Today Spain has taken the step that had been blocked for years: the Council of Ministers has approved the Royal Decree regulating the prescription, preparation, dispensing and use of standardised magistral formulas based on standardised cannabis preparations. This completes a political, parliamentary and technical journey that began more than four years ago. Publication in the Official State Gazette (BOE) is the last formal step; from then on, the planned implementation deadlines will start to run.
Despite the institutional triumphalism, understanding what has been approved requires looking back at the path followed, the tensions that shaped it and the concessions imposed article by article. Only then can we see in perspective what this regulation really means for patients, professionals and the industry.
From the parliamentary subcommittee to approval
What is approved today does not come from progressive political conviction, but from institutional momentum that has taken more than four years to become law.
2021–2022: the political origin
The process began with the Congressional Subcommittee (2021) set up to study comparative models. After months of hearings, the Health Committee approved the Report of Conclusions (27 June 2022), which recommended enabling controlled access to cannabis for medical purposes within the National Health System.
2024: the Ministry of Health moves because it could no longer stand still
On 14 February 2024 the public consultation on the Royal Decree was opened. On 30 September 2024, the AEMPS published the draft and submitted it for hearing and public information. At that point it was already clear that the model would be as narrow as possible: magistral formulas, standardised preparations, hospital channel, very limited conditions and total exclusion of flower.
2025: Europe does not block it and the Council of State gives the green light
In January 2025 the project was notified to the European Commission (TRIS procedure), and the standstill period ended without objections on 24 April 2025. The Council of State issued a favourable opinion in September, unblocking its submission to the Council of Ministers, which approves it today.
What exactly the Royal Decree regulates
The text does not open a market, does not recognise what already exists and does not resemble the most advanced European therapeutic models. To understand its real scope, we need to dissect its architecture, because that is where the true dimension of the regulation lies.
1) Purpose and scope
With a precision that is more defensive than protective, the decree sets out what can be done, who can do it and under what conditions. It does not open doors; it sets boundaries:
- It regulates the prescription, preparation, dispensing and use of standardised magistral formulas.
- It creates a register of standardised cannabis preparations at the AEMPS.
- It expressly excludes industrial medicines, investigational products, synthetic cannabinoids and any non-plant source.
2) Control
This section reflects the legislator’s obsession with control, not access. Anything containing THC ≥ 0.2% is considered psychotropic and subject to the regimes of the 1971 Convention and Royal Decree 2829/1977.
Moreover, the whole decree assumes that cannabis is still a narcotic subject to the 1961 Single Convention and Law 17/1967. No conceptual progress, no review in line with international evidence.
And yet it could have been worse:
It is worth remembering that the first version of the draft included an article 3.1 that literally stated that “cannabis flowering tops, regardless of their THC content, shall be considered narcotics”. Had that wording been kept, the impact on the CBD sector would have been devastating: all flower would have been controlled, even flower intended for products without psychoactive effects, leaving producers, shops and consumers outside the law. Thanks to coordinated pressure from the sector, associations and legal experts, that provision was removed before the text was sent to the European Commission and the Council of State, avoiding a far more restrictive scenario than the one finally approved.
3) National Formulary monographs
There is no room here for improvisation or clinical adaptation. Magistral formulas will only exist if they first appear in an official monograph to be published by the AEMPS. A maximum period of 3 months after entry into force is set to complete this part. Until then, nothing can be applied.
4) Manufacturing and supply
The rule limits who can produce, how and for whom, locking in an almost experimental model:
- Only under Good Manufacturing Practice (EU)
- Only with audited suppliers
- Only for hospital pharmacy services or export
- And if THC ≥ 0.2%, the licences under Royal Decree 2829/1977 and Law 17/1967 apply
5) AEMPS register
No open register and no deemed approval. The procedure is designed to filter rather than facilitate:
- A public register under the AEMPS
- Deemed refusal after 6 months
- 10 days to correct defects
- Fees, technical requirements and the possibility of new registrations in the event of changes
6) Prescription and follow-up
This block consolidates the restrictive approach. The rule does not open routes; it adds locks:
- Only four conditions:
- Spasticity due to multiple sclerosis
- Severe drug-resistant epilepsy
- Chemotherapy-induced nausea and vomiting
- Refractory chronic pain
- Only when authorised medicines do not work
- Only on prescription from a hospital specialist
- Only when prepared in a hospital pharmacy
- Only when dispensed under direct medical supervision
- Only with documented follow-up and periodic review
Even possible remote dispensing requires specific cases of vulnerability or geographical distance.
7) Community pharmacies
They are not authorised, but a future route is left open, with limits and small print: they could prepare formulas on behalf of hospitals, but not dispense directly.
8) Entry into force
The decree will apply from the day after its publication in the BOE. What matters will come later: monographs, the register, regional circuits and the first authorisations.
What still depends on implementation
None of what has been approved will be operational without:
- Publication in the BOE
- Monographs within 3 months
- An active AEMPS register
- Real implementation in hospitals and regions
Until that happens, there will be no effective clinical access.
What this regulation does not cover
Beyond the official discourse, there are deliberate silences:
- Primary care is left out
- Community pharmacies are left out
- Flower is left out
- The most common conditions among real users are left out
- Home growing is left out
- Clubs are left out
- The CBD market still has no recognition or legal certainty
A regulation that arrives late, arrives limited and leaves out those who use it most
The Government will sell the Royal Decree as opening up medical access to cannabis, but its practical scope is minimal. The list of conditions is residual, prescription is restricted to hospital specialists and dispensing is confined to the most rigid circuit possible. The total exclusion of flower puts Spain at the back of the queue compared with Germany or Portugal, which already dispense inhalable formats without regulatory drama.
The paradox is clear: what works for German, Swiss or Danish patients does not seem acceptable for Spanish ones. The result is a regulation approved more out of political exhaustion than health conviction. A framework that, although historic in symbolic terms, does not reflect the existing therapeutic reality and will continue to leave out most of those who already use cannabis for medical purposes. Spain has arrived, yes, but it has arrived afraid, with scissors in hand and looking more at the police than at patients.
S&F Abogados.
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