Article 34

MEASURES OF SUPERVISION AND INSPECTION

Commentary

1. This title contains the words "and inspection" even though the body of the article does not include any provision regarding inspection. Article 46 of the Second Draft of the Single Convention,) which corresponds to article 34 of the Single Convention, provided in its second paragraph that Parties should maintain a system of inspection. This paragraph was deleted by the Commission on Narcotic Drugs at its thirteenth session because it considered such an express provision to be superfluous, since all Governments provide in any event for inspection. It was, however, overlooked on that occasion, as well as later when the Third Draft of the Single Convention 2 was adopted, that the title accordingly required correction. This correction was also omitted by the Plenipotentiary Conference. a

2. As regards the obligation of Parties under the introductory paragraph of article 4; under article 29, paragraph 2, subparagraph (a); under article 30, paragraph 1, subparagraph (b), clause (i) and under article 31, para graph 3, subparagraph (b), to maintain a system of inspection of the various phases of the narcotics trade (agriculture, manufacture, wholesale and retail trade), see above, comments on those provisions. 4

1 Document E/CN.7/AC.3/7.

2 Records, vol. II, p. 17 (article 43 of the Third Draft).

3 See foot-note 5 to the comments on article 4.

4 See also comments on article 23, para. 2, subparas. (b) and (c).

Paragraph (a) with introductory part

The Parties shall require:

(a) That all persons who obtain licences as provided in accordance with this Convention, or who have managerial or supervisory positions in a State enterprise established in accordance with this Convention, shall have adequate qualifications for the effective and faithful execution of the provisions of such laws and regulations as are enacted in pursuance thereof; and

Commentary

1. A question arises as to the meaning of the phrase "all persons who obtain licences". Not only natural but also "legal" persons can obtain cultivation, manufacturing or trading licences in accordance with the Single Convention. 1 Although the text of paragraph (a) may appear to apply the requirement of "adequate qualifications", which it defines, only to natural persons, it is submitted that it cannot have been the intention of the authors of the Single Convention to subject private individuals and State enterprises, but not private corporate bodies (corporations or co-operatives), to conditions which are intended to ensure the "effective and faithful execution" of the laws and regulations enacted to implement the treaty. Corporate bodies as State enterprises can offer the assurance that they have the capacity and willingness to implement effectively and faithfully the rules of the narcotics regime only if their managerial or supervisory personnel has adequate qualifications for so doing. It appears to follow that the phrase "all persons who obtain licences" includes "legal persons", who must therefore also have the required "adequate qualifications", and may be considered to have such qualifications if their managerial or supervisory personnel has them. It can certainly be assumed that the authors of the Single Convention did not wish to subject private corporate bodies to a less strict regime than State enterprises.

2. The required "adequate qualifications" are meant to include moral as well as technical qualifications. 2 The Conference was well aware that this requirement was very vague. It found it impossible, however, to use more specific terms, since the differing conditions in various countries and the divergent activities involved (manufacture, trade, distribution, agricultural cultivation) required the application of different technical standards .3 The moral standards which must be required are of course everywhere the same, namely, a high moral character which gives assurance that the persons in question possessing it can be relied upon to carry out faithfully the laws and regulations concerned. This obviously excludes persons who have been convicted of intentional violations of the narcotics law, and beyond that, all persons who on account of their past behaviour cannot be fully trusted to be law-abiding.

3. The required technical standards can, in the case of manufacture, trade and distribution, be based on such factors as appropriate school degrees, a certain practical experience or the successful passing of specific examinations. While paragraph (a) does not apply to medical practitioners, it is nevertheless suggested that it would be in the spirit of this provision to require that these practioners including veterinarians and dentists, who in fact participate in the "distribution" 4 of drugs by dispensing and administering them, should have "adequate qualifications for the effective and faithful execution" of those rules of the narcotics laws and regulations which govern their professional activities. While the Single Convention does not prescribe the licensing of medical practitioners, some national laws stipulate that they must have special narcotics licences.

4. As regards manufacture, trade and distribution, paragraph (a) appears to be in fact only a special application of the general rule of the Single Convention requiring Parties to control all persons and enterprises carrying on or engaged in the manufacture of, trade in, or distribution of drugs. s It is moreover suggested that the obligation laid down in this paragraph is also implied in the requirement of the Single Convention that the manufacture of, trade in and distribution of drugs should be carried out by State enterprises or be licensed, and that the cultivation of the coca bush, of the opium poppy for the production of opium and of the cannabis plant for the production of cannabis and cannabis resin should also need a licence. 1 It is one of the objectives of this requirement that the persons and enterprises engaged in the activities in question should have the necessary qualities to ensure an effective and faithful implementation of those rules of the narcotics regime which concern them.

5. Paragraph (a) is not one of the provisions from whose application preparations in Schedule III are exempted. 6

6. The narcotics regime preceding the Single Convention did not have an explicit provision corresponding to paragraph (a). Its licensing requirements 7 and its general rule requiring control of all persons manufacturing, importing, selling, distributing or exporting the drugs concerned s appears, however, to imply in respect of the drugs in question a similar obligation to that laid down in article 34, paragraph (a), of the Single Convention.

1 Article 29, para. 1, article 30, para. 1, subpara. (a) and article 31, para. 3, subpara. (a); see also article 23, para. 2, subparas. (a) and (b), article 26, para. 1 and article 28, para. 1; article 34, para. (a) also applies to the licensed cultivators to which these provisions of articles 23, 26 and 28 relate.

2 Records, vol. I, p. 36, vol. II, p. 283 (foot-note 14) and 288 (foot-note 45).

3 Records, vol. I, p. 36; vol. Il, p. 145.

4 Article 30, para. 1, subpara. (a) subjects this distribution to the requirement of a licence, from which medical practitioners are however exempted pursuant to subpara. (c) of that paragraph; State enterprises need not have a licence.

5 Article 29, para. 2, subpara. (a); article 30, para. 1, subpara. (b), clause (i) and article 31, para. 3, subpara. (b); see also comments on those provisions of articles 29 and 30.

6 Article 2, para. 4.

7 Article 6, second para., subpara. (c) of the 1925 Convention, article 10, second para., subpara. (b) of the 1912 Convention, article 13, para. 1, subpara. (a) and para. 2, subpara. (a) of the 1931 Convention and article 3, para. 3 of the 1953 Protocol.

8 Article 6, first para. of the 1925 Convention, article 10, first para. of the 1912 Convention and article 13, para. 1, subpara. (a) and para. 2, subpara. (a) of the 1931 Convention.

Paragraph (b)

(b) That governmental authorities, manufacturers, traders, scientists, scientific institutions and hospitals keep such records as will show the quantities of each drug manufactured and of each individual acquisition and disposal of drugs. Such records shall respectively be
preserved for a period of not less than two years. Where counterfoil books [article 30, paragraph 2 (b)] of official prescriptions are used, such books including the counterfoils shall also be kept for a period of not less than two years.

Commentary

1. The term "governmental authorities" refers to State enterprises engaged in the manufacture of, and trade in drugs 1 and-it is submitted-to the national opium, coca leaf or cannabis agencies required to be maintained in countries authorizing respectively the cultivation of the opium poppy for the production of opium, the cultivation of the coca bush, or the cultivation of the cannabis plant for the production of cannabis or cannabis resin. 2 It cannot be assumed that the authors of the Single Convention intended to require other Government authorities to keep the detailed records required by paragraph (b). 3 The competent Government authorities must of course keep the records that they need for the administration of the regime of different licences provided for in the Single Convention and of the import certificate and export authorization system, for furnishing their estimates of drug requirements and their statistical returns to the Board, and for keeping their narcotics supplies to be obtained by manufacture or import or both, within the limits prescribed by the Single Convention; but the obligation to keep these records is implied in the provisions of the Convention dealing with these functions, and it is not a subject regulated by paragraph (b).

2. The paragraph under consideration does not normally require medical practitioners (physicians, surgeons, veterinarians and dentists) to keep any records. They are not "traders" within the meaning of this provision. 4 Some countries, however, require them to keep more or less detailed records of the kind to which paragraph (b) refers. Moreover, if a Party requires under article 30, paragraph 2, subparagraph (b), clause (ii) that prescriptions for drugs in Schedule I should be written on official forms taken from counterfoil books, article 34, paragraph (b) requires that such books, including the counterfoils, should be kept for a minimum period of two years by those who wrote the prescriptions, who are generally medical practitioners; but this is the only exception to the exemption of medical practitioners from the provisions of paragraph (b). It will furthermore be recalled that a Party is bound to require the use of such official prescription forms only if it deems such a measure "necessary or desirable". 5 Medical practitioners who have a hospital, or engage in scientific research for which they use narcotics, or engage in the sale of narcotic drugs to other persons than their own patients 6 must, however, in these capacities keep the records which hospitals, 7 scientists or pharmacists are bound to maintain. It will, however, sometimes be difficult to draw an exact borderline between the therapeutic and scientific use of drugs by medical practitioners.

3. "Scientists" within the meaning of paragraph (b) are individual research workers who do not perform their work as members of a scientific institution. If they do their research within the framework of such an institution or of a hospital, they need not keep records of the drugs which they use, in addition to those which the institution or the hospital must maintain.

4. It was the understanding of the Plenipotentiary Conference that the term "scientific institutions ... covered the whole field, including research and education institutions, such as universities". 8 Hospitals which engage in scientific research need not, however, be required to have separate records for the drugs to be employed for medical treatment and for those to be used for research. Normally hospital research will simultaneously be treatment. Research departments of drug manufacturers, whether private or State enterprises, might also appear to be scientific institutions for the purposes of paragraph (b). Their use of drugs for research would, however, be "disposal" as this word is employed in the paragraph under consideration, and drug manufacturers would therefore already be required in that capacity to record such use since they must keep records which show each individual disposal of drugs.

5. It has been submitted elsewhere that retail traders (pharmacists) need not be obligated to maintain records of their retail sales of drugs in Schedule II and their preparations. The same applies to all preparations in Schedule III, other than those which contain drugs in Schedule I, which the retail traders did not acquire in ready form from manufacturers. It appears to be necessary for purposes of control that the retail traders should keep a record of individual sales of preparations in Schedule III which contain drugs in Schedule I and which they compound themselves. They should also maintain records of all individual acquisitions of all drugs and their preparations, including drugs in Schedule II and their preparations as well as all preparations in Schedule III. 9

6. The records required by paragraph (b) serve two principal purposes. First, they enable the keepers of the records to furnish to the supervisory government authorities the data which the latter need for the compilation of their estimates of drug requirements and for the periodic statistical returns which they must furnish to the Board. 10 Secondly, they assist the supervisory authorities in the control of the activities of the persons, enterprises and institutions to which paragraph (b) refers with a view to discovering any diversions of drugs into illicit channels, or any illegal use of them. It is suggested that these two main purposes must guide the Governments in determining the contents of the records, that is, the data to be included in each entry regarding the manufacture of a quantity of drugs, an individual acquisition or individual disposal of drugs. The term "disposal" covers, in the case of manufacture, also use for the manufacture of other drugs, "I of substances not covered by the Single Convention, 12 and of preparations, including preparations in Schedule 111. 13 Consequently not only manufacturers of basic drugs and their salts, but also traders who compound preparations, whether listed in Schedule III or not, should maintain records on manufacture. Retailers who compound preparations for individual sales should, however, for the purpose of paragraph (b) not be considered as manufacturing such preparations, but should record those preparations as sales of the basic drugs which they contain if the drugs concerned are listed in Schedule 1. As mentioned above, a record need not be made by the retailer if the drug involved is listed in Schedule II.

7. It will be noted that paragraph (b) does not require the keeping of records on production, because the cultivators who "produce"-that is, separate the opium, coca leaf, cannabis or cannabis resin from the plants from which they are obtained 14-are quite often unable to keep such records, and may even sometimes be illiterate. The national opium, coca leaf or cannabis agency concerned, however, would have to write down the amounts of these drugs which they purchase from the cultivators, in consequence of their obligation to record "each individual acquisition" of drugs. If these agencies and the cultivators proceed in accordance with the requirements of the Single Convention 15-i.e. if the latter do not divert a part of their product into illicit channels-the total acquisitions of opium, coca leaves or cannabis recorded by the national agency concerned should be equal to the production of the drug involved in the country in question.

8. Since different conditions govern the manufacture of different drugs, preparations and substances not covered by the Single Convention, and also since somewhat different practices have proved their value in different coun tries, i6 it would be hardly practical to prescribe in a treaty or to describe in a commentary in exhaustive detail the data which an entry on manufacture should contain. It may, however, be stated as a general principle that each entry on manufacture should include such information as would make it possible to compare the drugs or poppy straw used as raw material with the product (drugs, salts, preparations or substances not covered by the Single Convention) which was obtained, in order to make it possible to determine whether the quantity of the raw material in question corresponds in fact to the quantity of the product obtained, and whether a part of the raw material was used for unrecorded purposes or a part of the product was not entered. This presupposes in any event that the quantity of the raw material (drug or poppy straw) used in the manufacture of a product will be indicated, as well as that the quantity of the product obtained from this amount of the raw material will be entered. The requirement of stating the quantity of a drug used as raw material for another product follows from paragraph (b) itself, since as stated before, such use is undoubtedly "disposal" within the meaning of this term in this provision. 17 The entry of the quantity of poppy straw used for the manufacture of a given quantity of "concentrate of poppy straw" or of morphine obtained from that straw appears to be required under other provisions of the Single Convention. 18

9. It does not seem that the Convention requires the recording of chemicals which are available in trade for various processes of chemical synthesis and which were used for the manufacture of "synthetic" drugs. 19 Some Governments may, however, find it useful for particular reasons to require such a record in the case of some or all "synthetic" drugs.

10. Whenever manufactured drugs are used as raw material, their pure drug content should be given. If the products which are obtained are drugs, their salts or preparations (including preparations in Schedule III), their pure drug content should also be entered. It is suggested that it would be useful for purposes of control if the quantities of substances not covered by the Single Convention which were made from drugs are also recorded.

11. It may often not be practical, but it would be useful where possible, to require a recording of the approximate content of cocaine and other ecgonine alkaloids in coca leaves used in the manufacture of ecgonine or cocaine. The same appears to be the case with poppy straw used in the manufacture of "concentrate of poppy straw" or of morphine. It is, however, suggested that the average morphine content of opium used in the manufacture of morphine can, and therefore always should be, taken down in the records of the manufacturer."

12. Where the products are opium preparations (including "medicinal opium" and extracts and tinctures of opium) or coca leaf preparations (extracts and tinctures and other preparations of coca leaf), their content of morphine or cocaine should be given. 21 In the case of extracts and tinctures of cannabis, it may be practical to enter only the quantity of cannabis and the amount of extract or tincture produced there from. 21

13. It may be mentioned that the drug content need not be repeated in entries relating to products whose content is made clear by their designation, nor particularly where a description of the composition of the same product is given in an earlier entry. The manufacturing records should also indicate the losses which occur in the manufacturing process.

14. It is finally suggested that the form of the product (pill, tablet, ampoule, etc .) 22 and the date 23 at which the manufacturing operation in respect of a particular lot of the product has been completed should also be taken down.

15. The entry of a sale or acquisition should clearly identify the buyer or seller and the goods, indicate their quantity and give the date of the transaction. The record of an import or export should also refer to the import or export authorization concerned by data, e.g. the number and date of the document, which clearly identify the permit in question.

16. What has been said above about entering the drug content and describing the form of the manufactured products should also be applied to the recording of acquisitions and sales. Traders need therefore not be required to record the pure drug content of those products whose composition is indicated by their designation, and described on labels on the wrapping or in the accompanying literature. This applies in particular to pharmacists who generally trade in such ready-made and standardized products. 24

17. It is suggested that it would be advisable to require manufacturers to record each individual sale of substances which were made from drugs and which are not covered by the Single Convention, giving the quantity, the iden tity of the buyer and the date of the transaction. It would also be useful if the person or enterprise which buys such substances from the manufacturer were required to note in his records his purchase, indicating the manufacturer, the quantity and the date of his acquisition. There appears to be no need for recording further movements of these substances, i.e. sales by other than those who manufactured them.

18. The fact that the authorities are able to compare the entries in the records of both parties to a transaction has proved in practice to be most effective in preventing fraud.

19. There are many other kinds of "disposal" than those mentioned in the preceding comments on paragraph (b). There is in particular a great variety of uses by which scientists and scientific institutions "dispose" of drugs. 25 It would hardly be possible to refer to all forms of possible legitimate disposal of drugs; but it may be emphasized that the entry of each individual disposal of drugs, no matter what its kind, should contain all data which would be required to enable the supervisory authorities to determine the legitimacy of the action in question.

20. Periodical inventories should be made and the amounts of drugs and preparations in stock should be recorded. This should be done at least once
a year. It is, however, admitted that only manufacturers, wholesale traders (including State enterprises) and opium, coca leaf and cannabis national agencies, and not retail traders, scientists, scientific institutions or hospitals, must under the terms of the Single Convention be required to record at least annually their stocks of drugs, whether in the form of pure drugs, their salts or preparations. 26, This obligation does not include preparations in Schedule 111. 27 It may, however, be advisable under the conditions of a particular country to require those who by definition cannot have "stocks", 23 i.e. retail distributors, medical practitioners, hospitals, scientists and scientific institutions, to record periodically and at least annually the quantities of drugs and preparations (other than preparations in Schedule III) in their possession and to report these figures to the supervisory authorities; and some Governments do so require.

21. Loss by fire or theft can hardly be understood to be "disposal" as this word is used in the paragraph under consideration. It is, however, suggested that it is within the spirit of this provision to require the govern mental authorities, enterprises and persons to which it applies to record the details of such events, and also to report them immediately to the supervisory authorities. It may also be advisable to impose this obligation on medical practitioners, especially if significant quantities of drugs, and particularly of those in Schedule 1, are involved.

22. Paragraph (b) does not state the form in which the records should be kept. It is left to each Government to prescribe a particular form if it wishes to do so. As far as the Single Convention is concerned, any usual form of recording business information in an orderly fashion would be permitted, not only in books, but also in card files. Retail traders may maintain a record of their sales by keeping a file of the medical prescriptions or of exact copies of them. 29 Where-as noted above-the use of official prescription forms to be taken from counterfoil books is required, the preservation of these books including the counterfoils is obligatory.

23. Paragraph (b) stipulates that the records with which it deals should be kept for a minimum period of two years. It is submitted that this period must be counted from the date of the last entry in the case of a record kept in the form of a bound book. A counterfoil book must therefore be kept two
years from the date of the latest counterfoil which it contains. In the case of a card file, cards containing only information which is older than two years may be discarded, but not those which in addition to such older entries include even
a single newer item. Where a file of prescriptions is kept, each individual prescription should be preserved for a minimum period of two years from the date at which it was last filled. 30

24. It may be mentioned that the period of two years is considered to be too short by some Governments, who consider that the records should be preserved for a longer time, e.g. five years. 31

25. For provisions in narcotics treaties preceding the Single Convention which required the keeping of records, see article 6, second paragraph, subparagraph (c) of the 1925 Convention; see also article 10, second paragraph, subparagraph (c) of the 1912 Convention; 32 and articles 13 and 17 of the 1931 Convention.

1 Article 29, para. 1; article 30, para. 1, subpara. (a) and article 31, para. 3, subpara. (a).

2 Article 23, article 26, para. 1 and article 28, para. 1.

3 The use of the term "governmental authorities" is in this context not very fortunate, nor the use of "autorites administratives" in the French version or the use of "autoridades administrativas" in the Spanish text.

4 Records, vol. 1, p. 36 and vol. II, pp. 145-146; see also above, comments on article 2, para. 2.

5 It is, however, considered that if such prescriptions are written by medical practitioners in their capacity of staff members of a hospital, the counterfoil books concerned must be kept by the hospital and not by the writers of the prescriptions.

6 See above, comments on article 30, para. 2, subpara. (b).

7 It was said by representatives at the Plenipotentiary Conference in favour of requiring hospitals to maintain records that "it was well known that they were one of the main sources of supply for drug addicts"; Records, vol. II, pp. 145-146.

8 Records, vol. II, p. 283, foot-note 15 and p. 288, foot-note 46.

9 See above, comments on article 2, paras. 2 and 4.

10 Some Governments base their import and export statistics on information furnished to them by their customs authorities.

11 Including salts, isomers, esters and ethers; see above, comments on article 1, para. 1, subparas. (j) and (n).

12 Article 1, para. 1, subpara. (n).

13 Article 2, paras. 3 and 4; see also comments on those provisions and on article 29, para. 1.

14 Article 1, para. 1, subpara. (t).

15 Article 23, para. 2, subpara. (d); article 26, para. 1 and article 28, para. 1.

16 No significant diversion from legal manufacture into illicit channels is known to take place at the time of this writing.

17 It follows also from article 20, para. 1, subpara. (b) as regards the use of drugs for the manufacture of other drugs, preparations in Schedule III and substances not covered by the Single Convention and as regards the use of poppy straw for the manufacture of drugs.

18 This requirement is implied in the provisions of article 20, para, 1, subpara. (b) and article 25, para. 1, subpara. (b).

19 Article 1, para. 1, subpara. (j). However a record of the amount of acetic anhydride used in the manufacture of heroin may also sometimes be useful.

20 This could be done in giving the percentage of morphine contained in the opium in an anhydrous state.

21 It is suggested that this would also enable the manufacturers, wholesalers and international traders to furnish to their Governments the data which the latter need for sending to the Board the required statistics on these preparations in accordance
with that organ's instructions. See instruction 4 of forms A/S (5th edition, November 1969) and C/S (4th edition, November 1969) of the Board.

22 Model Code, part II, chapter IV, para. 23; see also document E/CN.7/484/ Rev.1, para. 157.

23 The Model Code, part II, chapter II, para. 4 recommends that all entries of the manufacturer should be made "from day to day" as the operations in question (including the acquisition of raw materials to be recorded, the disposal (use) of these raw materials and the sale of the manufactured products) take place; see also document E/CN.7/484/Rev. 1, para. 150.

24 Pharmacists will, however, have to record the pure content of a drug in Schedule I in medicines which they make up themselves; see above comments.

25 For example, some scientists make animals and also humans inhale the fumes of cannabis, which they burn in order to observe the effect of such fumes.

26 This obligation is implied in the provisions of article 20, para. 1, subpara. (f) and article 1, para. 1, subpara. (x) and para. 2; it is however assumed that it does not follow from article 29, para. 3 and article 30, para. 2, subpara. (a) that the obligation to make periodical inventories of stocks applies also to poppy straw and that retail traders, scientists, scientific institutions, hospitals and medical practitioners have to make such inventories of the quantities of drugs in their possession; see above, comments on article 30, para. 2, subpara. (a).

27 Article 2, para. 4.

28 Article 1, para. 1, subpara. (x); see also Form C/S (4th edition, November 1969) foot-notes (a) and (b) to table II, p. 9.

29 See also article 6, second para., subpara. (c).

30 As regards the question of refilling prescriptions see above, comments on article 30, para. 2, subpara. (b), clause (i) and (ii).

3l Records, vol. II, p. 145.

32 These provisions have, however, a much narrower scope than article 34, para. (b) of the Single Convention.