The regulation of therapeutic cannabis in Spain could become a reality before the end of the year

The regulation of therapeutic marijuana in Spain is getting closer and closer. Last summer, the ruling urging the Government to launch all necessary measures, within a maximum of six months, to permit the use of cannabis to treat various illnesses, was finally approved. However, few days are now left to meet the deadline, and it’s still unclear whether 2023 will be the year when we’ll be able to find cannabis in Spanish pharmacies at long last.

When the ruling supporting the regulation of therapeutic cannabis in Spain was definitely approved by the Health and Consumer Commission of Congress on 27^th June 2022, the Spanish Government gave themselves six months to develop the Commission’s recommendations in a document that would give concrete form to the new regulations.

However, after the ruling was approved by Congress, there were many unknowns that still had to be defined before finally finding out what kind of regulations would be established, how many patients would benefit from them, how much patients would have to pay for the cannabis-derived products, and what the situation would look like for growers of cannabis for personal use.

The Government will have to take many factors into consideration and adjust the regulation to compete with the long-existing illegal market. The body designated to carry out this task is the Spanish Agency of Medicines and Medical Devices (AEMPS). This organisation has been shaping the insertion of the agreed recommendations into the regulation for almost six months. The Government also has a tremendous responsibility to start distributing cannabis for therapeutic purposes to thousands of people, to ensure that there isn’t a lack of it within the stipulated time limits, and to be prepared to control an entirely new legal cannabis sector.

The Ministry of Health has until 27^th December to comply with the agreement approved in Congress. “The AEMPS is currently working to deliver the task assigned in the aforementioned report within the established time frame”, replied the Ministry of Health’s spokesperson to a parliamentary question by the Ciudadanos party on 22nd November, when one of the party’s deputies asked to know about the roadmap planned until the end of the year, and whether the Ministry of Health had taken any actions to comply with the report approved by the Lower House.

In fact, Ciudadanos argued that there were ‘delays’ in this regulation, but the Ministry led by Carolina Darias maintained that they are indeed acting on it. They added that “a roadmap is being developed for the timely regulatory insertion and feasibility of such recommendations”.

What are the main measures to be regulated?

According to the AEMPS, the objective of this feasibility study is to ensure “the quality of these products”, especially for extracts and standardised cannabis preparations for therapeutic purposes, so that “their use contributes to the health of patients who may need them, and to the protection of public health”.

Nevertheless, the Ministry of Health didn’t take a stance on the other recommendations approved by Congress during this parliamentary response, so it’s still unknown whether any progress is being made regarding this. The main measures included in the report are as follows:

• To recognise the usefulness of cannabis for the following pathologies: spasticity in multiple sclerosis, some forms of epilepsy, nausea and vomiting caused by chemotherapy, endometriosis, cancer pain, and chronic non-cancer pain (including neuropathic pain).
• Products will be prescribed exclusively by health professionals, and preferably by doctors specialised in the areas that have been granted authorisation.
• Compound preparations containing cannabis extracts will be distributed by the network of pharmacies of the National Health System, giving preference to hospital pharmacies but also exploring the alternative of community pharmacies.
• The Interterritorial Council will draw up clinical guidelines on the therapeutic use of cannabinoids.
• There will be a centralised record of patients to whom these preparations will be prescribed.
• Annual reports by the Congress’ Health Commission, the AEMPS, and the Government’s delegation for the National Drug Plan, in order to assess the situation and evaluate its benefits.
• Assessment of flowering tops (cannabis flowers) for the development of experimental and research projects.

What can be expected once the deadline is met?

Therefore, the only thing that’s clear is that the Ministry of Health must present its ‘roadmap for the timely regulatory insertion’ of therapeutic cannabis in Spain by 27^th December. So does this mean that we’ll be able to find marijuana in pharmacies at the beginning of 2023? Well, probably not.

For the time being, the AEMPS could argue that it needs more time to outline all the details of the new regulation. And, even then, the Agency will have to coordinate with the different autonomous communities to define and implement the inspection and control functions of the proposed mechanisms.

Likewise, the AEMPS will have to draw an annual report on the therapeutic use of cannabis with the collaboration of the autonomous communities. This report will include prescribed services, treated patients, the volume of products dispensed, as well as efficacy and safety data.

To this end, the Agency should have ‘specific and final new funding’ to enable it to ‘successfully perform’ its new functions. This is a budget for which neither the total amount nor the specific amounts of the individual batches are yet known.

Lastly, the House ruling doesn’t specify what type of legislation should be approved by the Government, that is, whether it is to be a law, a decree, or another legal provision. The Government is only urged to make it possible to implement its conclusions and recommendations in the manner it deems most feasible.

Hence, we won’t know until 27th December when or how the long-awaited regulation of therapeutic cannabis will be implemented in Spain. The only thing we know for sure is the response that the government of Pedro Sánchez has issued at this point in the game: “We are working on it”. This is undoubtedly too ambiguous a statement and, just as it happened in the past with President Aznar, it could possibly turn the dream into a nightmare.