The Ministry of Health has launched its project to approve a medical cannabis program. The department headed by Mónica García has put its Draft Royal Decree for public consultation, which establishes the conditions for the preparation and dispensing of master formulas based on standardized cannabis preparations, and is explaining its plans to the affected civil and scientific societies. .
The text, which in this first version does not go into too much detail, explains that the standard has four objectives: “Establish the procedure for evaluating the quality of standardized cannabis preparations”; “establish the indications in which these medications can be used”; “establish the conditions for the prescription, preparation and dispensation of master formulas made with standardized cannabis preparations”; and “limit the preparation of master formulas containing cannabis to those that have a monograph in the National Formulary.”
The program planned by the ministry leaves marijuana buds and self-cultivation of the herb out of regulation, two of the main demands of the patients, according to what sources present in the meetings with Health have told this newspaper and the ministry confirms. Programs from other countries do include marijuana use.
The products will have to be authorized by specialist doctors from the National Health System (SNS). Private centers would also be excluded, according to the same sources.
At the moment the idea is to authorize cannabis oils with which master formulas will later be made. “The position of the AEMPS [Agencia Española del Medicamento y Productos Sanitarios] “is to always recommend treatments that contain cannabinoids and that are authorized in Spain, or import those authorized outside,” Ministry sources explain.
Although some types of oils are already marketed in Spain, not all are allowed (depending on their components) and the novelty now will be that if the doctor decides so, they will be financed by Social Security.
Regarding the pathologies to be treated, the standard contemplates that it be used for nausea and vomiting caused by chemotherapy, seizures and refractory pain (when the patient does not respond to other treatments), according to the text in public consultation. Will it be expanded to others at some point? “It is necessary to assess the available data and select those in which it is considered that there is a favorable benefit-risk relationship. It will also be necessary to consider the need to assess new available evidence and update the regulations accordingly,” the document explains.
Furthermore, the ministry intends to limit the dispensing of these preparations to hospital pharmacies and not community pharmacies, which according to patients makes access difficult, although Health has told interested groups that it is in the hands of the Autonomous Communities to extend these permits to ordinary pharmacies, according to sources present at those information meetings. “It is necessary to establish the conditions for the prescription and dispensing of these preparations, which comply with the previously mentioned indications, in environments that allow adequate monitoring and follow-up of patients,” the text reads.
The project that Health now presents emanates from a subcommittee of Congress that in the last legislature approved a document with a series of recommendations for a medicinal program. That text was supported by all groups except the PP and Vox, which voted against, and Bildu and Esquerra, which abstained.
Source: www.eldiario.es
