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Cannabis Legalization – the year in review part 2

Original Link in German on Leafly.de

To anticipate the bad news, neither the legalization of cannabis nor the decriminalization of users has been realized in 2019. In the black market, again this year, most likely more than 500 tons were traded without any state control over youth protection, prevention, product quality, tax revenues and organized crime. There are still 180,000 preliminary proceedings for cannabis, 2/3 of them against users. In Görlitzer Park in Berlin drug dealing is still alive, even in front of the eyes of the new Federal Drug Commissioner, who has finally paid a visit there.

However, a public discussion has developed in a way that was unthinkable just a few years ago. In this sense, 2019 was an eventful year that is worth looking back on.

Hemp Association and Schildower Kreis Conference

The German Hemp Association (DHV) has used the funds of the Christmas donation campaign of 2018 with more than 110,000 € to start a justice campaign to encourage judges and defendants to have the penalties for cannabis possession and consumption reviewed by the Federal Constitutional Court. For this purpose, two lawyers have developed a sample template which judges can submit directly to the Federal Constitutional Court. This is possible in the context of a concrete action for review of the constitutionality of a statute. In addition, an advertising campaign was placed in legal journals. The well-known juvenile court judge Andreas Müller has media-effectively already made use of this option. It remains to be seen whether this campaign will be successful, and if so, how quickly.

The new campaign of the hemp association next year aims at a broad publicity campaign, which should further increase the approval values for cannabis legalization in the population (currently 42%). Here, considerable resources are certainly needed to generate the same kind of media attention as in the cinema advertising campaign back in 2017.

In November the Schildower Kreis organized at the University of Frankfurt the 1st Antiprohibitionist Congress with more than 150 participants. The association of more than 122 professors of criminal law who signed a declaration against the prohibition of certain illegal drugs in 2013 is remarkable in itself. Half of the German professors of criminal law thus oppose the criminalization of users, especially the 4 million cannabis users. At the conference, certain regulatory models for cannabis and MDMA were presented. Regarding the success of a constitutional complaint against the cannabis ban, it was noted that it was only in early November, in connection with Social Security sanctions, that the Constitutional Court ordered the legislature to regularly review the effectiveness of a law. If this review were consistently applied to the cannabis ban and the latest scientific and social findings were applied, the constitutional complaints should actually be successful. For the law does not succeed in effectively curbing the use of cannabis, nor is it proportionate in achieving that objective.

Pressure from the municipalities / pilot projects

Pressure from the municipalities also remains high. The Bremen state government is planning a pilot project to distribute cannabis to adults. Also, the federal state SPD of NRW passed a motion at the party conference to make a model project for home-grown medical cannabis possible.

At the end of the year, the Berlin SPD actually sent an application for a model project on legal distribution of cannabis to consumers to the BfArM (German Drug Authority), on which a decision must be made within the next 3 months.

The parity welfare association Bremen (paritätischer Wohlfahrtsverband), as part of an umbrella organization with over 10,000 independent organizations, has called for new approaches for the state of Bremen, in particular the decriminalization of consumers and the release of private cultivation for personal use.

New federal drug commissioner

The position of the Federal Government Commissioner for Drugs has not been filled since the European elections in May. The right of replacement was granted to the CSU, due to the Unions internal power structure after Marlene Mortler’s departure for the European Parliament. As a result, a social debate developed on whether such an important position should be filled solely on the basis of party proportional representation or on the basis of competence. This debate led to a position paper of the leading drug policy organizations in Germany, which recommended the appointment of Burkhard Blienert. Burkhard Blienert was a member of the German Bundestag from 2013-2017 and drug policy spokesman for the SPD Bundestag group. In this function he played a decisive role in the legalization of cannabis as a medicine. Among other things, he was able to achieve that the sovereignty of therapy lies with the doctor and that the costs for medical cannabis must be covered by the health insurance under certain conditions. With this experience, he would certainly have been a suitable candidate for the position of Federal Drug Commissioner, who is to coordinate the Federal Government’s drugs policy, provide impetus and take up recommendations from experts.

Not least because of this initiative, Daniela Ludwig was then appointed the new Federal Government Commissioner for Drugs by the CSU, a transport politician from the Bundestag, in September.

In her first interviews at the end of September she publicly called for a new beginning in German cannabis policy. She will talk to all responsible organizations and institutions and also look around our European neighbors to see that they are doing differently and perhaps better. After her last visit to Görlitzer Park, however, misleading remarks were again made, as she apparently voted for a nationwide uniform personal consumption of 6 g cannabis. The Bavarian Police Union immediately followed this up by stating that there should be no shaking at the 6 g limit, as police investigation measures would have to remain „possible“. However, a more liberal approach to cannabis with regard to users looks different. Ludwig is also firmly opposed to the decriminalization of hard drugs.

For 2020 it remains exciting to see to what extent this „new beginning“ in drug policy will be accompanied and shaped by it.

International developments

International developments showed a mixed picture. Canada and California are obviously struggling with the inadequate regulatory conditions created by the legislature. In both countries, for example, there was excess capacity of several 100 tons throughout the year, which is currently in stock and cannot be sold out. This is partly because there are too few licensed points of sale, and partly because taxes on legal cannabis products are so high that consumers continue to resort to black market products. In addition, the share prices of the largest producers have fallen by up to 70%, so that some international colleagues are already asking whether the legalization has failed.

In contrast, further legalization efforts were made in Mexico and New Zealand. Due to a decision of the highest court, Mexico must create the legal basis for the legal distribution of cannabis. In the upcoming 2020 election, New Zealand voters will get a chance to legalize their own cannabis industry.

In France, a governmental panel of experts advising the government has recorded the negative consequences of cannabis prohibition and recommended legalization. France is one of the countries with the highest per capita consumption of illicit cannabis and at the same time has the strictest legislation to enforce prohibition.

Recently, contradictory reports have come from Italy, where at least „Cannabis Light“ should be legalised.

However, Luxembourg remains the highlight of the European development of legalization. The details of the legislative reform are to be worked out over the next two years. Thus Luxembourg will become a sting in the European community of states to finally break new ground in the use of cannabis for recreational use in Europe. The Minister of Health of Luxembourg, Etienne Schneider, has already called on the European neighboring countries to reconsider their cannabis legislation and develop a common position.

Turning point in the CDU

In view of these worldwide developments, the first votes from the CDU parliamentary group in the Bundestag came in October, questioning the party’s previous cannabis policy. Marian Wendt and Karin Maag openly admitted that the Union (CDU/CSU) is considering legalization. They could be the first serious conservative voices to allow a rethinking of existing cannabis policies among conservatives. Both stated that the party is increasingly reporting discontent to the Bundestag faction, in federal states and municipalities, as the situation on the ground no longer justifies the rigid attitude of the past decades.

In the Union we have often seen that people have long resisted social trends and liberal demands, such as the nuclear power plant phase-out, homosexual marriage and the abolition of conscription. However, as soon as a majority in the population becomes apparent, everything can suddenly happen very quickly. After decades of stagnation, this development in the Union can certainly be described as a turning point. Not least in North America, one can see the considerable economic potential that can result from legalizing cannabis. As soon as the Union as a party of the business community understands this potential, even the last resistance to a new start in drug policy will crumble.

Outlook

After the evaluation of the mid-term results and the SPD party conference with the election of a new leadership, the grand coalition now seems to want to govern until the end of the legislative period. This gives the SPD the opportunity to harmonize its decisions on cannabis at federal level. If the SPD decides to decriminalize consumers, there would already be a majority in the Bundestag. Although the FDP voted against a corresponding motion by the Left Party in the summer, this can be neglected as a Berlin tactical skirmish.

The petition of the hemp association as well as the cannabis control law of the Greens are still to be voted on in this legislative period. The Bundestgas groups have expressed a need for further consultation on this issue. As soon as the tactical conditions in the political groups are in place, a vote or a new vote seems quite possible. Here, the next weeks and months and the (re)positioning of the acting forces will have to be awaited.

The Greens, still strong in the polls (20-30%), will be able to present the most comprehensive proposal for the reorganization of cannabis policy with the Cannabis Control Act, which was already introduced in the Bundestag in 2017. By that time, it was dismissed, but it remains likely that this law will become the blueprint for legalization after the next federal elections in 2021 with a new federal government, and with the participation of the Green Party.

In order to avoid a hectic pace from September 2021 onwards, consideration should already be given to the details of a state-controlled distribution of cannabis. The aspects of youth protection and prevention are already considered in detail by the Cannabis Control Act. But do we really want a free market model, with the danger that large companies will end up dividing the market among themselves? Especially when requirements, regulations and conditions (see social concept employee certification) can only be met with immense initial investments? Is legalization also a social issue? What is the tension between the ban on advertising and the need for information in society? How do we manage to set up enough licensed distribution points to actually take up the fight against the black market? How can a German new beginning in drug policy in the European Union fit in?

So, it will remain exciting in 2020!

Stahlhof-Duesseldorf

CBD and Medical Cannabis – the year in review

Original link in German on Leafly.de

An eventful year for the cannabis industry is drawing to a close, time for a review of the year.

CBD

The year began with a completely surprising change in the Novel Food catalogue for cannabinoids. The first existing entry Cannabidiol defined extracts of Cannabis sativa L., in which the contents of CBD were higher than in the original plant, as novel food. In January 2019 the entry was then extended to Cannabinoids. From now on, all extracts from the hemp plant containing cannabinoids should be considered as novel food, regardless of the content.

In March 2019, the German Federal Office for Consumer Protection and Food Safety (BVL) specified the entry in the EU Novel Food Catalogue to the effect that a novel food is to be assumed whenever cannabinoids are specifically enriched or depleted.

We could see in June what the consequences of these changes were. The biggest German drugstore discounter DM had to take its CBD products off the shelves due to official pressure. The distribution ban was expressly justified by the application of the Novel Food Regulation.

But not only the big retail chains were affected by the change, but also many small and innovative hemp shops. Throughout the year there were police actions where not only the illicit CBD flowers were confiscated, but also corresponding CBD food. Be it with reference to the Novel Food Regulation, because the deliberate placing on the market of a novel food is a criminal offence according to § 1a Novel Food Regulation and can be punished with imprisonment up to one year or a fine. Or with reference to the German Medicines Act, if health claims have been made on the product itself or in connection with its specific environment.

The European Industrial Hemp Association (EIHA) has recognized this problem and is continuing its efforts in Brussels to amend the Novel Food catalogue. At its General Assembly in early November, however, it also decided to examine with its members whether joint applications for approval under the Novel Food Regulation make sense and should be implemented. Since 2016, only one application for approval of a CBD product as a novel food has been pending with the European Commission. A prerequisite for the application is the submission of a comprehensive and cost-intensive toxicological report confirming the safety of the product. Due to the immense costs, estimated at 300,000-400,000 €, many entrepreneurs shy away from this step.

In the long term, however, a market authorization according to the Novel Food Regulation will be unavoidable. The cannabis extracts, which contain cannabinoids, are to be qualified as novel foods, was only expressly confirmed by the Düsseldorf Administrative Court at the end of September and by the Hanover Administrative Court in November 2019. In both summary proceedings, the immediate enforcement of the ban on the sale of CBD food supplements was confirmed. The possibility cannot be ruled out that the manufacturing process in the structure of a foodstuff may lead to physical, chemical or biological changes in the ingredients used with potentially serious consequences for public health, the court stated. It is not known whether an appeal was lodged against the judgments in order to attack this little differentiated and intimidating argumentation. The grounds of the two judgments are strikingly similar, so that it can be assumed that other courts will agree with this view. Furthermore, taking into account the long duration of administrative court proceedings, a solution on litigation cannot be expected at this stage.

It is difficult for the consumer to understand the actions of the authorities as a whole. Food inspection in Germany is organized decentrally, and in addition it is completely overburdened and overtaxed both technically and personnel-wise. It is difficult to explain to the public seeking justice why in some cities the ban on CBD flowers and the Novel Food directive is enforced strongly, in some only a little, in many regions and in the Internet not at all.

However, the demand for such products among the population, not only in Germany but worldwide, cannot be ignored. The current handling of these products means that CBD products are now mainly traded on the hardly controllable Internet or are offered as aroma products without any warning or consumption instructions. The question may be raised as to whether this has not done consumer protection a disservice. At any rate, the establishment of quality standards by industry and trade, which could have been guaranteed above all by the large retail chains, failed to materialize in 2019.

For cosmetic products with CBD there was also a change in October. Until October 2019, no cosmetic product containing cannabis extracts was marketable. The CosIng Register, the European database for cosmetic products, had corresponding restrictions as a result of the provision in Article 14 of the European Cosmetics Decree, which refers to the Single Convention of 1961. The EIHA was able to reach with a position paper that at least the leafs were excluded from the scope of Article 14 of the European Cosmetic Decree. Cosmetics with the addition of Cannabis Sativa Leaf Extract is now possible. Whether this will be a manageable alternative for the cosmetics industry remains to be seen.

Medical cannabis

Patient numbers for medical cannabis continue to rise. In 2018, 3.1 tonnes of dried flowers alone were imported and a total of €78 million was reimbursed by health insurance companies for medical cannabis products. From January to June 2019, 54 million € have already been refunded, and 2.5 t of cannabis flowers have been imported, a significant increase again.

In May 2019, the Cannabis Agency successfully completed the award procedure for the cultivation and supply of medicinal cannabis in Germany. 13 lots with a total of 10,400 kg of cannabis were awarded, distributed over four years with 2,600 kg each. The first harvest is expected in the fourth quarter of 2020. The licenses were granted to three companies belonging to Canadian parent companies. The 13 lots of 200 kilograms each of medicinal hemp per year were distributed in five lots each to Aphria and the Berlin company Aurora Germany, making one ton per year. The Berlin startup Demecan is allowed to grow 600 kilograms of cannabis per year thanks to the remaining three lots.

The selling price to the German federal cannabis agency is 2.3 € per gram, as was last announced when the total volume was announced. It remains doubtful whether these prices will enable companies to make a profit in the long term in view of the enormous initial investments in production facilities. The systems must be protected against unauthorized access by third parties with enormous means and must comply with the highest production standards.

If even the possible production increases of 10% are exploited, Germany will continue to depend on imports to meet the demand for medical cannabis. Various European and non-European countries are getting ready to export to the German market and replace Canada and the Netherlands as the only export nations. In September there was already a first delivery of 500 kg from Portugal.

Industry insiders therefore assume that next year there will literally be a glut of medical cannabis on the market and that the supply problems will come to an end.

In June 2019, the Bundestag passed some improvements for cannabis patients through the law for more safety in drug supply. After in-patient treatment with cannabis as a medicine, the health insurance companies must decide within three days whether they will continue to approve the treatment. Patients do not need a new authorisation when changing dosage or switching between dried cannabis flowers or extracts. However, a change to cannabis flowers is still not possible, at least not without a new application.

The law also aims to reduce the price of cannabis from pharmacies. The previous pricing system is to be reformed and the pharmacy surcharge, as it exists up to now, is to be abolished.

An urgently needed step, considering that medical cannabis in the Netherlands, for example, is given to patients for 7 €/g instead of up to 24 €/g.

In May, the results of the accompanying survey were presented, which was adopted with the amendment of the law on cannabis as medicine in 2017. A total of 4774 data records were evaluated. Medical cannabis is most commonly prescribed for pain patients, almost 70%. What was particularly interesting about the study was the finding that patients with cannabis flower therapy are the least likely to report side effects. The discontinuation rate for medical cannabis flower therapy is 12.6%, compared to over 40% for Sativex and dronabinol.

Finally, the motion for a resolution of the European Parliament from February 2019 should be mentioned. MEPs call on member states to provide funding for cannabis research and clear legal definitions of medicinal cannabis. A first step towards harmonizing research and application in the European Union in the field of medical cannabis as well.

In the next column we will deal with the annual review of the developments in the legalization of cannabis for recreational use. Here, too, 2019 was a very exciting year.

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Legalised! – how legalization works in the USA – a travel report

German Version on Leafly.de

As a member of the International Cannabis Bar Association (INCBA), I again had the honor of speaking at the annual Cannabis Law Institute at the New York Law School early October this year. But before that, I decided to visit two states that had already legalized recreational cannabis for some time. The trip started in Denver, the capital of Colorado, from which the change in drug policy in the USA started at that time.

A client had kindly organized a guided tour through a grow. This facility was located in an inconspicuous industrial area of Denver, which can only be guessed from the outside by its massive lattice. We were welcomed by a friendly production manager, who guided us through the complete plant. The entire production process was explained to us, from cloning to trimming to packaging. A vast number of lists record when which room was cleaned, what weight loss results from drying, which water hose was last tested for bacteria and what values were obtained after the analysis. The authorities regularly register for visits and check the strict quality criteria that apply to cultivation in Colorado. The company has to bear up to more than 1000 € analysis costs per month.

In the past, stores in Colorado had to be vertically integrated, i.e. only what was grown by the same company could be sold in the retail stores. This scheme no longer applies, but the inspected grow still supplies his own three shops, which also have to buy in at the wholesale market in order to meet the demand. And everything, really everything works of course only with cash, because at the federal level cannabis is still an illegal substance.

In the dispensary, which is connected to the grow, there was then a friendly bustle. However, the choice was very limited, especially for the new products such as Vape Pens, Edibles and Beverages. Also, it was not very easy to talk to the sellers. A comprehensive consultation could not take place, since questions were always answered very briefly and concisely.
An explanation for this later arose in Seattle, Washington State on the west coast, when I visited a dispensary there and was able to talk to the owner. He reported that on Friday and Saturday up to 2,500 customers had to be served each evening: „We are trying to build a machine here“, he said, in order to cope with a huge crowd. There is no time for detailed discussions about new cannabis products and the mode of action of THC, for example in Edibles. Likewise, the salesmen, who are not specially trained, are instructed to keep this machine running and not to spend too much time with each individual customer.

This practice is far removed from the requirements of the Cannabis Control Act by the Green Party, the draft of which we discussed in the previous blog entries. We remember that specialist cannabis shops must therefore draw up a social concept and the staff working there must acquire the certificate of responsible selling. No one there has time to recognize risky drug use, let alone counteract it. However, dried cannabis flowers are then sold in plastic packaging that is so strong that it can only be opened with a knife or scissors.

He also said that in the end he didn’t believe in the creation of big brands. For him and the local customer it is important that there are always enough fresh flowers available at the best price. The customer would only pay attention to this and not to which brand it comes from. With finished products such as vapes and edibles this is something different, but with dried flowers it can be compared to buying potatoes on the marketplace. There it depends on the freshness and variety of the potato, but not on the farmer who sells it.

The CBD market is similarly confusing as in Europe, with the individual states each having their own regulations. Large drugstore chains in Washington offer a variety of CBD products in a small locked cabinet that must be unlocked by personnel. In New York there are also hemp shops as we know them from Germany. There CBD flowers, hemp seed oil, CBD oil and animal products with CBD are offered. All of the US is waiting for the FDA to decide how to regulate CBD products.

At the conference in New York Law School, it was impressive to see how committed and detailed the struggle is for a responsible solution for individual products. In a podium discussion, the regulators from the states, which will soon introduce legalization, reported for example how wax, an extremely high-percentage THC extract, is to be used or smoked by consumers for so-called dabbing. The aim of dabbing is to absorb as much active substance as possible effectively, which is very popular with certain patients in medical applications but can also trigger extreme intoxication among inexperienced users. „We are not happy with that“, so the tenor that Wax in Dispensaries would be available for purchase without further explanation or introduction to this practice.

Then the Canadian in-house lawyers of large licensed producers of medical cannabis reported how impressed they were with the records of various „master growers“ who were formerly active on the black market. They had meticulously kept records of their breeding results over decades, creating stable varieties from which the legal producers are still a long way off. This is an interesting aspect which not only concerns intellectual property issues, but also legalization as a social issue.

The vaping crisis was of course also an issue. It was agreed that hasty bans on liquids were no solution, as they would then be traded on the black market and cause even more problems. Legalization of cannabis at the federal level would be preferable, so that uniform quality standards and testing routines could be defined and monitored by the federal authorities.

New York itself is still struggling for legalization, but consumption has already been decriminalized. There are illegal consumption rooms, so-called Speakeasy, in which people can consume and buy. In the biggest and best-known New York Speakeasy an event took place on a topic that we here in Germany have to deal with in the long run. Steve de Angelo, the US-American pioneer of the legalization movement, introduced the „Last Prisoner Project“: „We will not rest and stop until the last cannabis prisoner is released“. Dealing with the rehabilitation of former offenders convicted of cannabis offences without violence is also one of the debates on legalization, similar to the 2017 German law on the criminal rehabilitation of consensual homosexual acts.
Overall, a progressive and responsible debate is taking place in the USA and in more and more states the black market is being replaced by a regulated market.

One would like more German regulators and politicians to look at these developments and debates in detail, perhaps to get an impression on the ground more often and discover the potential for society and the economy. How legalization works can now be seen, not in the model, but live.

Kai-Friedrich Niermann

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EuroAMCBC in Prague with KFN+

Happy to announce my participation at EuroAMCBC in Prague on 10/31/2019. I’ll be speaking about the status quo and the future of the German Cannabis market / Ich freue mich, an der EuroAMCBC in Prag am 31.10.2019 teilzunehmen. Ich werde über den Status quo und die Zukunft des deutschen Cannabismarktes sprechen.

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The Germany Cannabis Report by Prohibition Partners – with KFN+

download full report here

KAI-FRIEDRICH NIERMANN,
KFN+ LAW OFFICE, LAWYER

Medical

The market for medical cannabis has grown enormously since the change in the law. Total sales will reach €100 million by the end of 2019, with the share of finished drugs and cannabis preparations permanently exceeding unprocessed cannabis flowers. In the long term, not only will every European country set up a medical cannabis programme, but the international demand for medical cannabis will also rise steadily.

Against this background, the small quantities of cannabis grown, which have been put out to tender by the Cannabis Agency and have now been awarded for the first time, are not comprehensible. The German government currently does not want a medical cannabis industry like in Canada and the Netherlands. It is foreseeable that the tendered quantities will be far from sufficient and that imports will still be necessary over the next few years.

The Bundestag delegate Schinnenburg of the FDP wanted to know from the Federal Government in the context of a small inquiry in the Bundestag, what would happen with surplus quantities, which are possibly not needed in the local cultivation in Germany for the supply of the patients. The BfArM let it be known that such surpluses would be destroyed instead of being exported. I therefore assume that after the next regular elections in September 2021 (or earlier in the case of new elections) a new federal government will pursue a different policy and make possible a medical cannabis industry in Germany with the opportunity to export and to create thousands of new jobs. The FDP is already in favour of this.

All parties already now recognize that the research of medical cannabis must be promoted intensively. In 2018, an overarching resolution was passed in the European Parliament calling for increased research in this area and standardisation of standards within the European Union. Furthermore, the Federal Government supports a research project on medical cannabis at the University of Hohenheim.

Recreational

Popular support for the legalization of cannabis continues to grow.

In 2018, the German Hemp Association, one of the most active lobby groups for legalisation, launched a Bundestag petition with over 80,000 signatures, which the German Bundestag will have to vote on during this legislative period. In 2019, a justice campaign was launched with the aim of persuading judges and defendants to have the provisions of the Narcotics Law reviewed by the Federal Constitutional Court in the event of criminal proceedings.

It would be good if, after 25 years, the Federal Constitutional Court could once again deal with the prohibition of cannabis. In its 1994 decision, the Federal Constitutional Court gave the prosecuting authorities and politicians clear guidelines with regard to proportionality, which were never uniformly implemented. The courts have not discontinued every procedure for personal use, and the small quantity is still not uniformly regulated nationwide.
The black market has also grown considerably over the past 25 years, and the call for change from the judiciary and the municipalities has become unmistakable. In addition a state makes itself attackable, if legally a prohibition exists, which cannot be interspersed at all, and which confronts above all our police with unnecessary problems. If the purpose of the law cannot be achieved at all, existing regulations must be changed.
However, the Federal Constitutional Court is traditionally cautious if it should or would have to take action to shape the law itself. In 1994 it still said that cannabis has a certain dangerousness, which can be regulated by the legislator within the framework of its assessment prerogatives. In other words, the Federal Government and the Bundestag already know what they are doing.
If one of the cases in the justice campaign, which impressively summarizes the new scientific and legal findings, actually reaches the Federal Constitutional Court, the prospects for success are not foreseeable at all. He would be desirable.
In the meantime, all parties, with the exception of the CDU, have spoken out in favour of decriminalising consumers. The poll results of the Greens are still high, and here, too, a decision on the cannabis control law drafted by the Greens is due to be taken again in this legislative period. The Cannabis Control Act is based on a free market model, decriminalises consumers and legalises the trade in cannabis, taking strict account of social and drug prevention aspects. It can be seen as a blueprint for future legalisation, which will also generate thousands of jobs and billions in tax revenues.

However, since the grand coalition for major societal changes with the corresponding regulatory measures no longer has any strength, it can be assumed that a change in drug policy can only be expected with a new federal government at the next regular elections in September 2021. The development in Luxembourg will also be closely monitored from Germany. Luxembourg was the first country in the European Union to announce its intention to legalise cannabis and the Foreign Minister of Luxembourg called on his European colleagues to think together about a European solution.

Until then, pressure from local authorities, the police and the judiciary to introduce changes will continue to increase. Furthermore, several municipalities want to test the distribution of cannabis to adults in pilot projects. So far, however, these applications have always failed at the BfArM.

CBD

The CBD industry not only has to struggle with the fact that health-related statements are not possible due to the proximity to pharmaceutical law, but since March 2019 also with an amended entry in the Novel Catalogue of the European Union. Since then, a few sales bans have been issued against manufacturers and distributors, but not uniformly and on a large scale throughout the country. Even large retail chains have taken CBD products off their shelves again under pressure from the authorities.

Strictly speaking, only nicotine-free e-liquids with CBD are currently marketable. This does not apply to foods and dietary supplements obtained by an extraction process based on a specific enrichment of cannabinoids.

The necessary degree of legal clarity and predictability to develop a functioning industry with growth prospects on a sustainable basis is currently completely lacking.

The situation could only improve if companies applied for authorisation as novel foods for their products. Such an application has so far only been made once, for an isolate product in 2016, and has not yet been decided.

Another possibility would be for court proceedings to decide whether the application of the Novell Food Regulation to CBD products is legal at all. There are enough arguments against this, since hemp extracts have been used as food for centuries and only the technology for food production has improved. The fact that supercritical CO2 extraction is considered a safe process for food production is also expressly stated in several European regulations.

But even the large retail chains are reluctant to take legal action and give in to official orders. On the other hand, there are many black sheep whose products have unlawful health claims and do not even contain the ingredients that are stated on the packaging. Furthermore, it is not clear whether basic food production standards, such as hygiene and traceability rules, are always met.

Germany and Europe are also waiting for uniform industry standards that guarantee both the necessary level of consumer safety and reliable development prospects for the industry.

The EIHA (European Industrial Hemp Association) as a European industry association has addressed this problem and is developing various activities to define these standards at European level with the Commission. For example, a position paper has recently been sent to the European Commission calling for the authorisation of natural cannabis extracts in cosmetics and a corresponding change in the Cosing register with good arguments. The outdated and too strict THC guideline values in foodstuffs are also discussed by the EIHA with Brussels. These efforts also remain to be seen.

Cannabis Control Act, Product Safety and Vaping Crisis in the USA

Original Link on Leafly.de in German

Another aspect that determines the current discussion about the legalization of Cannabis, besides the already discussed aspect of social responsibility, is the often poor quality of the products available on the black market in Germany. Here, too, the Cannabis Control Act offers detailed regulations, which we would like to look at in detail today.

But first a word about the current vaping crisis in the USA. The market figures from the legalized US states and Canada show that 50 % of the market will be divided into smokables and extracts. Smokables are dried and unprocessed flowers as well as prefabricated joints for immediate consumption. Whereas the extracts „thc-infused“ are Vape Pens, Edibles and Beverages.
Now there were several 100 diseases and 7 deaths in the USA, which are said to have been related to E-Liquids containing THC. The products are said to have been available both on the black market and on the regulated market. The authorities are still trying with all urgency to clarify the causes. The first suspicions are that manufacturers have used additives that have caused the problems in the entire interaction and under heating.

For the just developing legal cannabis market in the USA, but also worldwide, this „vaping crisis“ is not a good signal. A panic is also not indicated, as it seems to be a very limited regional problem for the time being. However, the American legal system is designed to regulate and „tame“ the industry more through legal actions than through legal regulations. We can therefore expect a wave of lawsuits soon, which could bring the whole industry to a standstill. California was the first US state to introduce strict test methods for THC cartridges at the beginning of the year.

If we look at the Cannabis Control Act, product safety is another central component of this draft law. Thus, according to § 9 the

– the name of the placing on the market and the address of the manufacturer,
– the land of cultivation,
– the weight of the charge in grams,
– the date of harvest of the variety,
– the date of maximum durability,
– the list of other ingredients and
– the percentages of THC and at least one other cannabinoid, usually CBD,

must be specified.

Traceability is thus ensured. The consumer should also be able to assess the potential of the product he has purchased.
Furthermore, detailed warnings on the packaging and a package leaflet are prescribed, which must list contraindications and explain appropriate precautions, especially in the case of interactions. For proper application, the necessary instructions on dosage, type of application and duration of action, and instructions in the event of overdosage must be provided, among other things.

In § 10, which is expressly titled consumer protection, it is regulated that cannabis may not be placed on the market,
– if it has not been manufactured and tested in accordance with the state of the art in science and technology;
– mixing with tobacco products or alcohol is not permitted;
– Plant protection products, fertilizers, stock pesticides or pesticides may only be present in fixed maximum quantities.

Furthermore, the cannabis may
– not be contaminated with substances likely to endanger health, and
– not contain additives which are not clearly identified.

The problems with the partly poor quality of the cannabis flowers available on the black market in Germany, to which dangerous and even poisonous substances are partly added in order to increase the weight and thus the profit, have been well known for decades.

With these two paragraphs, the Cannabis Control Act aims to ensure the product safety of the future regulated market. This ensures that the consumer is protected from inferior and bad products from the black market or from dubious manufacturers.
This, of course, presupposes that these regulations are also strictly enforced and regularly reviewed. It must not be the case that, as in the Wild West, specialist shops are opened that are not licensed and the authorities do not follow suit in enforcing the licensing requirement. One might imagine one or the other corner in Berlin or another German city where something like this can happen.

Another challenge is the extensive control of the quality of the new cannabis products. In detail, it is still completely unclear and not regulated how it can always be ensured that only products with the required quality are put on the market.
For the new cannabis products, the extracts, there are already many legal provisions which must also be observed. Since THC and CBD have so-called CAS numbers (Chemical Abstract Numbers), they are subject to the European CLP and REACH regulations, with the corresponding additional requirements for product labelling. The Product Safety Act continues to apply to e-liquids, and the Tobacco Product Act will soon also apply to nicotine free liquids in Germany.

In the case of food products containing THC, there are also extensive food regulations.

As a rule, the legal system is structured in such a way that the entrepreneur must determine on his own responsibility which regulations apply to the products he wishes to bring onto the market. In addition, the law stipulates that a product must not endanger the safety and health of persons when used as intended or in a foreseeable manner. This must also be determined by the entrepreneur on his own responsibility. The entrepreneur must pay the greatest possible attention to product safety at every stage of economic activity, as considerable liability risks may arise.

However, there is usually no prior authorization requirement, such as for medicines, which brings us back to the vaping crisis in the USA. It is still being investigated whether the cases that have occurred are related to vitamin E acetate, which is reported to have been used in some THC concentrates. Thus, if traders, whether for greed or other reprehensible reasons, are too reckless in putting products on the market whose composition, when used as intended, cannot guarantee consumer safety, such a „crisis“ can be expected at any time.

It remains to be discussed whether the previous model, i.e. leaving it to the entrepreneur to decide first and foremost on his own responsibility whether to bring a safe product onto the market and only later to decide through controls or competition lawsuits whether this is really the case, is also suitable for the new, pharmacologically active cannabis products to come.

At least in the initial phase, as we now see in the hype surrounding CBD products, there will be many black sheep who promise the blue of the sky and whose products do not even begin to have the promised content of cannabinoids, or even worse, contain dangerous substances.

This will be the right balancing act between sufficient regulation and industry’s voluntary commitment. Strict requirements on the „compliance“ of the products pose a hurdle for market entry on the one hand, and generally already prefer larger and professional companies that can map these requirements, but on the other hand also guarantee the protection of the consumer.

In Canada, for example, where the new regulations on Edibles and Beverages will be introduced at the end of October this year, Aurora has been conducting an awareness campaign for several months now. In this campaign, the public is made aware of the new products, in particular about the effects of oral intake of THC, the dangers involved and how it can best be dosed.

After the last paragraph, the author himself sets off for a trip to the USA to get an overview of the legal markets in Colorado and California. A report will follow…

RA Kai-Friedrich Niermann
Lawyer

Kommentar zur Justizkampagne des DHV / comment on the Justice campaign of the DHV

Leafly.de about the Justice Campaing of the German Hemp Association (DHV)
https://www.leafly.de/justizkampagne-dhv-gegen-cannabisverbot/

with a comment of KFN+:

„It would be good if, after 25 years, the Federal Constitutional Court could once again deal with the prohibition of cannabis. In its 1994 decision, the Federal Constitutional Court gave the prosecuting authorities and politicians clear guidelines with regard to proportionality, which were never uniformly implemented. The courts have not discontinued every procedure for personal use, and the small quantity is still not uniformly regulated nationwide.

The black market has also grown considerably over the past 25 years, and the call for change from the judiciary and the municipalities has become unmistakable. In addition a state makes itself attackable, if legally a prohibition exists, which cannot be interspersed at all, and which confronts above all our police with unnecessary problems. If the purpose of the law cannot be achieved at all, existing regulations must be changed.

However, the Federal Constitutional Court is traditionally cautious if it should or would have to take action to shape the law itself. In 1994 it still said that cannabis has a certain dangerousness, which can be regulated by the legislator within the framework of its assessment prerogatives. In other words, the Federal Government and the Bundestag already know what they are doing.

If one of the cases in the justice campaign, which impressively summarizes the new scientific and legal findings, actually reaches the Federal Constitutional Court, the prospects for success are not foreseeable at all. He would be desirable.“

more information on the campaign:
https://hanfverband.de/richtervorlage

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KFN+ guest author on Leafly.de – The Cannabis Control Act and Social Responsibility

Column Leafly, August 2019
Kai-Friedrich Niermann, Lawyer, KFN+, Germany

The Cannabis Control Act and Social Responsibility

In the last column we dared to look into the future. Today we want to take a closer look at how a socially responsible legalisation could be implemented in practice. Here too, the Cannabis Control Act of the Bündnis 90/Die Grünen Group already mentioned in the last column offers a series of proposals on how to combine the protection of minors, consumer protection and prevention.
This column is the prelude to a regular series in which various aspects of the Cannabis Control Act and a possible legalisation of cannabis are presented and examined with a view to their practical implementation. As the law is a fully elaborated draft that takes into account fiscal aspects as well as foreign trade law and international obligations, it is likely that the Cannabis Control Act will be the blueprint for any reform towards a more modern drug policy. In this respect, it is worthwhile to take a detailed look at the regulations proposed there from time to time.

Social Concepts

The Cannabis Control Act provides for the approval of so-called cannabis specialist shops. Specialist cannabis shops directly attached to an agricultural holding may even bear the name „farm shop“.

Specialist cannabis shops may not be operated in the immediate vicinity of a school or other facility for children and adolescents. The federal states are authorized to regulate minimum distances between specialist cannabis shops and to set a maximum number of specialist shops.

The prescribed social concepts are a central component of the Cannabis Control Act. Before opening a specialist cannabis shop, a representative for the development of a social concept must be appointed, who develops a social concept for the specialist cannabis shop. This social concept must set out measures relating to the prevention of addiction, the protection of minors and the training of sales staff. Section 23 (2) even expressly states that risky cannabis use must be counteracted.

The sales personnel shall also refuse to hand over the goods if there are reasonable grounds to suspect that the goods have been passed on to children and adolescents. Before entering a cannabis specialist shop, an identity card check must be carried out to prevent the entry of adolescents and children. Sales staff must also provide consumers with adequate advice.

“Responsible Selling“ Certificate

To meet these requirements, sales personnel must have successfully participated in a training course and obtained a certificate called „Responsible Selling“. These training courses are to be held at the state or specialist agencies for addiction prevention or at comparably qualified institutions. This certificate is valid for two years and must be extended by further training.
In order to obtain this certificate, future cannabis sellers must demonstrate knowledge of cannabis use, in particular how cannabis works and is dangerous, and how risky patterns of use can be identified at an early stage. There is also a need to acquire knowledge on how to prevent cannabis dependence and how to refer people to counselling centres or treatment centres. The sales staff should inform the customers about the addiction risks of the cannabis products on offer and provide information about harm reduction in forms of consumption such as vaping or tobacco-free consumption.

Information material on risks of consumption and information and contact data on qualified counselling centres and therapy facilities shall be clearly visible.

Practical implementation

These rules make it clear that cannabis is not an ordinary product that can be sold like chips or chewing gum in petrol stations or supermarkets. The dealer doesn’t care who he sells his stuff to, but the cannabis control law does. The Cannabis Control Act is well aware that cannabis products have a pharmacological and psychoactive effect and that trade and sales require appropriate regulations and precautions.

The regulations ensure that children and adolescents are not given access to cannabis products. Customers with a risky consumption pattern, possibly a dependency, must be advised accordingly. The question whether the supply of cannabis products must also be refused in these cases cannot be answered unequivocally from the law.

The costs for the preparation of a corresponding social concept will not be insignificant for the operator of the specialist shop. So far we know such social concepts only with casino halls, with which a concept must be presented for the conversion of player and youth protection in gambling enterprises. Assuming that 5-8 billion € are actually traded on the black market, a huge number of specialist cannabis shops can be expected in the long run. Here alone, there are immense opportunities for company start-ups in the certification and training sector, as the social associations most probably cannot handle the task on their own.

The costs for the creation of a social concept for casino halls are currently around 2000 €. It is doubtful whether this amount will be sufficient for the initial licensing of a specialist cannabis shop. Too many complicated questions, as outlined above, are likely to lead to significantly higher costs, at least in the initial phase. The certificate „Responsible Selling“ should cost several 1000 € depending on the design and the scope of the training contents. Nor will it be easy to find motivated personnel with the appropriate know-how to provide consumers with sufficiently responsible advice in accordance with the law and to provide the required addiction prevention.

The barriers are therefore high for those interested in entering the cannabis retail market. In addition there are further costs for security measures, because according to § 14 certified safes are to be kept available, and rooms and transport vehicles are to be secured against removal by an alarm system or corresponding security measure. In addition, there are the costs for furnishing and initial inventory.

However, these high barriers to market entry are to be welcomed as they ensure the necessary level of consumer protection. On the other hand, it is to be expected that the required degree of compliance can only be achieved by professional and financially strong chains and brands. As larger professional economic entities, however, they are also better controllable overall.
Under the Cannabis Control Act, advertising is prohibited. Cannabis may only be advertised in specialist journals for professional circles. The external appearance of the specialist cannabis shops should be discreet so that it cannot have an incitatory or incentive character.

For those who wish to grow the plant themselves, the cultivation of up to three female flowering cannabis plants for personal or community use is permitted. In the pacified property of the breeder, under the condition of good security and that children and adolescents have no access, it is also permitted to store an annual harvest of up to three plants, even deviating from the otherwise applicable limit of 30 g own property.

Whether an advertising ban for cannabis is really effective should still be clarified. In this respect, it is the sole responsibility of the sales staff to provide information about the various products and their effects. However, information on cannabis use and widespread education will be essential to enable consumers to make important choices. Here, more differentiated regulations should be reconsidered in detail.

The same applies to whether a ban on mail-order sales in accordance with § 11 (2) really makes sense. By restricting distribution to specialty stores, the goal of preventing risky consumption is achieved. If it is ensured that risky consumption can be ruled out, for example through regular introductions in specialist shops, there is nothing wrong with a mail order business.
It should also be explicitly regulated whether it is allowed to consume in specialty shops, similar to coffee shops in the Netherlands, and at least whether non-alcoholic beverages can be offered. However, since the Cannabis Control Act does not explicitly provide for this, this possibility is to be assumed for the time being.

Both aspects, mail order and local consumption, would limit the traffic with and consumption of cannabis in the public image, which would at least be worth a further discussion.

Result:

The Cannabis Control Act with the regulations governing specialist shops describes a balanced system of social responsibility, in which the interests of users and consumers consistently come first. With these regulations a socially responsible legalization is possible. The lack of education and prevention associated with the black market would have come to an end.
However, many questions remain unanswered in detail. The best time to start discussing it is now!

Dried flowers account for only 50 % of consumption in legalised markets. A similar development can also be expected in Germany. In the next column we will therefore deal with new cannabis products and their product safety.

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