UN Ketamine Vote Could Spark Public Health Crisis in Developing World
The Commission on Narcotic Drugs (CND) in Vienna will soon decide between two opposite proposals by China and the World Health Organization (WHO) concerning the international control of ketamine, an essential anaesthetic in human and veterinary medicine.
China originally proposed bringing ketamine under the 1971 Convention’s most severe control regime of Schedule I, which would dramatically affect its availability for surgery in poor rural settings and emergency situations. The WHO Expert Committee reviewed all the evidence and advised against any international control of ketamine, arguing it would trigger a public health disaster.
A fact sheet produced by concerned NGOs has received endorsements from over 80 organizations around the world, including many medical associations of anaesthesiologists and palliative care. The International Federation of Red Cross and Red Crescent Societies additionally came out with its own statement of concern.
At Intersessional CND meetings in recent weeks in Vienna, several countries expressed their worry about the Chinese proposal and questioned the procedural legality of bringing it to a vote now that the WHO has strongly recommended against it. Confronted with broad opposition, China changed it proposal and now calls for inclusion in Schedule IV instead, the lightest control regime under the 1971 Convention.
The move is meant to soothe concerns and apparently several countries that opposed China’s original proposal are considering the softer option as an acceptable compromise.
Adding ketamine to Schedule IV, however, would still negatively impact on its availability in a number of countries -- albeit less severely compared to Schedule I -- leaving millions of people at risk of not having access to anaesthesia if they require surgery (see extended fact sheet). Moreover, too little attention has been given in the debate so far to the potential consequences for future scheduling decisions, as this would set a precedent to add substances to the treaty schedules, bypassing the WHO's expert advice.
In response to questions raised about the procedure, the United Nations Office on Drugs and Crime (UNODC) asked the UN Office of Legal Affairs (OLA) in New York for a legal opinion about the basic question: "Can the Commission on Narcotic Drugs schedule a substance under the Convention on Psychotropic Substances of 1971 if there is a recommendation from the World Health Organization that the substance should not be placed under international control?". Unfortunately, under time pressure, OLA produced an unhelpful, confusing and questionable legal argumentation concluding that "the Commission can schedule a substance under the Convention on Psychotropic Substances even if there is a recommendation from WHO that the substance should not be placed under international control" (E/CN.7/2015/14).
The 1971 treaty -- as explained in detail in its Commentary -- established a threshold for substances to be eligible for international control, which requires a careful weighing of their addictive and harmful properties against their medicinal usefulness. The review of the WHO Expert Committee on Drug Dependence is "determinative" regarding medical and scientific matters, whether or not a substance meets that threshold. Once the WHO has determined that a substance meets those minimum criteria warranting international control, the CND can discuss the WHO recommendation and consider additional arguments ("economic, social, legal, administrative and other factors it may consider relevant") to either adopt, reject or deviate from the choice for the particular Schedule recommended by the WHO. As spelled out in the Commentary on the 1971 Convention, if the WHO "recommends in its communication to the Commission that the substance should not be controlled, the Commission would not be authorized to place it under control" (§ 22, p. 71). Clear and simple, it seems, but apparently not for the Office on Legal Affairs.
In its legal opinion, OLA acknowledges that "WHO assessments are determinative as to medical and scientific matters of a substance," but then continues saying: "but the ultimate authority to decide whether the substance should be added in a Schedule rests with the Commission. In doing so, the Commission is required to take into account factors broader than medical and scientific factors." The CND "is expected to take a broader perspective, and is required to take into account all relevant factors to reach a conclusion." On those grounds OLA then reaches its controversial conclusion quoted above, contradicting the official Commentary, and clearing the path -- though the OLA advice is not binding in any way -- for bringing China’s proposal for scheduling to a CND vote next week.
Two-thirds of the 53 CND Member States would need to vote in favor to adopt it; in other words if 18 countries vote against it or abstain from voting the proposal would be rejected.
Following OLA's treaty interpretation means that the other factors that the CND needs to consider (economic, social, legal, administrative) may provide sufficient reason for adding a substance to a treaty schedule, including if the substance does not meet the required threshold of dependence-producing and harmful properties. The OLA opinion confuses the clear intention of the treaty to establish a minimum threshold to be determined on the basis of medical/scientific evidence by the WHO, with the subsequent discretion of the CND to deviate from WHO's specific recommendation about which schedule would be most appropriate, after taking into consideration other factors. It is difficult to understand how OLA arrived at such a fundamentally flawed judgement.
As OLA itself has confirmed, there is not a single precedent in the history of scheduling decisions under the 1971 Convention where the CND decided to schedule a substance that had not been recommended for scheduling by the WHO.
If the CND would decide to vote on the Chinese proposal to schedule ketamine, despite the fact that the WHO has already determined three times that it does not meet the threshold criteria for international control, it would therefore set a very worrying precedent. It effectively means the removal of the medical/scientific threshold for international control and abolishing the determinative nature of the mandate given to the WHO. The consequence of that for the future would be that any CND Member State from now on can call for a vote to put any substance on whatever schedule of the 1971 Convention (under the 1961 Convention this would be unthinkable), regardless of the opinion of the WHO Expert Committee. Tramadol and khat would be likely candidates to become scheduled in the coming years in a similar way, using the ketamine precedent to justify neglecting WHO’s expert advice again.
The OLA opinion was accompanied by a disclaimer saying that countries and the CND "may take a different view to the responses we provide. As such, our response should not in any way be construed as the only or definitive view." Countries should critically examine OLA's legal opinion and carefully consider its consequences for the future functioning of the UN drug control treaty system.
Allowing the CND to vote about the scheduling of ketamine contrary to the WHO’s recommendation makes a mockery of the evidence-based intentions of the treaties and politicizes scheduling decisions in the future. Countries that are genuine in their calls for a more health- and human rights-based drug control system, for improving access and availability of essential medicines and for a more evidence-driven drug policy making, cannot allow this to happen.