Spain Advances Restrictive Medical Cannabis Plan Amid Patient Criticism

After years and years of waiting, Spain may have a medical cannabis program before the summer. The Ministry of Health continues to take steps towards regulating cananbis as a last-resort treatment for certain pathologies – it is the main use contemplated at the moment – ​​and has sent its draft Royal Decree to Brussels, as required by Community regulations.

The Commission then has three months to respond. As soon as the response arrives, which the Ministry of Health expects to be positive, the Council of State will issue its mandatory but non-binding decision within two months and the Government may send the text to the Council of Ministers at its discretion.

The process will take a maximum of five months in total, and the counter has already started to tick. In this way, if the Executive wants it and its forecast that Brussels will not ask for changes to the text is met – the Spanish proposal is more conservative than those already in place in other countries – the Minister of Health, Mónica García, will be able to see the medicinal cannabis programme approved from June. Once the text is ready, it will be a question of political opportunity and the Government finding the moment it considers appropriate to approve it.

Spain will then join the pleiad of European and overseas countries that already allow the therapeutic use of cannabis. A demand for years by civil groups of users of cannabis for medicinal purposes.

However, it will be a diminished program, say patients: the Royal Decree drafted by the Ministry of Health excludes the use of cannabis flowers (cannabis buds), by extension of self-cultivation, and limits uses to master preparations (cannabis oils) and two medicines that have been in existence for years. In fact, the ministry only speaks of a “Royal Decree that regulates the dispensing of master formulas of standardized cannabis for therapeutic purposes”, it does not speak of a program or any similar term.

A conservative project in Spain

Nor, explains the Spanish Observatory of Medicinal Cannabis (OECM), will it be particularly innovative in terms of its uses. The Health Department contemplates a limited role for the preparations contemplated in its regulations. It will be the last resort, once conventional methods and cannabis-based medicines already on the market have been proven useless , for those pathologies “for which there is scientific evidence of therapeutic benefit from cannabis and its extracts,” according to the Royal Decree.

Something more down to earth: its use will be permitted for spasticity due to multiple sclerosis; rigidity and muscle 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 standard 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 register of standardised preparations will be created. But – and this is a point that patients strongly emphasise – “standardised magistral formulations will be used when there are no authorised medicines or these do not meet the patient’s needs”. In other words, it will be the last resort and will not always be available. The doctor will have to explicitly justify their use.

Patients and some cannabis researchers in Spain believe that the uses approved by the Government fall short. Cannabis is, according to some researchers , the most powerful anti-inflammatory that exists. It has antidepressant, analgesic, anxiolytic, antiemetic effects and helps protect the nervous system. In Spain it is used by patients with cancer, multiple sclerosis, Alzheimer’s, Parkinson’s and fibromyalgia, among others.

Two other aspects that current users of the Health Ministry’s proposal do not like are that it will only be allowed to be prescribed by specialist doctors, not by primary care doctors, and that it will be dispensed by hospital pharmacies, not by neighbourhood (community) pharmacies. These two measures drive away potential users of medicinal cannabis, according to civil organisations, who see them as obstacles to access.

Years of struggle in Spain

When it is approved –the composition of Congress suggests that it will go ahead– the Government will close a cycle that formally began four years ago. But long before that, several parties (Podemos, Ciudadanos, ERC) in SPain had presented individual initiatives to the Plenary –more or less ambitious, including some comprehensive regulation, also recreational–, but they were systematically discarded with the rejection of the PSOE.

The Socialists have always been the cornerstone for the legalisation of medicinal cannabis (also the obstacle to its not being done until now). The national right (PP and Vox) opposed and oppose it; the nationalist parties approve it, except Junts, which usually moves in the environment of abstention; the PSOE remained as the pivotal party.

While it refused to deal with the matter – for many years and alluding to the fact that the WHO did not find medicinal properties, a position that the party maintained even after the organisation changed its position on its therapeutic possibilities – there was no case for the patients. Until it finally gave in and on May 13th, 2021 it stuck to exploring the terrain.

That day, Congress approved the PNV’s proposal to create a parliamentary subcommittee to study the therapeutic programmes of other countries before proposing one in Spain. The pressure on the streets had been coming for a long time, but it was not able to penetrate the political class. In practically all the legislatures of the past decade, civil movements said “it has to be this one” , but then they only saw how other countries were creating their programmes while in Spain nothing was moving.

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(Featured image by Stephen Cobb via Unsplash)

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First published in elDiario.es. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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