Drug Abuse

Times had indeed changed since Governments had been prepared to go to war to protect the commercial interests of [their] factories, which used to flood the markets of distant countries with heroin.... Amphetamines and the barbiturates ... [are] at present being exported by the ton to those same distant countries, and that trade [is] legitimate. It [is] essential to give those distant lands the right to protect their peoples.
J. Mabileau, delegate of France, in a statement to the Vienna Conference, 1971

The Vienna Convention on Psychotropic Sub-stances was adopted on 21 February 1971 by a plenipotentiary conference in Vienna. Under it, amphetamines, barbiturates, tranquilizers, and hallucinogens will be brought under interna-tional control. How did these controls come about?

Behind the events leading up to Vienna was the underlying fact that problems related to the use of these "psychotropic" sub-stances occurred. Japan, for instance, had serious problems after World War II with widespread intravenous use of amphetamines. The WHO Expert Committee had taken note of this problem several times since 1949, though it had not, on those occasions, considered international action warranted. The Commission too had discussed amphetamines as well as barbiturates and halluci-nogens a number of times. At the 1%1 conference which adopted the Single Convention, some participant states had agreed that amphetamines, barbiturates, and tranquilizers constituted a public health hazard. However, a resolution calling for strict national control and for looking into the necessity and possibility of international control had failed to attain a two-thirds majority.

Moves towards International Control

At a session of the Commission later in 1%1, the question of the national and international control of barbiturates was re-introduced by Turkey, the United Arab Republic, and Yugoslavia (CND: 16th, 1%1). The proposal was reconsidered the following year, when it was rejected. Instead, the Commission agreed on a recommendation for national control of production, distribution, and use. Themes which were to recur were already developing. One was the concern of the Commission with drugs outside the scope of existing treaties. Another was the tendency of the developing countries to use this as an opportunity for turning the tables on Western industrialized countries and have the weight of control (hitherto felt most by them) spread equally over production of raw materials and synthetic manufacture. Yet another was the insis-tence by some of the protagonists that national, not international, control was the preferred and sufficient response.

In 1963 and 1964 the Commission considered LSD, a drug for whose control the U.S. was the chief proponent. In 1%5 Sweden came on the scene, advocating international controls over some stimulants. Sweden had been grappling with problems related to stimulants since the 1940s, when in response to a high rate'of oral consumption it had exerted national control through making most of the existing narcotics regulations applicable to these drugs. With the occurrence of intravenous stimulant use, Sweden had formally classified stimulants as narcotics and had sought to affect availability through law enforcement and a close watch over prescriptions. An illicit market developed with the reduction of licit supply, and the fact that other European countries did not control stimulants made for a great deal of smuggling. Sweden saw that international cooperation between police and customs author-ities was difficult to achieve unless other countries felt it incumbent upon them to accept treaty-bound obligations and enforce compat-ible drug controls. At the World Health Assembly in May 1965, Sweden was one of the sponsors of a resolution on sedatives and stimulants (WHA 18:47) containing recommendations for pre-scription control, health education, and research. The WHO secretariat was asked to study the "advisability and feasibility of international measures of control."

The WHO Expert Committee made a significant move when it recommended the following measures of control over stimulants and sedatives (WHO/EC DD, 1965):

1. Availability on medical prescription only

2. Full accounting for all transactions from production to retail distribution

3. Licensing of all producers

4. Limitation of trade to authorized persons

5. Prohibition of unauthorized possession

6. Establishment of an import-export authorization system

However, of these actions, only the last is international in character.

When the Commission met in 1965 a special committee was established to consider controls over such substances outside the drug conventions then in force as barbiturates, tranquilizers, and amphetamines. Before the time the committee met—this was eight months later in August 1966--the situation "was to change radically." LSD was singled out by it in a special resolution con-demning all usage other than for medical and scientific purposes (E/CN.7/498, 1966). To amphetamines, barbiturates, and tran-quilizers, the committee gave second place. Among the views of the committee regarding these drugs were those of some observers that the market for these drugs was "being overexploited"; that "super-fluous production and stocks" continued to increase the risk of diversion; and that "professionally and commercially the risks involved had been viewed too lightly." They also referred to "irres-ponsible prescribing and dispensing by doctors, improper self-medication by individuals," and "illicit introduction of these drugs into countries for abuse" (E/CN.7/ 498, 1966). At its session in 1966 the Commission accepted the committee's report and asked the Division to undertake, in consultation with WHO and the Board, a study on the legal, administrative, and other questions involved in initiating international action (CND: 21st, 1966). In May 1967 ECOSOC adopted a strong resolution for national controls over LSD (E/RES/1197 [XLII1). This was followed by a World Health Assembly resolution of a week later, similarly focused on LSD, in which a study on the feasibility of international control was urged (WHA/ 20.42). The Assembly also adopted a resolution on seda-tives and stimulants, asking for those national controls that were enumerated by the WHO Expert Committee in 1964, to which reference has already been made. In the Commissions's 1967 session a working group was appointed to study the implications of control.

The Positions Taken

Linked to the events just recapitulated are the views, reactions, and preferences promoted by nations, groups, and individuals with varying degrees of access to and influence on decision-making. What these were on the part of the Board and the Division are expounded in a document prepared by the Division in response to the Commission's request for a study on the administrative and legal aspects of control mentioned earlier.* On the assumption that a consensus existed on the necessity for international control, the document proceeded to spell out the choices which were available to the international community in the selection of control measures.

When the Commission asked for the study, it had directed that special priority be given to "the problem of LSD and similar substances." However, the Division's paper pointed out that the common denominator of the various positions held by WHO and the Commission was the necessity for mandatory national controls through an international treaty, new or adapted, and that this was fully consonant with the position held by these bodies in relation to amphetamines, barbiturates, and tranquilizers. A treaty "covering the whole field of psychotropic substances" would, however, have to reflect the "greater gravity" attributed to LSD.

The Board's views were expressed in a memorandum appended to the Division's paper. It considered several possibilities. One was the restriction of "undesirable commercial advertising of dan-gerous drugs" through articles 21 and 22 of the WHO constitution, authorizing the adoption by the World Health Assembly of, among other regulations, those concerning "advertising and labelling of biological, pharmaceutical and similar products moving in inter-national commerce." The Division's paper considered such restric-tion only "an ancillary measure of control" and advised against it. The Board had also considered the amendment of the Single Convention, and the conclusion of a special treaty. The Board argued against amending the treaty, and the Division concurred, with the comment that such an amended treaty would be a jigsaw puzzle. The Division's paper also ruled out the application of article 3 and proposed a new treaty. Although the Division emphasized considerations of practicality in the selection of control measures and the Board was mainly concerned with legal arrangements, the two bodies arrived at essentially the same conclusions.

The Board's paper also tackled the question of the application of article 3 of the Single Convention providing for the inclusion of drugs liable to similar abuse and productive of similar ill effects as drugs already included or readily convertible into drugs showing such a similarity. It was up to WHO, the Board thought, to interpret the term "similar," but some similarity in ill effects appeared to the Board to exist between morphine and barbitu-rates or some tranquilizers, between cocaine and amphetamines, and between cannabis and some hallucinogens. Nevertheless, the Board agreed with the WHO representative (Halbach) when he spoke to the Commission about the legal difficulties of applying article 3: "the drafter of the Single Convention had not intended to include dependence-producing drugs other than those listed in the schedules." The crux of the matter was what degree of similarity WHO considered a drug should display before it could be placed under existing international control. The Board's opinion was that a narrow definition of "similar" had in fact been intended. According to the Board it had been the understanding of the Commission when drafting the Single Convention and of the dglegates who adopted it at the conference in 1961 that ampehtamines, barbiturates, and tranquilizers could not be included on grounds of similarity. The draft resolution moved by some delegates on international control of these drugs would have been unnecessary if article 3 of the Single Convention were applicable to the drugs in question. The Board also thought it interesting that no government in favor of international control over psychotropic substances had initiated a procedure under article 3.

The Division's commentary provided the counterpoise to the Board's arguments. It stated that "in very general terms" depres-sants of the central nervous system "might be assimilated" to the group of drugs of the morphine type, the stimulants assimilated to cocaine and the hallucinogens assimilated to cannabis or cocaine or both. It further noted that the contents of the control schedules of the Single Convention had not been determined on the basis of a finding of similarity between the drugs controlled, and some national governments had not balked at including amphetamines and hallucinogens in narcotics legislation. Theo-retically, "given the heterogeneous character of the substances in the first two Schedules of the Single Convention, other heteroge-neous stimulants and depressants of the central nervous system might be assimilated to it." The paper concluded that "if for empirical or pragmatical reasons, control measures of a selected degree are to be applied to these substances, this is not absolutely precluded by the terms of article 3 of the Single Convention." Although it was unambiguously and unanimously affirmed by the 1961 conference which adopted the Single Convention that the Convention was not intended to cover, for example, tranquilizers and barbiturates "but only substances of a definitely narcotic kind" (Official Records II, 1%4: 86), there were those at the conference who were in favor of the principle of international control over these substances, but their views failed by one vote to obtain a two-thirds majority. The basis for the rejection was thus merely procedural. It could therefore be argued, the Division contended, that the drafters of the Single Convention had not intended to "keep out the other psychotropic substances at all costs for all time." The Division believed that "It is not lpgality which can stop the international community from using the instrument at hand, it is whether it would be practical and effective to do so."

The Board had also pointed to the practical difficulties of applying the Single Convention. On this point the Division agreed. Such application would entail amending the Convention and adding schedules, and this would result in the creation of a very complicated treaty causing "intractable administrative problems."

Further Moves

In late 1968 Sweden did what the Board had previously thought interesting that no one had yet done. It sent the UN secretary-general a notification asking that six stimulants (am-phetamine, dexamphetamine, methamphetamine, methylphen-idate, phenmetrazine, and pipradol) be placed under control in terms of article 3 of the Single Convention. Behind this move may have been a sense of frustration at the slow progress toward control, a pressing national problem, the continued lack of cooperation from other countries in stemming illicit drug sup-plies, and a reaction to the attention claimed by LSD at the expense of the other drugs.

Sweden's assumption of a more active role in international drug control was preceded by several preparatory steps. Its representatives attending as observers at the 1%8 meeting of the Commission had pleaded for controls over stimulants (CND:22d). At the World Health Assembly in 1%8 the Scandinavian coun-tries and Yugoslavia had moved that the Assembly should recommend the inclusion of stimulants in Schedule I of the Single Convention, although the resolution eventually adopted (WHA 21:42) was one which merely took account of the fact that the Commission was working to develop a new international instrument. Also in 1%8 the Swedish National Board of Health and Welfare organized an international conference on the abuse of stimulants to secure an information base on which to plan further action. On 1 January 1969 Sweden became a member of the Commission.

After the 1968 Commission session, the Division circulated a questionnaire to national governments on possible control meas-ures. The answers were analyzed in a special document for the Commission (E/CN.7/518 and Corr.1). The Division also distrib-uted a document entitled "Protocol on Psychotropic Substances Outside the Scope of the Single Convention on Narcotic Drugs" (E/CN.7/519). This draft consisted of hvo versions: A and B. Ver-sion A spelt out control measures which had to be applied in sets, whereas in B these measures could be applied separately. Version B also, allowed each party not to apply the controls decided upon.

Sweden followed up on its initiative with a further proposal that stimulants be placed under provisional control pending the definitive decision. In contrast to the position held earlier, the Division's response to this move was to invoke the arguments which had been offered by the Board against the applicability of the Single Convention to these drugs. In support of this new position, reference was made by the Division to the UN Office of Legal Affairs which had "consistently held that there were legal doubts" about the applicability of the Convention. Reference was also made to the Commission's opposition to the international control of amphetamines in 1955 and of barbiturates and tran-quilizers in 1957 and 1959 to 1%2 (CND: 23d, 1%9).

The various postures adopted in response to the Swedish initiative confronted each other at the twenty-third session of the Commission. The following extract from the report of the meeting is a record of some of the views that were articulated (CND: 23d, 1969).

Some representatives, including those of India and Yugoslavia, argued that . . . it was for the Parties themselves . . . to decide whether [the 1961 Convention] could or could not be applied to any substance or substances. These representatives reiterated their view that the 1961 Convention was applicable to the psychotropic substances. Accordingly they held that the most dangerous of the psychotropic substances could immediately be put under control by action in terms of article 3 of the Convention, by including them, for example, in Schedule I or Schedules I and IV. They argued that the criteria for applying the Convention consisted of similarity as regards the liability to abuse, and similarity as regards ill effects; there was ample medical evidence to indicate that the more dangerous psychotropic substances disqualify, in terms of these criteria, for control under the 1%1 Convention. Nor were the arguments about the understanding at the time of the drafting of the 1961 Convention decisive; today, there was much greater evidence of abuse liability and ill effects as concerns these substances, and had this evidence been available in 1961 the doctrine as to the scope of the 1%1 Convention might well have been conceived differently. As regards the administrative and practical difficulties, these difficulties had been unduly exaggerated and were far from insuperable. The representatives of Sweden and Yugoslavia felt that it was entirely appropriate to bring the six notified amphetamine-like substances under the control of the 1961 Convention, but that other psychotropic drugs should be reserved for a new international instrument. (E/CN.7/523 Rev. 1:67).

Even if Sweden thought it could secure majority support for its proposal for provisional control over stimulants, it nevertheless withdrew this proposal in favor of a unanimous resolution calling for immediate voluntary national action on stimulants. The major Western countries had been in opposition, and some had threatened to withdraw from or withhold ratification of the Single Convention. It had seemed to Sweden that a better dividend would be had from a general agreement to take rapid action at the national level and to bring stimulants into the new treaty than from a mere majority of votes to which those cast by the manufacturing countries did not contribute.

The contents of the resolution ranged from observations on the abuse of stimulants and the Commission's inability to reach agreement on the applicability of the Single Convention, to recommendations that governments should apply national con-trols corresponding as closely as possible to those provided by the Single Convention and that they should cooperate with each other and seek assistance from international bodies. The formal com-munication from Sweden regarding permanent control was not withdrawn, and the Commission noted that it was being transferred to the parties and to WHO, which would consider it.

The Draft Protocol

The Commission decided to accept version A as a basis for its work on the draft protocol despite the initial opposition of, among others, the U.S. representative, who argued for flexibility and the right of a party to reject a control decision. The proponents of version A—particularly Yugoslavia—held that national rejection of controls should not be allowed and that it would be inconsis-tent to prepare a weak instrument of control when there was agreement that the dangers arising out of the abuse of the psychotropic substances were grave. The Indian representative noted that the opium-producing countries had accepted strict controls in the interest of all mankind, and he expressed the hope that the developed countries manufacturing psychotropic sub-stances would now cooperate in ensuring truly effective measures for control of their products.

The Commission decided to have four schedules of drugs, instedd of the six which draft A had provided. Hallucinogens were to be placed under the most severe control regime, under schedule I. Following a discussion as to whether some stimulants should be controlled in the same way, agreement was reached that highly dangerous substances which were generally acknowledged to have medical utility should be listed in schedule II and be subject to controls "nearly analogous in most respects" to those of sched-ule I of the Single Convention. Schedules III and IV were to contain controls in decreasing order of stringency.

On the criteria for applying control, the Commission decided that potential for dependence should not be specified since the emphasis should be on the public health and social problems created by a drug's liability to abuse. The criteria should also encompass the capacity of a drug to produce stimulation, depres-sion, hallucinations, or disturbances in perception or thinking.

On the placement of drugs under control, both drafts A and B left it to WHO to initiate the procedure. The Commission proposed that each party should also have this right. The USSR, supported by India and Switzerland, further proposed that the possibility of applying provisional control be incorporated. The Commission's work resulted in a new draft protocol, with a number of provisions left open or accompanied by alternatives.

Work on the draft protocol continued at a special session of the Commission at Geneva in January 1970. In addition to the draft protocol the Commission had to consider the seventeenth report of the WHO Expert Committee (WHO/EC DD, 1970), which recommended that the psychotropic substances proposed for control be divided into four groups. The basic criteria for control should be on the one hand the degree of risk that the substance was liable to abuse, and on the other its medical usefulness. As far as stimulants were concerned, the Committee proposed that:

to meet the immediate emergency, urgent attention be given to the elaboration of a special temporary instrument that will provide for speedy international control (p. 23).

In response to the Swedish notification of stimulants, the WHO director-general, in a note-verbale dated 7 October 1%9 to the UN secretary-general, merely called attention to the "special temporary instrument" recommended by the expert committee without a commitment on his own part. He further stated that amphetamine, dexamphetamine, methamphetamine, methyl-phenidate, and phenmetrazine, but not pipradol, were pharma-cologically similar among themselves and sufficiently similar to cocaine in their pattern of abuse and ill effects to be assimilable to Schedule I of the Single Convention. He believed that "on purely technical grounds therefore . . . he would be obligated to make a recommendation" that the five substances be added to Schedule I of the Single Convention. He added, however, that this might not be appropriate, as the plenipotentiary conference which adopted the Single Convention had rejected control of stimulants, and a new treaty was being considered.

The lists proposed by the expert committee were accepted by the Commission as the basis for the negotiations of the coming plenipotentiary conference. Sweden thereby secured the inclusion of stimulants in the second schedule, against the initial resistance of, among other countries, the U.S. and Canada.

On the procedure for bringing drugs under control, the manu-facturing countries secured a relative weakening of WHO's role and a corresponding strengthening of the role of the Commission.

A clause provided that the Commision should take into account the findings and recommendations of WHO and, "bearing in mind economic, social, legal, administrative and other factors that it may consider relevant" decide whether a substance should be added to any of the schedules. A minority composed of Ghana, India, Iran, Jamaica, Sweden, Turkey, and the United Arab Republic proposed that the Commission's role be limited to accepting or rejecting the proposal of WHO. The representative of WHO declared that while they preferred the standpoint of the minority, they were willing to accept that of the majority, since it had been agreed that the decisions of the Commission would be based on grounds other than those considered by WHO.

Also noteworthy is the statement of the chairman, made on the demand of several delegations, that alcohol and tobacco were not to be included under the scope of the new international treaty. This may have been motivated by a wish to preempt future moves to bring these drugs under control. The 1%1 conference, too, had been "expressly instructed" by the secretary-general's representa-tive (Official Records, II, 1%4:94) and by the chairman that alcohol was outside the conference's terms of reference. No member had objected.

Finally, Sweden introduced a draft resolution calling for interim application of national and international control over psychotropic substances. Although weaker than the Single Con-vention, the controls embodied in the draft protocol were consid-erably stronger than those advocated by the critics of the protocol. These critics were making themselves heard in 1970.

Countermoves

Ranged against the interests of those nations pressing for control were the countervailing tendencies of other nations and groups. The statement of the Swiss delegate at the 1%6 session of the Commission, that amphetamines should not be placed under international control regimes because "the effects of ampheta-mines on the individual and society were far from being as harmful as those of cocaine, cannabis and synthetic drugs," is a reflection of the resistance by which the control-minded countries were constantly being checked (E/CN.7/SR 552).

A case against the protocol was being built up by the pharma-ceutical industry when the instrument was still in preparation. At a meeting in Stockholm in June 1968 the Pharmaceutical Industries Association (PIA) adopted a resolution expressing its views on an international instrument for the overall control of "certain dependence-producing drugs." In essence, what the resolution said was that legislation should be on a national level only, and that free international drug trade should not be unnecessarily hampered by complicated import/export rules. Reference was made by PIA to WHO's recommendations on national controls. The view was expressed that controls should be preceded by investigations of actual risks and based on statistical evidence of "social harm caused through use of drugs obtained from legitimate sources."

The keynote of the principles enunciated by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) in its resolution adopted in Rome in May 1969 was likewise the sufficiency of national controls. On the other hand it thought "the exchange of information and introduction of effec-tive national legislation might usefully be co-ordinated by the establishment of a special international treaty." Concern was expressed about the draft international agreement under ciinsid-eration by the Narcotics Commission. It envisaged, in the opinion of IFPMA, an overextensive system of control, which gave international organizations the exclusive right to determine which substances to control and the degree of control. IFPMA instead pledged its support to a draft convention which the organization itself had worked out, based on the principles it averred.

Further criticisms of the proposed treaty were voiced at the Twenty-ninth International Congress on Alcoholism and Drug Dependence organized by the International Council on Alcohol and Addictions (ICAA), which took place in Australia in Febru-ary 1970. In a paper delivered by Walter von Wartburg, legal adviser to Hoffmann-La Roche, the proposed controls were critically examined (von Wartburg, 1970). His thesis was that decisions on the final draft of the treaty should be based on consideration of "administrative practicability" and "medical availability." The psychotropic substances were different, accord-ing to von Wartburg, from narcotic drugs in a number of respects. The number of substances in the former category was considerably greater; they belonged to different groups pharma-cologically, whereas narcotic drugs presented similar "ill effects to the individual and to society"; and many of the drugs being considered for control were in "extensive medical use and administered daily to an untold number of patients all over the world." Thus one could not generalize from the apparent value of narcotics controls to the value of control of the psychotropic substances.

Other points made by von Wartburg may be summarized as follows. The heavy burden imposed by the new controls would lead to an increase in personnel and expenditures. The burden of rigid controls would outweigh advantages. The dissipation of resources might weaken existing international control, and organ-ized smuggling might profit. The effect of the American alcohol prohibition had been an increase in alcoholism and a growing disrespect for the law in general. Only an optimal level of control could bring about a minimum level of abuse; and while complica-ted controls might be acceptable or even desirable for a relatively small, homogeneous number of substances of no, or limited, use, they would be "unbearable in respect to the many untold substances" eventually to be covered by the new treaty.

As far as the problem of medical availability is concerned, von Wartburg thought that therapeutic use of psychotropic drugs did not, as a rule, induce physical dependence. Their abuse constitu-ted a problem only in a few countries. The control regime of narcotics might "sometimes even discourage the use of narcotic drugs for medical purposes." Von Wartburg stated further:

It is well known that administrative controls do not as such prevent the abuse of drugs by dependence-prone individuals. Control measures may be very useful in general, but in the case of psychologically defective persons they are directed at the repression of the symptoms rather than at the treatment of the underlying psychological difficulties. The cause of addiction is not drugs but human weakness, as has once been observed by Dr. Isbell from Lexington.

Von Wartburg's over-all conclusion was a plea for voluntary enactment of adequate national controls. On the specifics of the draft protocol, he argued that the coverage of the international instrument should be by definition limited to substances whose abuse posed an international problem, that emphasis should be placed on existing problems rather than potential ones, and that prime attention should be given to dependence-related abuse rather than to misuse contrary to medical practice.

To indicate the variety of ideas which were being expressed about the Vienna protocol and to see what their origins may have been we will sample another round of discussions, this time at the International Institute of the Prevention and Treatment of Drug Dependence, an international conference organized again by ICAA in June 1970 in Lausanne. Criticisms came this time from members of the pharmaceutical industry as well as from promi-nent medical scientists from the U.S., whose dissatisfaction was with the use of the criminal sanction in drug legislation and the encroachment of controls on scientific research and the freedom of medical practice. At the end of the conference, a panel, consisting of some of the speakers, presented a paper entitled "Principles of Effective Drug Abuse Control" for general discus-sion. The views contained in the paper included the following: drug laws should focus on the evil-minded rather than on the weak; they should enable concentration rather than dissipation of control effort; society should not impede the search for therapeu-tic relief; an international treaty would not by itself abolish undesirable conduct; national action was preferable; the exten-sion of narcotics control concepts to nonnarcotic drugs of great therapeutic value would "constitute an irresponsible interference with established medical practice on an international scale." The criteria for control proposed by the paper were similar to those advocated by von Wartburg. The increased consumption of psy-chotropic drugs for "medical, scientific and other legitimate purposes" which a "rapidly changing environment" was bringing about should not, the paper held, be arbitrarily prevented.

The paper was subjected to severe criticism by the representa-tives of the international drug organs and other members of the audience. The director of the UN Division of N arcotic Drugs (Vladimir KuKevie) stated that narcotic control had not restricted legitimate availability. WHO's representative (Dale Cameron) said that it was not intended to subject unauthorized drug possession to heavy penalties. Adolf Lande, ex-secretary of the INCB, advised the meeting against drawing the conclusion that innovative scientific inquiry would be hampered by control. After a vigorous debate, the subject was dropped.

One of the papers delivered at the conference is worthy of special note. This was Adolf Lande's "Principles of Effective Drug Control." Lande was one of the authors of the draft protocol and had played an influential role in the stimulants controversy. In an internal UN memorandum he had argued against the inclusion of stimulants under existing drug treaties on the same grounds as those on which the Division's views, expressed at the Commission's meeting in 1%9, were based. In the paper delivered at Lausanne, Lande conveyed his views on drug control in general:

I think most governments would not be inclined to deprive numerous people of their sleep by imposing the narcotics regime on barbiturates . . . . In deciding whether controls should be imposed and what measures should be applied, both the extent of medical use and the size of abuse must be taken into account. . . . The possibilities of international drug treaties to deal with the problems of personality and environment are even more limited than those of national laws. In fact they deal nearly exclusively with the agents, i.e., with the drugs . . . . The Legal Office of the United Nations ruled that the Single Convention on Narcotic Drugs could not be applied to barbiturates, amphetamines and tranquilizers, without an amendment. It did not exclude LSD and similar hallucinogenic drugs which in my view could be brought under international control by the operation of the Single Convention on Narcotic Drugs. In rejecting the application of the Single Convention to the psychotropic drugs with whose control it dealt, the Commission was not exclusively guided by legal considerations, but also by the opinion that the narcotics regime was not suitable for the drugs under consideration, that it was for some of them too strict and for others not strict enough . . . . The more broadly defined authority under the Single Convention on Narcotic Drugs was radically narrowed down by the understanding of the plenipotentiary conference which adopted this treaty that barbiturates, amphetamines and tranquilizers are excluded from the scope of the convention . . . . A satisfactory solution of the problem of the right of countries to reject control decisions of the Commission is in my view necessary to ensure the general acceptance of the protocol . . . . It is also essential that the control efforts of the international and national authorities are not dissipated, but concentrated on the real problems of abuse. . . .
In particular, the international regime should not be burdened by the control of drugs which constitute only a national and not an international problem . . . . If I am correctly informed, none of the drugs listed in Schedule IV of the Protocol constitute at present such a problem [emphasis added]. . . . In order to carry out this system of quantitative limitation [the estimate system], each country must allocate quotas to its manufacturers and/or import-ers. This restrictive system has proven its value in preventing the diversion of narcotic drugs from licit into illicit channels, particularly in the earlier years of its application. The Commission on Narcotic Drugs has, however, rejected the proposal of some of its members to introduce this system into the Draft Protocol on Psychotropic Drugs and—as I think—rightly so . . . . I think that an elimination of the import certificate and expert authorization system from the draft would make the Protocol more generally acceptable . . . . It appears also that the requirement of an advance approval of research projects involving use of drugs in Schedule I on human beings would be inconsistent with sound principles of free research . . . . The punishment meted out should be effective, i.e., sufficiently severe to be deterrent. (Lande, 1970).

It is interesting to note how close these views were to those of von Wartburg and the pharmaceutical industry. Lande in fact appeared at the Vienna Conference on behalf of the American Pharmaceutical Manufacturers Association.

In July 1970 IFPMA issued a commentary on the revised draft protocol. The commentary acknowledged the usefulness of an international protocol for the exchange of information on abuse and countermeasures and for a framework for the coordination of national activities. Its other comments were as follows: theAreaty should be flexible; the revised draft protocol still bore too much resemblance to the Single Convention, whereas the two treaties should be unrelated in view of the basic difference in coverage. An extension of international narcotic control to valuable drugs of daily medical use would be an error. Among such unsuitable provisions was the necessity to furnish world-wide statistical figures and the penal provisions. Further, the coverage was too heterogeneous. There was consensus within "the international community" only about the need for international control on dangerous hallucinogens and some stimulants. "To achieve a reasonably quick international control solution of the drug-abuse-related public health problems of today, a concentration of international control efforts primarily on the existing abuse would appear to be the preferable course of action." The proposal of the WHO Expert Committee for a limited temporary instrument was noted. The treaty should deal exclusively with dependence-producing psychotropic substances and base control on actual proof of substantial abuse. Precursors should not fall under the control, unless a problem existed. It "would be in the best interest of public health if manufacturers were to remain free in their ways and means to guarantee that industrially used substances" did not give rise to an abuse problem. A differentiation in degree of control had, "contrary to the wisdom of WHO," been made most prominently between schedules II and III although these substances were declared to be of equal risk. No differentiation, however, existed between schedules III and IV, "whereas it is exactly between those two Schedules that WHO has found a significant dissimilarity of risks." The Commission should only have the power to accept or reject recommendations by WHO. A consultation prodecure should be mandatory for WHO. "This would ensure that no substance is eventually placed under inter-national control without anybody being aware of the reasons and merits for such a decision." Any party should have an absolute right of rejecting control decisions (except in regard to substances under schedule I and in regard to request for mutual legal assistance in combating drug abuse). "Finally, a provision should be inserted to the effect that at least a reasonable number of important manufacturing countries must have ratified the new protocol before its entering into force."

Vienna

The diverse opinions confronted each other at the plenipoten-tiary conference in Vienna in early 1971.

We will examine article 2 as a test case. It deals with the scope of control of the various drugs and is of interest for two reasons. First, it represents an important departure from the Single Convention in the mechanism it spells out for putting drugs under control; and, second, the negotiations over it provide a good illustration of the generalizations we made earlier about the interests and conflicts of the various parties involved. It was one of the articles which had met with the most opposition in the committee which debated it, and the establishment of its text had taken four weeks (Official Records II, 1973: 66).

The mechanism differs from that of the Single Convention in its criteria for including drugs under control. In the new treaty these criteria are broader and more evidence is needed for a decision to control a drug. In the draft version, the requirement had been limited to a finding by WHO that the drug in question had the capacity to produce certain effects, but in the version which was actually adopted sufficient evidence that the substance in question was being or was likely to be abused was required before a control decision could be taken. The U.K. delegation pushed more than any of the others at Vienna for the necessity to have a strong basis of evidence for drug evaluation.

There were divergent opinions on the scheme of control. The West German representative, for example, repeatedly argued against controls over drugs listed in schedule IV: "Since it was not sufficiently clear," he declared, "that they did give rise to dependence and since no appreciable risk of abuse was involved, there was no need for any special regulations" (Official Records II, 1973: 7). In this he was supported by Belgium, Switzerland, the Netherlands, and Denmark. France thought it patently clear that these delegations "had set their minds" on weakening the protocol (Official Records II, 1973: 57). The developing countries, notably India and Togo, wanted fairly strict controls over all four drug schedules. The U.S. was also in favor of having four schedules but rather more relaxed associated controls than those sought by India.

The second departure from the Single Convention concerns the role of WHO, which had been reduced in the draft to that of assessing the medical and scientific factors relevant to control while the decision as to whether a drug should be controlled would be taken by the Commission based on social, legal, and administra-tive factors. At Vienna, Sweden and others proposed and secured a relative strengthening of WHO's role through the provision that WHO's evaluation should be determinative as to medical and scientific matters.

Another distinctive feature of the Vienna Convention is that it requires a two-thirds majority of the Commission to decide on an alteration to or change of schedule. At Vienna, the U.S. delegation abandoned its earlier compromise on this issue and proposed, unsuccessfully, a voting procedure requiring a three-fourths majority. Other delegations (USSR, Sweden, India, Yugoslavia) protested at this proposal, and the voting ratio of a two-thirds majority was retained (Official Records II, 1973: 183-4).

To gain support for the protocol from developing countries, Sweden emphasized that the Single Convention affected these countries' agricultural production adversely, whereas the Vienna protocol sought to regulate synthetic substances manufactured by industrialized nations (Official Records II, 1973:6). Others considered that, on the contrary, the difference in the nature of the drugs covered by the two treaties justified less stringent controls over "psychotropics." The Belgian delegate, for example, thought that the administrative burdens imposed by the protocol were unwarranted, that it would be simpler to check the quantities of raw materials imported and exported and to "control consumption without entering into the detail of preparations" (Official Records II, 1973: 8). The financial burden that implementing the protocol would entail was a plea used against extensive controls, ironically enough, by the wealthier nations (for example, Switzerland—see official Records II, 1973: 21). The assignment of control functions to the Board encountered much opposition from the very countries which argued in favor of this with respect to the Single Convention. Switzerland stated at Vienna that "The Board should not have the power to take action which might ruin the economy of any country" (Official Records II, 1973: 77). Export and import restrictions accepted as necessary by the adherents to the Single Convention were considered "impossible to carry out" and therefore unaccept-able (to West Germany) in regard to "psychotropics." Control measures should befall (according to Austria) importing and not exporting countries; statistics of manufacture and trade were of doubtful value (in the Danish delegate's opinion), and interna-tional trade in schedule IV would be hindered by the export declaration system that was being contemplated (Official Records II, 1973: 50-51).

Differences from the Single Convention apart, other features of the Vienna Convention bear noting. Against the opposition of the U.S., two drugs, diazepam (Valium) and chlordiazepoxide (Librium), which had been proposed for control under schedule IV, were deleted by the Conference. This created a curious situation where one of the American competitor drugs in the tranquilizer range, meprobamate (Miltown), came under control while the Swiss tranquilizers did not. The American position was dictated by the fact that, within the U.S., control of Valium and Librium had been advocated (President's Advisory Commission on Narcotics and Drug Abuse, 1%3).

The view has been expressed in Hoffmann-La Roche (the manufacturer of the two products) that the U.S. move in the international context was dictated in part by the internal failure, now overcome, to bring these drugs under control in the U.S. following a suit brought against it by Hoffmann-La Roche.* Through international control over Librium and Valium, national control of these drugs could be facilitated. La Roche's defense against this move was based on an analysis of 6,625 scientific papers on benzodiazepines (which include Librium and Valium) in which there were only forty-seven reported cases of abuse. The total number of cases reported by these papers was 254. Control was successfully evaded when the conference finally decided, on the proposal of the Technical Committee, that Librium and Valium be excluded from the control schedules.t

A number of delegations expressed surprise at the decision of the Technical Committee to drop these two products from the schedules. The Australian delegate, for one, observed that:

The deletion . . . seemed to have been due to a change of attitude on the part of some delegations between the first and second consideration of Schedule IV by the Technical Committee. Yet no new pharmacological data or information on social factors had come to hand in the interval tojustift such a change [emphasis added]. The reasons for it therefore seemed to be of a pharmaco-political or pharmaco-sociological nature (Official Records II, 1973: 113).

The chairman of the Technical Committee indicated to us later that the deletion was one of the necessary concessions for securing agreement on having a treaty at all (Bror Rexed, interview). This is an instance of the horse-trading which took place throughout the conference.

An omission with possibly more far-reaching consequences was that of the salts of the substances considered by the conference. The salts were not expressly included; yet it is in the form of salts that the substances are usually marketed. In the Single Convention such inclusion was secured by the use of special footnotes associated with the schedules. At one of the last plenary sessions, the chairman of the Technical Committee raised the question of providing for such inclusion in the schedules of the new treaty. Another member of the Technical Committee supported him, explaining that the committee's only reason for not including these salts was that it "had been hurried in its final report" (E/CONF. 58/SR.27). Both the USSR and the U.S. held that it was not pos-sible to generalize about the salts of all the substances involved.

In the course of the conference the U.S. delegation bargained for the right of rejection of controls on the part of a state which does not notify its acceptance of a control decision within a specified period. After hard bargaining between the contending parties, the model from the draft was retained, which allowed a state the right of partial acceptance under exceptional circumstances provided that it notified its decision. Agreement was reached that this right would be extended to all four schedules.

A Retrospective View

We will begin our review by asking who acted, for what interests, and through what means.

It will be clear from the foregoing section that the U.S. and Sweden were the initiators. In the chain of events leading up to the treaty, the Commission and Division had provided inputs of one kind or another. But the crucial role played by countries such as India, Yugoslavia, and the USSR must not be overlooked, even if their influence on events derived less from taking initiatives than from the support they rallied or the objections they raised to certain issues:A number of countervailing powers were obviously at work, chiefly among the industrialized countries (the Netherlands and West Germany, for example), offsetting the zealous endeavors of those pressing for controls. However, disentangling the various forces that worked on the decisions is complicated by the fact that the line between the procontrol and countervailing forces was seldom sharp. No one was against all controls, and those who were for controls had different ideas about how far to go.

To what extent did the UN organs fulfill their duty of respond-ing to new drug problems? WHO advocated controls at a fairly early stage but considered national ones sufficient to meet the problem. The Swedish notification of stimulants for control under the Single Convention elicited an uncertain response from WHO, and it appears that the basis of this response was largely political.

The WHO director-general had admitted that on "purely technical grounds" he would be obligated to make a recommendation for control under the Single Convention. Since it is precisely on technical grounds that WHO is required by its treaty obligations to make recommendations, there was no justification for its not doing so. By not making a recommendation, WHO froze the initiative to include stimulants in the Single Convention. Although the expert committee's recommendation of an interim instrument to cover stimulants was a positive step towards control (WHO/EC DD, 1970), in retrospect it appears ill-advised, since the realization of the proposal for an interim instrument would have further deferred the conclusion of the full Vienna Convention, or even have lessened the chances of its being concluded at all. The Swedish initiative to bring stimulants under the control of the Single Convention is open to the same criticism, although it may have served ta.ctical purposes, if the final effect was to prompt other countries to agree to stringent controls over stimulants in the new treaty.-

The Commission was a step or two behind WHO in proposing new controls. On the whole none of the international organs can be said to have played an active part in bringing about the new convention. Their usefulness lay in the mechanism they provided for the bargaining that went on between the main protagonists.

What interests were at work? The Vienna Conference was as much a battle of interests as any other UN conference. Some nations contended that public-health interests would be better served if others would agree to cooperative action. Others were particularly concerned with warding off any limitation upon the exercise of their national sovereignity; this was exemplified by the socialist group's insistence on the right of reservations and the demand by the U.S. for the right of rejection of controls. Commercial interests were there, the most significant expression of them being not so much the presence of pharmaceutical industry representatives on the delegations of the U.S. and Switzerland as the coincidence of national and commercial interests. A dividing line was perceptible in ..he manner of voting and argument between countries which manufacture psycho-tropic substances and countries without such industry. France was astride both camps, arguing, as it has nearly always done, for the necessity of controls, in contrast to the other Common Market countries.

A pressure group which made itself heard during the events leading up to the Vienna conference was the scientific community. Acting as advisers to national delegations, medical and social scientists were instrumental in influencing govern-mental readiness to consider more varied social controls, alterna-tives to punishment, and new provisions for treatment and rehabilitation of drug addicts. Scientific opposition to drug A controls modeled on those of the international treaties manifested itself before as well as after the Vienna Conference. It will be recalled that at the ICAA meeting in Lausanne in 1970, a case was presented against the proposed treaty. Later, in the U.S. Senate hearings on the ratification of the psychotropics convention, the scientific community was again among the opponents to the treaty, arguing against the new imposition of controls which had merely been sanctified by usage and had proved ineffective against the illicit traffic. One of their spokesmen, Neil Chayet, made a statement at the Vienna Conference itself expressing dissatisfac-tion with the use of the criminal sanction and concern for the challenge which drug controls represented to the independence of scientific research (Official Records II, 1973: 18-19).

VVhat means were used? To gain their ends the various interests empldied such means as influencing opinion by argument and entreaty, and enlisting support in voting. The arguments used in Vienna revolved around a number of themes: at one end, the primacy of public-health interests and the need to protect develop-ing countries from being injured by the products of developed ones; at the other, considerations of practicality and the need to ensure wide acceptability (as an argument against specificity and stringency of controls). Because of the disinclination of many countries to accept international obligations, a large number of arguments were directed at minimizing the degree to which the provisions were binding. Necessarily, the consensus on the final document could only be obtained at the cost of much weakening of its contents and much lowering of the level of control desired by the control-minded countries. One of the most decisive arguments for a lowered level of control was that this was a necessary price for having an international agreement. The force of this argument lay in the fact that there were moments during the conference when the countries desiring controls were not even certain that they would obtain a treaty which bore any resemblance at all to the original draft, so assailed were they by opposition. Their readiness to make concessions (as in the Valium and Librium case) was thus dictated to a large extent by their own estimation of how far they could go without jeopardizing their chances of securing a reasonable level of control.

Earlier we discussed the case presented by the pharmaceutical industry against international controls. A basic argument of the industry which was never explicitly challenged was the contention that the more widely a drug was used, the less it should be controlled, other things being equal, since the practical problems of enforcing controls, given the extent of the demand, would outweigh the vestigial benefit of control. However, even granted that in the case of marihuana, this is a cogent argument for relaxing controls, it is possible to interpose a contrary argument, that the more used a drug is, the more it should be controlled. Another tenet of the pharmaceutical industry's position is that a drug should not be controlled until found guilty of harmful effects. A differing view is that embodied in the 1931 Convention, in,which whole classes of drugs were placed under provisional control with provisions for individual drugs to be freed from control when shown not to be dangerous. This is the view underlying the Norwegian system of drug control, for example. Norway has limited its range of permissible pharmaceuticals to about three thousand only, and a new drug cannot be registered unless it demonstrates valuable propensities not possessed by those already registered. This makes for a cheap and effective form of drug control, easily supervised. It is not control for control's sake; rather it rests on the basic assumption that because of its profit motive, the drug-producing industry cannot be relied upon to market only those drugs that are strictly necessary, or to be the first to alert the public against using certain drugs. Current discussions on interna-tional drug control have not gone as far as envisaging such alternatives as public ownership of the drug industry, but it is worth mentioning that the 1931 Limitation Conference passed a resolution to that effect, with only one country, Germany, voting agianst it.

Neither are the arguments advanced by the Division of Narcotic Drugs in its brief to the Commission immune to criticism. As noted earlier, a perceptible change of position occurred betvveen 1%7 and 1%9; however, both positions were poorly argued. To say, as it did in 1967, that it was not a critical factor whether the drugs proposed for control satisfied the "similarity" condition for inclusion under control, is to pursue a dangerous line of argument, since this is in contradiction to the treaty criteria. The switch in 1969 to the legalistically based position that the 1961 conference had excluded central stimulants and other psychoactive drugs from the Single Convention (and that they could not therefore be assimilated to the drugs controlled by it) is equally weak, for the very reasons which the Division spelt out in 1967 in its brief when it argued against the judgments of the PCB. Only WHO did not evade the crucial question, when, in its note verbale in 1969, it said that some stimulants were similar to cocaine in the meaning of the Single Convention.

The point of all this is not one of legal interpretation; it is the importance of the role which differing legal interpretations can play in the political process.

Apart from arguments, other means were used by the various interests involved, in a way which is not immediately obvious to the outside observer. One such means was the use of technical literature to buttress a case. The pharmaceutical industry, the U.S., and Sweden all used it extensively. Representation was anothtr; Sweden secured a hearing only when it obtained a place on the Commission.

The outcome was that the conference concluded a treaty which was broader but considerably weaker than the Single Convention. The conference's purpose, after all, was (as the Danish delegate observed) to adopt a protocol that "would provide protection for all countries and could be accepted in practice by the producing countries" (Official Records II, 1973:59) (emphasis added). The necessity to facilitate ratification and adherence, it has been argued, justifies the lack of rigor of the control provisions. However, in the three years since it has been adopted, the Convention has acquired only sixteen ratifications.

SUMMARY

1. The development of the Vienna Convention is a paradigm of the treaty-making process which had led to the earlier drug conventions.

2. The chief movers for control were Sweden, the U.S., and African and Asian developing countries, led by India. Resistance came mostly from West Germany, Belgium, the U.K., the Netherlands, and Switzerland.

3. Various positions were taken vis-à-vis the draft protocol. Its critics, who included members of the drug industry, argued for national as opposed to international controls.

4. The international organs were less movers for control than tools for maneuver by the contending interests.

5. The breadth and strength of the new controls were decided on the basis of their acceptability to countries opposed to control.

 

* "The Control of Psychotropic Substances Not under International Control—Legal, Administrative and Other Questions." Note by the Secretary-General (E/CN. 7/509, 1%7).

* United States Court of Appeals for Third Circuit, No. 71-1299. Hoffmann-La Roche, Inc. v. Richard G. Kleindienst, Attorney General of the United States and John E. Ingersoll, Director, Bureau of Narcotics and Dangerous Drugs, United States Department of Justice.

-I- The votes of the Technical Committee were as follows: for and against retention of chlordiazepoxide-6 and 14 respectively, with 3 abstentions; for and against retention of diazepam-6 and 12 respectively, with 4 abstentions. Cf. corresponding votes on meprobamate-17, 3, and 2.

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