow whole-plant cannabis, while others have relatively relaxed laws that allow for personal medicinal cultivation, cannabis social clubs that supply medicinal users, and a range of different prescription medications.
Some of the countries marked in green don’t actually have medicinal cannabis laws at all, and haven’t approved any existing cannabis-based drugs, but still make medicinal cannabis or cannabis-based drugs available to certain patients under special access rules. In these countries, the national health authorities usually import the drugs on a strictly-limited, case-by-case basis. Obviously they are not ideal systems, but if laws have been passed or if there are patients receiving cannabis drugs or derivatives in those countries, then they get included in the green section of the map.
If you wish to know more about the cannabis-based drugs that are available in Europe today, please take a look at our post Cannabinoids in medicine – an overview for doctors and professionals, published in March 2016.
Sativex Availability In Europe
The Situation With Medicinal Cannabis In Europe – A Complete Overview
First, let’s take a look at Sativex availability. Although controversial, Sativex has won considerable success in gaining approval in much of Europe and in many other countries worldwide. The reasons for controversy surrounding Sativex are manifold.
Many activists and patients believe that licensing and regulating Sativex while cannabis itself remains illegal (as is now the case in the majority of Europe) is unfair and discriminatory, particularly given that it is a whole-plant extract and thus is essentially cannabis (unlike synthetic, single-molecule drugs like nabilone and dronabinol, which we will discuss later).
These issues are further compounded by the fact that Sativex is prohibitively expensive and inconsistently available in many countries. In the UK, Sativex is only available on the NHS in Wales. In August 2014, the All Wales Medicines Strategy Group (AWMSG) recommended that Sativex could be prescribed on the NHS (meaning that costs would be borne by the health authorities with just a small nominal charge to the patient) in Wales for treating MS-related spasticity.
However, the UK National Institute for Health and Care Excellence (NICE) did not recommend prescription of Sativex in England in their 2014 MS Clinical Guideline “because it is not a cost effective treatment”.
In April 2011, the Scottish Medicines Consortium (SMC – the Scottish equivalent to NICE) also announced that it was unable to recommend Sativex, as it had not received a marketing authorisation submission from GW Pharmaceuticals. Thus, patients in England and Scotland wishing to obtain Sativex must “go private” and cover all costs themselves.
A similar pricing issue exists in France, where authorities approved Sativex back in 2013, but have yet to agree a sale price with GW Pharmaceuticals’ European distributor, Almirall. Sensi Seeds reported in December 2015 that Sativex was still not available in France, and that there was little likelihood that it would be available in the near future.
In Finland, Denmark and Norway, Sativex is available on a strictly-limited, case-by-case basis, and is prohibitively expensive compared to other forms of medicinal cannabis. However, the situation in Finland has improved significantly over the last few years (since medicinal cannabis laws were passed in 2008); the number of patients receiving medical cannabis in the form of Sativex or Bedrocan products rose from just 12 in 2010 to around 200 in 2014.
In Ireland and Malta, Sativex has technically been approved but never prescribed – in Ireland, pricing issues have delayed the release of Sativex, while in Malta, the sole application received thus far was recently rejected by the health authorities.
GW Pharmaceuticals’ near-monopoly on legal medicinal cannabis allows it to profit significantly, while individuals growing personal quantities of cannabis continue to be criminalised throughout much of Europe. Many individuals that grow cannabis in small quantities intended for personal medicinal use do so as it presents the only truly affordable option. That these individuals continue to be persecuted for reasons that appear to be solely economic is a dire failure on the part of the national and supranational authorities of Europe.
Marinol/Cesamet Availability In Europe
The Situation With Medicinal Cannabis In Europe – A Complete Overview
Nabilone and dronabinol, marketed as Marinol and Cesamet (or Canemes in some countries), are two single-molecule, synthetic THC analogues that have also gained approval in many European countries. Generally, they are approved for nausea, vomiting and weight loss related to cancer and HIV.
As synthetic, single-molecule drugs, nabilone and dronabinol are of limited effectiveness, and are also associated with more severe side-effects than cannabis itself. Several countries have allowed use of nabilone and dronabinol while continuing to prohibit use of medicinal cannabis itself, such as Denmark, which has approved thousands of applications for Marinol in the last decade but none for Bedrocan.
Dronabinol and nabilone were developed over 30 years ago, and have never been particularly popular with either patients or healthcare professionals. Although they have been prescribed to many more patients than Sativex at this stage, there are clear signs that Sativex is now taking over in terms of availability, acceptability and popularity. This surely represents a step in the right direction, towards recognition of the superior medicinal value of whole-plant cannabis over single-molecule, synthetic therapies.
In Germany, nabilone and dronabinol are both apparently still available on prescription, but since 1991, they have not been available on the open market as finished medicinal products (i.e. they are not pre-packaged and available for purchase from pharmacies).
Interestingly, dronabinol is scheduled under international law, as it is a stereoisomer of THC, whereas nabilone is not scheduled as its molecular structure differs from true cannabinoids substantially. In Iceland, for example, dronabinol is technically banned, but has been exempted and authorized for use in special cases by the Icelandic Medicines Agency. Nabilone is not subject to a ban – but each drug has only been prescribed in a tiny number of cases, under special access rules.
Bedrocan Availability In Europe
The Situation With Medicinal Cannabis In Europe – A Complete Overview
Countries that permit the use of Bedrocan (or other products from the same manufacturer, i.e. Bediol, Bedrobinol and so on) are much more limited, and in most cases, the medicine can only be imported on a case-by-case basis by the national health authority of the country in question.
As Bedrocan products are whole-plant, herbal cannabis flowers, countries that allow its use would seem to be the more progressive of the European countries with regards to cannabis use. In reality, the situation is a little more complex.
Bedrocan products are considered preferable to Sativex for various reasons, but dissatisfaction among patients remains. In Norway and Finland, for example, Bedrocan products may only be imported on a strict case-by-case basis with approval from the national health authority. They represent a comparatively inexpensive option – in Finland, Sativex reportedly costs €650 for three spray bottles containing 810mg THC and 750mg CBD in total; equivalent total cannabinoids can be obtained from Bedrocan products costing €200 or less.
However, very few individuals actually have access to Bedrocan (in Finland: 123 in 2012, though numbers are likely to have risen since then), and the number of conditions for which it can be prescribed is greatly limited.
Bedrocan in the Netherlands
In the Netherlands, Bedrocan became the sole licensed medicinal cannabis producer in 2003, with the implementation of the 2001 law purportedly legalizing cannabis for medicinal use – which also saw the creation of the Dutch Office of Medicinal Cannabis (OMC).
But prior to this, medicinal cannabis (reportedly cheaper and more effective) was available from at least one other supplier (Maripharm BV, a company that is now restricted to making CBD-only products) and utilized by thousands more patients, who were prescribed cannabis by their doctors and obtained their medicine directly from over 1,000 different pharmacies. This situation wasn’t legal, but it was tolerated, and it appears to have been greatly preferable for patients.
In 2001, the OMC was established (according to UN treaty rules, a country must establish an office to oversee medicinal cannabis if it wishes to make it available), and in 2003, the new medicinal policy was implemented. But it may have had the effect of making medicinal cannabis less available to Dutch patients – according to the BSEMC (the Public Interest Foundation for Effective Medical Cannabis), 10,000–15,000 patients used medicinal cannabis each year under the old system compared to just 140 each year between 2003 and 2013.
A study from the University of Utrecht published in 2013 puts the figure considerably higher, at approximately 1,000 per year; we are currently awaiting figures from the OMC itself, and will update as soon as the information becomes available.
Patient concerns regarding Bedrocan products are not limited to availability or cost, however – all Bedrocan products are treated with gamma radiation to ensure pesticides, heavy metals and microorganisms are purged out. This is a requirement of the OMC, but has caused concerns over effectiveness and safety in some patients, and led many to purchase cannabis from coffeeshops in preference to pharmacy products. This video report from the Cannabis News Network goes into great detail on the subject of Bedrocan and medicinal cannabis legislation in the Netherlands.
Furthermore, as Sensi Seeds reported earlier this year, Bedrocan is struggling to provide other European countries with sufficient product. As the sole supplier of medicinal cannabis in Europe, demand for their services is rising rapidly, to the extent that a new production facility was opened in 2015 – but supply bottlenecks continue to occur.
European National Programs For Medicinal Cannabis Cultivation
In a small number of European countries, the national government has taken the stance that state control and regulation of the medicinal cannabis market is the sensible route forward. Ostensibly, these state-run programs have the advantage of offering cannabis to registered patients at a lower rate than currently-available forms.
Presently, the only European nations implementing state-controlled medicinal cannabis production are Italy, the Netherlands, and the Czech Republic. As already discussed, the Netherlands has awarded the sole license to produce medicinal cannabis to Bedrocan BV. Germany is now discussing plans to implement a similar program, but it is not thought that this will be in effect until at least 2017.
Here, we do not class the UK among countries producing medicinal cannabis, despite GW Pharmaceuticals’ license to grow cannabis and manufacture Sativex, as Sativex is not distributed as whole-plant, herbal cannabis flowers (and is not widely available in the UK).
In the Czech Republic, the logistics company Elkoplast is licensed to produce medicinal cannabis using Bedrocan strains and expertise. According to reports, Elkoplast distributed its first crop of 11 kg in February 2016; the cost of the Elkoplast cannabis is apparently around 100 Koruna (€3.70) per gram (compared to around 300 Koruna/€11 for imported Bedrocan). Elkoplast intends to produce 40 kg this year.
Last year, doctors registered to prescribe medicinal cannabis in the Czech republic (who currently number around 20) supplied cannabis to just 30 patients. It is thought that patients numbers will increase significantly with the implementation of the new system. Medicinal cannabis only became legal in the Czech Republic in 2013, so progress has been comparatively rapid to date.
In Italy, the army recently completed its first crop of cannabis intended for distribution to patients with a doctor’s prescription for medicinal cannabis. The Army plans to grow 100 kg this year – which is reportedly around double the quantity currently imported from the Netherlands, and regional health authorities aim to distribute it for €5–€15 per gram, compared to approximately €40 per gram for Bedrocan.
Interestingly, any doctor in Italy may prescribe medicinal cannabis to a patient – this situation differs dramatically from many other European nations, where cannabis may only be prescribed by specialists such as neurologists and oncologists. Furthermore, numbers of doctors willing to prescribe cannabis appears to be relatively high, and patient interest is rapidly growing.
On the other hand, this latter fact is known partially through the reported high volume of applications to import Bedrocan products made by Italian patients to the Dutch OMC. The Army crop is yet to be distributed, and the process has been subject to several delays thus far. However, Italy is demonstrating a very progressive attitude despite remaining mired in logistical difficulties, and the extent of progress here is highly encouraging.
State Control Of Cannabis May Not Be Ideal
Typically, the element of state control involved in such programs is simply licensing out the right to grow medicinal cannabis to a single producer. This is far from ideal, for various reasons: supply issues such as those experienced by Bedrocan and a lack of competition on price, quality and variety are commonly cited potential problems.
In Italy, state control of the production of cannabis does not exist alongside the right to cultivate personal quantities of cannabis, as is the case in the Netherlands and the Czech Republic. It was widely reported in January 2016 that cultivation of medical cannabis had been decriminalised in Italy, but it does not appear that this is entirely accurate.
Italian Prime Minister Matteo Renzi in January announced a long list of minor reforms, including the lifting of criminal penalties for violations of medical cannabis cultivation rules. However, it appears that this only applies to researchers or individuals “working in the field of medicinal cannabis”, and not to the general public.
Thus, the Italian system has been criticized as just another half-measure, which monopolizes potential profits and deprives patients of choice and anonymity. There are also doubts over whether the amount of cannabis produced by the army will be sufficient to meet patient needs, and as Italy operates on a regional healthcare system, some are concerned that the cost of state-produced cannabis will vary widely between locales. Reportedly, the crop will also be gamma-irradiated, which may raise similar concerns as in the Netherlands.
However, the next few years will continue to see decisive change in Italy. Currently, the Italian Parliament is holding talks on the possibility of implementing further steps towards both medicinal and recreational legalization of cannabis. Talks are still ongoing, and we will update this resource when the results of the discussions become clear.
The Situation With Medicinal Cannabis In Europe – A Complete Overview
Personal Cultivation Laws In Europe
The decriminalisation of personal cultivation is a very useful metric for establishing the level of tolerance a country holds towards the concept of medicinal cannabis.
Cultivation of cannabis by the general public is illegal in all European countries. However, a handful of nations have decriminalised or depenalised personal cultivation or personal cultivation for medicinal purposes; several other countries have taken steps towards decriminalisation or are in the process of implementing recently-passed laws, and several more have established precedents whereby medicinal growers have avoided criminal charges despite national laws.
Another thing to consider is the fact that many European countries have a disconnect between legislation and practice when it comes to personal possession and cultivation. Many countries operate unofficial tolerance policies that are at odds with their actual legislation; this is extremely difficult to assess due to the fact that these policies are unofficial, meaning that records may not be kept, and also that policies may change at any time without necessarily being backed up by legislation.
Thus, it’s very hard to be 100% accurate on the places where you can easily get away with growing a few plants, and we’ve done our best to clarify the picture with the information that we have available.
Spain, the Netherlands, the Czech Republic and Belgium are undoubtedly the most tolerant of cannabis cultivation by the public, and generally have legislation in place that confirms or protects the right of the individual to grow a certain number of plants (in the Netherlands and the Czech Republic, up to 5 plants, and in Belgium just one plant).
In Spain, there is no legislation that specifies that cannabis cultivation is permitted, but laws that attest to the right to possess and consume any drug in private, and a substantial set of legal precedents that have mounted up over the last 20 years or so. In 1993, the precursor to what would become cannabis social clubs sprang into existence, using the existing laws on drug possession to argue that collective, private cannabis-growing associations should also therefore be legal. After many years of challenging and disrupting the project, authorities eventually ceased their persecution and allowed the operation to proceed unhindered, opening the door to hundreds more clubs.
The UK is also an interesting case. Home-growing of cannabis is very widespread in the UK, and thousands of individuals grow for medicinal purposes. There have been several examples of individuals being treated very lightly or even escaping cultivation charges altogether after demonstrating medical need, while countless others continue to be criminalized across the country.
This discrepancy partly exists due to the uneven prioritisation of cannabis between different regional police forces – indeed, several UK police forces have reportedly implemented unofficial tolerance policies for cannabis growers due to the undoubted need to free up resources to tackle more serious crimes.
Switzerland has had a somewhat patchy record on cultivation rights – due to a legal loophole, Swiss citizens were from 1995-1999 allowed to cultivate “hemp” with no specified maximum THC limit, and even after the law was amended, shops continued to sell cannabis until at least 2005. Now, the law does not support personal cultivation, but reports of personal growers being prosecuted are extremely rare.
Several other countries have made some steps towards decriminalisation, such as removing jail sentences and imposing fines or administrative charges – such as the island nation of Malta, which recently passed laws decriminalising the cultivation of personal quantities of cannabis. However, it is not clear how these new laws will be implemented in reality.
Lastly, Sweden, Germany, and Bulgaria have all established precedents whereby medicinal growers have escaped prosecution.
Cannabis Social Clubs In Europe
The small number of European states that have decriminalised personal cultivation and also permit cannabis social clubs are arguably the most tolerant of all, although no country is without its problems. For the most part, social clubs have sprung up in countries that already had a strong subculture of cannabis use, and serve as a means of ensuring quality, safety and consistency relative to the black market.
It is important to note that cannabis social clubs are not an arbitrary concept by any means. In order to be recognized by ENCOD (the European Coalition for Just and Effective Drug Policies, which has played a fundamental role in the creation of social clubs throughout Europe), would-be CSCs must meet various requirements.
The club must be a legally registered association, and therefore accountable to local and national authorities. Furthermore, the ENCOD code of conduct for CSCs sets out five basic principles:
The club only produces cannabis for the personal consumption of its members.
The club is health oriented: in production & elaboration the norms of organic agriculture are adhered too.
The purpose of the club is not to make profit, but to support activism that seeks to bring to an end to cannabis prohibition.
The club is transparent to its members and open to dialogue with authorities.
Furthermore, the club has agreed to accept the mediation of Encod should a conflict arise with one of its members or with another CSC.
If a CSC does not meet these requirements, ENCOD will not recognize the club as a legal, official entity. Despite this, there are many CSCs currently operating (particularly in Spain) without official recognition from ENCOD.
In Spain, the original birthplace of the cannabis social clubs, the situation is complex. The system is generally working well, and cannabis is widely and cheaply available, but the country is not without its problems.
Although clubs are meant to be run on a non-profit basis, the potential to make substantial quantities of money has attracted many would-be entrepreneurs that do not necessarily prioritise patient well-being. Furthermore, contraventions of health and safety regulations and similar petty violations have presented authorities in Barcelona and elsewhere with the opportunity to close down hundreds of venues.
ENCOD currently recognises CSCs in just four countries: two in Belgium, seven in Spain, one in the Netherlands, and one in Slovenia. The Slovenia Cannabis Social Club is officially registered with the local authorities, and interviews suggest that they may be supplying their medical patients with cannabis – but Slovenian law does not yet support medicinal cultivation of cannabis by the public, despite a 2014 law allowing for the supply of medicinal cannabinoids.
Other countries are hard at work setting up the foundations of what will become official CSCs as soon as legislation allows it. These countries include the UK, Austria, France and Germany.
UKCSC.co.uk supplies a long list of “official” UK cannabis social clubs, some of which apparently do supply their members with cannabis – but it is important to note that, as the UK laws do not yet support personal cultivation, these clubs are not offically recognized by ENCOD. However, it is an important and rapidly growing network, which provides much-needed support and information to its members, as well as to the media, the government, and the interested public.
So Which Countries Are Most & Least Tolerant?
The Situation With Medicinal Cannabis In Europe – A Complete Overview
As we see, when we account for all the different variables, many of the countries that supposedly make medicinal cannabis available do not in fact do so, and in fact are no more advanced in practice than the countries that have thus far refused to consider the concept at all.
So we’ve rated all the countries in Europe on a scale of most to least tolerant, with 0 as the least tolerant and 24 as the most.
Unsurprisingly, the countries that are clearly the most favourable for medicinal cannabis in Europe are the Netherlands, Spain and the Czech Republic. The Czech Republic is perhaps the most striking in the alacrity with which it has diverged from its Soviet legacy and embraced modern, progressive drug policies which put it at the forefront of Europe.
These three powerhouses are closely followed by Germany and Italy, which are rapidly making progress, and Belgium, which has an inconsistent attitude to cannabis but many patients that are currently able to access or grow their own medicine.
Which Countries Are Most Hostile To Medicinal Cannabis?
Next we have countries that are making some progress, but have not yet made medicinal cannabis available beyond a small number of limited cases, or remain generally hostile to the necessary legislative changes. Such countries include France, Ireland, Iceland, Portugal, the Baltic states, and all of the Scandinavian nations.
Russia persists in its draconian drug policies, despite some recent, erroneous reports to the contrary. Medicalmarijuana.eu and MERCY state that Russia has decriminalised the cultivation of up to 20 plants for personal use, but upon closer investigation it appears that this is not the case: any amount of cultivation may lead to criminal charges, but 20 plants or more is considered a “large amount”.
Greece is arguably one of the most hostile countries in today’s Europe, as it aggressively criminalizes growers of all types, and does not recognise the concept of medicinal cannabis at all. Indeed, but for a few exceptions, the Balkan region remains locked in deeply regressive drugs policies.
Portugal remains surprisingly hostile to medicinal cannabis, despite its famous decision in 2001 to decriminalise personal quantities of all drugs. France too has persisted in hostile and regressive attitudes towards cannabis for years, and medicinal cannabis is very difficult to access.
The microstates San Marino, Monaco, Andorra, Luxembourg and Liechtenstein have made very little movement towards legalizing medicinal cannabis. For residents of Andorra, at least, medicinal cannabis may be easily accessed just a short distance away in Catalunya.
And Which Countries Are A Good Future Bet?
Countries that have made substantial progress, but still need a lot of work put in before medicinal cannabis becomes widely available include Switzerland, Austria and Slovenia. Poland is another, but recent reports suggest that the situation is set to improve considerably in the near future.
Malta, which has only just legalized medicinal cannabis in any form, is a surprising candidate. The small island nation has a thriving subculture of cannabis use; personal cultivation has just been decriminalised, and several forms of medicinal cannabis have been made nominally available (although a recent report tells us that they have thus far rejected their sole application (for Sativex) as it was not prescribed by a “specialist”).
Also worth noting here are Eastern European several countries that have only recently begun to diverge from the hardline Soviet attitude towards drugs that still persists throughout the region. Several of these countries – such as Slovenia, Macedonia, Croatia and Serbia – are exhibiting increasingly tolerant attitudes towards cannabis, and as such we may see considerable progress in this area in the near future. Croatia and Macedonia have both made headlines this year for implementing medicinal cannabis laws; Serbia and Slovenia have also recently legalized cannabis-based derivatives, although activists have criticised this as a placatory half-measure.
Finally, the UK has a strong base of activists and growers, but has experienced a string of governments that remain surprisingly hostile to cannabis. However, the strong grower/activist base coupled with the comprehensive network of regional cannabis social clubs that are taking shape indicate that change is imminent. On the other hand, uncertainty surrounding the Brexit vote may well see the question of cannabis legalisation pushed to the back of the queue, as it has been so many times in the past.
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In Serbia the law says minimum 3 years in jail for basically possession of cannabis, smoking in public or similar. I wouldn’t consider that green in any map. Thanks!
A number of setbacks, controversies and lawsuits keep the German cannabis market in limbo.
Germany is proceeding down the path to officially grow its own medical cannabis crops. Medical use became legal this year, along with a federal mandate for cheap access. That means that public health insurance companies, which cover 90% of Germans, are now firmly on the hook if not front line of the cannabis efficacy issue. As such, Germany’s medical market is potentially one of the most lucrative cannabis markets in the world, with a total dollar amount to at least challenge, if not rival, even California’s recreational market. Some say Canada’s too.
However, before “home grow” enthusiasts get too excited, this legislative move was an attempt to stymie everything but commercial, albeit medical production. Not to mention shut off the recreational discussion for at least another four years.
How successful that foray into legalization will be – especially given the chronic shortages now facing patients – are an open question. Not to mention other infrastructural issues – like doctor unfamiliarity with or resistance to prescribing cannabinoids. Or the public insurers’ so-far reluctance to cover it even though now federally mandated to do so.
Regardless, Germany decided to legalize medical use in 2017 and further to begin a sanctioned domestic cultivation for this market. The decision in the Bundestag to legalize the drug was unanimous. And the idea to follow UN regulations to establish this vertical is cautiously conservative but defendable. Very predictably German in other words.
Since then, however, the path has been far from smooth. Much less efficient.
Trouble in Germany’s Medical Cannabis Paradise
In April the government released its tender bid. And no matter how exciting it was to be in the middle of an industry who finally saw a crack of light, there were also clouds to this silver lining that promised early and frequent thunderstorms on the horizon.
By the time the tender bid application was due in June, it was already clear who the top firms were likely to be In fact, by the end of the ICBC conference, which held its first annual gathering in Berlin at the same time the bid tender was announced, the controversy was already bubbling. The requirements of the bid, for a laughably small amount of cannabis (2,000 kg), mandated experience producing high qualities of medical marijuana in a federally legitimate market. By definition that excluded all German hopefuls, and set up Canada and Holland as the only countries who could provide such experience, capital and backlog of crop as the growing gets started.
The grumbling from Germans started then.
However, so did an amazingly public race to gain access to the German market directly – by acquisition or capital expenditures that are not refundable easily (like real estate or even buyouts). The common theme? They were large amounts of money being spent, and made by major Canadian Licensed Producers who had the right qualifications to meet the standards of the bid. In fact, by the time the tender bid application was due in June, it was already clear who the top firms were likely to be. They were the only ones who qualified under the judging qualifications.
And while nobody would commit publicly, news of the final decision was expected by August. Several Canadian LPs even issued press releases stating that they were finalists in the bid. But still no news was forthcoming about the official list.
Delay, Delay and More Delay
A month later, as of September, and there was still no official pronouncement. Nor was anybody talking. BfArM, the regulatory agency that is supervising this rollout as well as the regulation of all narcotic drugs (sort of like a German version of the FDA) has been issuing non-statement statements since the late summer. Aurora, however, one of the top contenders for cultivation here, was quietly issued an ex-im license by both Canadian and German authorities. Publicly, this has been described as an effort to help stem the now chronic cannabis shortage facing patients who attempt to go through legitimate, prescribed channels. On the German side, intriguingly, this appears to be a provisional license. Privately, some wondered if this was the beginning of a backdoor approval process for the top scoring bid applicants for cultivation. Although why that might be remains unclear.
Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Late in the month, rumours began to fly that there were now lawsuits against the bid process. Nobody had much detail. Not to mention specifics. But CannabisIndustryJournal can now confirm in fact that there have been two lawsuits (so far).
The summary of the complaints? It appears that two parties, filing with the “Bundeskartellamt” (or regulatory office focusing on monopolies and unfair business practices) did not think the bid process or scoring system was fair. And both parties also lost.
But as of mid-October, there is still no public decision on the bids. What gives?
Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Even though the plaintiffs failed, some have suggested that the German government might force a complete redo. Others hint that it will likely be slightly revised to be more inclusive but the regulatory standards must remain. If a redo is in the cards, will the German government decide to increase the total amount of yearly cannabis to be delivered? At this point, it is only calling for 2,000 kg per year by 2019. And that, as everyone knows, is far too little for a market that is exploding no matter the many other obstacles, like insurance companies refusing to compensate patients.
What Is Behind The Continued Delays?
There are several theories circulating the higher levels of the cannabis industry internationally right now even if no one is willing to be quoted. The first is that the total number of successful applicants, including the recent litigants, will be slightly expanded, but stay more or less the same. There is a high standard here for the import of medical cannabis that the Germans intend on duplicating domestically.
The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval.The second is that the German government will take its time on announcing the final winners and just open the doors to more imported product. This will not be popular with German insurers, who are on the hook to pay the difference. However with Tilray now on track to open a processing facility in Portugal and Canopy now aligned with Alcaliber in Spain, cross-continent import might be one option the government is also weighing as a stop-gap provision. Tilray, who publicly denied in the German press that they were participating in the cultivation license during the summer, just issued a press release in October announcing a national distribution deal to pharmacies with a German partner – for cannabis oil.
But then there is another possibility behind the delay. The government might also be waiting for another issue to resolve – one that has nothing to do with cannabis specifically, but in fact is now right in the middle of the discussion.
The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval. In fact, on September 19, a prominent German politician, Sigmar Gabriel of the Social Democrats (SPD) made a major statement about his party’s willingness to support Germany’s backing of the deal. It might be in fact, that the German government, which is supportive of CETA, got spooked about the cannabis lawsuits as test trials against not cannabis legalization, but a threat to the treaty itself.
Quality control, namely pesticides when it comes to plant matter, and the right of companies to sue governments are two of the most controversial aspects of this trade deal. And both appear to have risen, like old bong smoke, right at the final leg of closing the cannabis cultivation bid.
Will cannabis be seen as a flagship test for the seaworthiness of CETA? On a very interesting level, that answer may be yes. And will CETA in turn create a different discussion about regulatory compliance in an industry that has been, from the beginning of this year, decidedly Canadian-Deutsch? That is also on the table. And of great concern to those who follow the regulatory issues inherent in all. Not to mention, of course, the industry itself.
Right now, there are none to be had.
However at present, the German bid process is several months behind schedule as Canadian producers themselves face a new wrinkle at home – the regulation of the recreational crop in the provinces.
It is also clear that there are a lot of questions and not a whole lot of answers. Not to mention a timeline when the smoke will clear.
Marguerite Arnold is an American expat now living in Germany. She has just recieved her EMBA from the Frankfurt School of Finance and Management. She has a 25 year background in both cannabis reform and technology. She has been covering the international marijuana industry as a journalist and author since 2014. She continues to cover developments in the industry as she launches her own cannabis-tech firm, a company called MedPayRx, which aspires to be the first insurance and banking solution for cannabis patients in the world.