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"When is the government going to fulfill the mandate of Congress to approve the medical use of cannabis?" The question of Josune Gorospe, deputy of the Basque Parliamentary Group (EAJ-PNV) in the Congress of Deputies, addressed to the new Minister of Health, José Manuel Miñones, in the control session to the Government, where it premiered, could not be clearer and more direct. This, paper in hand, responded on Wednesday in two interventions: the first, of 1 minute and 12 seconds, which caused perplexity to the deputy by referring to the fact that "its use cannot be recommended because we must go hand in hand with scientific evidence"; and the second, after not convincing with his first, of 1 minute and 44 seconds, where he threw balls out and said that "the Aemps works on that report, which allows us to establish what is the most appropriate regulatory fit, with two objectives: safety and efficacy ".

The report to which the minister referred should be in January (the Health subcommittee of the Congress of Deputies gave the Agency a period of six months in June), but the Aemps has clarified to this media that in January a draft was already written, with data of scientific evidence. That is, the Aemps has met the deadlines. So where is the problem? "The draft is under review by other areas of the Ministry," the agency added, without providing further details.

The Ministry of Health, for its part, in a query of this newspaper after the intervention in the congress limits itself to pointing out that "as the minister said in his appearance, work is being done to, according to the mandate of the subcommission, establish the most appropriate regulatory framework to ensure safety and reliability."

In his second speech, the minister explained that "there are already some medicines containing cannabis preparations, duly authorized and accessible to patients, such as those used in the relief of spasticity in multiple sclerosis or for numerous types of epilepsy." He was referring to Sativex (combination of THC and CBD) and Epidyolex (CBD), dispensed in hospital, indicated for some diseases such as moderate or severe spasticity due to multiple sclerosis and for seizures associated with Lennox Gastaut syndrome, Dravet or tuberculous sclerosis complex.

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Bless you.

Oils, capsules, vaporization... Routes of administration of medical cannabis (and none is smoking a joint)

  • Writing: ROCÍO R. GARCÍA-ABADILLO Madrid

Oils, capsules, vaporization... Routes of administration of medical cannabis (and none is smoking a joint)

Bless you.

This is how master formulas are made with cannabis in Italy

  • Writing: GEMA SUÁREZ MELLADO Madrid

This is how master formulas are made with cannabis in Italy

He added: "In this regard, and unfortunately for many other diseases, the information is insufficient. We cannot recommend its use and, therefore, we must go hand in hand with scientific evidence. With this we will be able to ensure the benefit-risk balance."

This is the scientific and regulatory evidence from other surrounding countries

Miñones added that "the Agency continues to work and is based on the analysis of the information from the scientific documentation existing in the scientific literature, but also from the existing regulations in other countries in order to establish the modality that best suits the needs of patients and also the Spanish regulatory system".

He also alluded to how cannabis is regulated internationally: "The regulatory framework establishes that the manufacture, export, import, as well as distribution, trade, use and, precisely, possession of narcotics in this Schedule 1 must be limited to that medical, and above all also scientific, purpose that we all seek. We are talking about an international treaty, the 1961 Convention, which is part of our domestic legal system and, moreover, binding."

Disappointment, not only from the deputy

After the intervention of the minister, the deputy of the Basque Group in Congress was "disappointed" by the "regressive" position of the new Minister of Health regarding the medical use of cannabis; he therefore requested that he appear before the Commission to provide explanations in this regard.

"You leave me frozen. His response is a regression to a position that is advanced with the work that was done in the subcommittee, "he said and threw in his face that "in the 2023 Regulatory Plan there is nothing about the medical-therapeutic use of cannabis, when there is a mandate from this House. It is not a Non-Legislative Proposition (PNL), but a subcommittee. Stop dizzying the partridge and give the patients of the State the same opportunity that other patients have elsewhere, "he said.

Along the same lines, Josep Allué Creus, member of Medicinal Plants and Homeopathy at the COF of Barcelona (COFB) and expert in the medicinal use of cannabis, explained to this newspaper that "there will be no scientific evidence until they let us use it as a medicine, and that depends on you, Mr. Minister". And he adds that Miñones' answer is the "standard of a lifetime."

Allué Creus clarifies that he has received news about the content of the draft, and he is not convinced: "There will only be one type of product derived from medical cannabis that we can use. The European pharmacopoeia establishes two monographs: cannabis flower extract and flowers as such, which are widely used in pharmacies in Europe. But it seems that they do not accept the use of flowers, and this will annoy us, but if they let us use the extract, go ahead."

Allué Creus adds that he also has evidence that the Aemps has already presented the documentation "and the Ministry put it in a drawer. I still don't understand who makes money delaying this. It is clear that the Collegiate Medical Organization (OMC) does not want to know anything about cannabis, although there are many doctors who would be willing to collaborate in the use of cannabis as a medicine. This has nothing to do with marijuana. And it seems that someone from the Ministry does not like this either."

Allué Creus indicates that "there is a lot of social pressure for the use of medicinal cannabis, not only in Spain, but throughout the world. I always say I'm talking about a medicinal plant for traditional use, with 8,000 years of history." That said, he adds that it's a plant that can be misused, "and morphine too. What do we do? Do we take morphine away from all terminally ill patients?"

On the same list as morphine

In 2020, the UN Commission on Narcotic Drugs removed cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs, where it was listed alongside addictive and lethal opioids such as heroin, but remains in Schedule I, within the "substances that are highly addictive or likely to be abused, and precursors that can be converted into narcotics that are equally addictive and also likely to be abused."

However, this Schedule I also includes morphine, which is used for medical purposes. According to Allué Creus, with this change "it can already be used as a medicine, with no more restrictions than its narcotic characteristic, which should also be seen. Now we can use this plant as a plant medicine, like so many others we have on the market."

One year since Aguilar's petition in Congress

Just one year ago, in March 2022, Jesús Aguilar, president of the General Council of COF, demanded that the Health Commission of the Congress of Deputies be able to dispense in community pharmacies "under strict pharmaceutical control" authorized medicines based on cannabinoids. He was referring to two drugs that have already been authorized and are currently dispensed in hospital, Sativex (combination of THC and CBD) and Epidyolex (CBD).

At the same time, Aguilar proposed "the dispensing of cannabis-based products that the Aemps could authorize in the clinical situations that were defined, both in the format of finished products and preparations of magistral formulas". To this end, it proposed to carry out a large-scale pilot project, such as the one developed in France, with more than 3,000 patients for 2 years, with the participation of pharmacists, doctors and nurses and under the supervision of the Aemps to evaluate the use of cannabis derivatives for medicinal use.

Allué Creus is one of the main supporters of the pilot project of magistral formulas in pharmacies in Spain, with medical prescription, which in June went ahead in the Subcommittee of Health of the Congress of Deputies, after the request in March of the General Council of COF. "Already before in Barcelona we presented it at the Generalitat de Catalunya and, when we went to present it to the Aemps, the coronavirus appeared".

Already in September he explained to this newspaper that once the framework of these possible studies with cannabis-based master formulas in pharmacies is decided, there is a lot of work still to be done: "We will have to decide what type of cannabis-based medicine (the flower, the oils ...) it could be used for the studies and which of the Sub-Commission's indications seemed most appropriate for the proposed pilot studies. Therefore, we must know how we can raise these studies of pharmacies in Spain ". That said, and assuming that the framework was already decided in January 2023, I foresaw that until May/June 2023 everything could not be ready.

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  • Cannabis
  • Pharmacology
  • Jose Miñones
  • Health