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You are here: Home / Policy & Legal / International / A Deeper Look in to World Health Organization’s Rescheduling Recommendations

A Deeper Look in to World Health Organization’s Rescheduling Recommendations

February 13, 2019 by Lezli Engelking Leave a Comment

On January 24th, 2019 World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD) released recommendations on the global rescheduling of cannabis and cannabis related substances. 

“The committee recognized the public health harms presented by these substances, as well as their potential for therapeutic and scientific use.  As a result, the committee recommended a more rational system of international control surrounding cannabis and cannabis related substances that would prevent drug-related harms whilst ensuring that cannabis derived pharmaceutical preparations are available for medical use.”

This is the first time the ECDD has performed a full scientific review of cannabis since the International Drug Conventions were established in 1961 and 1971. Cannabis has historically been under the strictest international controls (Schedules 1 and 4).

The ECDD is an independent group of experts in the field of drugs and medicines convened by WHO. The ECDD’s role is to advise on the scheduling of substances based on the following criteria:

  • Evaluations of potential for harm
    • Specifically, evidence of dependence potential
  • Dependence and abuse from a public health perspective
    • Actual abuse and/or evidence of likelihood of abuse
  • Therapeutic usefulness
    • Therapeutic applications of the substance
      • The ECDD’s responsibility does not include making recommendations on the use of substances for medical treatment.

According to WHO, “the goal of these recommendations is to ensure that international control measures can effectively protect people’s health, in particular the most vulnerable, but do not limit access to cannabis derived products with proven therapeutic properties.”

The recommendations from the ECDD have now been endorsed by WHO and sent to the UN Secretary General who will share the recommendations with the United Nations Commission on Narcotic Drugs (CND). The CND is responsible for monitoring the world drug situation, and developing strategies on international drug control, and recommending measures to address the world drug problem.

According to WHO’s website, the CND will vote on the recommendations at their next meeting in March 2019. However, the recommendations for cannabis and cannabis related substances actually arrived later than planned. WHO was scheduled to release them during the last CND meeting in December 2018 at the UN Headquarters. At that time, WHO was unable to make the recommendations, stating they required more time to complete a thorough scientific review of cannabis and cannabis related substances. Because WHO requested more time at the meeting in December, it is unclear whether the CND vote on the recommendations will take place at their next meeting in March 2019, or if it will be pushed to their next meeting in March 2020.

It is critical to understand that the ECDD recommendations are only that…recommendations. 

The CND is not bound by the assessment and recommendations of the ECDD and could very likely reach a different conclusion.

Until a formal vote by the CND member states takes place (either March 2019 or March 2020), we will not know what effect, if any, these recommendations will have on the international rescheduling of cannabis.

Most have seen the  letter with the ECDD’s recommendations from the WHO’s Director General to the UN Secretary General.

However, Annex 1, which accompanied the letter, is where the science and thought process behind the recommendations is covered in detail. The whole document is definitely worth a read, but there are certain statements that are particularly interesting:

Recommendation 5.1 Cannabis and Cannabis Resin

  • The committee recognized the limited robust scientific evidence on the therapeutic use of cannabis.
  • There are also a number of adverse events associated with long term cannabis use, particularly increased risk of mental health disorders such as anxiety, depression, and psychotic illness.
  • While the Committee did not consider that cannabis is associated with the same level of risk to health of most of the other drugs that have been placed in Schedule I, it noted the high rates of public health problems arising from cannabis use and the global extent of such problems and for these reasons recommended that cannabis and cannabis resin continue to be included in Schedule I of the 1961 Single Convention on Narcotic Drugs.
  • Cannabis and cannabis resin should be scheduled at a level of control that will prevent harm caused by cannabis use and at the same time will not act as a barrier to access and to research and development of cannabis related preparations for medical use.

Recommendation 5.2.1/5.2.2 Dronabinol (delta-9-tetrahydrocannabinol;Δ9-THC)

  • At the time of the adoption of the 1961 Single Convention on Narcotic Drugs, scientific research had not identified Δ9-THC as the main psychoactive ingredient in cannabis.
  • The CND did not adopt a previous WHO recommendation to place dronabinol in Schedule III of the 1971 Convention of Psychotropic Substances.
  • The Committee recognizes that cocaine, the principal active component in coca is placed along with the coca leaf in Schedule 1 of the 1961 Single Convention on Narcotic Drugs. And that morphine, the principal active compound in opium, is placed with opium in the same schedule. Placing Δ9-THC, the principal active compound in cannabis in the same schedule as cannabis would be consistent with this approach.

Recommendation 5.3.1/5.3.2 Tetrahydrocannabinol (isomers of delta-9-tetrahydrocannabinol)

  • Due to the chemical similarity of each of the six isomers to Δ9-THC, it is very difficult to differentiate any of these six isomers from Δ9-THC using standard methods of chemical analysis.
  • The Committee recognized that available evidence has not demonstrated abuse and ill effects of these isomers similar to those associated with Δ9-THC.
  • The Committee understood that placing these six isomers under the same Convention and in the same Schedule as Δ9-THC would facilitate the implementation of international control over Δ9-THC, as well as assist Member States in the implementation of control measures at country level.

Recommendation 5.4 Extracts and Tinctures of Cannabis

  • The Committee recognized that some extracts and tinctures of cannabis without psychoactive properties and including predominantly cannabidiol have promising therapeutic applications.

Recommendation 5.5 Cannabidiol Preparations

  • In keeping with the [previous] recommendation that preparations considered pure cannabidiol not be controlled and recognizing that trace levels of Δ9-THC may be found in such preparations, such as the concentration of 0.15% in Epidiolex, while acknowledging that chemical analysis of Δ9-THC to an accuracy of 0.15% may be difficult for some member states.
    • There is controversy over the recommendation to move the acceptable level of Δ9-THC from 0.1% to 2%  as it contradicts the 2009 United Nations Office of Drugs and Crime (UNODC) Recommended methods for the analysis of cannabis and cannabis products.
    • There are a couple of reasons for this controversy:
      1. The higher the level of Δ9-THC content, the higher the level of other cannabinoids will be. Moving the limit to 0.1% would increase the levels of other therapeutically beneficial cannabinoids such as CBN, THC-V, etc.
      2. Countries like Thailand and Mexico have deemed 0.1% Δ9-THC the acceptable level for food products. Limiting the global supply to a 0.2% Δ9-THC level will put countries like these at a disadvantage as it will become even more difficult to source materials with the required Δ9-THC level.
      3. Europe previously adopted the 0.2% Δ9-THC level, putting them at an advantage in the global marketplace.

Recommendation 5.5 Pharmaceutical Preparations of Cannabis and Dronabinol (delta-9-tetrahydrocannabinol)

  • The evidence concerning the use of Δ9-THC containing medicines [Sativex, Marinol, Syndros, Epidiolex] is that they are not associated with problems of abuse and dependence and they are not diverted for the purpose of non-medical use. As such, the Committee recommended these medicines be placed in Schedule III of the 1961 Single Convention on Narcotic Drugs.
  • The Committee recognized there is no difference in the therapeutic effects or adverse effects of synthetic Δ9-THC compared to Δ9-THC from the cannabis plant.
    • This contradicts what is regularly reported by patients using cannabis as medicine. In fact, there is a growing number of patients who are using whole plant cannabis therapies to treat the side effects of Epidiolex.

While the CND is the UN’s central drug-policy making body,UN resolutions do not have a specific impact in relation to individual country’s drug policies. All countries, whether Member States of the CND or not, can exercise discretion in how they will apply controls within their own territories.

For those who would like to learn more about the reasoning behind the ECDD recommendations, we have included links below to the individual Critical Review Reports the ECDD utilized during their review.

Cannabis and Cannabis Resins

Delta 9 tetrahydrocannabinol; Δ9-THC

Extracts and Tinctures of Cannabis

Isomers of THC

About Foundation of Cannabis Unified Standards (FOCUS)

Established in 2014 as The Cannabis Health and Safety Organization, FOCUS is a 501c3 non-profit that addresses the many shortcomings in quality, safety, and consistency that have become evident with the explosive growth of the global cannabis industry. FOCUS is not a cannabis company, an industry trade association, nor an advocacy organization. FOCUS is an unbiased, third-party with no financial stake in – or funding from – the cannabis industry. FOCUS does not advocate on behalf of or push cannabis policy. FOCUS exists to help assure the rapidly growing global cannabis industry has the necessary protections in place for the health, safety, success, and welfare of everyone. This autonomy fosters a principled, objective organization that protects end users, and acts as the much-needed neutral, nonpartisan bridge between industry and regulatory. 

www.focusstandards.org

Filed Under: International Tagged With: FOCUS, Lezli, World Health Organization’s (WHO) Expert Committee on Drug Dependence (ECDD)

About Lezli Engelking

Lezli Engelking
Founder | Foundation of Cannabis Unified Standards (FOCUS)

FOCUS is the only international, third party, non-profit, cannabis standards development organization created to protect public health, consumer safety, and safeguard the environment.

Through two-decades of professional experience across pharmaceuticals, mental health, non-profit and cannabis industries, Lezli realized the only way to build a truly sustainable, legal, cannabis marketplace – not just on a national level- but globally – was to develop international, voluntary-conformance cannabis standards suitable for adoption into regulation that would serve as the common language necessary to ensure the quality and safety guidelines required for international commerce.

Lezli’s ability to envision simplified solutions to complicated situations make her the perfect candidate to lead FOCUS and work in the formulation of international public policy to ensure the highest standards that protect public health and safety are met and maintained. www.focusstandards.org

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