The European Medicines Agency (EMA) requests scientific data to help establish the medicinal use of cannabis flower
The European Medicines Agency (EMA) is looking for scientific data to help it establish guidelines on the medical use of cannabis flower. The EMA's Herbal Medicinal Products Committee (HMPC) invites industry, healthcare professionals, patients and government institutions in EU Member States to submit scientific data on the medical use of cannabis flower.
The EMA is responsible for regulating and monitoring pharmaceutical medicines in the EU and the European Economic Area (EEA).
In a bid solicitation, published on January 25, the regulator said the research would be used to help the HMPC "evaluate the medicinal use" of the plant and create plant monographs for use by EU members.
The document states: "The HMPC invites all interested parties such as pharmaceutical industry associations, health professional groups, learned societies, consumer and patient associations, government institutions as well as EU and EEA-EFTA Member States to submit selected specific scientific data which could be used in the evaluation of Cannabis sativa L., flos in connection with the establishment of European Union herbal monographs and/or European Union list entries. »
EU monographs provide the information necessary for the use of a medicinal product containing a specific herbal substance or herbal preparation, including the use of the product and safety information such as side effects and interactions with other other medications.
The committee is only looking for documents relating to whole plant cannabis and “herbal preparations”, excluding isolates or any other cannabis-derived product.
An important step forward for patients
The call for research has been described as a "big step forward" by patient advocates, and a sign that regulators are finally recognizing the medicinal value of cannabis flower.
Carola Pérez, president of the non-profit organization The Spanish Observatory for Medical Cannabis Observatorio Español del Cannabis Medicinal and chair of the International Association of Cannabinoid Medicines (IACM) patient council told Cannabis Health that this decision could have important ramifications for patients across Europe.
"I think it's a huge step," Ms. Pérez said.
“The fact that the EMA makes this decision is going to be very important for patients, because [hopefully this means] the flower is going to be seen as having a role to play in the medicinal potential of cannabis. »
Spanish officials voted to legalize medical cannabis for a limited number of conditions in June 2022, but the draft proposals did not mention whether that would include cannabis flower or just oils. Ms. Pérez who pointed out that many patients rely on the fast-acting effects of the flower spray for symptoms such as chronic pain.
"As patients, we don't just need access to the oils, we need access to the flower to be able to vaporize it, especially for those living with conditions such as chronic pain" , said Ms Pérez, who hopes that the establishment of guidelines by the EMA could have implications for regulations related to cannabis flower in EU countries.
“As part of the proposals for medical cannabis in Spain, we have been told that the flower will not be recognized [as having medicinal properties], so this move by the EMA is a very good next step for us. »
Industry must “work together” to provide evidence
Ms. Pérez also called on the cannabis industry to “work together” to provide the data needed to make a strong case for the medicinal benefits of cannabis flower.
If patient organizations are able to provide "anecdotal evidence", she thinks medicinal cannabis companies that have already begun to gather clinical research will be instrumental in making their case.
"I don't know who the most important players will be," continues Ms. Pérez.
“But I think it will come down to companies that have worked with cannabis flower and have access to the data that the EMA has requested. »
She added: “It is important that the cannabis industry works together to try to present all the evidence available. »
