Regulatory Review

Updated  January 7, 2021

As the dark consequences previously associated with cannabis use have been rendered inaccurate or exaggerated with successful and well-regulated cannabis programs operating throughout the world, doubt has been cast upon the validity and efficacy of the antiquated and excessively restrictive approach the international community continues to take toward cannabis. As a result, these communities are beginning to revisit the topic under increased pressure from member states - especially those in Europe.

World Health Organization (WHO) Rescheduling Recommendations  

In January of 2019, the World Health Organization (WHO) formally recommended the rescheduling of cannabis and cannabis resin within the 1961 Convention on Narcotic Drugs, which currently sets global standards for drug policy. The recommendation was addressed to United Nations (UN) Secretary-General António Guterres - former Prime Minister of Portugal who was in office when universal drug decriminalization took place in the country - and suggested cannabis be formally rescheduled under international drug treaties in the following ways:

  • Whole-plant cannabis and cannabis resin would remain Schedule I but would be removed from Schedule IV – the most restrictive category of the Single Convention on Narcotic Drugs (1961).

  • Compounded pharmaceutical cannabis preparations, such as Sativex, would be placed in less restrictive Schedule III of the 1961 Convention.

  • Cannabidiol (CBD) and CBD-focused preparations containing no more than 0.2% THC would no longer be subject to international control.

The formal UN vote on the recommended rescheduling was delayed from its originally slated date in March 2019 to December 2020. In the interim, the European Parliament voted to advance a resolution that “allow[ed] doctors to make free use of their professional judgment in prescribing regulatory-approved, cannabis-based medicines to patients with relevant conditions, and to all pharmacists to lawfully honor those prescriptions.” The Parliament’s resolution did not formally change the legislative landscape of countries in the European Union, but it did encourage those countries that had not yet adopted a cannabis medical program into their healthcare system to do so in order to remain compliant with EU standards and in step with other countries across the region, as well as encouraging cannabis research.

United Nations Commission on Narcotic Drugs (CND) Rescheduling of Cannabis

In their 62nd session in March 2019, the Commission received a note from the Secretariat on changes in the scope of control of substances, which contained the scheduling recommendations by the WHO relating to cannabis and cannabis-related substances. After the Commission postponed voting on two occasions to give states time to consider the complex recommendations, it was decided at the reconvened 63rd session in December 2020 that cannabis and cannabis resin would be removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs, though it would remain in Schedule 1. All of the other WHO recommendations failed to be enacted.

Though a very promising step toward greater international acceptance of cannabis, given that the rescheduling made the official UN policy toward cannabis less restrictive and acknowledged its potential medicinal value, there remains much progress to be made. Under Schedule 1, there are still international controls on the production, manufacture, export, import, distribution, trade, use and possession of cannabis, which are limited to medical and scientific purposes exclusively. Essentially, the UN CND decision allowed for more leniency in medical cannabis regulation and will likely serve as a catalyst for country-level legalization efforts. However, it does not support the enactment or operation of recreational or adult-use programs, and it is up to each country whether and how it will implement local cannabis regulations.

Key Country-Level Regulations and Reforms 

  • Germany: Medical cannabis products are reimbursed for roughly two-thirds of applying patients covered by statutory health insurance, and a new reimbursement scheme was agreed upon by German pharmacies and insurers in March 2020, to reduce the average retail price to as low as €13 per gram depending on the quantity prescribed. Thus GKV statutory health insurers now pay a fixed amount based on quantity, encouraging pharmacies to use lower cost suppliers instead of incentivizing them to dispense expensive products for a greater markup. This has, in turn, led to lower prices for not only GKV insurers but for those paying for uncovered product out-of-pocket thanks to wholesale price pressure across the board.

  • United Kingdom: The UK’s medical market opened in late 2018 when laws allowed specialist doctors to prescribe cannabis-based products for medicinal use. With many patients experiencing setbacks and delays in treatment due to import requirements, recent (March 2020) changes on import restrictions were made to help patients avoid delays and interruptions in their treatment. Licensed wholesalers may now import larger quantities of cannabis-based products and hold supplies for future use by patients with prescriptions.

  • Austria: Cannabis is grown under the control of the Health Ministry. Access to product is somewhat restricted, patients with valid prescriptions are permitted to import finished pharmaceuticals such as Dronabinol, or Sativex. Health insurance covers the costs when prescribed for limited conditions.  

  • Switzerland: With a long and arduous registration process, very few sourcing and product alternatives, medical cannabis access in Switzerland has been highly limited. However, the Federal Office of Public Health (BAG) is considering relaxing restrictions on medical cannabis, making it easier for doctors to prescribe as well as considering broader insurance coverage - with a more robust program looking likely to materialize in 2021. Despite the restrictive nature of the country's medical program, Switzerland’s Lower House Health Commission cleared the way for a limited pilot program to allow for the legal production and distribution of adult-use cannabis (expected launch: 2022), and will monitor the effects of non-medical use of cannabis on areas such as public safety and illicit drug markets.

  • France: Regulators have been particularly restrictive in France. Though medical cannabis products have been permitted on an exceptional basis since 2013, a full medical market has not yet materialized. A two-year medicinal cannabis pilot program is expected to launch, however, in March 2021, allowing 3,000 patients access.

  • Spain and Netherlands: Although to outside eyes, both countries seem to be more cannabis-friendly with their cannabis social clubs and coffee shops, both countries' medical cannabis programs need further legislative work as they either do not offer product choices or are not available in all regions. The Netherlands, however, will soon be launching its adult-use pilot program in 10 municipalities, which may lead to the eventual legalization of adult-use nationwide.

  • Greece: Opened its medicinal market to help boost its economy in 2017-2018, and the program looks promising though sales have not yet commenced in December 2020.

  • Portugal: A decree that took effect on February 1, 2019 regulates the Law of Cannabis of Medical Use and established the rules for its usage. The decree enabled patient access to therapies including cannabis mixtures and substances, which were not legally accepted before, though domestic sales remain negligible as cannabis produced in the country tends to be destined for export to larger European markets.

  • Italy: Policies on medical cannabis vary by region, with reimbursement and authorized prescribing policies determined by regional authorities. Italy gave the exclusive right to domestically cultivate medical cannabis to its Military of Defense to ensure the raw material for medicinal products are always available. However, strong demand is still forcing the country to import most of its supply.

  • Denmark: Today, medical cannabis can be obtained legally through the country's medical cannabis pilot program, which entered into force on January 1, 2018 (to remain in place for four years with the possibility of extension), or through three other - smaller - exceptional use programs. On January 1, 2019, a financial supplement program took effect retroactively for the entire medical cannabis trial period, providing various levels of reimbursement for participating patients. Recently-launched domestic grows are expected to drive greater product availability and diversity beginning in 2021.

  • Luxembourg and Malta also have promising developments. It is reported that Luxembourg’s federal government is considering legalizing recreational cannabis through a strictly-controlled market. Luxembourg is a small country with a population of approximately 600,000. Though it borders Belgium, France and Germany, and canna-tourism is a possibility, the current plan includes a residency requirement designed specifically to prohibit this. Malta decriminalized the recreational use of cannabis in 2015 and legalized medical use in 2018. Legislation was also passed to allow companies to obtain a license to produce and manufacture cannabis for medical use on Maltese land. The current government has committed to legalizing recreational cannabis. However, it aims to educate the public on the harms of drug use before working on this reform.

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