Spain: ‘Unfulfilled promises’ leave regulation of medical cannabis in jeopardy

Patients in Spain have been left ‘devastated’ by ‘unfulfilled promises’, as the Health Minister confirms the country won’t see medical cannabis regulation before the upcoming election.

Speaking to local media, Spain’s Health Minister, José Miñones, has said that the government is still working on the regulation of medical cannabis, but it is unlikely to be in place before the general election in July.

It’s now over 12 months since the Health Committee of the Spanish Congress of Deputies approved a subcommittee’s draft report setting out a list of recommendations for the regulation of cannabis-derived medicines for therapeutic use, on June 27, 2022.

The Spanish Agency of Medicines and Medical Devices (AEMPS) was due to publish its own regulatory framework in January this year to ensure the availability of cannabis extracts or preparations on the market. However, this has seen considerable delays. 

Now, with a snap general election scheduled to take place on 23 July, the dissolution of parliament has meant that the bill, along with dozens of others, has come to a standstill.

Advocates working on behalf of medical cannabis patients and the industry have expressed concern that if the legislation is not passed in time, the country’s more conservative political parties, who are generally opposed to the regulation of cannabis of any kind, may put a stop to it all together. 

“The regulation of cannabis-derived medicines is a highly debated social issue in Spain,” Cristina Romero, partner at Madrid-based law firm, LOYRA, told Cannabis Health.

“On one hand, there are those who oppose regulation because they believe it could pave the way to the legalisation of cannabis in general, leading to greater availability and consumption. On the other, a significant portion of the Spanish population believes that cannabis should be regulated due to the potential benefits it can provide in treating certain illnesses.”

In an interview with a local news outlet on 22 June, Miñones confirmed that the government has now received the report from the AEMPS and promised to ‘keep working’ on the introduction of the regulations after the election.

“What we have done is serious and rigorous work. We have created that subcommittee, where work was being done on that therapeutic use, and we firmly believe in the therapeutic use of cannabis,” said Miñones, according to a translation. 

“In all this work, what was said is that the Spanish Medicines Agency would evaluate it with a rigorous report based on scientific evidence. In the last appearance in Congress we were awaiting that report. I promised that before the end of May we would have it and we already have it, but it is true that with the electoral period the Chamber is not working. At the moment that parliamentary activity returns, my first commitment is to transfer that report and continue taking steps.”

Excess caution or political reasons?

The reasons behind the delay to the AEMPS’ report have not been made clear. Miñones has previously put it down to what he describes as an ‘excess of caution’ on behalf of the regulator, while according to Romero, other sources suggest it might be related to the upcoming election and potential changes in governments. 

She says: “We understand that the reasons for this delay in the publication of AEMPS’ works can vary and may involve factors such as the complexity of the topic, the need for thorough scientific evaluation, potential concerns regarding safety and efficacy, internal review processes, and coordination among different departments within the Ministry of Health. Or, to be blunt, simply for political reasons.”

Last month, Miñones reiterated his commitment to presenting the AEMP’s regulatory framework before the end of May 2023. A promise that remains ‘unfulfilled’. 

“His emphasis on the importance of patient safety and treatment efficacy, suggested a political concern about presenting these regulations. As May came to an end (and now June as well), it is evident that the Minister’s promise remains unfulfilled,” Romero continues.

“Moreover, it appears increasingly unlikely that the promise will be fulfilled before the upcoming general elections scheduled for the end of July.”

Among suspicions that ‘internal factors’ are hindering the process, are concerns around what the legislation will actually look like, including potential restrictions on products and whether the framework will meet the ‘needs and expectations’ of patients.

“One thing is clear: delay is causing uncertainty,” she adds.

“Given the potential benefits of medical cannabis for certain patients and the economic prospects for the sector, a clear and open regulation should be published as soon as possible.” 

‘Playing with our hopes and health’

While some patients are able to access medicinal cannabis through social clubs and associations in the country’s larger cities, the majority of patients are buying online, off the street, growing their own or relying on friends and family to grow for them.

The proposed regulations would see the patients able to access cannabis-based medicines through specialist doctors and hospital pharmacies, for chronic pain, neuropathic pain, oncological pain, endometriosis, spasticity from multiple sclerosis (MS), some forms of epilepsy, and nausea and vomiting resulting from chemotherapy. However, it was hoped that this would be extended to include other conditions.

Carola Perez, a cannabis patient and president of non-profit organisation The Spanish Observatory for Medical Cannabis [Observatorio Español del Cannabis Medicinal](OECM), says patients are ‘devastated’ by how things have played out. 

 “We all feel devastated as we have had lots of promises that have not been fulfilled, says Perez.

“The minister said it’s [due to] a lack of time, but this is not true. We still have time. The real issue is that the government never wanted to regulate and they have played with our hopes and health.

“We are really disappointed, with a bittersweet taste you can imagine of finally ‘touching’ something after nine years of hard work, to then disappear with only silence and contradictory messages.”

Perez says she doesn’t trust the Health Minister when he says the government will continue working on the regulations following the election. 

“No, I don’t trust the ministry, because they have been lying and playing games with us for six months. We also don’t know if the document the AEMPS has done will be used in the next legislature,” she adds.

“Let’s see what happens during the election.”

Sector should ‘continue to strive’ for legalisation 

Alongside the potential to improve the quality of life of thousands of patients living with debilitating conditions, having clear regulations for the medical cannabis industry could generate significant benefits for the Spanish economy, Romero argues.

“Clear and published regulations could provide legal certainty, stimulating investment and growth in the medical cannabis sector, potentially fostering competition among pharmaceutical companies,” she says.

“This competition could drive innovation, leading to innovations in cannabis-based medications and therapies. Furthermore, this could also open a new source of revenue for the pharmacies allowed to dispense.”

However, Romero adds that despite the current lack of a regulatory framework, manufactures should continue to ‘strive for legalisation’. 

“Even though the recommendations from the AEMPS have not been published yet, it does not mean that the authorisation of medicines containing cannabis cannot be attempted as proved by the authorisation already granted to Sativex in Spain [Sativex was granted market authorisation for the treatment of MS in 2011],” she adds.

“But it is also true that patients are expecting a clear, open and permissive regulation of medical cannabis that Spanish medical authorities are not willing to grant, at least in the short term.”

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