In recent days, Spain's socialist party, PSOE, presented a motion for a resolution to regulate the therapeutic use of cannabis in the European country. The project recommends the Ministry of Health authorize the use of extracts or standardized preparations of cannabis "to respond to those patients to whom it is prescribed through the established channels." This document is the result of an agreement reached on May 9th of this year in the Health subcommittee of the Spanish Congress.
All the political parties that form part of the Health subcommittee have a period of 10 days to make their assessments and proposals regarding the proposal, generating a final resolution that will be voted on by the subcommittee on June 23rd and will then go to the plenary session of Congress on June 30. This process can be considered the first step to endorsing a more generalized use of cannabis-derived drugs for therapeutic purposes since the Ministry of Health previously committed to following the subcommittee's recommendations.
This process is soon to be a year old, as it was in June 2021 when the PNV presented the initiative to create the Health Commission. At that time, the PP and Vox parties were strongly opposed. However, during the commission's investigation, they had the opportunity to listen to experts and patients, their position having nuanced according to parliamentary sources. For those who support this proposal "it represents a step forward," as Josune Gorospe, deputy of the Basque Group and promoter of the subcommittee, affirms.
The PSOE highlights in its proposal the need to limit "greater availability and consumption outside the healthcare context. We do not want to do anything that could increase supply and consumption, as has happened in other countries". That is why it is essential to preserve and reinforce "the crucial role of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS)" to prescribe and dispense these products in the National Health System (Sistema Nacional de Salud, SNS).
Cannabis Will Be Under Strict State Supervision.
The main objective of this proposal is to authorize the preparation of "master formulas" from extracts or standardized preparations of cannabis for direct use in certain diagnoses. Drugs made from the plant are typically for patients who suffer from conditions such as multiple sclerosis, some form of epilepsy, and neuropathic pain. The document highlights that if the plant's medicinal use is approved, Spain would join the ten EU countries that already have it regulated.
Although there are two drugs made from the plant already marketed in Spain. The proposal aims at facilitating the "wholesale" commercialization of standardized cannabis preparations as is already the case in Germany, Italy, Portugal, and Denmark, considering that in 2020 the UN Drug Convention softened its consideration of cannabis taking into account its medicinal possibilities in certain cases.
This proposal under evaluation underlines that the medical efficacy of cannabis derivatives is concentrated in very specific ailments: "the scientific evidence is limited and restricted to some diagnoses". Those drugs available seek to combat pathologies associated with multiple sclerosis and some forms of epilepsy, benefiting thousands of patients. In addition, the Spanish Medicines Agency has been issuing permits for the controlled cultivation of the plant for the exclusive purpose of producing these products for some time.
This is a first step towards the opening of Spain to the use of medical cannabis on a large scale, but under a rather cautious model, since the document is undermined by precautions to prevent such a measure from encouraging other types of trade with hemp derivatives. Among its stipulations, it even obliges the parliamentary commission itself to make an annual evaluation of how the regulation is working. This would also apply to the Spanish Medicines Agency, based on data from the autonomous communities, and the National Delegation of the Plan on Drugs. In particular, the latter is urged to include data on "the frequency of consumption in the adolescent and adult population, signs of intensive consumption, signs of problematic consumption, and people who seek specialized treatment with cannabis as the main substance."