Spain publishes its regulatory framework for medical cannabis, without cannabis flowers

The Spanish Ministry of Health has launched a public consultation on its proposed framework for medical cannabis in the country.

Organizations and citizens now have until March 4 to submit their comments on the proposals, while the new Spanish government keeps its promise to move long-delayed deployment.

While stakeholders and patients have welcomed the opportunity to participate in the development of the sector, many have expressed frustration at the limited scope of products available and indications to be covered.

In particular, under the current iteration, medical cannabis flowers will be totally absent from the medical cannabis framework in Spain, a similar to that of France.

What happened?

Last week (February 14), the Spanish Ministry of Health announced through a press release that he had «begun the process of drafting a royal decree» with which he planned to approve the regulation of medical cannabis.

This draft Royal Decree has now been made public, and the government has called on all interested parties to comment on the proposals.

It would appear that a meeting took place last Tuesday between the Ministry of Health and a large number of representatives of the Spanish patient community, during which the proposals were explained and «all these organizations approved the regulations».

Meetings between the Ministry of Health and the various patient organizations will continue throughout the consultation period, which will allow organizations and individuals to submit their contributions until March 4.

Contributions can be sent to the following address: [email protected]

This consultation comes a few weeks after Business of Cannabis reported that Spain's new Health Minister, Mónica García Gómez, used her first appearance in Congress to reaffirm her commitment to establishing a framework for medical cannabis in the country, more than a year after the date originally scheduled for its implementation.

The draft royal decree on medical cannabis

In June 2022, after more than a year of research, a sub-committee tasked with studying medical cannabis frameworks deployed around the world presented its proposals on how a similar framework could be implemented in Spain.

In her January speech to Congress, Ms. García made it clear that these proposals would play a key role in the legislation drafted by her department.

The draft decree seems to be following these recommendations closely, proposing what appears to be a relatively prudent framework.

According to the text, the sub-committee's report recommends that the Spanish Agency for Medicines and Health Products (AEMPS) provide better access to medicines and health products. cannabis-based medicines for patients «in the form of master formulas, from extracts or standardized preparations».

«In this sense, and in line with the sub-commission's recommendations, the use of standardized preparations is the procedure that offers the most guarantees in terms of dosage, correct processing and stability.

«To this end, it is planned to draw up monographs that establish, among other things, methods of preparation and control of master formulas, technical specifications and conditions of labeling or storage, quality control and information provided to the healthcare professional and the patient.»

In short, it is understood that only cannabis oils will be authorized, and that they will then be used to make «magistral preparations».

These must be authorized by medical specialists from the Spanish National Health System (SNS), which means that it is unlikely that private industry will be allowed to operate.

In addition, dispensing of these preparations should be restricted to hospital pharmacies rather than Spain's 22,000 local pharmacies. This was one of the main concerns raised by campaigners when the recommendations were first discussed 18 months ago.

Crucially, cannabis flowers are absent, despite their availability being one of the main demands of the Spanish patient community.

In a message posted on social networks, the IACM Patient Council said that the absence of flowers was «far from ideal for patients who find the oil less effective», suggesting that these patients may have no choice but to turn to the illicit market.

Although no concrete details have been given on the indications for which medical cannabis will be prescribed, it is understood that the decree will aim to approve prescriptions only for conditions for which there is the most evidence of its efficacy.

These include chemotherapy-induced nausea and vomiting, refractory pain, rare forms of epilepsy, multiple sclerosis and endometriosis.

However, the draft clearly states that «the regulations are designed to evolve dynamically, allowing new elements to be incorporated as new information and experience from the medical cannabis program becomes available».