Spanish regulators have taken another step towards introducing the country’s long-delayed medical cannabis framework, but patients say the legislation does not go far enough.
On Monday 30 September, the Ministry of Health published a draft royal decree for public hearing, setting out the proposed regulations for the prescription of cannabis-based medicines.
The legislation has been a long-time coming, with a snap general election and subsequent change of government in 2023, delaying the process for over a year.
The Health Committee of the Spanish Congress of Deputies first approved a subcommittee’s draft report in June 2022, setting out a list of recommendations for the regulation of cannabis-derived medicines for therapeutic use.
In January 2024, the newly-appointed Health Minister, Monica Garcia, reaffirmed her commitment to establishing a medical cannabis framework, with draft proposals put out for public consultation.
The latest framework appears to follow the Health Committee’s recommendations closely, allowing cannabis medicines to be prescribed in the form of ‘master formulas, made from extracts or standardised preparations’.
Only specialist doctors will be permitted to prescribe the treatment for a limited number of qualifying conditions. This includes: Spasticity in multiple sclerosis (MS), severe forms of refractory epilepsy, nausea and vomiting due to chemotherapy, and refractory chronic pain (persistent pain that is not relieved by standard treatments).
After issuing a prescription, doctors will be required to continually evaluate the effects of the treatment and the risk-benefit ratio, as well as reporting any adverse events.
The Spanish Agency for Medicines and Health Products (AEMPS) is expected to update the National Formulary with the publication of a corresponding monograph to which the standardised magistral formulas must comply. In line with the previous proposals, the legislation will exclude medical cannabis flower.
Restrictive regulations could be a ‘mistake’
After years of campaigning for access to safe and legal cannabis medicines, patients have been critical of how restrictive the proposed regulations are.
“They have made it so restrictive… I think this is a mistake,” Carola Pérez, president of the Spanish Observatory of Medicinal Cannabis [Observatorio Español del Cannabis Medicinal, OECM] which celebrates its 10th anniversary this month, tells Cannabis Health.
“We have fought for 10 years for this and with no other options it’s going to leave patients forced to rely on the illegal market again. There are lots of social clubs in tourist destinations like Barcelona, but there are not so many in the rest of Spain, so patients have to turn to the street or home-growing and risk being criminalised.”
Aside from the limited number of conditions which will be eligible, the requirements for chronic pain patients to have tried all standard treatments, including opioids, according to Pérez, could have a significant impact on patients’ quality of life.
The government’s stance is that more research is needed to determine the safety and efficacy of wider medical cannabis prescribing. Despite a growing global evidence-base for the use of cannabis in a variety of indications, Pérez says regulators won’t acknowledge that which has been conducted overseas.
Meanwhile, she thinks Spain’s domestic cannabis producers are unlikely to invest in clinical trials having established successful business models exporting their product to other countries.
“If I am super realistic, it is not going to happen,” she says.
GP prescribing and community pharmacies
Another point of contention is the fact that the preparations will only be dispensed through hospital pharmacies, rather than in the community, meaning patients may have to travel considerable distances to collect them.
“For some patients, their nearest hospital is up to an hour away by car, it’s not possible to make that journey on days where we can’t even get out of bed,” she adds.
Pérez and others have also advocated for GPs to be permitted to prescribe cannabis medicines, as they are more closely involved in the management of their conditions and overall health.
As it stands, waiting lists to see specialist doctors for conditions such as chronic pain can be up to two years long, meaning it could be some time before patients see the benefits of these therapies.
Campaigners continue to fight
Local media sources are reporting that the royal decree can still be amended and is now open to the submission of contributions.
The OECM is preparing to launch a campaign in response to the proposed legislation, but it remains unclear what impact it would have at this stage.
“We are going to fight for the right to have the flower, for the right to have access at our local pharmacies, to have private practices and for not only specialists to be able to prescribe, but also GPs, who are the ones who are by our side every week,” says Pérez.
“We don’t know if we can achieve some changes or not before the decree is finalised.”
The biggest mistake, Pérez adds, is that medical cannabis became a ‘political issue’, rather than one of public health.
“It’s not about politics,” she says. “It’s about health and quality of life.”
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