Monthly Archives: March 2015

Ketamine secured for medical and veterinary use!

Originally posted here

By Willem Scholten

On Friday 13th March, the Commision on Narcotic Drugs discussed the possible bringing of ketamine under international drug control. Initially, China proposed to add the substance under Schedule I of the UN Convention on Psychotropic Substances. Such a scheduling means that the substance can be used for medical purposes only under direct governmental supervision, and in very limited situations. The proposal was very inappropriate for an essential medicine. However, thanks to the efforts of many, China amended its proposal to the less strict Schedule IV of the same convention. Again we opposed this and thanks to our opposition, China withdrew this morning its entire proposal. The CND then decided to postpone its decision on scheduling ketamine to a future date to allow more information to be gathered. A transcript of the debate is available on the CND Blog.




This is a very good result and I want to thank everyone who was involved in the lobbying to keep access to ketamine as a human and veterinary medicine for his or her efforts. In the end we had 87 endorsements on the fact sheet and several organizations came to Vienna to convince the delegates personally. Many went to their governments to convince the ministries of health and the drug controllers that any scheduling of ketamine was not a good idea.

Over the past few weeks it became more and more clear that we were successful, and many countries declared that they would oppose the scheduling. Initially, we were able to find over 19 CND members opposing schedule IV, and once we had these, we continued to  convince more CND Member countries to oppose all scheduling. This became clear only gradually toward last weekend. In my messages you may have seen the countries I recommended to focus your lobby on. On purpose we decided not to be transparent on the countries we had convinced. I hope for your understanding, as such transparency would have made it easy for China to lobby these countries back into its camp.

During the week at the CND (which started last Monday), we discussed with country delegations the possible ways forward, being afraid of unwanted precedents in the procedure. But finally today, it happened as some had predicted: China withdraw its proposal while saving face by saying that this allows for more data collection. How serious this “more data collection” is, is in this stage not completely sure. It may be that we never hear back about ketamine scheduling, but some vigilance is needed in the coming years.

What further to do? There are over 50 countries who have scheduled ketamine in their national legislation (i.e. independent form the international drug control conventions). In several of these countries, veterinarians and physicians may have experienced reduced availability of ketamine already. They and their organizations may want to discuss the issue now with their governments in order to re-increase availability. Because of this CND and Chinas proposal, the climate may have changed now. After some of the preparatory meetings, someone mentioned that this was the first time ever that the countries at the CND discussed medicines availability for over three hours. Never before there was such a focus at the internaitonal levle on the relation between drug control and medicines availability. Therefore, this is the moment that most drug controllers around the world are seeing that drug control has also the negative side for public health of medicines unavailability.
Medical and veterinary organizations may also want to use the opportunity for discussing the availability of medicines controlled as drugs more in a general way, e.g. the availability of opioid analgesics, long-acting opioids for the treatment of opioid dependence, phenobarbital and other controlled medicines.

For those who want to take action in this regard, I also refer to the WHO Guidelines on this issue, available in multiple languages, including English, French and Spanish.


Another UN agency savages the drug war

Originally posted here

The United Nations Development Programme (UNDP), the UN agency charged with developing strategies to reduce global poverty, has strongly criticised current international drug policy, highlighting the disastrous costs it is producing – particularly for the world’s poor.

In the agency’s formal submission to the UN General Assembly Special Session (UNGASS) on drugs (PDF), launched at the annual UN Commission on Narcotic Drugs which began last week in Vienna, the UNDP argues:

"While drug control policies have been justified by the real and potential harms associated with illicit drug production, trafficking, and use (e.g., threats to safety and security, health problems, crime, decreased productivity, unemployment, and poverty), evidence shows that in many countries, policies and related enforcement activities focused on reducing supply and demand have had little effect in eradicating production or problematic drug use."

The agency goes on to say:

"As various UN organizations have observed, these efforts have had harmful collateral consequences: creating a criminal black market; fuelling corruption, violence, and instability; threatening public health and safety; generating large-scale human rights abuses, including abusive and inhumane punishments; and discrimination and marginalization of people who use drugs, indigenous peoples, women, and youth".

With regard to the harmful impacts on international development specifically, the UNDP states that international drug policy is having a negative effect on “poverty and sustainable livelihoods; governance and the rule of law; human rights; gender equality; the environment; and on indigenous peoples and traditional and religious practices.”  Detailed sections on each of these topic areas follow in the body of the report.

Ketamine under international law

This blog was originally posted here

Psychoactive substances or ‘drugs’, often associated with recreational use, are in fact commonly used for a variety of medicinal purposes. It is even less understood that the supply of more than 100 of these drugs is regulated by a complex system of international drug control underpinned by three United Nations treaties with near universal ratification. This post explores the relationship of drugs and international law, specifically international drug control law and international human rights law, using the topical example of placing ketamine under international control.

International drug control law

The legal framework of international drug control is shaped by three treaties: the 1961 Single Convention on Narcotic Drugs (as amended by the 1972 Protocol), the 1971 Convention on Psychotropic Substances, and the 1988 Convention against the Illicit Traffic in Narcotic or Psychotropic Substances. Scheduling is the process established by the treaties to bring certain psychoactive substances under a graded scale of international control. Scheduling a substance creates positive obligations for States to implement regulatory processes that meet or exceed requirements established by the treaties. In some overburdened health systems, this can lead to over-restrictive controls that inhibit medical access to essential drugs, well documented in the case of opioid analgesics.

Uses of ketamine

Ketamine’s unique properties make it one of the most important and widely used drugsin emergency and surgical medicine globally.   Where most anaesthetics require electricity for ventilators and gas masks, ketamine—an injectable anaesthetic—can be safely administered in settings without regular access to power, for example, war zones or impoverished rural areas. The analgesic properties of ketamine make its use during emergency surgery, such as for caesarean sections, indispensible for improving mortality outcomes in less-developed countries throughout the Global South. It is because of these properties that the World Health Organisation (WHO) placed ketamine on its list of essential medicines for both children and adults.

Outside of clinical settings, ketamine is used recreationally, although such use is mainly in more developed countries. China, in particular, views the illicit production of ketamine as an “increasingly serious” domestic issue and has repeatedly requested the substance be subject to international control. It is with this direction from China, that ketamine has made its foray onto the international legal stage.

Scheduling ketamine under international law

Established in 1946 by ECOSOC, the Commission on Narcotic Drugs (CND) serves as the principal policy-making body of the UN drug control system and under the three drug control treaties, it is mandated to oversee the scheduling system. China is currently one of 53 members of the CND, and is authorised under the treaties—in the case of ketamine, the 1971 Convention on Psychotropic Substances—to introduce substances of concern for scheduling consideration.  Procedurally, article 2 of the 1971 Convention requires the CND to submit scheduling recommendations to the World Health Organisation (WHO) for an evidence-based review to determine if the substance meets the criteria elaborated under article 2(4) to require scheduling (or not) and its degree of restriction under the graded scheduling system. Under article 2(5) of the 1971 Convention, the WHO’s recommendations are “determinative” when it comes to the “medical and scientific” basis for adding substances to a schedule.

This is not the first time China has requested ketamine be scheduled. The WHO’s review this year and each time before (see here and here) determined the public health risks associated with recreational use did not merit any measure of scheduling. The conclusive nature of this recommendation under the 1971 Convention has been subject to much interpretative debate. The current prevailing interpretation has placed the status of such a recommendation within broader considerations such as “economic, social, legal, [and] administrative” factors listed in article 2(5).

What this interpretation signals is that despite WHO’s determinative assessment that ketamine does not meet the criteria for scheduling under article 2(4), its scheduling may now be subject to a purely political process (a two-thirds vote by the CND would place ketamine under international control).

The control of ketamine and international human rights law

The impact the control of ketamine has upon human rights is a critical consideration. While human rights are not explicitly mentioned in the 1971 Convention, they are contained within the meaning of “legal” considerations as written in article 2(5), which States must take into account when deciding to add a substance to a schedule.

As mentioned previously, scheduling a substance creates regulatory barriers that have made essential medicines completely inaccessible for those most in need. These barriers result in on-going violations of human rights—most notably the right to health. The normative scope and content of the right is contained within article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) and imposes upon States core obligations to be given immediate effect. General Comment 14 on the right to health elaborates further that amongst this minimum core is the obligation to provide medicines as indicated on the WHO’s essential medicines list. As such, ensuring ketamine is available, accessible, acceptable, and of sufficient quality forms part of a State’s core right to health obligations.

Should ketamine fall under the scope of international control, any restrictive measures a State subsequently imposes cannot interfere with current levels of access. The imposition of international control requirements would in many States, restrict current levels of access to ketamine and amount to a deliberate retrogressive action in violation of the right to health. This is relevant to any scheduling level under the 1971 Convention. While Schedule 1 imposes the most restrictive control measures, States can apply equally or more restrictive measures for any schedule level under article 23. As such, the same human rights assessment would apply as States with less complex regulatory systems often lump controls into one or two highly restrictive categories—see the example of phenobarbital, a Schedule 4 drug under the 1971 Convention.

As the vote fast approaches, a human rights framework offers States a powerfulnormative counterweight to the political pressure they face to place ketamine—an essential, life-saving medicine—under unnecessary international control.

Visit the International Centre on Human Rights and Drug Policy for more resources.

Daily updates from the CND can be found here.

The ketamine controversy, continued

This blog was originally posted here

UN legal opinion adds confusion while China changes its scheduling proposal

Friday, March 6, 2015

The Commission on Narcotic Drugs (CND) in Vienna will decide next week between two opposite proposals by China and the WHO about international control ofketamine, 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.

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 (seeextended 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