What Have We Learned From the First Nation to Legalize Cannabis? Not Enough

Uruguay was the first nation to legalize and regulate cannabis, back in 2013, so it would seem to be a gold mine for research attempting to measure the many effects of such a seismic change—social, medical, and biochemical. But researchers in that nation say they face hurdles that can slow and block their work, including some of the same kinds of hurdles faced by researchers in the U.S.  

After the cultivation and distribution of cannabis was made legal for medical and recreational uses, the government of Uruguay said it intended to inform public policy with research. More than half of Uruguayans did not agree with the law in 2013, but the government pushed it as a measure for the collective good. One part of the logic: If cannabis sales were regulated by the government, illicit markets would lose some power over the nation. And good research, government officials reasoned, might shine a light on other positive—or potentially negative—results. Yet some Uruguayan scientists blame bureaucratic barriers, low funding, and a cannabis stigma for seriously hampering such research.

Among the things that researchers hope to learn more about is how to turn the plant into regulated medicine. While the cannabis-based medicine that sits on Uruguayan shelves is produced locally, its raw material is imported from Switzerland. Research on local strains and extraction processes could eventually end the importation costs, thus making the medicine more accessible to consumers. Academics and researchers with backgrounds from social sciences to medicine aim to form a hub of Uruguayan cannabis research at Universidad de la República (UdelaR,) in Montevideo. But they say they’re facing difficulties.

When it comes to Uruguayan government officials, “the political willingness is in their expressions, but not in their actions,” says Carlos García, a researcher at UdelaR who leads the Núcleo Interdisciplinario de Estudios Sobre Cannabis (Interdisciplinary Group for Cannabis Research).

By the time the state launched a new agency for the regulation and control of cannabis—called the Instituto de Regulación y Control de Cannabis (Cannabis Regulation and Control Institute) — the research group had already designed the basic and preclinical experiments its researchers wanted to pursue. A collaboration between the medical and chemistry faculties and an UdelaR campus up north—the CENUR Noroeste— the group wanted to study the biology of the plant and aimed to develop medicines. But from there things have moved slowly.

In order to work with cannabis, researchers in Uruguay must get approval from the Cannabis Regulation and Control Institute, which is said to be understaffed, and also find funding. If the research involves human volunteers, then researchers need a permit from the Ministerio de Salud Pública (Ministry of Public Health) too. García, from the interdisciplinary group, said that the layer of licenses needed to work with cannabis puts a drag on the process. Waits have been said to last up to a year.

Funding, too, is a major hurdle in Uruguay, García says. The interdisciplinary team received initial funding for research from UdelaR to pursue projects that looked into, for example, the effect cannabinoids have on cerebral activity in sleep-wake cycles. But the 1,500 million pesos (or about $47,520) grant was to be distributed over the course of three years and between the group’s four projects. That leaves each group with a 125,000 pesos annually —just over $6,000—to conduct research, far short of what they need. One proposed budget, for example, was closer to $30,000.

When funding is needed for research in Uruguay, scientists look to the Agencia Nacional de Investigación e Innovación (National Agency of Investigation and Innovation) which has a budget of $44 million. But the grants are highly competitive, and even if investigators meet all of the requirements, they can’t be assured they will get money for their proposals. Garcia said a proposal he submitted last year was deemed “excellent” by the agency, but “we didn’t get the financing, for lack of funds.” For the project, García proposed to chemically profile two cannabis sativa varieties as well as optimize the cannabinoid extraction process.

Javier Varela, a chemist who proposed to document the chemical fingerprint of cannabis strains cultivated in Uruguay, was denied funding last year. Varela polished his proposal and hopes to get funding for his research this year, he said. “The competition is big, there are a lot of researchers, myself included, applying for these funds.”

In the United States, cannabis researchers also face high hurdles. Before they can get to work on cannabis research involving human participants, they must jump through layers of hoops—especially because of cannabis’ federal status as a Schedule 1 drug, the most restrictive Drug Enforcement Administration category. Research proposals must be approved by an Institutional Review Board, a group usually appointed by the institution where the research is being conducted and regulated by the Department of Health and Human Services.

Once the same plan is also approved by the Food and Drug Administration, researchers are allowed to request a cannabis supply from National Institute on Drug Abuse. Researchers’ supply comes from one farm at the University of Mississippi, operated by the federal government. It takes about twelve months to secure federal approval for a research protocol, and, depending on the cannabis product requested, it may take six months or so for the Mississippi farm to produce the material, according to Hampton Atkinson, the co-director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

However, while U.S. researchers face greater barriers obtaining a supply, they have more options for funding than their counterparts in Uruguay. For one thing, there has been a rise in private funding for cannabis research in the United States. The largest donation for cannabis research to date in the United States came last April from the Ray and Tye Noorda Foundation, in partnership with the Wholistic Research and Education Foundation, and went to the Center for Medicinal Cannabis Research: $4.7 million to study the effects of cannabinoids on autism. In Uruguay, scientists say these types of donations are very rare, but they are hopeful because foreign companies, such as Algae.Tec an Australian company, have flocked to Uruguay for cannabis research and production. In April, IRCCA, the cannabis regulatory agency, announced that nineteen companies, both local and foreign, have applied to produce medical cannabis in Uruguay.

U.S. researchers have another advantage: After legalization in states like California, some money from taxes on cannabis products is being put aside for research. That is not the case in Uruguay. “There has not been any type of stimulus to finance research in cannabis,” says Astrid Agorio, a biologist from the Instituto de Investigaciones Biológicas Clemente Estable.

Some research has managed to clear the hurdles in Uruguay. For example, a group of researchers at the social sciences school in the UdelaR has been able to publish findings that looks into social aspects of Uruguayan regulation, such as consumer behavior, and on shifting public opinion on cannabis. The group launched a project called Monitor Cannabis, a site that aims to inform the public through articles, news aggregation, and surveys. One Monitor Cannabis analysis looked at the local cannabis market and found that the black market has not shrunk as much as the government intended when it legalized cannabis, but has instead transformed by offering cheaper and lower quality drugs.

Some researchers are concerned that the limited approval for research and investigations is a ploy by authorities to control the information on the impacts of the legalization of cannabis, according to a 2018 Brookings Institute report. The report goes on to detail how the Ministerio de Salud Pública is required to submit an annual report on the impacts of the legalization since 2014—but the ministry has only submitted such a report once, in 2016, and the findings were not made public.

García hopes that researchers can fill in the gap if, in the future, public money is specifically set aside to foster cannabis research in Uruguay. Until then, he says, he’s working with the circumstances, “We’re moving at a turtle’s pace, slowly but surely.”

Source link

Leave a Reply