Cannabis for therapeutic uses is difficult to find in Italy

Italy has a cannabis shortage problem. Although since 2006 hemp-based medicines have been prescribed by doctors to counter the effects of various diseases, it can be difficult to obtain them for those who need them. Firstly, because not all pharmacies prepare and sell these medicines: in 2020 there were fewer than 400 out of about 20 thousand. But also because those same pharmacies can easily run out of raw material: both the national production of hemp grown for therapeutic purposes and imports from abroad are limited by very strict rules and quotas, which prevent the needs of the sick from being met.

In 2021, according to data from the Ministry of Health, slightly less than 1,300 kilograms of cannabis inflorescences were sold (and supposedly consumed) in Italian pharmacies. It is a lower quantity than the estimate made by the same ministry of the total demand for the whole year based on the needs supplied by the Regions, which was estimated at 1,400 kilos.

The same amount appears even more insufficient when compared to other estimates of national needs: according to the International Narcotics Control Board (INCB), the United Nations agency in charge of combating the illegal drug trade and controlling the legal one, in the 2021 Italy would have needed 2,900 kilos of cannabis inflorescences. However, even this estimate is much lower than the real demand for cannabis, according to the groups of people to whom it is prescribed and who for years have complained of the low availability of the substance.

(A lexical note: technically “cannabis” or “hemp” is the name of the plant from which the active ingredients used both for therapeutic purposes and to relax and experience pleasant sensations are obtained, in the case of the most common illegal use. cannabis contains several, the same word is also used to indicate all or some of these substances.)

According to a survey recently carried out by the Medical Cannabis Patients Committee, a group that brings together and represents people to whom cannabis has been prescribed and who was invited by Undersecretary of Health Andrea Costa to join a “permanent technical table” to solve the shortage of the substance, the annual requirement of 287 people is equal to 163 kilos of inflorescences. Taking into account that according to the ministry there are about 50 thousand patients who need cannabis-based therapies, the real national demand would be almost 30 tons of inflorescences.

74 percent of people involved in the Medical Cannabis Patients Committee survey reported “difficulty finding therapy”; about half have had to resort to other solutions to make up for the lack of legal cannabis, and of these people 10 percent have resorted to the illegal market.

There are also people who have chosen to grow cannabis themselves, facing the possibility of being reported and facing the criminal consequences: for example, it happened to Walter De Benedetto, a rheumatoid arthritis patient who for years fought for access to medical cannabis. De Benedetto, who died in May, was acquitted of drug possession and drug dealing charges because the investigating judge responsible for his case acknowledged that he grew cannabis to relieve his pain.

To solve the problem of cannabis shortage it would be necessary to increase domestic production or imports from abroad, but both are not easy due to the restrictions on drugs, of which cannabis is a part.

Starting with two ordinances signed in 2006 by Francesco Storace and Livia Turco, who took turns as ministers of health, some medicines containing THC, one of the two main active ingredients of cannabis, have become legal.

In particular, since 2006 it has been possible to import Dronabinol, the pharmaceutical version of THC. In 2013, however, it was made possible to import SativexR, a spray medicine produced by the British company GW Pharmaceuticals: it contains both THC and CBD, the other main active ingredient in cannabis, and can be prescribed to patients with multiple sclerosis to reduce spasms. painful caused by this pathology.

Also since 2013, Italian pharmacies have been able to buy and treat cannabis inflorescences directly to make medicinal preparations: doses of dried product suitable for inhalation or taken via decoction, or capsules or extracts (essentially oils), depending on medical prescriptions. Since the end of last year, in theory, the same thing can also be done using an extract with 15 percent THC imported and distributed by the Italian company Farmalabor: in this case, pharmacists just need to dilute the product according to the doctors’ instructions.

In general, with the exception of SativexR which, however, is prescribed only to a limited group of patients, all medicines containing THC that can be sold by Italian pharmacies are masterful preparations, that is, made by the pharmacists themselves starting from the inflorescences or from the extract of Farmalabor, following the instructions provided by doctors in terms of dosage and method of administration.

In theory, pharmacists would be free to buy as much cannabis as they believe, as long as they have a suitable laboratory for masterful preparations, which only about one sixth of Italian pharmacies have. Marco Ternelli, galenist pharmacist and editor of the Farmagalenica blog, explained however how in fact orders start only when pharmacies receive prescriptions. And the cannabis sent is less than that requested: “We know that there is a shortage problem and we need 200 grams, we order 500. But we receive less: since in the last two years the raw material has always been lacking , for suppliers it makes no sense to try to satisfy the requests of the individual pharmacist and so they give little to everyone ».

Most of the raw material used for the preparations made by pharmacists is imported from the Netherlands, where for decades the sale and consumption of cannabis has also been allowed for recreational purposes, as they say, for adults in the so-called ” coffee shop “.

It can be purchased directly from local health companies (ASL), or from five distribution companies that then sell it to pharmacies: it is sold exclusively by the Bureau voor Medicinale Cannabis (Office for medical cannabis) of the Ministry of Health, Welfare and Sport. Dutch, in relation to its availability of inflorescences for exports.

The fact that imported cannabis is sold by a state body guarantees that it has been subjected to a certain type of stringent controls: not all hemp plants have the same content of active ingredients, as so many different varieties have been selected. and the Bureau voor Medicinale Cannabis (which in the Netherlands has a monopoly for production for therapeutic purposes) guarantees the quality of its own.

As for the Italian production, on the other hand, the guarantees are provided by the Ministry of Defense, given that all the hemp produced for medical purposes is grown and sold by the Military Pharmaceutical Chemical Plant of Florence (SCFM).

In this way, the health authorities have strong guarantees on the quantity of active ingredients and the quality of the inflorescences; the plant follows very strict procedures, like a pharmaceutical company, to make sure that the plants are not attacked by bacteria during growth and by molds during and after drying. In addition, both Dutch and SCFM production provide the assurance that the raw material for medicines is legally produced, given that the cultivation of cannabis continues to be severely restricted internationally due to its ‘narcotic’ character.

The problem with Italian production is that it is limited by the size of the Florence plant: although it has always increased since 2016, the year in which it was launched, it is still reduced. For this year, the production of 400 kilos of inflorescences has been authorized, only a hundred more than those produced last year. For this reason, importation remains essential and in fact last year it was decided to increase it: however, that cannot be done since it is in turn conditioned by the limits of production and export of the Netherlands.

Also to try to solve the problem of cannabis shortage, in April the Ministry of Defense published a call to find Italian companies candidates for the cultivation of cannabis plants on behalf of the Military Pharmaceutical Chemical Plant of Florence. The aim of the initiative – open until 6pm on June 27 – is to find a way to increase national cannabis production, but even if suitable companies were to propose themselves, the shortage will not be resolved quickly because it will only be the beginning of a process. which could last a few years.

Andrea Costa had presented it thus: «The selection of economic operators will be divided into 4 phases: qualitative selection of candidates; technical inspection and suitability judgment; confirmation of the expression of interest and transmission of invitations to the restricted procedure; start of the trial with final evaluation and suitability judgment. All the tests, the inspections, the assessments will be carried out or in any case monitored by the military chemical pharmaceutical plant of Florence, in agreement with the Ministry of Health ».

While waiting for this or similar initiatives to address the cannabis shortage, people who are prescribed the drug are then faced with other problems.

The main one is certainly the cost of the therapies, for a good part of them. In fact, although the laws leave enough freedom for doctors to determine when to prescribe cannabis, as long as there is an accredited scientific literature that suggests its use in the specific context and that more conventional therapies have proved ineffective or inadequate, only for certain conditions the national law provides for reimbursement to be paid by the National Health Service.

These conditions are: pain associated with multiple sclerosis and spinal cord injury; nausea and vomiting caused by chemotherapy, radiotherapy and HIV-related therapies; lack of appetite for people with cachexia, anorexia, cancer or AIDS; involuntary movements caused by Tourette’s syndrome and ocular tension due to glaucoma.

For all other conditions for which a doctor may prescribe cannabis medicines – including epilepsy, even in children, because cannabis reduces the frequency of seizures – there are no reimbursements and the cost to sufferers can be expensive. , given that they are chronic therapies, that is, they are taken for a long time: «A therapy produced with inflorescences can cost up to 340 euros per month», explains Marco Ternelli. “Preparations made with extracts cost less, but we are still talking about a hundred euros a month”.

In general, the rules on reimbursements and the conditions for which they are provided vary from region to region and in some it is not possible to obtain any reimbursement because the regional authorities have never implemented the national law: they are Calabria, Molise and Valle d’Aosta. The use of Farmalabor extract can help to contain the costs of the preparations, but only for prescriptions that require a low concentration of THC, and for the moment the preparations made with this specific product are reimbursed by the Health Service in only four regions. : Emilia-Romagna, Lombardy, Marche and Sicily.

The article is in Italian

Tags: Cannabis therapeutic difficult find Italy

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