Spain’s long-awaited medical cannabis program has finally taken a step forward as a draft of a Royal Decree has been sent to the European Union for approval.

If approved, this should give Spanish patients legal access to medical cannabis for the first time in the country’s history later this year.

However, despite the country now being one of Europe’s leading cultivation locations, the proposed framework has been described as ‘feeble’ and would represent one of the most conservative medical cannabis models in any country to legalise it.

Despite continued efforts from the country’s advocacy groups and businesses alike, there now seems to be little room for the program to be expanded in future, providing little respite for patients.

What happened?

Late last month, the Spanish Agency of Medicines and Medical Products (AEMPS) submitted its draft decree to Brussels, following numerous public consultation periods.

As Business of Cannabis reported at the time, the draft decree was immediately criticised for its restrictive nature, preventing the country’s extensive network of local pharmacies from being able to prescribe and dismissing cannabis flower as an option for patients.

Despite continued calls for reform, it appears little was changed in the draft, and it may have gotten even more restrictive.

The EU now has three months to respond to the draft, and if approved, Spain’s Council of State will issue a non-binding recommendation, after which the government can finalise the law.

This means that in theory, Spain could have a medical market by summer. However, given that domestically grown cannabis is strictly for export only, and there are no suggestions this could be changed if the draft is passed, it’s likely that additional time will be needed to import products, develop formulations, and train medical professionals.

What’s in the draft?

The proposed bill will mean that cannabis can only be prescribed as a last resort, after a patient has proved other treatments have failed to be effective.

Even then, cannabis can only be prescribed for spasticity in multiple sclerosis, severe therapy-resistant epilepsy, nausea and vomiting caused by chemotherapy, and chronic therapy-resistant pain.

Conditions such as fibromyalgia, Parkinson’s, Alzheimer’s, and depression, which have documented benefits from cannabis use, are excluded.

A primary concern among patient advocates is that cannabis flower will also not be allowed, but only standardised oils.

Furthermore, only medical specialists will be allowed to prescribe, not general practitioners, and these will only be accessible through hospital pharmacies, meaning those in rural areas will struggle to gain access.

Manuel Guzmán, Professor of Biochemistry and Molecular Biology, member of the Spanish Royal Academy of Pharmacy, and member of the Board of Directors of the International Association for Cannabinoid Medicines, says he is ‘deeply frustrated’ by these limitations.

“This decree—while better than nothing—remains highly restrictive. The approved conditions are limited, access to dispensation is costly and tightly regulated, and only medical specialists—not primary care doctors or general practitioners—will be allowed to prescribe it,” he told Business of Cannabis.

“We are deeply frustrated by these limitations, but as the saying goes, if you look for the bright side of life, at least we will finally have a decree—hopefully by summer 2025, provided Spain’s unpredictable political landscape doesn’t derail the process.”

Chief Executive Officer of Linneo Health, Don Bellamy, echoed this sentiment, calling it a ‘feeble’ law that ‘doesn’t help many people.’

However, he argued that it was an important starting point, enabling the industry to demonstrate that it ‘doesn’t lead to addiction, that it doesn’t fuel criminal activity, and that it doesn’t result in illegal trafficking through pharmacies. Instead, let’s gather real-world evidence that it actually does good’.

“The truth is, we estimate that there are around 250,000 patients in Spain at this moment. And right now, without exception, they have no legal coverage—there is no medical cannabis law protecting them. These patients are forced to seek treatment through illegal means and the black market, exposing themselves to unnecessary risks while still not receiving the proper care they need.

“Yes, this new law is weak, and it doesn’t align with what’s happening in the rest of Europe. But it’s better than nothing. So, let’s start by acknowledging that while this is a feeble first step, it is still a step forward.”

Crucial clause removed 

Despite his glass-half-full approach, Bellamy suggests that the draft which sent to the EU removed a crucial clause which provided a doorway for the framework to be expanded in the future.

He explained that in an earlier version of the decree, ‘there was at least a provision to allow research into cannabis flower,’ meaning expansion to include flower prescriptions was a potential prospect in the coming months and years.

“That was important because it would have allowed companies like Linneo to legally approach doctors or research institutions, propose clinical trials, and start collecting data on its efficacy. Even if the law was weak, that small provision would have opened the door for generating evidence to convince the government to expand it in the future.”

However, somewhere along the way, this clause was removed, meaning it’s now unclear how businesses will be able to generate the data in Spain needed to push for further reform.

“Without that data, how do we prove that this law should be expanded? That’s the real challenge now.”

Regardless, Mr Bellamy believes it is his company’s ‘civic duty’ to engage with the system as it currently stands.

“I’m not counting on Spain being a major market for us. Under this framework, we have the ability to produce oils and put them on the market, and even if we only sell ten units, I think we should go ahead and do it.

“From an ethical standpoint, it’s incredibly difficult for us as a leading producer of medical cannabis products to be in a position where we can’t provide even one gram to a single patient in Spain.

“So, I believe we have a responsibility to work within the law, to introduce whatever products we can, and to keep pushing for further dialogue with the government on how to improve and expand access.”