w ·0
R L 0 HEALTH ORGANJ ZATION
I'EGIONAL OFFICE FOR
•
ORGANISATION MONDIALE DE LA SANTE
THE WESTERN
PACIFIC
BUREAU R.;GIONAL OU PACIFIQUE OCCIDENTAL
REGIONAL COMMITTEE Thirty-sixth session · Manila 16-20 September ! 985 Provisional ·agenda item 13.
WPR/RC36/7 26 June 1985 ORIGINAL: ENGLISH
REPORT OF THE AD HOC SUB-COMMITTEE OF THE REGIONAL COMMITTEE ON THE ACTION PROGRAMME ON ESSENTIAL DRUGS AND VACCINES
The ad hoc Sub-Committee of the Regional Committee on the Action Programme on Essential Drugs and Vaccines met in Manila in June 1985 to review the implementation of the Action Programme on Essential Drugs and Vaccines in the Region, to identify and discuss priority areas of activity where cooperation among Member States needs to be strengthened, and to recommend suitable means of cooperation in such priority areas. The report of the ad hoc Sub-Committee is hereby presented for the consideration of the Regional Committee. Section 2 contains a description of the current situation in regard to the Action Programme in the Region. The conclusions and recommendations of the Sub-Committee are set out in section 3.
WPR/RC36/7 page 2
1.
INTRODUCTION
At its thirty-fifth session in 1984, the Regional Committee adopted resolution WPR/RC35.Rll on the "Action Programme on Essential Drugs and vaccines", which, among other things, requested the Regional Director to convene a meeting of an ad hoc Sub-Committee of the Regional Committee, to be composed of representatives of selected Member States, to consider means of cooperation among Member States in the field of this programme. The meeting of the ad hoc Sub-Committee of the Regional Committee on the Action Programme on Essential Drugs and Vaccines was held in Manila from .5 to 7 June 1985. Representatives of thirteen Member States, representing different stages of development, attended the meeting. In addition, observers were invited from certain bilateral agencies, United Nations agencies and nongovernmental organizations. Because of the highly technical nature of the subjects, five temporary advisers who were conversant in various areas related to the programme were also invited. A list of the representatives, observers and temporary advisers who attended the meeting is given in Annex 1. The objectives of the meeting were: (1) (2)
to review the implementation of the Action Programme on Essential Drugs and Vaccines in selected countries of the Region; to identify and discuss priority areas of activity where cooperation among Member States needs to be strengthened, including: (i) (ii) (iii)
drug quality assurance; drug supply and management; exchange of information; and
(3)
to recommend suitable means of cooperation among Member States in priority areas.
In his opening address, the Regional Director, Dr H. Nakajima, noted that many developing countries had already adopted the concept of essential drugs and that significant progress was being made towards the implementation of their national drug policies. Intercountry cooperation was essential to accelerate the development and implementation of the many activities contributing to the provision of safe and effective drugs within each country. The countries of the Region, both developing and developed, had achieved different levels of progress in the field of drug policy and management. They could now share their expertise and experience in the spirit of technical cooperation to complement each other's national efforts to give impetus to the improvement of health standards in the Region. Mrs Catalina Sanchez, Philippines, was elected Chairman of the meeting. Dr G.R. Boyd, New Zealand, was elected Vice-Chairman and Mr Liew Kee Hooi, Malaysia, Rapporteur. The provisional agenda, focusing on drug supply management, regulatory and quality control, information exchange and the government's role in consumer protection, was adcpted ()n the understanding that discussions would not necessarily be limited to those areas.
WPR/RC36/7 page 3
2.
CURRENT SITUATION IN REGARD TO THE ACTION PROGRAMME IN THE R EGlON
2.1
Situation in Member States
The Sub-Committee reviewed progress in the implementation of national essential drugs programmes in selected developing countries in the Region. It was noted that problems facing those Member States varied considerably, depending on their stage of development and socioeconomic conditions. Some countries had successfully developed establishments for the local production of essential drugs and were even exporting drugs to the international market whereas other countries were heavily dependent on external resources for the acquisition of even the most essential drugs. The general situation in regard to the programme in the Region might be summarized as follows: 2.1.1 Drug policies, Hst of .essential drugs In spite of the above differences, it was noted that there were general indications that the Action Programme had created an awareness of the essential drugs programme in many countries of the Region. This had resulted in the formulation and implementation, in varying degrees, of national drug policies. During the last few years, more countries had adopted or further promoted the concept of essential drugs. In Lao People's Democratic Republic, for example, a list of essential drugs for different levels of health facilities had been officially adopted in 1983. In Viet Nam, a list of essential drugs had been formulated in 1984. In Samoa, a similar list had been introduced in 1980 and a list of 7 3 drug items for health centres put into use in 1984. It was observed that, in general, most developing countries in the Region had their own list of essential drugs for use in the government sector. Some countries, such as Malaysia and Singapore, had established mechanisms for the continuous revision of the list. In the Philippines, measures had been taken to apply the concept of essential drugs to rationalize drug importation. 2.1.2 Procurement and distribution It was observed that considerable progress had been made recently in the improvement of storage and distrib~tion systems through computerization in Malaysia and Singapore. Although the WHO plan for establishing a bulk purchasing scheme among the developin$ countries in the South Pacific had not materialized, the general drug supply situation there had improved as a result of informal cooperation among governments in that area as well as increased competition among commerciaJ distributors. In Fiji, a new approach was being adopted for the establishment of community pharmacies in areas where there were no retaiJ pharmacies as an extension of its primary health care approach through the national bulk purchasing scheme. On the other hand, the availability of essential drugs for primary health care was still limited in som_ e countries which depended considerably on externaJ resources for the acquisition of essential drugs and had difficulties distributing such drugs to the periphery owing to limited means of transportation and inadequate storage facilities.
WPR/RC36/7 page 4
Some countries had successfully developed the local production of drugs. In countries where a supporting industry was not sufficiently developed, difficulties had been encountered in the acquisition of active ingredients and auxiliary materials indispensable for production. 2. 1.3 Quality assurance
In Member States which had local manufacturers, increased pdority was being given to drug quality assurance activities, including the implenientation of good manufacturing practices, good storage practices, development of quality control laboratories and inspection programmes. It was noted that, among the developing countries in the South Pacific, no country or area had a quality control laboratory. However, some Member States utilized the instrument of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce, or made bilateral arrangements for a limited number of samples to be tested by foreign laboratories. Manufacturers' assay certjficates and such factors as the reputation of, and past experience with, the suppliers were also accepted as indirect assurances of drug quality.
The Sub-Committee noted that the establishment and maintenance of drug quality control laboratories required adequate funding support and trained personnel. The shortage of such resources made it difficult for some countries to give priority to drug quality control programmes.
2.1.4 Information for the rational use of drugs Although lists of essential drugs had been established in most developing countries, unbiased information to ensure the rational use of those drugs was not widely available in some countries, especially at the periphery. Sometimes, local health care personnel had difficulty in understanding labels written in the language of the country from which the drugs originated. Information available to drug users was generaJly scarce in such developing countries, where there was no organized generation, collection, collation, compilation and dissemination of information. In some countries, however, inappropriate information on drugs made it difficult for the user to choose the right drug and use it rationally. 2.1.5 Regulatory control The Sub-Committee observed that one of the main instruments available to implement national drug policies was pharmaceutical legislation. A major development in that area was the enactment in 1984 of the law on drug administration in China, which aimed at streng thening measures to ensure the quality, safety and efficacy of pharmaceuticals. Steps were being taken for the implementation of a drug registration l2w in Malaysia. In some countries in the Region, pharmaceutical legislation was inadequate and needed revision. However, the implementation of a law required administrative machinery with adequately trained personnel and funding support, and this was often the area where constraints existed.
WPR/RC36/7 page 5
2.1.6 Manpower development The Sub-Committee noted that the shortage of clinical pharmacologists and pharmacists and other health care personnel was a serious constraint on the implementation of national essential drugs programmes, particularly in the South Pacific. Fiji and Papua New Guinea were operating a training course for pharmacy technicians and had accepted a number of trainees from neighbouring countries. Even in countries with established pharmaceutical coHeges, there was. a shortage of manpower in speda!ized fields such as advanced drug quality control techniques, drug production and supply management, good manufacturing practices and pharmaceutical administration. In some cases, lack of funds might be the rea! cause of manpower shortage. The provision of additional training opportunities for existing scarce staff, who were already overloaded with other duties, would not be an effective solution in those cases. 2.2 Activities of \\lHO
The Sub-Committee reviewed the programme on essential drugs and vaccines implemented by the WHO Regional Office for the Western Pacific. In the South Pacific, an intercountry project aimed at providing technical advice in drug supply management had been initiated in 1984. This service was being provided by a WHO pharmacist based in Samoa to several countries or areas in the South Pacific in the field of drug procurement and distribution. Within the framework of technical cooperation among ASEAN countries, WHO, with financial support from the United Nations Development Programme; was continuing to support various activities in such areas as drug supply management, good manufacturing practices, exchange of information, development of quality control laboratories and reference standards, and drug evaluation and control. In the context of cooperation with individual countries, ~ollaboration had been extended to several Member States for the strengthening of national capability in drug and vaccine production, in the improvement of storage and distribution systems as well as in manpower development. The Sub-Committee noted that, within the framework of WHO activities, intercountry cooperation was being promoted and implemented between developed and developing countries, particularly in the areas of feHowship training and provision of consultants. At the global level, WHO Headquarters was providing technical support to Member States and the Regional Office through the provision of technical publications, information and other materials. 2.3 Activities of bilateral and multilateral agencies and nongovernmental organizations
Although comprehensive information was not available to the Sub-Committee about bilateral programmes and activities undertaken by other international agencies and nongovernmental orga nizations, it was believed that the programme in this Region was now attracting more international support than before. Examples of this were the support provided by the Swedish International Development Authority to a pharmaceutical project in Viet Nam for the production, selection, distributioh and use
WPR/RC36/7 page 6
of drugs; collaboration between Japan and Lao People's Democratic Republic in the establishment of a pharmaceutical manufactuting facility and in the provision of a study programme in the field of pharmaceutical administration for selected participants from developing countries; support extended by UNICEF to programmes for the production and distribution of vaccines and oral rehydration salts in some countries of the Region. It was noted that the World Federation of Proprietary Medicine Manufacturers was now, as a result of a dialogue held at the regional level, offering three fellowships from the Region in drug quality control and good manufacturing practices, including free tuition and Jiving expenses. In addition, since 1979, the International Federation of Pharmaceutical Manufacturers Associations had been operating a programme in cooperation with WHO for the training of some government officials from the Region in qt~ality control.
3.
CONCLUSIONS AND RECOMMENDATIONS
3. J
Common problem areas in the implementatlon of the Action Programme
The Sub-Committee observed that, despite the progress and encouraging developments noted in the preceding paragraphs, most developing countries were obliged to operate their health programmes under tight budgetary conditions. This inevitably imposed serious constraints on the supply of essential drugs. Although the seriousness of each problem varied considerably from one country to another, the following common problem areas had been observed, in addition to the financial constraints. Jack of manpower or expertise in selecting essential drugs for different levels of health care facilities; lack of facilities, manpower or expertise in drug procurement storage, distribution and inventory control; Jack of appreciation and understanding of the specialized needs for storage of drugs and the need to upgrade existing facilities; lack of facilities, manpower or expertise in the local production of simple pharmaceutical preparations; lack of facilities, manpower.or expertise in drug quality control; lack of manpower or expertise in drafting, revising, and enforcing drug regulations; Jack of awareness on the part of some health personnel of the benefit of the rational u-se of drugs; Jack of consumer education on the rational use of drugs, including self-medication;
WPR/RC36/7
page 7
lack of an adequate system for collection and processing, for local use, of the large amount of drug information available from existing sources; lack of an adequate system for generating data within the country on drug usage patterns, adverse drug reactions and other relevant health statistics; lack of an efficient system of exchange among Member States of unbiased information about drug usage, adverse drug reactions, drug registration and marketing practices; lack of facilities, manpower or expertise in the production and quality control of vaccines; lack of resources for training of health manpower. 3.2 Priority areas for intercountry cooperation
In order to facilitate the implementation of intercountry cooperative measures, the Sub-Committee considered it desirable that each individual country should identify its own most urgent areas of concern based on the priority areas selected and Hsted below, which are neither in order of importance nor all-inclusive: (j}
the procurement, transportation, distribution of drugs;
storage,
inventory
control
and
(2) (3) (4) {5) (6) (7) (8) (9)
the quality assurance of drugs, including the production and use of standard reference substances and infra red reference spectra; local production of pharmaceutical preparations, whenever feasible; the quality control and, where feasible, production of vaccines; acquisition of expertise in the conduct of clinical trials on drugs; acquisition of expertise in the post-marketing surveillance of drugs; acquisition of expertise in the establishment and operation of drug information centres serving both the health profession and the public; the promotion of healthy living habits to reduce the demand on drugs and the promotion of rational use of drugs; the strengthening of regulatory activities including controls on advertising;
(I 0) the development and strengthening of national capability in the training of health personnel in drug management.
WPR/RC36/7 page 8
Proposed means of cooperation The Sub-Committee considered that the exchange of experience and information should be the principal means of cooperation among the countries in the respective priority areas identified earlier. A task force should be commissioned to coordinate the evaluation and identification of the most urgent areas of concern of individual countries or areas and to collate this information so that appropriate programmes for cooperation might be drawn up • . For the effective implementation of these programmes, the Sub-Committee urged that the Regional Office, in conjunction with UNICEF, UNDP and the other United Nations agencies, should provide the direction and initiative in the organization of workshops and seminars for group training, the arrangements for feJlowship training in the appropriate subjects, and the provision of consultants. The Sub-Committee acknowledged the contribution made by some developed countries through the provision of essential drugs, raw materials and facilities for the production of such drugs and manpower training. It also acknowledged the indirect support of the developed countries in the implementation of WHO activities for the provision of technicaJ ac;lvice and feJJowship training. It was felt that the continued provision of such support would alleviate considerably the difficulties currently being experienced by some developing countries. The Sub-Committee noted with appreciation the prov1s1on of training opportunities for fellows from the Region by the pharmaceutical industry. Such cooperation should be strengthened to enhance manpower development in the field of drug manufacturing and quality control. The Sub-Committee recognized that drug regulatory agencies, the health profession, the pharmaceutical industry and consumer groups should cooperate to produce public education programmes to foster reasonable expectations concerning the beriefits to be derived from the rational use of drugs.
WPR/RC36/7 page 9 ANNEX 1 ENGLISH/FRENCH ANGLAIS/FRANCAIS
LIST OF REPRESENTATIVES OF MEMBER STATES REPRESENTATIVES OF THE UNITED NATIONS AND RELATED ORGANIZATIONS, TEMPORARY ADVISERS, OBSERVERS AND SECRETARIAT LISTE DES REPRESENTANTS DES ETATS MEMBRES, DES REPRESENTANTS DES NATIONS UNIES ET OES INSTITUTIONS APPARENTEES, DES CONSEILLERS TEMPORAIRES, OBSERVATEURS ET DU SeCRETARIAT
I.
REPRESENTATIVES OF MEMBER STATES REPRESENTANTS DES ETATS MEMBRES Dr John Cable Acting Assistant Secretary Pharmaceutical Branch Therapeutics Division Department of Health Canberra, A.C. T. 2600
AUSTRALIA AUSTRALIE
CHINA CHINE
Mr Yang Jingxun Deputy Chief Pharmacist National Institute for the Control of Pharmaceutical and Biological Products Temple of Heaven Beijing
FIJI FIDJl
Mr Vijay Garib Chief Pharmacist Ministry of Health and Social Welfare Government Buildings Suva
WPR/RC36/7 Annex 1 page 10
FRANCE
Madame Made-Daniele Campion Chef du Bureau de la coordination des affaires communautaires et internationales Direction de Ja pharmacie et du medicament 14, Avenue Duquesne, 7~ 75700 Paris Mr Tatsuo Kurokawa Deputy Director International Affairs Division Minister's Secretariat Ministry of Health and Welfare Kasumigaseki, Chiyoda-ku Tokyo 100 Mr Takashi Kunieda Senior Staff Planning Division Pharmaceutical Affairs Bureau Ministry of Health and Welfare Kasumigaseki, Chiyoda-ku Tokyo lOO
JAPAN JAPON
MALAYSIA MALAISIE
Mr Liew Kee Hooi Director Government Pharmaceutical Laboratories and Stores Ministry of Health University Road, Peta1ing Jaya Selangor Dr G.R. Boyd Deputy Director Division of Clinical Services Department of Health WeUington Mr Robert C. Whaites Chief of Pharmaceutical Services Department of Health P.O. Box 3991 Boroko
NEW ZEALAND N OUVELLE-ZELA N DE
PAPUA NEW GUINEA PAPOUASIENOU VELLE-GUIN EE
WPit/RC36/7 Annex 1 page 11
PHILIPPINES
Mrs Catalina Sanchez Director Bureau of Food and Drugs Ministry of Health San Lazaro Compound Sta Cruz, Manila Dr Kang-Choo Lee Director, Pharmaceutical Affairs Division Ministry of Health and Social Affairs of the Republic of Korea Seoul 100 Mr Samuelu Kaleopa Chief Pharmacist Health Department Apia Dr Gerald G. Moy, Ph.D. Multilateral Programme Coordinator International Affairs Staff Office of Health Affairs, Food and Drug Administration 5600 Fishers Lane Rockville, Maryland M. Nguyen Duy Cuong Vice-Ministre de la Sante Ministere de la Sante 138A rue Giang Vo Hanoi
REPUBLIC OF KOREA REPUBLIQUE DE COREE
SAMOA
UNITED STATES OF AMERICA ETATS-UNIS D'AMERIQUE
VIETNAM
--
--
M. Bui Ky Chau Departement de pharmacie Ministere de la Sante 13&A rue Giang Vo Hanoi
WPR/RC36/7 Annex 1 page 12
II.
REPRESENTATIVES OF THE UNITED NATIONS A>ND RELATED ORGANIZATiONS REPAii::S.ENTANTS DE~ NATIONS UNIE.S ET·£5ls iN§TtTUfiONS . APf>~~lf'N:TEES ·
UNITED NATIONS CHILDREN'S FUND FONDS DES NATIONS UNIES POUR L'ENFANCE III.
Ms· Bituin Gonzales Programme O:ffic~r Makati, Metro
Manit~
OBSERVERS QBSER vATEURS Mr Paul Belford Pharmaceutical Manufacturers Association United States of America Mr Leo Wassmer General Manager Eli Lilly (Philippines) Inc. Makati, Metro Manila
INTERNATIONAL FEDERATION OF PHARMACEUTICAL MANUFACTURERS ASSOCIATIONS FEDERATION INTERNATIONALE DE L'INDUSTRIE DU MEDICAMENT
WORLD FEDERATION OF PROPRIETARY MEDICINE MANUFACTURERS FEDERATION MONDIALE DES PRODUCTEURS DE SPECIALITES PHARMACEUTIQUES GRAND PUBLIC
Mr John Pentecost Executive Director Proprietary Association of Australia G.P.o. Box 3968 Sydney, NSW 2001 Australia
UNITED STATES AGENCY FOR INTERNATIONAL DEVELOPMENT
Ms Joy-Riggs Perla Health Development Officer Manila
WPR/RC36/7 Annex 1 page 13
IV.
TEMPORARY ADVISERS CONSEILLERS TEMPORAIRES Ms Mary C. Ball
Supervisory Cons.1.1mer Affairs Specialist (Director, Program Planning and Outreach) Food and Drug Administration Office of ConSYmer AffairS Rockville, Maryland 20857 United States of America Dr John Jennings 1100 Fifteenth Street, N. W. 'Washington D.C. 20005 United States of America Dr Maurice L. Mashford Reader in Clinical Pharmacology University of Melbourne St Vincent's Hospital Fitzroy 3065 Queensland Australia Dr Peter Howard Rheinstein Director Office of Drug Standards Food and Drug Administration Center for Drugs and Biologics 5600 Fishers Lane Rockville, Maryland 20857 United States of America Mr Wong Yip Lung 40 Windsor Park Road Singapore 2057 Singapore
WPR/RC36/7 Annex 1 page 14
V. WHO~WPRO
SECRETARIAT
BUR~AU REGIONAL DE L.'QMS POUR
LE
PACIFig(JE OCCIOEN tAL
Dr Liu Guo-bin Director Drug Policy, Environmental Health and Health Technology Directeur, Politique pharmaceutique, salubrite de l'environnement et technologie pour la sante Mr T. Yoshida Scientist Pharmaceuticals Attache scientifique Produits pharmaceutiques Dr I. Geizer Medical Officer Health Laboratory Medecin responsable, Laboratoire de sante Dr H. J. Park Regional Adviser Health Manpower Development ConseiJler regional, Developpement des personnels de sante Mr H. Stephenson Pharmacist Pharmacien Apia, Western Samoa Miss Y. Hiraiwa Associate Expert, Pharmaceuticals Expert assode, Produits pharmaceutiques WHO/HQ SIEGE DE L'OMS Dr E. Lauridsen Programme Manager, Action Programme on Essential Drugs WHO Geneva, Switzerland Directeur, Programme d'action en matiere de medicaments essentiels OMS Geneve, Suisse
WPR/RC36/7 Annex 1 page 15
Mrs M. Helling-Barca Senior Scientist Action Programme on Essential Drugs WHO Geneva, Switzerland Attache scientifique Programme d'action en matiere de medicaments essentiels OMS Geneve, Suisse