SWITZERLAND’s ‘Weed Care’ pilot, set to be Europe’s first ever THC adult-use cannabis trial, is now due to begin on January 30, 2023 following a four-month delay.
The landmark study, expected to ‘open the door’ for more adult-use cannabis trials to take place across Switzerland and Europe, is now back on track after a second batch of cannabis was approved for use.
Pure Production AG has confirmed that it has received renewed approval from Swiss health authorities to supply the trial, after its first 30kg batch ‘narrowly’ failed to meet quality standards.
Those involved are hopeful this delay will provide ‘the first learnings’ for the project and make it easier for the numerous other major studies expected to be granted ‘within the next weeks’.
The Delay
The Weed Care pilot was initially set to be launched in Switzerland’s third most populous city, Basel, on September 15, and would have run until March 2025.
However, just days before the regulated sale of adult-use cannabis was set to launch across selected Basel pharmacies, the city’s health department announced that the cannabis provided ‘narrowly failed to meet a quality standard stipulated in the Ordinance on Pilot Trials under the Narcotics Act’.
The Swiss legal framework surrounding the controlled sale of adult-use cannabis for research purposes demands that the products used must be grown organically, rather than via much more tightly controlled indoor cultivation.
Analysis of Pure’s first batch was found to contain 0.1–0.2 parts per million (ppm) of fluopyram, a pesticide ‘not approved for organic cultivation’, thought to have come from the greenhouse soil contaminated ‘years before’ Pure began using the site.
While the levels of fluopyram fell well within the limits of conventional food consumption (lettuce is 15ppm), the legislation’s strict guidelines meant that the decision was made to incinerate the 30kg batch and place the trial on hold while a solution was found.
Lino Cereghetti, COO of Pure Production, told BusinessCann: “In the end, for us it was never an option to release this batch, unless they chose to revise the thresholds, because we’ve been fighting for quality in cannabis in Switzerland for years.”
‘Limited Options’
This began a ‘six-week’ discussion between the government and the study’s proprietors on how to find an alternative source of product to ensure the study could start as soon as possible.
“The options were limited, to be honest; there are not many recreational markets in the world that are able to export. Canada was considered, but then we had to make sure that suppliers were cultivating organically according to Swiss regulation, which decreased the potential suppliers even further,” Mr Cereghetti explained.
While the option to import products from Canada was reported in the Swiss press amid radio silence from Basel authorities, it is understood that this was only ever a ‘fallback option’ should Pure’s second batch also fail to be approved.
“Even if we would have used Canadian products, this would have only been to bridge the gap; it would have been replaced by Swiss production.”
As these discussions were ongoing, Pure successfully harvested a second batch on an alternative site that ‘has been run organic for the last 30 years’.
It has now received its permit from the federal office, and its second batch has been confirmed to ‘match all the criteria of the quality assurance’.
As originally intended, Pure will supply two hashish and four cannabis flower products to selected Basel pharmacies, which will be available to purchase from January 30, 2023.
Despite the delay, the Basel-Stadt health department, the University Psychiatric Clinics, Aargau Psychiatric Services and the University of Basel have continued to press ahead with recruitment.
Around 340 of the total 370 participants have now been signed up and will be included in the study, with the remaining 30 expected to be onboarded before the start date.
Lessons Learned
Mr Cereghetti said that while he ‘doesn’t see any more hurdles for this project to roll out’ it is not called an ‘experimental article by accident’.
He suggested that the study’s entire approach was to gather evidence in order to create a better regulatory system, and that this delay will ‘provide the first learnings for large-scale regulation afterwards’.
Furthermore, he argued that the lessons learned from this delay will make it ‘easier and faster’ for what is expected to be nearly a dozen similar pilots that will follow in the coming weeks and months.
“We’re doing pioneering work here for the whole cannabis industry in Switzerland. Whoever is going to follow us will have it easier because of the price of learning we paid.
“A lot of stuff has actually been tested out now for the first time. A lot of processes and pathways that didn’t exist before have now been created.”
