Spain has several medical cannabis licensed producers, and at least one already exports flower to countries such as Germany.
But these products remain unavailable to Spanish patients, and a recent government reply to a member of parliament indicates the situation will not change for the time being.
In a reply to a question by Josune Gorospe, a member of the Congress of Deputies of Spain, the government erased any near-term hope that domestic patients can expect the country to launch a medical cannabis program.
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 because of 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 proved through “controlled clinical trials.”
The reply also lists the cannabis-derived or -related medicines currently authorized for sale in Spain: GW Pharmaceuticals’ Sativex and Epidiolex, as well as the 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.
- Medalchemy.
- Medical Plants.
- Oils4cure.
In addition, the 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 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.”
Alfredo Pascual can be reached at alfredop@mjbizdaily.com
