ABSTRACT
Control of psychotropic substances in the Federal Republic of Germany
Participation of the Federal Republic of Germany in the United Nations Conference for the Adoption of a Protocol on Psychotropic Substances
Signature and ratification of the 1971 Convention by the Federal Republic of Germany
National legislation in the Federal Republic of Germany
Potential consequences of the implementation of the 1971 Convention
Summary and final remarks
Annex
Author: O. SCHR?DER
Pages: 1 to 19
Creation Date: 1982/01/01
The Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances 1971 have been implemented in the Federal Republic of Germany as follows:
No distinction is made between narcotic drugs and psychotropic substances: all substances which are controlled and non-exempted preparations containing such substances fall under the legal designation of "narcotic drugs";
The same control measures as for narcotic drugs apply to all substances in Schedules II, III and IV of the 1971 Convention, i.e. control of manufacture, trade, import and distribution;
Under the new Narcotics Act of the Federal Republic of Germany, which entered into force on 1 January 1 982, preparations containing substances listed in Schedules II and III of the 1971 Convention are subject to the same full control measures, including mandatory special prescriptions, with the exception of approximately 50 preparations from substances in Schedule III of the 1971 Convention. These 50 preparations are also subject to import, export and transit controls under the Narcotics Act;
The approximately 50 preparations containing substances in Schedule III of the 1971 Convention, as well as all preparations containing substances in Schedule IV of this Convention (about 340), are treated as "exempted preparations" under the Narcotics Act. These preparations, however, may only be dispensed under medical prescription which is in conformity with the provisions of article 9, paragraphs 1 and 2 of the 1971 Convention;
Within the meaning of the Narcotics Act, the term "exempted preparations" denotes that no mandatory special prescriptions are required for these preparations but only the normal medical prescriptions. A number of regulations of the Narcotics Act apply to these exempted preparations, including:
Licence of manufacture ;
Records of dispensing of exempted preparations by the manufacturer to the first acquirer ;
Import, export and transit regulations for the exempted preparations containing substances listed in Schedule III (Schedule III B in the Narcotics Act);
Export bans for countries which have prohibited import.
In the Federal Republic of Germany, all preparations containing substances listed in Schedules II, III and IV of the Convention on Psychotropic Substances 19711 are dispensed under medical prescription only, according to the requirements of article 9, paragraphs l and 2, of the1971 Convention.
In addition, the substances listed in Schedule II - with the exception of phencyclidine, which is neither used for medical purposes nor abused in the Federal Republic of Germany, and methaqualone, which was rescheduled in February 1979 - as well as preparations containing these substances, were placed under the same control as narcotic drugs during the period preceding 1974. Since l April 1974, the use of these substances has been subject to the issuance of mandatory special prescriptions [2] . These prescriptions are written on official forms comprising three parts [3] , with provision for carbon copies, as laid down in article 30, paragraph 2 (b) (ii), of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 19612.
Therefore, with the exception of the preparation Mandrax, which contains methaqualone and diphenhydramine, there are no particular problems in the Federal Republic of Germany with regard to the abuse of psychotropic substances placed under control of the 1971 Convention. Since l July 1981, Mandrax has also been placed under the same control as narcotic drugs by a special order and may only be dispensed by special prescription. Other substances which have in recent years occasionally been observed on the drug scene, but which are not controlled under the 1971 Convention, are Captagon (containing fenethylline), Fortral (pentazocine) and Valium (benzodiazepine). These substances are not placed under the same control measures as narcotic drugs, but may only be dispensed by medical prescription.
This report deals only with substances listed in Schedules III and IV of the 1971 Convention, since these are the only drugs which cause problems for the Federal Republic of Germany in implementing the 1971 Convention. These problems are related to the large number of preparations - approximately 400 - that are available on the market. It would not be useful to list all of these preparations here, but 12 of them, containing substances listed in Schedule III of the 1971 Convention, will be placed under the same control measures as narcotic drugs from 1 January 1984 [5] . Accordingly, these substances will be dispensed by special prescription only. The remaining preparations may, without exception, be obtained only by normal medical prescription.
Referred to here as the 1971 Convention [1] .
Referred to here as the 1961 Convention [4] .
The Federal Republic of Germany attended the United Nations Conference for the Adoption of a Protocol on Psychotropic Substances, which took place at Vienna from 11 January to 19 February 1971, and was elected to the Technical Committee and the Committee on Control Measures [[6] , p. 4]. At the Conference, the representative of the Federal Republic of Germany:
"said that the Federal Republic of Germany wholeheartedly approved the objectives of the draft Protocol, namely, to bring under control the psychotropic substances which were being abused and which could give rise to dependence. In particular, his delegation supported the provisions under which the distribution of and trade in those substances and their preparations would be made subject to a licensing system. His delegation also supported the proposed provisions for the substances included in Schedules I and II and considered that the regulations governing those substances should be similar to those embodied in the Single Convention. In the case of the substances in Schedule III [of the 1971 Convention], he thought that a declaration should only be required for exports and imports, as provided for in article II of the draft Protocol. As to the substances in Schedule IV [of the 1971 Convention], he considered that, since it was not sufficiently clear that they did give rise to dependence and since no appreciable risk of abuse was involved, there was no need for any special regulations" [[6] , p. 7].
In accordance with this general principle, the representative of the Federal Republic of Germany objected to the inclusion in the 1971 Convention of the substances listed in Schedule IV [[6] , p. 115] and also to the stringent measures of control envisaged for substances listed in Schedule III of the 1971 Convention. In this connection, specific objections were raised regarding articles 2, 3, 5, 8,11,12, 13,15 and 16 of the 1971 Convention [[6] , pp. 38, 39, 49, 50, 54, 59, 64, 85,114, 148,153,156,171 ,174 and 178]. As the Federal Republic of Germany did not succeed in gaining support for its position, it abstained in the final voting on the Convention [[6] , p.121] and was not among the 23 countries which signed the Convention at Vienna on 21 February 1971.
Although it did not sign the 1971 Convention at Vienna, the Federal Republic of Germany believed that, within four to five years, the 40 accessions and ratifications necessary for the enforcement of the treaty would be achieved. In addition, it believed that following the entry into force of the 1971 Convention, Member States would demand from their trading partners the application of the conditions of import and export provided for in the l971 Convention, regardless of whether the trading partner was or was not a signatory of the Convention. Furthermore, at its general meeting at Ottawa, in September l971, the World Association of Medical Doctors recommended early ratification of the 1971 Convention by Governments [7] . The Federal Republic of Germany therefore signed the l971 Convention, subject to ratification, on 23 December 1971, in New York. Additional reasons for signing and later ratifying the l971 Convention were:
Awareness of the necessity for international solidarity in taking world-wide measures against the increasing abuse of drugs and, in particular, for internationally coordinated control of the manufacture of and international trade in psychotropic substances;
A certain moral obligation to support the objectives of the 1971 whose pharmaceutical industries exported their products to developing countries;
Enhancement of the reputation of the pharmaceutical industry of the Federal Republic of Germany.
The appreciation of the objectives of the 1971 Convention demonstrated by official and legislative bodies in the Federal Republic of Germany was not reflected in the affected business circles of the pharmaceutical industry and trade. These viewed the 1971 Convention as a group of control measures unnecessarily added to those measures already exercised in the form of mandatory medical prescription and therefore objected to the 1971 Convention, its ratification and its transposition into national law.
In drafting national legislation in compliance with international policy and interests, the Federal Republic of Germany took into consideration national interests and so transposed the 1971 Convention into national law.
Therefore, before ratification of the 1971 Convention took place, its effects on national law and concerned professional and specialized associations, such as medical doctors, pharmacists, the pharmaceutical industry and wholesale trade, were examined.
During the process of examination of the 1971 Convention, the pharmaceutical industry and trade objected primarily to:
The inclusion of preparations containing substances listed in Schedules III and IV of the 1971 Convention pursuant to article 3, paragraph 1;
The mandatory security measures pursuant to article 8, paragraph 2;
The obligations concerning record-keeping pursuant to article 11, paragraphs 2 and 4.
ln this connection it was argued that other industrialized nations were reluctant to ratify the 1971 Convention, whereas the Federal Republic of Germany was urging that ratification be expedited. It was finally concluded that difficulties would arise when implementing article 11, paragraphs 2 and 4 of the 1971 Convention, and concerning these provisions legislative bodies decided to make two reservations.
When the Law on Ratification of the 1971 Convention was passed in July 1976, the Parliament requested the Federal Government to submit, without delay, a new Narcotics Act which would integrate the regulations of the 1961 and 1971 Conventions. However, because of a shortage of personnel, this reform could not start before Spring 1978. The objectives of ratifying and transposing the 1971 Convention into national law were not achieved earlier because of other priorities of legislature. These included ratifying the 1961 Convention and the 1972 Protocol amending this Convention, introducing special prescriptions for narcotic drugs, and preparing the Law on Drugs, 1976.
The reform of narcotic drug legislation in the Federal Republic of Germany was designed to compress and simplify the legislation contained in one law and 16 regulations, into one law and 4 regulations. Legislation refers to "narcotic drugs" only. Therefore the term "narcotic drugs" includes both narcotic drugs and psychotropic substances and no differentiation is made between them. Legislation passed by the Federal Republic of Germany provides for the following classification and grades with regard to the availability of drugs and narcotic drugs:
(a) Drugs (national control only);
Available without medical prescription and outside pharmacies;
Available in pharmacies only;
Prescription drugs;
(b) "Narcotic drugs" including both narcotic drugs (1961 Convention) and psychotropic substances (1971 Convention):
Subject to special prescription;
Licit "narcotic drugs" - but not available as such on special prescription;
Illicit "narcotic drugs".
The distinction between the normal medical prescription and the special prescription for narcotic drugs (official forms according to article 30, paragraph 2 (b)(ii) of the 1961 Convention) constitutes at the same time the distinction between drugs which are not under international control on the one hand, and narcotic drugs and psychotropic substances which are placed under international control on the other hand. Such a distinction is determined by the classification of each substance in accordance with the recommendations of the World Health Organization, decisions of the United Nations Commission on Narcotic Drugs and the international drug control treaties. This classification does not take into consideration preparations containing narcotic drugs or psychotropic substances which, although under international control, are only subject to normal medical prescription and not to special prescription, i. e. preparations of substances in Schedules III and IV of the 1971 Convention. In other words, it was impossible to make all those preparations available only by special prescription in the Federal Republic of Germany. Therefore, the large number of 400 preparations had to be exempted from this requirement in the legislation passed by the Federal Republic of Germany. This measure does not mean a weakening of international drug control laid down in the 1971 Convention. On the contrary, all the provisions of the 1971 Convention concerning international control measures are applicable to the "exempted preparations" and, in part, even stronger provisions have been established.
Simplified legislation also entailed a simplification of the different control measures provided in the 1971 Convention. This, at times, led to the introduction of even more stringent regulations than those contained in the 1971 Convention itself. Therefore, in the Federal Republic of Germany, notwithstanding article 12, paragraph 2, of the 1971 Convention, import and export authorization are also required for substances listed in Schedules III and IV and for all preparations containing substances listed in Schedule III. In addition, 12 preparations containing substances listed in Schedule III may only be dispensed on presentation of the special prescription for narcotic drugs.
With respect to licit use and trade, all "narcotic drugs" have been divided into three schedules (see annex):
Schedule I: Illicit "narcotic drugs" (e. g. cannabis, heroin, phencyclidine, lefetamine and all the substances of Schedule I of the 1971 Convention);
Schedule II: Licit "narcotic drugs" not available as such on special prescription (used only as raw materials and intermediates such as coca leaves, codeine, poppy straw concentrate, Papaver bracteatum and Papaver somniferum, thebaine);
Schedule III: Licit "narcotic drugs" available on specialprescription.
Schedule III of the Narcotics Act of the Federal Republic of Germany 1982 is also subdivided into sections A, B and C. This division does not reflect any difference in legal effects or control measures or degrees of danger. It is a systematic division of exempted preparations and it is also of historical importance. Part A comprises the traditional narcotic drugs available by special prescription, i. e. those of the 1961 Convention and Schedule II of the 1971 Convention. Part B covers the substances of Schedule III, and part C of Schedule IV of the 1971 Convention.
All preparations of substances listed in Schedule IV of the 1971 Convention were "exempted" within the meaning of the Narcotics Act of the Federal Republic of Germany (see annex, Schedule III, part C). This exemption also applies when, for example, a combined preparation additionally contains codeine and only one other substance from Schedule III or IV of the 1971 Convention. In this case, the total psychotropic ingredient must not exceed the lower of the two levels (see annex, Schedule III, part C). The levels fixed for individual substances are so high that all preparations on the market made from substances in Schedule IV of the 1971 Convention fall thereunder. Justification for this measure can be claimed since the barbiturates listed in Schedule IV are long-acting substances and as such are supposed to be relatively seldom abused. Apart from glutethimide, Schedule III of the 1971 Convention lists the barbiturates of short and medium action which, in comparison, are abused more often. Of approximately 60 preparations from substances listed in Schedule III, 12 preparations containing these substances in high doses were therefore placed under the same control measures as narcotic drugs. The remainder of the preparations were "exempted" because they were in low dosage form and were in addition used in combination with other active substances so diminishing the risk of abuse.
However, these exceptions are in conformity with the requirements of the 1971 Convention that:
None of the exempted preparations is exempted from the control measure of article 9, paragraphs l and 2 of the 1971 Convention, i. e. from mandatory medical prescription;
Exempted preparations containing substances listed in Schedule III are under complete control with regard to import and export (in conformity with article l2, paragraph l of the 1971 Convention);
Exempted preparations are subject to full control measures under "narcotic drug" legislation until they have been dispatched by the manufacturer to the first purchaser. This means that the manufacturers of exempted preparations have to comply with the regulations of articles 8 and 15 of the 1971 Convention;
Manufacturers also have to keep records in accordance with article ll, paragraph 6. In this way the obligation of notification on the part of the Government according to article l6, paragraph 4 is ensured;
Embargoes have to be observed to those countries which have prohibited import of certain drugs under the provisions of article 13 of the 1971 Convention.
The possible abuse of non-exempted preparations from substances in Schedule III is expected to stop, because the preparations will henceforth only be dispensed on presentation of a special prescription for narcotic drugs. From our experience, this measure has resulted in a considerable decrease in the number of medical prescriptions for narcotic drugs [3] . Following the introduction of special prescription forms on 1 April 1974 and up to the end of 1980, the number of narcotic drug prescriptions decreased by more than 60 per cent. A considerable decrease in sales, i.e. economic losses for the manufacturer, usually follows when a substance is placed under the same control as a narcotic drug.
Strict control is ensured with regard to the manufacture, trade, import, export and medical application of all psychotropic substances under control of the 1971 Convention. Control serves both national and international interests. At the international level control will, however, remain incomplete as long as the 1971 Convention is not globally ratified and implemented.
The implementation of the 1971 Convention, as described above, should not create any difficulties in the Federal Republic of Germany and may point the way to a simplification of international drug control. In implementing the 1971 Convention, one of the major problems for countries with extensive pharmaceutical industries is the integration into their national laws of preparations containing substances listed in Schedules III and IV.
While this problem can, of course, be solved by implementing the provisions of the 1971 Convention, this Convention requires a considerable amount of work from the Member States and from the international authorities involved in its implementation, such as the United Nations Commission on Narcotic Drugs, the Division of Narcotic Drugs, the International Narcotics Control Board and the World Health Organization. In addition, because of the existence of two Conventions, many measures have to be taken twice: for narcotic drugs as required by the 1961 Convention, and also for psychotropic substances as required by the 1971 Convention.
The Federal Republic of Germany has therefore endeavoured to combine the principles of appropriate extension of control and uniformity with simplification of legislation into a reasonable synthesis. This was the aim of the new Narcotics Act of the Federal Republic of Germany which - as outlined above - makes no distinction between narcotic drugs and psychotropic substances.
SCHEDULES OF THE NARCOTICS ACT OF THE FEDERAL REPUBLIC OF GERMANY (1982)
(Illicit narcotic drugs)
Sufentanil
| N-{4-Methoxymethyl-l-[2-(2 thienyl)ethyl]-4- piperidyl}propionanilide
|
Tenocyclidine
| 1-[l -(2-Thienyl)cyclohexyl]piperidine
|
Tetrahydrocannabinol
| Tetrahydro-6,6,9-trimethyl-3-pentylbenzo[c]chromen-1-ol
|
Trimeperidine
| 1,2,5-Trimethyl-4-phenyl-4-piperidylpropionate
|
Schedule I also includes:
The isomers of the substances in this schedule unless specifically exempted, and where the presence of such isomers may occur under the special chemical name;
The esters, ethers and molecular compounds of the substances in this schedule unless they are listed in a different schedule and where the presence of such esters, ethers and molecular compounds may occur;
The salts of the substances listed in this schedule where the presence of such salts may occur;
The preparations of the substances listed in this schedule unless:
Without being applied to human or animal bodies, they serve diagnostic or analytical purposes only and their content of one or several narcotic drugs does not exceed 0,001 percent; or
They are specifically exempted.
(Licit narcotic drugs - but not available as such on special prescription)
Pholcodine
| 4,5&alpha-Epoxy-17-methyl-3-(2-morpholinoethoxy)-7- morphinan-6&alpha-ol Except in preparations containing, without any additional substance listed in Schedules I to III, up to 2.5 per cent or, per dosage unit, up to 100 milligrammes of pholcodine, calculated as base
|
Propiram
| N-(l -Methyl-2-piperidinoethyl)-N-(2-pyridyl) propionamide Except in preparations containing, without any additional substance listed in Schedules I to III, up to 100 milligrammes of propiram and not less than the same quantity of methylcellulose
|
Racemorphan
| (±)-17-Methyl-3-morphinanol
|
Racemoramide
| (±)-3-Methyl-4-morpholino-2,2-diphenyl-1-(1-pyrrolidinyl)-butanone
|
Tetrahydrothebaine
| 4,5&alpha-Epoxy-3,6-dimethoxy- I 7-methylmorphinan
|
Thebaine
| 4,5&alpha-Epoxy-3,6-dimethoxy- I 7-methyl-6,8-morphinadiene
|
Schedule II also includes:
The isomers of the substances in this Schedule unless specifically exempted and where the presence of such isomers may occur under the specific chemical name;
The esters, ethers and molecular compounds of the substances in this Schedule unless listed in a different schedule and where the presence of such esters, ethers and molecular compounds may occur;
The salts of the substances listed in this Schedule where the presence of such salts may occur;
The preparations of the substances listed in this Schedule unless
Without being applied to human or animal bodies, they serve diagnostic or analytical purposes only and their content of one or several narcotic drugs does not exceed 0,001 percent; or
They are specifically exempted.
(Licit narcotic drugs, available upon special prescription)
(a) Up to 500 mg of meprobamate per dosage unit; or (b) However, together with any additional substance of Schedule III, part B or C, no larger a quantity of narcotic drugs than the smaller quantity established in one of the substances (save codeine) for exempted preparations.
| |
Methylphenobarbital 5-Ethyl-i-methyl-5-phenyl barbituric acid Except in preparations containing, without any additional substance listed in Schedules I to II (save codeine): (a) Up to 200mg methylphenobarbital per dosage unit; or(b) However, together with another substance of Schedule III, part B or C, no larger a quantity of narcotic drugs than the smaller quantity established in one of the substances (save codeine) for exempted preparations.
| |
Methyprylon 3,3-Diethyl-5-methyl-2,4-piperidinedione Except in preparations containing, without any additional substance listed in Schedules I to III, up to 200 mg of methyprylon per dosage unit
| |
Phenobarbital 5-Ethyl-5-phenylbarbituric acid Except in preparations containing, without any additional substance listed in Schedules I to III (save codeine):(a) Up to 10 per cent or, per dosage unit, up to 300mg of phenobarbital, or(b) However, together with another substance of Schedule 111, part B or C, no larger a quantity of narcotic drugs than the smaller quantity established in one of the substances (save codeine) for exempted preparations.
| |
Phentermine &alpha,&alpha-Dimethylphenethymaline Except in preparations containing, without any additional substance listed in Schedules I to III, up to 16 mg of phentermine per dosage unit
| |
Pipradrol &alpha-(2-Piperidyl)benzhydrol Except in preparations containing, without any additional substance listed in Schedules I to III, up to 1.5 mg of pipradrol per dosage unit
|
Schedule III also includes:
The isomers of the substances in this Schedule unless specifically exempted and where the presence of such isomers may occur under the specific chemical name;
The esters, ethers and molecular compounds of the substances in this Schedule unless listed in a different schedule and where the presence of such esters, ethers and molecular compounds may occur;
The salts of the substances listed in this Schedule where the presence of such salts may occur;
The preparations of the substances listed in this Schedule unless:
Without being applied to human or animal bodies, they serve diagnostic or analytical purposes only and their content of one or several narcotic drugs does not exceed 0.001 per cent; or
Specifically exempted.
l. Convention on Psychotropic Substances 1971 (United Nations publication, Sales No. E.78.XI.3).
002Federal Republic of Germany, Article 9 of the Order concerning the prescription, dispensing and recording of the whereabouts of narcotic drugs, 24 January 1974, in "UN laws and regulations" (E/NL.1974/22), p. 12.
003H. E. Ehrhardt and O. Schr?der, "The effects of prescription orders on the control of narcotic drugs", Bulletin on Narcotics , vol. 29, No. 2 (1977), pp. 1 - 7.
004Single Convention on Narcotic Drugs. 1961, as Amended by the 1972 Protocol Amending the Single Convention on Narcotic Drugs, 1961 (United Nations publication, Sales No. E.77.XI.3).
005Federal Republic of Germany, Narcotics Act, 28 July 1981, Article 40, para. 5, Federal Law Gazette 1981, part I, p. 693.
006United Nations Conference for the Adoption of a Protocol on Psychotropic Substances, Vienna, 11 January - 19 February 1971 , vol. II : Official Records (United Nations publication, Sales No. E.73.XI.4).
007Federal Republic of Germany, Letter of the Federal Medical Council (Bundes?rztekammer) of 5 November 1971 to the Federal Government.