One more step towards the (very moderate) therapeutic use of cannabis. The Ministry of Health has put for public consultation the full text of the royal decree by which the department headed by Mónica García intends to finally create a medicinal cannabis program. Following the postulates put forward in the draft royal decree published almost eight months ago, the ministry’s proposal limits the uses of the plant to “master formulas” (oils based on active cannabis ingredients) and leaves aside the flowers of the plant (marijuana). buds), a decision which did not please the main patient associations.
In fact, the ministry only speaks of a “royal decree which regulates the delivery of master formulas of standardized cannabis for therapeutic purposes”; does not use the term program or anything similar. The text specifies the pathologies which can benefit from oil-based preparations, the only form of therapeutic cannabis consumption considered at the moment. The pathologies included in the text are “those for which there is scientific evidence of the therapeutic benefit of cannabis and its extracts”, according to Health.
More specifically, its use will be authorized for spasticity due to multiple sclerosis: muscle stiffness and spasms associated with multiple sclerosis; for severe forms of refractory epilepsy (certain types of epilepsy that do not respond to conventional treatments); against nausea and vomiting due to chemotherapy; and against chronic refractory pain (persistent pain that is not relieved by usual treatments).
The list, adds the ministry, “could be expanded or modified, with the necessary agility based on scientific evidence”. Furthermore, explains the ministry, a register of standardized preparations will be created. But – and this is a “but” that patients emphasize a lot – “standardized master formulas will be used when there are no authorized drugs or when they do not correspond to the patient’s needs”.
In Spain there are already at least a few cannabis-based medicines approved and sold to the public (the most famous is Sativex). Doctors will only be able to prescribe compound preparations when Sativex does not work or is not applicable, and they will have to justify their decision. “The rationale for treatment with standardized master formulas of standardized cannabis preparations must be documented in the clinical history, in relation to other treatments the patient has received. The patient must also be informed of the available clinical evidence, the expected benefits and the possible risks,” according to the dietitian.
The AR also confirms other relevant issues that were already in the first draft, such as the fact that cannabis can only be prescribed by specialist doctors and not primary care doctors and that it will only be dispensed in hospital pharmacies and not community pharmacies, both issue an error. for patient associations because, they claim, it is a question of limiting access.
Progress, but slow
With the publication of the Royal Decree, the Ministry continues to take steps towards the regulation of medical cannabis, a process that began in 2021 with a subcommittee of the Congress of Deputies. But the regulations are progressing more slowly than patients would like and also with less ambition than the associations would like, which point out that other European countries are already legalizing the recreational use of the plant while here the use flowers (buds) do not. I didn’t even get accepted into a medical program.
There are also protests against the few indications for use accepted by Health. “We are satisfied with this first step, but we hope that the indications and routes of administration can soon be opened,” says Carola Pérez, president of the Spanish Observatory of Medicinal Cannabis (OECM), one of the associations of patients most involved. entrance hall made for a settlement. “It hurts to see that neurodegenerative diseases like ALS or palliative care are left behind. These are people who have no other choice and we must offer them all the quality of life possible,” he adds.
They also disagree with the OECM that only specialists can prescribe and that hospital pharmacies can dispense. “We hope that the specialist waiting lists and the hospital pharmacy have adequate training and sufficient capacity to deal with this issue,” hopes Pérez. Otherwise, these access limits could push potential users to continue resorting to the black market as they have done until now, he warns.
