Wednesday, January 26, 2022
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Germany: Demecan receives the green light for the production of medical cannabis

Demecan, one of the three companies to have received a medical cannabis production license in Germany, but the only German one alongside Aurora and Tilray, has received its EU-GMP (good manufacturing practices) certification for its production site located near Dresden, Saxony.

EU-BPF certification (or EU-GMP for “Good Manufacturing Practice”) guarantees the quality of medical products throughout the manufacturing process. It is issued independently by the pharmaceutical authorities and now allows Demecan to produce “medicines” based on cannabis.

Dr. Adrian Fischer, MD and Managing Director of Demecan, welcomed the announcement: “GMP certification is the highest standard that manufacturers have to meet, as high quality pharmaceutical products are expected. The fact that we now have this certificate in our hands is an extraordinary step in the young history of Demecan and an important step for the development of a German cannabis center in Saxony. »

The way is now clear for the first delivery of 100% “Made in Germany” medical cannabis flowers. The first flowers produced in Germany have already arrived in pharmacies but were produced by Aphria / Tilray, a company of Canadian origin. With the GMP certification, Demecan will also be able to test the effectiveness of medical cannabis through clinical trials.

Demecan plans to deliver its first cannabis flowers to the National Cannabis Agency and, through it, to pharmacies in the first quarter of 2022. The company already supplied imported cannabis to German pharmacies, in this case a Florestura variety (Super Haze x Amnesia) 20% THC grown in Australia.

United States: Amazon supports the Republican plan to legalize cannabis

Amazon, the second-largest private employer in the United States, supports a Republican-led bill to legalize, tax and regulate cannabis at the federal level.

The company’s public policy division said Tuesday it was “happy to support” Republican Rep. Nancy Mace’s bill, which filed the States Reform Act in November as an alternative to the legalization projects championed by the Democrats.

“Like many others in this country, we believe it is time to reform national cannabis policy and Amazon is committed to helping this effort,” said the company, which has previously expressed support for a separate legalization bill, led by Democrats.

Brian Huseman, Amazon’s vice president of public policy, said the bill offers “comprehensive reform that demonstrates the emergence of a bipartisan consensus to end federal cannabis prohibition.” »

Last year, Amazon decided to stop testing most of its workers for cannabis and erase the “records” of former workers who were disciplined for testing positive, allowing them to be rehired.

The reason for the abandonment of cannabis drug testing is multiple, Amazon said at the time. The growing state-level legalization movement has made it “difficult to implement a fair, consistent, nationwide pre-employment cannabis testing program,” with data showing that drug testing “has a disproportionate impact on people of color and are a barrier to employment”. Removing this requirement also broadened the company’s pool of candidates.

Amazon and its bipartisan support

The Republican legalization bill would end the federal ban on cannabis while taking specific steps to ensure businesses can continue to operate unhindered by changing federal rules. It also incorporates certain fairness provisions such as expunging the criminal records of people with non-violent cannabis-related convictions and imposing an excise tax, the revenue from which would support community reinvestment, law enforcement and the activities of the Small Business Administration (SBA).

Amazon also supports the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act, a project carried by the Democrats. Although they hold a majority in both chambers, in addition to controlling the White House, the margins for adoption are slim.

The MORE Act was approved in September by the House Judiciary Committee last September. Senate leaders are preparing to file a separate legalization proposal after unveiling a draft version in July.

Thailand: The cannabis decriminalization project validated by the authorities

The Food and Drug Administration (FDA) has drafted a bill to legalize the cultivation and consumption of cannabis. The country could also legalize its recreational use in certain places.

FDA Secretary General Paisarn Dunkum said Monday that his administration had drafted a bill in line with the Department of Public Health’s resolution to exclude cannabis from the list of narcotics. The FDA bill would allow people to grow cannabis for their own consumption, as long as they report such cultivation to their respective provincial administrative organizations. Domestic consumption would be reserved for medical purposes.

Companies wishing to engage in the commercial cultivation, import, export, sale and advertising of cannabis will need to obtain specific approval from the Narcotics Control Board (ONCB).

Health Minister Anutin Charnvirakul confirmed yesterday that the ONCB had approved the removal of cannabis from the list of controlled drugs. This withdrawal must now be officially signed by the Minister of Health and will enter into force 120 days after its publication in the official journal.

A possible legalization of cannabis

Regarding the recreational use of cannabis, Dr. Paisarn said it could be in some places that have not yet been specified.

“Of course, we will not go to the stage of coffee shops, but there are different models for its recreational use in other countries. We will choose the one that best suits our social context,” the FDA secretary general said.

A committee of the Ministry of Public Health, chaired by its permanent secretary, will develop specifications for places for recreational cannabis use, he added.

The bill provides for a three-year prison term and/or a 30,000 baht fine for violators.

A public hearing on the new bill will take place next month, Dr Paisarn said.

The CBD sector delighted with the return of hemp flowers to stores

They all have a little ” hangover “, today, the fault of a short and festive night. Yesterday, around 6 p.m., the Council of State granted a great victory to the actors and actresses of the French CBD: they can again sell hemp flowers. So inevitably, many celebrated it as it should.

“I think the whole CBD industry woke up with a hangover this morning”, jokes Mao Aoust, boss of the chain of 180 High Society stores. “Yesterday, when the decision fell, everyone was crazy. We opened a few bottles of champagne, and we celebrated! It was a bit like our New Year’s Eve, since New Year’s Eve was ruined”, smiles the Marseillais, in reference to the decree of the government published on December 31.

Others let go of their vocal cords to celebrate. “When my lawyer informed me of the news, I asked him if I could sing a little, and I sang Seven Nation Army White Stripes, laughs Aurélien Delecroix, president of the Professional Union of Hemp. It’s really a great victory. »

For Ingrid Metton, lawyer who defends CBD traders ” since seven years “, this decision does a lot of good. “It is an immense professional joy. I tell myself that, finally, CBD entrepreneurs will be able to carry out their activity normally. »

Flower neither forbidden nor legal

However, after the party, it will be necessary to get back to work quickly to clarify the situation. Today, the flower is neither prohibited nor fully legal. The law will remain unclear for a few more months. The Council of State must issue a final decision – an “appeal for annulment” – within six months to a year. It may go in the same direction as the first decision, or say the opposite.

“The marketing of flowers and CBD products at less than 0.3% is authorized today! In criminal law, the prohibition is the exception, the principle is freedom. To prohibit something, you have to write it down., recalls Yann Bisiou, teacher-researcher in private law, and legal consultant to the Union of CBD Professionals.

After a break, the dialogue must resume between the actors of the CBD and the public authorities. “This judgment of the Council of State is a strong signal which must force the authorities to review their copy. As of yesterday evening, I wrote to the MILDECA to invite them to finally sit around a table”, hopes Aurélien Delecroix.

Embarrassed political staff

For his part, the political staff is embarrassed. In the front row, the MILDECA does not wish to express itself and is hunkered down while waiting for the storm to pass. Gérald Darmanin, him, “regret” this decision of the Council of State. He was the guest of France Inter this morning and attempted a punchline which some would say had nothing to do with the schmilblick: “We did not increase the price of tobacco to €10 for us to accept the legalization, the decriminalization of cannabis”.

At the National Assembly, the Minister of Health had a little more trouble explaining himself. Responding to a question from deputy François-Michel Lambert addressed to Gérald Darmanin, who did not want to answer, Olivier Véran maintained that “The Council of State canceled part of the decree for reasons of form, considering that the health reasons were perhaps excessive. It is up to us to show that the health reason is valid ”.

Darmanin and Véran are notoriously in conflict on the subject. The first is in favor of a very firm framework on illegal drugs. The second is more favorable to Cannabis, but seems to have lost the political battle on the subject.

“If I were the government, I would rewrite the whole decree, plead with Newsweed the deputy (LREM) Jean-Baptiste Moreau, fervent supporter of hemp. At the time, II had said that the decree would fall on the first legal action. The government still decided to pass this text. And so I wouldn’t want to pass for an old fart, but I had told them.

Medical cannabis experimentation receives its sublingual tablets

The Israeli company Panaxia has announced that it has exported its first sublingual cannabis tablets intended for French experimentation with therapeutic cannabis.

According to the company’s statement, Naxiva-Panaxir tablets contribute “to better response to treatment and greater patient satisfaction, primarily due to treatment efficacy, simplicity and accuracy of use “.

Dr. Dadi Segal, CEO of Panaxia Israel, said, “We are pleased to take another important step in implementing our strategy. We are proud to be part, alongside our partner, Neuraxpharm, of the spearhead of the main global cannabis players selected for the ANSM program. »

“In addition, we are the only company in this program to provide sublingual medical cannabis tablets. According to our forecasts, the French market should become one of the most advanced medical cannabis markets in the world, which will be a remarkable engine of growth for Panaxia. »

Panaxia had been selected for two batches of medical cannabis:

  • Oral form to ingest THC > 5 mg/ml, CBD < 1 mg/ml (Panaxir T20/C0)
  • Oral form to ingest THC and CBD > 5 mg/ml (Panaxir T10/C10)

Managing Director of Neuraxpharm France, Dr Pierre-Hervé Brun, said: “It is a great achievement for us, together with our partner Panaxia, to have been selected as one of the few specialists to offer medical cannabis on the French market as part of the ANSM program”.

“As the only companies in the program offering sublingual medical cannabis tablets, we are able to offer our patients a variety of patient-oriented and easier-to-use presentation forms. Going forward, we will continue to work with Panaxia to further our strategy in the growing medical cannabis sector and bring innovative forms of consumption to market.”

French experimentation with medical cannabis began with the dispensing of CBD and/or THC oils, then flowers last summer.

The world of CBD makes its voice heard before the Council of State

They are all there, or almost. A small smile, a fist-to-fist salute – Covid obliges – before entering under the gilding of the Palais-Royal, in the very center of Paris. Under a beautiful winter sun, they hope today to cancel the ban on the flower, recently decided by the government. With a little surprise guest: Yannick Jadot. The environmentalist presidential candidate came for a few minutes for a photo, the time to denounce the attitude of the executive.

After climbing a few stairs, CBD industry and government officials enter a beautiful, well-lit room. The judge in chambers, Mrs Von Coester, is waiting for them, seated behind the desk in the center of the room. The representatives of the CBD – called claimants – sit on his right. Those who defend the government come face to face.

The Council of State judges the conflicts between the citizens and the administration. The judges who sit there have the power to annul decisions of the government or of a prefecture, if the latter is disproportionate and/or illegal.

Today, the world of CBD has filed an interim release and several interim suspensions to bring down the order prohibiting the CBD flower. The interim release presupposes a “serious and manifestly illegal attack on our fundamental freedoms”. The second must testify to an emergency situation. Today, the economic emergency is highlighted by the stores, since they derive 70% of their income from the flower.

A flower market at “300 to 400 million euros”

The hearing looks like an attack-defense. Lawyers from the Hemp Professional Syndicate (SPC) and the Union of CBD Professionals (UPCBD) are attacking the government’s recent decision. The judge listens to them, sometimes agrees. Then the government – ​​notably represented by MILDECA and the Ministry of Health – defends itself and justifies its choice.

“We are talking today about a decree which absolutely and immediately prohibits the sale of the flower”, begins the lawyer Charles Morel, also president of the UPCBD. “I have dozens of accounting documents that prove that the flower represents two-thirds of sales in our stores”. The judge nods, concentrating.

To support his argument, he mentions the case of a CBD trader, prosecuted. “The reasons invoked were precisely the decree of December 30, which we are talking about today”, supports Morel. The merchant he is talking about is at the back of the room. He stands up for the judge to see him, arms crossed, focused.

Judge Von Coester then asks what is the economic weight of the flower in France. 300 to 400 million euros currently, but it can go up to 1 billion euros in a mature market”, answers Aurélien Delecroix, the boss of the SPC.

To prove the economic emergency, lawyer Cédric Uzan Sarano, who defends the SPC and the Green Leaf company, came with tea bags. He shows them to the summary judge. These are the same CBD herbal teas that Green Leaf markets, via “Monoprix, Auchan, Crossroads of well-established brands”, says the lawyer. Problem : “In our recent emails, supermarkets tell us: ‘Happy New Year… By the way, what is this decree?!’ You can check it yourself, the emails are on file. »

“Apple juice is fine; the apple is amazing”

Then comes the time for contradictions: the recent decree authorizes the CBD extract, but not the flower. “The government tells us, ‘Apple juice is fine. The apple is amazing, and I’m hardly exaggerating!“, jokes the lawyer Cédric Uzan Sarano.

Another contradiction: the reason for public health, put forward by the government to ban the flower. “The Constitutional Council issued a decision very recently, on January 7, in which it precisely defines a narcotic. He tells us that it is a psychotropic substance with an addictive effect, and harmful effects on health“. And according to him, CBD is none of that. The MILDECA observes him, without a word.

The government’s anti-drugs office also writes that cannabidiol is “psychoactive”. What makes lawyer Xavier Pizarro jump: “Madam President, recent studies have proven that looking at your dog causes a release of hormones! ». Bursts of laughter in the room.

CBD advocates are also trying to dismantle the government’s argument that CBD is banned because it can be smoked. “Mais it would then be necessary to prohibit the cigarette, this argument does not hold one second, one can close the debate! », attacks the lawyer Uzan Sarano, very effective in his speeches. His client, Aurélien Delecroix recalls that Belgium and Luxembourg consider cannabidiol as a “smoking plant”, with the same taxation as tobacco.

MILDECA struggles to be heard

The executive finally puts forward the imperative of “public order”. For him, it is impossible to authorize the CBD flower because it looks like two drops of water to a THC flower. The various unions in the sector point out the existence of rapid and inexpensive tests to make this distinction. Why does the government put forward the reason of public order? Because the Court of Justice of the European Union tells us that there is no public health problem. So that’s all there is left! », continues Pizarro.

In the midst of all its attacks, the government bench is struggling to be heard. It is made up of two representatives from the Ministry of Health and Valérie Saintoyant, general delegate of MILDECA. In France, we do not have tests capable of detecting 0.3% THC”, she answers, briefly.

The judge then asks him why make a distinction and authorize the CBD extract by prohibiting the flowers. “There is no special fate for the flowers, it is the cannabis plant as a whole which is classified under international law and French law”, answers Valérie Saintoyant. On several occasions, she deliberately uses the term “cannabis”. Opposite, we prefer “hemp”. Two words that speak of the same plant, but with very different definitions in the collective imagination.

After two hours, the president thanks everyone for these “Lights in Joy”. The lawyers all thank her for her holding of the debate, very effective it must be said. The judge in chambers will have left the floor to everyone, without rushing or stepping aside. She gives an appointment to all the parties next week, for the deliberation of the decision.

Why the Council of State is reinstating the sale of CBD flowers

This is a big win for CBD professionals. The Council of State suspends the ban on the sale of cannabidiol flowers, wanted by the government. This decision of the highest French administrative court allows the 2000 CBD product stores to sell hemp flowers again, legally. Why did the judge make this decision?

The order threatened “seriously and immediately” CBD sellers

Several unions and hemp lobbies have put forward “economic emergency” in front of which they have been since the publication of the decree. The Shyw company, which manages The CBD House brand, even highlighted a risk of bankruptcy in the very short term” during the hearing.

The Council of State has obviously heard their arguments. The contested decree prejudiced by seriously and immediatee to the situation of its members, by forcing them to destroy their inventory of hemp flowers and leaves and depriving them of income representing between 50 and 70 % of their turnover », underlines the report of the judge in chambers.

Because the decree contained too many contradictions

The decree of December 30, 2021 authorizes the CBD extract, but prohibits the flower… even though it is from it that the extract comes. During the hearing, the lawyer for the Professional Hemp Union, Cédric Uzan-Sarrano, made the audience laugh by saying: “The government tells us: ‘Apple juice is allowed. But the apple is narcotic’”. Obviously, his argument hit the mark.

The summary judge does not use the same terms as the lawyer, but the idea is close. According to her, the decree prohibits flowers even if their content THC, substance classified as narcotic, is below the threshold of 0.30 %, while this threshold is considered under the I of the same arrested as the one below which cannabis plants sativa L. are devoid of narcotic properties. » In other words: the government has become entangled.

Because it is possible to distinguish between CBD and THC flowers

This was one of the government’s key arguments. According to MILDECA, the “internal security forces […] must be able to simply discriminate between products, in order to determine whether or not they come under the criminal policy for the fight against narcotics”. Translation: police and gendarmes must differentiate at a glance a CBD flower from a THC neighbor. This explains the ban on flowers with a high percentage of cannabidiol.

For hemps and traders, there are quick and cheap tests to differentiate between the two. The Council of State therefore agrees with them. It does not result more than iL would not be possible to mobilize the means to control this content, while ofs means of control are detailed, for the entire plant, in the appendix to the order, in order to distinguish hemp leaves and flowers which, due to their very low THC content, could be regarded as devoid of pramazing properties », argues the judge.

She concludes curtly: ” The means taken from this that the general and absolute prohibition measure taken is disproportionate is naturale to create serious doubt as to its legality”.

Because CBD flowers are no more harmful than its extract

Another argument put forward by the executive: CBD flowers are consumed mainly in joints, often with tobacco. And “the risks associated with the smoke route have been established”, according to MILDECA.

The judge once again rejects the government’s argument. ” He does not result from the instruction, on the date of this order, that hemp flowers and leaves whose THC content is not higher thanand at 0.30 % would wear a degree of harmfulness to health justifying a prohibition measure generale and absolute of their sale to consumers and their consumption. »

In summary, CBD flowers are back in store!

Belgium must pay €90,000 in damages for improperly storing a seizure of CBD flowers

The Belgian State will have to pay compensation of more than €90,000 to a seller of hemp flowers. The suspicious materials had been seized for analysis, but poorly preserved and therefore unsaleable thereafter.

“In October 2018, the police seized more than 6 kilograms of cannabis from my client’s warehouse,” said lawyer Hamid El Abouti. “The man runs a store in the center of Brussels that sells cannabidiol, better known as CBD. »

“The substances were seized because passers-by noticed a strong smell of cannabis in the store. During a search, thirteen bags containing a total of 6.837 kilograms of cannabis were seized. In each bag, a sample was taken for analysis. My client did not resist, but asked to recover his equipment as soon as possible. »

Six months later, the trader was told he could get the confiscated goods back, but when he arrived at the police station, it turned out that the CBD flowers had been stored incorrectly. The man refused to take the cannabis back, saying it was unsaleable. The public prosecutor then ordered the destruction of the flowers, but the trader hired a lawyer to seek compensation for his losses.

90,000 euros in damages

The case was brought before the French-speaking court of first instance in Brussels at the end of 2021, which condemned the Belgian State to pay more than €90,000 in damages. According to the court, it is certain that the police made a mistake by not storing the flowers correctly. For each gram of Cannabis that the trader has thus lost, he will receive €12.50. In addition to the €85,462.50, the man was also awarded €5,000 in additional damages.

CannaSwissCup: The 35 best Swiss CBD cannabis strains have been selected

The preselection of the best varieties of Swiss CBD cannabis by a VIP jury took place on Sunday 16 January. The 73 varieties submitted to the competition have been tested beforehand to detect the presence of nicotine, pesticides, mycotoxins and synthetic cannabinoids. 11 varieties were excluded from the CannaSwissCup 2021/22 due to the detection of pesticide residues not authorized by the regulations of the CannaSwissCup association.

The 11 members of the VIP jury, made up of international experts in growingmedia and three consumer representatives from the three linguistic regions of Switzerland (German-speaking Switzerland, Ticino and Romandie) met on January 16 in the Absinthbar in Solothurn for a day among VIP experts.

The coded varieties – only their category (indoor, outdoor, greenhouse) was known – were evaluated according to appearance, aroma and taste. The 17 best indoor strains, the 10 best outdoor strains and the 8 best greenhouse-grown strains have been selected and will be part of the box jury for the CannaSwissCup 2021/22, available from Tuesday 1 February in hemp stores throughout the Switzerland as well as on www.cannaswisscup.ch.

All the varieties submitted to the competition have been analyzed in an SCC laboratory (Swiss Certified Cannabis) on their CBD, CBG and THC content and – apart from the analysis of pesticides and mycotoxins – were also checked for the possible presence of synthetic cannabinoids. All of the strains entered in the competition had a THC content below 1% and none of the strains entered had any nicotine or mycotoxin residues.

No traces of synthetic cannabinoids found

However, 11 varieties were excluded because they contained pesticide residues. This shows that most of the Swiss CBD sector works cleanly and carefully, despite the lack of regulation. Since pesticide limit values ​​have not yet been defined for cannabis, the organizers of the CannaSwissCup demand that a zero tolerance for pesticides must be observed for the CannaSwissCup, as is for example the case for market gardening.

In addition, the organizers point out that the problem of pesticides and synthetic cannabinoids is much greater in the case of illegal cannabis than in that of legal CBD cannabis and that a rapid regulation of the cannabis market is necessary and judicious.

How is the best grass chosen?

Any adult residing in Switzerland can acquire a jury box and thus participate in the choice of the best Swiss CBD weed 2021/22. A trip to Amsterdam will be chosen among the participants. In addition, the box jury includes two day passes for the CannaTrade 2022, where the CannaSwissCup Awardshow will take place on Saturday, May 21, 2022

All information about the CannaSwissCup: www.cannaswisscup.ch

All information about Swiss Certified Cannabis : www.swiss-certified-cannabis.ch

Back to normal for Denmark’s medical cannabis program

After a two-and-a-half-year absence, medical cannabis oils are back in the Danish program, which should give this struggling device a boost.

After a strong start, with patient numbers reaching 2,000 in 2019, the program came to a halt after oil-based products supplied by state-owned Stenocare were pulled from the market.

With the number of patients down to around 1,500, it is expected to start rising again as people who prefer cannabis oil products can once again get their favorite drugs.

Stenocare CEO Thomas Skovlund Schnegelsberg says the new product is expected to be available to patients in the first quarter of this year, subject to international import and export certificates.

Extended trial period

He said: “This announcement reinforces our position as the first and only supplier of cannabis oils for the Danish pilot program. This underlines our position as the undisputed market leader in Denmark. »

The challenge for many patients in recent years is that only three products containing cannabis flowers have been approved by the Danish Medicines Agency (DMA) and made available to patients.

Products in the form of oil therefore offer a real method of administering medical cannabis to patients.

The oils’ readmission to the program also marks the start of a new four-year trial period and comes as new rules allow domestic companies to grow cannabis and produce cannabis-based medicines beyond. the end of the new trial period, in 2026.

Conor O’Brien, an analyst at Prohibition Partners, believes these developments will give a boost to patients who use medical cannabis in the Scandinavian country.

He said: “The release of Stenocare oils from the experimental program in Denmark had a big impact on the cannabis industry. Many patients started sourcing medical cannabis from magistral preparations (extracts and isolates prepared in pharmacies) or turned to pharmaceutical products like Epidiolex when it hit the market in 2020.”

Strict regulations

“However, many patients appear to have exited the legal cannabis market following the loss of cannabis oils from the pilot program, with patient numbers declining by more than 20% 12 months after the event. The reintroduction of the oils will be a welcome development for many patients in the country, although it remains to be seen how many patients will return to using these oils after switching to alternative treatments. »

The 2019 cannabis oil supply disruption is the result of Health Canada’s identification that several batches purchased by Stenocare from Canadian producer Canntrust were grown in unapproved facilities.

Health Canada then suspended parts of Canntrust’s license, which led to Stenocare ending its collaboration with Canntrust and stopping imports.

Mr Schnegelsberg said the number of patients rose rapidly from 300 to around 1,100 after the introduction of the oil-based products, which pushed Stenocare sales in the first five months of 2019 to 4 .4 MDKK (around €600,000).

No other oil-based products have been approved by the DMA in the meantime, and Stenocare is currently working with the DMA to get two more oil-based products approved for the pilot program: a CBD oil and a blended oil. THC-CBD.

Mr. Schnegelsberg added: “The Danish regulatory regime is recognized as being by far the most difficult to pass in Europe. We have only been able to achieve this thanks to the experience of our regulatory team and the ability of our supplier, AgMEDICA Bioscience, to meet the requirements of the Danish Medicines Agency. »