Dana Ciccone, chief executive officer of Steep Hill Hawaii, has been a patient advocate and leader in cannabis education in Hawaii, as well as a member of the Hawaii Medical Marijuana Dispensary Task Force, an organization formed by the University of Hawaii College of Social Sciences Public Policy Center to develop regulations for the state. “We are proud not only to be the first cannabis lab to be licensed in the State of Hawaii, but also now the first lab to achieve ISO certification as well,” says Ciccone. “Industry businesses, medical professionals, state regulators, and patients can be confident that our lab and its testing standards will operate to the highest international standards.”
According to the press release, the laboratory will offer services for testing cannabinoid profiles (potency), terpenes, pesticides, heavy metals, biological screening, and residual solvents, testing for 17 Cannabinoids and 43 terpenes. The release states they are locally owned and operated, providing testing services for not just industry businesses, but in-state card-holding patients as well.
“This is a turning point for the industry – we have moved very quickly to raise the industry standards in Hawaii to internationally recognized certification,” says Ciccone. “I am very proud our scientific team for the professionalism and hard work they put in to achieve this certification.”
There is a great deal to be happy about with medical cannabis legalization in Germany. This is the first country that has mandated insurance coverage of the drug – at least at the federal legislative level.
However, as the government evaluates the finalists in the first tender bid for domestically grown and regulated cannabis, a real crisis is brewing for patients on the ground. And further one that the industry not only sees but is trying to respond to.
Spektrum Cannabis GmbH, formerly MedCann GmbH began trying to address this problem when they obtained the first import license for Canadian cannabis last year. They are also one of the apparent five finalists in the pending government bid to grow the plant domestically for medical purposes. According to Dr. Sebastian Schulz, head of communications for Spektrum, “Shortly after the new cannabis law was reformed we experienced a huge increase in demand from the side of patients. We had prepared for that. The German population is very curious about cannabis as a medicine and in general very open to natural remedies.”
People are curious here. But like other places, the law in Germany has evolved slowly. Much like Israel, the government has allowed a trickle of patients to have access to cannabis by jumping through multiple, time consuming hoops. The process of getting cannabis prescribed, much less getting a pharmacy to stock it, was difficult. Patients had to pay out of pocket – a monthly cost of about $1,700. While that is expensive by American standards, to Germans, this is unheard of. The vast majority of the population – 90% – is on public health insurance. That means that most Germans get medications for $12 a month, no matter what they are. Allegedly, German patients were supposed to get about 5oz a month for this price. At least that is what the law says.
People are curious here. But like other places, the law in Germany has evolved slowlyAs in other countries, no matter what Germans think about recreational reform, the clear majority of them at this point support medical use. And at this point, both legislatively and via the courts, the government has said and been required to provide the drug to Germans patients at low cost.
Unintended Effects & Consequences
Since the law went into effect in March of this year however, things have suddenly turned very dire for patients.
The handful of people who had the right to grow at home – established under lawsuits several years ago – were suddenly told they could no longer do so. They had to go to a doctor and regular pharmacy. Even regular patients in the system found that their insurance companies, allegedly now required to pay, are refusing to reimburse claims. Doctors who prescribed the drug were abruptly informed that they would be financially responsible for every patient’s drug cost for the next two years (about $50,000 per patient).
To add a final blow to an already dire situation, German pharmacies that carried the drug, then announced an additional fee. It is about $9 extra per gram, added at the pharmacy, pushing the price of legitimate cannabis north of $20 dollars per gram. This is justified as a “preparation fee.” Cannabis bud is technically marked as an “unprocessed drug.” This means the pharmacies can charge extra for “processing” the same. In reality this might be a little bud trimming. If that. The current distributors in the market already prep and pre-package the drug.
What this bodes for a future dominated by infused products, oils and concentrates is unclear. However the impact now is large, immediate and expensive in a country where patients also must still go to the pharmacy in person for all prescription drugs.
There is no mail order here, by federal law. Online pharmacies are a luxury for Auslanders.
At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow.While nobody has challenged this situation yet en masse, it is already a sore point not only for patients but across the industry. It means that an already expensive drug has gotten even more expensive. It also means that the government regulations are not working as planned.
At least not yet. For the large Canadian companies now coming into the market with multimillion-dollar investments already sunk in hard costs, Germany will be a loss-leader until the system sorts itself out.
According to Schulz, whose company is now in the thick of it, the new law is very vague. “Currently, there are almost no cannabis flowers available in German pharmacies because companies like us are not allowed to sell them,” says Schulz. “Various different regulatory demands come up that seemed to change on a monthly basis. We are ready to deliver even large amounts of cannabis for a market that might well explode soon – but we first need to overcome the regulatory nightmare that leads to the suffering of so many patients here these days.”
At minimum, this could mean that without some relief, German patients will go right back into the black market and home grow. Black market costs for cannabis are about $10-15 a gram. In other words, exactly the situation the government was hoping to avoid.
What Is Causing The Situation?
The intended effect of the legislation was twofold, according to industry insiders: To legalize cannabis in such a way to meet a rising public demand and, in the face of a court decision, to limit the home grow movement. The latter of which, despite federal regulations, is thriving here. Germans like to grow things, and cannabis is a rewarding plant to nurture.
High attendance at the Mary Jane Grow Expo in Berlin in June is just one sign that the genie is out of this particular bottle. BfArM – the federal agency in charge of regulating narcotics and medical devices – cannot stuff it back.Patients are going back to the way things were
However home grow does not build a professional, high volume cannabis market, much less a highly regulated medical one make. The government also made clear that it is going to have strict inspections and quality controls, and will technically buy all the cannabis produced, per the terms of the bid application process.
However, it is not entirely clear when the government will start actually doing the buying. And why the buying has not started yet. If insurance companies are refusing to pay, this means the government is not reimbursing them. The same government, which has also agreed to do so, as of March 2017.
What Gives On Good Old German Efficiency?
On the streets, patients are going back to the way things were. Many are used to fighting for the only drug that makes them feel better. The euphoria in May, for example, has been replaced with weary acceptance that things might get a bit worse before they really improve.
That said, there is also a realization that more activism and lobbying are required on just about every front. If an extrapolation of data from say Colorado or California is applied to Germany, there are already at least a million eligible patients here, based on the qualifying conditions. The government is planning for an annual increase in medical patients of about 5-10,000 a year, including in the amount of cannabis they are planning on buying from the licensed producers they choose. The numbers, however, are already not matching.Even existing patients are literally being forced into the black market again.
Added to this wrinkle is the other reality that is also looming, particularly now.
With one exception, all of the firms now apparently in contention as finalists for the German government bid will also be supplying a domestic market in Canada that is going rec next summer. One year, in other words, before the German companies even begin producing.
What Is The Upshot For Patients?
Guenther Weiglein is one of the five patients who sued for home grow rights in 2014. He is now suing again for the right to extend home grow privileges until the government figures out its process. He is not the only one. Earlier this year he was told he had to stop his home grow and integrate into the “mainstream” system. So far, he, along with other patients who are suing, including for insurance coverage, have not been able to get cannabis easily through the system, although they are starting to make progress.
Weiglein’s situation is made even more frustrating by the fluidity of the situation. As of late July, he had finally gotten agreement from his insurance company to cover the drug. But now he cannot find a doctor willing to accept the financial risk of prescribing it to him. And in the meantime he has no access to medication.
Talk to any group of advocates right now, and there is one ongoing story. Even existing patients are literally being forced into the black market again.
And those that can’t afford it? They are out of luck. Some patients say a tragedy like someone dying will create the impetus to move this into public eye. A hunger strike here by a leading cannabis doctor earlier this summer has so far not had much impact on policy. There is a great deal of pessimism here, as promised change earlier this year has turned into a long and drawn out multiyear question mark.
If this sounds like a bubbling and untenable situation, especially before a national election, it is. The prospect of another four years of Angela Merkel does not bode well for fast cannabis reform.
That said, the German government is now in an interesting situation. The law has now clearly changed to say that sick Germans are allowed to use cannabis as a drug of choice for chronic diseases when all else fails. Further, the national government has bound the insurance industry to cover it. So far, every patient who has sued for coverage has won. That has not, however, moved the insurance industry altogether. Nor has it solved the problem with doctors prescribing the drug.
Many now ask what will? It is clear, however, that it will change. The question is when, how fast, and in what situations.
The problem will undoubtedly ease by 2019, when the first German crops are finally ready, although it will be far from completely solved.
The Senate Appropriations Committee approved the amendment to continue protecting state-legal medical cannabis markets from the Department of Justice. The amendment, previously known as the Rohrabacher-Farr Amendment, prevents the DOJ from using funds to target medical cannabis operations, patients and businesses in states where it is legal.
Every time Congress reviews the budget, this amendment needs to be included to keep protecting the medical cannabis community. While the rider still needs to make it through the final version of the appropriations bill, it is a big win for the status quo.
According to Aaron Smith, executive director and co-founder of the National Cannabis Industry Association (NCIA), this indicates that Congress is resisting Attorney General Jeff Sessions’ calls to end the protections. In a letter sent back in May, Sessions urged the Senate on both sides of the aisle to stop protecting medical cannabis.
Many see this morning’s vote as Congress standing up to Jeff Sessions, and standing up for medical cannabis patients. In a letter to NCIA members, Smith says that a lot of work still needs to be done, but this is an important first step. “This is not the end of the story. There are still many steps to go before a new budget is finalized,” says Smith. “But this is an important indicator that our allies in Congress are standing up for us, even in the face of DOJ opposition.” In an official NCIA statement, Smith acknowledges the hurdles that still face the amendment. “Now it’s time for the House to do the same,” says Smith. “Patients deserve access to care, states deserve respect, and members of the House deserve the opportunity to vote on amendments like this that have the strong support of their constituents.” Bipartisan support like this in Congress is needed to prevent the current administration and the DEA from meddling in states with legal medical cannabis.
Earlier this week, SC Labs issued a press release announcing they achieved ISO/IEC 17025:2005 accreditation for the cannabinoids panel at their Santa Cruz location.
“We are thrilled to announce our ISO accreditation as this is one of our most important achievements over the past seven years of serving the cannabis industry and demonstrates our commitment to serving our clients with integrity,” says Jeff Gray, co-founder and chief executive officer of SC Labs. ISO 17025 accreditation represents an international standard for a laboratory’s technical competence in producing accurate test results.
“Being accredited to this International Standard demonstrates our robust quality system, technical competence, the calibration and suitability of our instrumentation and our ability to produce precise and accurate test data,” says Gray. “For clients, it enhances their confidence in our services and their choice in a business partner, provides them with additional legal defensibility in complying with upcoming regulations, and enhances the integrity of their products based on SC Labs results.”
SC Labs is currently expanding in California, growing their Southern California and Santa Cruz locations, and adding field offices throughout the state, according to the press release.
On Election Day last year, voters in Massachusetts approved a measure to legalize recreational cannabis. With recreational sales beginning in July of 2018, lawmakers have tried to get a bill through the state legislature to settle on, among other things, a tax rate and regulatory framework.
On Wednesday, multiple news outlets reported that the legislature has reached a compromise on a bill that would change the measure that voters passed to allow for lawmakers to implement higher taxes, a strategy on local bans and a regulatory framework, reports The Boston Globe.
In a statement to supporters, Matt Schweich, director of state campaigns at Marijuana Policy Project (MPP), the biggest changes are in local control and taxation. “After weeks of persistent advocacy from Massachusetts residents, the Senate and House have reached a compromise that largely respects the will of the people,” says Schweich. “The legislation adjusts the local control policy, allowing local government officials in towns that voted “no” on the 2016 ballot initiative to ban marijuana businesses until December 2019. For towns that voted “yes” in 2016, any bans must be placed on a local ballot for voters to approve.” Therefore if a town wants to ban cannabis sales, they need to bring it to a vote for the people to decide. 72% of the population voted in favor of the ballot initiative. “The maximum tax rate — which depends on whether towns adopt optional local taxes — will increase from 12% to 20%,” says Schweich. “Under the bill, the state tax will be 17%, and the local option will be 3%.” A major push behind increasing the tax rates concerned lawmakers’ worries that the original 12% tax rate would not cover regulatory costs and government expenditures on the industry.
The ballot initiative created the Cannabis Control Commission, the regulatory body overseeing the industry, with three board members. That agency will remain in the new bill, just with five board members that will write the rules on things like marketing, safety, fines and penalties and fair business practices.
Schweich says the MPP helped orchestrate over 1,000 calls to legislators, urging them to reject the House’s version of the bill, which some have called draconian. “The bill isn’t perfect, and we preferred the original language of the ballot initiative,” says Schweich. “However, given how problematic the House bill was, we are satisfied with the final compromise.”
The bill is expected to pass votes in both the House and Senate on Thursday and Governor Charlie Baker is expected to sign the bill that same day.
According to a press release published earlier this week, DB Labs achieved accreditation, becoming the first ISO 17025-accredited cannabis laboratory in Las Vegas. DB Labs received their accreditation with the help of Perry Johnson Laboratory Accreditation, Inc., an organization that provides third-party assessments to ISO/IEC 17025:2005. DB Labs was also the very first cannabis-testing lab in the state of Nevada.
According to Susan Bunce, president of DB Labs, ISO accreditation is one way the cannabis lab space is being standardized. “As the first cannabis-testing laboratory in Nevada, DB Labs has always taken patient safety very seriously and has always tried to raise the bar,” says Bunce. “The world of cannabis testing is often compared to the Wild West: each lab uses state regulations to set their standards, but it leaves a lot of room for subjective interpretations. The ISO accreditation removes the ambiguity and guarantees a consistent level of testing to users. We are proud to be a part of that.”
According to Tracy Szerszen, president and operations manager at Perry Johnson, ISO/IEC 17025:2005 is an international standard utilized to accredit testing laboratories. “This accreditation provides confidence to end-users that the test results they receive are reliable,” says Szerszen. “Laboratories achieving this accreditation have demonstrated their ability to adequately perform tests using appropriate equipment, environmental conditions and technical staff.” She says another requirement for that accreditation is a quality management system, which essentially helps manage operations and client needs. “Achieving this type of accreditation is quite challenging for laboratories especially with all of the new up-and-coming regulations, technologies and methods in the cannabis industry,” says Szerszen. “Laboratory testing is such a critical part of this industry and becoming accredited provides assurance that they are performing to the highest standard.”
As Szerszen points out, laboratory accreditation can provide a consumer that sense of confidence and trust in the product’s lab testing. “PJLA would like to commend DB Labs for achieving their ISO/IEC 17025:2005 accreditation and their commitment towards meeting the standard,” says Szerszen.
The news of their accreditation comes at an opportune time: With surging consumer demand at the outset of recreational sales, the state has raked in millions of dollars in sales within the first weekend. Recreational cannabis sales in Nevada began on July 1st, and a statewide cannabis product shortage recently led to Governor Sandoval issuing a statement of emergency, allowing more applications for distribution licenses to be considered.
According to an article on Reuters, Uruguay’s pharmacies opened for recreational cannabis sales on Wednesday for those over the age of 18. Uruguay beginning recreational sales marks an important milestone as the first country to fully legalize cultivation, sales and recreational use of cannabis.
The country legalized cannabis more than three years ago, but it has taken a while for the government to work out and implement their regulatory framework. Only two companies, Symbiosis and Iccorp, received government licenses for growing, packaging and distribution, according to Reuters.
Consumers are required to register with the government and are only allowed to purchase up to 40 grams of cannabis per month. 5-gram packages are the only products for sale currently at $6.50 a piece. As of now there are only two types of cannabis that consumers can purchase: “Alfa 1”, and indica, and “Beta 1”, a sativa. According to Reuters, neither has a particularly high concentration of THC.
The government says they will carefully monitor production and registrations to prevent diversion and cannabis leaving the country. Only citizens of Uruguay over 18 are permitted to register to buy cannabis. With over 3.4 million people residing in Uruguay, less than 5,000 have registered by Wednesday. All sales must go through a pharmacy, according to the Reuters article.
On July 1st, dispensaries in Nevada began recreational cannabis sales, where thousands flocked to retail shops on opening day throughout the state. In Las Vegas, 38 dispensaries were flooded with customers in long lines, with waits up to three hours, according to the Las Vegas Sun. Nevada joins four other states, Oregon, Colorado, Washington and Alaska, in legal recreational cannabis sales.
Another article on the Las Vegas Sun claims the state did a total of $3 million in total rec cannabis sales in the first four days of it being legal. Over the next six months, it is estimated the state will do $30 million in total cannabis sales. According to that article, that generated roughly $500,000 in tax revenue for the state in those first days.
An article in the Reno Gazette Journal quotes Nevada Dispensary Association Executive Director Riana Durrett as estimating roughly $1 million in tax revenue for the state in the first four days. The four dispensaries in Reno that are open for recreational cannabis sales reaped hundreds of thousands of dollars within a few days, according to Will Adler, executive director of the Sierra Cannabis Coalition.
Blum, a dispensary with locations in Las Vegas and Reno, owned by Terra Tech, did roughly $100,000 in revenue on the first day at their Reno location, according to the Reno Gazette Journal. On Friday, July 7th, after a week of record sales, the state acknowledged there might be a shortage of cannabis, with growers unable to meet market demands. In an email sent on Friday, the Nevada Department of Taxation announced Governor Brian Sandoval endorses a ‘statement of emergency’, giving officials the ability to consider more applicants for distribution licenses, according to the Reno Gazette Journal. “Based on reports of adult-use marijuana sales already far exceeding the industry’s expectations at the state’s 47 licensed retail marijuana stores, and the reality that many stores are running out of inventory, the Department must address the lack of distributors immediately,” says Department spokeswoman Stephanie Klapstein. “Some establishments report the need for delivery within the next several days,” says Klapstein. Nevada legalized recreational cannabis on Election Day in 2016, when voters approved Ballot Question 2.
Election Day last year also yielded legal recreational cannabis in Maine, Massachusetts and California, all of which are expected to roll out regulations and implement recreational sales in 2018. Given Nevada’s massive numbers in sales and tax revenue in the first week, many anticipate high opening day sales revenue numbers in Maine, Massachusetts and California.
According to a press release yesterday sent out by the National Hemp Association (NHA), on Wednesday, June 28th, Board Chairman Geoff Whaling met with senior U.S. Department of Agriculture staff, along with Erica McBride from the Pennsylvania Industrial Hemp Council. The press release says this is the first time that Agricultural Secretary Perdue has had his staff meet with the hemp industry. “The meeting reaffirmed critical elements of the working relationship that the hemp industry has established with the USDA since the enactment of Sec. 7606 of the 2014 Farm Bill,” reads the press release put out by the NHA.
The press release says the USDA will support hemp pilot projects, considering grant and loan applications and other means of funding under the USDA and NIFA. “All hemp industry participants are encouraged to participate in these funding opportunities,” says Whaling. “USDA confirmed that nine Industrial Hemp funding requests to NIFA are being processed and that USDA has encouraged those who submitted previous requests to resubmit them.”
“USDA also offered to provide a quick response to any Secretary or Commissioner of Agriculture who is looking for clarification on either the Farm Bill or SOP, which may be preventing the States that have enacted enabling Industrial Hemp legislation from advancing research,” says Whaling.
A big driver of the meeting was the support of the Industrial Hemp Farming Act of 2018 on behalf of the NHA. That bill, which Congressman James Comer (R-KY) plans on introducing in July, would essentially remove hemp from the Controlled Substances Act, allowing industrial cultivation of the plant. It also would set a THC limit and give states the power to regulate their own hemp industries.
“There is new leadership in the USDA, on the Hill and within our industry,” said Whaling. “I am confident that this group will advance our industry to a level never before achieved.”
According to the Independent, Prime Minister Alexis Tsipras announced last week that Greece will legalize medical cannabis, allowing doctors to write prescriptions for it. “From now on, the country is turning its page, as Greece is now included in countries where the delivery of medical cannabis to patients in need is legal,” says Prime Minister Tsipras at a press conference.
Catalonia, an autonomous region in Spain, legalized consumption of recreational cannabis and cannabis clubs last week. The government voted in favor of the measure with wide support after a 67,500-signature petition brought the debate to the center stage.
According to the Independent, the rules seem relatively restrictive, with measures in place to prevent the capital of Catalonia, Barcelona, from turning into a cannabis tourism capital, such as Amsterdam. One of those rules requires a waiting period for new members of clubs before they can purchase and consume cannabis. However before this measure passed the vote, cannabis clubs were in a legal gray area, with fines for public consumption. These European markets could present excellent opportunities for cannabis companies, which could cause other EU countries make the plunge into legal cannabis.