The European Medicines Agency (EMA) is looking for scientific research to help it establish guidance on the medicinal use of cannabis flower.
The EMA’s Committee on Herbal Medicinal Products (HMPC) is inviting industry, healthcare professionals, patients and government institutions from EU member states, to submit scientific data on the medicinal use of cannabis flower.
The EMA is responsible for regulating and monitoring pharmaceutical medicines in the EU and European Economic Area (EEA).
In a request for submissions, published on 25 January, the regulator said the research would be used to help the HMPC ‘evaluate the medicinal use’ of the plant and create herbal monographs for use by members of the EU.
It states: “The HMPC invites all interested parties such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit selected specific scientific data, which may be used in the assessment of Cannabis sativa L., flos as part of the establishment of European Union herbal monographs and/or European Union list entries.”
EU monographs provide information required for the use of a medicinal product containing a specific herbal substance or preparation, including what the product is used for and safety information such as side-effects and interactions with other medicines.
The committee is only looking for papers related to whole-plant cannabis and ‘herbal preparations’, not including isolates or any other cannabis-derived products.
An important step forward for patients
The call for research has been described as a ‘huge step’ by patient advocates, and a sign that regulators are finally recognising the medicinal value of cannabis flower.
Carola Pérez, president of non-profit organisation The Spanish Observatory for Medical Cannabis [Observatorio Español del Cannabis Medicinal] (OECM) and chair of the International Association of Cannabinoid Medicines (IACM) Patient Council told Cannabis Health that the move could have important ramifications for patients across Europe.
“I think this is a huge step,” said Ms Pérez.
“The fact that the EMA is making this move is going to be very important for patients, because [hopefully it will mean] flower is going to be considered as having a part to play in the medicinal potential of cannabis.”
Spanish officials voted to legalise medical cannabis for a limited number of conditions in June 2022, but draft proposals made no mention of whether this would include cannabis flower or just oils. Ms Pérez who highlighted that many patients rely on the fast-acting effects of vaporised flower for symptoms such as chronic pain.
“As patients we don’t just need access to oils, we need access to flower to be able to vaporise, especially for those living with conditions such as chronic pain,” said Ms Pérez, who is hopeful that the establishment of guidance from the EMA could have implications for regulations related to cannabis flower in EU countries.
“Under the proposals for medical cannabis in Spain, we have been told that flower is not going to be recognised [as having medicinal properties] so this move by the EMA is a very good next step for us.”
Industry must ‘work together’ to bring forward evidence
Ms Pérez has also called on the cannabis sector to ‘work together’ to provide the data needed to make a strong case for the medicinal benefits of cannabis flower.
While patient organisations may be able to provide ‘anecdotal evidence’, she believes medicinal cannabis companies which have already begun to gather clinical research, will be key in making the case.
“I don’t know who the most important players are going to be here,” Ms Pérez continued.
“But I think it will come down to the companies which have been working with cannabis flower and have access to the data which the EMA has requested.”
She added: “It is important that the cannabis industry works together in trying to bring forward all the available evidence.”
Where to submit research
Research can be submitted to the HMPC until 14 May and contributions can be sent by email to: [email protected]
Peer-reviewed scientific papers are preferred but the committee says it will consider non-peer-reviewed data provided it is of an ‘adequate quality’.
Find out more about the requirements and how to submit research here
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