Is Italy's medicinal cannabis market in jeopardy?
A thirty-year-old Italian law could turn back the clock on the nation's medical marijuana industry. Patients groups and businesses are reminded that pharmacies cannot ship medical marijuana preparations to customers. This move is far off base from how patients in the southern European country have accessed their medicinal marijuana for several years.
The majority of medical marijuana that is dispensed by pharmacies in Italy is shipped directly to patients. It is noted that in-store purchases have significantly lower sales. The government's intention to enforce the law was signalled by a recent document from the Medical Devices and Pharmaceutical Service of the Italian Ministry of Health.
The second-largest European market for marijuana flower and full-spectrum extracts is in Italy. One of the biggest challenges that face international medicinal markets is the restrictive regulations that govern how medical marijuana is legally accessible to cannabis patients. The strict rules can be attributed in part to fewer business opportunities in the cannabis sector.
The regulations can often result in only a fraction of patients having access to the marijuana plant as a medicinal therapy. Most of the pharmacies in Italy do not dispense medical marijuana due to the required specialized technology specifications. Shipping medical marijuana has been a common practice for years, and it has only increased since the COVID-19 infected the world.
The Ministry of Health could be stopping this practice and enforcing the law that requires narcotic drugs to be dispensed directly to the patient or representative in a pharmacy building. This action may be a driving force that forces medical patients to shop through the illicit cannabis market.
Why enforce the law now
THC Lab, an Italian think tank whose consultant, Andrea Ferrari, believes that a likely explanation for this action could be that the authorities enforce the rule for a particular reason. The government is likely looking to encourage a decentralized distribution network, which would allow pharmacists to provide medicinal marijuana to patients in their neighbourhoods.
The ultimate hope is to discourage a few specialized pharmacies in the country whose majority of sales are from shipping medicinal marijuana across the country, by encouraging pharmacies to serve medicinal marijuana patients who reside within their own neighbourhoods.
How will it work
Authorities will have to make the plan more attractive to pharmacies so that it encourages them to join the network. Currently, there are only a small number of pharmacies that dispense medical marijuana, according to Andrea Ferrari.
This week's open letter was drafted by patients, doctors, and pharmacists in an effort to get the government to reconsider its position. Many patients do not have transportation to pharmacies or medicinal marijuana dispensaries. Having to present a medicinal marijuana prescription and then return later to pick up the medication, is a hardship for many cannabis patients. The letter was sent to the Health Minister, October 21, 2020, as confirmed by a signatory Carlo Privitera, a physician specializing in medical marijuana.
Medicines added to Italy's narcotics laws.
Ingestible formulas with marijuana plant-derived CBD have been added to a table of medicines in the narcotic law books in Italy. The Italian Minister of Health published the decree and included in the order are compositions required for oral administration of CBD, cannabidiol extracted from cannabis, and this information is located in section B of the table of medicines' narcotic law. These compositions are next to barbiturate-type medications that need to have a strict level of control.
To pave the way for authorization of sales of the plant-derived CBD drug Epidiolex, which GW Pharmaceuticals sold, this shift was a necessary action. It is unclear if the Italian government will be covering the cost of the drug through the country’s public health system.
When Epidiolex becomes available in Italy, doctors will have the ability to prescribe the drug-using non-repeatable prescriptions due to the classification of Epidiolex in the narcotic law books. Patients, however, will not be able to renew medicinal marijuana prescriptions multiple times. The procedure is not possible with medicines in Section E of the narcotic law. This section currently includes such drug compositions as clonazepam, lorazepam, and diazepam.
The preparations of the marijuana plant-derived CBD for patient's oral consumption, are now classified as a narcotic and, as such, require more controls than CBD manufactured synthetically. Due to this classification, some pharmacies may have the incentive to purchase synthetically derived CBD medicines compared to marijuana plant-derived medicines.
The CBD active substances purchased by pharmacies to dispense to medical marijuana patients must be provided by a limited selection of certified Good Manufacturing Practice facilities.