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Álvaro Soto
Madrid
Wednesday, 2 October 2024, 07:12
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After three years of delays, Spain's Ministry of Health published on Monday 30 September the draft royal decree to allow the prescription of cannabis preparations, a text that will now be submitted for hearing and information before its final approval.
The draft establishes broad restrictions on the medical use of cannabis and specifies very specifically the pathologies for which it can be used: multiple sclerosis (stiffness and muscle spasms associated with the condition); severe forms of refractory epilepsy (certain types of epilepsy that do not respond to conventional treatments); nausea and vomiting caused by chemotherapy; and refractory chronic pain (persistent pain that is not relieved by the usual treatments). In all these cases, experts believe that there is "scientific evidence" of the benefits of medical cannabis.
Meanwhile, the preparation and dispensing of cannabis compounds (basically, oils, inhalants or oral drugs) will be the sole responsibility of hospital pharmacies and specialist doctors, who must justify the treatment in the user's medical record and who will inform the patient "about the available clinical evidence, the expected benefits and the possible risks".
The prescription will be given "when there are no authorised medicines or when they do not meet the patient's needs," the document stresses. In addition, the compounds must be included in the new register of standardised cannabis preparations, which will be managed by the Spanish agency of medicines and health products (AEMPS). "Scientific evidence has shown a variable degree of benefit of cannabis and its extracts in some therapeutic indications," says the draft, which stresses that these formulas "can constitute a personalised alternative when conventional treatments fail".
A subcommittee was created to look into the medical use of cannabis in May 2021, when the benefits and risks of the proposal began to be analysed. On 28 June 2022 the subcommittee gave the health ministry six months to draw up a report specifying the medicinal uses of cannabis. However, socialist ministers Carolina Darias and José Miñones ignored the request, despite the fact that it had the support of PSOE, Podemos, Ciudadanos, PNV and PDeCAT and the abstention of ERC and Bildu, for whom the initiative fell short. When she took office as health minister in November 2023, Mónica García pledged to push ahead with the project.
For patients, the regulation is "too restrictive". Carola Pérez, president of the Spanish medical cannabis observatory, regrets that they have been excluded during the process of drafting the law and considers that, with the current wording, "very few people" will benefit from its use. "We believe that it will be a failure and that it will lead users to the black market," she said.
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