IDPC contribution for the pre-review of CBD and Tramadol at the 39th WHO Expert Committee on Drug Dependence

Marie Nougier
IDPC Advocacy Note
November 2017

idpc tramadol cbdThe Expert Committee on Drug Dependence (ECDD) of the World Health Organization (WHO) will hold its 39th meeting from 6th to 10th November 2017 in Geneva. The ECDD is mandated by the 1961 and 1971 UN drug conventions with the task of undertaking scientific reviews of substances and recommending their appropriate scheduling to the Commission on Narcotic Drugs (CND), taking into account both risks related to non-medical use and therapeutic usefulness.

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In the context of the proliferation of new psychoactive substances, the principle of scientific review is of greater importance than ever. In this regard, scheduling plays a key role in both restricting non-medical use of controlled substances and ensuring access to controlled medicines. The UNGASS Outcome Document gives due prominence to ensuring access to controlled medicines with an entire chapter dedicated to the issue, thereby raising the profile of the ECDD, which work in maintaining the principle of scientific review is critical and fully supported by IDPC.

At its 39th session, the ECDD will review a number of psychoactive substances and make recommendations to the UN Secretary General on whether and how these substances should be internationally controlled. Sixteen substances will be under review at the upcoming meeting, including cannabidiol (CBD) and tramadol. In this advocacy note, IDPC offers some analysis and key recommendations on these two substances to inform the ECDD’s meeting.

Recommendations on tramadol

IDPC recommends that tramadol remains under WHO surveillance, but that the ECDD does not request its scheduling in the international drug control treaties to ensure its continued availability to respond to moderate to severe pain, especially in developing countries.

Recommendations on CBD

The pre-review report on CBD has found ‘no effects indicative of any abuse or dependence potential’, that it has demonstrated to be ‘an effective treatment of epilepsy’, that it ‘may be a useful treatment for a number of other medical conditions’, and that ‘there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD’.

The Expert Peer Review No. 2 also concludes: ‘Based on available evidence CBD lacks psychoactivity, reinforcing properties and abuse liability. On the other hand, emerging findings suggest promising therapeutic usefulness. Scheduling this substance could impact accessibility for scientific and medical research’.

We agree with Expert Peer Review No.1 that the pre-review ‘does not justify scheduling of the substance’. We request, however, that the announced pre-review of ‘cannabis extracts and tinctures’ on the agenda of the upcoming special cannabis ECDD meeting in May 2018 clarifies the status of CBD within that broad category and, in light of the outcomes of the pre-review, considers a re-definition that explicitly excludes CBD in order to end the current ambiguity.

Procedural concerns

There are procedural issues that IDPC wishes to raise ahead of the November 2017 session. On the webpage of the 39th session of the ECDD, a note at the bottom states that ‘Depending on the outcome of the pre-review, the Expert Committee on Drug Dependence (ECDD) may proceed to a critical review at the same ECDD meeting’. In specific cases, the WHO can rule that a pre-review for a substance is not needed and it can proceed directly to a critical review. This is possible in three instances: in the case of a notification of a party, upon review request by the CND, or when ‘information is brought to WHO’s attention that a substance is clandestinely manufactured, of especially serious risk to public health and society, and of no recognized therapeutic use by any Party’.

While the WHO Guidance on substance review, approved by the WHO Executive Board in January 2010, provides for the option to skip a pre-review and immediately undertake a critical review in those cases, the note on the website seems to indicate that during the same meeting the ECDD could now also decide to treat a pre-review as if it were a critical review and proceed to make scheduling recommendations on the basis of a pre-review only. If that were indeed the case, that would be a worrying and unauthorised change of the standing rules of procedure, which explicitly state that the ‘pre-review is a preliminary analysis and findings at this stage should not determine whether the control status of a substance should be changed’.

 
Moving in that direction would be particularly problematic for substances like tramadol and CBD, which require an appropriate period of time to consider all available evidence regarding both illicit use and harms, medical and scientific usages, and potential impacts of placing them under international control. Moving immediately to scheduling recommendations on the basis of a pre-review without the additional scrutiny of a critical review would significantly undermine the scientific basis of the ECDD’s scheduling recommendations.