By Manuel-P. Jimenez-Garcia, PhD. | Director of Medical and Scientific Affairs
The therapeutic properties of the cannabis plant have been claimed in Spain since the time of Al-Andalus. Perhaps that’s why most of us bemoan Spain’s apparent regulatory inertia when it comes to cannabis, noting that others in the European Union (EU), such as Germany and Portugal, have already regulated medicinal use under a modern framework. However, recent developments in Spain have given some a reason to change their tune, with the Government backing reforms. Here’s our initial take on this important headline.
A Brief History of Medicinal Cannabis Regulation in Spain
The main legislation that applies to the medicinal use and cultivation of cannabis in Spain still derives from the 1961 Single Convention on Narcotic Drugs and its updated protocol (specifically Law 17/1976 on narcotics and subsequent modifications). However, to date patient access to legal medicinal cannabis (excluding pharmaceuticals such as Sativex) has been extremely limited, if not to say non-existent.
Looking back into the history of our country, we discover that intense campaigning for legalization of medical cannabis has seen limited success, both at a national level as well as various autonomous communities. For example, the Catalonian parliament passed a progressive bill in 2001, which urged the central Government to carry out the necessary steps needed to federally authorize the therapeutic use of cannabis. Alas, it would be two decades before seeing any real progress on the matter.
Meanwhile in 2005, Sativex, a cannabinoid-based drug prescribed to alleviate certain symptoms of multiple sclerosis, was approved for use by AEMPS (The Spanish Agency of Medicines and Medical Devices). Then in 2021, Epidyolex, an anticonvulsant for the adjuvant treatment of Lennox-Gastaut and Dravet syndromes, considered two of the most severe forms of epileptic encephalopathy, was also approved. While some patients in Spain enjoy greater access to cannabis-based medicines after these developments, the combined sales of Sativex & Epidyolex suggest that the majority are still turning to grey or illicit markets for supply.
A Small Step In The Right Direction
In mid 2021, after mounting political and social pressure calling for the Government to implement a broader, more inclusive regulatory framework, the Congress of Deputies (Congress) finally decided to act. A sub-committee was setup with a mandate to analyze the regulation of cannabis for medicinal use in other countries, among other topics. Interdisciplinary experts took part and submitted their reflections, which culminated in a draft technical report being issued in May 2022, which included recommendations to be considered as guidelines for developing the regulation. After some debate and negotiations resulting in amendments to the initial draft, the sub-committee approved the report’s recommendations on June 21st 2022.
The following week, the Health and Consumption Commission (a permanent legislative commission within Congress) gave the report its formal approval on June 27th 2022, marking the beginning of the process of creating the regulation which will govern the medicinal use of cannabis in Spain.
At this point, AEMPS, has six months to adopt the recommendations of the Commission and fit them into existing Spanish law. Although, it’s unclear whether this is a fixed deadline or the Agency will request additional time considering the size of the task at hand. It’s also our understanding that since the Government has already agreed to follow the recommendations laid out in the report, and rejected the need to elevate the subject to Congress for debate and approval, the regulations prepared by AEMPS will not be subject to subsequent votes, be that in Congress or the Senate.
What Was Recommended?
There’s a lot to unpack from the reports recommendations but also a lot left to define. As the saying goes, “the devil is always in the detail”. In this case, the detail rests on AEMPS and how they interpret the initial guidelines, which should translate into regulation by the end of the year.
The report recommends that medicinal cannabis be restricted to a subset of patients seeking relief from a defined list of indications, which include:
Access to medicinal cannabis can be extended to other therapeutic cases not already indicated when studies provide consistent evidence of its efficacy.
Reading between the lines, the recommendations imply that patients will not be able to access medical cannabis as a treatment option of first resort. Instead, it appears that cannabis should be considered only when more conventional treatments have failed. Nevertheless, it must be noted that this is not entirely clear in the report.
Who Will Prescribe?
The report recommends that prescriptions of medicinal cannabis must be carried out exclusively by health professionals and preferably by medical specialists with skills in areas covered by the authorized indications, as long as they are free of potential conflicts of interest. In their interpretation of these recommendations, it’s our hope that AEMPS broaden the scope of prescribers to include other specialists and GP’s in order to facilitate better patient access. The report also indicates that training in the use of medicinal cannabis among qualified prescribers should be carried out – the content of which and by who are also not clear at this stage.
A lot of debate centered around distribution mechanisms, particularly decisions regarding where medicinal cannabis will be dispensed. The final report states that dispensing must be done from the health system pharmacy network and preferably hospital pharmacies. However, the door has been left open to the inclusion of community pharmacies that meet certain requirements. Whether this includes general or compounding pharmacies, or both is yet to be determined.
Types of Products
On this particular subject covered by the recommendations, there’s a lot left open to interpretation. It appears the type of medicinal cannabis products allowed under new regulation will be limited to extracts and/or standardized cannabis preparations. Furthermore, the use of magistral formulas (individual medications that are prepared by the pharmacist) based on extracts and/or standardized preparations will also be evaluated for certain cases. A more precise definition and under what conditions products will be manufactured, registered and distributed still needs to be developed.
Cannabis flower and other types of preparations that are available in European Union countries will also be considered for approval but only for R&D purposes i.e. strictly for use in clinical and other scientific trials.
Those expecting a six month turn around, as some headlines have suggested, may be disappointed. Practically speaking, it could take at least 12-18 months before we see medicinal cannabis available in the Spanish market. What lies ahead is an incredibly complex task to assemble all the elements of a robust, patient-centric and inclusive medicinal cannabis system. Even if regulation is in place by the end of the year, there’s a lot that comes after this.
A multidisciplinary effort is needed to develop things like pathology-driven treatment protocols, general and specific education for health professionals in the field of cannabis medicine, product registration process, supply chain infrastructure, downstream services including clinical assistance programs for patients and much more. This of course is assuming that the political winds keep blowing in the right direction. With a federal election slated for late 2023, there may still be an additional twist to this tale.
Spain is more prepared than many other EU countries were prior to their regulatory reforms. For starters it boasts a rich ecosystem supported by top scientists and academics from leading universities with deep expertise in cannabis research already. It has a thriving agricultural sector with active medicinal cannabis cultivation projects, ensuring long-term production sovereignty (a total of 16 research and commercial licenses already issued at time of writing this article) and world-class pharmaceutical-grade manufacturing capabilities. Perhaps most importantly, Spain has significant public support for the legalization of medicinal cannabis.
Overall, we remain extremely optimistic about the prospects of a regulated medicinal cannabis market in Spain. It won’t always be perfect; it will evolve as we do. What’s certain today is that we’ve taken our first steps and that’s good news for everyone – especially for those patients whose lives could materially change thanks to one amazing plant called cannabis.
Conclusions and recommendations in the subcommittees’ report (pages 57-58):
Minutes from the Health Commissions’ debate and subsequent approval of the subcommittees report on June 27, 2022 (pages 2-11, 20-21):