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The Great GMP Debate–What Actually Counts as Certified Medical Cannabis Around the World

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There has been a marked change in the world of cannabis over the last 24 months. Namely the entire market, no matter where it exists, is getting far more certified and regulated. The days of bootleg product may not be entirely over, but at this point the writing is on the wall. Just about everywhere.

What that level of regulation has to be, however is far from homogenized—even in regions like Europe. In the United States, because reform has come state by state, there is no national regulating mandate (so state regulations vary widely). Indeed, in the aftermath of federal reform in the United States, there will also be a period where state markets recognize mutual certification standards. 

As a result of the 2018 Farm Bill, hemp crops in the U.S. are being brought more or less to a national standard as well as national regulations.

But that is just the tip of the iceberg.

The International Market Is Moving to GMP – But Whose Counts?

In Europe, the discussion of equalizing standards is two-fold and already very much in the room. Here is why.

While the EU-GMP standard is supposed to be uniform and accepted by states across the bloc, in fact it is the importing country whose standards must be met. Germany’s standards are recognized as the highest in Europe. This has already caused problems for producers in other countries even within the EU.

Outside of this region, the standards must be met by producers in countries who have specific treaties with the EU on recognition of medical standards and processing procedures. Even here, however, as in places like Australia or Canada, German inspectors must walk the floors of a cultivation plant before it is given the green light. This is one of the reasons for the delay in more certifications being issued. COVID-19 has impacted the ability of said inspectors to do this vital work.

Bottom line, when dealing with the regulating supply chain, EU-GMP is the certification that matters. And even here, there are other factors at play (like regional treaties and mutual recognition of medical standards). All is still difficult in a world where the WHO maintains cannabis as a Schedule I drug globally.

Generally, however, producers all over the world are racing to meet this standard—except…and here is where this all gets intriguing. If not extremely complicated.

Gaps Remain All Over the Place

The first confusing wrinkle in all of this has been primarily caused by the way that the European market has developed so far. Namely, there was demand for medical cannabis that has not been met yet by the German produced cannabis per the first tender bid (and never will be since the amount determined by the bid is already too small to meet demand). However, that cannabis has to come from some place. 

Initially, outside of Holland, German medical cannabis hailed from Canada—where none of the public companies had a completely GMP compliant infrastructure. In the meantime, other regulations were swapped out as a temporary stop gap measure. Canadian producers, in other words, were producing what is known as GACP (or good agricultural and cultivation practices) to Canadian, not German spec. Or not (see the spectacular explosion of CannTrust two summers ago). For those who intend to meet compliance, this means generally that a crop has to be produced at organic standards and inside, to even meet this grade. All of the other processes, however, from drying to extracting, must meet the GMP standards. 

For this reason, there has been growing concern by authorities that a supply chain that does not include GMP grown cannabis from the beginning is actually a flaw in the supply chain that endangers consumers. Right now, there are certainly producers who are still using this loophole, but it will not last for long. Industry insiders in Germany have reported that this practice is due to come to an end (at least in Germany) within the next six to twelve months.

Bottom line? If you plan on importing to Europe’s medical market, your supply chain must be totally GMP from start to finish—plus you have to plan to work with regulators and lawyers.

Is that all she wrote? The answer, surprisingly, is no. There are still other models in the offing. And while this is unlikely to put a crimp in the current urgent demand for more cultivation of medical crops, there are already several other alternatives in the room. 

Even in Europe.

The Great Home Grow Non-GMP Escape Hatch

The reality is that there is not enough medical cannabis under cultivation right now to meet medical demand at the EU-GMP level. And while regulators and national medicines agencies everywhere are creating an infrastructure that a large part of the medical cannabis consumed here will go through, even in Europe there are some growing exceptions.

For example, in Holland, the de facto “medical market” cannabis produced at an EU-GMP standard is all for export. There has been some discussion in homogenization circles about whether the Dutch regulations meet muster (most notably so far in Poland). Most Dutch cannabis patients also must buy their own cannabis from coffee shops.

In Italy, hardly a hotbed of hippie liberalism, and with a medical industry that was initially run by the military, the country also has allowed citizens to grow up to three plants. This appears also to be the tact that the island of Malta is pursuing.

More intriguingly, although not likely to get adopted in Europe at least any time soon, the Thai government has started to let community groups grow six plants per group member to be delivered to local hospitals for medical distribution by prescription.

This is hardly likely to be adopted in Europe. However, as reform rolls on, it is also very likely that home grow and limited non-profit collectives will be allowed to proceed in some way. 

The demand for the drug medically already is so far beyond what is being produced that it is going to be decades before the market catches up. And in the meantime, this is the cannabis industry. Stay tuned for more change in this space.



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