The reform of the Israeli medical marijuana industry aims to transition it from an era of the “wild, wild weed” to one that looks more like a conventional sector of the global pharmaceuticals market.
But the reform, which went into effect in May, has aroused a lot of criticism from some of the 50,000 or so authorized users of medical marijuana in Israel. They say they can’t get the kind of cannabis they once did that was so effective and complain that prices have gotten much higher.
In an interview with TheMarker, Prof. Arnon Afek, who in July was appointed chief medical adviser to the Health Ministry’s medical cannabis unit, on a temporary basis, acknowledged that the reform has created problems but he says that’s only for a minority of users. He said the “medicalization” of medical marijuana is the only way to go.
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“At the end of the day, no doctor can prescribe a patient Blue Moon [a strain of cannabis] without knowing what the active ingredients are. How do you know, for example, that what you’re prescribing doesn’t contain THC?,” referring to the psychoactive compound that gives marijuana users a high. “A physician has to be a lot more cautious than a person buying in the open market,” he said.
Until the reform went into effect, Israelis authorized to use medical marijuana bought directly from growers. Prices were fixed at 370 shekels (about $105) a month, regardless of the amount. That meant that light users subsidized heavier users.
Under the reform, users are gradually transitioning to buying cannabis from their local pharmacy. Cannabis products are now subject to standardization based on their concentration of active ingredients in the plant, THC and CBD. Doctors prescribe the concentration and monthly dose.
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On the supply side, suppliers are now required to meet good manufacturing practices for growing, processing and supplying the product, set by the Health Ministry.
Meanwhile, users complain of a shortage of medical marijuana, which Afek said was due to the fact that not all of these veteran suppliers have met the new GMP standard. To ensure a reliable supply, the ministry has extended existing licenses through the end of 2019 and, in the case of the neediest users, such as people with cancer and children with autism, until June 2020.
Meanwhile, prices have risen to 120-270 shekels for 10 grams, depending on the product (oil, capsule, level of THC, etc.) The average price is now 180 shekels for 10 grams. For the heaviest users, that has spelled a big increase in monthly costs.
Medical cannabis is not in the government’s “basket” of subsidized drugs, but the Health Ministry is considering a plan to introduce price controls. It calls for a ceiling of 180 shekels for the first 10 grams (100 shekels for children and people with cancer), with the second 10 grams priced at 22% less. The ministry estimates that under this plan, 90% of users would pay no more than they did before the reform.
Afek knows the sector well. The associate director general of Sheba Medical Center, Tel Hashomer, he was in charge of medical cannabis issues during an earlier stint as director of medical affairs in the Health Ministry.
Medical marijuana is more “emotional” than many areas of the pharmaceutical industry, Afek said. “It attracts a lot of attention so it has many opponents on one side and unqualified support on the other.”
He is cautiously optimistic about the field. “Today I can say unequivocally that cannabis helps a lot of people in a lot of medical conditions. We do not yet understand its full potential, but it’s not the panacea for all the world’s sick. There are areas, especially in regard to people with mental illness, where there is a risk in using it.,” Afek said.
The challenge, he said, is to make up for decades during which no research was being done. Although the cannabis plant has been used for medicinal purposes for centuries, in 1937 the United States designated it as a dangerous drug. International agreement in the decades that followed defined it that way, thus clinical and other research was difficult to undertake.
“The problem for the health care system is that there is no evidence-based medicine in connection with cannabis,” he explained.
But there is a lot of anecdotal evidence that cannabis has helped with chronic pain and other conditions?
“Correct. A large part of the reforms are aimed at providing an answer to the problem that [cannabis] is a plant and not an isolated substance – for the medical system that’s a very difficult problem to contend with, The plant is amazing and contains hundreds of constituents, not all of which we understand,” said Afek.
Isolating a specific constituent of the plant may cause it to lose some of its efficacy. On the other hand, there is enough research yet to say with certainty what the added efficacy of using the while plant produces. Until it does, the industry can’t forgo using the plant.
“That means the regulations we are developing have to address medicinal plants and not a single substance,” he said. “For the medical world that’s difficult to cope with. Nevertheless, has one big advantage, Prof. Raphael Mechoulam,” he said, referring to the Hebrew University chemist who did pioneering research in THC at a time when it was effectively banned in most of the world.
In the meantime, however, people in Israel are complaining they can’t get cannabis varieties that had been working for them or can’t get medical cannabis at all. Is the reform failing?
“What have we tried to achieve through medicalization? We said let’s build an organized system that consists of the following elements. First, we want the products to be as close as possible to being medicine, even though [cannabis] is a medicinal plant. At least the concentration in the range of the substances we know will be at a set standard,” said Afek.
“Second, pharmacy distribution and dispensing. It’s the closest it can be to medicine. Why is it important? Take, for example, the child receiving epilepsy treatment. The parents need to know that the vial they buy contains concentrations of active ingredient similar to the previous vial and to the one that follows it. In the past they produced oil from varieties grown in different places and there were differences in concentrations. “
Afek said the reforms have had a positive side, too, even if there are running-in problems right now.
For one, it is easier to obtain a prescription than in the past. “When you look at the big picture of medicalization, it’s providing a solution for thousands of people who beforehand had no good solution,” said Afek. “Had it not been for reform, staff training and model building, we would not have reached 50,000 patients. We don’t have the privilege to stop.”