Congress gives its first approval to the regulation of medical cannabis

Day of celebration for thousands of people. The congressional subcommittee that studies the regulation of medicinal cannabis has approved this Tuesday a report with basic guidelines for the government to regulate therapeutic cannabis. It still needs to be definitively approved by the Health Commission next week, but parliamentary sources explain that with this morning's vote that is already a formality. The document gives six months to the Spanish Agency for Medicines and Health Products (AEMPS) to decide how this future program fits into Spanish regulations.

Keys for the regulation of cannabis for medicinal use that Congress is beginning to address

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The ball is in the court of the Executive now, but parliamentary sources express little doubt that the law will go ahead: With the government parties and their investiture partners supporting the regulation, the report is more than a recommendation, it is a mandate. After years of vindication, Spain is about to stop being a European anomaly and have its own therapeutic cannabis program.

The negotiation in Congress has made the proposal more accessible: use is opened to cancer patients, the possibility of including the buds in the program and dispensing in pharmacies will be assessed

The report has been approved with the support of PSOE, UP, Cs, PNV and PDECAT, while Bildu and Esquerra have abstained. The PP and Vox have voted against.

The main discrepancies in the vote that took place this Tuesday were in the small details: who (which patients) will be able to access therapeutic marijuana? Can it be dispensed in community pharmacies or only in hospitals? Will primary care doctors be able to prescribe it or only specialists? Will self-cultivation be authorized?

The PSOE's initial proposal was conservative (within these parameters), but it has relaxed slightly during the negotiation with United We Can. The purple formation has agreed with the socialists on the possibility of dispensing in community pharmacies (it was not in the initial proposal), including cancer pain and endometriosis among the ailments to be treated, assessing the use of the cannabis flower (popularly known as “bud”) “to develop experimental medicinal projects” and exclude the obligation, established in the socialist proposal, that the pharmaceutical industry be the only one authorized to produce extracts or standardized preparations (in the form of oil).

The proposals

The approved report is not a regulation proposal in itself, but it establishes the basic lines on which the Government must elaborate the law. After the negotiation between PSOE and UP, the document has included some measures to facilitate the access of more patients to the future medicinal program.

The text calls for "the availability of cannabis-derived medicines for therapeutic use" to be guaranteed, for "formulas to be made available on the pharmaceutical market for standardized cannabis extracts or preparations that currently do not have marketing authorization" ( there are only two approved drugs but they are not suitable for all treatments) and introduces the novelty of assessing "the development of experimental projects when they are requested, such as the flowering tops of cannabis" (the buds).

Among the main novelties is the inclusion that "competent pharmacy services can prepare master formulas from extracts or standardized cannabis preparations for direct use in certain cases", a role that in the original version was limited to hospital pharmacies. Now there is talk of it being preferred, but not only. All the groups that have ended up supporting the text were against this limitation, as well as patient associations, because it means, de facto, putting obstacles to access to medical cannabis.

The obligation for medical specialists to prescribe cannabis has also been removed from the first version, although it is still requested that they do so “preferably”. The prescription in the private system is also opened, which in principle had been left out.

Regarding who will be able to access, the document maintains that “at the present time they seem to focus on spasticity in patients with multiple sclerosis, some forms of epilepsy, nausea and vomiting derived from chemotherapy, endometriosis, cancer pain and chronic non-cancer pain ( including neuropathic pain)”, although it leaves the door open for these groups to be expanded as scientific evidence is created.

Finally, the existence of a centralized registry of patients prescribed medical cannabis is maintained, a measure with which many groups did not agree.

Finally, the text closes with two points aimed at "preventing the availability of cannabis for therapeutic uses from leading to greater availability and consumption of cannabis outside the health context" and also appeals to "prevent the therapeutic use of extracts or standardized preparations of cannabis for certain patients with specific indications, is confused with a generic invocation of the general use of cannabis by the population”.

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