Abstract
Manufacture of drugs by the Parties to the Single Convention is allowed only under licence except where such manufacture is carried out by a state enterprise or state enterprises.1 Such licences are required for two purposes: (a) for authorization to engage in the manufacture of drugs; and (b) for the use of establishments and premises in which such manufacture may take place.2 Manufacture of drugs under licence, includes basic drugs, their salts and preparations,3 including preparations in Schedule III. The state enterprises will not, for obvious reasons, need a formal licence in this regard, yet they are not allowed to manufacture drugs, salts and preparations, other than those for which permission may be given to a private manufacturer.4 However, a licence will detail the names of drugs, their quantities and the period for which the manufacturer concerned will be allowed to use it, and similarly, where a state enterprise is authorized to manufacture drugs, the aforementioned procedure shall also be observed, in order to ensure that the manufacture of a particular drug in a given country or territory does not exceed the limit permitted by the Single Convention.
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Notes
Article 29. Licence in this context refers to a written government authorization, whatever name may be given to it in a municipal legal system.
Article 29(2)(b). A separate licence is necessary for each establishment and premises on which manufacture of drug(s) may take place.
Article 2, paragraphs 3 and 4 of the Single Convention and Article 1 of the 1972 Protocol.
A private manufacturer may mean a firm or even an individual.
Commentary on the Single Convention, op. cit., p. 318.
Article 10(1).
Article 6.
Article 29(2)(a).
This is chiefly with a view to preventing diversion or theft of drugs. See further UN Doc. E/CN/7/519, pp. 33 and 93.
Article 29(2)(c).
Article 21, paragraphs 1–3.
Article 3 and Article 5(5) of the Limitation Convention, 1931.
These permits should not be confused with licenses. Whereas the former is an authorization of a limited nature allowing a manufacturer to manufacture drugs until further notice, the latter is a general authorization certifying the eligibility of a manufacturer to manufacture drugs under certain conditions.
Article 21(4)(a).
Prior to the coming into force of the Single Convention, the limitation regime applied only to substances falling under the Limitation Convention of 1931 and the 1948 and 1953 Protocols, i.e., manufactured drugs other than extracts and tinctures of cannabis and opium. It was also not applicable to cannabis, cannabis resin and coca leaves.
Article 21(2).
Drugs released for “licit use” not only includes the drugs which have been released for commercial purposes, but also those which have been released to the non-profit distributors.
Form C/S (13th edition, November 1978) table II, column F, p. 8.
Article 21 (4); see also Article 14(2) of the Single Convention and Article 6 of the 1972 Protocol. While, under the previous Conventions, the Permanent Central Board had an obligation to impose an embargo in the event of excessive imports, the Single Convention authorizes the International Narcotics Control Board to exercise its discretion as to whether or not such an embargo should be imposed upon a country.
Under the Limitation Convention the Parties were only required to submit annual statistics and not quarterly statistics in respect of the drugs included in Group II (Article 13(2)(c)(i) of the Limitation Convention of 1931).
Article 4.
See Articles 6, 7, 8, 12 and 14(2) of the Limitation Convention of 1931 and Article 8, paragraphs 10 and 11 of the 1953 Protocol.
These substances are not listed in Schedule I or Schedule II, and are therefore not “drugs.”
“Production” under the Single Convention means “the separation of opium, coca leaves, cannabis and cannabis resin from the plants from which they are obtained.” See Article 1(1) (t).
See instructions 3 and 4 of Forms C/S and A/S of the International Narcotics Control Board (13th edition, November 1978).
See Commentary on the Single Convention, op. cit.; see also UN Doc. E/CN.7/ 484/Rev. 1, paragraph 88, and the Commentary on the Limitation Convention of 1931, op. cit., paragraph 89.
See the Commentary on the Single Convention, op. cit., p. 269.
See also Article 9 of the 1972 Protocol.
See UN Doc. E/INCB/W.7 (May 1968), paragraph 12; see also Commentary on the Single Convention, op. cit., p. 269.
The Board may only request such explanations under Article 13(3); see also Article 6 of the 1972 Protocol amending Article 14, paragraphs 1 and 2 of the Single Convention.
Article 29(2) (c).
Official Records, vol. I, p. 27 and vol. II, pp. 124–125.
Article 14, Article 21 and Article 31(l)(b).
“The Board shall fix the date or dates by which and the manner in which, the estimates as provided in article 19 shall be furnished and shall prescribe the forms therefor.” Article 12, paragraph 1; see also Article 12, paragraphs 4 and 5 of the Single Convention concerning supplementary estimates of drugs. Article 12, paragraph 5 (of the Single Convention) should be read with Article 5 of the 1972 Protocol.
Article 19 of the Single Convention; see also Article 9 of the 1972 Protocol.
Article 19 of the Single Convention and Article 9 of the 1972 Protocol. 36a Prior to the 1953 Protocol, the governments were advised by the Permanent Central Board to supply their “consumption” statistics along the following line: “Unless a Government has established that in column 1 (‘Consumption other than for Government purposes’) should be reported the quantities supplied to pharmacists, doctors, dentists, veterinarians and to hospitals, dispensaries and similar health institutions both public and private that have authority to supply narcotic drugs. Quantities of drugs dispensed through a national health scheme would also figure in this column, regardless of the fact that the system is administered by the state. The figures in column 1 should not include amounts consumed in the form of exempted preparations.” Form C/l of the Permanent Central Board (Title: “Annual Statistics of Consumption,” 9th edition, November, 1959, Instruction No. 4).
See Form C/S of the International Narcotics Control Board, 13th edition, November 1978, Instruction No. 3.
The drugs contained in such preparations are, however, separately shown in the statistics by governments. This is necessary for the purpose of ascertaining the drugs used in the manufacture of preparations in Schedule III Article 2, paragraph 4 and Article 20, paragraph 1, sub-paragraph (b). Governments are also obliged to furnish estimates of the quantities of drugs which they require for the manufacture of such preparations (Article 2(4) and Article 19(1) (b)).
In so far as the estimates of “consumption” are concerned, the Board advises that such estimates should be established on the basis of the features of past consumption. An average calculated on the basis of consumption over the period of the past three years may be a useful guide. The Single Convention, however, has not encouraged the system of “margin” for adjustment of demand in the case of contingencies, which was a feature of the Limitation Convention of 1931. (The 1953 Protocol also did not support the policy of “margin” in estimating the requirements of drugs.) The absence of the “margin” system in the Single Convention lies in the fact that the stocks of drugs which the Parties are supposed to maintain presuppose a consideration of such “margins.”
According to the corresponding provisions of the Limitation Convention and the 1953 Protocol (Article 5(2) (a) and Article 8(1) (a) respectively) the estimate for “consumption” included the amounts needed for the compounding of “preparations for the export of which authorizations are not required.” The consumption of drugs whether for domestic or other purposes had no relevance. However, in so far as the Single Convention is concerned, the Board requests the governments not to include the amounts needed for the stocks of manufacturers, wholesalers and importers other than the retail pharmacists. Yet, should the circumstances require an increase in the “stocks” of retail distributors (the stocks of retail pharmacists are not stocks under the Single Convention; see also Article 1 (1) (x)), such a quantity may be taken into account in computing the estimates of consumption, whether it is to be obtained by manufacture or by import. See further Commentary on the Single Convention, op. cit., p. 225.
See Form B of the International Narcotics Control Board, February, 1979. Under the regime preceding the Single Convention, a consolidated figure had to be given in respect of each drug needed for conversion (see Article 1(4) and Article 5(2)(b) of the Limitation Convention, 1931). Article 8(1) (b) of the 1953 Protocol however required information on the estimated quantities of opium required for the manufacture of alkaloids.
See Form B, General Instruction 10; see also “Yellow List” (Annex to the statistical forms).
See further Commentary on the Single Convention, op. cit., p. 227.
Coca leaves to be used for extraction of alkaloids in pursuance of Article 27(2) are subject to estimates and statistical information.
The amount of cannabis required for the manufacture of drugs for nonmedical purposes would be subject to estimates pursuant to Article 49(3) (b).
Article 1(1)(x).
See also Form B of the International Narcotics Control Board February, 1979, General Instructions 14 and 13; see also Commentary on the Single Convention, op. cit., p. 229.
Such “stocks” are not “stocks” in terms of Article 1, paragraph 1, subparagraph (x).
According to the Commentary on the Single Convention, however, such estimates will include an account of the stocks of drugs which are intended for use in industry for other than medical and scientific purposes under Article 2, paragraph 9, whereas the aforesaid Article provides that “Parties are not required to apply the provisions of this Convention to drugs which are commonly used in industry for other than medical or scientific purposes, provided that: (a) They ensure by appropriate methods of denaturing or by other means that the drugs so used are not liable to be abused or have ill effects (Article 3, paragraph 3) and that the harmful substances cannot in practice be recovered; and (b) They include in the statistical information (Article 20) furnished by them the amount of each drug so used.” The inclusion of the amount of each drug after use by the Parties in the statistical information, and the submission of estimates of such drugs before use are two different things. The above provision does not imply that the Parties are obliged to include such drugs in their estimates. See Commentary on the Single Convention, op. cit., p. 230.
Article 49, paragraph 4.
Article 1, paragraph 1, sub-paragraph (x).
Article 12(1), Article 19, paragraph 1, sub-paragraphs (a)-(c) and Article 9 of the 1972 Protocol.
Form C/S of the Board (13th edition, 1978) footnote (b) to table II, p. 9.
Article 1(1)(w).
See the Commentary on the Single Convention, op. cit., 232.
Article 1(1)(w) and (x); and also Article 19(l)(c).
This Article should be read with Article 9 of the 1972 Protocol. See also Commentary on the Protocol Amending the Single Convention, pp. 45–46.
Article 21, paragraph 3: “If the Board finds that the quantity manufactured and imported in any one year exceeds the sum of the quantities specified in paragraph 1, less any deductions required under paragraph 2 of this article, any excess so established and remaining at the end of the year shall, in the following year, be deducted from the quantity to be manufactured or imported and from the total of the estimates as defined in paragraph 2 of Article 19.” See also Article 9 of the 1972 Protocol.
It is for this reason that decisions on supplementary estimates receive the urgent consideration of the International Narcotics Control Board and in the event of its not being in session, even by telegraphic consultation with its members, if necessary.
Article 1, paragraph 4, third sub-paragraph of the Limitation Convention, 1931; see also Article 8, paragraph 6 of the 1953 Protocol.
It is to be noted that the same form is used for both “regular” and “supplementary” estimates; in the case of the latter however a government is required to indicate to which heading of the form (form B) each of the drugs belongs or state to which the various quantities of drugs mentioned in Article 19, paragraph 1, the new figure relates.
See Article 9 of the 1972 Protocol, amending Article 19(5) of the Single Convention.
Article 21 (b) of the Hague Opium Convention, 1912; Article 10 of the Geneva Agreement, 1925; Articles 22 and 23 of the International Opium Convention, 1925; Article 13(2) (c) and Article 22 of the Limitation Convention, 1931, Article 4(c) and Article 9 of the 1953 Protocol.
See also Article 14(3) of the Limitation Convention, 1931, Article 12(2) of the 1953 Protocol and Article 15(1) of the Single Convention.
See also Article 29(3) and Article 30(2)(a).
Usually two different kinds of forms are used for furnishing statistical information, viz. (a) form C/S for annual statistical information; (b) form A/S for quarterly reports to be made under Article 20.
See Form C/S (13th edition) instruction 3, and Form A/S (14th edition) instructions 3 and 5.
See further Form C/S— instruction 4; see also Form A/S- instruction 4.
Article 1(1)(t).
Article 1(1)(n).
See footnote 74.
Manufacture, as used in Article 20(1) (a) does not include the transformation of base drugs into their salts.
See further Commentary on the Single Convention, op. cit., p. 247.
See form C/S (13th edition), column C of table I.
Article 2(9)(b).
Article 1(1)(n). In this connection see the Commentary on the Single Convention, according to which “the Board may not under the sub-paragraph under consideration require information on the quantities of crude drugs utilized for the making of refined drugs.” p. 249.
See the definition of the “concentrate of poppy straw” in Schedule I.
See Article 1(1)(r).
Form C/S, instruction 3.
Article 1, paragraph 2: “For the purpose of this Convention a drug shall be regarded as ‘consumed’ when it has been supplied to any person or enterprise for retail distribution, medical use or scientific research; and ‘consumption’ shall be construed accordingly.”
See the Commentary on the Single Convention, op. cit., p. 250.
See Form C/S, 13th edition, November, 1978.
Drugs belonging to Group II in the Limitation Convention, 1931, which had a similar legal position to those belonging to Schedule II of the Single Convention, were excluded from consumption statistics.
See Form A/S, 14th edition, November, 1978.
The Limitation Convention of 1931 only provided for annual statistics of imports and exports of drugs belonging to Group II. Article 13(2) (c) (i).
See Form A/S, instruction 10; see also the Commentary on the Single Convention, op. cit., p. 252. According to the Single Convention, “import” and “export” “mean in their respective connotations the physical transfer of drugs from one state to another state, or from one territory to another territory of the same state”, see Article 1(1)(m).
See Form A/S, instruction 5.
Figures regarding morphine and concentrate of poppy straw made available in trade should be supplied separately, Form A/S, columns 6 of Part I and Part II of the tables.
Form A/S, item II in the first column of Part I of the tables.
Form C/S, table II, footnote (e).
See Form C/S (13th edition, November, 1978), Notes to Table II, footnotes (b) and (d). Quantities held for “special government purposes” include in particular the requirements for armed forces. The phrase “exceptional circumstances” is meant to cover such catastrophic events as large-scale epidemics and major earthquakes.
Statistics in respect of such stocks which will include opium, coca leaves, cannabis, cannabis resin and extracts and tinctures of cannabis (except the stock held for retail outlets or as “special stocks” by government) should be furnished separately. For provisions of earlier treaties regarding statistical returns on stocks, see Article 22, paragraph 1, sub-paragraph (c) of the International Opium Convention, 1925 and Article 9, paragraph 1, sub-paragraph (b) of the 1953 Protocol.
See further Form C/S, table II, footnote (b).
Parties to the Single Convention however have to furnish, in addition to the amounts of drugs refined and/or crude actually used, such other data regarding preparations in Schedule III as the Commission may request, as and when necessary. See also Article 18, paragraph 1.
Article 20, paragraph 2, sub-paragraph (a); see also Form C/S, p. 4.
See also Article 22(2) of the International Opium Convention, 1925 and Article 19(l)(c) of the 1953 Protocol. It appears that the Single Convention has followed the provisions of the previous narcotic treaties in this matter.
Article 20(2) (b).
Article 20, paragraph 4.
See Form C/S, table II, footnote d, and Form A/S, instruction 12; see also Article 1(1)(w).
See also Article 20(2) (b).
See Form A/S, Part I of the tables, first column, line II, pp. 4–6.
Form C/S, table II, column D.
See further Commentary on the Single Convention, op. cit., p. 224.
Form B, General Instruction 11; see also the Commentary on the Single Convention, op. cit., p. 227.
For example, heroin, which is an intermediary product in a continuous process of the manufacture of nalorphine, an uncontrolled substance, from morphine. However, if after obtaining the heroin the process of manufacture of nalorphine is interrupted (e.g., in these cases where heroin made by one manufacturer is to be delivered to another manufacturer for transformation into nalorphine) the amount of morphine should be included in the estimate of the amount of that drug to be utilized for the manufacture of other drugs, heroin being such an “other drug,” and the amount of heroin should be included in the estimate of this quantity of heroin to be utilized for the manufacture of substances not covered by the Single Convention. See the Commentary on the Single Convention, op. cit., p. 228.
Article 19(1)(c). Article 27(2) and Article 49(3)(b) are however exceptions to the above system; see also Form B, column 4.
See Commentary on the Limitation Convention, 1931, op. cit., paragraph 52, and L. N. Doc. C.521.M.362.1937.XI.
In fact, the Board discussed this matter at its session in Autumn of 1970.
See Comments on the Limitation Convention and the 1953 Protocol, see above, sub. sec. 4.4.4.1.
See above, pp. 292–294.
See further Article 9 of the 1972 Protocol, amending Article 19 of the Single Convention.
Form C/S, Article 20(l)(f) and paragraph 2 (a).
For example, see UN Doc. E/INCB/6, Add 1, 2.
See further Commentary on the Single Convention, op. cit., p. 236.
Article 19, paragraph 5: “Subject to the deductions referred to in paragraph 3 of article 21, an account being taken where appropriate of the provisions of article 21 bis, the estimates shall not be exceeded.” See also Article 9 of the 1972 Protocol.
Article 19, paragraph 3.
Article 12, paragraph 3.
See Article 1(1)(t).
See Article 1(1)(n).
Concentrate of poppy straw will, however, be taken into account for the purpose of statistical return, if it has been made available in trade.
Article 20(l)(b).
According to Article 1(1)(b) “cannabis” means “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated,” and therefore, leaves of the cannabis plant when not accompanied by the tops are not “cannabis” and hence not a “drug.”
Article 2, paragraph 4, see also Article 1 of the 1972 Protocol.
Article 21, paragraphs 1 and 2; see also the Commentary on the Single Convention, op. cit., p. 255.
Stocks held by retail pharmacists are not considered as “stocks” under the Single Convention, and therefore, returns on them do not have to be furnished.
See Official Records, vol II, op. cit., p. 41 and vol. I, p. 137.
See especially the view of the British delegate who, in fact, abstained. Official Records, vol. I, op. cit., p. 137.
See also Article 10 of the 1972 Protocol.
Article 1(1)(w).
See Article 12, paragraph 4, Article 13, paragraph 4, Article 19, paragraph 1(d) and Article 20(1) (f); see also Form C/S, notes (b), (c) and (d) to table II, Form A/S, instruction 12.
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Chatterjee, S.K. (1981). Manufacture and Importation of Drugs: Limitation Thereof. In: Legal Aspects of International Drug Control. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-7066-8_10
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