Light at the end of the tunnel? The regulation of medical cannabis in Spain could be a reality this summer

The regulation of medical cannabis in Spain could become a reality in less than five months if the deadlines are met and the European Union gives the green light to the Government’s Royal Decree that will regulate its medicinal use. The road to this point has been fraught with political debates, technical reports, and strong social demand from patients and healthcare professionals. What stage has been reached in the process? What milestones have already been achieved? And, most importantly, what lies ahead on the regulatory roadmap?

How we got here

The route to the regulation of medical cannabis in Spain kicked off in June 2022, when the Health and Consumer Affairs Committee of the Spanish Congress of Deputies approved a report with recommendations to regulate its therapeutic use, following a five-month consultation period with 23 national and international experts. This laid the foundations for the implementation of a regulated model that would guarantee patient access to prescription cannabis-based treatments.

The report was drawn up after years of pressure from patient and health professional associations, who demanded a clear legal framework for the use of cannabis for medical purposes. Until then, Spanish patients who wanted access to these treatments had to resort to imported products, homemade alternatives, or the black market, without any guarantees of quality or safety.

Subsequently, the Spanish Agency of Medicines and Medical Devices (AEMPS) spent 6 months working on a draft regulation, considering aspects such as distribution in hospital pharmacies and the need to follow strict quality and control criteria. However, the process was delayed due to changes in government, lack of consensus on key aspects of the legislation, and the need to adapt it to the European drug guidelines.

It was not until October 2024 (more than two years later than initially planned) that the Ministry of Health completed the drafting of the Royal Decree which would establish the definitive framework for the regulation of medical cannabis in Spain. The regulations state that access to these treatments will be limited to certain patients with very specific pathologies – a very short list of diseases including spasticity caused by multiple sclerosis, refractory epilepsy, chronic refractory pain, and the side effects of chemotherapy. In addition, products will be distributed exclusively in hospital pharmacies “to ensure their correct tracking and avoid their diversion to the recreational market”.

The European Union, the last hurdle before final approval

Once the Royal Decree draft was completed, it was sent to the European Commission at the end of January 2025 for review and validation. It is the EU that must confirm that the Spanish legislation is aligned with EU regulations, avoiding conflicts with previous legislation on drugs and pharmaceutical products.

This review process by Brussels can take up to six months, although in most cases objections are usually resolved within three months. European regulations stipulate that medical cannabis must comply with strict safety, quality, and efficiency controls, so the European Commission will analyse whether the Spanish model guarantees these requirements.

If the European Commission doesn’t raise any substantive objections, the government could definitively approve the Royal Decree before the summer, allowing the regulation to come into force progressively. However, if Brussels proposes changes, the process could be delayed and require further negotiations before its final approval.

Next steps and possible complications

If the European Union gives the green light to the text without any significant changes (the Spanish proposal is more conservative than those already in place for other countries), the Council of Ministers could approve the Royal Decree between April and June 2025. From that moment, the gradual implementation of the new regulatory framework will begin, with the publication of the decree in the Official State Gazette (Boletín Oficial del Estado – BOE), which will mark the beginning of its effective implementation.

Hospital pharmacies will have to adapt their facilities and protocols for the distribution of medical cannabis, which could take several more weeks. Furthermore, specific training programmes for health professionals will be developed, ensuring that doctors and pharmacists are adequately trained to prescribe and dispense these products. In parallel, monitoring systems will also be established to assess the efficacy and safety of treatments, collecting data on their impact on patients.

Nevertheless, the process could be distorted if political or technical complications arise. At national level, a change of government could affect the initiation of the regulation, delaying its implementation or modifying key aspects. In the European context, the Commission could impose additional conditions which would slow down the adoption of the text.

In addition, the debate on whether medical cannabis should also be available in community pharmacies could generate further discussions and possible regulatory changes. The key will lie in the ability of the Spanish government to efficiently coordinate the implementation of legislation and avoid administrative or political blockages.

A limited project that has been widely criticised

If everything goes as planned, and almost four years after the process was launched, the regulation could be fully operational by the end of 2025, providing patients with access to safe and controlled cannabis-based treatments.

Spain will then join a group of European and world countries that already allow the therapeutic use of marijuana. Nonetheless, this will be a programme with multiple shortcomings, since the Royal Decree drafted by the Ministry of Health excludes the use of cannabis flowers (and, by extension, self-cultivation) and limits its uses to some magistral preparations (cannabis oils) and two drugs that have been around for years.

Cannabis Social Clubs wouldn’t be part of the system either, although they’ve been responsible for providing flowers and oils for therapeutic use for decades. For this reason, the Royal Decree has received strong criticism from patients, activists, and the scientific community, with many of them claiming that the main beneficiary of the Ministry of Health’s project will be the powerful pharmaceutical industry lobby, and that the government is not setting this regulation in motion for the people but rather for the market.

One of the main criticisms is that the regulations are overly restrictive, limiting access to only a small group of patients with very specific diseases, and leaving out many people who could benefit from medical cannabis, including those suffering from chronic pain not included in the initial list of pathologies.

In addition, the prescription of medical cannabis will be the last resort, once conventional methods and cannabis-based drugs already on the market have proven to be useless for those pathologies “for which there is scientific evidence of the therapeutic benefit of cannabis and its extracts”, according to the Royal Decree. Additionally, it is the patient’s doctor that must explicitly justify its use.

Another point that hasn’t been well received is the fact that only specialist doctors (and not those in primary care) will be allowed to prescribe medical cannabis, in the same way that only hospital pharmacies (and not neighbourhood pharmacies) will be allowed to dispense it. This has been perceived as an additional barrier for patients, who may have difficulties in accessing their treatment, especially in rural areas or in regions far from large hospitals.

Researchers and experts in the field have also been heavily critical of the fact that the regulation doesn’t sufficiently encourage research on medical cannabis in Spain. Many scientists believe that the country could play a key role in the development of studies on the therapeutic effects of cannabis, but current regulations don’t provide clear incentives to boost the research and development of new treatments.

All in all, although the Royal Decree is already in Brussels and patients are finally beginning to see the light at the end of the tunnel after almost five years, many still consider it insufficient and hope that changes will be made in the future to broaden access and encourage research. The legal recognition of cannabis for medical purposes is a significant step forward in Spain, but it remains to be seen whether a more flexible regulation adapted to the true reality of patients will be achieved in the coming years.