The monitoring of trade in and control of psychotropic substances to guard against their diversion
A. Preventing the diversion of natural products
B. Prevention of diversion of manufactured products
Author: I. BAYER
Pages: 3 to 13
Creation Date: 1983/01/01
The establishment of international control of opiates has been an important achievement of the international community; this is substantiated by the fact that, at the beginning of this century, legally manufactured morphine and heroin were the principal sources of illicit supply, whereas at present the illicit traffic in these drugs is supplied from illicit sources. The poppy straw process has helped to promote measures to control opium poppy cultivation in a number of European countries; Turkey has been a successful example of such control. The present large-scale illicit traffic in cannabis resin and cocaine is the consequence of the lack of the implementation of provisions of the Single Convention on Narcotic Drugs, 1961, to control the cannabis plant and the coca bush at the national level.
The provisions of the 1971 Convention on Psychotropic Substances, being largely a result of international compromise, are not designed in the best possible way to prevent the diversion of psycho- tropic substances from legal sources to illicit channels. There are no appropriate provisions for the control and monitoring of international transactions. There is a discrepancy between the rather limited scope of international control of substances listed in schedules III and IV of the 1971 Convention and the much larger scope of control of hypnotics, sedatives and tranquillizers at national levels. The provisions of the 1971 Convention, however, constitute a legal basis for bilateral and multi- lateral actions for the detection of suspected diversion cases, and offer possibilities of promoting the prevention of diversion of psychotropic substances. At present, the relationship between the control of psycho- tropic drugs, including the prevention of diversion and the organization of the national drug supply system, as well as the efficacy of national control over pharmaceutical products, has not been fully recognized by the international community.
Before the establishment of the international drug control system, the diversion of legally manufactured narcotic drugs constituted a major source of supply for illicit traffic. There are many reports on this kind of diversion of psychotropic substances. Consequently, the study of possibilities for preventing such diversion has been extended to an analysis of the development of control measures used by Governments and the international community in the case of narcotics.
This article describes measures aimed at preventing the diversion of drugs from legal sources of supply to illicit channels and deals with both natural and manufactured products. The paper is divided accordingly into the following sections:
Preventing the diversion of natural products
Establishment of a functional control system
Elimination of opium production
Preventing the diversion of manufactured products
Schedule I substances
Schedule II substances
Schedules III and IV substances
Psychotropic drugs not under international control
Opium is the best example for the study of methods to prevent the diversion of natural narcotic drugs. In principle, there are two policy options for prevention: the establishment of a functional control system and the elimination of opium production.
The aim of a control system in an opium-producing country is to prevent diversion from each of three levels: from farmers, from opium factories and from the distribution system. For two main reasons India provides an excellent example of this system: it is the only country where such a system has been in operation for several decades, and Indian regulations and practices have served as models for international treaty provisions.
It is not by chance that measures for the control of opium poppy cultivation have been included among the provisions of international narcotic treaties only at a 'relatively later date. The explanation for the reluctance of the international community to take a decision on this important issue is that there was no precedent for including the control of an agricultural activity into an international treaty, and it was realized that without a well-designed national policy and appropriate national control machinery, international treaty provisions could never be implemented. In other words, the control of opium poppy cultivation was a national obligation as a consequence of international treaty provisions. In this case, the functioning of the international drug control system was even more dependent on national policies and practices than was the functioning of systems based on other treaty obligations.
A few decades ago, the Commission on Narcotic Drugs was led by the same considerations when it rejected proposals for the international control of Catha edulis (khat). The representative of one of the most important producing countries stated that his Government had neither the intention nor the means to introduce national control measures against the free cultivation of khat.
Without well-designed national policies and appropriate national control machinery, international treaty provisions for the control of agricultural activities cannot be implemented. The two best examples are cannabis and coca leaves: the large-scale illicit traffic in cannabis resin and cocaine is the consequence of uncontrolled cultivation of the cannabis plant and coca bush, which is due to the lack of national bases for the introduction and implementation of the respective provisions of the Single Convention on Narcotic Drugs, 1961.
Fortunately, the case of opium poppy cultivation in India offers a constructive example of the real possibilities for the control of agricultural activities. Evidence indicates that, at present, opium from licit production is practically not connected with the opium supply of clandestine heroin laboratories, which are supplied by illicit opium producers. However, owing to limitations of space, this paper will deal with the basic characteristics of the system rather than with a description of the control of opium poppy cultivation in India.
Licensing of cultivation and opium production by farmers form the basis of the control system. Licences are granted exclusively in areas of the country where the control of the farmers' activities can be assured. The necessary control mechanism is maintained by the Government. Opium processing is a governmental monopoly, to which farmers must sell their products. The key element of this system lies in the provision that the farmers' entire production must reach government stores.
Opium collected under this! system is processed in the governmental opium factory, where safety measures against diversion can be easily assured. In India, diversion from the processing level and from stores is prevented by this method.
There has been a spectacular decrease in the therapeutical use of medicinal opium in this century because of the conversion of opium by scientific development from a medicine into a starting material for the pharmaceutical industry. In many countries, opium no longer appears in its original form at the pharmacy level. As a consequence of this development, special measures for preventing the diversion of opium in the retail trade are needed only in countries with traditions of opium use for non-medical or quasi-medical purposes and where the old distribution system of opium vendors, opium shops etc. has survived in any form.
In 1925, the invention of the poppy straw process for the manufacture of morphine and other opium alkaloids by J. Kabay, a young Hungarian pharmacist, opened new ways of preventing opium diversion. By 1934, the advantages of the Kabay process were acknowledged by the League of Nations.
In countries such as Hungary, where the poppy has been cultivated for seeds and not for opium, the economic advantages of the Kabay process were of great importance because valuable alkaloids could be extracted from an inexpensive agricultural by-product. More and more countries followed Hungary's example and, as a consequence of this development, more opium alkaloids are extracted industrially from poppy straw than from opium on a world scale at present.
The poppy straw process prevented the introduction of opium production in many European countries, while in some other countries (e. g. Yugoslavia and the Union of Soviet Socialist Republics) traditional opium production has been eliminated. The most spectacular step against the diversion of opium was made by Turkey, where opium production has been eliminated by the Government. The existence of the Kabay process has been of great importance in the case of Turkey: poppy straw can now be extracted and alkaloids are manufactured in a new Turkish factory, constructed with United Nations assistance as an acknowledgement of and compensation for the services of the Government of Turkey in eliminating the possibilities for opium diversion in that country.
There is practically no legitimate manufacture of cannabis preparations, and the licit manufacture of cocaine does not contribute to the large-scale illicit cocaine market. Corisequently, the study of possible diversion of manufactured narcotic drugs can be restricted to the question of narcotic analgesics.
From the point of view of manufacture, there are four types of narcotic analgesics which can be obtained through:
Extraction of natural alkaloids from poppy straw or opium, such as morphine;
Conversion of a natural alkaloid into another natural alkaloid, such as the conversion of morphine into codeine;
Conversion of a natural alkaloid into an artificial alkaloid, such as the conversion of morphine into heroin or thebaine into dihydrocodeine; and
Synthesis of narcotic analgesics, such as pethidine and methadone.
The establishment of the international control system for the manufacture, trade, distribution, export and import of opiates is one of the great achievements of the international community. It is a fact that at the beginning of this century the legal manufacture of morphine and heroin were a major source of supply for illicit traffic. Huge amounts of legally manufactured opiates were diverted into illicit channels as a consequence of their unrestricted manufacture and uncontrolled trade. The step-by-step development of a well-designed international drug control system, including the national control of manufacture and distribution, the import and export authorization mechanism, the estimate and statistical return system and the monitoring of transactions by the International Narcotics Control Board, has led to the decrease or elimination of diversion of opiates from legal sources to illicit channels in most countries of the world. The compliance of Governments to this system is an outstanding example of an efficient international mechanism for the prevention of diversion cases.
The large-scale illicit traffic in heroin is the consequence of the existence of clandestine laboratories; the link between illicit traffic and the licit manufacture of and legal trade in opiates no longer exists as it used to.
There are minor loopholes in the system. In some developing countries, the lack of development of the health care system in general, and of the pharmaceutical supply system in particular, makes possible the diversion of pharmaceutical preparations containing opiates, usually in small quantities. This question is closely related to the problem of the diversion of pharmaceuticals containing psychotropic substances.
As a consequence of a number of compromises during the development of the 1971 Convention on Psychotropic Substances (hereafter referred to as the 1971 Convention), an enormous gap remained between the international and national control levels in respect of the scope of control of drugs having psychotropic properties.
The group of psychotropic substances is heterogeneous, and, consequently, substantial differences exist between control measures to be applied for the different schedules.
For the purpose of this review the diversion problems of psychotropic substances have been divided into the following four sections:
Schedule I substances of the 1971 Convention
Schedule II substances of the 1971 Convention
Schedules III and IV substances of the 1971 Convention
Psychotropic drugs not under international control
There are no diversion problems in the case of schedule I substances, which include mainly hallucinogens such as lysergic acid diethylamide (LSD) and phencyclidine (PCP). AS a consequence of their limited legitimate use, licit demand and manufacture are practically negligible compared with the large-scale clandestine production and illicit demand for these substances.
This study is not extended to the diversion of precursors and intermediates which can be used for the illicit manufacture of these substances.
The large-scale illicit traffic in amphetamines is supplied mainly by clandestine laboratories, but the diversion of pharmaceutical preparations containing amphetamines also contributes to the illicit traffic.
The provisions of the 1971 Convention for the prevention of diversion cases are inadequate. The lack of estimates and statistical reports hinder the monitoring of the functioning of the export and import authorization system. This shortcoming has, to a certain extent, been compensated for by the exemplary voluntary compliance of Governments with the recommendation of the Commission on Narcotic Drugs.
There are cases of amphetamine diversion from licit sources into illicit channels during international transactions. The following factors mainly contribute to such diversion:
Several important manufacturing countries are not Parties to the 1971 Convention, and compliance with its provisions depends more on the willingness of pharmaceutical manufacturers than on governmental controls in these countries;
Some Governments and manufacturers or exporters are not aware of or familiar with the provisions of the relatively new 1971 Convention; some countries do not exercise the necessary control measures on compounded pharmaceutical preparations containing schedule II substances;
The lack of control of imported pharmaceuticals in some developing countries facilitates the introduction of compounded preparations without control and without being noticed by the competent authorities.
There is a substantial decrease in the use of amphetamines for therapeutic purposes. The therapeutic importance of amphetamines was over-estimated in Some countries. The use of amphetamines and derivatives as slimming pills is no longer considered good medical practice. In some countries, amphetamine preparations were deleted by the drug regulatory authorities from the list of registered pharmaceuticals. Current evidence suggests that, as a consequence of the lack of licit demand, licit manufacture of amphetamines may be drastically reduced in the near future. It may be expected that the amphetamine situation could become similar to the case of hallucinogens - for example, illicit traffic may be supplied mainly by clandestine laboratories and in such a case the number of diversion cases will be reduced.
The abuse of methaqualone, particularly preparations containing methaqualone in association with diphenhydramine, constitutes a major problem in a great number of countries. Diversion of methaqualone from licit into illicit channels plays a very important part in the illicit methaqualone supply.
Methaqualone was put under international control in 1971. It soon became evident that diversion could not be prevented by the measures provided for schedule IV Substances; consequently, methaqualone was transferred by the Commission on Narcotic Drugs from schedule IV to schedule II in 1979.
The transfer of methaqualone to schedule II, the compliance of Parties with provisions of the 1971 Convention in respect of schedule II and voluntary reporting, as recommended by the Commission, made possible the better monitoring of international transactions and the easier detection of diversion cases. Evidence shows that even Governments that are not Parties to the 1971 Convention co-operate with other Governments by applying control measures on an individual basis.
The study of control measures provided in the 1971 Convention for schedule III and IV Substances reveals that the measures have limited value for the preventing of diversion. Although this paper does not intend to analyse the 1971 Convention, some features of the existing situation should be mentioned.
Without entering into a critical study of the scheduling criteria of the 1971 Convention, a general profile of psychotropic substances listed in schedules III and IV (although somewhat simplified) is of interest. The general characteristics of schedule III or IV substances are:
They are pharmaceutical products, usually hypnotics, sedatives or tranquillizers;
They are manufactured in great quantities by legal pharmaceutical firms;
They are prescription drugs, at least in industrialized countries;
They constitute the ingredients of many pharmaceutical preparations, including combination products;
They are marketed under a great variety of proprietory names;
There is an important domestic and international trade in these substances;
Cases of their diversion are rare or unnoticed;
There are no or exceptionally rare reports on their illicit manufacture;
With exception of codeine, their legitimate consumption is much larger than consumption of any drugs listed in other schedules of international treaties;
Their over-prescribing and over-consumption create problems;
There are many reports on cases of their abuse, frequently in association with alcohol, and few reports on cases of dependence;
Even in countries where the incidence of cases of abuse of these substances is relatively high, compared with the high incidence of cases of licit use, the extent of their abuse is proportionally low.
It is of interest to mention that several elements of these general characteristics have been used as arguments against the international control of schedules III and IV type drugs. In 1971, these arguments led to far reaching compromises during the establishment of drug lists and influenced the formulation of provisions containing control measures for schedules III and IV Substances.
In the majority of countries with developed health care systems and pharmaceutical services, many hypnotics, sedatives and tranquillizers that are in conformity with the "profile" described for schedules III and IV substances are marketed. With a few exceptions, these classes of drugs are indeed Subject to identical national control measures. The basic problem lies in the discrepancy between the very large scope of control of the substances at national levels and the limited Scope of international control of a few representatives of the same class of drugs in schedules III and IV.
As a consequence of further international compromises, the 1971 Convention contains more provisions for the control of schedules III and IV substances at national levels than provisions for the monitoring and control of international transactions.
These problems have been Studied by expert groups and it is expected that recommendations for the amendment of the 1971 Convention will be examined by the Commission on Narcotic Drugs in the near future.
Even the shortcomings of the 1971 Convention do not diminish the importance of the existence of schedules III and IV in preventing diversion. The provisions of the 1971 Convention offer several possibilities which can be used by Governments for this purpose. Article 21 (b), (c) and (d)provides, inter alia, that "Parties shall:
"Assist each other in the campaign against the illicit traffic in psychotropic substances. . . Co-operate closely with each other and with the competent international organizations . . . Ensure that international co-operation between the appropriate agencies be conducted in an expeditious manner."
The importance of these general provisions lies in the fact that they constitute the legal basis of any bilateral and multilateral action for the detection of suspected diversion cases and the co-operation between governmental agencies.
Article 16 (paragraph 3 (a), (b), (c) and (d))stipulates that Parties shall report to the Secretary-General any case of illicit traffic which they consider important because of (a)new trends disclosed; (b)the quantities involved; (c)the light thrown on the sources from which the substances are obtained; or (d)the methods employed by illicit traffickers.
In the author's opinion this type of information is more useful for competent national authorities than for global statistics on manufacture and foreign trade.
Article 13 constitutes an important provision against diversion. An importing country is in a position to notify exporting countries that it prohibits or restricts the import of specified psychotropic substances, and exporting countries being so informed are obliged to take measures in accordance with the notification.
For the time being, the importance of this provision has not been fully realized. It offers a realistic approach for the solution of the existing conflict between exporting and importing countries. Many developing importing countries, owing to the underdevelopment of their control services, are not in a position to establish functional mechanisms for controlling shipments of imported pharmaceutical products. Owing to the great number of manufacturers and exporters in industrialized countries, many exporting countries are not in a position and are not bound by the 1971 Convention to check every shipment of pharmaceutical products. Article 13 offers a possibility for an importing country to specify psychotropic substances that are unwanted in the country enabling exporting countries to introduce measures against the free export of the specified psychotropic substances to countries that have notified the Secretary-General.
There is a practical example for the proper use of article 2 of the 1971 Convention as an instrument against diversion. Methaqualone was transferred by the Commission from schedule IV to schedule II. Article 2, paragraph 1 , of the 1971 Convention contains provisions for the addition of a drug to one of the schedules and also for the transfer of a substance from one schedule to another : ". . . when a Party or the World Health Organization (-WHO) has information justifying the transfer . . .". Cases of diversion justify such an action. The possibilities offered by this provision have not been exploited by Governments ; most Governments usually wait for an initiative from WHO without taking into account that the competence of WHO is limited to medical and scientific issues. Consequently, WHO does not systematically collect information on diversion cases.
The difference between the scope of national control regimes and the scope of schedules III and IV of the 1971 Convention has been described in the previous section. It must be admitted that the scheduling criteria of the 1971 Convention leave room for arbitrary decisions and the author of this paper does not believe that it would be possible to develop evaluation criteria for abuse potentials of a given Substance that would be acceptable from a scientific point of view and realistic from a practical point of view. The main reason for such doubt lies in the fact that the choice of drug abusers is, to a large extent, influenced and determined by the availability of individual psychoactive pharmaceuticals ; thus scientifically evaluated and quantified abuse potentials of drugs are of secondary importance. This fact must be taken into account when Governments and international organizations are undertaking measures to prevent the diversion of drugs. In other words, it would be a mistake to neglect the possibility of the diversion of other psychoactive pharmaceuticals that are not yet scheduled but could be used and abused in the same manner as substances listed in schedules III and IV of the 1971 Convention.
This problem cannot be separated from the control of pharmaceutical products in general, because:
There is a large number of pharmaceutical products containing psychotropic substances or similar drugs;
The proportion of these products in drug consumption statistics is very high ; .
Pharmaceutical preparations containing psychotropic ingredients constitute an integral part of drug therapy;
Prevention of over-consumption, over-prescribing, abuse and dependence is the task of national public health authorities;
The role of law enforcement authorities in the control of these substances is much more limited at the national level than in the control of narcotics and drugs listed in schedule I of the 1971 Convention,
The above statement does not diminish the importance of the role of national law enforcement services (customs, police) in this field but in contrast to cases of narcotic offences that can be dealt with by law enforcement agencies with no or little involvement of public health authorities, efforts of the same agencies would be ineffective in cases of psychotropic pharmaceuticals without the co-operation of the competent pharmaceutical control authorities. On the other hand, at the international level, co-operation between national law enforcement agencies is of capital importance.
At present, the relationship between the control of psychotropic drugs, including the prevention of diversion and the organization of the national drug supply system, as well as the efficacy of national control over pharmaceutical products, has not been fully recognized by the international community.
With respect to the diversion of psychotropic drugs, the author raises the following two questions :
Would it be possible to prevent the introduction of any psychotropic drugs, including schedule III or IV substances, into a country where every pharmacist has the right to import any pharmaceutical product without the knowledge of the national authorities?
How can diversion cases be detected in a country where the marketing of 2,370 pharmaceutical preparations was approved by the authorities but the number of such preparations exceeded 15,000?
The underdevelopment of the national drug supply system and pharmaceutical control services are the most vulnerable points of efficient preventive measures against diversion. It would be the duty of the competent international organizations to promote technical co-operation with a view to assisting in the development of these services in developing countries as one of the priorities in their work. Co-operation between the United Nations, WHO and the United Nations Industrial Development Organization (UNIDO) should be extended to this field, and the United Nations Fund for Drug Abuse Control could assist the organizations in their efforts.