Drug Abuse

Article 30

TRADE AND DISTRIBUTION

General comments

1. It may be concluded from the word "special" in the heading of article 31, which is entitled "Special Provisions Relating to International Trade", that article 30 governs trade in general, and not only domestic trade and distri bution. This was also the understanding of the Plenipotentiary Conference. 1 The provision of article 30, paragraph 1, subparagraph (b), clause (i) would therefore also apply to the international trade even if it were not repeated in article 31, paragraph 3, subparagraph (b).

2. The international trade is governed by all provisions of article 30 which can be so applied.

3. Article 30 provides for four different kinds of authorizations:
(a) A specific authorization, referred to as a "licence", to be granted by the Government to engage in the trade in and distribution of drugs (paragraph 1, subparagraph (a));
(b) A specific authorization, also referred to as a "licence", to be granted by the Government to use an "establishment" or "premises" for the trade in and distribution of drugs (paragraph 1, subparagraph (b), clause (ii));
(c) The general authorization, which may be provided in domestic law, of persons who are duly authorized to perform therapeutic or scientific functions, to trade in and distribute drugs and to use their premises for such trade and distribution while performing such functions, without the special authorizations (licence) referred to under (a) and (b) (paragraph 1, subparagraph (c)); and
(d) The special authority to be granted by a medical prescription, required for the supply or dispensation of drugs to individuals (paragraph 2, subparagraph (b), clause (i)).

1 Records, vol. 1, pp. 71 and 72.

Paragraph 1, subparagraph (a)

1. (a) The Parties shall require that the trade in and distribution of drugs be under licence except where such trade or distribution is carried out by a State enterprise or State enterprises.

Commentary

1. The "licence" referred to in this subparagraph must be a special authorization in writing, issued by the competent Government department, to engage in the trade and distribution of drugs. A general authorization to
trade in everything would not be sufficient. The "licence" need not, however, be physically a separate document. The special authorization relating to drugs may be included in another document, e.g. in a licence to trade in pharmaceuticals or chemicals, but the authority in respect of the drugs should in such cases be explicitly mentioned. An authorization to operate a retail pharmacy may, however, be understood to include the right of retail trade in narcotic drugs. The name given by national law to the governmental authorization is irrevelant, and it need not be called "licence" or the equivalent in other languages.

2. The licence should expressly state whether it authorizes wholesale
or retail trade. It might be advantageous from the viewpoint of carrying out the provisions of the Single Convention if the wholesale licence specified to which individual drugs it relates. 1 The licence of a manufacturer (article 29, paragraph 1) may be considered to cover the right to engage in all trade activities which normally fall within the scope of a manufacturer's operations. This includes the purchase for sale of drugs which he is authorized to make himself, but which he does not have in stock for the execution of an order at a particular moment. It is submitted that a manufacturer's licence cannot be deemed to include authority to trade in drugs which he is neither authorized to make nor could need for the manufacture of such drugs. If he deals in drugs he is not authorized to make and does not need for manufacture, he requires a separate licence to engage in the wholesale trade in the drugs involved. His licence does not in any event automatically include the retail trade in drugs. It is also suggested that authorization of a drug manufacturer to engage in the retail trade may in some cases result in gaps of control. 2

3. As mentioned elsewhere, 3 the notion of "licence" requires that the Government department concerned should have some degree of discretion in issuing it. An appropriate measure of freedom for the authorities to grant or refuse a licence will be helpful in ensuring the high technical and moral qualifications of the management of the trade enterprises in accordance with article 34, paragraph (a), in limiting the number of traders to facilitate control, and in obtaining compliance with desirable conditions by the licensee. The authorities should for the same reasons also have some discretion to revoke a licence to trade in drugs.

4. A licence to undertake the wholesale or retail trade in drugs may be granted to an individual, to a partnership or a corporate body (including a co-operative).

5. A State enterprise does not need a "licence" to trade in drugs; but it does not follow that any Government owned enterprise may engage in such trade. The only State enterprises which may do so are those given that function by the Government authorities concerned, which in making such assignments must be guided by similar considerations of control as those which must be taken into account by Government authorities when issuing trade licences to private businesses.

6. The subparagraph under consideration also applies to preparations of all drugs, including preparations in Schedule III as required by article 2, paragraphs 3 and 4. Unlike the corresponding provisions of the narcotics treaties preceding the Single Convention, drugs in Schedule II, 4 their preparations and all preparations in Schedule 111 5 may not be sold to individual users by unlicensed vendors.

7. The duly authorized persons who under article 30, paragraph 1, subparagraph (c) are exempted from the requirement of licensing for retail trade and retail distribution when performing their therapeutic or scientific functions are medical practitioners (including veterinary surgeons and dentists) and scientists. c

8. The text of article 30, paragraph 1, subparagraph (a) closely follows the wording of article 29, paragraph 1 requiring the licensing of drug manufacturers; see comments on the latter provision.

9. For the relation between article 30, paragraph 1, subparagraph (a) and article 31, paragraph 3, subparagraph (a), see below, comments on that provision of article 31.

10. For corresponding provisions of earlier narcotics treaties, see article 10, second paragraph, subparagraph (b) of the 1912 Convention and article 6, second paragraph, subparagraph (b) of the 1925 Convention.
 

1 The statistical information which Governments require for the purpose of compiling their statistical returns in respect of each drug under article 20 must generally be based on data supplied by manufacturers and wholesalers; information furnished by them may also be needed for the preparation of some of the estimates pursuant to article 19, para. 1.

2 E.g. where the retail sale of drugs in Schedule II or of preparations of drugs in Schedule II or of those included in Schedule III is permitted without medical prescription; see article 30, para. 6 in connexion with article 2, paras. 3 and 4. In such cases,
it may also be advisable not to grant to the same enterprise a licence to engage simultaneously in the wholesale and retail trade in drugs.

3 See above, comments on article 29, para. 1.

4 I.e. those corresponding to drugs in Group II of the 1931 Convention and of the 1948 Protocol.

5 Le. those corresponding to preparations excluded under the earlier treaties by express provision or by operation of article 8 of the 1925 Convention, from administrative controls. See article 4, para. (d) of the 1925 Convention and article 13 of the 1931 Convention. See also, Commentary on the 1931 Convention, para. 135.

6 See below, comments on article 30, para. 1, subpara. (c).

Paragraph 1, subparagraph (b), clause (i)

(b) The Parties shall:
(i) Control all persons and enterprises carrying on or engaged in the trade in or distribution of drugs;

Commentary

1. The clause under consideration follows closely the text of article 29, paragraph 2, subparagraph (a) requiring Parties to "control all persons and enterprises carrying on or engaged in the manufacture of drugs". The comments made above on that provision of article 29 therefore apply mutatis mutandis to clause (i).

2. The admittedly rather vague term "control" must be interpreted in a reasonable and practicable manner; but it may be assumed that it covers
such measures as periodical, or at least occasional, inspections,) and exclusion from the wholesale and retail trade of persons who are suspected of engaging in the illicit traffic.

3. The term "persons" covers all physical persons engaged in the trade, not only the owners or managers of the trade enterprise, but also technical personnel, office workers and manual labourers.

4. The term "enterprise" covers also the buildings or parts of buildings (premises) and their appurtenances and equipment used in the trade; it includes "State enterprises". Clause (i) must also be applied to persons duly authorized to perform therapeutic or scientific functions when distributing drugs in the exercise of those functions. Article 30, paragraph 1, subparagraph (c) exempts such "trade" activities of these persons only from the licensing requirements of subparagraphs (a) and (b), but not from other control measures. Clause (i) therefore applies to medical practitioners, including dentists and veterinary surgeons, and to scientists using drugs in their experiments.

5. It may be noted that the clause governs the wholesale and retail trade in all drugs (including drugs in Schedule 11) and in their preparations, including preparations in Schedule III.

6. For corresponding provisions of earlier treaties, see first paragraph of article 10 of the 1912 Convention and first paragraph of article 6 of the 1925 Convention. 2

1 The obligation to carry out inspections may also be based on the introductory paragraph of article 4; see comments on this article.

2 See also article 13 of the 1931 Convention and article 1, paragraph 4 of the 1948 Protocol. Article 6 of the 1925 Convention does not apply to retail trade in drugs in Group II of the 1931 Convention and of the 1948 Protocol, i.e. those corre sponding to the drugs in Schedule 11 of the Single Convention; it also does not apply to preparations exempted from the administrative controls of the 1925 Convention by operation of article 8 of that treaty, or by specific provisions (article 4 of the 1925 Convention and article 13 of the 1931 Convention).

Paragraph 1, subparagraph (b), clause (ii)

(ii) Control under licence the establishments and premises in which such trade or distribution may take place. The requirement of licensing need not apply to preparations.

Commentary

1. Clause (ii) contains in respect of the trade in drugs the same provision as article 29, paragraph 2, subparagraph (b) in respect of the manu facture of drugs and their preparations. The above comments to the provision of article 29 apply mutatis mutandis to the interpretation of corresponding words in this clause of article 30.

2. An enterprise trading in drugs must have a licence or licences pursuant to clause (ii) in addition to the licence required by article 30, paragraph 1, subparagraph (a).

3. As in the case of the other licences provided for in articles 29 and 30, the designation in national law of the licence required by clause (ii) is irrelevant. Any written authorization by the competent Government department allowing the use of the establishments or premises in question in the trade in drugs is a "licence" in the sense of clause (ii).

4. A trade enterprise may have one or more establishments 1 and premises. It needs a separate "licence", i.e. a special authorization in writing for each of its establishments and premises; but these separate "licences" for different establishments and premises of the same enterprise need not be separate documents. Authorizations to use different establishments or premises may be included in a single document, and even in the licence provided for in paragraph 1, subparagraph (a). The use of particular premises must be separately "licensed", i.e. expressly authorized, even though those premises form a part of a "licensed" establishment. The licence of premises should clearly identify the building or part of the building concerned, and should describe the safeguards against diversion of drugs which it requires.

5. The premises of medical practitioners and scientists do not require a licence if used for the distribution of drugs under the conditions of subparagraph (c). 2

6. State enterprises are not exempted from the requirement of authorization of establishments and premises under clause (ii). The written assignment by the competent government department of an establishment, 3 building or part of a building to use by a State enterprise for the trade in drugs constitutes a "licence" in the sense of clause (ii); but in making such assignments the Government must provide for the same kind of safeguards against diversion of drugs as in the case of private enterprises.

7. The clause under consideration does not apply to the trade in preparations; it applies, however, to the trade in salts of drugs, since such salts are "drugs" in the sense of the Single Convention. 4

8. Prior to the coming into force of the Single Convention, the international narcotics regime did not require "licences" for establishments and premises used for the trade in drugs.

1 For the meaning of the term "establishment", see in particular above, comments on article 29, para. 2, subpara. (b).

2 See below, comments on subpara. (c).

3 Le. place of business; see above, comments on article 29, para. 2, subpara. (b).

4 See last paragraphs of Schedules I and lI in connexion with article 1, para. 1, subpara. (j).

Paragraph 1, subparagraph (c)

(c) The provisions of subparagraphs (a) and (b) relating to licensing need not apply to persons duly authorized to perform and while performing therapeutic or scientific functions.

Commentary

1. Medical practitioners, including physicians, veterinarians and dentists, are the "persons duly authorized to perform ... therapeutic functions"
referred to in subparagraph (c). The authorization which is required may be obtained in some countries by a special licence from the competent health authorities, and in other countries by acquiring a relevant academic degree or by passing prescribed examinations. Pharmacists do not perform therapeutic functions, and therefore do not fall under subparagraph (c); they require a licence under article 30, paragraph 1, subparagraph (a) to engage in the retail trade in drugs, and also an authorization pursuant to subparagraph (b) clause (ii) to use an establishment or premises in such trade. 1 Their licence as pharmacist may, however, be deemed to include a licence to engage in the retail trade in narcotic drugs. 2

2. Scientists using drugs in their experiments appear to be the scientists whom subparagraph (c) exempts from the licensing requirements.

3. Medical practitioners who, in addition to the performance of their therapeutic functions, use drugs in scientific experiments may in respect of such use be considered to perform also scientific functions under subparagraph (c).

4. Only the medical practitioner's administration or dispensation of drugs, 3 including the sale of drugs to his own patients or to possessors of animals which he treats, and the acquisition of drugs for these purposes are under subparagraph (c) exempted from the licensing requirements. There is no exemption for his sale of drugs to persons who are not his patients or to possessors of animals which he does not treat. Physicians in some countries are authorized to engage in the retail trade in drugs, that is, to sell drugs to persons who are not their patients, particularly in places without an authorized pharmacist. Such retail trade does not appear to be a "therapeutic" function in the sense of subparagraph (c), and therefore appears not to be exempted from the licensing requirements of subparagraphs (a) and subparagraph (b), clause (ii).

5. Subparagraph (c) exempts only from the licensing requirements but not from other controls. Subparagraph (b), clause (i) therefore applies "to persons duly authorized to perform while performing therapeutic or scientific functions".

6. The principal effect of subparagraph (c) is that medical practitioners and their offices, and also scientists using drugs in their experiments and their laboratory facilities, do not require licences, but must otherwise be controlled under the relevant terms of the Single Convention. 4

1 As regards the compounding of preparations by medical practitioners and pharmacists, see above, comments on article 29, para. 1.

2 In some countries medical practitioners need a separate narcotics licence, which may be withdrawn on such grounds as alcoholism or personal drug addiction, although the practitioners concerned may be allowed to continue to exercise their profession without using or prescribing narcotic drugs.

3 Records, vol. I, p. 31.

4 In addition to article 30, para. 1, subpara. (b), clause (i), e.g., article 4, para. (c) and, if they import drugs, article 31, paras. 4-15.

Paragraph 2, subparagraph (a)

2. The Parties shall also:

(a) Prevent the accumulation in the possession of traders, distributors, State enterprises or duly authorized persons referred to above, of quantities of drugs and poppy straw in excess of those required for the normal conduct of business, having regard to the prevailing market conditions; and

Commentary

1. The subparagraph under consideration applies to wholesale and retail trade and distribution a rule very similar to that of article 29, paragraph 3 concerning drug manufacturers.) It does not apply to the retail trade and distribution of drugs in Schedule II, and in view of article 2, paragraphs 3 and 4, consequently also does not apply to the retail trade in preparations of these drugs and in preparations in Schedule III, whatever may be the schedule of the drug that they contain. 2 It governs State enterprises, but not drugs in Schedule 11 and the two groups of preparations just mentioned in the possession of State enterprises, or of divisions of such enterprises, engaged only in the retail trade and distribution. In view of the fact that the provision of article 30, paragraph 2, subparagraph (a) does not apply to drugs in Schedule II held by retail traders and retail distributors, it may appear somewhat surprising that the Single Convention does not provide for the same exemption in respect of poppy straw, which is not even a "drug" in the sense of this Convention. 3 Moreover these retail outlets will generally not hold any poppy straw.

2. The amounts required for the normal conduct of business will differ in the case of different drugs, of different countries or territories and at different times in the same country or territory. The "prevailing" market conditions have to be taken into account; but they are not the only consideration which may be relevant. 4

3. The Convention does not prescribe the methods by which Parties should prevent the excessive accumulation of drugs and poppy straw in the possession of traders and distributors. In order to be able to furnish to the Board their statistical returns under article 20, Governments must require wholesalers to report at least annually, on inter alia their drug stocks 5 and the quantities of drugs which they have supplied "to any person or enterprise for retail distribution, medical use or scientific research" 6 in the year in question.

This annual information on stocks may in many cases be sufficient to enable Governments to implement the subparagraph under consideration in respect of drugs in the possession of wholesale traders; some Governments, however, require more frequent stock reports on drugs held by wholesalers. 7

4. Drugs held by retail traders, by retail distributors and by persons duly authorized to perform therapeutic and scientific functions are, however, not "stocks" in the sense of the Single Convention, ° but are considered to have been "consumed". c Governments are not required to obtain from these retail outlets the information which they need on consumption, but they may receive the necessary data from wholesalers, who report on their supplies to retail outlets. Some Governments, however, require retail distributors, including medical practitioners and scientists, to report periodically on the quantities of drugs in their possession. Many countries do not provide such an obligation, in particular for medical practitioners and scientists, and in general limit themselves, for the purpose of subparagraph (a), to investigating those retail distributors whom, on the basis of information which they received or as a result of occasional inspections, they suspect of holding excessive quantities of drugs.

5. It has already been mentioned above that it appears somewhat surprising that the subparagraph under consideration covers poppy straw held in the retail trade; but the application of this subparagraph to the straw presents some other problems. If-as the context suggests-only poppy straw held by drug traders and distributors, including State enterprises engaged in the drug trade, are covered by the subparagraph, there would be no obligation to prevent the excessive accumulation of the straw in the hands of other traders dealing in agricultural products. If, on the other hand, all traders in the straw were covered by subparagraph (a), State farms and farmers who accumulate large amounts of straw because they have been unable to sell all they have grown, may also be considered to be "traders", and therefore have to be included among those to be controlled.

6. It may seem somewhat incongruous to limit the quantities of poppy straw held by licensed traders in drugs and by State enterprises engaged in the drug trade, that is, by persons and enterprises whose operations are under Government control and to permit excessive quantities of the straw to remain in the hands of businesses and persons who are not controlled. In view of the fact, however, that poppy straw not in the possession of drug manufacturers and not in international trade is not covered by the statistical control system of the Single Convention, s and that the limitation of the amounts of straw held by traders is of very little if any value from the standpoint of narcotics control, it is suggested that the more restrictive interpretation of subparagraph (a), which the context undoubtedly permits, should be given preference. This view accords also with the practice of many Parties to the Single Convention, who do not control the quantities of poppy straw held by other enterprises than those manufacturing 9 or trading in drugs, and in particular not those held by farmers. It may therefore be concluded that subparagraph (a) applies only to poppy straw held by traders, distributors and State enterprises engaged in the drug trade or in drug distribution.

7. The failure to exclude from the application of the subparagraph under consideration preparations in Schedule III held by wholesale traders or distributors may be due to an oversight of the authors of the Single Convention. 4

8. Subparagraph (a) does not apply to stocks of drugs held by a State enterprise on behalf of the Government "for special Government purposes and to meet exceptional circumstances", since they form "special stocks". to

9. Apart from their obligation arising from the subparagraph under consideration, Parties are also bound under the provisions of the estimate system of the Single Convention 11 to exercise control over, and to limit, the stocks of drugs held by wholesale traders. They are also obligated under the provisions requiring them to limit possession and consumption of drugs to medical and scientific purposes, 12 to carry out some measures of supervision over the quantities of drugs in Schedule I and II in the possession of retail outlets. Such measures might be periodical or at least occasional inspections of, and inquiries about, their inventories and records. 13

10. The narcotics regime preceding the Single Convention did not have a provision corresponding to article 30, paragraph 2, subparagraph (a). It required Governments, however, to limit the stocks of wholesalers, and to control the quantities held by retail outlets, by provisions very similar to those of the Single Convention regarding estimates and restriction of consumption to medical and scientific purposes. 14
 

1 In the English and French versions both texts are mutatis mutandis practically identical. In the Spanish version, the provision of article 30 is drafted in terms somewhat different from the wording of the corresponding provision of article 29, e.g. the former provision uses the word "comercio" for the "empresa" in the latter. Both provisions use the word "poder" for "possession" in the English and French texts; but these drafting divergencies appear to be without substantive importance.

2 Article 30, para. 6; for the reasons given in the comments on article 29, para. 3 it may be assumed that article 30, para. 2, subpara. (a) is also not intended to apply to the wholesale trade in preparations in Schedule III.

3 Article 1, para. 1, subpara. (j); see above, comments on article 25.

4 See above, comments on article 29, para. 3.

5 Article 20, para. 1, subpara. (f).

6 Article 1, para. 2 in connexion with article 20, para. 1, subpara. (c).

7 Including manufacturers; see article 1, para. 1, subpara. (x), clause (iv).

8 Article 20, para. 1, subparas. (b) and (d); see also article 25 and comments thereon.

9 See article 29, para. 3.

10 Article 1, para. 1, subpara. (w); see also comments on subparas. (w) and (x) of that paragraph. But if the provision of the Convention were taken literally, this exemption would not cover poppy straw, because the straw cannot form a part of "special stocks". It is, however, more than doubtful that the authors of the Single Convention wished to apply article 30, para. 2, subpara. (a) to poppy straw held by a State enterprise on behalf of the Government for the purposes for which "special stocks" are destined, e.g. to form a reserve stock for the manufacture of morphine and codeine for the needs of the armed forces in the event of a shortage of raw materials (opium or poppy straw) available for this purpose.

11 Article 19, para. 1, subpara. (c) and para. 5; article 21, para. 1, especially subpara. (d).

12 Article 4, para. (c); see also article 33.

13 Article 34, para. (b).

14 Article 5, para. 2, first subpara., clause (c) and second subpara. and article 6, para. 1, subpara. (d) of the Convention; and article 5 of the 1925 Convention.

Paragraph 2, subparagraph (b), clauses (i) and (ii)

(b) (i) Require medical prescriptions for the supply or dispensation of drugs to individuals. This requirement need not apply to such drugs as individuals may lawfully obtain, use, dispense or administer in connexion with their duly authorized therapeutic functions; and
(ii) If the Parties deem these measures necessary or desirable, require that prescriptions for drugs in Schedule I should be written
on official forms to be issued in the form of counterfoil books by the competent governmental authorities or by authorized professional associations.

Commentary

1. The first question which arises is whether "oral" prescriptions, which would be permitted in urgent cases, would be "medical prescriptions" in the sense of clause (i). Some countries authorize pharmacists to supply some drugs in urgent cases on the basis of "oral" prescriptions.

2. An "oral" prescription is an authorization given by a medical practitioner by telephone to a pharmacist to supply an indicated quantity of a given drug. If Governments find it necessary to admit such telephonic authorizations, they must of course take all measures necessary to ensure that the supply of drugs on "oral" prescriptions takes place under such conditions as to achieve the aims of the requirement of medical prescriptions in the Single Convention. It is suggested that it would in any event be necessary to require that the pharmacist should accept oral prescriptions only from physicians personally known to him, and that he should record the name of the physician as well as all the other data which a medical prescription should contain. He should in particular take down the name and address of the patient, and if the drug is to be sold to another person buying on behalf of the patient, also the name and address of that person. He should verify the identity of the person to whom he sells the drug by demanding the production of an appropriate document of identification. The pharmacist should also be required to keep the record of a sale on oral prescription for a period of not less than two years. 1 It is advisable to require the physician giving the telephonic authorization to confirm it by a written medical prescription, to be sent to the pharmacist without delay.

3. In any event, if oral prescriptions are allowed, they should be subjected to restrictive conditions. They should be limited to urgent cases. The drugs which may be so prescribed should be indicated in the legislation, and the amounts to be sold on oral prescription should be limited to such small quantities as would be needed until a written medical prescription could be obtained under local circumstances.

4. A medical prescription should contain the data required to identify the authorizing physician as well as the patient, and in a veterinary case, the person in possession of the animal, the date of issue, the name and quantity of the drug to be supplied, and when appropriate, instructions on the use of the medicine. It is also suggested that it would be necessary to limit the quantities of drugs which may be authorized by a single prescription, particularly in the case of potent substances. It also appears strongly advisable not to permit the refilling of prescriptions for drugs. In any event, refilling should be authorized only in the case of less potent drugs, and each filling should be recorded on the prescription. Prescriptions which are not refillable or no longer refillable should be retained by the pharmacist. He should make a copy of all refillable prescriptions which he does not retain.

5. The Single Convention does not require medical prescriptions for drugs in Schedule 11, 2 for their preparations, or for preparations in Schedule III. 3 It might, however, be advisable to limit this exemption from the prescription requirement to preparations in Schedule III and to such preparations of drugs in Schedule II as offer a relatively minor risk of abuse. 4

6. The word "dispensation" means in this context "making up and giving out". 5 The making up includes the compounding of preparations. 6

7. The term "individuals" is used twice. 7 The first time it refers to patients by whom the drugs are to be used, to the possessors of the animals for which the drugs are destined, or to persons acquiring the drug on behalf of such patients or possessors of animals. The second time, the term "individuals" 3 covers persons duly authorized to perform therapeutic functions, that is, medical practitioners, whether physicians, dentists or veterinarians.

8. The second sentence of clause (i) exempts from the requirement of medical prescription the acquisition of drugs by medical practitioners for use in carrying out their therapeutic functions, and such use. It is, however, submitted that the exemption of such acquisition only makes explicit what is already implied in the notion of "medical prescription". Authorized persons engaged in the drug trade and distribution, including manufacturers, 9 wholesale and retail traders, 10 medical practitioners and scientists 11 are of course entitled to acquire the drugs required for the performance of their legal business functions, professions or occupations. Medical prescriptions in the common sense, and within the meaning of the Single Convention, are authorizations given by medical practitioners to acquire drugs for use, or to use drugs on particular human beings or animals. Prescriptions do not refer to authorizations for acquisition of drugs by authorized persons in carrying out their legal trade in or distribution of drugs. These persons normally have general authority to acquire drugs on the basis of their licence or their right to carry out their therapeutic or scientific profession. They may be required by their respective national laws to use official order forms. Although this may be advantageous from the viewpoint of drug control, it is not required by the international treaty. Medical practitioners who acquire drugs for use in carrying out their therapeutic functions should, however, if they are not bound by national rules to use special order forms, confirm in writing to the selling pharmacists the receipt of the drugs. The receipts 12 should be retained by the pharmacists for a period of not less than two years. 13 They may be written on the medical practitioner's prescription forms, and may therefore often be called "medical prescriptions", though they are not prescriptions within the meaning of the Single Convention.

9. The word "administer" means in this context "to apply the remedy in
question to the patient or animal concerned". 14 In the case of an administration of the drug, the medical practitioner injects the medicine into the patient or animal or makes the patient or animal ingest it. The term "dispense", as defined above, involves the handing over of the drug to the patient or possessor of the animal, 15 who may use it outside the medical practitioner's office or in his absence. The term "use" has a wider meaning, and covers "administer"
as well as "dispense". It covers any employment of the drug by the medical practitioner in performing a therapeutic function.

10. The question may arise whether self-administration of a drug by a medical practitioner is performance of an authorized therapeutic function within the meaning of clause (i). Some countries permit physicians to acquire drugs for their personal use without the prescription of another physician, while others do not. Since the incidence of drug addiction is relatively great among physicians in several countries, it may be advisable to require for a physician's acquisition of drugs for personal use the prescription of another physican. As far as dentists are concerned, self-administration will generally be apart from treatment within the scope of their profession, and therefore will normally not be the performance of a therapeutic function as intended by clause (i), and consequently not be exempted from the requirement of a physician's prescription. Self-administration by a veterinarian will of course
never be so exempted. Clause (i), on the other hand, does not bind Parties to require veterinarians to obtain the prescription of another veterinarian for use of drugs on their own animals.

11. One will note that in contrast to the exemption of article 30, paragraph 1, subparagraph (c) from the licencing requirement, the exemption of clause (i) of paragraph 2 does not expressly refer to "scientific functions". In practice, however, scientific experiments on human beings, in order to be permitted at all, would have to be carried out by physicians, and would generally have simultaneously some purpose of treatment, and thus qualify as being therapeutic for the purpose of clause (i). A scientist authorized to use drugs on animals would, for the reasons mentioned above, not need a medical prescription for the acquisition of the drugs, nor-it is suggested-would he need one for their administration to animals. He would, however, be required to keep the records provided for in article 34, paragraph (b), and would have to be under the control provided for in article 30, paragraph l, subparagraph (b), clause (i). i6

12. A physician's sale of drugs to persons who are not his patients would not be a therapeutic function in the sense of article 30, paragraph 2, subparagraph (b), clause (i), and would therefore require a prescription of another physician. As mentionned elsewhere, in several countries certain physicians are authorized to engage in such sales. 17

13. The counterfoil books mentioned in clause (ii) contain prescription forms, each form consisting of two parts: one to be retained by the prescribing physician, and the other to be given to the patient. The part kept by the doctor must contain the basic data of those included in the patient's prescription. The physician has thus a record of all prescriptions which he issues. Where the use of conterfoil books is required, the physician must preserve these books including the counterfoils for a period of not less than two years. 18

14. Clause (ii) must be carried out in good faith, like all the other provisions of the Single Convention. 19 It is therefore not the views which a Party claims to have, but its real views, that are relevant for the purposes of this clause. If a Party considers the use of official forms in the shape of counterfoil books necessary, or only desirable, it has an obligation to make their use mandatory; but this obligation relates only to the prescription of drugs in Schedule I and their preparations, and is, as formulated, of hardly any practical importance.

15. It may finally be mentioned that a survery undertaken by the World Health Organization in 1956 found that the results obtained from the employment of official forms for the prescription of drugs justified the introduction of such a system. 20

16. For the requirement of medical prescriptions under the narcotics regime preceding the Single Convention, see article 6, second paragraph, subparagraph (c) in connexion with article 9 of the 1925 Convention.

17. As regards the exemption from this requirement of drugs in Group 11 of the 1931 Convention or the 1948 Protocol (i.e. of drugs corresponding to those in Schedule 11 of the Single Convention), see article 13, paragraph 2, subparagraph (a) of the 1931 Convention and Commentary on the 1931 Convention, paragraph 135, pp. 174-175; see also article 1, paragraph 4 of the 1948 Protocol.

 

1 Article 34, para. (b).

2 Article 30, para. 6.

3 Article 2, paras. 3 and 4.

4 Article 39.

5 The Concise Oxford Dictionary of Current English, Fifth Edition, Oxford, Clarendon Press, 1964, p. 352, entry "dispense"; the Spanish version uses for "dispensation" "despacho" and for "dispense" "entregar". Although the meaning of the Spanish words differs from that of the English words and of the corresponding words "dispenses" and "dispenser" in the French version, it is submitted that the meaning of the three language texts of clause (i) as a whole is the same.

6 See also above, comments on article 29, para. 1.

7 In the English text. The French text uses in both cases the word "particuliers" and the Spanish text the first time "particulares" and the second time "una persona". This difference in the Spanish version does not affect the identity of the meaning of the three versions, "una persona" having the sense of "individuals" or "particuliers" respectively used the second time in the two other language texts.

8 "Particuliers" in the French text and "una persona" in the Spanish text.

9 Article 29, para. 1.

10 Article 30, para. 1, subpara. (a).

11 Article 30, para. 1, subpara. (c).

12 Or copies of the official order forms where their use is required.

13 Article 34, para. (b).

14 The Concise Oxford Dictionary referred to in foot-note 5 above, entry "administer", p. 17.

15 The word "entregar", which the Spanish text uses for the English "dispense" and the French "dispenser", actually means "to hand over" or "to deliver".

16 See above, comments on article 30; para. 1, subpara. (b), clause (i) and on subpara. (c).

17 See above, comments on article 30, para. 1, subpara. (c).

18 Article 34, para. (b).

19 See above, comments on article 2, para. 5, article 22 and article 24, para. 1, subpara. (b).

20 Records, vol. II, p. 33.

Paragraph 3

3. It is desirable that Parties require that written or printed offers of drugs, advertisements of every kind or descriptive literature relating to drugs and used for commercial purposes, interior wrappings of packages containing drugs, and labels under which drugs are offered for sale indicate the international non-proprietary name communicated by the World Health Organization.

Commentary

1. Paragraph 3 represents only a wish ("voeu") of the Plenipotentiary Conference, and is in fact only a recommendation. No legal obligation is provided. Even if a Party should find it desirable to require the use of nonproprietary names as indicated in this paragraph, it would not be legally bound to do so.

2. It is very difficult indeed to select any non-proprietary name which, after thorough search, would not be found to have possibilities of conflict with existing rights, or could be legally protected in all of the numerous countries of the world. 1 Moreover, such a name may have a meaning, or be similar to a word having a meaning, in one or more of the world's many languages which would make its use unacceptable in the country or countries involved. This explains why the authors of the Single Convention refrained from imposing on the Parties a legal obligation under paragraph 3.

3. The Single Convention does not prescribe the procedure by which the World Health Organization should establish non-proprietary names for the purposes of paragraph 3. The World Health Organization may to this end adopt the procedure it considers appropriate, 2 and may modify it in the light of changing conditions. 3

4. The World Health Organization communicates its actions on nonproprietary names to all its member States. It is, however, suggested that for the purposes of paragraph 3, the Organization should also communicate the names that it selects to the Secretary-General of the United Nations who in turn should forward this information to the Members of the United Nations, to non-member States Parties to the Single Convention and to other States whose co-operation in this matter he finds desirable. The Convention does not state to whom the World Health Organization's communication should be addressed. It is submitted that the Secretary-General of the United Nations, being the depositary of the Single Convention, would at all times be in the best position to have an up-to-date list of the Parties to that treaty. Moreover, it has been submitted elsewhere that the Members of the United Nations are bound under the Charter of this Organization to co-operate in the international fight against drug abuse. 4 Finally, the Secretary-General furnishes the secretariat services of the Commission on Narcotic Drugs and of the International Narcotics Control Board, which are the main organs charged with functions under the Single Convention, 5 and may consequently also be in the best position to know which countries, in addition to Members of the United Nations and non-member States Parties to the Single Convention, should be addressed because their co-operation in the case involved would be essential.

5. The "advertisements of every kind" include those in periodicals destined for medical practitioners or pharmacists, and also those in newspapers or on television addressed to the general public. It may, however, be mentioned that advertisement of dangerous drugs to the general public would in any event be undesirable from the viewpoint of public health, even if they indicate the non-proprietary names in question. 6 By adopting the text of the paragraph under consideration, the Plenipotentiary Conference does not seem to have expressed any view as to the desirability of indicating the non-proprietary names of drugs on the labels of bottles or other containers of medicines sold to individual patients. It will be noted that paragraph 3 does not declare it desirable to use non-proprietary names in descriptive literature which often accompanies medicines so sold, but only in literature which is used for commercial purposes. Unlike the paragraph under consideration, article 31, paragraph 4, subparagraph (b) makes mandatory an indication of the non-proprietary names of drugs, if such a name exists, in import and export authorizations.

6. See also article 19 of the 1931 Convention, which inter alia requires that the labels under which drugs controlled by that treaty or their preparations are offered for sale should indicate "the name of the drugs as provided for in the national legislation". 8
 

1 Commission on Narcotic Drugs, report on the twelfth session, para. 54; Official Records of the Economic and Social Council, Twenty-fourth Session, Supplement No. 10 (E/3010/Rev. 1).

2 The procedure applied by the World Health Organization at the time of the Plenipotentiary Conference is described in paragraph 50 of the report of the Commission referred to in the preceding foot-note; see resolution of the Executive Board of the World Health Organization E.B.15.R7 (January 1955) and Official Records of the World Health Organization No. 60, annex 3 ; see also resolution E.B.37.R9 (January 1966) with annex and the earlier resolutions of the World Health Assembly WHA 3.11 (May 1950) and of the Executive Board E.B.12.R.24 (May 1953). The procedure in force in 1961 at the time of the Plenipotentiary Conference distinguishes between "proposed" and "recommended" non-proprietary names. "Proposed" names were published in the Chronicle of the World Health Organization and notified to States members of the World Health Organization, and to national Pharmacopoeia Commissions or other bodies designated by these States. Notice could also be given to persons having an interest in the proposed name. If no formal objection from any interested person was filed within four months of the date of publication in the Chronicle, the "proposed" name became a "recommended" name, and the same procedure of notification was followed as in the case of "proposed" names. States members of the World Health Organization were at the same time requested to recognize the recommended name as the non-proprietary name and to prevent the acquisition of proprietary rights therein. No name could be selected as a recommended name if and as long as there existed any formal objection to it.

3 Resolution E.B.37.R9 referred to in foot-note 2 authorized the Director General of the World Health Organization to modify the General Principles governing the
determination of non-proprietary names in the light of scientific developments and
suggestions of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.

4 See above, comments on article 3, paragraph 7 and on article 14, para. 1, subpara. (a); see also foot-note 21 to comments on article 8.

5 Article 16; the Secretary-General is even the organ of communication in regard to actions taken by the World Health Organization under article 3.

6 See also the Vienna Convention on Psychotropic Drugs, article 10, para. 2, document E/CONF.58/6.

7 See below, comments on article 31, para. 4, subpara. (a).

8 See also article 1, para. 4 of the 1948 Protocol.

Paragraph 4

4. If a Party considers such measure necessary or desirable, it shall require that the inner package containing a drug or wrapping thereof shall bear a clearly visible double red band. The exterior wrapping of the package in which such drug is contained shall not bear a double red band.

Commentary

1. Paragraph 4 applies to the domestic as well as to the international trade. The measure described in this provision is primarily intended to facilitate the task of control officers, and particularly of customs officials checking shipments crossing the border of a country or territory, or checking carriage of drugs by international travellers. 2 Such offices and officials will often not be familiar with the names and characteristics of narcotic drugs, and in particular of synthetic drugs which are developed in increasing numbers. 3 It has also been asserted that the suggested double red band might be helpful in calling the attention of physicians to the dangerous character of some medicines which they might prescribe. 4 Marking of narcotics consignments for purposes of identification is, on the other hand, of very little use, if any in the fight against the illicit traffic. It may be of some value in the rare cases in which drugs diverted or stolen from legal sources are shipped in their original wrappings. 5

2. Opponents of the marking by a double red band pointed to the danger that it would call the attention of illicit traffickers or addicts to the narcotics contents of the consignment concerned and thus invite theft. 6 The last sentence of paragraph 4 therefore expressly prohibits the double red band on the exterior wrapping of the package containing drugs. It is submitted that the purpose of this provision would also require that such wrapping should not have any other marking which would indicate the narcotic contents of the package.

3. The English and Spanish texts of the paragraph under consideration mention the inner (interior) wrapping 7 as a place on which the "clearly visible double red band" may be affixed. They do not, however, exclude any other place on or in the inner package. 8 The double band may be affixed on bottles or other containers included in the package, and particularly on the labels of such bottles or containers; but it must not be visible to a person looking at the exterior wrapping of the package. 9

4. It may be mentioned in this connexion that the narcotic content of an international shipment 10 is indicated to the examining customs or other official by the copy of the export authorization which, according to article 31, paragraph 6, must accompany the consignment. It must be concluded from the wording of paragraph 4 that a Party is legally bound to require the double red band as provided in the first sentence of this paragraph if it "considers such measure necessary or desirable". 11

5. The earlier narcotics treaties do not contain a provision corresponding to the paragraph under consideration. 12

1 Records, vol. I, p. 72; see also above, general comments on article 30.

2 Article 1, para. 1, subpara. (y); Records, vol. II, pp. 140-141.

3 Records, vol. I, p. 28, 29 and 30.

4 Records, vol. 1, pp. 28 and 32.

5 Records, vol. II, pp. 29-31.

6 Records, vol. I, p. 33.

7 Spanish: "la envoltura interior".

8 The Spanish text separates by a comma the words "el paquete" from the words "o la envoltura interior". The context and in particular the last sentence of the paragraph make it clear, however, that what is meant is the interior package ("el paquete interior").

9 The French text does not specifically refer to the inner wrapping. The word "conditionnement" means in this context inner package, whether the whole contained in an inner wrapping or the individual bottles or containers included in the exterior wrapping. The word "colis" used in the last sentence of para. 4 means in the context the exterior package, and thus gives the prohibition the same meaning as the two other language texts which forbid the double red band on the exterior wrapping ("envoltura exterior").

10 Or of a consignment from one territory to another territory of the same State; article 1, para. 1, subparas. (m) and (y).

11 Para. 4 must of course be implemented in good faith; see above, comments on article 2, para. 5, article 22, article 24, para. 1, subpara. (b) and article 30, para. 2, subpara. (b).

12 The Economic and Social Council adopted, on the recommendation of the Commission on Narcotic Drugs, resolution 436 G (XIV) in 1952. Operative para. 3 (e) of this resolution requested the Secretary-General to draw the attention of Govern ments to the desirability of making regulations to ensure that all packages containing synthetic narcotic drugs should be clearly marked by a double red line to facilitate identification by the competent services. In 1959 the Council decided to take no action on a draft resolution recommended by the Commission which would have urged all Governments to require that any package moving in trade and containing a narcotic drug, whether natural or synthetic, show a clearly visible double red band on its label, but not on the exterior wrapping; Commission on Narcotic Drugs, report on the fourteenth session, Official Records of the Economic and Social Council, Twentyeighth Session, Supplement No. 9 (E/3254), chapter XIV, section 1, draft resolution E; and resolution 730 F (XXVIII) of the Economic and Social Council.

Paragraph 5

5. A Party shall require that the label under which a drug is offered for sale show the exact drug content by weight or percentage. This requirement of label information need not apply to a drug dispensed to an individual on medical prescription.

Commentary

1. It will be noted that paragraph 5 does not apply to the retail trade in drugs in Schedule 11 and their preparations, and consequently not to the
retail trade in any preparation in Schedule 111, no matter whether the latter contains a drug in Schedule I or II. 1 As regards the retail trade the provision under consideration relates only to drugs in Schedule I 2 and to their preparations other than those included in Schedule III. It is intended to call attention to the degree of risk of abuse of medicines containing the more potent drugs under the narcotics regime.

2. The bottles or other packages containing drugs or their preparations, which are offered for sale or sold by manufacturers to traders (wholesalers or retailers) or by traders to other traders, must in any event have labels containing the information indicated in paragraph 5. It is submitted that "the exact drug content" means in this context "the pure drug content".

3. The term "individual" in the second sentence of the paragraph under consideration covers the patient acquiring the drug for his own use, the possessor of the animal for which the drug is destined, or the person obtaining the drug on behalf of the patient or of the possessor of the animal. 3

4. If the second sentence were interpreted literally, only drugs dispensed on medical prescription, and consequently not those dispensed by physicians to their patients without any prescription in accordance with article 30, para graph 2, subparagraph (b), clause (i), second sentence, would be exempted from the requirement of label information. It is, however, suggested that it would be compatible with the aims of paragraph 5 to exempt from this requirement not only drugs dispensed on medical prescription by pharmacists or by physicians to other persons than their own patients, 3 but also those dispensed by physicians to their own patients without prescriptions.

5. It has been mentioned above 4 that the word "dispense" means
"to make up and give out". It is suggested that in the context of paragraph 5 the making up which is an element of dispensing not only includes the compounding of preparations, but also the removal from the original package or the weighing of such a quantity of the drug or preparation concerned as the medical prescription in question may indicate. 5

6. It seems to have been the intention of the Plenipotentiary Conference to exempt from the requirement of label information all drugs and preparations sold on medical prescription. 5

7. The second sentence of paragraph 5 of course does not prevent a Party from making obligatory the label information required by this paragraph in respect of all sales or certain kinds of sales of drugs or preparations which would be exempted from this requirement by the Single Convention. 6

8. For a corresponding provision in earlier narcotics treaties, see article 19 of the 1931 Convention. The first sentence of that article required that the labels under which any of the drugs controlled by that Convention or preparations containing those drugs were offered for sale should show the percentage of the drugs. 7 Drugs in Group II 8 of that Convention, and even preparations "for the export of which export authorizations are not required", 9 that is, preparations corresponding to those in Schedule III of the Single Convention, were not exempted from that requirement of article 19. 10 It must also be assumed from the text of article 19 that drugs and preparations dispensed to individuals on medical prescriptions were subject to this provision. Numerous Parties to the 1931 Convention have, however, without objection by other Parties, permitted the dispensation of drugs and preparations on medical prescription without this label information.

1 Article 30, para. 6 in connexion with article 2, paras. 3 and 4.

2 Whether or not also listed in Schedule IV.

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

4 See above, comments on article 30, para. 2, subpara. (b) and foot-note 5 thereto.

5 See also Records, vol. II, p. 131, right-hand column (summary of the Committee's instruction to the Drafting Committee) and page 268.

6 Article 39. Attention is also drawn to the French use of "prescription magistrale" for the English phrase "medical prescription", The French text of article 30, para. 2, subpara. (b) uses the term "ordonnance medicale". The Spanish text uses "rotulado" for "label information" in the English version, and "renseignements sur !'etiquette" in the French version. "Rotulado" means label; (New Revised Velazques, Spanish and English Dictionary, Heinemann, London, 1961, p. 584). Freedom from the requirement of the label includes of course freedom from the requirement of information on this label. The Spanish text employs on the other hand "etiqueta" for the English "label" and the French "etiquette" in the first sentence of para. 5.

7 See also article 1, para. 4 of the 1948 Protocol.

8 I.e. those corresponding to drugs in Schedule II of the Single Convention.

9 Articles 4, 8 and 12 to 17 of the 1925 Convention; article 13, para. 2, subpara. (b) of the 1931 Convention and article 1, para. 4 of the 1948 Protocol.

10 Commentary on the 1931 Convention, para. 189 (p. 208).

Paragraph 6

6. The provisions of paragraphs 2 and 5 need not apply to the retail trade in or retail distribution of drugs in Schedule 11.

Commentary

1. Paragraphs 2 and 5 of article 30 as applied to the retail trade and distribution are the only provisions among those governing drugs in Schedule I from which the Single Convention expressly exempts drugs in Schedule II.

2. Parties are thus not required under article 30, paragraph 2, subparagraph (a) to prevent the accumulation of excessive quantities of drugs in Schedule II and their preparations 1 in the possession of retail traders, retail distributors and of State enterprises or their divisions engaged only in the retail trade or retail distribution. 2

3. They are also not bound under article 30, paragraph 2, subparagraph (b), clause (i) to require medical prescriptions for the supply or dispensation of drugs in Schedule II and their preparations' to individuals, and under clause (ii) of that paragraph they are not obligated to require the use of official forms in the shape of counterfoil books for medical prescriptions of these drugs and preparations 1 even if they consider such a measure "necessary or desirable". Finally, Parties need not, under article 30, paragraph 5, require that packages (bottles or other containers) holding drugs in Schedule II or their preparations, 3 which are offered for sale or sold in the retail trade, 4 should have labels showing the exact drug content by weight or percentage.

4. As regards the suggestion that an understanding exists among Parties to the Single Convention that retail traders (pharmacists) need not under article 34, paragraph (b) keep records of individual disposals of drugs in Schedule II and their preparations,' see above, comments on article 2, paragraph 2.

5. It may again be pointed out in this connexion that, apart from the provisions just mentioned, all rules of the Single Convention governing drugs in Schedule I also apply to drugs in Schedule II, while under the earlier nar cotics regime the whole retail trade in drugs in Group II of the 1931 Convention, that is, in those drugs corresponding to drugs in Schedule II of the Single Convention, was exempted from control. The retail trade in drugs in Group II could even be carried on by unlicensed businesses. 5 Attention may be invited here to article 39, which provides inter alia that the Single Convention does not preclude a Party from requiring that preparations in Schedule III and drugs in Schedule II be subject to all or some of the control measures which are applicable to drugs in Schedule I, but from which these preparations or the drugs in Schedule II are respectively exempted.

6. See also above, comments on article 2, paragraph 2 and on article 30, paragraph 2, subparagraphs (a) and (b) and paragraph 5.

1 And of preparations in Schedule 111, whether or not containing drugs in Schedule I or II; article 2, paras. 3 and 4.

2 As regards some supervisory measures concerning the quantities of drugs in Schedule II held by retail outlets, see above, comments on article 30, para. 2, subpara. (a).

3 Or preparations in Schedule III, whether or not containing drugs in Schedule I or 11; article 2, paras. 3 and 4.

4 Or given out in the course of retail distribution.

5 Article 13, para. 2 of the 1931 Convention and article 1, para. 4 of the 1948 Protocol; see also Commentary on the 1931 Convention, para. 135, p. 174. Article 19 of the 1931 Convention applies, however, to the retail trade in drugs in Group I1.

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