The level of “available evidence” is “insufficient to recommend its generalized (medicinal) use,” the reply says.
The Spanish situation is not unusual in international medical cannabis markets, where governments are keen to capitalize on exports without allowing for the development of a domestic medical marijuana industry.
However, experts say such a model could prove to be unsustainable for businesses due to the uncertain nature of the medical cannabis export market.
The document also clarifies that the decision to create a medical cannabis program in Spain will be analyzed using “a criteria as close as possible to the criteria that applies to the authorization of medicines.”
“The efficacy and safety evidence is mainly obtained through controlled clinical trials,” the reply adds.
The Spanish government’s position is that “the therapeutic use of cannabis” must comply with the same rules that apply to other medicines, for which “quality, efficacy and safety” must be proven through “controlled clinical trials.”
The reply also lists the cannabis-derived or cannabis-related medicines currently authorized for sale in Spain: GW Pharmaceuticals’ Sativex and Epidiolex, as well as exceptional use of nabilone or dronabinol.
Despite the government reply citing a lack of evidence as the reason why Spain does not have a medical cannabis program, as of Sept. 17, the Spanish Agency of Medicines and Medical Devices (AEMPS) website showed the following companies were authorized to produce cannabis for medical and scientific purposes:
- Cáñamo y Fibras Naturales
- Linneo Health
- Medical Plants
In addition, AEMPS website listed eight other licenses for scientific purposes.
Linneo Health flower is currently available – under different brands – in Germany as well as in Israel.
Carola Perez, president of the Spanish Medicinal Cannabis Observatory, wants the Spanish government to allow sales to local patients.
“While our government blocks domestic patients in need (of) access to medical cannabis arguing there’s lack of evidence, it grants production licenses and allows exports,” Perez told told Marijuana Business Daily.
“Patients in Spain see how Spanish-grown cannabis helps patients in other countries improve their quality of life, but they can only dream of one day having access to that same product here.”