The ketamine controversy, continued

UN legal opinion adds confusion while China changes its scheduling proposal
06 March 2015
Opinion

The Commission on Narcotic Drugs (CND) in Vienna will decide next week between two opposite proposals by China and the WHO about 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, TNI among them, has received endorsements from over 80 organisations around the world, including many medical associations of anaesthesiologists and palliative care. The International Federation of Red Cross and Red Crescent Societies came out with its own statement of concern. At intersessional CND meetings past 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, less severely so when compared to Schedule I, but millions of people would still be 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 WHO's expert advice. In response to questions raised about the procedure, 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 favour 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.

OLA also looked into the scheduling history to determine whether there have been any precedents for the situation the CND is confronted with now in the case of ketamine. Two previous cases, in 1991 and 1999, were identified as possibly relevant cases to consider. After acknowledging their different nature compared to the question at hand and that "these two cases seem to indicate that the Commission has generally followed WHO recommendations", OLA then concludes in what again appears to be a difficult-to-follow twist of the argument that "the practice of the Commission to reject WHO recommendations is still relevant as it indicates that the Commission has not felt itself bound by WHO recommendations." For the matter under consideration not only a confusing but also an irrelevant remark, because nobody questions that the CND has considerable discretion under the 1971 Convention (more than allowed under the 1961 Convention) to deviate from WHO scheduling recommendations. The treaty and the Commentary make very clear that indeed, the CND is not "bound by WHO recommendations". The one thing the CND is not allowed to do, however, is scheduling a substance that the WHO has reviewed and concluded that it does not meet the threshold that warrants international control. In the case of ketamine, the WHO has reviewed and decided that three times now...

In one of the previous cases the OLA refers to, arguments were raised in the procedure that could in fact be relevant for the current situation. In short, Spain, worried over the amount of new psychoactive substances appearing on the market, tabled in 1999 a proposal to add all isomers, esters and ethers of substances already on Schedule I or II, placing all such chemically similar substances under the same control. The WHO reviewed the Spanish proposal, and recommended instead to only add substances falling under the much narrower definition of "stereoisomers" and only for Schedule I. The CND adopted by vote the WHO recommendation, and according to the OLA document "there is no record of any action taken with respect to the substances to which WHO objected". And indeed, correctly following treaty procedures no vote was taken on the Spanish proposal because that included a much broader range of substances that the WHO had not recommended for international control.

The Netherlands argued at the time that the 1971 Convention "prescribes that new substances should first be carefully examined by WHO and then could be added to one of four Schedules if deemed necessary" and that the Spanish proposal therefore "may contradict the scheduling procedure". The Netherlands "attaches great importance to a balanced and thorough expert opinion on health and social risks created by new substances before they are included in a schedule. As indicated above, WHO is required by the Convention to examine and evaluate each individual substance. Applying unconditional analogue scheduling would, however, substantially diminish the importance of this WHO task. In the opinion of the Netherlands, this would be a loss of expertise and negatively affect the scientific basis of the decision-making process within the Commission on Narcotic Drugs."

As the OLA opinion confirms (in spite of its confused wording), 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 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...

See also my previous blog: “CND decision to schedule ketamine would undermine WHO treaty mandate”, 16 February 2015

World Medical Association warns against making essential anaesthetic a controlled drug, WMA press release, March 6, 2015

Friday, March 6, 2015