Europe's first adult-use cannabis trial with THC set to launch in January 2023 after four-month delay

The Swiss «Weed Care» pilot project, which is intended to be the very first first attempt at legal cannabis distribution The sale of THC products for adult use in Europe is expected to begin on January 30, 2023, following a four-month delay.

This landmark study, which is expected to «pave the way» for other cannabis trials for adults in Switzerland and Europe, is back on track following the approval of a second batch of cannabis.

Pure Production AG has confirmed that it has received approval from Swiss health authorities to supply the trial, after its first batch of 30 kg «narrowly» failed to meet quality standards.

Those involved hope that this delay will allow them to draw initial lessons from the project and facilitate the completion of the many other important studies that are expected to be approved «in the coming weeks.».

The Delay

The Weed Care pilot project was originally scheduled to launch in Switzerland's third-most-populous city, Basel, on September 15, and was set to run through March 2025.

However, a few days before the launch of regulated cannabis sales for adult use at certain pharmacies in Basel, the city’s health department announced that the cannabis supplied «narrowly failed to meet a quality standard stipulated in the ordinance on pilot trials under the Narcotics Act.».

The Swiss legal framework governing the controlled sale of cannabis to adults for research purposes requires that the products used be grown organically, rather than through indoor cultivation, which is subject to much stricter controls.

Analysis of the The first batch of Pure revealed the presence of from 0.1 to 0.2 parts per million (ppm) of fluopyram, a pesticide «not approved for organic farming,» which is believed to have come from the greenhouse soil that was contaminated «years before» Pure began using the site.

Although fluopyram levels are well within the limits for conventional food consumption (the limit for lettuce is 15 ppm), the strict guidelines set forth in the legislation led to the decision to incinerate the 30-kg batch and suspend the trial pending a solution.

Lino Cereghetti, COO of Pure Production, said at BusinessCann : «Ultimately, for us, releasing this batch was never an option unless they chose to revise the thresholds, because we’ve been fighting for the quality of cannabis in Switzerland for years.»

Limited options

That marked the beginning of a «six-week» discussion between the government and the pilot project’s leaders on how to find an alternative source of the product so that the project could begin as soon as possible.

«To be honest, the options were limited; there aren’t many recreational markets around the world that are capable of exporting. Canada was considered, but we then had to ensure that suppliers were practicing organic farming in accordance with Swiss regulations, which further reduced the number of potential suppliers,» explained Mr. Cereghetti.

While the option of importing products from Canada was reported in the Swiss press amid radio silence from the Basel authorities, it is understood that this was merely a «fallback option» in case the second batch of Pure was not approved. The import would have been legally possible, as the controlled distribution of cannabis for adult use is governed by experimental and research regulations, which’very clearly authorize international conventions.

«Even if we had used Canadian products, it would have been only to fill the gap; they would have been replaced by Swiss production.»

While these discussions were ongoing, Pure managed to secure a second batch from another site that «has been organically farmed for 30 years.».

She has now received approval from the federal agency, and it has been confirmed that her second batch «meets all the criteria of the’»quality assurance".

As originally planned, Pure will supply two hashish-based products and four cannabis flower-based products to select pharmacies in Basel, which will be able to purchase them starting January 30, 2023.

Participants will be able to legally purchase these six products during the pilot project – Credit Pure Holdings AG

Despite this delay, the Basel-Stadt Department of Health, the university psychiatric clinics, the Aargau psychiatric services, and the University of Basel continued to recruit participants.

Approximately 340 of the 370 participants have been enrolled and will be included in the study; the remaining 30 are expected to be enrolled before the start date.

Lessons Learned

Mr. Cereghetti stated that, although he «does not see any other obstacles to the implementation of this project,» it is not called an «experimental project» by chance.

He suggested that the entire approach of the study was to gather evidence in order to create a better regulatory system, and that this delay «will provide initial insights for future large-scale regulation.».

In addition, he argued that the lessons learned from this delay will make what are expected to be nearly a dozen similar pilot programs—which will follow in the coming weeks and months—«easier and faster.».

«We’re doing pioneering work here for the entire cannabis industry in Switzerland. Those who follow in our footsteps will have an easier time thanks to the learning curve we’ve gone through.»

«Many things were tried for the first time. Many processes and approaches that didn't exist before have now been created.»