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Few Medical Cannabis Licenses in Portugal Have Been Awarded

Ever since Tilray decamped for Portugal during the early days of the German cannabis cultivation bid circa 2017, the country has been touted as “the place” within the European Union (EU) for the German distributors to source their product.

That said, the actual progress of the industry has been a little slower than that—in part because of the length of time it takes for legislative change to happen. In fact, Ministerial Order No. Finally, Ministerial Order No.83/2021 was released. Local legal professionals claim that this order clarified many aspects of the application process. These include reference prices.

The proof of the pudding is evident when you look at the progression of cannabis cultivation licenses. To date, 114 applications have been submitted for cultivation permits to Infarmed’s National Medicines Agency. Of these, just 23 are “under analysis,” 11 are awaiting a response from the cultivators, and 61 are waiting to be inspected (a major issue facing almost every budding cannabis cultivator thanks to COVID.)

These are just a few of the more troubling statistics. Only three of the 19 cannabis cultivation plants currently in operation can produce medical-grade extracts or products. One of these is in business solely for the purposes of providing “quality control.” The remaining facilities are in business to cultivate the plant as a “raw material,” or, of great interest of course to every German distributor looking for new sources of EU cultivated product, “active substances.”

How can we know?

EU GMP is not an easy certification

The medical authorities are strict, despite the fact that it is a popular country, and the fact that there has been a legislative attempt to legalize adult-use marijuana. They have to be. They are the country’s version of the Federal Drug Administration (or FDA).

Tilray, in fact, announced this February that it received Portugal’s first market authorization for medical marijuana products. All other cultivators are now cultivating cannabis for export (not just to Germany). Many German distributors (for starters) are currently importing raw flower (or flos) as “Active Pharmaceutical Ingredients” or APIs. The market is there for similar products.

Capital is required to obtain a medical license. Also, it’s clear that Portugal doesn’t have the only option. The room is now being opened to African, Macedonian, Greek and Macedonian cannabis.

Additionally, although there’s a lot to be excited about, on the whole, the cannabis revolution for recreational use, it is difficult to grasp the medicinal side of the game, even after capital has been raised. Although this isn’t always an easy task, it is evident that Infarmed will not be a passing agency.

According to Rob Smallman, a highly experienced Canadian cultivator who has been involved in multiple European projects, including in Portugal, “experience and a focus on the actual business in the room is a far better strategy than just satisfying investors.”

Michael Sassano is the founder and CEO of SOMAI Pharmaceuticals. He was also the recipient of an innovation product grant from the Portugal 2020 Committee. “Cannabis entrepreneurs need to know exactly what they are doing to succeed and receive full certification,” he said. “Medical cannabis growing, and manufacturing requires more than just a lot of capital. It requires deep knowledge of regulations and GMP standards plus serious knowledge of the cannabis plant to surpass timely building, operational, and international sales goals.”

Portugal 2020, a partnership agreement between Portugal & the European Commission is to help fund the policy goals of both member states as well as the EU in general.

However, domestically there’s a catch. In a land known rather infamously if not accurately as “anything goes,” on the “illicit drug” front, cannabis as medicine is just as foreign here as it is everywhere else. Medical cannabis can be very costly, as it is everywhere. It is not affordable for most people, even if many.

Portugal’s Pending Recreational Reform: What Does It Mean?

This question has many answers. The first and most obvious one is “nothing” since Infarmed only regulates a medical market, not a broader consumer one (more like BfArM in Germany than the FDA in the United States).

This is not necessarily the best solution. Forward reform of Portugal’s legislative approach to recreational reform has repeatedly stalled, even as both Switzerland (outside of the EU) and Luxembourg (within it) have progressed.

Of course, there is a twist. This is exactly what the Czech Republic (and Switzerland), are now discussing (and Holland has also been doing the same since 2017, when Dutch insurers stopped paying for the drug in the same month that the German BundestagThe Parliament has voted to make it covered. Deutsch public health insurance), the entire discussion of “medical” cannabis is coming under scrutiny. Particularly for domestic usage, and not foreign export.

It is still a simmering problem. It will remain in the discussion, especially with the progress of European cannabis reform.

In the meantime, it is clear that Portugal is proving to be a stringent port of call for all things medically cannabis related—and far from just a pass-through cultivation or extraction state.