On Monday August 7, the Ministry of Health published its proposals for the reform of medical cannabis in Israel. These reforms, which should begin to be implemented from December this year, are “great news for tens of thousands of Israeli citizens and for the economy”, according to Health Minister Moshe Arbel.
While some believe that the changes do not go far enough to ensure rapid access for many patients, everyone agrees that this is a positive and significant step forward for the sector.
First-line treatment
The most important upcoming change according to the government is the transition of medical cannabis from a “treatment of last resort” to a “first line treatment”.
From December this year, doctors will be able to issue prescriptions to patients without them needing to prove that they have tried other drugs for a year.
While the change is expected to see Israel’s patient population of 125,000 rise significantly after a steady decline since 2021, some have argued it does little to address the bottleneck caused by the lack of doctors able to prescribe medical cannabis and issue licenses.
Prescription-based model
Another major change that should ease patient access and see patient numbers increase significantly is the removal of the need for many patients to obtain cumbersome and time-consuming government licenses.
Business of Cannabis reported in March that under the new reforms, this problematic licensing structure would be replaced by a new prescription model, run by the country’s four official health insurers.
Participation in a medical insurance plan with one of these four “sickness funds” is compulsory.
At the time, Avihu Tamir, general manager of Kanabo, hinted that these measures could double the number of patients.
This transition is expected to take place in January 2024, but will initially only affect around 10% of patients.
Patients with cancer, Crohn’s disease, dementia, autism, multiple sclerosis, HIV and those who have been given less than six months to live will now be able to get prescriptions from their doctors without need a license.
Critics argued that the measure did not meet the needs of people with post-traumatic stress, chronic pain, fibromyalgia and other conditions, who were at risk of turning to alternatives to opioids.
Speaking to the local newspaper MaarivDr. Ofir Levon, president of the Israeli Society of Toxicology within the Medical Association, said: “This should lead to a situation where the dialogue between the patient and the doctor will be more effective, which will allow them to try to give the treatment without setting too many conditions.
“We are going to proceed in stages, it cannot be done all at once, there is a strong desire for it to be done quickly. HMOs organize for this, but it also takes time. The first steps will take place towards the end of the year.
CBD could be legalized
The reforms will also tackle the gray area surrounding CBD regulation, stating that the government is “studying the possibility” of legalizing it permanently.
Currently, CBD is part of the Controlled Substances Act and is considered a “dangerous drug”.
Starting in February 2024, Israel will “examine the possibility” of removing CBD and other cannabinoids that are not part of the THC family (such as HHC and THCV) from the Controlled Substances Law.
This “refinement of the definition” could limit “only cannabis and psychoactive components with a THC concentration greater than 0.3%” to the Controlled Substances Act.
While this is a significant step forward for the country’s CBD industry, which is far stricter than many European countries despite its progressive stance on medical cannabis, some have expressed disappointment that the The government’s commitment was no more concrete.
Research
The new guidelines also aim to encourage cannabis research, introducing a number of measures to make it easier to approve new research.
The document suggests that “considerable relief from research approval mechanisms” will be introduced by providing a “clear procedure” for initiating clinical trials to prove the safety and efficacy of the substance.
Strict controls on the import of raw materials will be relaxed for research purposes, increasing the genetic diversity available to researchers, although limits on the import of finished products are expected to remain in place.
Packaging and Advertising Restrictions
As well as liberalizing many of the current rules, the reforms will also impose a number of new advertising and packaging restrictions.
Overall, there is a significant move towards the “medicalization” of the industry. The products will be presented as medicines and no longer as consumer goods. As a result, eye-catching colored packaging will no longer be permitted, as a new “defined packaging standard” requiring products to be predominantly one uniform color has been introduced.
According to the Israeli media Cannabis Magazinenew regulations that have yet to be officially released may also ban “tempting” variety names.
The Department of Health said: “The current situation, where there is no defined packaging standard, has led to a wide variety of packaging in different colours, scripts and graphics. »
“This situation has given rise to very marked and unacceptable commercial characteristics in the medical field. Not only does it not promote better medicine, but it distracts the business activity of pharmacies and increases costs for practitioners, which may ultimately affect the price of the product for the patient”.
These packaging restrictions will also impose limits on information about the active constituents of varieties.
Specific percentages of THC and CBD, for example, will no longer be required and may even be prohibited.
The controversial provision, which critics say could prevent patients from choosing the most appropriate products, is seen as an attempt to undermine patients’ growing preference for high-THC strains.
The Department of Health says there is no scientific evidence to say that higher THC levels improve treatment efficacy, and there is some data to suggest that lower doses of THC improve relief from pain. pain.
