Two Ways Countries Regulate Medical Cannabis: The "Cannabis Agency" Model and the "Medicines Pathway" Model

💼 Cannabis Business & Industry Licensing & Compliance
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Every country that supplies cannabis to patients lawfully has had to answer the same question: is this a medicine, handled by the medicines regulator like any other, or is it a special case needing its own agency? The answer a country gives determines who your customer is, what certification you need, and whether an import quota stands between you and the market.

This article is about international regulatory architecture, not Thai law. Thailand’s own arrangement — cannabis flower as a controlled herb under the Notification of the Ministry of Public Health Re: Controlled Herbs (Cannabis), B.E. 2568, dispensed on prescription form PT 33 — is covered separately in our article on Thailand’s cannabis rules 2022 to 2026. Nothing below describes what is permitted in Thailand.

1. The Layer Above National Law

Before any country designs its own system, it is already constrained by treaty. The Single Convention on Narcotic Drugs, 1961 is the top-level international agreement governing controlled substances, and three of its features shape every national medical cannabis programme.

Article 4 limits controlled drugs to medical and scientific purposes. Production, manufacture, trade, distribution, use and possession are all confined to those two purposes. This is the treaty basis on which the International Narcotics Control Board has repeatedly stated that legalising non-medical cannabis use contravenes the Convention.

Articles 23 and 28 require a national agency where cultivation is permitted. The framework was written for opium and extended to cannabis: where a country allows cultivation, it must designate a government agency that licenses cultivators, takes physical possession of the entire harvest within four months of the end of harvest, and holds exclusive rights over wholesale trade, stocks, import and export. Article 28 carries an important carve-out — the Convention does not apply to cannabis grown exclusively for industrial purposes (fibre and seed) or horticultural purposes, which is the treaty foundation of the industrial hemp sector.

Articles 19 to 21 create the estimates system. Each country submits an annual estimate of its national requirement for medical and scientific purposes, and the total it may manufacture and import in a year is capped against that estimate. The International Narcotics Control Board (INCB), based in Vienna, confirms the estimates, administers the system and monitors the global flow; countries also file statistical returns. Under Article 19, a country may file supplementary estimates during the year if its annual estimate proves too low. So supply into a regulated market is not a matter of demand alone: an exporter’s access is bounded by the importing country’s current estimate, which can be revised, but only through this formal process.

One change is worth noting because it is frequently misdescribed. On 2 December 2020 the Commission on Narcotic Drugs voted, following a WHO recommendation, to remove cannabis and cannabis resin from Schedule IV of the Single Convention. Schedule IV was the most restrictive category, reserved for substances considered to have particularly dangerous properties and little therapeutic value. Cannabis remains in Schedule I, still subject to all levels of control under the Convention. The decision removed a symbolic and practical obstacle to medical research and use; it did not deschedule cannabis.

2. Model One: A Dedicated Cannabis Agency

In this model, the state creates or designates a body that handles cannabis separately from other medicines. It licenses growers, contracts production, controls the supply chain, and manages import and export. Cannabis is handled as its own category, with its own rules for who may prescribe, dispense, cultivate and hold stock.

The obvious advantage is that it satisfies the Single Convention’s agency requirement directly, and lets a country build a supply chain quickly without waiting for cannabis products to complete conventional medicines registration. The obvious cost is that it creates a parallel system: cannabis sits outside the normal pharmaceutical machinery, with its own quirks, its own paperwork and, often, its own political exposure.

3. Model Two: The Medicines Regulatory Pathway

In this model, cannabis-derived products go through the same route as any other medicine: registration by the medicines regulator on the basis of quality, safety and efficacy data, then prescription and dispensing through the ordinary pharmacy system.

Its advantage is coherence. A registered product has an approved indication, an approved dose, a package leaflet, a pharmacovigilance obligation and a manufacturer accountable for it. Its cost is speed and breadth: the conventional development route, including clinical trials, has not been completed for most cannabis products, which is precisely why the category sits in this awkward position. Registered cannabinoid medicines are few, and in most jurisdictions herbal cannabis flower is not one of them.

Both models rest on the same three pillars — quality, safety and efficacy held to high standards. They differ in the machinery, not in the objective. Most countries are hybrids: an agency handling supply, and the medicines regulator handling registered products alongside it.

4. Real Examples

  • Netherlands (agency model). The government’s Office of Medicinal Cannabis has been responsible for implementing the Single Convention for cannabis since 1 January 2001, with a monopoly on supplying medicinal cannabis to pharmacies and on its import and export. Pharmacy dispensing on prescription began in 2003, making it one of the longest-running pharmacy-based programmes. The prescriber–pharmacist side of the Dutch system is covered in a separate forum article.
  • Germany (hybrid). A Cannabis Agency was set up within the federal medicines regulator, BfArM, in 2017. It contracts domestic cultivation by tender, takes possession of the harvest and sells it on to manufacturers, wholesalers and pharmacies, while imports continue under BfArM permits.
  • South Korea (registered medicines only). Since a 2019 amendment to its narcotics law, South Korea has, according to press reports at the time, allowed patients to access only cannabinoid medicines already approved abroad (such as Epidiolex and Sativex), imported through a state orphan-drug centre. Unapproved extracts and flower remain illegal.

5. The Opium Precedent

One argument that this can work is that it already has, for a drug class with higher acute risk.

The UN Conventions and national law together permit opium poppy to be cultivated in Tasmania, shipped to pharmaceutical manufacturing sites worldwide, and dispensed as codeine, morphine or oxycodone by hospital and community pharmacies. Cultivation, manufacture, distribution and dispensing are each tightly controlled.

Applying that architecture to cannabis largely means extending an existing framework rather than inventing a new one. That helps explain why many cannabis requirements resemble those already applied to opioids, though whether each one fits cannabis is a fair subject for debate.

6. Where Both Models Leak

Whichever model a country picks, access is the test. Where few prescribers are trained or willing to prescribe and the legal channel is hard to reach, patients do not stop using cannabis; many turn to illicit or semi-legal supply with no testing, where potency is unpredictable and contamination is a real risk. A programme that is legally sound but practically inaccessible does not remove patient use. It moves that use to an untested supply chain, and a business plan should account for this rather than assume it away.

7. Why This Matters Commercially

For anyone building a business in this sector in Asia, the model a target market has chosen determines four practical things.

Question Under a cannabis agency Under a medicines pathway
Who is the customer? The agency or licensed importers/wholesalers it authorises A pharmaceutical marketing authorisation holder
What must the product be? Standardised herbal material to the agency’s specification A registered medicinal product with a dossier
What certification is required? GACP, plus GMP for the manufacturing step Full GMP with a marketing authorisation behind it
What limits volume? The national estimate filed with the INCB The estimate, plus the registered indication’s patient population

In both cases, the national estimate sets a ceiling before any commercial negotiation begins. A supply agreement that exceeds the importing country’s estimate is more than a commercial risk: it cannot be delivered until that country’s estimate is revised, for example through a supplementary estimate confirmed by the INCB.

8. The Direction of Travel

One shift in terminology in this field reflects a real change in thinking. “Medical cannabis” is increasingly giving way to “cannabinoid therapy” — a class defined by the compounds (THC, CBD and other constituents such as terpenes) rather than by the plant. That reflects how understanding has developed, from the plant to the endocannabinoid system, its receptors, the endocannabinoids the human body makes, and the phytocannabinoids the plant makes.

It also has a regulatory implication. The further a product moves from herbal material towards a characterised compound with a dossier behind it, the more naturally it fits the medicines pathway and the less it needs a special agency. Whether that is progress or a narrowing depends on whether you think whole-plant preparations have properties that isolated compounds do not, which is still an open scientific question.

If you have dealt with a licensing authority in any Asian market — an application, an import permit, a quota question, a refusal — the procedural details are worth more to this community than any published summary. What did they actually ask for, and how long did it take?

References

This article is part of the Asiannabis Community educational series on regulation and compliance. It is general information about international regulatory frameworks, not legal advice, and it does not describe Thai law. Verify current requirements with the relevant authority before acting.