Medical cannabis has been completely legal since 2013;This article, updated on November 23, 2020, describes the necessary steps to prescribe cannabis for medical purposes and to access treatment. In Italy, a brief summary of what has happened will help to better understand the issues addressed in this article, namely:
- the drug prescription process and the patient’s procedure to access treatment
- Reimbursement and regional diversification
- Supply process for patients, hospitals/ASLs, pharmacies, and licensed distributors
- costs
Index
- 1. A brief history of medical cannabis in Italy
- 2. How is medical cannabis prescribed?
- 3. Obtaining medical cannabis with a white prescription (medication billed to the patient)
- 3.1 Issues related to obtaining medical cannabis with a white prescription
- 4. Medical cannabis prescription SSR Charge
- 4.1 What must the patient do?
- 5. Purchasing medical cannabis from pharmacies
- 6. Purchasing medical cannabis from AUSL/hospitals
- 7. Costs of medical cannabis
- 8. Cannabis prescription: conclusions
- 9. References
1. A brief history of medical cannabis in Italy
Regarding the medicinal use of cannabis in Italy, the first changes occurred in 2007dronabinol when tetrahydrocannabinol (THC) – as a pure substance – was included in the list of narcotics that could be used for the manufacture of medicines. At that time, however, the most restrictive interpretation considered that pure THC (i.e., the synthetic form obtained in pharmaceutical laboratories) could be used, but not cannabis as a whole plant (containing THC).
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For this reason (and for other reasons), in 2013, the phrase “plant-derived drugs based on cannabis (substances and plant preparations, including extracts and tinctures)” was inserted (ministerial decree 23/01/2013, Official Journal no. 33 of 08/02/2013), definitively establishing the legal use of cannabis in Italy among the drugs that can be used for the preparation of medicines.
2. How is medical cannabis prescribed?
Like all medications, therapeutic cannabis can be prescribed by any doctor (surgeon or veterinarian) who, in good faith and conscience, considers it the most appropriate.
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Medical cannabis can be prescribed at the patient’s expense for any disease for which there is a minimum of accredited scientific literature. We addressed this topic in another article:
Suggested reading:
What are the diseases that benefit from medical cannabis?
Some conditions are reimbursed by the regional health system. For all others, doctors are required to make a decision based on published scientific evidence. The aim of this article is to clarify these issues. Learn more » In partial derogation from this discourse, it must be said that if the freedom for the Doctor is total (according to the current legislation Law 94/98) when the medication is paid for (i.e., the patient buys it out of pocket), when the medication is, on the other hand, the responsibility of the Regional Health System (SSR) (i.e., free for the patient), there are more constraints for the doctor. In this case, we talk about prescriptive relevance.
According to what is written above, in wanting to explain what the process of obtaining cannabis is for a patient medically, it is necessary to distinguish between the moment when cannabis is prescribed on a private and paid prescription (the “white” prescription) and cannabis prescribed by the regional health system (SSR).
In other words, access to medical cannabis is:
- very simple if prescribed for a fee
- from the simplest to the most complex if prescribed by the SSR (the difficulty varies from region to region)
To help you navigate this topic, you can learn more in this article: “Medical cannabis and reimbursement region by region”
In general, the law that governs the main prescription of medical cannabis is law 94/98 known as the “Lawthe Doctor to report, among other things, the type of cannabis, the reason why the doctor asks the pharmacist to prepare it and (for privacy protection) an alphanumeric code Di Bella” (that’s right, ONLY Professor Di Bella) and by ministerial decree 9/11/2015. In short, this law obliges (numbers and letters) to be placed at the first name or surname.
Anonymous data on age, sex, weight of the cannabis, the dosing and treatment requirements are also required for statistical purposes, as required by the pilot project, by filling out the data collection form for treated patients to be sent to the region territorially competent based on the indications that the regions themselves will provide.
3. Obtaining medical cannabis with a white prescription (medication billed to the patient)
The process described is as follows:
- the patient goes to the doctor (any: basic, private, specialist, hospital, etc…)
- if the doctor diagnoses and assesses the necessary medical therapy for cannabis according to law 94/98, issues a “white” medical prescription that gives the patient (there is no limit on quantity)
- the patient goes to a compounding pharmacy that prepares medical cannabis
- wait a certain time for the preparation, pay and pick up the cannabis-based medication
Nothing more. But of course, reality is not as simple as theory. Here are the main problems encountered.
3.1 Issues related to obtaining medical cannabis with a white prescription
many doctors refuseFirst of all, a doctor is NEVER obliged to prescribe a treatment (whether based on cannabis or any other medication), especially if, in good faith and conscience, he considers it is not the necessary medication for your patient. Currently, many doctors do not consider cannabis as a therapeutic option because they do not know it and do not want to know it or “because it is an abusive drug.”
Second problem: after finding the doctor who prepared the prescription, it remains to find a pharmacy that prepares medical cannabis (about 600 out of 19,000 in Italy). Once found, this pharmacy must be stocked with one of the nine legally prescribable varieties: not everyone may know that for the past two years, we have been living in a state of continuous cannabis shortage related to very high demand (from both doctors and patients) and limited supply (related to insufficient imports to Italy from the Netherlands or Canada).
It is worth remembering that in 2017, the Ministry of Health, through the Central Office of Narcotics, fined pharmacies informing patients of the availability of cannabis several thousand euros Medica (by informing and letting them know where to find it), considering it “indirect advertising propaganda.”
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4. Medical cannabis prescription paid by the SSR
The reimbursement of cannabis-based medications is not provided by all regions, but only by regions that have legislated on the distribution of “cannabinoid medications.”
Since most regions have NOT yet granted free prescription of medical cannabis, in some regions (e.g., Piedmont, Veneto, Emilia-Romagna, Tuscany, Marche, Campania, Apulia), it is possible for the patient to obtain free cannabis, but (already said, let’s repeat it) ONLY for certain therapeutic indications, that is, only for certain types of diseases.
In other words, it does not matter whether you are exempt from civil rights or disabled, but only these factors count:
- the region in which you reside
- if, in that region, the disease you are affected by is recognized for cannabis provided free of charge
It follows that for the same disease, a patient residing in region X can obtain free medical cannabis, while in region Y, he still has to pay for it.
Unlike the purchase of paid cannabis, there is no single prescription process, but it varies (as repeated) from region to region.
cannabis can be reimbursed, but despite the previously mentioned DM 9/11/2015 decree, the pathologies for which reimbursement is recognized vary from region to region, which legislates independently of pathologies, pharmaceutical forms, and sometimes methods of prescription.
In fact, some regions require a treatment plan (which can be taken care of and followed by the general practitioner) to recognize reimbursement, while others have only determined certain cannabis varieties or types of preparation. To be sure of the possibility of reimbursement, it is always useful to refer to the competent territorial body as the situation is very uneven, not to mention that some regions have not deliberated, others have only deliberated, and others have already completed the entire implementation process.
The regions that have enacted regional laws regarding the distribution of “cannabinoid medications,” providing for a real free distribution on the territory, are as follows:
- Campania
- Emilia-Romagna
- Friuli Venezia Giulia
- Lazio
- Lombardy
- Marche
- Piedmont
- Apulia
- Sardinia
- Sicily
- Tuscany
- Umbria
- Veneto
- For more information on reimbursement region by region, consult this guide.
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4.1 What must the patient do?
In wanting to describe (still schematically) the average process that a patient must follow for medical cannabis to be the responsibility of the SSR, one could say that:
- the patient goes to the contracted specialist doctor or to the hospital facility authorized to prescribe
- the specialist doctor/authorized facility establishes a treatment plan (valid for 3 to 6 months) with which he sets up the treatment with medical cannabis (dosage, route of administration, dosage, etc…)
- with the treatment plan, the patient goes to the primary care physician who establishes a “red” prescription (NHS) with the monthly requirement (moreover, each month, the patient must redo the prescription, which has a maximum validity of 30 days)
- the patient goes to a compounding pharmacy that prepares medical cannabis
- wait a certain time for the preparation, pay and pick up the cannabis-based medication
Here too, the critical problems are the same as those reported previously, namely the availability of doctors to follow the cannabinoid-based therapeutic pathway and the availability of the medication in Italian pharmacies.
In other regions, however, the process of obtaining medical cannabis supported by SSR is simpler:
- the patient goes to the general practitioner
- if the doctor diagnoses and assesses the necessary medical therapy for cannabis and the disease is reimbursed by the Region, he issues a “ad hoc” medical prescription (can be “red” or “white”) with a maximum of 30 days of treatment and delivery to the patient
- the patient goes to a compounding pharmacy that prepares medical cannabis
- wait a little time for preparation, then take the cannabis-based medication for free
In conclusion, cannabis dependent on the SSR is “only for the therapeutic indications that the Region has accredited as recognized.” Currently, the uses (other than therapeutic indications) recognized by the ministerial decree 9/11/2015 for free SSR prescriptions are:
- Multiple sclerosis
- oncological and chronic pain
- cachexia (in cases of anorexia, HIV, chemotherapy)
- vomiting and lack of appetite caused by chemotherapy
- glaucoma
- Tourette syndrome
Important: each region is autonomous to decide which pathologies are part of the free distribution and which are not.
5. Purchasing medical cannabis from pharmacies
Italian pharmacies that prepare medical cannabis (estimates are over 600 out of 19,000) can obtain cannabis from different suppliers based on origin:
- Dutch medical cannabis: The pharmacy orders it from one of the five authorized Italian raw material distributors (ACEF, Fagron, Farmalabor, Fl-Group, Galen)
- Italian medical cannabis: the pharmacy orders it from the Military Pharmaceutical Chemical Institute of Florence
- Canadian medical cannabis: a pharmacy orders it from the Military Pharmaceutical Chemical Institute of Florence
The methods used by the pharmacy to procure medical cannabis are the same as for all other medications, that is, with a purchase order in three copies to be sent (digital signature PEC or original paper) to the company.
In the purchase order, the pharmacy clearly indicates the desired cannabis variety and the quantity in grams divided by the number of bottles: for example, to order 250 grams of cannabis flowers, the pharmacy will not indicate a generic “250 g,” but “25 bottles of 10 g” or “1 package of 250 g” depending on the available cuts.
Upon arrival at the pharmacy, the medical cannabis in flowers is entered into the entry/exit register and gradually unloaded with the medical prescriptions that the pharmacist will prepare from time to time.
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6. Purchasing medical cannabis from AUSL/hospitals
AUSL and hospitals (hospital pharmacies) use the same modalities for territorial pharmacies described in the previous chapter.
Additionally, they can, however, resort to direct importation, that is, request the importation directly from Holland (only from Holland) of medical cannabis flowers, without going through an intermediary distributor, by ministerial decree 11/02/1997 valid for the importation of narcotics not registered in Italy.
In this way, it is possible to provide medical cannabis to several patients and with coverage for several months (for example, three months) with a single order. This method, widely used in the past, is slowly coming to an end as it requires prolonged lead times (generally at least two months), an ad hoc internal organization of the hospital structure, and the direct reimbursement by the Region (paid by the SSR, as explained at the beginning of the article). Moreover, if they are not organized in time, subsequent treatments arrive at the hospital/AUSL only when previous stocks are finished, which subjects patients to a possible interruption of treatment.
7. Costs of medical cannabis
When the patient pays for the medication out of pocket, the question that immediately comes to mind is: “How much does it cost?
medical cannabis being a compounding medication (that is, prepared from time to time by the pharmacist) and not being a finished industrial medication (like those we are used to buying at the pharmacy with a fixed dosage, a fixed number of doses, a fixed amount of substance), it is impossible to give a unique price for cannabis-based medication” The .
For compounding medications, the pharmacist is NOT completely free to decide the price, but must refer to a rate established by the Ministry of Health with which he calculates the prices of all the compounding medications he manufactures (cannabinoid-based and non-cannabinoid-based, from syrups to suppositories, from papers to eye drops).
The only certainty is that the Ministry of Health requires you to sell cannabis for €9 per gram 10% VAT (on medications) regardless of the cost requested from the pharmacist, which generally varies from €9 to €11 VAT 22% (for raw materials).
To this price, you must add the preparation and container costs (which vary depending on the prepared pharmaceutical form and its danger), always established by the Medicines. By combining everything, it is possible to give some examples of costs to understand the cost of a therapy (excluding the cost of containers, excipients, and the number of technological operations):
- 30 papers of 100 mg of cannabis flowers: about €65
- 30 papers of 500 mg of cannabis flowers: about €190
- 30 papers of 1000 mg of cannabis flowers: about €330
- 50 ml of cannabis oil (5 g/50 ml): about €90
- 100 ml of cannabis oil (5 g/50 ml): about €160
As these are medications, the expense is tax-deductible (like for industrial medications) by means of a “talking receipt” or invoice.
Furthermore, according to the decree of November 9, 2015, the necessity for titration of preparations and oil extracts is added, which must be analyzed by law.
The decree imposes analysis, but not the cost to be attributed to the patient and/or pharmacist, as it is not present in professional fees and is not specified in any regulation (for example, except for Lombardy, which has so far set a maximum spending cap for the reimbursability of analyses). There is therefore a considerable price difference that is currently being evaluated by the responsible bodies.
8. Cannabis prescription: conclusions
Medical cannabis can only be purchased with a prescription, being classified as a narcotic (even if low in THC). The prescription has a shelf life of thirty days.
medical cannabis can be purchased at the hospital/AUSL or in the pharmacies open to the public that manufacture compounding medications and have them in stock.
Please note that, in order to demonstrate the legality of possession of the magistral preparation based on medical cannabis, a copy of the prescription stamped and signed by the pharmacist at the time of delivery must be provided to the patient or the person who collects the magistral preparation based on cannabis, without prejudice to the prohibition provided by article 44 of the TU. With the ministerial decree of 9/11/2015, the pharmacist is required to always provide a dated, stamped, priced, and signed copy, even without the patient requesting it. The patient can then use the pharmacist’s copy of the prescription to prove that the cannabis used is legal and for therapeutic use.
The doctor can contact your region, or the territorially competent AUSL, to find out how to dispense these medications and how regional laws are applied for use within the SSR where these laws have been enacted.
9. References
This article was written thanks to the knowledge and experience of Dr. Mark Ternelli. For more information on cannabis and prescription, we suggest consulting the Official Journal of the Ministry of Health:
- http://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2017-06-03&atto.codiceRedazionale=17A03680&elenco30giorni=false
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