Israel’s Ministry of Health Medical Cannabis Association (IMCA), locally known as Yakar, recently enacted reforms to medical cannabis regulation. These include changes to reduce barriers to patient access, specific licensing requirements for production, and expanding the number of access points approved of sale.
The main goal of the reform is to ease bureaucratic hurdles for patients and to improve the quality and consistency of medical cannabis. There are two main sections to the reform, one for businesses and the second for patients:
Reform to cannabis business licensing process:
- The licensing process for cannabis research institutes and cannabis dispensing pharmacies expanded and clarified.
- The licensing process for cannabis disposal facilities and cannabis transportation defined.
- As part of the review process, after approving applicants based on standard criteria, an initial permit is given. This permit encompasses business planning and development pending final approval.
- The initial permit given by the IMCA cannot be transferred.
- The owner of the initial permit must notify the IMCA director immediately of changes in the business (address, contacts, etc.) and obtain prior written approval for any change in ownership or to the material shareholders.
Reform to medical cannabis access for patients:
Israel’s Dangerous Drugs Ordinance will be amended to reclassify medical cannabis in the same category as any other prescribed medication. For specific conditions, cannabis prescriptions will become the purview of physicians and not require special dispensation from the Ministry of Health.
The criterion for eligibility:
- Controlled cannabis products sold in pharmacies
- Patients over the age of 18 (excepting children with severe epilepsy)
- Registered by a specialist physician
- Maximum prescription of 40g/month
Medical cannabis may be prescribed without an IMCA license for the following medical indications:
- Oncological diseases
- Inflammatory bowel disease
- Neurological indications such as epilepsy, Parkinson’s
- Severe epilepsy in minors
Although the reforms were developed with the intention of helping patients, the road to implementation has been rocky at best and those bearing the brunt are the sick. Patients have experienced delays in licensing, the inability to renew licenses, unavailability of specific strains, and diminished quality and quantity of prescription cannabis. These barriers are harming already vulnerable patients in what amounts to an infringement of basic human rights.
The Israeli Ministry of Health is being scrutinized and criticized for failing to adequately provide access to medical cannabis where justifiably prescribed. In a recent report by Israel’s State Comptroller on the validity of public complaints against the Ministry of Health, in 2017, 83% of reported complaints against the Ministry for unjustifiably denying access to cannabis were found to be valid.
The Israeli cannabis reform went into effect on April 1, 2019, during CannaTech’s annual flagship conference. In an effort to publicize the harm precipitated by the new regulatory framework, protesters set up outside of the venue. Throughout the day, these dedicated advocates shared their stories of adversity with us. Following the event, we sat down with a couple of patients’ rights activists for a painful conversation about the Ministry’s failure to protect chronically ill and palliative patients.
Ofir and Erez are medical cannabis patients and advocates. Sitting in a quiet yard in a small town twenty minutes from Tel Aviv, both men explained that they emphatically support the need for reformed cannabis regulation. However, the current state of affairs is untenable and fundamentally unjust. Since the reform, Erez says, patients have been harmed at numerous levels: the chain of treatment, availability of targeted strains, increasing cost, and invasion of privacy in the licensing process.
The shifting regulatory cannabis landscape in Israel has negatively impacted quantity, quality, and availability of product. While the reform is meant to simplify the process, in the meantime licenses are hard to get or renew, and even if a patient makes it through the maze of requirements, prescription amounts have been radically slashed and the range of available strains reduced.
One of the main challenges to the supply chain has been the closure of a major grower holding upwards of 40% of Israeli medical cannabis licenses. Although many patients were shifted to other dispensers, and operations are meant to resume next month, thousands of Israelis found themselves suddenly without medication. Furthermore, specific strains targeting conditions including refractory epilepsy have been available in the interim. For Ofir, who suffers from a chronic pain disorder, this has meant chasing down the strain that is most effective for his specific ailment from pharmacy to pharmacy, often without success. During our conversation, Ofir shifted in his seat, unable to find a comfortable position and in obvious pain. Without medication, he is unable to work, care for his children, or even walk short distances. The reform that was intended to help patients has done nothing but harm thousands of people like Ofir.
One main push for the reform was to expand access to medical cannabis by permitting general practitioners to prescribe up to 100 grams. In the past only specialist physicians could submit a request for a special license to the Ministry, creating long wait times and limited access. However, despite the reform, many physicians remain wary of widespread prescription, and as growers scramble to meet the new stringent requirements implemented in the reform, the availability of high-quality medical-grade cannabis has dropped dramatically. Furthermore, even once the supply recovers, it may not be sufficient to meet the demand resulting from expanded prescription parameters, nor will an adequate variety of strains be available. The shortages, diminished quality, and protracted process recently galvanized the implementation of a separate cannabis unit by one of Israel’s largest HMOs, Meuchedet, this June. By taking ownership of medical cannabis operations, Meuchedet hopes to shorten wait times and expedite prescriptions for needy patients.
An additional challenge, explain Ofir and Erez, is that while physicians may prescribe up to 100 grams, for patients treated with oil this quantity is insufficient. For many of the sickest patients treated with cannabis, consumption by combustion, vaporizer, or edible is not feasible or effective. In such cases, the prefered mechanism of delivery is oil, however, the currently approved oil is not high-concentration. It takes, Erez says, 300 grams of flower to produce just 40 grams of full-spectrum, high-efficiency cannabis oil. The oil currently available to patients through the regular channels is less potent, leaving some patients to extract oil from prescribed flower independently. The dearth of quality cannabis oil directly harms some of Israel’s sickest and most vulnerable patients, including those in palliative care.
One way that that oil may be obtained is through the efforts of a network of dedicated volunteers who prepare oil on behalf of medical cannabis patients, regardless of legality. These volunteers extract and prepare full-spectrum high-concentrate cannabis oil, known as RSO, that is unavailable through official channels. In doing so, oil-makers risk stiff penalties as in the case of Nir “the Angel” Yupatero who was arrested for preparing RSO for hundreds of adult medical cannabis patients. Furthermore, until the reform, patients paid a flat fee per month regardless of quantity. The new pricing scheme will charge per gram and will require a special license for prescription amounts surpassing 100 grams. This means that for patients using oil or requiring higher prescriptions, the cost per month will increase dramatically and the bureaucratic hurdle to licensing will remain, exacerbating the harm to already-vulnerable individuals. Essentially, the sickest patients will benefit the least from the Israeli cannabis reform.
Some of these patients have been treated like common drug dealers and addicts by doctors and government officials in response to high-volume prescriptions, been publicly shamed and accused, and have had their prescriptions arbitrarily slashed. The stigma against individuals treated with medical cannabis remains despite decades of legalized use, marking a fundamental gap in government and medical attitudes towards cannabis compared with other medications, such as opioids or psychiatric medications. The requirement to provide invasive personal information, undergo ongoing reassessment and field accusations amount to an infringement of fundamental rights to healthcare and privacy.
If the Ministry has, as it claims, the best intentions to incorporate cannabis into standard treatment for a wide range of intractable and end-stage health conditions, this gap in attitude must be remedied and the bumps in the road to reform smoothed for Israeli patients.
In a conversation with Ofir just a couple of weeks ago, he expressed deep disappointment and frustration in the current state of affairs, but also hope:
“Despite the failures of the reform to date, patients appreciate the need for changes in the provision of medical cannabis. However, there are a few things that need to happen for the reform to actually serve those who need it most: external supervision of YAKAR, quality assurance of product, preserving access to full spectrum cannabis, maintaining the chain of treatment, and keeping cost to end users down. If these things are accomplished, the reform will be a success. But right now this seems unlikely.”