For a natural medicine or herbal preparation to be granted the status of «traditional herbal medicinal product» by the European Parliament and to be introduced into the official health systems of the entire European Union (EU), only 30 years of traditional use (15 of them within the EU) must be demonstrated.
Ayahuasca meets these criteria as its medicinal use has been documented for hundreds of years and its use in the European Union since 1987 when the first ayahuasca was taken in Madrid (Spain) and the first clinical trials in 2001 in Barcelona by Dr. Jordi Riba.
This regulatory path published in the «Journal of the European Union» is DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of March 31, 2004.
amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Today I received it from Jose Carlos Bouso, the scientific director of ICEERS, a non-profit organization that legally and politically defends ayahuasca and studies it at a scientific and ancestral level and that would be according to my point of view the most appropriate organization to design and present this proposal to the European Parliament for approval.
It is a route that does not require clinical trials as it is a natural medicine and can be used for plants and plant preparations that are safe at the physiological level as ayahuasca, which has already demonstrated its lack of toxicity, cardiac and hepatic safety, absence of addictive potential and therapeutic use demonstrated with evidence and millions of testimonials throughout Europe and the world. Therefore, this route should be studied as the fastest and most economical.
It can also be used for psilocybe mushrooms, san pedro cactus and peyote.
Ayahuasca is not illegal in Spain, Portugal, Ireland, Austria, Luxembourg and many other countries of the European Union but this would imply an even more structured regulation and would make it at the level of the entire European Community and would also integrate its use in the official public systems. If we try to do it by the Spanish way, we would have to rely also on article 51 of the Royal Legislative Decree 1/2015, of July 24: https://www.boe.es/buscar/act.php?id=BOE-A-2015-8343
I attach here the link so you can read it translated into Spanish:
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