Three tons—this is the Italian requirement of medical cannabis for the current year (together with San Marino and Vatican City) predicted by the INCB (International Narcotics Control Board), the watchdog of international narcotics conventions. The figure is up 50% on the previous year and more than double what was predicted in 2018. However, by the end of the year, only about 1,000 kg of cannabis will actually be dispensed. In Italy, medical cannabis is now a mirage for too many patients.
In the last 60 days, there are 16 regions where there have been problems with the supply of medical cannabis, as documented by the patients themselves on monitorcannabis.it. Yet it’s enough to take a look at the specialized groups on social media to come across desperate messages from patients who cannot find the type of cannabis required by their therapeutic plan and risk interrupting their treatment. It is an unresolved problem that has persisted since 2017, despite the pledges made and legal regulations.
“I’m going crazy: dozens of phone calls and hundreds of messages from patients who can’t find the preparation I’ve prescribed and are justifiably anxious about their treatment,” Francesco Crestani, an anesthesiologist and president of the Therapeutic Cannabis Association, which is celebrating its 20th anniversary this year, tells us between shifts. “It is a cyclical phenomenon that there is a lack of raw material, and now this is the case with Fm2 [the variety produced by the military pharmaceutical plant in Florence], which is no longer available. For myself, who had trusted Italian production, it sounds like I’ve been fooled.”
The problem is not only the prescriptions: “Yes, it is necessary to rewrite the prescriptions, but this is the least of the problems. Bediol and Fm2, although titrated with similar percentages of THC, are different drugs because they come from different plants. You have to recalibrate doses, sometimes redo entire treatment plans. This often means going back to the specialist, with an increase in time and costs for patients.”
And then there is the problem of the ministerial memo of September 23, 2020, which suddenly excluded some types of preparations. “The memo has created significant problems,” Crestani recalls. “For example, by prohibiting eye drops for glaucoma, which was one of the first applications of medical cannabis and allowed those who do not respond to traditional medications to keep their eye pressure under control. A couple of drops were enough, with zero side effects.” The memo “makes no sense from a scientific and regulatory point of view,” concludes Crestani, but despite the complaints to Minister Speranza made by civil society and a hunger strike with almost 400 adherents in progress, it has not yet been withdrawn.
Marco Ternelli, Galenic pharmacist and one of the authorities for the preparation of medical cannabis in Italy, is clear about the ministerial memo: “It’s a disaster. Shipping is no longer possible, so some patients have organized in groups to pick up a number of prescriptions en bloc. But most remain uncovered.” And furthermore, “we have discontinued eye drops, creams, and all non-oral preparations. This has caused so many patients to despair.” In the absence of any response from the Ministry of Health to the complaints, the pharmacists have hired lawyers: “At the beginning of May, we will have a hearing at the TAR of Lazio for the appeal that I have filed together with other 12 pharmacies,” Ternelli says.
From his laboratory, Ternelli acknowledges the supply problems: “2021 has started very badly. The first supply was only on February 10, which had to cover a shortage of the previous 2 months, so it ran out immediately. Then, nothing more. The next supply is expected after Easter, and a reduction in quantities from the Netherlands is expected.” The outlook for the current year is very poor, “also because the extraordinary import contract for 2019 (won by the Canadian company Aurora) is about to expire, which has been used very little in any case.” What about the Italian production? “Since November, the military no longer have Fm2,” Ternelli reports, “and the next supply, initially announced for March, is said to actually arrive in May.”
And it is precisely the Italian production that is the big issue. Despite having received funding and authorization to produce up to 500 kg per year, the production of the Military Chemical and Pharmaceutical Plant in Florence is at a standstill. The official data from the website of the Ministry of Health is discouraging: in 2017, the plant produced and distributed about 60 kg, and in 2017 and 2018 about 150 kg on average. As Ternelli points out, however, “among the quantity distributed, there is also cannabis imported under extraordinary approval,” so the actual national production stopped at only 60 kg in 2018 and 140 kg in 2019. It’s not even 5% of the theoretical need for 2021.
But the solution already exists, and has been made into law since the conversion of the 2017 tax decree: to also authorize other entities, public or private, to cultivate and produce medical cannabis. The patients would benefit first and foremost, but also the entire country, which would thus be able to have a quality product at a lower cost than the imported one. Historically, Italy is a country that has always cultivated cannabis, and now, a century later, it could once again become an exporter, paving the way for a new supply chain in a highly specialized sector with strong global growth. The UN also broke the taboo in December, recognizing the full therapeutic value of cannabis. Will those at the Prime Minister’s office take notice?