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Home , Amfepramone, Benzphetamine, Lefetamine, Morazone

.LTH ORGANIZATION

.- - . .. - .- - - - AN ISA I ION MON

REVIEW OF UNCONTROLLED AMP FOR PROVISIONAL INTERNATION

Report submitted b

chael C. Gerald, Ph.D. t, Division of Mental Health Gorld Health Organization

Ce document ne constitue oas une oublication. tuld not be reviewed, II ne doit faire I'objet d'aucun compte rendu ou ~utthe agreement of r6sun-d ni d'aucune citation sans I'autorisation de ation. Authors alone I'Organisation mondiale de la SantB. Les opinions em expressed in signed exprimdes dans les articles rig* n'engagent que leurs auteurs. NNH/PAD/84.10 page 2 This paper provides a prologue to an summarizes those events that have lead to th convening of an Ad Hoc Committee of WHO to review uncontrolled for recomm for their provisional international control.

Plans for the Ninth Review of Psychoactive Substances

As of 8 February 1982, most -like and hallucinations with abuse potential were included on the Schedules of the Convention of psychotropic list, still current, includes: STP (DOM) in Schedule I; amphetamine, dexamphetamine, , , and in Schedule 11; and (diethylpropion), , (SPA), , , phente pipradol in Schedule IV. At the Thirtieth Session of the Commission on ~arcoticD conducted in February 1983, Resolution 4 (XXX) requested that the World Health Organ inter alia "undertake as soon as possible the review and assessment of [uncontrolledl ~phetaminetype substances . . . [and] make available its findings and rec tions, on a substance by substance basis . . .l* . During the Spring 1983, active plans were initiated to convene the Ninth Review Psychoactive Substances, from 5-9 March 1984, with the express purpose of reviewing "uncontrolled amphetamines and ; copies of the draft agenda and the psycho substances proposed for review appear in Annex 1.

Formal requests were submitted to the International Criminal Police Organization and the United Nations Division of to obtain ". . . data on the status drugs in illicit traffic as well as their production in clandestine laboratories . . regional offices were asked to collect data from their regions on the therapeutic av control, and utilization and the public health and social problems associated with t individual drugs (Annex 2). The ~nterdationalFederation of Pharmaceutical Manufact Associations (IFPMA) was asked to solicit information from its members concerned on t marketing and national control of these substances (Annex 3). Letters of invitation participation at this meeting were sent to Temporary Advisers and responses received.

At the seventy-third session oftheWO Executive Board conducted in January 198 in support of the Report of the Director-General, "Action in Respect of Internation Conventions on Narcotic Drugs and Psychotropic Substances" (EB73119 and Add.l), the the United Nations Division of Narcotic Drugs formally expressed the desire that WHO able to complete its review of the 30 amphetamine-type stimulants "within a reasonabl of time", to permit the Commission to evaluate the WHO assessment at its Thirty-first early in 1985. In response, the Direc~orof the Division of Mental Health assured Director that at least a partial review A$ these substances would be possible on the available information as per Article 2, para, 3 of the 1971 Psychotropic Convention ( The following month, the Eighth Special Sesbioh of the>United Nations Commission on N Drugs noting the "serious health and social problems'posed by amphetamine-like drugs" "growing traffic and abuse" approved Resolution E/CN.7/1984/~.4 which inter alia ca review of amphetamine-like drugs and urged WHO ". . . to select any of those amphet drugs for which data has been collected and which represent the most serious social consequences and to review those substances immediately . . . and consistent with th of the new review procedures . . . (EB73.Rl11, and make its findings available to the regular session of the Commission . . .11 . (This resolution appears in its entirety Annex 5 .)

Modified review for provisional control during transitional period

While all invited parties were collecting data in preparation for their reports Ninth Review, contemporaneously a need was strongly perceived by the Secretariat to r the procedures by which WHO reviews psychoactive substances for international control November 1983, the Secretariat decided to postpone the Ninth Review dealing with the

ompted by the decision of th iat to postp the uncontrolled amphetam r one year until April 1 cussed below. amphetamines for one year, until April 1985, at which time new procedures could be employed for the WHO review of psychoactive substances such as the amphetamines. ed that this review be undertaken by an expert committee rather than temporary ng the WHO review meetings.

January 1984 Report of the Director-General to the Eaecutive Board (~~73/19),it d that the new procedure developed for psychoactive substance review "must be quite formal, and fully known to governments and all interested parties"; these were approved in resolution EB73.Rl l of the Executive Board wherein "their rapid was urged.

foregoing description, an obvious conflict was evident between forces advocating on vs. those seeking more protracted and reasoned deliberation. That is, those absolute essentiality of an expeditious review of uncontrolled amphetamine-type ed upon the available evidence vs. those callin oratorium upon further oactive substances until new procedures could lished that would respond ms by certain interested parties and serve WHO in the future.

pt to respond to each of these concerns, it was de he more formal uld be postponed until 1985 and that a two-part meeting would be convened:

overnment committee members, and interested pharmaceutical manufacturers. 4

6 summarizes the characteristics of the U e-type psychoactive PAD / 4

9TH REVIEW OF PSYCHOACTIVE SUBSTANCES FOR INTERNATION

Geneva, 5 - 9 March 1984

Inaugural Session on 5 March at 9.0 a.m.

DRAFT AGENDA

-PP Anncau 1

and availabi lity in diff

3. Basic oharmacoloew and toxicitv:

organs, CNS, 'ance, physic

ii. Toxicity: acute and chronic

4. Behavioural nhnrmnooloev:

ural effects

and toxicol

in man: physic ho la

iii. utic efficacy

6. Public health and social consequences:

i. Extent and pattern of consumption and utilization

ii. Abuse liability

iii. Public health problems .- iv. Social problems &J

v, Information from WHO regional offices and countries Annex 1 /

vi. Data from INTERPOL v vii . Data from the United Nations Division of Narcotic Drugs viii. Data from DEA (USA)

7. Decisions regarding control of individual drugs:

i. The need for control

ii. UPder what Convention should the drug be

iii. Degree of control warranted

Consideration of Future Programme

Notification if received from the Secretary-General of the UN

Any other matter for consideration Annex 1

9TH REVIEW-OF PSYCHOACTIVE SUBSTANCES FOR INTERNATIONAL CONTROL

Geneva, 5-9 March 1984

1. (norpseudoephedrine) 2. Cathinone 3. 4. 5. Dimethoxybromoamphetamine (DOB) 6. (ethylamphetamine) 'L 7. 8. Fencamfamine 9. Fenetylline 10. 1 1 . 1 2. Levamfetamine Mef enorex v Methoxyamphetamine (PMAI1 [see No. 201 ~ethox~meth~lenediox~am~hetamine~[see No. 291 Methylene dioxyamphetamine (MDA) para-me thoxyamphetamine para-oxyamphetaminel Pemo line Trimethoxyamphe tamine (TMA) 4-Bromo-2,s-dimethoxyphenethylamine 2,5-Dimethoxy-4-ethylamphetamine (DOET) N,N-Dimethyl amphetamine (dimetamfetamine) N-~thyl-3,4 ,~ethylenedioxyamphetamine (N-Ethyl-MDA) 5-Methoxy-3,4lnethylenedioxyamphetamine (MMDA) 3,4-Methy lenedioxymethamphetamine (MDMA)

Identical compounds. MNH/BAD/.84.10 page 7

Those listed below 26 .May 1983

9TH REVIEW OF PSYCHOACTIVE SUBSTANCES FOR INTERNATIONAL CONTROL, 5-9 MARCH 1984 quest of the thirtieth session of the UN Conrmission on ~arcoticDrugs which met ebruary this year, WHO'has planned to review the benefit and risk ratio of ues of amphetamine which are not under international control, and some of which international trade and are available in certain developing countries and have

from all ' the Begions . ,

indly financially support one expert from your Region, or reconmend another

Dr Inayat Khan MNH/PAD/84.10 page 8 ANNEX 3

36 26 Mr Michael Peretz Vice-President ~2/87/11 (9) Manufacturers Association (IFPMA) Nordstrasse 15 P.O.B. 328 CH-8035 Zurich

Pharmaceutical Manufacturers Association to assist in obtaining information needed review of drugs being considered for internati of the Executiee Board of the Wotkd Health Org WHO is soliciting assistance from a variety of interested parties, including the pha industry. In this regard the International Federation of Pharmaceutical Manufactur

* WHO wauld like you t6 request frm the relevant pharmaceutical companies the fs information! (1) the trade names of these drugs; (2) the countries in whSch they ar marketed; (3) the nature of naefoaal conttol (if any) in each of the countries in wh

Yours sincerely,

Dr Inayat Khan Senior Medical Officer Division of Mental Health r ies

R

L). 42 Art. 2-Scope of control of substances

the Single Convention.l49 Consequently the comments of the 1961 m Commentary on the provision of the Single Convention apply also to the Secretary-General is required to transmit only such information as he P considers relevant. If he chose not to transmit the requested additional data A provision of the Vienna Convention. Some of the points raised in that 0 commentary may be noted here. in order to avoid bulky reproduction and heavy costs of translation which he considers unnecessary, or for any other reason, the Party concerned may, of 2. In the case of a notification received from a State which is not a Party course, itself send the additional data which it considen relevant to the to the Vienna Convention, the Secretary-General may inform the Govern- Commission, to WHO and to all those Parties it desires to inform. ment of that State that he will not take action under article 2, patagraph 2, since only Parties to the treaty or the World Health Organization arc entitled 6. The Secretary-General is not required to send to WHO the notifi- to make sufh notifications. However, he may also choose to forward to cation which he isrues and the information which he selects as relevant if it is Parties, to the Commission and to WHO a notification received from a State that Organizati~which initiated the procedure by its notification. It is not a Party, and leave it to these organizations to refuse to take action. By so nevertheless suggested that it might be useful if the Secretary-General would doing he may bring to the attention of the World Health Organizati~nand of in such a case send those documents also to WHO, which would thus be enabled Parties relevant information which might "require", i.e., justify, a change in to request the SecretaryGeneral to transmit supplementary data to the Schedules of the Vienna Convention, and thus enable that Organization or a Parties and to the Conmission. Party to make the necessary notification. 7. Atthough the treaty does not require it, it would also be useful if the 3. The Secretary-General may sometimes find it advantageous not to - Secretary-General would send to the Board a copy of the notification and of reject a limine a notification of a State whose character as a Party may raise the supporting information, in order to enable that organ to take all the controversial kgal questions, and thus leave it to the Commission and to preparatory steps which may be required to facilitate a quick execution of WHO to decide such a legal problem. He may in such a situation seek to avoid the Commission's decision concerning the control status of the substance concerned when taken. Although the Board is given no formal role in the taking a position on a controversy of that kind, although he may hold that the notifying State is in fact not a Party. procedure ef article 2 on the control status of substances which are the object of a notification, its representative to the Commission and to the WHO 4. The Treaty requires that the Secretary-General should transmit a Expert Committee on Drug Dependence would be enabled to play a more notification of a Party to Parties, the Commission and WHO useful role at meetings of those organs considering such substances if the two Organizations have to take action in respect of the CO Board had in advance obtained the relevant data contained in the notification substance concerned and the Parties should be enabled, and in the ac:ompanying information. The Board is regularly represented at furnish additional relevant information and comments. the meeting of those two organs. notification and Information supporting it, the Parties shoul to consider, pursuant to article 2, paragraph 3, the poaibiii apply to substances which appear suitable for inclusion in P-gmph 3 appropriate rkgirne governing one or the other of those Sc 3. If the infwmtion transmitted with such a notification indicates 5. The notification and the accompanying idormation should also be that the substance is suitable for inclusion in Schedule I or Schedule I1 sent to the Party from which it was received. The Secretary-General is pursuant to paragraph4, the Parties shall examine, in the light of aU required to transmit the notification "to the Parties" and this term covers information available to them, the possibility of the provisional applica- also the notifying Party. Apart from such an argument based on the letter of tion to the sslbstance of all measures of oantrol applicable to substances the law, transmitting the notification to the Party from which it was in Schedule I or Schedule 8,as appropriate. originally obtained is also justified on the grounds that that Party would thus be enabled to see whether the Secretary-General has chosen, from the information which he had received in support of the notification, all the Commentary requ~red"relevant" data. The Party may ask the Secretary-General to send to 1. The Single Convention has two provisions concerning provisional the Parties, to WHO and to the CO-ion information which it had sent to control of a substance whose international control status is being considered him and which he has oxpittqd. It may, hqwwer, be noted that the bv the Worbd Health Organization and the Commission: one leaving the supporting information received from the Secretary-General, but all the othe data readily available to them. However, they are not bound to uhdertake special research or even an extended search ib order to be able to decid whether the application of provisional contrbl nieasures is possible. 3. Although a Party may find that the application of provisional control measures is possible, it is not bound to impose such meitsures, no matter what its reasons may be: whether economic, social, legal, administrative or other factors.lS3 A Party is not accountable for the reasons for which it may refuse to apply provisional control, and is not required to explain its refusal to do so to other Parties or to an international organ. 4. Under the Single Convention Parties are bound to examine the possibility of applying provisional control to any substance, not yet under control, whose control status is being examined by WHQ and the Commission in the procedure which that treaty prescribes for that purpose.1s4 k does tiot matter whether the substance appears suitable for ihclusion in Schedule I,in Schedules I and )V, or in Schedule I1 of the Single Convention. Pursuant to the Vienna Convention Parties are not bound to examine the possibifity of or liieiihood of applying provisional control in regard to a11 substances whose international a kgime is being considered in the procedure which the ~onvehtionhas established to this end.' S Parties have that obligation only in respect of those substances not yet controlled or in Schedules 111 and IV of the Vienna Convention which appear suitable for inclusion b'l Schedule I or I1 of that treaty, and in respect of substances in Schedde I1 appearing suitable for Cbrnmemg~ inclusion in Schedule I. i 1: The khemical styucture, as such, of the substance to be exami 151 Article 3, paragraph 3, subparagraph (ii); ses abo article 11, paragraph 1 of the WHO pu&uant to the paragraph undw consideration is not relevant 1931 Convention and artick 2 of the 1948 Protocol,~cZ19df Cbmmntcuy oh article 9, purpose. 0f ajiplying subptagraph (a), clauses (i) and (ii), i.e. of esta paragraph 3, subparagraphs (i) and (H) ofthe Single ConWntion. the liability of a Substrlnce to be abused, although there is of course a 152 The Vienna Convention says fn Englil: "in the U& of 'a&' ififormation avaihble to them"; in French: 'P b bmlh de 'tour' Ies renae@eme?atr dont eUer rklationship between thk chemistry bf a substance and its effects on the disposeront': and in Spanish: "tenieudo en cuennfo 'W' k infkt~~k?n*dc qut person crrnsumiog it; but minor niodifications of the chemical formula of a dispongon':' the Single Convention us* the phma in English: "M the litof the substance may result in great changes in its phaintacological properties, available information"; in French: "compte tenu der nnkignemmta diqxmala':' and in including also its apacity to muse dependence. Substances belonging to Spanish: "tenlmdo en euento IP inf0rmrtfir)n de que ae*&spo~@': hes ss fir& vdrdohs of the Vienna Convention qualify the information by the ward "61". "to&" arld "took" afferent chemical groltps may produce similar pharmacological effects, and and those of the Single Convention do not; it is neverthelea suggested thot &where Is @a those belon&g to a particufar cheIfiical group may have very different difference under both treaties in the wope of infw-lfon which Parties hovt to toko phnnacofogi~alprdpertiesies, Chemical classifications alone, therefore, cannot into account. be the basis for determiniing the need for control. 153 See blow lrtick 2, paragraphs 5 and 6. - ., , . . l . .., , r ... l..'-..^,.- ...l,:.& +&om"n~..nr a,, ",,+ ,C. . . . - mipm/84.10 page 12

ANNEX 6

CHARACTERISTICS OF AMPHETAMINE-TYPE STIMULANTS AND HALLUCINOGENS