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Peter Homberg is Partner and Head of the German Life Sciences Practice at Dentons, one of the top 10 global law firms present in more than 50 countries. He and his colleagues advise on Germany’s new regulations regarding the legalization of cannabis for medical use.

There are many unusual questions to be asked, so this time we caught up with a very different kind of expert: Peter Homberg is Partner and Head of the German Life Sciences Practice at Dentons, one of the top 10 global law firms present in more than 50 countries. He and his colleagues advise on Germany’s new regulations regarding the legalization of cannabis for medical use.

Peter, the effect and use of cannabis are highly controversial. What is the significance of cannabis for medical purposes and what does the legalization mean for patients?

Before the law was liberalized, patients who suffered from certain diseases, like multiple sclerosis, cancer or chronic pain, could only use cannabis if they had applied for a specific exemption at the Federal Institute for Drugs and Medical Devices (BfArM). As regulations were extremely strict, only a few hundred patients were granted the permission to use the cannabis plant for medicinal purposes.

So what does it do? The plant is famous for containing THC, short for tetrahydrocannabinol, which binds to specific cannabis receptors (CB) in the central and peripheral nervous systems. The activation of CB1 in the spinal cord, for instance, reduces the perception of pain. In terms of medical use this means that cannabis can give relief to people suffering from cancer, multiple sclerosis, chronic pain and other serious diseases

The change in law means that patients can now receive a prescription from their doctor. If the doctor decides that there are no therapeutic alternatives to alleviate the patient’s suffering, the prescription allows the patient to obtain cannabis at the pharmacy. Although the restrictions have been lifted slightly, these processes are still strictly controlled by the BfArM.

The change in German law means that cannabis can now be prescribed as a pain killer by GPs
What is the current state of affairs in regards to legislation and what is the legal process for obtaining a license to cultivate cannabis?

With the legalization of cannabis, the BfArM established a cannabis agency within the institution to organize and control the cultivation of cannabis for medical use. As a result, a public tender has been released, and numerous companies have applied for the cultivation license.

Companies have to abide to strict guidelines to obtain a cultivation license
Of course, the process is taking much longer than expected, as this is a totally new field and the BfArM is asking for very specific qualifications: A company needs to have had some kind of past experience with cannabis products, they have to own indoor premises for the cultivation of the plants and have specific security measures in place in order to qualify.

Although we don’t have companies in Germany that have experience with growing cannabis, we do have some that have imported the plants from outside of Germany. They have significant experience in handling the product, be it through packaging or security measures.

For example, here in Germany there is a subsidiary of a larger Canadian company that has been producing the plants to a large extent. So this is a great advantage for them as they can build on their experience in Canada and fulfil the necessary requirements to qualify as legal cultivators.

You’ve been able to legally smoke weed in the Netherlands since the 1970’s, other countries like Italy and Denmark liberalized the medical use years ago. Germany seems quite slow in catching-up, why is that?

The legalization of cannabis for medical use in Germany occurred through a chain of unforeseeable events
Germany has one of the strictest narcotic drugs laws in Europe. In my opinion, if the German Federal Administrative Court hadn’t made a very specific decision, then the changes in legislation would never have been made. But through a chain of unforeseeable events, the following occurred:

One of the patients who had received the exemption from the BfArM, started growing his own cannabis at home, stating that the exemption included not only the purchase, but also the cultivation of cannabis. When BfArM sent him a cease and desist order, he took the issue to court.

In the last instance, the court ruled in his favour. This meant that all people who had previously received an exemption from BfArM would be able to legally grow cannabis at home. As this ruling would have resulted in a loss of control by the BfArM and in extension the government, cannabis was legalized for medical use and the complete control over cultivation and distribution returned to the government.

What role is Dentons playing in this whole transition process?

First and foremost we have been informing our international clients on regulatory issues and the new legislation in Germany. With cannabis everything is new, it’s a completely new field and different from any other topic in the life sciences.

THC – tetrahydrocannabinol – binds to specific cannabis receptors in the central and peripheral nervous systems
We have an international cannabis group at Dentons that is at the forefront of current affairs and keeps up to date on the topic. Our work includes regulatory advice, mergers and acquisitions and intellectual property. For instance, we have advised clients, one of them a large Canadian company, on the acquisition of a cannabis distributor in Germany to get a strong foothold in the country and on the European market.

In future, we will also have to handle various disputes. It will be very interesting to see how they evolve, how to handle them and their outcome. If one company, for example, receives the permission to cultivate cannabis in Germany and others don’t, then these decisions will certainly be challenged.

What can Germany… what can Europe learn from Canada?

Canada is well ahead in the use of cannabis for medicinal purposes. What is happening in Germany now is following the Canadian pattern: Today, we have a tender in the public procurement field that came from BfArM. It invited qualified companies to put forward their bid on specific cannabis plants in order to sell these to BfArM. In turn, BfArM will sell these plants to the pharmacies. Like in Canada, a government controlled process.

Germany can learn from Canada in issues of quality control as well. BfArM wants to overlook the cultivation and distribution process, because patients have to be able to count on a high quality product. Quality control includes specific laboratories, which check the type of insecticides or pesticides used or how much THC a plant contains.

There is much to learn from the Canadians, such as quality control, and cultivation and distribution processes
How do you see this niche developing from a legal but also from a medical perspective? What do you personally hope to see happen?

Our clients hope to see a greater liberalization, also for casual use. In my opinion this is not going to happen neither in Germany, nor in other countries in Europe. Nevertheless, more countries in the world are considering the medical use of cannabis and consequently, investors are looking into it as they expect a significant growth in the market.

We will also see a certain amount of effort put into research. With this new kind of liberalisation the indications that qualify for cannabinoid treatment have to be defined. Today we know that cannabis can help patients with for example chronic pain, cancer or multiple sclerosis, but in future we may discover more indications that will qualify for the treatment with cannabis.

“Germany has one of the strictest narcotic drugs laws in Europe”
Accordingly, the group of patients who can use cannabis as a medicinal product will grow. But the market in Germany is very competitive, so it will be interesting to see how companies and institutions will position themselves on the market to get a piece of the cake that is bound to become larger and larger every year.

Personally, I am glad that cannabis has been made available as a medicinal product for people who suffer severe pain. For many it is the best painkiller with less side effects than other drugs.

Want to learn more about the legal aspects of cannabis as a medicinal product? Visit Dentons here!

Images via Miss Nuchwara Tongrit, Africa Studio, Shutterstockphoto3, Zerbor/Shutterstock

What you need to Know about the Legalization of Cannabis for Medical Use

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The Ministry of the Interior writes in his reply that in 2015 there were 1736 alcohol deaths in Bavaria, six more than in the previous year. Of these 123 were between 25 and 44 years old and two were under 25 years. Men were affected in about two-thirds of alcohol-related deaths. In addition, according to the Ministry, deaths are attributable to alcohol consumption, which is an accompanying factor, for example, in certain cancers. The Landesamt für Gesundheit und Lebensmittelsicherheit (German Health and Food Safety Authority) therefore assumes around 12,000 deaths per year.

09/15/2017
Oans, zwoa, totgsuffa
Every year there are over 1700 alcoholic beverages in Bavaria. Young people drink again less – more for this

What would happen if not alcohol, but cannabis the Volksgestge number 1? Two and a half weeks at the Oktoberfest from the teenager to the retiree, over the course of the evening, several grams of grass would be ordered, look at each other in the light of the light of the joint and danced to the latest Wiesn hits. What is unimaginable with cannabis is normal with alcohol. In Germany 74,000 people die each year from the effects of alcohol abuse.

More than every second of the 11 to 17-year-olds have already drunk alcohol, 13 percent have a drunken at least once a month, 4500 children and adolescents have to be admitted to the hospital every year. “In Bavaria around 270,000 people are dependent on alcohol,” write Katharina Schulze and Ulrich Leiner (both Greens) in their request. They wanted to know from the state government the consequences of alcohol consumption in Bavaria.

The Ministry of the Interior writes in his reply that in 2015 there were 1736 alcohol deaths in Bavaria, six more than in the previous year. Of these 123 were between 25 and 44 years old and two were under 25 years. Men were affected in about two-thirds of alcohol-related deaths. In addition, according to the Ministry, deaths are attributable to alcohol consumption, which is an accompanying factor, for example, in certain cancers. The Landesamt für Gesundheit und Lebensmittelsicherheit (German Health and Food Safety Authority) therefore assumes around 12,000 deaths per year.

Not to mention the people who were killed under the influence of alcohol in the wheel. Their number rose by nine to 58 persons from 2015 to 2016, the number of injured persons by 31 to 2616. And the dead will probably be no less. According to the epidemiological search survey in Bavaria, 17.4 percent of adults drink alcohol at high risk – especially younger people. Nearly 37 percent are between 18 and 24, while the 60 to 64-year-olds are just under six percent. Here, too, men are particularly affected.

Alcohol abuse leads to violence and high economic costs

Alcohol abuse does not only affect the drinkers themselves. The economic costs of alcohol-related diseases in Germany are estimated at more than 26 billion euros. On the other hand, income from the state is derived from alcohol-related taxes of just 3.2 billion euros. In addition, there are social consequences, such as violence among alcohols. In one third of all violence in Bavaria alcohol was involved. The attacks of drunders on the police and rescue service have increased in comparison with the previous year to nearly all Bavarian police droids. Overall, the number of suspects who have committed criminal offenses rose by 1800 to 41 430 compared to the previous year. Some of the drunken accused were not yet 14 years old.

The Minister of Interior Minister Joachim Herrmann (CSU) can not say whether local alcohol bans can help to reduce the rate of crime development. An increasing number of municipalities and cities would, however, issue such decrees. “Thus,” […] can effectively reduce […] regulatory disorder and offenses committed under influence of alcohol, “the reply says.

The Ministry of Health praises itself for having further increased the starting age for the first consumption of alcohol by means of prevention programs such as “Strong Will Instead of Proliferation” or the “HaLT” action. In fact, teens drink less alcohol. The proportion of those who have consumed cannabis in the last 12 months has risen by four to 22 per cent, according to the Munich Institute of Therapies Research. Kiffen instead of drinking on the Wiesn – perhaps it is nevertheless no utopia. (David Lohmann)

INFO: Alcohol Consumption
Alcohol has a long history in Bavarian culture: it is both a pleasure and a drug. According to science, there is no alcohol consumption without a health risk. Recommended quantity for women: You should not drink more than 12 grams of pure alcohol per day, which is about 0.3 liters of beer or 0.15 liters of wine or sparkling wine or about four centiliters of an alcoholic drink such as liqueur, corn or vermouth. Recommended quantity for men: You should not drink more than 24 grams of pure alcohol per day, which is about 0.6 liters of beer or 0.3 liters of wine or sparkling wine or about eight centiliters of liquor.

Advice for women and men: The German headquarters for addiction recommends to abstain from alcohol on at least two to three days a week. Risks: In the long term, there is a risk of becoming dependent. In case of excessive consumption, alcohol can cause severe cardiovascular disease, liver disease and various types of cancer. Renouncement: For health reasons people should stay sober when they take medication. Pregnancy: If a drinking mother becomes an alcohol, it may interfere with the babies’ baby’s development and cause premature birth or premature birth. Children and adolescents: For them alcohol can have serious consequences for the developing organism, starting with a blood alcohol value of 0.5 per thousand, there is the danger of becoming unconscious.

http://www.bayerische-staatszeitung.de/staatszeitung/landtag/detailansicht-landtag/artikel/oans-zwoa-totgsuffa.html


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Canopy Growth will supply medical marijuana seeds to the Spanish pharmaceutical company Alcaliber

Canopy Growth will supply medical marijuana seeds to the Spanish pharmaceutical company Alcaliber, becoming the latest licensed Canadian producer to expand its footprint in Europe.
Alcaliber will use the seeds to grow and export medical cannabis from its facilities in Spain. The seeds will be provided through a supply deal involving Smiths Falls, Ontario-based Canopy and its German subsidiary, Spektrum Cannabis, according to a news release.


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Volatility In Cannabis Land (Germany) – How will it affect prices for consumers? – by Marguerite Arnold

The debate about the price of cannabis as well as its imminent “collapse” or price hikes has been around since there has been a legal market.
In general, the conventional wisdom is a bit off the mark. For the most part, even when it is accurate, it is highly regional and at best temporal, subject to uncertain if short-lived winds. Why? Every cannabis market these days is a different animal thanks to regulations. Further, the American state focussed industry is very different from any other country right now. Canada, Germany, Israel and Australia are more alike to each other than any similarities they share with the U.S. state industry. In any state.

Then there are new wrinkles that so far have not been priced into any of these predictions. If anything, the price of cannabis is going to increase, dramatically, globally over the next 18 months.

U.S. State Markets Are Different
There is a body of evidence that shows that the price of cannabis, to the consumer, has dramatically fallen in places like Colorado. This is understandable for very easy to grasp economic concepts. Supply and demand. The market in Colorado has normalized. There is risk, but there is less of it and all of it is in-state. This all goes into cannabis pricing that is absolutely felt by the consumer. Not to mention all the way along the line until it gets to retail. There is also evidence that the California state cannabis market is going through a similar transition, along with Washington State.

In turn, this along with other pressures are pushing growers to cut costs. But those pressures include major issues, like water, land and energy conservation. None of the investment in such initiatives is tax deductible, either. In other words, this is a rich man’s game of high equity and razor thin margins that those who are well capitalized enough are now playing. Everyone else is being marginalized.

Further, the temporary ups and downs of state markets in the U.S. is by definition, limited to those state markets. It is illegal to transport anything cannabinoid over state lines. And while CBD may be the first to fall on this front, for now, what happens in Boulder, stays in Colorado.

Canadian Markets Will Be Stressed Next Year
There is ample evidence already, just based on the domestic situation in Canada, that there well might be a global medical marijuana shortage until 2020. This has a great to do with how the international as well as domestic Canadian markets are shaping up.

Right now, domestic licensed producers in Canada are expanding. They have great access to global equity markets. They are entering foreign territories. Plus they have large stockpiles of cannabis. The medical patient population is also growing at about 10% a month. In other words, it could double right at the time recreational takes off.

And there is already a rec market in Canada that is easily large enough to compete with even domestic patients.

On top of that, the entire German medical market could be sourced from Canada for the next 18 months to two years. Patient populations, even as estimated by the government (and they are conservative) will put a significant dent in Canadian supplies also.

Even though two new developments may in fact serve to help alleviate the supply of medical grade cannabis, that is already a huge demand that well may drive prices up even if over “just” the next two years.

And while Australia and Israel have just jumped into the cannabis export game, the former via its apparent intent to source most domestic cannabis from Tasmania, this is unlikely to have much of an effect. Yes, Tasmania supplies 40% of the world’s legal heroin. Medical cannabis, however, is a fish of an entirely different flavour.

There is zero chance that any national government at this point, will source the majority of their medical crops or even medication from down under. It is just too expensive. Importing cannabis into Australia (primarily from Canada) also just got very controversial.

For that very reason, all the pricing indicators and market pressures point to at minimum, ongoing upward price trends on the raw plant from growers all the way through to consumers.

German Patients Are In Trouble
If there is one place in the legalizing world right now where price has gone through the roof, it is Germany right now. In an effort to kill the home grow market, the German government passed a new law at the beginning of the year. It will be revolutionary, once they get the kinks out. For now, however, insurers are having to be widely sued to begin covering the drug. Doctors are reluctant to prescribe it. And patients are facing uncompensated costs at pharmacies that have risen dramatically even this year for reasons that have nothing to do with production or distribution, but a locally imposed “pharmacists processing fee.” A month’s supply to a German patient right now, is around $2,400.

It is the German situation, in fact, which dramatically underscores all of the discussions about price volatility and supply.The legal cannabis world is under licensed and way too small to even meet existing demand.

State markets in the U.S. are their own animal for right now. Outside of this very differently refracted local lens, however, the cannabis commodity market has a global footprint that is fairly easy to track, predict and understand when seen from this perspective.

[Featured image credit: commons.wikimedia.org]

Marguerite Arnold | September 11, 2017 at 5:29 am | Tags: Cannabis, cannabis prices, consumer cannabis proce, German cannabis, Israel cannabis, Medical Cannabis | Categories: Business, Opinion, Regulations | URL: http://wp.me/p8nEcz-Mg


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German Medical Marijuana patients continued suffering despite the new law – from Hemp Magazine

After a small request from the federal government that the health insurance funds have to approve a therapy with medical cannabis before the statutory health insurance takes over the costs for the treatment, Frank Tempel, a sign of the drug policy of the left fraction, gives answers Questions that could be asked by those concerned. Meanwhile, the draft of a cannabis control law of the Green Bundestag fraction of March 2015 was rejected.
As beautiful as the new “Act on the Amendment to Narcotic Drugs and Other Provisions”, which came into effect on March 10, 2017, it raises a few dark shadows that could have a negative impact on the patient in the future. One of the central problems is the cost of a cannabis therapy by statutory health insurance. While pain patients receive the treatment in most cases, the world looks quite different in mental disorders, for example cases of ADHD or depression, Tempel reports on his website.
Requests for reimbursement would often be rejected in these patients. This also applies to patients who had already received a special permit from cannabis therapy from the “Federal Institute for Drugs and Medical Devices” prior to the entry into force of the Act. Because of this, it was already the first complaints of patients against the health insurance companies, it goes on. Temple also drew attention to the fact that there are some tips and hints to be able to claim the right to the costs.
The right to therapy with cannabis may be to patients if “a generally accepted medical standard” is either “not available” or “can not be used”, as well as “a not distant prospect perceptible positive effect on the course of the disease or on serious symptoms, “the Federal Government said in response to the small request from the left. According to the government, the treating physician must confirm these criteria and justify his decision against the health insurance company. But what helps if the cash registers?
Support the doctor
Tempel points out that it is easy for health insurance funds, especially through the second criterion, to refuse an application for the costs. This would be due to the lack of studies on the use of cannabis as a medicine, explains the deputy chairman of the Committee on Internal Medicine of the Bundestag. The 48-year-old, therefore, recommends “to refer to the introduction of a companion for which the patients have to participate if the costs of the therapy are to be reimbursed.”
In addition, he advises the physicians to assist in the completion of the application, since the health insurance companies would reject it at the smallest form defect. A sample application that could make life easier for the doctors offers the “Arbeitsgemeinschaft Cannabis as medicine” on their website http://www.cannabis-med.org . In order to take the perhaps still inexperienced doctor in this area further, the politician recommends in a discussion with the doctor also, professional-medically-based information to these to pass.
Where can I find a suitable doctor?
But already the search for a supervising doctor prepares the patient difficulties. The doctors would have little desire for more of the unpaid work and the effort they have to do, so temples. This is understandable. In addition to disputes with the health insurance companies, the treating physician must collect information about his patient and then pass it on to the “Federal Institute for Drugs and Medical Devices”. Temple once again refers to the “Cannabis as a medical community”, which can be asked for a doctor from the region who already has experience in prescribing medicinal hemp.
What to do if the cash office refuses?
If the applications, which are usually processed by the health insurance company within three weeks, but which can be withdrawn at the time the medical service is examined for examination of the application for five weeks, Tempel recommends that the supervisory authority, the relevant cash register. A protest may also be filed against the decision. A generator can also be found on the website of the “Arbeitsgemeinschaft Cannabis als Medizin”.
By a contradiction, the patient can also provide additional time, so that further advice can be brought into the boat, informs Tempel and writes to the following: “Do you have only courage to protest against the refusal of the health insurance company. There are cases in which the health insurance funds have approved it after the objection and a new application for reimbursement. “As a last option, the politician is considering taking legal action before the Social Court. The “Cannabis Consortium for Medicine” is even considering the support of the patient in court cases, provided that good prospects for success would exist, Tempel continues.
The Greens fail with a bill
Even though Germany has taken a clear step in the handling of marijuana through the “Act for the Amendment of Narcotic Drugs and Other Provisions” in the recent past, there are, of course, still sets-up parameters that can be worked on. The Greens tried their luck already two years ago in March 2015.
At that time, the Bundestag’s party draft a cannabis control law and presented it to the health committee of the Bundestag, which was voted on Wednesday. Although the Greens had the left fraction on their side, they failed with their draft, however, to the factions of the Union and the SPD, who opposed it.
The Greens drew attention to the fact that the cannabis control law had been an alternative to the prohibiting policy which had taken place here because it was “completely failed.” In the case of marijuana, which is the most widely used illegal drug in Germany, the criminal law provisions of the Narcotics Act should no longer apply , so the desire of the Greens. Instead, they pleaded in their template for a controlled, legal market with a regulated cannabis trading chain.
“The no from the Union and the SPD to our cannabis control law is a no to youth and consumer protection,” the “Ärtzeblatt” cites Greens Group spokeswoman Katja Dörner and the spokesman for drug and addiction policy, Harald Terpe. Cannabis is not harmless, the party made clear, precisely because of this, youth and consumer protection should not be left to the dealer.


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“It has not suddenly rained dogs and cats”

In parts of the USA, cannabis use has been legalized. Prohibition here is not contemporary. A conversation with Maximilian Plenert
Interview: Kristian Stemmler

In the US state of Colorado, marijuana is legally planted (Denver, 30 December 2013)

Maximilian Plenert is a member of the Management Board of Accept. V., the Federal Association for Accepting Drugs and Human Drug Policy, and an expert on cannabis.

Instead of dealing with the many deaths caused by tobacco, alcohol and heroin, Federal Commissioner for the Environment, Marlene Mortler of the CSU, has recently demonized cannabis in the presentation of the current drug report. Do you think of this?

No, this is typical of the selective perception in drug policy. I can quote from Mortler’s report: “No statistically significant changes since 2006 have been seen in the clinically relevant or problematic cannabis use.” In contrast, the increase in the number of victims of illegal drugs such as heroin before Mortler’s homecoming Bavaria, Germany. There, the municipal level from Nuremberg to the Bavarian District Day calls for drug use. Nevertheless, these tried and tested instruments remain taboo in Bavaria, because the CSU crosses itself.

Mortler warns of legalization of cannabis by saying investors from the US are ready to make a huge deal. What do you think?

As if other businessmen would not be doing a huge business today. In this point, I can even partially understand Mortler. Critical scientists in the USA see the danger of a “McDonaldization” of the cannabis market, which I would not have here.

Mortler also argues that the use of cannabis is now more problematic because the content of the active substance THC is about five times as high as 30 years ago.

If the consumer knew how much active substance is contained in his cannabis, he could easily adjust the amount, you also drink no liquor from beer glasses. But he can not do it thanks to the prohibition. Or to quote Bremen’s lawyer Nicole Krumdiek from a hearing in the Bundestag: “The uncontrolled THC salary is a result of the prohibition and can not therefore be taken as a justification for the same.”

In the drug report, long-term intensive use of cannabis can lead to “cognitive impairments, affective disorders, psychoses, anxiety disorders and physical damage”. What is it?

When did you last read the instruction leaflet of an over-the-counter medication? Because of my experience with the side effects of many drugs, I can only say: Cannabis is a comparatively harmless substance. Clearly there are problems when people consume particularly early and intensively and also have further problems. But it is also true that regular cannabis use is safe in adults. At least safer than many other activities of everyday life.

No one has ever died by killing. For this, the tobacco demands about 121,000 dead a year, the alcohol around 74,000. One wonders why the substances are legal, but cannabis is illegal.

It is a nonsense to believe that 100 years ago the wisdom of the sciences had prevailed and decided which drugs should be allowed and which should be forbidden. The truth is that the drug policy has been and is determined by various political and economic interests. The British government’s top drug consultant lost his job because he compared the dangers of drugs with activities like the Reitsport. “You can not compare a legal activity with an illegal one,” Jacqui Smith, the then Minister of the Interior, told him.

In other countries you are even further in the USA, where more and more countries are admitting cannabis. Are you still hoping for a lifting of the prohibition here?

Yes, it is only a matter of time. Not under this government, but the mood is also changing. We just have to pinpoint the policy on it. The pictures from the USA speak a clear language: There has not suddenly rained dogs and cats. We do not need to speculate what would happen in legalization, we know it. Also from decades of coffeeshop policy in the Netherlands. Even if this model is anything but perfect, on the whole it runs.

https://www.jungewelt.de/artikel/317760.es-hat-nicht-pl%C3%B6tzlich-hunde-und-katzen-geregnet.html