One step closer to the (very moderate) therapeutic use of cannabis. The Ministry of Health has put out to 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 advanced in the draft Royal Decree published almost eight months ago, the Ministry’s proposal limits the uses of the plant to “master formulas” (oils made from active ingredients of cannabis) and leaves out the flowers of the plant. marijuana (the buds), a decision that has not sat well with the main patient associations.
In fact, the ministry only speaks of a “royal decree that regulates the dispensation of master formulas of standardized cannabis for therapeutic purposes”; does not use the term program or anything similar. The text specifies the pathologies that may benefit from oil-based preparations, the only form of therapeutic cannabis consumption contemplated 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.
Specifically, its use will be allowed 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 with usual treatments).
The list, adds the ministry, “could be expanded or modified, with the necessary agility based on scientific evidence.” In addition, the ministry explains, a registry of standardized preparations will be created. But – and this is a “but” that patients put a lot of emphasis on – “standardized master formulas will be used when there are no authorized medications or they do not fit the patient’s needs.”
In Spain there are already at least a couple of cannabis-based medications approved and sold to the public (the most famous is Sativex). Doctors will only be able to prescribe compounded preparations when Sativex does not work or is not applicable, and they will have to justify their decision. “The justification for treatment with standardized master formulas of standardized cannabis preparations must be documented in the clinical history, in relation to other treatments that the patient has received. The patient must also be informed about the available clinical evidence, the expected benefits and the possible risks,” according to the RD.
The RD also confirms other relevant issues that already appeared in the first draft, such as that cannabis can only be prescribed by specialist doctors and not primary care doctors and that it will only be dispensed in hospital pharmacies, not community pharmacies, both issues an error for patient associations because, they claim, they mean limiting access.
Progress, but slow
With the publication of the Royal Decree, the Ministry continues to burn steps towards the regulation of medicinal cannabis, a process that began in 2021 with a subcommittee in the Congress of Deputies. But regulation is advancing at a slower pace than patients would like and also with less ambition than desired by associations, which point out how other European countries are already legalizing the recreational use of the plant while here the use of flowers ( the buds) doesn’t even make the cut for a medical program.
There are also protests with the few indications for use accepted by Health. “We are pleased with this first step, but we hope that the indications and routes of administration can be opened soon,” says Carola Pérez, president of the Spanish Observatory of Medicinal Cannabis (OECM), one of the patient associations that most lobby has done for a regulation. “It hurts to see that neurodegenerative diseases like ALS or palliative care are left out. These are people who have no other option and we must give them all the quality of life possible,” he adds.
Nor do they agree from the OECM that only specialists can prescribe and hospital pharmacies can dispense. “We hope that both the waiting lists of specialists and the hospital pharmacy have adequate training and have sufficient capacity to deal with this issue,” hopes Pérez. Otherwise, these limits on access may push potential users to continue on the black market as they have been until now, he warns.
Source: www.eldiario.es
