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Calabria: Where Medical Cannabis Still Suffers the Consequences of a Legal Vacuum

The problem of the supply of cannabis-based medicines in Italy is not only limited to production and importation. There are still regions in Italy where, even though it has been possible to prescribe medication derived from the plant since 2006, there are still no local regulations allowing patients to access them. One of these areas is the region of Calabria, located in the south of the Mediterranean country, where local patients have been suffering the consequences of the absence of regulations for the use of the drugs they need to treat their ailments for more than 15 years.

Unfortunately, Calabria is today one of the last territories in Italy where the State has no control over the distribution and dispensing of cannabis-based medicines. In addition to the lack of individual monitoring of each patient who requires this type of treatment. According to the Ministerial Decree, signed on November 5, 2015, the use of cannabis for therapeutic purposes is considered a supportive treatment to the standard treatments. To use in case they do not produce the expected effects or generate intolerable secondary contraindications in the patient, or if they require increases in dosage that could lead to adverse side effects.

To comply with this ministerial decree and establish a regional regulation, the bipartite bill entitled: "Modalities of supplying of cannabinoid drugs for therapeutic purposes" is under discussion in the Regional Council of Calabria. The text is now in charge of the Health Commission of Palazzo Campanella, and its approval will allow it to be examined by the Regional Council. The bill also contemplates including the reimbursement of cannabis-based medicines by the Calabria Regional Health Fund. With this, a historical debt will be fulfilled to the Calabrian patients, the main victims of this situation.

"It's About Providing Timely Responses to a Punctual Health Need."

Dr. Francesco Amato, one of the most prominent experts in treating pain in Italy, looks favorably on the bill's approval. Dr. Amato maintains his position in favor of a Calabrian regulation for the use of medical cannabis: "Beyond the scientific evidence on the real efficacy of the therapy, we cannot prevent some patients from using these drugs". His opinion is important within the Italian medical community, as he is the director of the Complex Operative Unit of Pain Therapy of the Annunziata Hospital of Cosenza, and as director of the Department of Onco-Hematology and CP of the regional Hub. He also serves as an advisor to the director general for Health Programming at the Italian Ministry of Health, where he is the coordinator of the technical table for pain therapy.

According to Dr. Amato, there is work to be done to build a distribution model that serves to dispense care, without just looking at outcomes. A system that generates value is only useful if it generates health. To this end, Amato advocates a more humane health model, focused on social welfare and the alleviation of incurable diseases, where the patient can choose, be informed, and follow up on their condition.

Amato points out, by way of criticism of the ineffective way in which the 2015 ministerial decree has been implemented, that despite the diversity of situations in each region, patients are discouraged because they have no direction to manage their care and most of the time they are left to choose at random, without providing them with information on treatment options and processes.

Amato also adds: "Now it is a matter of providing timely responses to a specific health need, regardless of whether there are places of supply and use identified by the standard. It is necessary, regardless of the regulatory framework on the use of cannabis, to follow a network management logic that allows the coordination of all the supply units, just as the ministerial decree establishes."

Because of this, the doctor envisages a model that includes a specific personalized therapeutic plan and not in silos, in the same way as with permanent drugs. The model must include precise and urgent controls, on the processes carried out in clinics, that avoid or reduce the risk of deterioration towards inappropriate behaviors. Therefore, it will be logical to think of a monitoring network, where there is always someone who can synthesize all the problems related to an individual patient who needs to use cannabis. As opposed to how it happens now, the patient calls the health facilities in the event of a mishap. According to Amato, this is how it works for those with experience dealing with rare diseases.

To specify such a model of clinics, it is necessary to understand the financial figures. Even today, the real figures related to the demand for cannabis-based medicines on the Italian market are not clear. Efforts should also be made to strengthen the production networks of the Chemical Pharmaceutical Establishment of Florence so that it can receive raw materials from other regions and process them to generate medicines on a larger scale.

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