Almost three years after the promulgation of the law that implemented the National Medicinal Cannabis Program, the Presidency of the Republic is taking the last steps to regulate cannabis-based magisterial formulas, one of the measures most demanded by patients and businessmen linked to the sector.
“A lot of work was done,” assured the deputy secretary of the Presidency, Rodrigo Ferrés, to The Observedr in reference to the decree that regulates magisterial formulations created from cannabis extracts. The initiative was long awaited by Uruguayan patients and stakeholders in the cannabis industry and is in its final phase of study and review. “In the next few days the signatures of the Council of Ministers will be collected,” confirmed Ferrés.
Implying
Las formulaciones magistrales prescriptas por médico tratante y elaboradas por químicos farmacéuticos constituyen una de las vías de acceso al cannabis medicinal que tienen los pacientes uruguayos, según se desprende de Ley 19.847. La normativa, promulgada a fines de 2019, declaró de interés público “las acciones tendientes a proteger, promover y mejorar la salud pública mediante productos de calidad controlada y accesibles, en base a cannabis o cannabinoides, así como el asesoramiento médico e información sobre beneficios y riesgos de su uso”.
A nivel clínico, las fórmulas magistrales basadas en cannabis atacan los síntomas de enfermedades severas como esclerosis múltiple, epilepsia refractaria, y evidencia científica respalda su uso para dolor crónico, colitis ulcerosa o enfermedad de Crohn. A su vez, se utilizan también para reducir la ansiedad y con efecto analgésico.
Today, those Uruguayans who are prescribed THC (the psychoactive component of cannabis) for their treatment must resort to the clandestine market, and those who need CBD (the active component) can only access it in very low concentrations (3% , 5% and 10% CBD), as detailed by the CEO of the company YVY Science, Andrea Krell to The Observer.
“Es lo que da la solución más rápida a los pacientes que hoy después de casi 10 años de legalización no tienen acceso a productos regulados en base a cannabis”, dijo la empresaria en relación a las fórmulas magistrales y destacó que la oferta actual no resulta suficiente. “Las formulas magistrales le dan una herramienta al médico de poder formular específicamente lo que el paciente necesita”, apuntó Krell.
Por su parte, el fundador del holding de cannabis Terraflos, Facundo Garreton, opinó: “Me alegra que Uruguay no se quede, hoy ya se accede a formulaciones magistrales en Colombia, Perú, Ecuador, Argentina e incluso en Brasil de forma compasiva”.
El empresario afirmó que la reglamentación de esta ley es esperada por miles de pacientes de diversas enfermedades que hoy no tienen acceso o bien "acceden a preparados en el mercado irregular y de dudosa calidad".
El emprendedor de cannabis hizo énfasis en la importancia de que los médicos conozcan los cannabinoides en función de las distintas patologías para poder incorporar el CBD, el THC u otros combinados a sus tratamientos.
In this sense, the medical director of the Program for the Medicinal Use of Cannabis of the Spanish Association, Fernanda Coutinho, pointed out that “implementation is everything”and pointed out that many patients can benefit from this, although it all depends on the formulations being the right ones and for that, education aimed at health professionals is key.
For the specialist, at the educational level “training tools are needed to formulate—in the case of pharmacies and chemists—and to prescribe, doctors.”
In practice, Coutinho witnesses more and more patients being referred by doctors to be treated with medical cannabis. “Patients from rheumatology, psychiatry, cardiology are referred to me,” he said. Also, he pointed out that there is more and more openness and less prejudice around working with cannabis. “The biggest difficulty is not having the tools to prescribe and incorporate it into practice,” she concluded.
A noose to the industry
For businessmen in the sector, this regulation represents a breaking point in a business that until now had strangled them. “It has the potential to save the industry,” said the CEO of the company YVY Science.
“Because of the lack of regulation of a local market, companies that have raised millions of dollars in investments and produced large amounts of flower have not been able to market them,” Krell said.
Although a part of this production is exported, the entrepreneurs are in need of a local market that makes their business sustainable. “It is an industry that is totally stifled right now and Enabling magistral formulas would give air so that these companies that have medicinal quality material in stock can use this flower as the base of these formulations”added the CEO of YVY Science.
