2024 was a reform year, not the starting point of every treatment
Spain's medical-cannabis position in 2024 combined existing authorised medicines with work on a broader framework for standardised preparations. The key distinction was between a medicine with an established authorisation and a proposed new system for pharmacy-compounded formulas. The latter was still going through consultation during the year. Patients' access therefore depended on the particular medicine and clinical indication, rather than one general category called medical cannabis.
Sativex addressed a defined multiple-sclerosis symptom
AEMPS product information identifies Sativex for adults with moderate-to-severe spasticity due to multiple sclerosis who have responded inadequately to other antispasticity medicines and show clinically significant improvement during an initial treatment trial. It is an additional treatment under specialist supervision. The target is the symptom of spasticity, not a claim to cure multiple sclerosis. This illustrates how an authorised cannabinoid medicine is connected to a defined patient group, clinical response and professional responsibility.
Epidyolex was a different medicine
Epidyolex contains cannabidiol and received EU marketing authorisation on 19 September 2019. EMA describes its use for specified rare epilepsies, including Lennox–Gastaut and Dravet syndromes with clobazam, and tuberous sclerosis complex with other epilepsy treatment. It is a prescription medicine supervised by a clinician experienced in epilepsy. Its regulated composition and clinical evidence distinguish it from a consumer CBD product. The shared cannabinoid name does not make the products interchangeable.
The September draft proposed a pharmaceutical system
On 30 September 2024, the Health Ministry announced the public-hearing stage for a draft royal decree governing preparation and dispensing of standardised cannabis preparations in specified formulas. Contributions were invited until 21 October. The ministry described a framework for patients for whom authorised medicines had not been effective, with clinical evidence guiding the relevant uses. At that stage, publication of the draft was a step in policymaking, not the final decree entering into force.
What happened after the 2024 debate
The final framework arrived through Royal Decree 903/2025 in October 2025, with a national-formulary monograph following in 2026. Its structure connects standardised products, specialist prescribing, hospital pharmacies and follow-up. These later milestones explain where the 2024 process led while keeping the chronology accurate. The enduring distinction is between an authorised medicine, a pharmacy-compounded formula and a nonmedical product. Each has a different evidential and regulatory basis, even when cannabinoids appear in all three.
Sources & further reading
General information, not individual legal or medical advice.