This Monday, the government took a first step to regulate the use of cannabis for therapeutic purposes in Spain. The Ministry of Health has just published the draft standard which establishes, among other measures, Which patients will benefit from medical cannabisincluding those with chronic pain or severe forms of epilepsy or those who may help to lessen the effects of chemotherapy.
All this is included in the draft royal decree which establishes the conditions of preparation and delivery of master forms are standardized cannabis-based preparations, which the Ministry of Health sent this Monday for public hearing and information.
The standard aims to regulate prescription, preparation, dispensing and use of typed master formulas of standardized cannabis preparations and establishes an evaluation and registration procedure in a specific register for these preparations, guaranteeing their quality.
The ministry adds that this rule, which responds to the request of the subcommittee created to analyze the regulation of medical cannabis at the request of the Health and Consumer Affairs Commission on May 13, 2021, is articulated in such a way that Necessary improvements can be incorporated to meet patient needs based on the evaluation of its implementation since its origin.
The royal decree aims facilitate access to medicines containing standardized cannabis-based preparations to certain patients in whom the authorized medicines have not been effective. Indeed, the text determines the pathologies which can benefit from the therapeutic use of cannabis, “those for which there is scientific evidence” of its benefit.
More specifically, this includes the multiple sclerosis spasticity (muscle stiffness and spasms associated with multiple sclerosis), severe forms of refractory epilepsy (certain types of epilepsy that do not respond to conventional treatments), nausea and vomiting due to chemotherapy and refractory chronic pain (persistent pain that is not relieved by usual treatments).
“It is important to emphasize that the draft royal decree provides that the monograph of the National Formulary will specify the legally recognized indications for these medications. SO, the list of indications could be expanded or modifiedwith the necessary agility, based on scientific evidence and future regulatory decisions,” he insists.
Medicines and laboratories
THE Spanish Agency for Medicines and Health Products (AEMPS) will publish the monograph in the National Formulary for standardized master formulas of standardized cannabis preparations. The monograph will include the action and legally recognized indications of these medications.
On the other hand, the draft royal decree provides that laboratories manufacturing standardized preparations must comply with EU standards for proper manufacturing of medicines and ensure compliance with correct manufacturing standards.
Mónica García, Minister of Health, in an archive image.
In addition, they will be obliged to guarantee “good distribution practices” from its suppliers, audit them regularly and document the supply chain of each raw material. “They can only supply these preparations to hospital pharmacy services or for export,” emphasizes Santé.
Furthermore, Standardized preparations must be registered in the AEMPS public register. created for this purpose. Manufacturing laboratories must apply for registration, providing the required information in the annex for evaluation before registration.
In contrast, Santé establishes that typical master formulas They will be used when there are no authorized drugs or these do not meet the patient’s needs. In this regard, it emphasizes that the prescription is limited to specialist doctors who treat the indications detailed in the monograph.
“Treatment must be justified by the medical history and the patient must be informed. on clinical evidence, benefits and risks. The doctor must periodically evaluate the usefulness and safety of the treatment and consider stopping it if there is no benefit or if the benefit-risk ratio is unfavorable,” he explains.
