Draft WHO Guidance Document Will Substantially Enhance the International Controlled Substance Scheduling Process

September 24, 2007

The United Nations (“UN”) drug control system is given authority, through treaties (called “conventions”), to establish international controls and monitor medicines that are subject to abuse.  Member countries that are signatories to the conventions are committed to control substances at the same level as dictated by the UN.  In the United States, this is accomplished through enforcement of the federal Controlled Substances Act.

International control and restrictions on these medicines affect patient access to medicines in every country, but in the Third World the effect of scheduling controls for medicines can be devastating, as the New York Times reported in a September 2007 article, titled “Drugs Banned, Many of World’s Poor Suffer in Pain.”

Understanding and navigating the UN’s drug control system is not easy.  Very broadly, the international scheduling process can be described as encompassing the interaction of two distinct bodies.  In the usual scheduling sequence, the World Health Organization (“WHO”) conducts a scientific and medical review that forms the basis for a scheduling recommendation that is submitted to the UN Commission on Narcotic Drugs (“CND”).  The CND is constituted as a kind of legislature, comprised of representatives of the signatory nations.  The CND will consider the WHO recommendation in the context of social, behavioral and other matters related to the public health and safety to make a final scheduling decision.  These decisions become amendments to the international control treaties which member countries are then bound to adopt.

When substances are put forth to be considered by WHO for scheduling recommendations, interested parties who would seek to provide information relevant to such decisions often find just knowing how to proceed is a challenge.  The conventions and their commentary are a tangle of frequently obscure and conflicting guidance.  Administrative due process of the kind we enjoy in this country is virtually nonexistent under the convention system.

There is, however, good news to report.  At WHO, where the critical medical evaluation is formulated for a scheduling recommendation, new and much improved guidance has been proposed for the deliberations of the expert committee that WHO uses to conduct the scientific and medical review that forms the basis for the scheduling recommendation.  This document, which is lugubriously entitled “Guidelines for the WHO review of psychoactive substances for international control,” is intended to replace the even more lugubriously entitled “Guidelines for the WHO review of dependence-producing psychoactive substances for international control.”  The new guidance will be put before the Executive Board of the World Health Assembly for adoption in January 2008.  If adopted, the process at WHO will improve considerably.

If adopted, the new guidance will enhance the ability of industry to work with WHO.  For the first time interested parties, and not just governments and WHO-recognized nongovernmental organizations (“NGOs”), will be formally permitted to present information to the expert committees.

The new guidance promotes quality in the work of the expert committees.  The guidance declares that the decisions must be evidence-based.  The primary reference used by the committees is a paper created for their use, called the “critical review document.”  Under the new guidance, this vital document will now be given two peer reviews to assure quality.  In addition, the important documents in the WHO review will now be put in the public domain, on the Internet at WHO’s website.

Another important change, one that the authors of the New York Times article would appreciate, is the express recognition that availability of medicines should be considered in the expert committee’s reviews.

The new guidelines document, if adopted, will certainly help to improve the medical judgments made in the UN’s scheduling process.  Our firm, and in particular Jim Phelps, has made significant contributions in the development and promotion of this much improved guidance.