Health begins the procedures to regulate medicinal cannabis in Spain

MADRID, 14 Feb. (EUROPA PRESS) -

The Ministry of Health has begun the procedures to develop the Royal Decree with which it plans to approve the regulation of cannabis for medicinal use in Spain, once conversations have begun with the groups involved and after obtaining evaluations prior to the draft presented by the State Agency of Medicines and Health Products (AEMPS).

According to reports, the text is in the "dialogue and discussion phase" with civil society to receive their contributions. In parallel, an email has been opened on the Ministry's website so that citizens can make contributions.

The regulation of the medicinal use of cannabis proposed by the Ministry is a "rigorous measure based on the best scientific evidence available," they say. In addition, evaluations will be carried out periodically to verify its effectiveness and the standard will be provided with sufficient flexibility so that it can be expanded.

The approval of this measure has been dragging on for a long time since on June 27, 2022, with Carolina Darias as Minister of Health, a subcommittee was held in the Congress of Deputies to study the regularization of cannabis for therapeutic purposes, which concluded with a mandate to the AEMPS to prepare a report within a period of six months, which has not been met since it has now been, a year and a half later, when this draft has been sent to the Ministry.

"The draft Ministerial Order establishes a very guaranteeing regulation, designed to be improved from the framework of scientific evidence and treatment of cannabis as medicine," Ministry sources told Europa Press last January.

From Health they reiterate that the proposed regulation is a guarantee "in terms of the quality of the products and the safety of patients", enabling the legal channels available to be able to have therapeutic compounds based on standardized cannabis preparations that have shown evidence to the time to relieve the pain and suffering of patients, considering the oral administration of these compounds as it is the most appropriate in terms of therapeutic effectiveness and safety for patients.

This regulation is designed to evolve dynamically, allowing new elements to be incorporated as more information and the experience of the therapeutic cannabis program becomes available. In addition, he adds, "it will allow us to contribute to generating more and better evidence on the use of cannabinoids for therapeutic purposes."

With this regulation, Spain becomes similar to neighboring countries that have regulations that allow the use of medicinal cannabis, such as Portugal, the United Kingdom or Norway. And it is also positioned in line with the World Health Organization and the United Nations, which recognize the therapeutic potential of these compounds.

The Ministry addresses this regulation based on the conclusions of the Subcommittee of the Congress of Deputies. The roadmap presented by the AEMPS has also been validated by the Government Delegation for the National Plan on Drugs, which has collaborated together with the Spanish Agency for Medicines and Health Products during its preparation.

This week the Secretary of State for Health, Javier Padilla, met first with the European Observatory of Cannabis Consumption and Cultivation and, subsequently, with professional associations and scientific societies. All of them had participated at the time in the Subcommittee of the Congress of Deputies to analyze experiences with the regulation of cannabis for medicinal use. Javier Padilla will also meet soon with the Spanish Observatory of Medicinal Cannabis.

This Tuesday's meeting at the Ministry was attended by representatives of the General Council of Medical Colleges and the General Council of Official Colleges of Pharmacists. In addition, the Spanish Society of Palliative Care, the Spanish Society of Pain, the Spanish Society of Epilepsy, the Spanish Society of Studies on Alcohol, the Spanish Society of Hospital Pharmacy, the Spanish Society of Primary Care Pharmacists, the Spanish Society of Hematology and Hemotherapy, the Spanish Society of Primary Care Physicians, the Spanish Society of Family and Community Medicine and the Spanish Society of General and Family Physicians.

In addition, it has met with the Spanish Multidisciplinary Pain Society, the Spanish Society of Neurology, the Spanish Society of Pulmonology and Thoracic Surgery, the Spanish Society of Medical Oncology, the Spanish Society of Dual Pathology, the SED-ESOM Working Group, the Spanish Society of Psychiatry. and Mental Health, and the Spanish Society of Rheumatology. All of these organizations approved the new regulation.

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