WORLD HEALTH ORGANIZATION j i EB81/24 ORGANISATION MONDIALE DE LA S ANT： —7 16 November 1987

EXECUTIVE BOARD

Eighty-first Session

Provisional agenda item 17

ACTION IN RESPECT OF INTERNATIONAL CONVENTIONS ON NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES

Report by the Director-General

This report describes action taken by WHO during 1987 in compliance with the statutory obligations assigned to it by the international drug control treaties. The thirty-second session of 1 the United Nations Commission on Narcotic Drugs approved WHO s recommendations to place five barbiturates under schedules of the 1971 Convention. The fourth Programme Planning Working Group in March 1987 recommended 14 substances for review by the WHO Expert Committee on Drug Dependence and selected benzodiazepines for pre-review evaluation.

The Director-General, taking into account the advice of the Expert Committee in its twenty—fourth report, sent to the Secretary-General of the United Nations the recommendation to place under control five analogues of controlled substances ("designer drugs"), to transfer secobarbital from Schedule III to Schedule II and to include racemic methamphetamine under Schedule II of the 1971 Convention. Out of 14 preparations for which exemption was requested by Finland, 12 were accepted； it was decided that the other two required additional controls. The recommendations will be debated at the session of the United Nations Commission on Narcotic Drugs in Vienna in February 1988.

A brief account is provided of other WHO initiatives to promote the rational use of psychoactive drugs. A brief report of the United Nations Conference on Drug Abuse and Illicit Trafficking held in June 1987 is also provided.

I. INTRODUCTION

1. This report covers activities undertaken during 1987 in compliance with WHO statutory obligations under the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol (hereafter referred to as the Single Convention), and the Convention on Psychotropic Substances, 1971. The previous report was submitted by the Director-General to the Executive Board at its seventy-ninth session (document EB79/6).

II- COLLABORATION WITH THE UNITED NATIONS COMMISSION ON NARCOTIC DRUGS

2. Having examined the twenty-third report of the WHO Expert Committee on Drug Dependence (WHO Technical Report Series No. 741), the Director-General of WHO recommended to the Secretary-General of the United Nations the scheduling of the following five barbiturates:

butalbital； allobarbital; butobarbital； secbutabarbital； and vinylbital.

The Commission decided to include butalbital in Schedule III of the 1971 Convention on Psychotropic Substances and allobarbital, butobarbital, secbutabarbital and vinylbital in Schedule IV of that Convention. EB81./25 Annex 1 Page 508

3. The Commission examined the situation with respect to the exemption of preparations under the provision of article 3 of the 1971 Convention. In its Resolution 3 (S-IX) in February 1986 the Commission had recommended that WHO should defer the evaluation of exemption notifications until à substantial number of such notifications were presented to the Secretary-General. A notification of 14 exempted preparations has now been received by the Secretary-General from the Government of Finland.

4. It was the consensus of the Commission (Decision No. 6 (XXXII) in the report of its thirty-second session)-'- that WHO should resume its review of the pending notification and that the Secretary-General should contact governments to request suggestions for means to improve the system of review of exempted preparations. It was also agreed that the Secretary-General should remind governments of their treaty obligations under article 3 of the 1971 Convention.

III. CONSULTATION ON COLLABORATION WITH THE PHARMACEUTICAL INDUSTRY AND INTERNATIONAL 2 AGENCIES TO REDUCE DRUG ABUSE

5. The consultation was held on 26 and 27 January 1987 to explore areas in which the pharmaceutical industry could collaborate with WHO to alleviate the growing problem of drug abuse and improve psychotherapeutic drug use ； it was attended by the Executive Director of UNFDAC, the Secretary-General of the United Nations Conference on Drug Abuse and Illicit Trafficking and a representative of the United Nations Division of Narcotic Drugs, WHO staff and temporary advisers, and representatives of the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) and the industry. The recommendations outlined four areas for collaboration between WHO and the industry :

(1) Better drug distribution; collaboration between WHO and industry in this area could begin with a pilot study to establish the nature and extent of abuse of licit drugs in selected countries as a basis for future action.

(2) Information and education of health professionals and the general public.

(3) Control and registration; collaboration could be strengthened without prejudice to WHO'S obligations under international treaties in the following areas:

(a) early analysis of dependence-producing capability;

(b) post-marketing monitoring of side effects, dependence and abuse；

(c) pre-review activities which would involve WHO, the industry and the competent national authorities.

(4) Research and development; a number of projects could be undertaken jointly by WHO and industry. Discussions were held between WHO and IFPMA which resulted in the selection of certain projects. The advice of the fifth Programme Planning Working Group will be sought before proceeding further.

Dialogue between WHO and IFPMA about collaboration in these areas is continuing.

IV. FOURTH PROGRAMME PLANNING WORKING GROUP

6. The fourth Programme Planning Working Group met in Geneva from 2 to 7 March 1987.^

7. The Group considered economic aspects of drug scheduling under the international treaties and recommended that WHO should assemble information on this point and prepare a working paper for consideration by the Group.

8. The Group considered that the WHO Mental Health Programme should continue to examine the use of psychoactive substances by various medical specialists and to develop guidelines for prescribing within these specialities in collaboration with other WHO programmes concerned. It advised WHO to continue educational activities.

1 United Nations document E/1987/17(E/CN,7/1987/18). ? See document MNH/PAD/87.1.

3 See document MNH/PAD/87.2. EB81./25 Annex 1 Page 509

9. The Group commented on the report of the consultation on collaboration with the pharmaceutical industry and supported the recommendation that epidemiological studies on drug use and abuse should be undertaken and should seek, as a first priority, to identify the effects of the review process and of scheduling on the availability and use of psychoactive substances. Since the possibility of conflict of interest with the industry, or the fear of such conflict, was ever present, the Group recommended careful deliberation at each stage of development of the studies. Nevertheless, the Group saw the opportunity as promising.

10. The Group further deliberated on the development of WHO procedures for review of exempted preparations under the 1971 Convention. It also recommended that 14 listed substances should be reviewed by the Expert Committee on Drug Dependence in April 1988. This recommendation was in reply to the request of the United Nations Commission on Narcotic Drugs in its resolutions, after a first pre-review selection by the fourth Programme Planning Working Group. Two of the substances listed were included at the request of the Government of the United States of America.

11. The Group recommended that, after a pre-review selection in April 1988, the Expert Committee at its meeting in April 1989 should review marketed benzodiazepines.

1 V. EXPERT COMMITTEE ON DRUG DEPENDENCE, TOENTY-FOURTH REPORT

12. The Expert Committee, which met from 9 to 16 April 1987, recommended to the Director-General of WHO the international control of seven out of 13 substances reviewed under the Single Convention and the 1971 Convention. The Director-General accepted the recommendations of the Expert Committee and has notified the Secretary-General of the United Nations of the recommendations for control of the following substances:

Secobarbital• It was recommended that secobarbital should be transferred from Schedule III to II of the 1971 Convention, as originally requested by the Government of the United States of America.

Analogues of controlled substances ("designer drugs")：

alphamethylfentanyl； 3-methylfentanyl； acetyl-alphamethylfentanyl； PEPAP； MPPP.

It was recommended that all these analogues should be placed in Schedules I and IV of the Single Convention.

Racemic methamphetamine was recommended for control under Schedule II of the 1971 Convention.

The Expert Committee also reviewed the request of Finland for exemption of 14 preparations and accepted 12 exemptions. It recommended that Gastrodyn сотр. (diazepam, 2 mg； glycopyrronium bromide, 1 mg: per tablet) and Trimigrin (diazepam, 2 mg; ergotamine tartrate, 1 mg; prochlorperazine, 8 mg: per tablet) should be terminated in part, so that the requirements of article 8, paragraph 1, and article 11, paragraph 5, should apply to the extent that the provisions relate to importers and exporters.

(These recommendations of the Director-General of WHO will be discussed in Vienna, during the session of the Commission on Narcotic Drugs, from 8 to 21 February 1988.)

VI.工INTERNATIONAL CONFERENCE ON DRUG ABUSE AND ILLICIT TRAFFICKING, VIENNA, AUSTRIA, 17-26 JUNE 1987

13. WHO participated in the preparations for the Conference. A paper was presented on behalf of the Director-General of WHO to the plenary session. Approximately 3400 persons participated； 138 States were represented, some of them by ministers or by persons of Cabinet rank, as well as a wide range of intergovernmental organizations, specialized agencies and 178 nongovernmental organizations. The Prime Minister of Malaysia was elected President of the Conference. TOO staff attended throughout.

14, The principal outcome was the adoption by consensus of two texts: the Comprehensive Multidisciplinary Outline of Future Activities in Drug Abuse Control, and a Declaration on Drug Abuse and Illicit Trafficking.

1 To be published in the WHO Technical Report Series. EB81./25 Annex 1 Page 510

15. The Comprehensive Multidisciplinary Outline listed, under 35 targets, a wide range of suggestions and recommendations for action that could be taken by all concerned, applicable to narcotic drugs and psychotropic substances and intensification of the fight against illicit traffic in these drugs and substances. The preface and numerous passages of the Outline draw attention to the harmful effects and the alarming extent of drug abuse and to the nefarious activities of illicit traffickers and their effects on society.

16. The targets, recommendations and suggestions for action are grouped under four broad headings : prevention and reduction of the illicit demand for narcotic drugs and psychotropic substances； control of supply; suppression of illicit trafficking； and treatment and rehabilitation of drug addicts. Their object is to offer to national authorities, international bodies and nongovernmental organizations a compendium of practical measures - within the limits of their competence - to ensure the effective control of drug abuse and to fight illicit trafficking• The Outline is not a binding legal instrument； rather, it is intended to reflect the collective will of States to take such effective action and to cooperate with one another and with the international bodies concerned in achieving its 35 targets. Attention is drawn to the urgent need for States that are not yet parties to the international conventions governing the control of narcotic drugs and psychotropic substances to ratify or accede to these instruments.

17. Each target sets forth suggested courses of action (1) at the national level for national legislature, judicial and law enforcement authorities, ministries, other governmental agencies and community and nongovernmental organizations； (2) at the regional and international levels, for governments, regional and intergovernmental organizations, specialized agencies and bodies and programmes of the United Nations.

18. The other document adopted by the Conference, the Declaration on Drug Abuse and Illicit Trafficking, embodies the expression of the political will of the participating States to take vigorous national and international action against drug abuse and illicit trafficking and their recognition of the important role of the United Nations system in that respect, with specific reference to the important role of the Secretary-General, and the various agencies concerned.

19. Also mentioned in the Declaration are eight concepts - two for each of the four broad headings covered by the Outline 一 that should guide development of action in the international community. In the final paragraph the Secretary-General is requested to keep under constant review the activities referred to in the Declaration and the Outline and "to propose, in the context of the United Nations programme and budget and within available resources, how the priority attached to the field of drug abuse control can best be carried out". Finally, the Declaration provides that the Commission on Narcotic Drugs should examine the most suitable modalities for following up these activities, as appropriate, at the international level.

20. The Conference also approved a suggestion that the General Assembly might wish to decide on the observance of an annual day on the fight against drug abuse and illicit trafficking, the date to be chosen in the light of the existing calendar of international events and days of commemoration.

21. During the general debate, further suggestions were made concerning the establishment of an international reference centre and the convening of a second international conference on drug abuse and illicit trafficking in five years.

VII. OTHER ACTIVITIES UNDERTAKEN DURING THE YEAR UNDER REVIEW

22. A consultation on further development of strategies and procedures for the "pre-review" of psychoactive substances by WHO was held in Washington, D.C. , from 8 to 10 June 1987 (see document MNH/PAD/87.9). WHO headquarters and РАНО collaborated with the Drug Enforcement Administration (Department of Justice), United States of America, in convening the consultation, which examined the procedure established on the basis of recommendations of the EB81./25 Annex 1 Page 511

third Programme Planning Working Group (3-8 March 1986),1 with a view to identifying possible ways of improving the procedure. It paid particular attention to the identification of sources of information for the pre-review process from a wide variety of sources, using benzodiazepines, the next group of substances for pre-review, as an example.

23. A WHO multidisciplinary team visited China and conducted a seminar at Beijing Medical University on the role of medical schools in rational prescribing of psychoactive substances. Thirty participants came from 19 medical schools in China. The team also visited Xian, Chendu and Kun Ming where extensive discussions took place with members of the medical profession active in teaching and delivery of care. In Chendu and Kun Ming about 110 physicians and pharmacists were involved in discussions relating to the role of medical 1 schools in helping in drug abuse control activities in the People s Republic of China. The 1 People s Republic of China has further extended its collaboration with UNFDAC in law enforcement activities and reduction in demand. The WHO team reviewed activities relating to reduction in demand and made recommendations to the Chinese authorities.

24. A meeting on "assessment of issues relative to illicit substances of abuse and controlled substance analogues" was held in Rabat, Morocco, from 8 to 11 September 1987 (see document MNH/PAD/87.12), a collaborative effort of WHO, the Drug Enforcement Administration (Department of Justice), United States of America, and the Ministry of Health of Morocco. The subject has assumed great importance during the last three years and was reviewed by the WHO Expert Committee on Drug Dependence in 1987， which recommended control of five "designer drugs". More than 60 participants from about 21 countries attended the meeting on analogues in Rabat, representing different sectors and disciplines, including law enforcement, health care and drug abuse control. Representatives from INTERPOL, UNFDAC, the United Nations Division of Narcotic Drugs, the International Narcotics Control Board, IFPMA and WHO were present. The report of the meeting is now available.

25. A meeting to finalize guidelines for clinical evaluation of psychotropic drugs for psychiatric disorders was held in Oslo, Norway, from 13 to 16 October 1987, at the invitation of the Directorate of Health of Norway. The participants recommended the text of guidelines which will be published in 1988.

26. A meeting oil education about psychoactive substances in schools of pharmacy, to be held in London in December 1987, will review the role of schools of pharmacy in the rational use of psychoactive substances.

27. The following publications have appeared in 1987;

(1) J. Idanpaan-Heikkila, H. Ghodse and I. Khan, Psychoactive drugs and health problems. National Board of Health, Helsinki, 1987. (2) The rational use of anxiolytics and hypnotics in medical practice (Proceedings of a 1 seminar in the People s Republic of China, August 1986). R.H. Drew, Cai Zhi-Ji， Inayat Khan and Zhu Li-Qin, Canberra, 1987. (3) M.E. Vartanian, P.V. Morozov and I. Khan, ed., Rational use of psychotropic drugs with special emphasis on tranquilizers in non-psychiatric settings. Excerpta Medica, 1987.

The procedure recommended in 1986 has the following steps: (i) A preliminary list is to be compiled and communicated for updating to a number of listed organizations, agencies and persons. (ii) Based on the resultant information a final list is prepared. (iii) A request is then submitted to IFPMA, the United Nations Division of Narcotic Drugs and INTERPOL for data collection, as required in the model data sheet proposed by the third Programme Planning Working Group. (iv) At least two reviewers are selected who will receive all information from WHO. (v) Independently they will complete the pre-review data sheets for specific information on the individual substances. Each will make two lists, one which suggests substances that do not require thorough review, and the second which suggests substances for which a thorough evaluation and critical review appear to be warranted. (vi) The data sheets will then be reviewed by the next Programme Planning Working Group for final selection of substances for review by the Expert Committee on Drug Dependence.