The Spanish Congress gives the green light to medical cannabis: What can we expect next?

The long-awaited regulation of medical cannabis in Spain could be a reality before the end of this year, with a deadline of December 27th, 2022. But what some consider a huge advance for patients’ rights could become the funniest joke of all time, as there is still nothing clear about how the government will manage an issue that, beyond its political implications, affects society as a whole.

On June 27th, Spain gave the definitive ‘yes’ to the regulation of medical cannabis, when the Health and Consumer Affairs in the Congress of Deputies Committee approved the medical cannabis subcommittee report that gave the endorsement to the plant regulation for therapeutic purposes, after hearing 23 national and international experts over the course of five months.

The Spanish Ministry of Health had already said that it would accept the conclusions of this parliamentary committee, a report supported by the left-wing parties PSOE, Unidas Podemos, Ciudadanos, PNV and PDeCAT, with the abstention of ERC and Bildu (both independent parties) and the vote against from the right-wing party PP and the far right party Vox. So the report will not have to be voted on in a Congress plenary session in order to be effective. The report findings will be sent directly to the Government for consideration.

From there, and within a period of 6 months, the Spanish Agency of Medicines and Medical Devices (AEMPS) will carry out the necessary work so the subcommittee advices could be included into the legislation and be viable, allowing medical cannabis “availability in the pharmaceutical market”.

However, although some of the parliamentary groups have considered this regulation as a “giant step”, it could end up being a step backward instead, given that there is still much room for improvement of the proposed text, as we will try to point out below.

What kind of cannabis will be regulated?

According to the agreed proposal, these will be magistral formulas (individualised medication prepared by a pharmacist for a specific patient) “from cannabis standardised extracts or preparations for direct use in certain cases, ensuring stability and uniformity”. The cannabis flower or bud is excluded, although the door is left open to “other preparations that are available in European Union countries” for medical purposes. That is, as long as they are intended for “trial projects”, a concept that is undoubtedly too ambiguous.

Who will be able to access medical cannabis?

On its initial approach, the PSOE party restricted the therapeutic use of cannabis to the two existing drugs (Sativex, for spasticity, and Epidiolex, for seizures of two types of epilepsy). But after long negotiations, the socialists have agreed to include several ideas of the other groups, so the report proposes extending medical use to endometriosis and cancer pain, in addition to non-oncological (also neuropathic), spasticity in patients with multiple sclerosis, some forms of epilepsy, nausea and vomiting derived from chemotherapy. The possibility also extends “to other therapeutic indications when studies provide consistent evidence”.

Will patients be able to self-cultivate?

However, the Commission voted against the amendment tabled by Unidas Podemos, ERC and Bildu claiming to allow cannabis flowering tops self-cultivation for “prescription patients who choose this access route”. Therefore, it is a very restrictive regulation, since currently there are hundreds of thousands of people who are using this resource to which this law will not give answers, an important sector of patients who will remain in a legal limbo and even in a situation of regression, having to rely on the black market again.

Where can cannabis be dispensed?

One of the most important novelties is that the door is opened to the distribution of medical cannabis in pharmacies, as they claimed, for example, from Unidas Podemos. The final text states that it will be distributed “at the health system pharmacies network, preferably at hospital pharmacies and that the alternative of community pharmacies that may meet the requirements will be explored”. However, these requirements are not specified in the document.

Who will be able to prescribe marijuana?

According to the report, only healthcare professionals should prescribe “in a context free of possible conflict of interest” and “preferably by medical experts”. But not only by specialist doctors who attend to the areas for which medical cannabis is going to be indicated, as the PSOE wanted at the beginning, but that “training in the therapeutic use of cannabis should be promoted among these medical professionals”, the text stresses. How this formation will be addressed, remains a mystery.

How the use of cannabis will be controlled?

The report also advises the implementation of a patient’s centralised registry coming from each Regional Health Service records. It has also been recommended that the cannabis medical use and the population use data be regularly evaluated. Thus, both the AEMPS and the National Drug Strategy (PNSD) would have to make an annual report that includes prescription services information, treated patients and the amount of dispensed product, to “progressively improve the medication knowledge”.

What about recreational marijuana?

In addition, the Commission has rejected the individual votes of Ciudadanos, liberal party, which intended to open the debate on the regulation of cannabis also at the recreational level. The PSOE has been categorical about this: “We have tried since minute 1 not to confuse cannabis for medical purposes with the recreational use. They are two different debates. The first one will help people with pain, the second won’t,” said President Pedro Sánchez’s party.

What can we finally expect from this regulation?

After the Congress approved the report, many questions remain to be answered regarding the type of legislation that will eventually be put in place. For example, how many patients will benefit, how much they will have to pay and in what situation will remain those who get their own consumption through self-cultivation.

Therefore, we still don’t know how the distribution of cannabis through administrative channels will be, since through self-consumption, a use that is more than consolidated in our society, would undoubtedly be cheaper and accessible.

In addition, in other countries where medical cannabis is legal, patients are not convinced by products prescribed by the state and are more likely to go to the black market, where they can choose. For this reason, the Government should focus on how it adapts the rule without favouring third parties (such as multinationals in the sector) and a fraudulent market that has always existed.

Therefore, despite the report approval which is the future law draft, everything it’s all up in the air. The Government does not actually contemplate or mention figures, not even approximate ones; although, according to different associations we could be initially talking about between 250,000 and 500,000 people. And serving them all, making sure that they can access cannabis within the stipulated time frame, seems a most complicated task.