Global Cannabis Playbook Emerges Amid U.S. Uncertainty

While international markets move steadily toward harmonized medical
cannabis regulations, the United States remains mired in uncertainty.
Without federal reform, U.S. operators risk being sidelined just as the
groundwork for a global industry is being laid. Other countries are
advancing with pharmaceutical-grade standards and unified frameworks, while
the U.S. clings to a patchwork, recreational-first approach that may not
meet international requirements. The question now is whether America can
adapt quickly enough to join the conversation or be consigned to watching
from the sidelines as others set the rules.

Adding to the complexity, U.S. cannabis companies are up against global
competitors with access to lower-cost labor, better cultivation climates,
and more advanced infrastructure. All of this puts U.S.-based consumer
packaged goods (CPG) brands hoping to compete globally at a disadvantage.
Although the U.S. has the potential to lead in cannabinoid science and
therapeutic development, the country risks being left behind in the global
market.

The disconnect between U.S. and international markets was a key topic at
the inaugural Global Cannabis Regulatory Summit in Washington, D.C. — a
landmark event that brought together regulatory, medical, and trade
officials from seventeen countries. The summit marked the first coordinated
international effort to align standards and set the groundwork for a
unified global industry.

Spearheaded and funded by Will Muecke and Stanton McLean, partners at
London-based investment firm Artemis Growth Partners, the summit also
focused on discouraging Europe from replicating the U.S.’s fragmented
regulatory model. “It became very apparent that where we are in the
cannabis cycle in Europe could easily turn into the U.S.’s fragmented
system,” said Muecke, who — thanks to an Artemis office in San Jose,
California — has watched the industry develop on both sides of the
Atlantic. “We’re at a change point. We need a playbook of concrete steps to
get to what we think is a very robust medical market.”

He emphasized adult-use legalization in Europe depends on first ensuring a
healthy medical industry. “If medical fails, then we’ll never get to adult
use,” he said. “And I think right now we all see medical as a huge success.”

To drive global cohesion, Artemis convened an invite-only group of
regulators and policy leaders from the United Nations, European Union trade
groups, U.S. state agencies, and international standards bodies including ASTM
International, United States Pharmacopeia (USP), and the International
Organization for Standardization (ISO). According to Muecke, the goal is to
establish a permanent institution representing the entire global supply
chain and serving as a trusted point of contact for regulators worldwide.
“We hope to create a single, authoritative body regulators can engage with,
whether that’s the INCB [International Narcotics Control Board], EU health
ministries, or U.S. federal agencies once reform happens,” he said. “The
current ‘walled garden’ approach in the U.S. won’t work on a global scale.”
The shifting international landscape

Despite a growing international reform movement, the global cannabis
industry remains highly fragmented. Regions are progressing at markedly
different speeds in terms of regulation and market development. In North
America, for example, Canadian operators are expanding abroad because
they’re facing flat domestic sales. At the same time, U.S. multistate
operators (MSOs) remain boxed in by high taxes, limited capital access, and
a continuing federal ban on interstate and international commerce.

With medical markets expanding across twenty-one EU member states, Europe
currently leads in regulatory momentum. Germany’s landmark legislation in
April 2024 set the tone. Pilot programs in the Netherlands, Switzerland,
and the UK are testing different models, with France and Greece preparing
to scale up. However, progress in countries like Spain, Portugal, and
Poland has slowed.

In Latin America, exports are the primary focus. Colombia has emerged as a
global leader in genetics and bulk supply. Brazil is steadily broadening
medical access and easing penalties for personal use, but political and
legal uncertainty continue to stymie Mexico’s potential.

Oceania’s medical markets, particularly in Australia and New Zealand, are
thriving, though regulatory scrutiny is increasing. Africa is still in the
early stages of development; South Africa has legalized home cultivation,
and Morocco is building out its infrastructure to support medical exports.

Asia remains the most conservative region. Thailand recently backtracked on
its adult-use legalization and is redesigning its regulatory framework,
while Japan is cautiously expanding medical cannabis and CBD access under
strict controls.
International frameworks take shape

In 2020, the World Health Organization (WHO) and United Nations took a
landmark step by removing cannabis from Schedule IV of the Single
Convention on Narcotic Drugs. The category is reserved for substances
deemed to have little or no medical value. Althought the move didn’t
legalize the plant globally or lift existing restrictions in member
countries, rescheduling acknowledged the plant’s therapeutic potential and
opened the door for expanded medical research and regulatory reform.

At the heart of international enforcement is the INCB, one of four key
bodies tasked with overseeing compliance with global drug-control treaties.
Alongside the Commission on Narcotic Drugs, the WHO, and the UN
Secretary-General, whose drug-related functions are carried out by the UN
Office on Drugs and Crime, the INCB monitors adherence to the 1961 Single
Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances,
and the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and
Psychotropic Substances.

Despite growing public support and scientific validation of cannabis’s
medical uses, enforcement remains complicated by a fragmented global legal
landscape. Countries like Canada and Germany have adopted progressive
regulatory frameworks, while others maintain a strict interpretation of
international treaties. The patchwork presents challenges for the INCB as
it navigates the tension between treaty compliance and national policy
shifts driven by research, patient needs, political expediency, and
consumer demand.
Pharma-grade standards set the course

The playbook by which a global industry will operate already is being
written in Europe and other regions that are developing medical-first
markets. The vast majority of these markets require pharmaceutical-grade
protocols, including EU Good Manufacturing Practices (EU-GMP) and Good
Agricultural and Collection Practices (GACP), as well as
pharmaceutical-level laboratory testing.

Cannabis medicines in Europe must meet the same stringent standards as
other controlled substances under the UN’s Single Convention on Narcotic
Drugs and national medicines acts. This means all producers of cannabis
products must prove consistent chemical composition, define dosage forms,
and verify efficacy.

Lisbon-based Somai Pharmaceuticals is among the manufacturers with
international aspirations who’ve surmounted the challenges. The company
produces EU-GMP-compliant products in accordance with the EU’s herbal
medicine pharmacopoeia and currently operates in twelve countries, with
plans to expand to eighteen by the end of 2025. Under EU law, all herbal
medicinal products must obtain marketing authorization before export, be
evaluated by the European Medicines Agency, and be approved by the European
Commission. Once authorized, products may be distributed in any EU nation
that has legalized cannabis.

“It takes roughly two and a half years to get through validation, batches,
stability testing, and then regulatory approval for sales to multiple
markets,” said Somai Chief Executive Officer Michael Sassano. “Without it,
you can’t export to other countries.”

Sita Schubert, Secretary General of the European Medicinal Cannabis
Association and a leading voice on regulatory policy, sees this
pharma-grade model as the foundation for the industry’s future in Europe.
“The EU’s requirement for herbal medicines to have market authorization
validates product quality, because it fulfills the EU-GMP standards. But
the final part — clinical trials and proven efficacy for a specific
indication — is still missing,” she said.

Whether or not a company plans to develop a full pharmaceutical product,
Schubert advises all operators to adopt rigorous standards from the outset.
“For Americans thinking about entering the European market, you need to
understand that we are a medical market. You need to think like pharma and
act like pharma,” she said. Her message is clear: Companies must shed the
U.S.’s “recreational mindset” and align with strict regulatory expectations
to compete globally.

Muecke also pointed to Germany as a model for what a functioning medical
market should look like, including providing a legal pathway for developing
and commercializing cannabinoid-based medicines. “If you were to create a
cannabinoid medicine in Germany, you’d have a legal market to sell it
into,” he said. “There’s no innovation in the U.S. on the medical side,
because you have no way of selling a finished product.”

Muecke believes moving the plant to Schedule III under the U.S. Controlled
Substances Act could change that, giving pharmaceutical companies the green
light to invest in cannabinoid drug development. As the law stands now,
with cannabis planted on Schedule I alongside illegal drugs like heroin,
opium, and fentanyl, there’s no incentive for American pharma companies to
invest in developing new cannabinoid medications.

Muecke estimates the opportunity represented by rescheduling could unlock a
$100-billion global pharmaceutical segment driven by cannabinoid
formulations. He and others argue that establishing and adhering to
GMP-level standards isn’t about merely compliance; it’s also about building
products that benefit both medical patients and recreational consumers.

As the global market moves toward standardized quality and safety
benchmarks, the U.S. risks being left behind. With no national requirement
for GMP compliance, American brands may find themselves struggling to adapt
when international trade barriers begin to lift. “How will the U.S. compete
against markets delivering consistent, safe, pharmaceutical-grade
products?” Muecke asked. “Because that’s what GMP means.”
Standards bodies chart the path forward

Mueuke identified ASTM International as “the tip of the spear” in pushing
the industry toward pharmaceutical-grade standards. Together with ISO, ASTM
is helping lay the groundwork for a globally interoperable system.
Standardization begins at the plant level, spanning breeding, cultivation,
manufacturing, dosage, and data collection.

At the moment, ASTM is the only global organization with a working group
devoted to developing performance and product safety standards for
cannabis. Its Committee D37 on Cannabis has published more than sixty
standards, with at least thirteen U.S. states adopting or referencing those
standards in their regulatory frameworks.

But significant gaps remain. “While the organization is a leading voice,
there’s still a need for a central global body to coordinate just
cannabis,” said David Vaillencourt, vice chairman of ASTM’s D37 committee.

He noted a shortage of qualified technical experts across multiple domains
as one hurdle to creating a set of unified standards. “We need pharmacists
to help with dosing protocols for medical cannabis, hardware engineers for
vaporizer standards, and toxicologists for evaluating formulations,” he
said. Though thirty countries participate in ASTM standards-setting,
representation from key scientific and regulatory voices remains limited.

Vaillencourt also pointed to a critical disconnect between the cannabis
industry and UN voting members and treaty experts familiar with the Single
Convention on Narcotic Drugs. “That’s one of the last links to unify the
global industry,” he said. “But many [experts and policymakers] have been
reluctant to engage due to political sensitivity.”

He applauded the Artemis team for bridging that divide by establishing a
summit that attained buy-in from not only regulators, but also law
enforcement. “Bringing two former members of the Bureau of International
Narcotics and Law Enforcement to the Global Cannabis Regulatory Summit was
a huge step forward,” Vaillencourt said. “It finally got the conversation
going at a serious international level.”
States begin looking beyond borders

The Cannabis Regulators Association (CANNRA) is a nonpartisan,
international association comprising government agencies that oversee
cannabis and hemp regulation across more than forty-five U.S. states and
territories, as well as four additional countries: Canada, the Netherlands,
Malta, and Albania. While most members focus on implementing and enforcing
policy in their own jurisdictions, conversations increasingly turn toward
what international commerce may require.

“This is still a nascent policy area, so state regulators are largely
focused on making things work in their respective states,” said CANNRA
Executive Director Gillian Schauer, PhD, MPH. “But we do have conversations
about how regulations need to evolve for interstate commerce in the U.S.
and how global trade may eventually impact regulations as well.”

Schauer anticipates continued variation across state and national
regulatory frameworks but stressed the importance of establishing shared
minimum standards to ensure product safety and consumer protection. She
pointed out the conversation is already underway in the hemp cannabinoid
space, where interstate and even international commerce is quite lively.

“The key is determining how individual governments can ensure products from
other jurisdictions comply with their regulations,” she explained. “This
could involve specific licensing and registration requirements, third-party
certification programs that verify adherence to specific standards, or
intergovernmental agreements that recognize certain jurisdictions as
compliant. Or, it could mean a combination of all three.”

Eventually, regulators will need to tackle deeper questions. How can
regulatory systems effectively communicate across borders to support
tracking and compliance? What parts of the supply chain are best suited for
management at the local, state, or international level?

“We’re not there yet in the U.S.,” Schauer admitted. “The state-by-state
infrastructure was born out of necessity as states experimented with
legalization in the absence of federal reform. That makes it difficult for
states to think much beyond the task at hand in their own jurisdiction.”
Will rescheduling change the game?

According to attorney Jason Adelstone, who specializes in cannabis and
international law at Harris Sliwoski LLP, rescheduling cannabis from
Schedule I to Schedule III in the U.S. will do little, at least initially,
to unlock international trade. “Not much will change as far as
international trade goes because, still, only DEA registrants will be
permitted to export and import marijuana,” he said, referring to the U.S.
Drug Enforcement Administration. “State-legal operators will remain
prohibited from accessing the international market.”

Nevertheless, Adelstone believes there could be a major inflection point on
the horizon if the DEA shifts its definition of medical cannabis away from
the Food and Drug Administration-approved pharmaceutical model and moves
toward a more EU-style botanical flower framework. Such a change could open
the door for DEA-registered producers to supply medical-use products to
Europe’s fast-growing markets, particularly Germany.

“In all of my conversations with international businesses, people want DEA
marijuana for their medical programs because of its perceived high quality
standards,” said Adelstone. He believes the botanical medical model may
serve as a “middle ground” between strict pharmaceutical systems and the
broader adult-use market.

“The middle ground is between pharmaceuticals, food, and supplements,” he
explained. As a plant, “cannabis doesn’t fit into those three FDA approval
lanes, so if the FDA created a pathway under the [Food, Drug, and Cosmetic
Act] for botanical substances — like cannabis flower or psychedelic
mushrooms — that could be a good middle ground for establishing the type of
medical marijuana system you see in Europe.”

Adelstone added another possible middle ground would be for the DEA to
allow registered bulk manufacturers to export flower to countries that will
utilize it in their medical systems. “Over time, production and sale by DEA
registrants may normalize marijuana flower as a medical product in the
U.S.,” he said, “which could lead to a domestic medical program and
possibly even the botanical pathway I mentioned.”

Adelstone already is seeing rapid momentum as international supply chains
form despite the lack of U.S. participation. “The supply chains are being
developed, and the language is being written,” he said. Even if U.S.
companies can’t yet take part in cross-border commerce, now is the time to
align operations, documentation, and terminology with international norms.
Doing so, Adelstone said, will allow American companies to “integrate more
seamlessly” once permitted.

He also sees a rare first-mover opportunity for DEA-registered operations
to insert themselves into the international supply chain, especially for
scientific and, potentially, medical purposes. “If I were an MSO with
money, I would be trying to acquire a DEA registrant right now,” Adelstone
suggested, urging companies to begin laying the groundwork for compliant
trade and strategic business relationships.

In addition, he pointed to growing investor interest in international
markets, emphasizing that even though U.S. companies are restricted from
exporting, they can participate abroad. “It’s not explicitly in the
statutes, but under current judicial precedent, operating a foreign
marijuana company or investing in one does not violate the Controlled
Substances Act,” he explained.

Canadian companies like Organigram and High Tide are capitalizing on this
window of opportunity by investing in EU cannabis supply chains through
mergers, acquisitions, and international partnerships.
What’s at stake now

The Global Cannabis Regulatory Summit marked a strategic convergence of
regulators, scientists, and industry leaders determined to build the next
phase of a global economy. For the United States, the message was clear:
Reform cannot be delayed forever without consequences.

Yet the story is not finished. With its deep bench of scientific expertise,
entrepreneurial drive, and consumer demand, the U.S. still holds the
potential to help shape international norms — if it chooses to engage. By
embracing medical-first frameworks and aligning with pharma-grade standards
already in place abroad, American operators can position themselves to
reenter the global conversation not as bystanders, but as partners.The
opportunity remains, but it requires foresight. Rather than being locked
out, the nation that sparked the legalization movement could still help
lead its future — provided it seizes the moment.
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Charting the Next Steps for a Global Cannabis Market

1. Why is global cannabis alignment important?

A unified framework ensures product safety, trade consistency, and
credibility with international regulators. Fragmented systems slow growth
and increase compliance risks.
2. What role do pharmaceutical-grade standards play?

EU-GMP and GACP standards are setting the baseline for international
trade. Without pharma-level protocols, companies can’t access most global
medical markets.
3. How does U.S. rescheduling affect global trade?

Moving cannabis to Schedule III could encourage U.S. pharma investment,
but DEA restrictions mean only registrants will initially access export
channels.
4. What actions should U.S. cannabis operators take now?

Experts recommend aligning operations with GMP standards, building
international partnerships, and preparing compliance systems to integrate
seamlessly once trade opens.