Currently, the Commission on Narcotic Drugs is meeting in Vienna, Austria and one of the most debated issues is whether the Commission will vote to schedule the drug ketamine under the Convention of Psychotropic Substances of 1971. Regarding this issue, a critical legal interpretation question exists – does WHO have the power to veto the scheduling of a substance under the aforementioned Convention? Bottom line: If WHO does not have veto power, and if the parties to the Convention decide to schedule ketamine, then a high risk exists that a drug on the Essential Medicines List may become much harder to access and acquire. By way of background:
Ketamine: Ketamine is a medication on WHO’s Essential Medicines List. Ketamine is mainly used for anesthesia purposes and is often used in developing countries and in crisis situations. Ketamine is often used during childbirth in developing countries. It is also often used in veterinary medicine. In particular situations, WHO has found Ketamine’s ease of administration is advantageous compared to using anesthetic gases, which are difficult to use due to limited equipment availability and lack of appropriately trained specialists.
However, Ketamine is also used as a recreational drug with hallucinogenic effects. Further, the illicit manufacture of ketamine is of increasing concern in east and South-East Asia according to the United Nations Office on Drugs and Crime. Convention on Psychotropic Substances of 1971: The Convention is a United Nations treaty that establishes an international control system for psychotropic substances. Substances subject to the Convention are scheduled on a scale of 1 to 4. A Schedule 1 substance presents a high risk of abuse, posing a particularly serious threat to public health, with very little or no therapeutic value. A Schedule 4 substance presents a lower risk of abuse, poses a minor threat to public health, with high therapeutic value.
In determining whether to schedule a substance, the Commission shall take into account the assessment of WHO, whose assessments shall be determinative as to medical and scientific matters, and bearing in mind the economic, social, legal, administrative and other factors it may consider relevant.
If a substance is scheduled, parties to the Convention must take a variety of actions depending on which Schedule the substance falls into. These actions can include licensing, dispensing only by prescription, and adoption of measures regarding export, import and repression of acts contrary to the Convention. As a result of such actions, the availability of a scheduled substance may be reduced and access to the substance may become challenging, even if the substance has significant medicinal value. Current situation:
In March of 2014, China, through appropriate notification channels, recommended that ketamine should be placed on Schedule 1 of the Convention. Schedule 1, as previously described, is for substances with a high risk of abuse and are a serious threat to public health. If ketamine were placed on Schedule 1, its availability on the formal market would be significantly curtailed. Currently, ketamine is not scheduled. Of note, in early March, China amended its recommendation to recommend scheduling ketamine as a Schedule 4 substance rather than a Schedule 1 substance. This amendment reduces but does not eliminate potential barriers to access of ketamine as a result of scheduling ketamine under the Convention.
In accordance with the Convention, the views of parties to the Convention and WHO were sought about the potential scheduling of ketamine. Countries provided various comments regarding the proposed scheduling. WHO, after completing its internal review process, recommended that ketamine should not be placed under international control at this time and should not be a scheduled substance under the Convention.
WHO’s recommendation created questions regarding the legal interpretation of the Convention. Namely, can the Commission schedule a substance under the Convention if WHO recommends that the substance should not be placed under international control? The Convention clearly states that WHO’s assessments are determinative as to scientific and medical matters. The question is whether this determinative assessment means that WHO’s views must be followed such that the Commission would not be able to schedule a substance under the Convention if WHO recommended against scheduling – essentially granting WHO veto power on whether to schedule a substance.
The United Nations Office of Legal Affairs provided a legal opinion that concluded that the Commission could schedule a substance under the Convention even if WHO recommended that the substance should not be placed under international control, provided that the Commission has taken into account the relevant factors outlined in the Convention. Other scholars, however, have found the language of the Convention and past practice provide for such a veto. My view, for what it is worth:
I agree with the legal opinion of the UN Office of Legal Affairs that WHO does not have veto power. Although WHO’s views are determinative with regards to medical and scientific matters, these are two of six explicitly mentioned factors. Medical and scientific matters should hold significant weight, as noted in Commentary to the Convention, but are not the exclusive factors for determining whether a substance should be scheduled.
More abstractly, if WHO had a veto, it would present an interesting situation where a recommendation that comes from the secretariat of an international organization (with input from experts and governments) could trump the votes of countries who are parties to the Convention regarding whether a particular activity should be applicable under international law.
However, even though I do not believe that WHO has veto power, I would be very hesitant to support the idea that ketamine should be a scheduled substance under the Convention. Ketamine is an essential medicine and any barriers to access, especially the impact of the Convention’s licensing requirement, must be critically analyzed under the economic, social, legal and administrative factors. I believe there is a strong argument that in addition to the medical and scientific factors, the economic, social, legal and administrative factors sway the analysis towards refraining from scheduling ketamine under the Convention at this time.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.