The position of preparations of narcotic drugs under tfhe narcotics treaties, with special reference to "exempted preparations"

Abstract

Correspondence between governments, other interested authorities and the Secretariat of the United Nations has indicated that the. treaty régime relating to preparations of narcotic drugs has given rise to certain problems of interpretation, and that this is apparently due to the variety of régimes applying to different types of preparations, as well as to difficulties resulting from the terminology used in the narcotics treaties. It may for this reason be useful to publish the following account of the treaty position of preparations of narcotic drugs.

Details

Pages: 1 to 5
Creation Date: 1959/01/01

The position of preparations of narcotic drugs under the narcotics treaties, with special reference to "exempted preparations"

Correspondence between governments, other interested authorities and the Secretariat of the United Nations has indicated that the. treaty régime relating to preparations of narcotic drugs has given rise to certain problems of interpretation, and that this is apparently due to the variety of régimes applying to different types of preparations, as well as to difficulties resulting from the terminology used in the narcotics treaties. It may for this reason be useful to publish the following account of the treaty position of preparations of narcotic drugs.

I. THE TERM "PREPARATIONS"

The use of terms in the narcotics treaties, concluded as they were at different times, and-having, as authors many persons of different linguistic backgrounds; is often not fully consistent. This applies in particular to the term "preparations ". The narcotics treaties refer by this term not only to preparations in the technical meaning of this word - i.e., to pharmaceutical preparations - but also to other substances. Pharmaceutical preparations of narcotic, drugs may be defined as mixtures, solid or liquid, containing such drugs.[1]

II. PREPARATIONS OTHER THAN PHARMACEUTICAL PREPARATIONS

Substances which technically are not preparations, but which are referred to in the narcotics treaties by this term, are:

  1. "Preparations made directly, from raw or medicinal opium and containing more than 20% of morphine" (article 1, paragraph 2, of the Convention for limiting the manufacture and regulating the distribution of narcotic drugs, signed at Geneva on 13 July 1931)(subsequently referred to as the "1931 Convention ").

Such "preparations" are "drugs" for the purposes of the 1931 Convention and as between Parties thereto, also for purposes of the International Opium Convention signed at Geneva on 19 February 1925[2] (subsequently referred to as the "1925 Convention ") and subject to all the control provisions of these conventions applicable to "drugs "

  1. "Preparations made direct from the coca leaf and containing more than 0.1% of cocaine" (article 1, paragraph 2, of the 1931 Convention).

The position of these "preparations" (as "drugs") under the 1925 and 1931 Conventions is the same as that of the preparations, mentioned under ( a).

  1. "Galenical preparations (extracts and tinctures) of Indian hemp" (cannabis) (article 4( f) of the 1925 Convention).

Such "preparations" are "drugs" for the purpose of the provisions of the 1925 Convention and generally speaking subject to the same provisions of this convention as morphine. The 1931 Convention does not apply to them.

The following differences between the régime governing such drugs as morphine and that governing the extracts and tinctures may, however, be noted under the terms of the 1925 Convention: annual statistical returns (article 22, paragraph 1 ( b) of the 1925 Convention) on the manufacture of morphine but not of extracts and tinctures of cannabis are required. The premises on which morphine is manufactured must be licensed. This requirement does not apply to the cannabis extracts and tinctures (article 6 ( a) in connexion with article 4 of the 1925 Convention). The situation is exactly reversed for preparations (i.e., pharmaceutical preparations) of these drugs. The requiremeat of licensing premises applies to the preparations of extracts and tinctures of cannabis (i.e., to the preparations of the "galenical preparations" of cannabis) but not to morphine preparations. Annual statistical return on manufacture must be furnished for the preparation of cannabis extracts and tinctures but not for morphine preparations. This somewhat peculiar situation is due to the fact that the preparations of the extracts and tinctures of cannabis were placed under the control régime of the 1925 Convention by operation of article 10 thereof (articles 4 ( g), 6 ( a), and 22, paragraph 1 ( b) of this Convention). Preparations of cannabis extracts and tinctures which are capable only of external use are not subject to international control.[3] The fact that under the terms of the 1925 Convention the preparations of cannabis extracts and tinctures are subject to a more severe régime than the basic drugs is, however, not reflected in national legislations or in the Practice of the Permanent Central Opium Board.[4]

  1. "Ordinary preparations-of which the resin[5] forms the base (such as hashish, esrar, chins, djamba)" (article 11, paragraph 1 ( a), of the 1925 Convention).

As indicated by the samples, these "Ordinary preparations " are generally simply the crude resin as separated by mechanical means,[6] and unless mixed with other substances are not pharmaceutical preparations as defined above.

The "ordinary preparations" are not subject to the general régime provided by the 1925 Convention for narcotic drugs and their (pharmaceutical) preparations. They are, however, subject to the provisions of Chapter V of this Convention, relating to the control of international trade, and to those of article 11, paragraphs 1 ( a) and 2 concerning the requirement or a "special import certificate" and the "effective control of such a nature as to prevent the international illicit traffic". The annual statistical returns on the narcotic substances which have been confiscated on account of illicit import and export and the quarterly import and export statistics (article 22, paragraph 1 ( e) and paragraph 2 of the 1925 Convention) must also include the ordinary preparations. [7] The special measures provided for in articles 24 and 26 of the 1925 Convention can also be applied if the dangerous situation mentioned therein arise in respect of the "ordinary preparations".

III. PHARMACEUTICAL PREPARATIONS

This article will not deal with such mixtures containing "raw opium ","prepared opium ", coca leaves, cannabis and cannabis resin as are destined for pleasure - i.e., for purposes other than medical or scientific. As the basic drugs which they contain, these mixtures which strictly speaking would be covered by the above definition of pharmaceutical preparations are not subject to the full control régime applicable in general to narcotic drugs, but only to limited régimes differing in the case of each of the drugs.

It is, however, believed that preparations of opium of any kind (including" raw opium "'and "prepared opium") and of coca leaves enjoy this privileged position only within the limits necessary to facilitate the tolerated practices of opium smoking, opium eating and coca leaf chewing. Depending on their morphine or cocaine content, they must otherwise be considered to be subject to the régime by which preparations containing these drugs would be governed.

The term "medicinal opium " [8] includes opium processed in a certain way in accordance with the requirements of the national pharmacopoeias, whether mixed with neutral materials or not. If so mixed, "medicinal opium" would constitute a 'pharmaceutical preparation as defined above. Inks pure or mixed forms, "medicinal opium '.' is not governed by the régimeprovided by the 1925 Convention for morphine, but by that applicable to morphine preparations - i.e., the requirements of licensing premises of manufacture and of furnishing manufacturing statistics do not apply to" medicinal opium ".

The term " exempted preparations", although commonly used, is not a treaty term. When one employs this term, one refers generally to those (pharmaceutical) preparations which by reason of their small narcotics content are by express treaty clause or by specific decision of the Health Committee of the League of Nations (World Health Organization) exempted from the provisions of the 1925 Convention.[9] Preparations adapted to a normal therapeutic use of drugs subject to the régime applicable to drugs in Group II of article 1, paragraph 2, of the 1931 Convention (subsequently referred to as drugs of Group II) are also often called "exempted preparations ", since, in accordance with article 13, paragraph 2, of the 1931 Convention, as interpreted by the Advisory Committee (of the League of Nations) on the Traffic in Opium and Other Dangerous Drugs (subsequently referred to as the Opium Advisory Committee) [10] and apparently also by the parties to 'this convention, they are not subject to the control provisions of the 1925 Convention. The 1931 Convention refers to such "exempted preparations "[11] as " preparations for the export of which export authorizations are not required "[12]

The term "preparations for the export of which export authorizations are not required ", as well as the term "exempted preparations" are, however, somewhat misleading. The first term seems to be too narrow, the second one too broad. The preparations concerned are, on the one hand, exempted from more control provisions than those requiring the application of the import certificate and export authorization system, and on the other hand, are exempted only from the provisions of the 1925 Convention but not from those of the 1931 Convention, including the provisions aiming at the world-wide limitation of the supplies of narcotic drugs (manufacture and import) to the amounts needed for medical and scientific purposes (estimate system).

The term "exempted preparations" may also 'not be very appropriate for the preparations of cannabis extracts or tinctures capable only of external use. They are not subject to the control provisions of the 1925 Convention nor to those of the 1931 Convention which, in its turn, does not deal with cannabis or its products. The Health Committee of the League of Nations declared in 1939 that its recommendation adopted in 1935 in accordance with article 10 of the 1925 Convention to place preparations of cannabis, extracts and tinctures under the international, control system provided for by that convention did not apply to preparations which were capable of external use only. Whether this declaration constitutes an "exemption" under article 8 of the 1925 Convention appears to be a matter of doubt.[13]

Leaving aside the special régimes provided by the international narcotics treaties [14] for raw opium, coca leaves, cannabis and cannabis resin, in their pure forms, or in appropriate mixtures for non-medical consumption in such tolerated practices as opium smoking, opium eating, coca leaf chewing, smoking or eating of cannabis, and limiting oneself to an examination of the provisions of the general narcotics régime such as is established for the control of narcotic drugs and their preparations intended for medical and scientific purposes, one finds that the only preparations free - or if one wishes to say "exempt " - from international control are the preparations of extracts and tinctures capable only of external use. All other (pharmaceutical) preparations of narcotic drugs, including the so-called "exempted preparations" are subject to various régimes of differing rigidity as follows:

  1. Diacetylmorphine preparations

The most rigidly controlled preparations are those containing diacetylmorphine. They are not only subject to all the standard provisions of the 1925 Convention applying to preparations of drugs belonging to Group I of article 1, paragraph 2, of the 1931 Convention (subsequently referred to as drugs of Group I), such as morphine, but in addition to the special export restrictions of article 10 of this Convention, according to which their export is prohibited except to a country in which diacetylmorphine is not manufactured, at the request of the government of such a country. The request must be accompanied by an import certificate; the quantifies exported must be limited to such amounts as are necessary for the medical and scientific needs of the importing country and must be consigned to the government department indicated in the certificate. The imported preparations must be distributed by and on the responsibility of the government of the importing country. In view of the opinion of the World Health Organization that diacetylmorphine is not necessary for medical practice, some consideration might be given to the question whether, under article 10 of the 1931 Convention, any expor of diacetylmorphine preparations (and, of course, of the basic drug itself and its salts) for other than scientific purposes (including clinical experiments) could be considered legal.

  1. Preparations of drugs of Group I

The international régime applicable to them is in general the same as that governing the basic drugs of Group I. Premises on which such preparations are being manufactured need, however, not be licensed.[15] Statistics on the manufacture of the preparations need not be furnished to the Board.[16]

  1. Preparations of drugs of group II other than those adapted to a normal therapeutic use [17]

Such preparations are subject to the same régime as the basic drugs which they contain if one adopts the interpretation given by the Opium Advisory Committee to article 13, paragraph 2, of the 1931 Convention.[18] This would mean that as far as the provisions of the 1925 Convention are concerned, these preparations are subject to the control provisions governing the manufacture of and wholesale and international trade in narcotics drugs, but not to those relating to the (domestic) retail trade.

  1. Tincture of opium, Sydenham laudanium and Dover powder

These preparations, depending on their morphine content, are in principle subject to the same international régime as morphine preparations, but any Party may authorize chemists to supply them to the public, at their own discretion, as medicines, for immediate use in urgent cases. The maximum dose which may be supplied must not contain more than 25 centigrammes of officinal opium, and the chemist must enter in his books the quantities supplied (article 9 of the 1925 Convention).

  1. "Exempted preparations"[19]

With the reservations mentioned above, we understand under this term the following groups of preparations:

  1. Preparations which, because of their small narcotics content, are, by express treaty provisions, automatically exempted from the control régime of a particular narcotics treaty;

  2. Preparations expressly exempted, under article 8 of the 1925 Convention by decisions of the Health Committee ofthe League of Nations (World Health Organization);

  3. Preparations of drugs, of Group II adapted to a normal therapeutic use.

  4. Preparations which, because of their small narcotics content, are, by express treaty provisions, automatically exempted from the control régime of a particular treaty.

The preparations are differently, defined by related provisions of the 1912 Convention, the 1925 Convention, and the 1931 Convention, each subsequent treaty applying more rigid standards.

  1. 1912 Convention

According to article 14 ( b) and ( c) of the 1912 Convention, Parties are not required to apply to preparations containing not more than 0.2% of morphine, 0.1% of cocaine, or 0.1% of diacetylmorphine the control required under this Convention for the manufacture, import, sale or export of opiates and cocaine.

The automatic exemptions granted by the 1912 Convention are of little, if any, practical importance. The relevant provisions of this treaty were replaced by the provisions of the 1925 Convention as between Parties thereto.[20] They seem also to have ceased to be in force for Parties to the 1912 Convention who, although not Parties to the 1925 Convention, have become Parties to the 1931 Convention.[21] Very few Parties to the 1912 Convention are Parties neither to the 1925 Convention nor to the 1931 Convention.

  1. 1925 Convention

In view of the provisions of article 4 ( d), the control régime of the 1925 Convention governing manufactured narcotic drugs, or for that matter any other control provisions of this convention, do not apply to preparations containing not more than 0.2% of morphine or 0.1% of cocaine. There is no automatic exemption for diacetylmorphine preparations.

The control provisions of the 1912 and 1925 Conventions from which automatic exemption is respectively granted cover the same ground- i.e., administrative control of national and international trade; in particular, they do not relate to the estimate system for the limitation of narcotics supplies, a system governed by the 1931 Convention.

  1. 1931 Convention

As between Parties to the 1931 Convention, the automatic exemption from the provisions of the 1925 Convention can only be granted to solutions or dilutions containing not more than 0.2% of morphine or 0.1% of cocaine, if they are compounded with an active (i.e., pharmacologically active) substance, liquid or solid. Morphine or cocaine preparations compounded only with an inert substance cannot be so exempted. Again there is no automatic exemption for diacetyl-morphine preparations.

Since the automatic exemptions granted under the 1925 or 1931 Conventions apply only to obligations arising from the provisions of the 1925 Convention, it follows that the automatically exempted preparations are subject to the relevant provisions of the 1931 Convention as well as to those of the Convention of 1936 for the Suppression of the Illicit Traffic in Dangerous Drugs (subsequently referred to as the "1936 Convention ") and thus not "exempted from international narcotics control".[22]

ii) Preparations expressly exempted under article 8 of the 1925 Convention

Under the original (unamended) text of the 1925 Convention, the Health Committee of the League of Nations was authorized, after consulting the Permanent Committee of the Office international d'Hygiène publique, to exempt from the provisions of this convention narcotic drug preparations which cannot give rise to drug addiction (" drug habit ") on account of the medicaments with which the narcotics drugs concerned were compounded and which, in practice, precluded the recovery of the narcotic drugs. This right of the Health Committee was transferred to the World Health Organization by the Protocol signed at Lake Success on 11 December 1946.[23] This Organization, under article 8 of the 1925 Convention as amended by this Protocol, must consult the "expert committee appointed by it ".

The Health Committee of the League of Nations exempted a number of preparations. The World Health Organization exempted several Ipecopan preparationswhich it seems, however, were already automatically exempted under the relevant treaty provisions.[24] A list of preparations exempted by application of article 8 was recently published in Schedule III of the Third Draft of the Single Convention on Narcotic Drugs, which was completed by the Commission on Narcotic Drugs at its thirteenth session, in spring 1958.[25]

It may be noted that preparations of drugs of Group II cannot be exempted by operation of article 8 of the 1925 Convention.[26] Such an exemption seems, however, not to be necessary. If the preparations are "adapted to a normal therapeutic use" they enjoy in general the same privileged position of exemption as preparations exempted by virtue of article 8 of the 1925 Convention. If they are, however, not so adapted there seems to be hardly any need for exemption, in particular also because the provisions of the 1925 Convention governing the (domestic) retail trade do not apply to them.

Preparations exempted by virtue of article 8 of the 1925 Convention are subject to the same régime as preparations exempted automatically by the specific provisions of the 1925 and 1931 Conventions. This means they are only exempted from the provisions of the 1925 Convention, but not from those of the 1931 and 1936 Conventions.

In theory, some legal problems may arise from the fact that the 1925 Convention is in force in its amended [27] as well as its unamended form and that under the unamended text of its article 8 it was the now defunct Health Committee of the League of Nations which was granted authority of exemption, while under the amended text the World Health Organization holds this power. It is, however, the view of the World Health Organization, not disputed by governments, that States, whether Parties to the unamended or amended [27] 1925 or 1931 Convention, may make use of all exemptions - of those granted by the Health Committee, as well as those granted by the World Health Organization. It was therefore not found to be necessary for the World Health Organization to repeat, for the benefit of States Parties to the amended Conventions, exemptions granted by the Health Committee of the League of Nations.

It seems that in the light of later experience some of the exemptions granted by the Health Committee of the League of Nations have not proved to be justified. It cannot be excluded for the future that, in the light of the evidence available at the time, exemptions may again be granted, which, by later experience, may prove to be harmful to public health. The text of article 8 in its unamended as well as its amended form does not expressly provide for authority to rescind exemptions once granted. It may, however, be considered on more general legal grounds whether, despite the lack of such an express provision, the World Health Organization does not have this authority. If - as seems to have been widely assumed-the exemptions granted are considered to be irrevocable, it may tend to induce the World Health Organization to be more reserved in granting exemptions than would otherwise be necessary, and this may not constitute a desirable situation from the viewpoint of some national administrations. When the Health Committee of the League of Nations omitted several preparations,exempted earlier, from its Recapitulatory List of Preparations exempted from the Provisions of the International Opium Convention by Application of Article 8 of that Convention,[28] it seems that at least some of its members assumed that the Committee had authority to rescind an exemption granted under article 8.

It may also be noted that while decisions to place a drug under full international control must be initiated by a government,[29] decisions to exempt a preparation from the provisions of the 1925 Convention, under (the amended) article 8 thereof, may be adopted by the World Health Organization on its own authority.[30]

  1. Preparations of drugs of Group II adapted to a normal therapeutic use

If the somewhat obscure provisions of article 13, paragraph 2, of the 1931 Convention are interpreted in accordance with the views of the Opium Advisory Committee, such preparations are exempted from the provisions of the 1925 Conventions.[31] They are, in general, subject to the same régime as the preparations exempted by virtue of article 8 of the 1925 Convention. In some places of the 1931 Convention the term "preparations for the export of which export authorizations are not required "'applies to preparations of drugs of Group II adapted to a normal therapeutic use, as well as to preparations exempted by specific treaty provisions or by operation of article 8 of the 1925 Convention from the provisions of this Convention.[32] In other cases, however, this term does not include the preparations of drugs of Group II.[33] It is held that Parties to the 1931 Convention need not include in the annual statistics furnished by them to the Permanent Central Opium Board the amounts of drugs of Group II used by manufacturers and wholesalers for the compounding of preparations adapted to a normal therapeutic use, while such information must be supplied in respect of preparations exempted from the 1925 Convention either by express treaty provisions or under article 8 of this Convention.[34] Similarly, the Permanent Central Opium Board need not include in its annual statement [35] the amount of drugs of Group II used for the compounding of preparations adapted to a normal therapeutic use, although this information must be given, for other preparations exempted from the 1925 Convention.[36] Preparations of drugs of Group II adapted to a normal therapeutic use are, of course, subject to the other relevant provisions of the 1931 Convention as well as to those of the 1936 Convention.

It can be seen that the provisions relating to the control of preparations of narcotic drugs in general, and to the so-called exempted preparations in particular, are varied and complicated. Such differences as exist were not necessarily motivated by substantive considerations but are frequently due to drafting defects often caused by the conditions of pressure under which the relevant provisions were drafted and adopted. The obscurities, complexities and differences are, however, not of great practical importance. Of the various standards which, under the treaty provisions, would literally be applicable to different Parties, only the highest ones are generally used in national practice. It may be said that a State which would not conform with the higher requirements would hardly escape criticism by reference to the fact that it is only bound by the lower standards. This may reasonably be expected - e.g., in the case of a government which is a Party to the 1925 Convention but not to the 1931 Convention and which, in accordance with article 4 ( d) of the 1925 Convention, would grant automatic exemption to a preparation containing not more than 0.2% of morphine or not more than 0.1% of cocaine, unless the preparation is compounded with an active substance as required by article 13, paragraph 2, of the 1931 Convention. The exact grounds, whether legal or otherwise, on which such a government may expect criticism need not be examined here. The expectation is based on the experience in a great number of cases in which governments actually have been subject to criticism because they have not applied higher standards set by later narcotics treaties to which they have not formally become Parties.

1

United Nations document E/CN.7/AC.3/9, para. reference number 28.

2

See article 13, para. 1 ( a) of the 1931 Convention

3

League of Nations circular letters: CL.161.1936.XI; CL.161(a). 1936.X1; CL.99.1939.XI; CL.99.(a).1939.XI; and CL161.1939.XI

4

See Statistical Form of the Permanent Central Opium Board, C/2

5

i.e., cannabis resin.

6

Bulletin on Narcotics, Volume II, No. 2, English edition, pp. 35 and 42.

7

Forms A. 1 and E of the Permanent Central Opium Board.

8

Article 1 of the 1925 Convention and article 1, para. 3, of the 1931 Convention.

9

Or - a not very practical case - (by express treaty clause) from the provisions of the International Opium Convention, signed at The Hague on 23 January 1912 (subsequently referred to as the" 1912 Convention ").

10

League of Nations document C.191.M.136.1937.XI, para. 135, English edition, p. 175.

11

i.e., to the preparations exempted from the provisions of the 1925 Convention, not to those exempted from the 1912 Convention.

12

See article 5, para 2( a); article 6, prom. 1 ( a); article 14, para 3( g); article 17 (last sub-paragraph); and article 22 of the 1931 Convention. See also Form of the permanent Central Opium Board, B/2.

13

League of Nations documents CL.99.1939.XI; CL.99(a).1939.XI; CL161.1939.XI; and CFL1396. From the relevant report of the Office international d'Hygiène publique, and from the communication by the Council of the League of Nations of this decision under article 10 of the 1925 Convention, it would appear that the action relating to preparations capable of external use only was one of clarifying the earlier decision taken under this article recommending the control of cannabis extracts and tinctures (CL.161.1936.Xl), rather than an exemption taken under article 8 of the Convention.

14

i.e., the 1912 and 1925 Conventions. See also the Agreement concerning the Manufacture of, Internal Trade in and Use of Prepared Opium, signed at Geneva on 11 February 1925, and the Agreement for the Control of Opium Smoking in the Far East, signed at Bangkok on 27 November 1931.

15

Para. 6 ( a) of the 1925 Convention.

16

Article 22, para. 1 ( b), of the 1925 Convention.

17

i.e., in case of preparations of codeinc and ethylmorphine (dionine): dry preparations (pills, tablets, etc.) containing more than 0.1 g of either substance and solutions containing more than 10% might be considered not to be "adaptedto a normal therapeutic use ". See Report of the Health Organization to the Council on the work of the twentieth session of the Health Committee (League of Nations document C.652.M.312. 1933.III p. 6).

18

League of Nations document C.191.M,136.1937.XI, para. 135, p. 175 of the English edition.

19

As regards preparations of cannabis extracts and tinctures capable only of external use, see above.

20

Article 31 of the 1925 Convention.

21

Article 13, para. 1, of the 1931 convention, in connexion with article 31 of the 1925 Convention.

22

For preparations of cannabis extracts and tinctures capable of external use only, see above. Such preparations are " exempted from international narcotics control ".

23

See also Protocol of 22 July 1946 concerning the Office international d'Hygiène publique.

24

World Health Organization Technical Report Series No. 57, English edition, p. 4; see article ( d) of the 1925 Convention and article 13, para. 1 ( b) of the 1931 Convention.

25

ECN.7/AC.3/9/Add.1, Schedule III English edition, pp. 11-24; see also Bulletin on Narcotics, Volume III No. 4, pp. 2-8

26

Article 13, para. 2, of the 1931 Convention.

27

i.e., by the Protocol signed at Lake Success on 11 December 1946.

28

League of Nations document C.114.M.54.1932.III

29

Article 11 of the1931. Convention and article 1 of the Protocol of 19 November 1948 for bringing under international, control drugs outside the scope of the 1931 Convention.

30

It may, however, be mentioned that under article 10 of the 1925 Convention, as amended, the World Health Organization may, on its own initiative, place a drug under the control provisions of this Convention.

31

League of Nations document C.191.M.136.1937.XI, para. 135, English edition, p. 175.

32

Article 5, para. 2 (a); article 6, para. 1 (a); and article 17, last sub-para., of the 1931 Convention.

33

Article 14, para. 3 (g) and article 22 of the 1931 Convention.

34

Article 22 of the 1931 Convention.

35

Article 14, para. 3 (g) of the 1931 Convention.

36

League of Nations document C.191.M.136.1937.XI, paras. 154 and 193, English edition, pp. 189 and 213.