Spain’s long-awaited and hard-fought legislation to launch a medical cannabis market in the country has been slammed by pharmacists, patient advocacy groups and cannabis businesses.
The draft decree, which was published earlier this year, 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.
With the deadline for the second public consultation period on the proposals now passed, the industry has once again been left waiting to understand what shape Spain’s medical cannabis industry might take.
What happened?
Two weeks ago, the public comment period on the draft decree, which was published on September 30, came to a close.
As per the draft decree, Spain’s plan for medical cannabis use outlines four specific indications for its application: spasticity due to multiple sclerosis, severe refractory epilepsy, nausea and vomiting caused by chemotherapy, and chronic refractory pain.
Notably, the list of approved indications may be expanded or modified based on emerging scientific evidence, ensuring the plan remains adaptable to new developments.
The plan also establishes a register of standardized cannabis preparations, which will be used in specific circumstances. Standardized magistral formulas will only be employed when authorised medications (like Sativex) are unavailable or unsuitable for a patient’s needs. In such cases, doctors must thoroughly justify their decision, documenting the rationale in the patient’s medical history.
Additionally, patients will be informed about the available clinical evidence, expected benefits, and potential risks associated with medical cannabis use.
The plan imposes certain restrictions on the prescription and dispensing of medical cannabis. Only specialist doctors will be authorised to prescribe medical cannabis, excluding primary care physicians from this process. Furthermore, medical cannabis will only be dispensed in hospital pharmacies rather than community pharmacies.
It’s worth noting that Spain already has approved and marketed cannabis-based medicines, such as Sativex. Under the new plan, doctors will only be able to prescribe medical cannabis (in the form of magistral preparations) when these authorized medicines are ineffective or inapplicable, meaning flower currently will not be prescribed.
No flower
This development is significant, as Spain is one of Europe’s major medical cannabis production hubs, with an estimated output of 23.4 tonnes in 2023.
While the upcoming framework is expected to drive growth in Spain’s medical cannabis cultivation market, with production output for export projected to increase by 50% according to Prohibition Partners, the lack of inclusion of flower in the domestic market presents a huge missed opportunity for one of Europe’s most prolific growers.
Currently, the industry is relatively concentrated, with seven licensed companies for medical and scientific purposes.
Over a dozen companies also have research licenses, utilising a large proportion of Spain’s cultivated cannabis (4,365 kg in 2023) for research purposes
Currently, the few companies with a commercial cultivation licence, such as Linneo Health and Medalchemy, export large volumes of medical cannabis abroad.
Another company with a commercial cultivation licence is Canamedics, the only licenced grower in Spain’s most prolific cultivation region, Catalonia, which also currently exports large volumes of medical cannabis across Europe.
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In a recent LinkedIn Post, the company said of the restrictions around prescribing flower in the draft decree: “It is surprising that most of the medical cannabis produced under authorization in Spain is for the production of medical cannabis flower (not extract) for medical purposes that is prescribed to patients in many other countries around us.”
They continued: “The draft says that a standardised cannabis preparation can only be one or more standardised extracts previously registered by the Aemps. The definition of a standardized cannabis preparation seems very restrictive to us if we analyze the reality and quality of the evidence.
“We must continue to fight for a regulated market where patients have real access to the treatment that works for them.”
No dispensing in local pharmacies
Furthermore, the dispensing of these preparations is expected to be limited to hospital pharmacies rather than Spain’s 22,000 local pharmacies. This was one of the key concerns raised by activists when the recommendations were initially discussed in 2022.
The Ministry of Health has justified this decision, claiming that it takes into account the conclusions of the Subcommittee which analysed the regulation of medical cannabis back at the beggining of the process, despite the final opinion of the recommendations in 2022 requesting their inclusion.
It also argues that the given conditions for which medical cannabis will be prescribed require monitoring, which is carried out in a hospital setting.
A chorus of discontent has now erupted from Spanish pharmacists over the government’s omission.
The General Council of Pharmaceutical Colleges has expressed regret that the Ministry of Health has not considered the potential of community pharmacies in dispensing standardised cannabis preparations.
“We believe that there are no health, safety or legal reasons that justify limiting the dispensing of standardized cannabis preparations to hospital pharmacy services,” a spokesperson told Público.
This sentiment is echoed by the Council of Pharmaceutical Colleges of Catalonia, which has also spoken out against the exclusion of community pharmacies from dispensing cannabis prescriptions.
The Spanish Society of Primary Care Pharmacists (SEFAP) has been particularly vocal in its objection, highlighting the absurdity of patients having to travel long distances to hospitals to access their medication.
“It is absurd… It seems that we are going backwards with cannabis, when pharmacies have already been dealing with narcotics on a daily basis for a long time. It is too timid,” said José Manuel Paredero, President of SEFAP.
The Spanish Observatory of Medicinal Cannabis (OECM) has also weighed in, lamenting that patients’ needs have not been taken into account in the regulation. “Just as those of us who need it now pick up fentanyl at the pharmacy next to our house, we could pick up cannabis oil… Patients have the right to the best possible quality of life. We may not be curable, but we can be cared for,” said Carola Pérez, President of OECM.
Other organizations, including the Spanish Society for Individualized Medication (LASEMI) and the Independent Professional Association of Pharmacists Formulators (APROFARM), have also joined the chorus of discontent.
LASEMI’s President, Concepción Chamorro, emphasized the benefits of accessibility and cost savings, saying: “Pharmacies improve access for all patients who need it… The community pharmacy is a guarantee of the preparation, custody and dispensing of individualized medicines derived from cannabis.”
What next?
Following the comment period, the Ministry of Health will analyse the feedback received and potentially revise the draft Royal Decree, a process expected to take around 2-4 weeks, depending on the volume of comments and the extent of the revisions.
Potential Timeline:
- Analysis and Revision (2-4 weeks): October 22, 2024 – November 18, 2024 (expected)
- Interministerial Consultation (1-2 weeks): November 19, 2024 – December 2, 2024 (if necessary)
- Approval by the Council of Ministers (1-2 weeks): December 3, 2024 – December 16, 2024
- Publication in the Official State Gazette (BOE): December 17, 2024 – January 7, 2025 (estimated)
- Entry into Force: Estimated January or February 2025, depending on the publication date and any potential transitional periods.
While the Ministry of Health had promised to roll out the medical cannabis framework this year, considering the extensive delays to the process to date, patients could still be waiting months before meaningful progress is made.
