Two weeks ago the Ministry of Health issued a new resolution creating the category of “Vegetable products based on cannabis and its derivatives intended for use in human medicine”. And just 10 days ago, Governor Gerardo Morales of Jujuy released photos where he himself participated in the first local harvest of 80,000 plants of cannabis what -they affirm in Jujuy- will allow reaching an initial production of 1,000 kilos of active pharmaceutical ingredient extracted from cannabinoids. This is how the last two happened Steps on the still slow path that Argentina tries to follow to have its own medical cannabis industry.
“This ministerial novelty is important because a new specialty is created that puts cannabis in a special place: it is neither a medicinal nor herbal product, but rather something very specific,” he told NEWS Pablo Fazio, president of the Argentine Chamber of Cannabis (ArgenCann). And he added: “in principle we see it as something positive because the use of this type of phytotherapic product is growing throughout the world and -even- although today it is a category designed for cannabis, in the near future it could be extended to other elements (for derivatives of certain fungi) on which there are already indications that they may also have a therapeutic effect in the treatment of certain conditions”.
In keeping with time, the other accolade came from the other side of the political spectrum, since the highest political authority in Jujuy witnessed the first harvest of cannabis plants that was carried out on the property of the provincial company that is leading the way to become a producer of these prepared.
for the neurologist Andrea Micciulli, professional at Eva Perón Hospital and member of the group CAME (Medicinal Cannabis Argentina), the current situation of the medicinal derivatives of cannabis is still somewhat complex and is still immersed in a kind of “crack” between the homemade manufacture of artisanal producers for their own consumption or for sale in small quantities and a sector of the pharmaceutical industry that wants to get involved in this production and commercialization but following the rules of the industry in terms of quality control.
“There is a discussion on the subject and it is complex to resolve,” Micciulli told NEWS. “But this problem is better understood considering that cannabis left the category of dangerous drugs in Argentina just 18 months ago.” What is certain, said this specialist who gives training on therapeutics and cannabis, is that “we have to ensure that patients can access products based on this plant that are safe and of high quality and that is one of the things that the industry ensures with its standards and controls.” Of course, that does not necessarily mean that it must be produced by large laboratories. “It can also be a state laboratory. The important thing is that whoever synthesizes, fractionates and markets medicinal cannabis products complies with the quality guidelines that any medicine must have and that they are controlled by specialized agencies.”
The reason for this vision is simple: patients must be able to receive safe and effective cannabis drugs with temporary continuity. This implies that each batch contains the active ingredients that it claims to have, that they are stable, contained in a pure form and without contaminants, in order to be able to take them in the doses and concentrations indicated by the doctors. This is also essential so that patients and professionals can analyze if there are drug interactions or some adverse effect. “The new category now established by the Ministry could help regularize this situation and ensure that we have a controlled and safe production”, the professional hopes.
History
Although there are records of the use of medicinal cannabis since the heyday of ancient Egypt, Greece and China, during the last century in most countries its use has been forbidden by a succession of penal laws. Only in the last fifteen years of the XXI, some positive effects on health began to be demonstrated, in a scientific format and with evidence: for example, its effectiveness in the treatment of seizures caused by a type of refractory epilepsy and its effectiveness in calming the pain and inflammation associated with fibromyalgia.
These results occurred all over the world. For example, a study carried out by Garrahan professionals that included 49 adolescents suffering from drug-resistant epilepsy clearly demonstrated that the use of Cannabis oil was 80% effective.
After the first solidly endorsed results, new clinical trials to test other effects of cannabis. And according to Micciulli, signs were found that – apart from its proven use in drug-resistant epilepsy, “evidence is accumulating that it has a lot to contribute to the well-being of patients oncological under chemotherapy treatment; in therapy of pain, especially in people affected by neuropathic pain; in spasticity associated with Multiple Sclerosis and in people with HIV who suffer from anorexy. Good responses are also being found in cases of patients with autism to whom it helps to improve anxiety and control several symptoms that currently have no treatment, including aggressiveness and sleep disorders. But, the expert clarifies, in Argentina all these uses are, for now, ‘off-label’. That is, they can only be taken with the indication of a professional and in agreement with each patient, since there is no “official” recommendation.
Doubts
Beyond receiving the new regulation with optimism since It is a positive step Fazio from ArgenCann expressed that he still has certain doubts about how the new resolution will be regulated, since past experience shows that the opinions of the various state agencies may differ. “I don’t know what ANMAT’s view of that ministerial resolution will be, sinceand historically it is an Agency that has been very restrictive in its view on the regulation of Cannabis”, he explained. And he added: “we will have to see the fine print, how much active principle it can contain or if it is possible to combine other cannabinoid molecules”. In summary, in theory the new category should facilitate the commercialization of these types of products but the devil is in the details.
Another point that also crosses this debate is that of the professionals. Is that there are still many specialists who reject add this option in terms of treatment, even when it is proposed by their own patients. For Micciulli “this happens because the use of cannabis challenges us all and also our place as health specialists. Until a few years ago, many professionals used to feel like the “owners” of the truth and imposed a treatment without “agreeing” or giving many explanations. This is changing and patients have access to knowledge and may want to explore other formats. “I think it should be a topic to talk between the patient and his doctor and to be able to put together a therapeutic plan that is the result of an agreement”, he highlighted. And he recalled an extra benefit of this approach: “This agreement, among other things, has an extra positive effect: that the patient is compliant and more adherent to their treatment.”
250 million pesos to do research
In mid-April, the Minister of Science, Daniel Filmus, presided over the presentation of the “Cannabis Research and Development Program”. This call will offer $250 million to to finance research and development projects in cannabis, hemp and its derivatives. And not only for medicinal, therapeutic and palliative uses but also for industrial uses, and the associated social and cultural aspects. The projects may be presented by institutions of the scientific and technological system and will have a maximum subsidy amount of $10 million that will finance up to 70% of the total amount of the project. The topic is interesting because it involves a lot of money. According to a report prepared in 2021 by the ArgenCann team “by 2025 it is estimated that this industry can create about 10,000 jobs in the country, an internal sales market for an amount of 500 million dollars per year since there are about 15 million potential users of these drugs for various common pathologies. And, in addition, they estimate power add foreign sales of about 50 million dollars a year.
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