Someday in the second half of April, after the tumult of the election has died down, and probably after the Passover holiday, the "determining day" will be announced for the new cannabis reform to come into force. The potential of the Israeli market is not less than NIS 600 million, with some 46,000 patients using cannabis products, but despite the efforts of the Ministry of Health to explain exactly what the reform is, how it will affect the quality of treatment, and patients' pockets, and how it will change the market, the number of growers, and the way cannabis is consumed, the public is still confused. "Globes" spoke with people in the field to bring order to the confusion.
"The grower-patient nexus - the root of all evil"
The person who determined how "the day after" will look is Yuval Landschaft, head of the medical cannabis unit at the Ministry of Health and architect of the reform. Landschaft, who does not often give interviews, agreed to talk to "Globes" about the reform in order to dispel what he sees as the public's ignorance.
Landschaft is a pharmacist by profession. He took up his post as head of the cannabis unit in 2013, and since then he has been in the eye of many storms, and has even had his life threatened. Among other things, he has been accused of having a conflict of interests because of business ties with pharmacies. "I feel like a marathon runner who has run for years with a small group and now we're entering the stadium," Landschaft says. "A few minutes of running before the finish, and only now they're cheering us and shouting at us and there's a big noise. Those who get very excited perhaps throw drink cans at us by mistake."
Landschaft seems to enjoy the drama, however, and so he doesn't hesitate to warn that the reform was vital in order "to break the nexus between patient and grower, which the root of the evil of imprecision."
He means that up to now patients have received prescriptions stipulating how many grams of cannabis they are permitted to consume, and have been assigned to a grower, who is charged with the task of supplying the product to the best of his understanding. The grower mostly supplies a particular strain of cannabis, "but a dose of cannabis should not be measured in grams of the plant," Landschaft says, "but in grams of the active substance."
What products will it be possible to sell under the new reform?
"There are 40 active substances in cannabis. We are developing a scale called a potency estimate that will define for the consumer the concentrations of as many as possible of these substances. We initially focused on two of them, THC and CBD. We grade the levels of THC and CBD in the material according to twelve grades, in order to characterize the product."
One thing that patients and growers were angry about at the start of the reform was that the concentrations of THC and CBD defined for the products did not match the concentrations in the growers' most popular plants. So, for example, if a patient was assigned to Tikun Olam and used a pure Avidekel strain, now, in order to obtain the concentrations permitted under the new reform, it would be necessary to blend Avidekel with another plant.
Landschaft claims that the strains method does not contradict the ingredient grades method. "Study is the antidote to ignorance, and all the grumbles about strains arise from a lack of study. Under the new regulations, there is no patient who will not be able to obtain his or her strain. We've constructed a conversion table, and if a patient says 'At present I take Avidekel', the doctor will prescribe one of the twelve categories that Avidekel most falls into." Landschaft will allow products to be labelled with the strain as well as the ingredients.
The grades method is a relatively new development in the reform; in the past, the plan was to indicate only the composition, and not all the ranges. With that approach, some strains would disappear from the market. According to Dana Bar-On, CEO of the Medical Cannabis Association, the claim that all the strains are included in the composition grades is not quite true, and the switch from strains to compositions is not scientifically based. "I, for example, use a strain that has 21% THC, but I mustn't use CBD at all, because it totally paralyses me. After years of being a guinea pig, the strain that suits me was identified, but this strain does not belong to any grade under the reform. Besides that, every grade in the reform allows a range of ingredients, for example between 0% and 4% CBD. I cannot consume a range. The focus on two ingredients, and even 40 ingredients in the future, is not scientific, because every strain contains thousands of different ingredients."
The cannabis market in numbers
According to Yaron Berger, CEO of online drugstore epharma.co.il, which has set up cannabis activity under the name Green Pharma, "When patients have not managed to obtain the strain they were used to, they continued by using other strains from other growers. In other words, this whole strains notion doesn't hold water. For growers, it's important that a patient should ask for a certain cannabis strain, because they want to hold onto their customers." Berger believes that customers will fairly quickly become used to requesting the product according to the proportions of THC and CBD, and not by strain.
Later on, there will be further developments: the EP scale for measuring and labelling 40 active ingredients in cannabis, in the hope that doctors will more precisely prescribe the composition suitable for the patient. The scale is an Israeli invention, like the reform as a whole. Israel is a startup nation in medical cannabis, and for Landschaft it's very important that Israel should preserve its pioneer status, even if that means that in every area it has to develop both the know-how and the regulatory mechanisms from scratch.
Nadav Gil, who heads the cannabis practice at Deloitte Israel, agrees. "The entire world is looking at our regulatory framework," he says.
What will a prescription look like under the reform?
"We're not a rubber stamp," Landschaft stresses. "Around the world, many doctors prescribe grass to make a living. They're known a kush doctors ("kush" is slang for high-quality cannabis - G.W.), and most doctors don't want to prescribe something that some bird has defecated on and put it directly into the lungs of a patient with no immune system.
"500 doctors have been trained to prescribe cannabis without the need for approval by the medical cannabis unit. The prescription states the make-up of active ingredients that the patient should receive. If a doctor who has not undergone training wishes to prescribe cannabis, he or she can do so, but such a prescription has to receive approval form the medical cannabis unit."
How many doctors considered leaders in the cannabis field have not undergone the medical cannabis unit course?
"Of the 100 or 500 promised doctors, in December only 30 were ready. The medical cannabis unit supervises prescriptions through its central computer. This is a Big Brother system that allows bureaucrats to decide contrary to the decision of the doctor. That's not democracy," Bar-On says.
According to Dr. Ronnie Benshafrut, a senior partner at intellectual property law firm Reinhold Cohn and an expert on cannabis, "Under the reform, doctors and pharmacists do not have a great deal of freedom of action. The Ministry of Health defines which composition is suitable for which illness. But today, when it comes to cannabis, because of genuine gaps of knowledge in science, it's actually the patient who knows best what works for him or her. Listening to the patient is the missing part in the existing regulations."
On what basis is the doctor able to write a prescription?
Landschaft: "We published the 'Green Book' containing all the existing scientific knowledge. It's known, for example, which composition is anti-inflammatory, and which must not be given to someone with liver disease. We ask the doctors to start with a low dosage and to increase it carefully. On the other hand, we don't want to err by being over-cautious either. So we built a bridge, one that might not be built from solidly based medical evidence along its entire length, but strong enough to allow 46,000 people to be treated. A regulator is not a bureaucrat."
Up to NIS 800 monthly instead NIS 370
After receiving a prescription, the patient is supposed to go to a pharmacy and present the pharmacist with the composition recommended for him or her, and choose between several brands. There are currently about five brands in the market, but not every pharmacy stocks every brand, and basically what's on the shelf will determine what the patient with receive. "As far as I'm concerned, competition for a place on the shelf is competition over quality," says Landschaft.
The patients fear that the price could rise to thousands of shekels a month.
"Under the old regulation, each patient bought for NIS 370 monthly whatever quantity the doctor prescribed. After the reform, the pharmacies can set any price, and there's competition between them. An examination we carried out showed that for 82% of the patients the doctors will prescribe up to 40 grams. For these people, the product will not become more expensive. For another 15%, it will become little more expensive. For 3%, the product will become more expensive, and we hope that the government health basket or the health funds will finance it for them."
Benshafrut warns that that there may be a temporary shortage of material, but that, even by the end of the year, there might actually be excess supply in the market. According to Adv. Hagit Weinstock of Weinstock Zehavi & Co., by the end of the year some 15 cannabis farms will be set up, and in the longer term 40-50 farms. "I believe that there will be prescriptions for 100,000 patients in Israel, double the number today. Each one, however, will consume a lower quantity. They won't take 50 grams and share it with the neighborhood anymore."
A petition has been filed in the High Court of Justice against the reform by Adv. Miriam Brainin and Adv. Yasmin Mizrahi representing the Medical Cannabis Association, containing severe claims of patients concerning the scientific basis of the Green Book's approach, the high prices, and expected shortage of the plant, and the approach to strains. "Unfortunately, interested parties are not concerning themselves with the facts, or else relate to unusual, extreme cases," says Landschaft.
Published by Globes, Israel business news - en.globes.co.il - on April 7, 2019
© Copyright of Globes Publisher Itonut (1983) Ltd. 2019