The report on medical cannabis approved by Congress includes a proposal to expand the therapeutic use of cannabis to relieve cancer pain and symptoms of endometriosis, among other health problems, always under prescription made “exclusively by health professionals” and so that be dispensed “preferably” in hospital pharmacies, as stated in the final document of the Proposal for Conclusions and Recommendations that the subcommittee has just voted on and that has received the approval of PSOE, United We Can, Citizens, PNV and PDeCAT, with the abstention of ERC and EH Bildu and the rejection of PP and Vox.
Specifically, the report indicates that the pathologies in which the use of medicinal cannabis would be indicated are: “spasticity in patients with multiple sclerosis, some forms of epilepsy, nausea and vomiting derived from chemotherapy, endometriosis, cancer pain and pain non-oncological chronic pain (including neuropathic pain), and may be extended to other therapeutic indications when the studies provide consistent indications”. These treatments must have a determined and controllable duration.
Although initially the PSOE intended to restrict the medicinal use of cannabis to the two drugs already available in Spain – Sativex, to treat muscle spasticity caused by multiple sclerosis, and Epidiolex, indicated for seizures associated with two serious and rare types of epilepsy –, to standardized preparations and master formulas, after negotiations it has accepted the inclusion of proposals from other groups that extend its therapeutic use to other conditions.
The use of medicinal cannabis would be indicated in “spasticity in patients with multiple sclerosis, some forms of epilepsy, nausea and vomiting derived from chemotherapy, endometriosis, cancer pain and chronic non-cancer pain”
This proposal must be voted on next week -probably on the 27th- in the Health Commission, and later, “within 6 months”, the Spanish Agency for Medicines and Health Products (AEMPS) will carry out the necessary steps to that these councils “fit into the regulations and are viable, allowing the availability of standardized cannabis extracts or preparations in the pharmaceutical market.”
Recommendations on the use of medical cannabis
The approved document classifies the recommendations into five points:
- Guarantee the availability of cannabis-derived medicines for therapeutic use.
- Preserve and reinforce “the central role of the AEMPS as a pillar in the regulation of medicines and a key player in the regulation of cannabis-derived preparations”.
- Strengthen the role of key health actors in the therapeutic use of cannabis.
- “It must be avoided” that the availability of cannabis for therapeutic uses “may lead to greater availability and consumption” outside the health field.
- Periodically evaluate the therapeutic use of cannabis and the consumption data in the population.
The report also points to the possibility of medical cannabis being dispensed in community pharmacies: “The dispensing of master formulas with standardized cannabis extracts or preparations must be carried out from the health system’s network of pharmacies, preferably in hospital pharmacies and exploring the alternative of community pharmacies that may qualify”.
The president of the Spanish Observatory of Medicinal Cannabis (OECM), Carola Pérez, affirms that this is “a first giant step”. From this body they celebrate the agreement reached and recall that this project was launched in 2015 and that “it has been an honor to fight for the rights of at least half a million patients who use medical cannabis”.
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