Health leaves marijuana buds in the medical cannabis regulation project

The Ministry of Health has launched a project to approve the medical cannabis program. The department was headed by Monica Garcia presented a draft royal decree establishing the conditions for the preparation and issuance of basic formulas for public discussion based on standardized cannabis preparations and explaining its plans to affected civil and scientific communities.

The text, which is not discussed in much detail in this first version, explains that the standard has four objectives: “to establish a procedure for evaluating the quality of standardized cannabis preparations”; “Identify the indications in which these drugs can be used”; “Determining the conditions for prescribing, preparing and dispensing basic formulas made with standardized cannabis preparations”; and “restrict the preparation of cannabis-containing basic formulas to those that have a monograph in the national formulary.”

The ministry’s planned program leaves out of regulation marijuana buds and self-cultivation of herbs, which are two of the main demands of patients, as sources present at the health care meetings told this newspaper and confirmed in the ministry. Other countries’ programs cover the use of marijuana.

Products must be authorized by specialist doctors of the National Health System (SNS). According to the same sources, private centers are also excluded.

At the moment, the idea is to authorize the hemp oils that will later be used to make the main formulas. “AEMPS position [Agencia Española del Medicamento y Productos Sanitarios] “You must always recommend medicinal products that contain cannabinoids and that are authorized in Spain, or import those that are authorized outside,” explained ministry sources.

Although some types of oil are already sold in Spain, not all are allowed (depending on their components) and the news will now be that if the doctor decides, they will be financed by social security.

As for the medical conditions, the standard calls for it to be used for chemotherapy-induced nausea and vomiting, seizures and refractory pain (when the patient does not respond to other treatments), according to the text of the public consultation. Will it expand to others at some point? “It is necessary to evaluate the available data and select those that are believed to have a favorable benefit-risk relationship. It will also be necessary to take into account the need to evaluate the new available evidence and update the regulations accordingly,” the document explains.

In addition, the ministry plans to limit the dispensing of these drugs to hospital pharmacies rather than community pharmacies, which patients say will make access more difficult, although health care has told stakeholder groups that it is up to the autonomous communities to distribute these permits more than usual. in pharmacies, according to sources present at these informational meetings. “It is necessary to establish conditions for prescribing and dispensing these drugs that are consistent with the above-mentioned guidelines in an environment that allows for adequate monitoring and observation of patients,” the text reads.

The project that Health Now presents comes from a congressional subcommittee that approved a document in the last legislature with a series of recommendations for the medical program. This text was supported by all groups except PP and Vox, who voted against, and Bildu and Esquerra, who abstained.

Source: El Diario





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