SOMAÍ Pharmaceuticals is a leading EU-GMP vertically integrated Multi-Country Operator (MCO) company with a global footprint of distribution for the largest and most advanced EU GMP-certified cannabinoid-containing pharmaceutical extract portfolio.
Michael Sassano brought his expertise in product development from the US market with him. As the medical cannabis explosion continues in Europe and around the globe, Spain has finally approved medical cannabis access for its population. See below Michael Sassano’s article about recent Spain’s medical cannabis development.
Article starts here:
As I pointed out in my last article, Spain has been a strange experiment in cannabis access. The country allowed social clubs to purchase unregulated market products to sell to its members, but medical patients had no access to quality pharmaceuticals. As Spain turns the corner to more improvements in its cannabis market, medical patients can hail this first step as a big win.
A good start for Spanish therapeutic cannabis
After three years of political delays, Spain has taken a big step toward starting what it promised in terms of equitable access to quality medical cannabis. There is much to be happy about in the regulations — and many further improvements to hope for.
Indications included in Spanish medical cannabis access
Access to medical cannabis typically comes slowly; we have seen other countries taking it step by step, too. Eventually, the countries that start with limited usage for only serious conditions like epilepsy, multiple sclerosis, and stage three cancer therapy add more indications. Spain has accepted all three aforementioned serious indications and added refractory chronic pain, opening access to cannabis therapy for a larger swath.
Although this limited access is not enough in the long term — even the United States Department of Health and Human Services (HHS) report includes 15 indications — it is an excellent start to resolving this long, drawn-out political football game.
Spanish medical cannabis regulations
The Spanish Agency of Medicines and Medical Products (AEMPS) will regulate cannabis products and provide guidance.
Medical cannabis formulations in Spain
To begin, Spain will follow the example of Germany, Poland, and many other EU countries and offer magistral extracts. Although magistral formats are now fairly common for cannabis, they are of a lesser quality standard than EU-GMP finished dosage forms. Like in other countries, dosage forms are expected to resemble finished dosage form products closely. The AEMPS will most likely allow oral solutions, inhalation products, and other oral applications.
Since the subcommittee to discuss medical cannabis in Spain began in May 2021, it has been like watching the endless back-and-forth sports match as strict political ministers tried to claim that cannabis has no medical applications and logic-driven advocates swatted those falsehoods away with facts. In the end, Spain codified strict medical rules backed by scientific reasoning.
Still, the exclusion of so many indications — including Crohn’s Disease and mental indications like stress, anxiety, and insomnia — leaves hope for increased access with future debate.
The rules surrounding medical cannabis access in Spain are also a nod to compound pharmacists, giving them specific control over the dispensing and manufacturing of these products. As time will show, however, there is little need for true compound pharmacists in today’s world, as this model generally disadvantages patients with higher-priced products that are available at much lower prices in finished dosage forms. Countries like Australia have demonstrated this, cracking down on compounding pharmacies since October 1. We can — hopefully — look toward this example for the future of medical cannabis access in Spain and other magisterial markets.
The future of medical cannabis in Spain and beyond
Any access to medical cannabis is an excellent place to start. As time passes, all countries with medical access in the EU and beyond are moving away from the hard stance of limited medical access and drifting toward increased accessibility and affordability.
Spain, although slow, will inevitably follow the same path and move toward lighter, more accessible medical regulations for access. After all, cannabis is a far safer alternative to other medications, as per HHS. With enough data, Spanish authorities will come to the same conclusion, though it might be a while from now.
In any case, let’s all hail this as a win and hope that more people can reach the quality products they need. With new regulations, social clubs will have their crowd, and medical patients will have their access. The two models will mix when authorities come to understand how beneficial regulated access to cannabis is.