The new Royal Decree (Real Decreto) issued 7 October by the Spanish Ministry of Health establishes the conditions for the preparation, prescription and dispensing of standardised cannabis-based medicine. While it’s been presented as a historic step forward, its actual design and scope reveal a considerable gap between cannabis regulation and access. Its overt focus on product quality has left out guarantees for the quality of life for the thousands of patients who will use these treatments. Although this new legislation guarantees technical standards, it does not constitute a genuine public policy on medical cannabis. It “legalises” a product, but once again fails to address access, equity and the practices that already sustain care in real life.
Social clubs and patient networks left out
The first point that needs clarification is that this Royal Decree is not a regulation of medical cannabis in the Spanish State. As its title says, it simply defines conditions for preparing and dispensing standardised formulas within an exclusively medical–pharmaceutical circuit. It does not consider existing access routes to this medication, nor does it recognise existing patient communities and medical use networks. Only specialist physicians within the National Health System may prescribe these formulas, and only from hospitals.
Sadly, it makes no mention of the access models, like social clubs and organised self-care initiatives, that have provided therapeutic support and education for patients across Spain for over two decades. These practices are set to remain outside the legal medical cannabis framework, without recognition or dialogue, despite having been an informal lifeline for many, and being a source of education around the risks, effects, and interactions of medical cannabis with other treatments.
Medical cannabis products are set to only be dispensed from hospital pharmacies. One possible pathway for alternative access does exist: community pharmacies could dispense some medications, albeit in highly restricted cases of dependency, vulnerability or geographical distance – subject to prior regional authorisation. In practice, this exception will depend on the administrative sensitivity (and political alignment) of each autonomous community, opening the door to new territorial inequalities.
Key community knowledge erased
This highly hospital-centred approach does not acknowledge that many patients who use therapeutic cannabis already rely on informal networks for guidance on dosage, effects, interactions or routes of administration. The Decree creates no mechanisms to integrate this existing knowledge into the medical system, or the possibility for collaboration with civil society; this is ironic, given that one of the purposes of the Decree is to monitor for “adverse reactions” stemming from consumption.
This suggested model of access is duplicating the work already done informally by patients and patient networks. Instead, it encourages health professionals to engage in pharmacovigilance, encouraging not only the detection of these “adverse reactions”, but also of the periodic assessment of patients’ treatment plans to determine whether it is still “clinically beneficial” or not – a decision that often is taken without patients’ input, especially when dealing with still-stigmatised substances.
With this new framework for medical cannabis being presented as an administrative text, there was no opportunity to debate its implementation or advocate for greater patient representation; at the end of the day, it’s an administrative text drafted almost entirely by technical staff that prioritise pharmacological risks over therapeutic rights or needs.
Concerns with limited access
As is the case with many incremental medical cannabis systems, access is limited by design to a very small set of conditions. These include muscle spasticity from multiple sclerosis, severe forms of refractory epilepsy, chemotherapy-induced nausea and vomiting, and refractory chronic pain. Similar to the United Kingdom, where legal patient access to medical cannabis is only a fraction of its actual need, Spain issued tight restrictions in its prescription: medical cannabis is to only be prescribed as a “last resort”. All other treatment pathways must be exhausted before medical cannabis is considered.
This framing positions cannabis not as a legitimate therapeutic option, but a final favour offered by the state. It does not align with basic principles of patient autonomy and right to physical and mental integrity that are recognised in Spanish legislation as fundamental rights.
Official sources note that the list is not entirely closed and that the monographs to be published by the Spanish Agency of Medicine and Medical Devices (AEMPS) in the National Formulary may introduce nuances or new indications. However, this flexibility is conditioned by the regulatory will of the Ministry of Health and by the internal dynamics of the Agency, which have historically been slow adopters of medical cannabis evidence.
The decree grants the AEMPS absolute control: from the public registry of standardised preparations to the assessment of their quality, safety and purity; including the authorisation of preparations, the supervision of producers, the resolution of incidents and the power to revoke authorisations. It also centralises pharmacovigilance, allowing patients themselves to directly report suspected adverse reactions.
While technical guarantees are necessary, the practical outcome is a rigid, bureaucratic and potentially slow circuit in which administrative timeframes and inspection criteria are still unclear. Fees, response times and technical requirements are not accompanied by transparency mechanisms enabling stakeholders to anticipate costs and procedures, which may generate inequality between those with sufficient logistical capacity to adapt (like large pharmaceutical laboratories) and those without (like small-scale or cooperative projects).
The requirement that producers must be established within the European Union, the demand for exhaustive traceability and the control standards mean production is likely to happen only at an industrial level. This guarantees quality, but consolidates a structure in which most national production remains geared towards export. Spain is already a huge international medical cannabis exporter, having produced around 36 tonnes of product in 2024. All this product serves international markets, while Spanish patients continue to lack easy and affordable access.
The Decree excludes any possibility for actors with different types of experience, especially those from civil society or cannabis associations, to formally participate in the medical system. There is no vision for participatory mechanisms to gather knowledge from patients, associations, professionals from the social field or networks that have historically accompanied and educated users.
The Decree excludes a large proportion of the conditions for which thousands of people today use cannabis with perceived benefit: non-oncological neuropathic pain, severe sleep disorders, treatment-resistant anxiety, symptoms related to HIV, endometriosis, Ehlers Danlos syndrome and even its use as a harm-reduction tool for opioid use or benzodiazepines, among many others.
The future of medical cannabis legislation in Spain
There’s a real fear that this framework is overly concerned with product safety, deprioritising access safety. In its current form, the Decree is set to create a model that is excessively centralised, specialist-dependent, and bureaucratic – a reality disconnected from the current experience of thousands of patients who have spent decades managing their health with cannabis through existing models. If the goal is to balance safety and access, the path requires structural changes: more agile procedures, transparency in fees and timeframes, participatory processes to develop monographs, mechanisms enabling the progressive integration of local actors, and a perspective that includes wellbeing, autonomy and health justice, are desperately needed.
The only obvious opening in the Royal Decree is the possibility for the Ministry or the AEMPS itself to develop and update the regulation. It also contemplates the possibility of specific regulations allowing pharmacies to prepare these formulas. However, this flexibility may become a double-edged sword: it enables future adaptations but leaves ample room for discretionary administrative decisions that could further delay access, tighten requirements or deepen the hospital-centred model.
Today, the Spanish State regulates a medical product, but continues to fail to regulate the lives of those that need it. The future may bring a new model of access – but it still needs tremendous work.
