Legal framework for medical cannabis in The Netherlands, November 2023

Over the past 20 years, the Netherlands has become internationally well-known for its unique policy on making medical cannabis available in inpatient and outpatient care.[1] The special status of this policy lies in the fact that the Dutch state has been very proactive in facilitating the production of high-quality medical cannabis, while other Member States have been more hesitant in facilitating the production of medical cannabis. 

While the Netherlands still upholds its leading position with regard to the production of medical cannabis, we've seen that over the last few years, the international policy and market for medical cannabis is developing more rapidly.[2] This is partly due to the fact that internationally, the positive therapeutic effects of medical cannabis on patient outcomes are being recognized – also as a result of a growing body of medical scientific research. In order to maintain its leading international position the Dutch state has recently proposed a few changes to the current policy framework surrounding medical cannabis.[3]

In the following paragraphs we will first provide a short analysis on the current Dutch regulatory framework surrounding medical cannabis. After that, we will provide insight in the proposed policy adjustments by the government and their implications for the existing regulatory framework.

Legal status and current Dutch regulatory framework regarding medical cannabis

Is the production and use of medical cannabis currently legal in the Netherlands?

In the Netherlands the production and use of medical cannabis is legal under national law. Since September 1, 2003, doctors and pharmacists are authorized to prescribe medical cannabis to patients. In order to ensure the safety and quality of the medical cannabis the government institution 'Bureau Medicinale Cannabis' ('BMC') is authorized to supply medical cannabis to licensed pharmacists and also scientific research institutions.[4] The BMC holds a permit that grants them the privilege to legally grow cannabis for therapeutic and scientific purposes. Those who do not hold this permit are prohibited from cultivating cannabis for financial gain.[5] Based on the current regulatory framework the aforementioned permit can only be obtained by specific governmental institutions. In the following paragraph we will elaborate on how this permit can be obtained. 

Current Dutch regulatory framework

The Dutch regulatory framework with respect to the cultivation, processing, trading or marketing of medicinal cannabis is primarily based on the United Nations Single Convention on Narcotic Drugs 1961 ('UN Convention'), as amended in 1972.[6] The UN Convention is currently undersigned and ratified by 190 UN Member States, including the Netherlands. Therefore, the Netherlands, among other Member States is obligated to adhere to the provisions of the treaty. The provisions of the UN Convention are incorporated into the national legislation, specifically the (1) Opium Act and (2) Medicines Act. 

The Opium Act primarily aims to protect the public against potentially dangerous narcotics (opioids). Therefore, the provisions of the Opium Act specifically extend to prohibiting and preventing the production, commerce and use of forbidden substances, as referred to in the so-called list I and II A of the Opium Act. However, article 8 of the Opium Act creates an exception by stating that the Dutch Minister of Health, Welfare and Sport can grant a permit to grow cannabis.

In conjunction with the Opium Act, the Medicines Act provides a regulatory framework for ensuring the quality of medical cannabis, as well as additional regulations concerning the communication, production, sale, and advertising of medical cannabis. The Medicines Act is based on the directive 2001/83/EC of the European Union. The EU directive 2001/83/EC provides a basic legal quality and assessment framework governing the application of a marketing authorization for drugs and medicinal products, including herbal medicinal products. However, because medical cannabis is not registered as a pharmaceutical drug (medicine), medical cannabis is not subject to the quality and assessment framework of the EMA nor to that of the national governmental institution 'College ter Beoordeling van Geneesmiddelen'. 

However, the intended use of medical cannabis is similar to the intended use of drugs and/or other medical products. As a result, medical cannabis must meet the same legal quality requirements as 'regular' drugs or other similar medical products. 

What is the legal procedure to obtain an Opium license in the Netherlands?

The prohibitions described in the Opium Act concerning the cultivation, processing, trading or advertising of medical cannabis do not apply to pharmacists, doctors, dentists, veterinary doctors or institutions who have been authorized by the government to do so (article 5 of the Opium Act). However, research institutions (universities, hospitals, etc.) are obligated to apply for an Opium exemption permit (article 6 of the Opium Act). 

An exemption to cultivate, process, trade or advertise can be granted by Farmatec and BMC – both organs of the Dutch Ministry of Health Care – for the following purposes (article 8 of the Opium Act): (1) public health, (2) animal health, (3) scientific or analytical-chemical research and (4) instructional purposes. Farmatec, in conjunction with the BMC, will determine whether the applicant is eligible to receive an Opium exemption permit. If Farmatec-BMC grants the Opium exemption, the permit will be valid for five years with the possibility of an extension.

The Dutch governmental organization 'Inspectie Gezondheidszorg en Jeugd' ('IGJ') is tasked with overseeing companies and institutions with an Opium exemption license, on the basis of article 8j of the Opium Act.

Are there developments to be expected within the legal framework in your jurisdiction?

Lifting the maximum restriction on the export and production capacity of medical cannabis

In 2012 the Dutch government set a restriction on the export of medical cannabis, in terms of a maximum amount which could be exported yearly (100 kgs per country to which cannabis is exported). The maximum restriction ban on export of medical cannabis consists of qualitative as well as quantitative measures. The qualitative restrictions ensure that medical cannabis is only distributed to other Member States or to authorized institutions / representatives of the Member State. The qualitative measures aim to protect the quality of the medical cannabis and are intended to remain in place. The quantitative measures have proven to be ineffective with respect to changes in the market over the last few years. Considering the growing demand for high- quality medical cannabis by other Member States the Dutch government intends to lift the maximum restriction on the export of medical cannabis as well as the restriction on production. 

Encouraging international marketing and trade of medical cannabis

In order to enter the market the BMC has to grant an Opium exemption permit to the party that wants to produce, deliver or market medical cannabis for pharmacists or medical scientific research, as described in paragraph III. However, the BMC rarely grants an Opium exemption permit to outside parties. 

The fact that the BMC rarely grants an Opium exemption permit to outside parties has caused research institutions to be limited to the production capacity of the BMC. For this reason, the Dutch government finds it beneficial to reconsider the current framework that is in place to obtain an Opium exemption permit by Farmatec-BMC, thereby granting outside parties more possibilities to be involved in the cultivation, processing or trading of medicinal cannabis. 

These proposed changes to the legislation do not have a concrete timeline yet. 

Are there any financial benefits (state aid, tax benefits, etc.) implemented to foster the medical cannabis industry?

No.

Within the framework for medical cannabis in your jurisdiction, is there opportunity or scope for entrepreneurs in the wider eco system (e.g. information sharing between practitioners or patients)?

As medical cannabis can be prescribed by doctors, the general legal rules applying to the doctor-patient relationship are applicable. As such, doctors can of course share information with their patients. 

[1] In healthcare settings as well as non- healthcare settings (provided by pharmacists).
[2] Letter from the Minister of Health, Welfare & Sport dated 30 May 2022, 3368655-1029160-GMT (in Dutch).
[3] Letter from the Minister of Health, Welfare & Sport dated 6 March 2023, 3534670-1043526-GMT (in Dutch).
[4] The BMC is a governmental institution which is part of the Ministry of Health, Welfare and Sport. 
[5] In the Netherlands the BMC is the only organization that holds the license for legally producing and supplying medical cannabis to pharmacists and/or for the purpose of medical scientific research.
[6] United Nations Single Convention on Narcotic Drugs 1961.