Media Report: The regulation of medicinal cannabis, an increasingly close reality in Spain

El Pural reports in detail, the following

The Ministry of Health, led by Monica García, plans to approve “coming soon” the regulation of cannabis use with medicinal purposes, a measure that has been pending for a long time and that has the support of the government coalition. This has been confirmed by sources from the Ministry, who have indicated that they already have a draft Ministerial Order prepared by the State Agency for Medicines and Health Products (AEMPS).

The draft establishes a “very guarantee” regulation”, which treats cannabis as a medicine and which is based on scientific evidence. Before publishing the Ministerial Order, the Ministry will hold a round of meetings with the groups involved, especially the Medicinal Cannabis Observatory, to collect their contributions and evaluations.

The exact date of approval of the regulation is not yet known, but is expected to be “in the coming months”. Once it takes effect, medicinal cannabis will have to be prescribed by doctors specialists and can be used to relieve pain in certain diseases or pathologies.

This initiative is part of the Sumar program, which defends a “full regulation” of cannabis and the model of cannabis associations of self-consumption and non-profit, decriminalizing production and own consumption. Sumar also supports the legalization of cannabis for medicinal purposes, which is pending to be approved this 2024.

The regulation of medicinal cannabis has been delayed more than expected, since in June 2022 a subcommittee was held in the Congress of Deputies that commissioned AEMPS to report with a term of six months, which was not complied with. The former Minister of Health, José Miñones, apologized for the delay and attributed it to a “excess zeal”. He promised to present the document in May 2023, but finally it was the new minister, Mónica García, who received it in December. Miñones assured that he was still working for ensure the safety and efficacy of cannabis treatment and that the analysis of the AEMPS could soon be known.

Comparison with international regulations

Thus, the regulation of medicinal cannabis in Spain is still in an incipient phase, since there is no specific law regulating it, but is based on the authorization of the Spanish Agency for Medicines and Health Products (AEMPS) for cultivation, the import and use of cannabis derivatives for research or therapeutic purposes. However, other countries have made further progress in this regard, such as UruguayIsrael and Holland, they were pioneers in legalizing the medicinal use of cannabis, or Canada and various states of the United States, who have also legalized recreational use.

In addition, the regulation of medicinal cannabis varies by country in terms of requirements, procedures, authorized products, indications, doses, quality controls and access and dispensing systems. For example, in Europe, some countries like GermanyItaly or France allow the use of medicines based on cannabis or cannabinoids, such as Sativex or Epidiolex, which have been approved by the European Medicines Agency (EMA), while others such as PortugalCzech Republic or Denmark allow the use of cannabis extracts or flowers under medical prescription.

Also, this regulation of medicinal cannabis also has implications at the international level, since it affects treaties and agreements about drugs that govern the control of narcotic and psychotropic substances. These treaties, signed by most of the countries of the world, establish that cannabis and its derivatives must be subject to the strictest control measures and can only be used for medical and scientific purposes. However, some countries have taken measures that contravene these treaties, such as the legalization of the recreational use of cannabis, which poses a challenge for the international drug control system.

For all these reasons, the regulation of medicinal cannabis has to take into account the scientific evidence to support its therapeutic use, as well as the possible risks and benefits for public health. Cannabis and its derivatives have pharmacological properties that can be useful to treat various diseases or symptoms, such as chronic pain, spasticity, epilepsy, multiple sclerosis, glaucoma, HIV / AIDS, cancer, or chemotherapy-induced nausea and vomiting. However, cannabis and its derivatives can also have adverse effects, such as psychological, cognitive, cardiovascular or respiratory disorders, as well as the potential for abuse and dependency. Therefore, it is necessary to evaluate the risk-benefit balance of each case and establish safety, efficacy and quality criteria for the use of medicinal cannabis


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