From last resort to first line: Israel’s major reforms to medical cannabis

Via Business of Cannabis 

Israel could soon see a dramatic increase in the number of medical cannabis patients as the government publishes proposals for sweeping reforms aimed at streamlining access.

On Monday 7 August, The Health Ministry published its highly anticipated proposals for medical cannabis reform in Israel, which has already seen the stock prices of local cannabis operators spike.

These reforms, which are expected to begin being rolled out from December this year, are ‘great news for tens of thousands of Israeli citizens and the economy’, according to Health Minister Moshe Arbel.

While some have argued the changes do not go far enough to ensure timely access for many patients, there is a general consensus that this is a positive and significant step forward for the industry.

We have summarised the key elements of the new reforms below:

‘First-line treatment’

Perhaps the most significant upcoming change outlined by the government is the transition of medical cannabis from a ‘last resort treatment’ to a ‘first-line treatment’.

This means that when the new regulations come into force from December this year, doctors will be able to issue prescriptions to patients without them needing to prove that they have tried alternative drugs for a year.

While this change is expected to see Israel’s 125,000 patient demographic grow significantly following an ongoing decline since 2021, some have argued that it does little to address the bottleneck caused by a lack of doctors able to prescribe medical cannabis and issue licences.

Prescription-based model

Another major change which is expected to ease patient access and see patient numbers grow significantly is the removal of the need for many patients to obtain cumbersome and time consuming government licences.

Business of Cannabis reported in March that the new reforms would see this problematic licence structure replaced by a new prescription model, handled by the country’s four official health insurance organisations.

Participation in a medical insurance plan with one of these four ‘sick funds’ is compulsory.

At the time, Kanabo’s CEO Avihu Tamir suggested these measures could see the number of patients double.

This transition is expected to take place in January 2024, but will initially only impact around 10% of patients.

Patients suffering from 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 obtain prescriptions from their doctors without obtaining a licence.

Critics have argued that this fails to address the needs of those suffering from PTSD, chronic pain, fibromyalgia and other conditions, potentially seeing them turn to opioid alternatives.

Speaking to local news publication Maariv, Dr Ofir Levon, chairman of the Israeli Society of Toxicology in the Medical Association said: “This should lead to a situation where the patient’s dialogue with the doctor will be more effective, enabling them to try to give the treatment without making too many conditions.

“We will roll this out in stages, it cannot happen all at once, there is a strong desire for it to happen quickly. HMOs are organising for this, but this also takes time. The first stages will happen towards the end of the year.”

CBD could be legalised 

The reforms will also address the ongoing grey area surrounding CBD regulation, stating that the government was ‘examining the possibility’ of rolling out definitive legalisation.

Currently CBD remains part of the Controlled Substances Act and is considered a ‘dangerous drug’.

From February 2024, Israel will ‘examine the possibility’ of removing CBD and other cannabinoids that are not part of the THC family (like HHC and THCV) from the Controlled Substances Act.

This ‘refinement of the definition’ could limit ‘only cannabis and psychoactive components with a concentration of THC above 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 voiced their disappointment that the government’s commitment was not more concrete.

Research 

The new guidelines also seek to encourage more cannabis research, introducing a number of measures designed to make getting new research approved less cumbersome.

The document suggests that ‘dramatic relief in research approval mechanisms’ will be introduced by providing a ‘clear procedure’ to launch clinical trials to prove safety and effectiveness.

Crucially, the strict controls on importation of raw materials will be eased for research purposes, enabling the expansion of genetic diversity available to researchers, though it’s expected that limits on the importation of finished products will remain in place.

Restrictions on packaging and advertising 

Alongside the liberalisation of many of the current rules, the reforms will also see a number of new restrictions imposed around advertising and packaging.

Overall, there is a significant shift towards the ‘medicalisation’ of the industry, meaning that products will be made to appear more medicinal, and less like consumer goods.

As such, colourful, attention-grabbing packaging will no longer be allowed, with a new ‘defined packaging standard’ requiring products to mostly be of a uniform colour being brought in.

According to Cannabis Magazine, new regulations that have not yet been officially published may also see ‘tempting’ strain names banned.

The Ministry of Health has stated: “The current situation, where there is no defined packaging standard, has led to a wide variety of packaging in different colours, writings, and graphics.

“This situation has resulted in marketing characteristics that are very prominent and not acceptable in the medical field. Not only does it not promote better medicine, but it diverts the professional activity of pharmacies and increases costs for the practitioners, which can ultimately affect the product’s price for the patient.”

These packaging restrictions will also see limits imposed on the information pertaining to the strains active components.

Accurate percentages of the balance of THC and CBD, for example, will no longer be required and may even be banned.

This controversial stipulation, which critics claim could hinder patients ability to choose the most suitable products, is understood to be an effort to undermine the growing patient preference for the highest THC strains.

The Ministry of Health says there is no scientific evidence to support the notion that higher-THC improved the effectiveness of treatment, and that some evidence suggested lower THC doses improved pain relief.

This article was originally published by Business of Cannabis and is reprinted here with permission.