Skip to content
Article

What is Spain’s New Medical Cannabis Regulatory Framework?

Aug. 02, 2024 by SOMAÍ Pharmaceuticals

Ultimately, patients deserve access to safer alternatives to current over-prescribed pharmaceutical medicines.


Spain has become the latest large European country to announce its long-awaited medical cannabis access plans. Although this is just the first step toward parliamentary procedures, it marks definitive progress for Spain. 

The proposal does not mention flower sales, seemingly favoring extract producers. The emphasis on non-flower cannabis products is not surprising, given the debate over the last few years and the proliferation of cannabis social clubs.

A Brief History of Spain’s Path to Medical Cannabis

Spanish politicians and the Health Ministry have promised cannabis regulatory reform for years. 

In June of 2022, the Spanish Congress of Deputies passed medical cannabis reform based on a report by a special health commission. By the end of 2022, regulatory bodies announced the bill would come in early 2023 and that “nobody will get all they wanted.” 

At the end of March 2023, the sentiment seemed to shift as then-Spanish Minister of Health José Miñones announced the information available on medical cannabis “is insufficient and we cannot recommend its use.” 

At the start of 2024, the outlook of the Spanish cannabis industry changed again when the current Minister of Health, Mónica García, announced they would bring reform “in line with global standards.” 

The most recent Spanish Health Ministry announcement discusses following the example of  Portugal, the United Kingdom, and Norway. The announcement also highlights policies in line with regulatory frameworks established by the World Health Organization (WHO) and the United Nations (UN). The omission of references to Germany and its legalization framework seems to be a major snub to the German cannabis industry.

The Spanish Health Ministry’s Medical Cannabis Proposal

The Health Ministry has proposed updating medicinal cannabis laws in line with those of surrounding countries. This update to allow legal medical cannabis is long overdue, as the country is already home to many cannabis social clubs. These clubs sell adult-use cannabis to their members and operate in a so-called legal grey area. 

Many of the existing proposals were previously approved by the Subcommittee of the Congress of Deputies, which interviewed and solicited opinions from the Spanish Agency of Medicines and Health Products in conjunction with the Government Delegation for the National Plan on Drugs. 

Contributors to the Proposal for Spanish Medical Cannabis

The Ministry of Health called for public opinion on its website and consulted with various advocacy groups and physician societies:

  • European Observatory of Cannabis
  • Spanish Observatory of Cannabis
  • General Council of Official Colleges of Pharmacists
  • Spanish Society of Palliative Care
  • Spanish Society of Pain
  • Spanish Society of Epilepsy
  • Spanish Society of Alcohol Studies
  • Spanish Society of Hospital Pharmacy
  • Spanish Society of Pharmacists of Primary Care
  • Spanish Society of Primary Care Physicians
  • Spanish Society of Family and Community Medicine
  • Spanish Society of General and Family Physicians
  • Spanish Multidisciplinary Society of Pain
  • Spanish Society of Neurology
  • Spanish Society of Pulmonology and Thoracic Surgery
  • Spanish Society of Medical Oncology
  • Spanish Society of Dual Pathology
  • SED-ESOM Working Group
  • Spanish Society of Psychiatry and Mental Health
  • Spanish Society of Rheumatology

This announcement by the Ministry of Health made it clear that Spain is taking advice from all the most relevant voices that could lend rules and credibility to the proposition.

Looking Toward the Future of Medical Cannabis in Spain

The proposed regulations are designed to be fluid and allow evolving access to medical cannabis as the industry matures. 

A Shift Toward Pharmaceutical Preparations of Cannabis

Magistral preparations and extracts appear to be the only path for physicians and patients; flower sales are not mentioned. 

The shifting focus away from flower conforms to most new medical recommendations and is likely a similar path to France and Morocco. Doctors in countries with emerging markets are becoming less comfortable prescribing flower and feel more at ease with traditional pharmaceutical delivery methods like oral drops and capsules.

Scientists Warn Some Prescriptions Don't Mix Well with Cannabis
Photo by Karolina Grabowska from Pexels

Accordingly, social clubs seem to be the preferred venue for flower products. 

Pharmacy model advocates seem to be a driving force behind the magistral preparation format for cannabis extracts. Medical societies are advocating for trials in their respective specialties, too. 

Optimism for Spain’s Nascent Medical Cannabis Market

Although Spanish lawmakers have gone back and forth about medical cannabis, and regulatory predictions are — inevitably — unpredictable, the gravitas of the Spanish Health Authorities announcement makes it clear they have thought this out and sought input from all the most relevant organizations. 

This announcement is a significant step forward for a large EU country that has shown potential as a major market for years. Ultimately, patients deserve access to safer alternatives to current over-prescribed pharmaceutical medicines. This patient access effort appears to have the legs to make it through in Spain!

This article by Michael Sassano was originally published in Legal Reader: https://www.legalreader.com/what-is-spains-new-medical-cannabis-regulatory-framework/