WORLD HEALTH ORGANIZATION
ORGANISATION MONDIALE DE LA SANTE
Regional Office for the Western Pacific Bureau ~ional du Pacifique occidental
REGIONAL COMMITTEE
WPR/RC39/14 30 June 1988
Thirty-ninth session Manila 12-16 September 1988 Provisional agenda item 18.1
ORIGINAL: ENGLISH
CORRELATION OF THE WORK OF THE WORLD HEALTH ASSEMBLY, THE EXECUTIVE BOARD AND THE REGIONAL COMMITTEE Consideration of resolutions of the Forty-first World Health Assembly and the Executive Board at its eighty-first and eighty-second sessions
Resolutions adopted by the Forty-first World Health Assembly of interest for the work of WHO in the Western Pacific Region are hereby presented to the Regional Committee for comment, together with short analyses of their implications for Member States of the Region and for WHO's programme of cooperation. Resoiutions directly related to other items on the provisional agenda of the current session of the Regional Committee form part of the documentation for those individual agenda items. Resolutions of the eighty-first session of the Executive Board are reflected in the resolutions of the Health Assembly. The resolution adopted by the Executive Board at its eighty-second session in May 1988 is not of direct relevance to the work of the Regional Committee for the Western Pacific.
WPR!RC39/14 page2 1. Infant and young child nutrition (resolution WHA41.11)
Attention is drawn to operative paragraph 2. Decreasing use of breast-milk substitutes has been noted in most of the countries of the Region. Adequate legislative control measures are being exercised in ten countries where national codes on breast-milk substitutes have been formally adopted. Several countries have increased their efforts in the promotion of prolonged breast-feeding, strengthened health education for the general public, and training programmes for health workers. They have placed more emphasis on rooming-in, and introduced improved legislative measures for lactating mothers. Research, surveys and studies have been conducted in many countries to increase the knowledge available on nutritional problems affecting infants and young children. Member States with WHO collaboration should continue to make all possible efforts to establish an effective nutrition surveillance system in all the countries of the Region. Their nutritional and dietary patterns should be assessed, and non-health indicators should be included, so that comprehensive results can be profitably utilized by national planners. Additional efforts need to be made in some areas where, although national codes on breast-milk substitutes have been introduced, they are not yet widely enforced and appropriate and timely supplementary foods have not been introduced. In other countries, existing favourable policies need to be maintained and supported so as to continue increasing breast-feeding practices. Special efforts and cooperation are needed to introduce national codes on breast-milk substitutes in countries where these do not exist. WHO continues to monitor the progress of infant and young child nutrition in the countries of the Region. 2. Rational use of drugs (resolution WHA41.16)
Attention is drawn to operative paragraphs 3 and 4, requesting all concerned parties to support developing countries in setting up and carrying out programmes to ensure the rational use of drugs and to cooperate in the control of falsely labelled, counterfeited or substandard drugs. Although there has been increased awareness in the Region about the need to ensure the rational use of drugs, opinions tend to diverge on approaches to take in setting up concrete programmes toward this end. Efforts need to be strengthened at both national and regional levels to further develop effective programmes for this purpose.
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3.
Ethical criteria for medicinal drug promotion (resolution WHA41.17)
Attention is drawn to operative paragraph 3 and the ethical criteria annexed to this resolution. It is understood that the ethical criteria, worked out by a group of experts and endorsed by this resolution, constitute general principles that could be adapted by governments to their qwn situations, and that they do not constitute legal obligations. Member States are however urged to take account of these ethical criteria in developing their own appropriate measures and to implement them in order to ensure that drug promotion supports the aim of improving health care through the rational use of drugs.
Member States which have not yet developed such measures are encouraged to do so.
4.
WHO certification scheme on the quality of pharmaceutical products moving in international commerce (resolution WHA41.18)
Attention is drawn to operative paragraphs 2 and 3, as well as the attached revised text of the expanded WHO certification scheme. Member States which are not yet participating in the scheme are invited to do so. Full implementation of all the provisions of the expanded scheme is also recommended. Owing to difficulties in conducting satisfactory inspection of manufacturers in respect of good manufacturing practices, many Member States in the Region are not yet participating in the previous certification scheme, which was adopted in 1975. Besides, the extent of its use by importing governments is rather limited in the Region. Further studies will be needed at the national and regional levels to identify existing constraints in the effective utilization of the scheme.
5.
Traditional medicine and medicinal plants (resolution WHA41.19)
Attention is drawn to operative paragraph 1, which urges Member States to examine the situation with regard to their indigenous medicinal plants and to take effective measures on their conservation, as well as to encourage their sustainable utilization. The Region is rich in experiences and resources of traditional medicine and medicinal plants. However, many of the plants in the Region are also threatened with extinction. The situation is particularly serious in the Pacific tropical areas, where large scale logging is undertaken, destroying the areas' ecosystem. In most of the countries, inventory surveys of medicinal plants have already been undertaken, but information on these surveys is rather fragmented, particularly in the case of those that were conducted by expatriate researchers. Each Member State is encouraged to
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collect and examine all the information on this important aspect and, if necessary, to conduct another inventory survey. The development of botanical gardens and gene banks of medicinal plants is also encouraged. WHO's programme on traditional medicine continues cooperation with Member States on the promotion of the rational use of medicinal plants. A theoretical first step is to examine the status of their indigenous medicinal plants. A bibliography of medicinal plants in the South Pacific would be developed in cooperation with research and information institutes, libraries and other Member States. Consultant services would continue to be provided to interested countries in the conduct of inventory surveys on medicinal plants. Cooperation would be extended in the evaluation of the safety and efficacy of medicinal plants, information exchange through seminars, meetings, publications, etc., to promote the rational use of medicinal plants and thus avoid unnecessary depletion of precious resources. 6. Action programme on tobacco or health (resolution WHA41.25)
A Working Group on Tobacco or Health was held in Tokyo from 4 to 6 November 1987, attended by members from 15 countries and areas in the Region. The meeting considered action which should be taken by WHO and by Member States to increase and strengthen tobacco-orhealth activities in the Region. Areas of special concern included national policy and programme development; legislative action to restrict the use of tobacco; and the creation of educational materials. WHO was requested to take an active role in coordinating and facilitating the activities of the various governmental and nongovernmental organizations in the Region. It is realized that several Member States in the Region depend on tobacco production and sales as a major source of income but countries are being encouraged to develop alternative crops and income sources.
The world's first No-Tobacco Day on 7 April 1988 was celebrated successfully in all countries in the Region and it is hoped that a no-tobacco day will become an annual event. WHO has supported action on this programme in a number of Member States in the Region and the tobacco-or-health programme is fully integrated with activities in other programmes such as cancer and cardiovascular diseases. A further regional working group on tobacco or health will be held in 1990 and it is planned that a regional action plan will be prepared at this time. WHO will continue to support Member States actively in the development of tobacco-or-health activities and will seek additional resources as required. 7. Leadership development for health for an (resolution WHA41.26) All operative paragraphs have clear implications for Member States and WHO.
WPR/RC39/14 pageS
Paragraphs 1 and 2 represent a reaffirmation of the need for leadership to sustain and develop progress towards health for all. The declaration of personnel commitment could be a useful model for individual use at country level. Paragraph 3 emphasizes the need for countries to utilize all possible entry points for leadership development, and calls on Member States to exert further efforts in this regard. Paragraph 4 similarly calls on educational institutions and universities to accelerate efforts to change curricula to promote health for all and the primary health care approach. This call for action urges various sectors of the community to promote health development by building up health leadership which is able to interpret and advocate the values of health for all. The resolution calls on the Director-General and the Organization as a whole to: (a) (b) maintain and develop the health-for-all initiative; support national, educational and nongovernmental efforts to develop health-for-all leadership; establish and foster a technical resource network, and to disseminate information and experience; and evaluate the impact of the leadership development initiative in conjunction with the second evaluation of the global strategy in 1991.
(c)
(d)
WHO is then also required to use all possible entry points for leadership development. Particular attention will be paid to the leadership content of existing activities and programmes.
8.
The role of epidemiology in attaining health for all (resolution WHA41.27)
At the central level, many countries continue to give too much emphasis to the compilation of national totals and averages rather than using the data, albeit incomplete, as a tool for planning to attain health for all. Also, most of the countries in the Region are not using the data in their disaggregate form to identify local problems and pinpoint inequalities in health services and disease incidence. Operative paragraph 1 urges Member States to make proper use of all data from health, economic, social, cultural and other sectors in formulating health policies to achieve health for all. This will entail organizing services to provide complete and prompt epidemiological data. In some cases it will involve computerization, with development and strengthening of the health information system.
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Operative paragraph 2 will result in the reorientation of training in schools to meet the modern needs of the health services to achieve health for all by the year 2000. Operative paragraph 4 applies to WHO cooperation. It may indicate the need for the Western Pacific Region to organize a working group of experts to define the role of epidemiology in support of health-for-all strategies. More technical collaboration will also be needed in the development of health information systems and computerization. Support may be necessary to medical schools in revising and reorienting the curriculum for the training of epidemiologists.
9.
Global eradication of poliomyelitis by the year 2000 (resolution WHA41.28)
The expanded programme on immunization in the Western Pacific Region was established in 1976. Through the collaborative efforts of Member States, the estimated regional immunization coverage, which was less than 10% at the outset of the programme in 1976, attained over 60% in 1987 for all vaccines (DPT3, TOPV3, BCG, measles) resulting in the reduction of the incidence of the EPI target diseases in the Region. Most countries arc achieving high coverage, and zero incidence of poliomyelitis is being reported by 28 out of 35 countries and areas of the Region. Member States still reporting endemic poliomyelitis will have to increase TOPV3 coverage by over 90% and allocate additional resources to achieve this. All the Member States will need to maintain over 90% coverage of TOPV3, develop active surveillance by district, strengthen laboratory support and undertake case investigations and outbreak containment activities. WHO will need to provide additional technical support for the development of national plans of operations, training, strengthening laboratory support, and frequent monitoring and evaluation through country visits. Additional funds therefore will be necessary for personnel, training and supplies and equipment. Regional activities for poliomyelitis eradication were initiated in the South Pacific Basin in 1986 and an EPI managers' workshop, which was held in June 1988, established the goal of polio eradication. Presently it is hoped that by 1992 all the countries and areas of the Region will be free from poliomyelitis caused by wild virus and will have definitively eradicated it by 1995.
10.
Radionuclides in food: WHO guidelines for derived intervention levels (resolution WHA41.29)
Guidelines for the management of the consequences of a nuclear accident involving extended timescales and transboundary radioactive contamination have been developed to assist
WPR/RC39/14 page 7 national authorities in instituting coherent and consistent responses. The initiation of these activities by WHO was in response to the widely variable national measures which were imposed following the Chernobyl accident in April1986. The guidelines are based on health protection principles aimed at reducing the radiological risk to the population to a level of broad national acceptability while taking into account sensitive groups (e.g. children). Their acceptance would promote less dislocation in national activities, particularly in trade, by encouraging a harmonized post-accident response without imposing unnecessary constraints. Past experience suggests that a prolonged education campaign will be necessary before the concept of desired intervention levels receives widespread acceptance. A number of countries in the Region are continuing to promote comprehensive radiation monitoring of food imports. Additionally, Member States who have not already done so are being encouraged to establish basic monitoring capabilities for use in the event of radiological emergencies. In the areas of information exchange, radiation monitoring and the development of measures to control contamination, WHO is working to enhance its collaboration with other international organizations such as the International Atomic Energy Agency (IAEA), Food and Agriculture Organization of the United Nations (FAO) and United Nations Environment Programme (UNEP).
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 20 INFANT AND YOUNG CHILD NUTRITION The Forty-first World Health Assembly,
WHA41.11 11 May 1988
Having considered the report by the Director-General on infant and young child nutrition; Recalling resolutions WHA33.32, WHA34.22 and WHA39.28 on infant and young child feeding and nutrition, and resolutions WHA37.18 and WHA39.31 on the prevention and control of vitamin A deficiency and xerophthalmia, and of iodine deficiency disorders; Concerned at continuing decreasing breast-feeding trends in many countries, and committed to the identification and elimination of obstacles to breast-feeding; Aware that appropriate infant and young child nutrition could benefit from further broad national, community and family. interventions; 1. COMMENDS governments, women's organizations, professional associations, consumer and other nongovernmental groups, and the food industry for their efforts to promote appropriate infant and young child nutrition, and encourages them, in cooperation with WHO, to support national efforts for coordinated nutrition programmes and practical action at country level to improve the health and nutrition of women and children; 2. URGES Member States: (1) to develop or enhance national nutrition programmes, including multisectoral approaches, with the objective of improving the health and nutritional status of their populations, especially that of infants and young children; (2) to ensure practices and procedures that are consistent with the aim and principles of the International Code of Marketing of Breast-milk Substitutes, if they have not already done so; 3. REQUESTS the Director-General to continue to collaborate with Member States, through WHO regional offices and in collaboration with other agencies of the United Nations system, especially FAO dnd UNICEF: (1) in identifying and assessing the main nutrient and dietary problems, developing national strategies to deal with them, applying these strategies, and monitoring and evaluating their effectiveness; (2) in establishing effective nutritional status surveillance systems in order to ensure that all the main variables which collectively determine nutritional status are properly addressed;
a view to improving breast-feeding rates;. (5) in developing recommendations regarding diet, including timely complementary feeding and appropriate weaning practices, which are appropriate L:o national··. circwnstances; (6) in providing legal and technical assistance, upon request from Member States, in the drafting and/or the implementation of national codes of marketing of breast-milk substitutes, or other similar instrwnents; (7) in designing and implementing collaborative studies to assess the impact of measures taken to promote breast-feeding and child nutrition in Member States.
Fourteenth plenary meeting, 11 May 1988
A41/VR/l4
FORTY-FIRST WORLD HEALTH ASSEMBLY A~enda
WHA41.16 13 May 1988 RATIONAL USE OF DRUGS
item 23
The Forty-first World Health Assembly, Recalling resolutions WHA37.33 and WHA39.27 on the rational use of drugs; Having reviewed the report of the Executive Board on the implementation of WHO's revised drug strategy, aimed at ensuring the rational use of drugs; 1. NOTES with satisfaction that, in spite of severe financial constraints, the revised drug strategy is being carried out almost in its entirety, the implementation of the remaining components having been delayed solely due to lack of resources; 2. CONGRATULATES all parties concerned that have fulfilled their responsibilities in compliance with resolution WHA39.27, and encourages them to continue to do so; 3. INVITES bilateral agencies, multilateral agencies inside and outside the United Nations system, and voluntary organizations, to support developing countries in setting up and carrying out programmes aimed at ensuring the rational use of drugs, particularly essential drugs programmes, and thanks those that are already doing so; 4. REQUESTS governments and pharmaceutical manufacturers to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations 5. REQUESTS the Director-General: (1) to implement the remaining components of the revised drug strategy, seeking extrabudgetary resources in addition to those in the regular budget to this end; (2) to include in his biennial reports to the Health Assembly information on the implementation of the revised drug strategy, and to provide reports thereon to the Executive Board from time to time, as necessary; (3) to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations, and to cooperate with the Secretary-General of the United Nations in such cases when the provisions of the international drug treaties are violated.
Fifteenth plenary meeting, 13 May 1988 A41/VR/15
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 23 ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION The Forty-first World Health Assembly, Recalling resolutions WHA21.41 and WHA39.27;
WHA41.17 13 May 1988
Having considered the report of the Executive Board concerning the ethical criteria for medicinal drug promotion based on a draft prepared by an international group of experts; Convinced that observance of ethical criteria for medicinal drug promotion by all parties concerned will contribute to a more rational use of drugs; 1.
THANKS the international group of experts for its work;
2. ENDORSES the ethical criteria for medicinal drug promotion that are annexed to this resolution, on the understanding that they constitute general principles that could be adapted by governments to countries' circumstances as appropriate to their political, economic, cultural, social, educational, scientific and technical situation, their national laws and regulations, disease profile, therapeutic traditions, and the level of development of their health system, and that they do not constitute legal obligations; 3. URGES Member States: (1) to take account of these ethical criteria in developing their own appropriate measures to ensure that medicinal drug promotion supports the aim of improving health care through the rational use of drugs; (2) to monitor and enforce, where appropriate, the implementation of the measures they have developed; 4. APPEALS to pharmaceutical manufacturers and distributors, the promotion industry, health personnel involved in the prescription, dispensing, supply and distribution of drugs, universities and other teaching institutions, professional associations, patient and consumer groups, the professional and general media (including publishers and editors of medical journals and related publications), and the public: (1) to use these criteria as appropriate to their spheres of competence, activity and responsibility; (2) to adopt measures based on these criteria as appropriate, and monitor and enforce their standards; 5. REQUESTS the Director-General: (1) to ensure the wide dissemination of these criteria in all official languages;
(2) to follow the practice of these criteria and to report to the Executive Board from time to time as appropriate. Fifteenth plenary meeting, 13 May 1988 A4lfVR/15
tJHA41.l7 pagcf .2
ETHICAL. CRITERIA FOR. MtDtCINAt. CONTENts··
DRUG PROMOTiON Paragraph
Introduction . ......................... . .............. . ....................... . Objective .......... . ... . .. . ......................................... . ........ . Ethical criteria ....... . ......................... . ....... . ................... . Applicability and implementation of criteria . . .......... . .......... . ... . ..... . Promotion ....... . ..... . ...................................................... . Advertising .... ; . . , ... , ... •:.................. . ... . ...... .... , . . ..... . ......... , Medical representatives ... . ...................... . .......... . ... . .. . .. . .... .. . Free samples of prescription drugs for promotional purposes . .. ~ ........ . . • ...• Free samples of non-prescription drugs to the general public for promotional purposes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Symposia and other scientific meetings ... .. .......... . ......... ·•.. , .. , ....... , . . Post-marketing scientific studies, surveillance and dissemination of · information . .. . : ..... ... ... ......... • . .. .. .. : ...... . .. . . . ... ..... . , . . ..... . ... Packaging and labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Information for patients: package inserts, leaflets and booklets . . . . . . . . . . . . .
1 2 3 4
6 10
17 20 21
-5 -9 - 16 - 19
22 - 24 25 - 27 28 29 - 30 31
Promotion of exported drugs . .- . . . .•. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix - Sample drug information sheet Introduction
1. Following the WHO Conference of Experts on the Rational Use of Drugs held in Nairobi in November 1985, WHOpreparec:l. a revised drug strategy which was endorsed by the Thirty~n i nth World Health Assembly in May 1986 in resolution WHA39.27. This strategy includes, among other components ; the . establishment of , ethical criteria for drug promotion based on the updating and extension of the ethical .and scientific criteria established in 1968 by the Twenty-first World Health Assembly in resolution WHA21 . 41. The criteria that follow have been prepared in compliance with the above on the basis of a draft elaborated by an international group of experts . Objective 2. The main objective of ethical criteria for medicinal drug promotion is to support and encourage the improvement of health care through the rational use of medicinal drugs . Ethical criteria 3. The interpretation of what is ethical varies in different parts of the world and in different societies . The issue in all societies is what is proper behaviour. Ethical criteria for drug promotion should lay the foundation for proper behaviour concerning the
WHA41.17
page 3
promotion of medicinal drugs, consistent with the search for truthfulness and righteousness. The criteria should thus assist in judging if promotional practices related to medicinal drugs are in keeping with acceptable ethical standards. Applicability and implementation of criteria 4. These criteria constitute general principles for ethical standards which could be adapted by governments to national circumstances as appropriate to their political, economic, cultural, social, educational, scientific and technical situation, laws and regulations, disease profile, therapeutic traditions and the level of development of their health system. They apply to prescription and ,non-prescription medicinal drugs ("over-the-counter drugs"). They also apply geRera1ly to traditional medicines as appropriate, and to any other product promoted as a medicine: The criteria could be used by people in all walks of life; by governments; the pharmaceutical industry (manufacturers and distributors); the promotion industry (advertising agencies, market research organizations and the like); health personnel involved in the prescription, dispensing, supply and distribution of drugs; universities and other teaching institutions; professional associations; patients' and consumer groups; and the professional and general media (including publishers and editors of medical journals and related publications). All these are encouraged to use the criteria as appropriate to their spheres of competence, activity and responsibility. They are also encouraged to take the criteria into account in developing their own sets of ethical standards in their own field relating to medicinal drug promotion. 5. The criteria do not constitute legal obligations; governments may adopt legislation or other measures based on them as they deem fit. Similarly, other groups may adopt self-regulatory measures based on them. All these bodies should monitor and enforce their standards. Promotion 6. In this context, "promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs . 7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion -making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word "safe" should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature. 8. Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs. 9. Scientific and educational activities should not be deliberately used for promotional purposes.
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Advertising (a) Advertisements in all forms to physicians and health-related professionals
10. The wording and illustrations in advertisements to physicians and related health professionals should be fully consistent with the approved scientific data sheet for the drug concerned or other source of information with similar content. The text should be fully legible. 11. Some countries require that advertisements should contain full product information, as defined by the approved scientific data sheet or similar document, for a given period from the date of first promotion or for the full product life. Advertisements that make a promotional claim should at least contain summary scientific information. 12. The following list, based on the sample drug information sheet contained in the second report of the WHO Expert Committee on the Use of Essential Drugs and appended for ease of reference, can serve as an illustration of the type of information that such advertisements should usually contain, among others: - the name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug; - the brand name; - content of active ingredient(s) per dosage form or regimen; - name of other ingredients known to cause problems; - approved therapeutic uses; - dosage form or regimen; - side - effects and major adverse drug reactions; - precautions, contra-indications and warnings; - major interactions; - name and address of manufacturer or distributor; - reference to scientific literature as appropriate. 13. Where advertisements are permitted without claims (reminder advertisements), they ought to include at least the brand name, the international nonproprietary name or approved generic name, the name of each active ingredient, and the name and address of the manufacturer or distributor for the purpose of receiving further information. (b) Advertisements in all forms to the general public
14 . Advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without a prescription. While they should take account of people's legitimate desire for information regarding their health, they should not take undue advantage of people's concern for their health. They
1 WHO Technical Report Series, No. 722, 1985, p. 43.
WHA41.17 page 5
should not generally be permitted for prescription drugs or to promote drugs for certain serious conditions that can be treated only by qualified health practitioners, for which certain countries have established lists. To fight drug addiction and dependency, scheduled narcotic and psychotropic drugs should not be advertised to the general public. While health education aimed at children is highly desirable, drug advertisements should not be directed at children. Advertisements may claim that a drug can cure, prevent, or relieve an ailment only if this can be substantiated. They should also indicate, where applicable, appropriate limitations to the use of the drug. 15. When lay language is used, the information should be consistent with the approved scientific data sheet or other legally determined scientific basis for approval. Language which brings about fear or distress should not be used. 16. The following list serves as an illustration of the type of information advertisements to the general public should contain, taking into account the media employed: - the name(s) of the active ingredient(s) using either international nonproprietary names (INN) or the approved generic name of the drug; - the brand name; - major indication(s) for use; - major precautions, contra-indications and warnings; - name and address of manufacturer or distributor. Information on price to the consumer should be accurately and honestly portrayed . Medical representatives 17. Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Such training should include instruction regarding appropriate ethical conduct taking into consideration the WHO criteria . In this context, exposure of medical representatives and trainees to feedback from the medical and allied professions and from independent members of the public, particularly regarding risks, can be salutary. 18. Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data sheet or other source of information with similar content. 19. Employers should be responsible for the statements and activities of their medical representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit . such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate. Free samples of prescription drugs for promotional purposes 20. Free samples of legally available prescription drugs may be provided in modest quantities to prescribers, generally on request.
WHA41.17
page 6
Free samples of non-prescription drugs to the general public for promotional purposes 21. Countries vary in their practices regarding the provision of free samples of non-prescription ,drugs to the general public, some countries permitting it, some not. Also, a distinction has to be made between provision of free drugs by health agencies for the care of certain groups and the provision of free samples to the general public for promotional purposes. The provision of free samples of non-prescription drugs to the general public for promotional purposes is difficult to justify from a health perspective. If this practice is legally permitted in any country, it should be handled with great restraint. Symposia and other scientific meetings 22. Symposia are useful for disseminating information. The objective scientific content of such meetings should be paramount, and presentations by independent scientists and health professionals are helpful to this end. Their educational value may be enhanced if they are organized by scientific or professional bodies . 23. The fact of sponsorship by a pharmaceutical manufacturer or distributor should be clearly stated in advance, at the meeting and in any proceedings. The latter should accurately reflect the presentations and discussions . Entertainment or other hospitality, and any gifts offered to members of the medical and allied professions, should be secondary to the main purpose of the meeting and should be kept to a modest level. 24. Any support to individual health practitioners to participate in any domestic or international symposia should not be conditional upon any obligation to promote any medicinal product. Post-marketing scientific studies, surveillance and dissemination of information 25 . Post-marketing clinical trials for approved medicinal drugs are important to ensure their rational use. It is recommended that appropriate national health authorities be made aware of any such studies and that relevant scientific and ethical committees confirm the validity of the research. Intercountry and regional cooperation in such studies may be useful. Substantiated information on such studies should be reported to the appropriate national health authorities and disseminated as soon as possible . 26. Post-marketing scientific studies and surveillance should not be misused as a disguised form of promotion. 27. Substantiated information on hazards associated with medicinal drugs should be reported to the appropriate national health authority as a priority, and should be disseminated internationally as soon as possible. Packaging and labelling 28. Appropriate information being important to ensure the rational use of drugs, all packaging and labelling material should provide information consistent with that approved by the country's drug regulatory authority. Where one does not exist or is rudimentary, such material should provide information consistent with that approved by the drug regulatory authority of the country from which the drug is imported or other reliable sources of information with similar content. Any wording and illustration on the package and label should conform to the principles of ethical criteria enunciated in this document.
WHA41.17
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Information for patients :
package inserts. leaflets and booklets
29. Adequate information on the use of medicinal drugs should be made available to patients. Such information should be provided by physicians or pharmacists whenever possible. When package inserts or leaflets are required by governments, manufacturers or distributors should ensure that they reflect only the information that has been approved by the country's drug regulatory authority. If package inserts or leaflets are used for promotional purposes, they should comply with the ethical criteria enunciated in this document . The wording of the package inserts or leaflets, if prepared specifically for patients, should be in lay language on condition that the medical and scientific content is properly reflected. 30 . In addition to approved package inserts and leaflets wherever available, the preparation and distribution of booklets and other informational material for patients and consumers should be encouraged as appropriate. Such material should also comply with the ethical criteria enunciated in this document. Promotion of exported drugs 31. Ethical criteria for the promotion of exported drugs should be identical with those relating to drugs for domestic use. It is desirable that exporting and importing countries that have not already done so should use the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
WHA41.17 page 8
Appendix SAMPLE DRUG INFORMATION SHEETl Dru& information sheets Various types of information are needed by prescribers and consumers to ensure the safe and effective use of drugs. The following list is a sample that should be adjusted to meet the needs and abilities of the prescriber. (1) International Nonproprietary Name (INN) of each active substance. a brief description of pharmacological effects and
(2) Pharmacological data: mechanism of action. (3) Clinical information: (a) (b) Indications: provided.
whenever appropriate, simple diagnostic criteria should be
Dosage regimen and relevant pharmacokinetic data: - average and range for adults and children; dosing interval; - average duration of treatment; - special situations, e.g., renal, hepatic, cardiac, or nutritional insufficiencies that require either increased or reduced dosage.
(c) (d) (e) (f) (g)
Contra-indications. Precautions and warnings (reference to pregnancy, lactation, etc.). Adverse effects (quantify by category, if possible). Drug interactions (include only if clinically relevant; self-medication should be included). Overdosage: - brief clinical description of symptoms; - non-drug treatment and supportive therapy; - specific antidotes. drugs used for
(4)
Pharmaceutical information: (a) (b) (c) (d) (e) (f)
Dosage forms. Strength of dosage form. Excipients. Storage conditions and shelf-life (expiry date). Pack sizes. Description of the product and package. Legal category (narcotic or other controlled drug, prescription or non-prescription). Name and address of manufacturer(s) and importer(s) .
(g) (h)
1 Reproduced from The use of essential drugs: second report of the WHO Expert Committee on the Use of Essential Drugs (WHO Technical Report Series, No. 722, 1985, p . 43).
FORTY-FIRST WORLD HEALTH ASSEMBLY Agendai:teDi 23
WHA41.18
13 May 1988
WHO' CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS MOVING IN INTERNATIONAL COMMERCE The Forty-first World Health Assembly, Taking <note >df previcfus reSolutions on the question; Having ' examined the ' Director-Gemiral ( s· ·report oti the ra·tional us·e · of drugs, arid • in particular the propo·sed <amendments to the WHO Certification ' Scheme on the Quality of Pharmaceutical Prod\:icts Moving in Intei'n<itional Commerce; Noting the fact that, in any case of obvious doubt, any Member State may request the Organization for assistance in finding an independent collaborating centre to carry out batch tests . for tlle purposes of quali ty··cotitrol; l. ADOPTS the attached revised text of the expanded WHO Certification Scheme on the Quality of Pharmaceutical: Products Moving in International ·Commerce; ..
:·•
~
2.
INVITES Member States which are not yet participating in the Scheme to do so; . ;i,
3. RECOMMENDS to Member : States that 'tney implement as far as possible all the provisions of the expanded -WHO Certi'fication ·Scheme; 4. REQUESTS the Director-General to repor'tj · in the context of his report'on WHO's revised drug strategy to a future World Health Assembly, on the progress accomplished in the implementatio'ti of the expanded WHO Certification Scheme.
Fifteenth plenary meeting, lJ' May 1988 A41/VR/15
WHA4l.l8 page 2 ANNEX
Part ,I - Certification of a Pharmaceutical Product 1. For the purpose of this Certification Scheme "pharmaceutical prod~ct" means any medicine intended for human use, or a veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, when it is subj~ctto control by legislation in the exporting Member State and in the importing Member State. It should be noted that, as a matter of policy, some Member States do not inspect manufacturers of starting materials, while in other countries such inspection is limited to selected active ingredients. 2. A pharmaceutical product exported or imported under this Certification Scheme would be certified by the competent authority of the exporting . Member State on a Certificate of a Pharmaceutical Product, issued at the request of the interested party, to be sent to the competent authority of the importing Member State, which would decide to grant or to refuse the authorization for sale or distribution of the certified product, or to make the authorization conditional on the suqmission of . supplementary data. 3. The. issue of the Certificate of a Pharmaceutical Product would be subject to. the conditions required by the competent authority of the exporting Member State in order to certify that : (a) the product is authorized for sale or distributionwithin the exporting Member State (if not, the reasons therefore would be stated on the certificate); and (b) the manufacturing plant in which the product is produced is subject to inspection at suitable intervals to show. that the manufacturer .conforms to requirements for good practices in manufacture and quality control, as recommended by the World Health Organization, in respect of products to be sold or distributed within the country of origin or to be exported . A suggested layout of a notes is attached. Certific~te
0 £ a Pharmaceutical Product with explanatory
~
4. Certification of individual batches of pharmaceutical products and substances is only undertaken exceptionally by the competent authorities of Member States. Even then, it is rarely applied other than to vaccines and other biologicals. If certificates of individual . b atches of a product covered by a Certificate of a Pharmaceutical Product are required, . such certificates could be issued either by the manufacturer or by the competent authority of the exporting Member State, according to the nature of the product and the requirements of the exporting Member State or of the importing Member State . The batch certificate would indicate the name and dosage form of the product, the batch number, the expiry date and storage conditions, a reference to the Certificate of a Pharmaceutical Product, and a statement that the batch conforms either to the requirements of the competent authority for sale or distribution within the exporting Member State (with reference to the authorization) or, as the case may be, to published specifications, or to established specifications to be provided by the manufacturer. The certificate could also include data on packaging, labelling, nature of the container, the date of manufacture, results of analysis and on stability, and other information such as an approved technical summary of the data regarding safety and efficacy on which the domestic marketing authorization is based.
WHA41.18
page 3
Part II - Exchange of Information 1. Upon the request of the competent authority of the Member State into which a pharmaceutical product covered by this Certification Scheme is to be or has been imported, the competent authority of the exporting Member State should provide: (a) information on the implementation of the Requirements for Good Practices in the Manufacture ayd Quality Control of Drugs as recommended by the World Health Organization; (b) information on controls of the product as exercised by the competent authority of the exporting Member Statei (c) the names and functions of the persons designated to sign certificates of individual batches of the product to be exported; (d) copies of all information and labelling supplied with the product, as provided on packaging materials and package inserts, and whether directed to the prescriber or the patient, that have been approved by the competent authority in the exporting Member State, together with the date(s) on which such approval was accorded. Information on general and specific standards for quality control of the product to be exported, in so far as they are required to comply with legislative provisions of the importing Member State, could also be supplied with the consent of the manufacturer. 2. In the case of quality defects of products imported under this Certification Scheme that are considered to be of a serious nature by the importing country, not attributable to local conditions and circumstances, and appearing after the introduction of a particular batch into the importing Member State, the competent authority should notify the occurrence, together with the relevant facts, to the competent authority of the exporting Member State that had issued the Certificate for the product concerned, with a request to institute inquiries. Conversely, if the competent authority of the exporting Member State ascertains serious quality defects, that competent authority should notify the competent authority of the importing Member State. Part III - Participating Member States 1. Each Member State agreeing to participate in the Certification Scheme shall communicate (a) the name and address of its principal authority to be considered as competent within the meaning of the Certification Scheme, and (b) any significant reservations relating to its participation, to the Director-General of the World Health Organization, who would notify all other Member States. 2. that: (a) authorization for sale or distribution of pharmaceutical products is subject to appropriate testing measures, by the competent authority, designed to ensure their quality and stability, and that adequate laboratory facilities are available for this purpose; Exporting Member States participating in the Certification Scheme shall ensure
1 It is realized that in some countries this may require the consent of the manufacturer.
WHA41.18
page 4
(b) the pharmaceutical industry is obliged to conform to requirements for good practices in the manufacture and quality control of drugs as recommended by the World Health Organization; (c) the competent authority is empowered to conduct appropriate investigations to ensure that manufacturers conform to the requirements referred to in (b), including , for example, the examination of records and the taking of samples; (d) the inspectors in the services of its competent authority have appropriate qualifications and experience . 3. Exporting Member States participating in the Certification Scheme should, whenever possible, ensure that the international nonproprietary names, whenever available, are used in the description of the composition of the product on the Certificates and, as far as possible , appear on the labelling of pharmaceutical products to be exported under the Certification Scheme.
WHA41.18 page 5
CERTIFICATE OF A PHARMACEUTICAL PRODUCTl (Proposed layout) Name and dosage form of product: ........ ~ ................................... . Name and amount of each active ingredient: ................................. . Manufacturer, and/or when applicable, the person responsible for placing the product on the market: .................................................. . Address(es): It is certified that: This product has been authorized to be placed on the market for use in this country. Number of permit and date of issue (if applicable): ............... . The enclosed documents constitute the complete text of all labelling and prescribing information which is authorized for use in this country. This product has not been authorized to be placed on the market for use in this country for the following reasons: ................ . It is also certified that (a) the manufacturing plant in which the product is produced is subject to inspections at suitable intervals and (b) the manufacturing conforms to requirements for good practices in the manufacture and quality control, as recommended by the World Health Organization, in respect of products to be sold or distributed within the country of origin or to be exported. (See Explanatory Notes.) (Signature of designated authority) (Place and date)
Explanatory Notes Certificate of a Pharmaceutical Product This certificate is intended to define the status of the pharmaceutical product and it8 manufacturer in the exporting country. It is issued by the competent authority in the exporting country in accordance with the requirements of the competent authority of the importing country. It may be required by the importing country at the time of the first importation and subsequently if confirmation or updating is required. The requirements for good practices in the manufacture and quality control of drugs mentioned in the certificate refer to the text adopted by the Twenty-eighth World Health Assembly in its resolution WHA28.65 (see WHO Official Records, No. 226, 1975, Annex 12, Part 1).
1 The certificate is intended to be product specific. The approved information for different dosage forms of the same active substance frequently differs in fundamental aspects. Confusion will inevitably arise if information relating to different products, or even different dosage forms, is attached to the same certificate. 2 Use, whenever possible, international nonproprietary names (INNs) or national nonproprietary names.
WHA41.18 page 6
Batch certificates Certification of individual batches of a pharmaceutical product or substance is only undertaken exceptionally by the competent authorities of Member States. Even then, it is rarely applied other than to vaccines and other biologicals . If certificates of individual batches of products covered by a Certificate of a Pharmaceutical Product is required, such certificates could be issued either by the manufacturer or by the competent authority of the exporting Member State, according to the nature of the product and the requirements of the exporting Member State or of the importing Member State. The batch certificate would indicate the name and dosage form of the product, the batch number, the expiry date and storage conditions, a reference to the Certificate of a Pharmaceutical Product and a statement that the batch conforms either to the requirements of the competent authority for sale or distribution within the exporting Member State (with reference to the authorization) or, where appropriate, to published specifications or to established specifications to be provided by the manufacturer. The certificate could also include data on packaging, labelling, nature of the container, the date of manufacture, results of analysis, stability data and other information such as an approved technical summary of the data regarding safety and efficacy on which the domestic marketing authorization is based.
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 23 TRADITIONAL MEDICINE AND MEDICINAL PLANTS The Forty-first World Health Assembly,
WHA41.19
13 May 1988
Recalling resolutions of the Health Assembly concerning traditional medicine in general (WHA40.33) and medicinal plants in particular (WHA31.33); Realizing that, as a consequence of the loss of plant diversity around the world, many of the plants that provide traditional and modern drugs are threatened with extinction; Commending the Director-General for having taken the initiative of convening an International Consultation on the Conservation of Medicinal Plants, in association with the International Union for the Conservation of Nature and Natural Resources and the World Wildlife Fund; Noting reaffirming through the sustainable that the Consultation resulted in commitment to the collective goal primary health care approach, and development outlined in the World the adoption of the Chiang Mai Declaration of "Health for All by the Year 2000" to the principles of c~nservation and Conservation Strategy;
Endorsing the call for international cooperation and coordination to establish programmes for the conservation of medicinal plants, to ensure that adequate quantities are available for future generations ; 1. URGES Member States: (1) to examine the situation with regard to their indigenous medicinal plants;
(2) to take effective measures to ensure their conservation and encourage their sustainable utilization; 2. REQUESTS the Director-General: (1) to promote intercountry meetings for the dissemination of knowledge and the exchange of experience on the subject; (2) to collaborate with Member States in the design and implementation of programmes for the conservation and sustainable utilization of medicinal plants; (3) to report on the progress achieved to a subsequent World Health Assembly. Fifteenth plenary meeting, 13 May 1988 A41/VR/15
l Document A41/INF . DOC./8.
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 22 ACTION PROGRAMME ON TOBACCO OR The Forty-first World Health Assembly, HEALTH~
WHA41.25 13 May 1988
Recalling resolutions WHA31.56, WHA33.35 and WHA39.14 and emphasizing the importance of ensuring that these resolutions are fully implemented; Having considered the Director-G~neral's report on Tobacco or Health, 1 the comments on it by the Executive Board a~d the report of the Advisory Group on a WHO Global Action Plan on Tobacco or Health; Encouraged by the response to the first world no-smoking day on 7 April 1988; REQUESTS the Director-General to draw up a plan of action, bearing in mind the recommendations of the Advisory Group and covering in particular: (i) the special problems of developing countries which at present depend upon tobacco production as a major source of income; (ii) targets and intervention plans including consideration of future no-smoking days, for example, on annual World Health Day; (iii) the administrative and management structure including relations of this programme with other programmes of the Organization; (iv) (v) resource needs; sources of finance and other support
for submission, through the Programme Committee, to the eighty-third session of the Executive Board.
Fifteenth plenary meeting, 13 May 1988 A41/VR/15 1 Document A41/4. 2
Document EB81/1988/REC/2, pp. 36-43. 3 Document A41/INF.DOC./6.
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 12 LEADERSHIP DEVELOPMENT FOR HEALTH. FOR ALL The Forty-first.World Health.As~emqly,
WHA41.26
13 May 1988
Recalling resolution WHA30.43 and WHA34.36 by which .the Member States of WHO have unanimously adopted a policy and Strategy for achieving the goal of health for all by the year 2000; Alma-A~a Oecl~ration
Noting the progress made at this midpoint between the adoption in 1978 of the on Primary Health.Car~, .which set a. new course for action for hea~th; and the. y~ar 2000, but also qeing aware of the need for accelerated.progres~ to achiey~ th~ collectively agreed goal of.health for all; Stressing that accelerated progress will. require an even gr~ater involvement of people from all walks of lif~ and mobilization.of all potential~resources ~n~society in support of primary health care; Recogp.izing that informed and commit;:ted leadership at all levels of sqciety is crucial for harnessing this potential; Recalling resolution WHA37. 31 on the role of universities. in the strategies .for health for all; resqlution WHA38.31 op..collaboration with. nongovernmental organizations in implementing the Strategy; resolution WHA39.7 on the evaluation of th~ Strategy; and resolution. WHA39. 22. on intersectoral. action for health; 1. ENDORSES the Declaration of Personal Commitment 1 and the report on "Leadership development for Health for All" of the Technical Discussions held during. the Forty•first World Health Assembly; 2 AFFIRMS. that ep.lightened an<;). eff~ctive leadership is vital to 2. social and political action for health for all; 3. CALLS UN ~ntensify
ar1d sustain
Member Staces:
(1) to develop le."ldership f()r healthfot; all ac~ively.qy us:j.ng all educational entry points; and. by sensitizing current. l~~<;).ersh~p. to.the.issues. involved an<:l generating continually new leadership, inorder to acc~lerate progre§S 0 towards health for all through primary health care;
1 See •·Al1nex•l. 2 Document A41/Technical Discussions/7.
WHA41.26 page 2 (2) to launch renewed efforts to increase understanding of health for all and primary health care, utilizing effective communication strategies, including sensitizing.the leadership of the media to their social responsibility in promoting communication for health;. (3) to accelerate decentralization and socioeconomic and structural reforms which favour active involvement of people and encourage the emergence of leadership potential and provide opportunities for setting examples of effective leadership at all levels;
(4) to make renewed and innovative efforts to involve people and communities creatively so as to empower them, develop self-reliance and leadership at local level; (5) to expand supportive partnerships with communities, nongovernmental organizations, educational institutions and other community-based organizations to bring their creativity and commitment to bear on the challenge of health for all;
4. CALLS ON the leadership of educational institutions and universities to demonstrate their commitment to achieve health for all through primary health care, by:
(1) accelerating changes in the curricula for the training of health and other professionals, including teachers, involved in health action to promote the value system of health for all and enhance the potential of leadership for health for all; (2) shifting academic reward systems and providing career opportunities so as to acknowledge and encourage career academic commitments to primary health care; (3) including in the curricula of institutions throughout the educational system from primary schools on, education for health, social values, attitude change and leadership development;
5. URGES the leadership of national and international nongovernmental organizations to expand their partnership with governments and educational institutions to accelerate progress towards health for all, and to use their flexibility and creativity in developing leadership potential and capacities at community level, involving particularly women and youth groups; 6. REQUESTS the Director-General: (1) to publish the Declaration of Personal Commitment and the report on "Leadership development for health for all" of the Technical Discussions, and disseminate it widely to all governments, educational institutions and universities, nongovernmental and voluntary organizations, and other interested groups;
(2) to ensure the continuity and sustainability of the Leadership Development Initiative within WHO, building upon the strong beginnings already realized, and establishing other appropriate mechanisms so that it becomes an integral part of WHO's support for the Health for All Strategy, at all levels; (3) to support the efforts of Member States, educational institutions and nongovernmental organizations in their endeavours to develop leadership to accelerate social and political action towards health for all through primary health care and encourage the use of WHO resources, particularly fellowships, for leadership development; (4) to establish and foster a technical resource network drawn from educational institutions, and health leaders, to provide support to health for all ·and leadership development;
WHA41.26 page 3 (5) to promote and encourage leadership potential through documenting and disseminating information on successful and innovative initiatives in primary health care, through creating incentives such as awards and recognition for such endeavours, and provide simplified and relevant documentation for lay people and community leadership; (6) to evaluate the impact of the leadership development initiative in implementing the Global Strategy . for Health for All in conjunction with the second evaluation of the Strategy in 1991, and to report thereon to the eighty-ninth session of the Executive Board and the Forty-fifth World Health Assembly in 1992.
Fifteenth plenary meeting, 13 May 1988 A41/VR/15
WHA41.26 page 4 Annex 1 DECLARATION OF PERSONAL COMMITMENT We, the participants at the Technical Discussions on "Leadership Development for Health for All" (held in Geneva on 5-7 May 1988, during the Forty-First World Health Assembly), representing people from many walks of life, including governments, nongovernmental organizations, universities, educational institutions, voluntary agencies, United Nations agencies, make the following declaration: I. We believe that :
There is a need for greater concern and commitment to achieve the goal of Health for All by the Year 2000 through primary health care, among political, professional and community leaders; Building self-reliance and leadership capabilities at local level is the most important ingredient for sustained development and progress in health; The development of leadership that can be sustained as a continuing process at all levels is an important strategy to mobilize greater social and political commitment for the total Health-for-All movement. II. We therefore commit ourselves and urge others in leadership and other strategic positions to adopt the following Five-point Personal A~enda for Action: 1. To inform ourselves, our colleagues, fellow-workers, community members and others about the fundamental values, principles and processes to achieve Health for All by the Year 2000 through primary health care, and to ~enerate a social conscience in people to the health conditions and needs of the under-served, socially deprived and vulnerable population groups; 2. To make a serious review of progress towards the specific targets set in our respective countries, to identify where the critical needs and gaps are, and to provide leadership in identifying and implementing corrective actions; 3. To serve as prime movers for change, particularly in areas which fall within our respective roles, and to motivate others to accelerate the changes required in order to achieve the goal of Health for All; 4. To develop and promote partnerships and new alliances of support for health, including the professional associations, institutions of higher education, religious leaders, people's organizations, concerned nongovernmental organizations and individuals, philanthropic groups, the private sector and the media; 5. To promote self-reliance and enable others, particularly within the home and community level, to take greater responsibility for their own health and the health of their communities, through informing and educating them and developing their leadership potential. III. We are convinced that additional courageous and innovative strategies and tactics will be needed to ensure that all people of the world will be covered by primary health care. Leadership development is one such strategy which provides new opportunities to inform and communicate, to expand partnerships among people - people who are empowered and motivated - who then take on new responsibilities for their health, the health of their families and of their communities.
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 12 THE ROLE OF EPIDEMIOLOGY IN ATTAINING HEALTH FOR ALL
WHA41.27 13 May 1988
The Forty-first World Health Assembly, Noting the importance of epidemiology as a tool for the formulation of rational health policy; Recognizing the essential role of epidemiology not only in studying the causes and means of prevention of disease but also in health systems research, information support, technology assessment, and the management and evaluation of health services; Recalling that the role of epidemiology in the work of WHO has for many years been emphasized by the World Health Assembly; Emphasizing the needs of Member States for relevant epidemiological input in preparing and updating their health-for-all strategies, defining related targets and monitoring and evaluating their attainment; Noting with concern the discrepancy between the content of training in epidemiology in most schools of medicine, public health and other health sciences and the needs of Member States; Encouraged by the interest shown by epidemiologists and their associations including the International Epidemiological Association in promoting the broader view of epidemiology encompassing consideration of economic, social, cultural and other factors relevant to contemporary health problems, and in promoting related training; 1. URGES Member States to make greater use of epidemiological data, concepts and m6thods in preparing, updating, monitoring and evaluating their health-for-all strategies; 2. APPEALS to schools of medicine, public health and other health sciences to ensure training in modern epidemiology that is relevant to countries' needs regarding their health-for-all strategies and, in particular, the needs of developing countries; 3 WELCOMES the involvement and willingness of many epidemiologists around the world to collaborate with WHO in promoting new trends in epidemiology and related training; 4. REQUESTS the Director-General: (1) to convene as soon as possible a group of experts including adequate representation from developing countries to define the desired nature and scope of epidemiology in support of health-for-all strategies and related training in the expanded role of epidemiology;
Fifteerithplenary' meeting, 13 May 1988 A41/VR/15
FORTY-FIRST WORLD HEALTH ASSEMBLY Agenda item 12 GLOBAL ERADICATION OF POLIOMYELITIS. BY THE YEAR 2000 The Forty-first World Health. Assembly,
W}li\4.1. 28 13 May 1988
Appreciating the rapid progress beingachieved by the Expanded PrograiJif!le on Immunization, as evidenced by coverage for a third dose of . poliomyelitis, or, diphtheria/pertussis/tetanus vaccines of over 50% of children under the age of one year in developing c.o untriE!s, ~1s well as by the prevention of t}1e death of more than ,one million children from measles, • . FE!<:>natal tetanus or pertuss~~ and the prE!vention of the cr,ipp1ing of nearly 200 000 children througl1 poliomyelitis .. annually in these countries; Confident that these coverage rates will continue to rise rapidly and be sustained, in pursuit of the goal endorsed by the Thirtieth World Health Assembly in 1977 (resolution WHA30.53) - the provision of immunization for all children of the world by 1990 - and will lead to . further marked reductions in the incidence of most of the target di.seases; . 1. ' . . . . .
Aware that poliomyelitis is the target disease most amenable to global eradication, and that regional eradication goals by or before the year 2000 have already been. set in the Regions of the Americas, Europe and the Western Pacifie; Recognizing., that, the global eradiiatior .of poliOJnyefitis . by the year 2000, a ·goal cited in the Declaration of Talloires, represents both a fitting ,, challenge to be updertaken no~, · on the Organization's fortieth anniversary, and an appropriate gift, toge.ther with the.eradication of sm4llpox, from thetwent;ieth to thE! , twenty-first century; Noting:. (1) that achievement of the goal will depend on t}1e political will . of countries and the investment of adequate human and financial resources; (2) that this achievement will be facilitated by the c 0 ntinued strengthening. of the Expanded Programme on Immunization within the. context of primary health care and by impro:ving current poliomyelitis vaccines and clinical andlaboratory surveillance; (3) . yhat ,efforts to eradicate. poliomyE!l~tis serve to strengthen other immunization and health services, especialiy those for women and children;
1 See document A41/10 Add.l: Collaboration within the United Nations System General Matters: International collaboration· for · child survival and development .
WHA41.28 page 2
1. DECLARES the commitment of WHO to the global eradication of poli.omyelh:is by the year. 2000.; 2.. . EMPHAs r.zEs . t:~~t ...~• ~.~tits~t\gg · ett:~rr~\'~?~.~~~ ..-~f R~E~¥~? ·rn r~~t~ Jwhcf.•~? ~57'~.~~.then .. the development of the Expande'& Progratiune oti Inilfiunizatiott as A whole; fostering its' contribution, in turn, to the development of the health infrastructure and of primary health care; 3. INVITES Member States which have covered at least 70% of their target populations with a protective course of poliomyelitis vaccine, and which continue to have cases of poliomyelitis, to formulate plans for the elimination of the indigenous transmission of wild poliomyelitis viruses in ways which strengthen and sustain their national immunization programmes; 4. ENCOURAGES Member States which have not yet attained a 70% coverage rate to accelerate their efforts so as to surpass this level as quickly as possible through means which also improve and sustain the coverage for' the other vaccines included torithiri the national immunization programme; 5.
REQUESTS Member State's which have confirmed the absence of the indigenous · transmission of wild poliomyelitis viruses to sustain their success and to offer their technic'a l expertise, their · resources and support to countries stili working to achieve this goal; URGES ali Member States: (1) to intensify surveillance to ensure prompt identification and investigation of cases of poliomyelitis and control of outbreaks and accurate and timely reporting of cases at national and international levels; (2) to make all possible efforts to permit the rehabilitation of as many as possible of the children who still become disabled by poliomyelitis;
6.
7. THANKS · the many partners already collaborating in the Expanded Programme on Immunization (includingthe United Nations ·agencies, multilateral and bilateral development agencies, private and voluntary groups and concerned individuals), ~specially UNICEF for its overall efforts and ' Rotary International for its Polio-Plus initiative, and requests them to continue to work together in support of national immunization programmes, including activities aimed at the eradication of poliomyelitis, and to ensure that adequate resources are available to accelerate and sustain these programmes; 8. REQUESTS the Director-General: (1) to strengthen the technical capacities of WHO in order to be able to respond better to requests from government~ · for collaboration iri: (a) strehgth~ning planning, training and superVi~ion wi~hin national immunization programmes and undertaking country-specific evaluation to facilitate tortective action to~ards achieving this goal in countries with coverage of less than 70%; (b) improving programme monitoring and evaluation at national, regional and global levels; (c) improving national disease surveillance systems to permit the rapid control of outbreaks and the investigation and confirmation of clinical diagno~es of poliomyelitis through serological and virus isolation techniques;
\ ')
WHA41.28 page 3 (d) (e) strengthening clinical laboratory services; improving the quality control and production of vaccines;
(2) to pursue efforts to promote the development and application of new vaccines, other new technologies and knowledge which will help to achieve the eradication goal; (3) to seek from extrabudgetary contributions the additional resources required to support these activities; (4) to submit regular plans and reports of progress concerning th e poliomyelitis eradication effort through the Executive Board to the Health Assembly in the context of the progress being achieved by the Expanded Programme on Immunization.
Fifteenth plenary meeting, 13 May 1988 A41/VR/15
FORTY-FIRST WORLD HEALTH ASSEMBLY A~enda
WHA41.29 13 May 1988 WHO GUIDELINES FOR DERIVED INTERVENTION LEVELS
item 25 RADIONUCLIDES IN FOOD:
The Forty-first World Health Assembly, Having considered the report of the Director-General 1 on the work of WHO on guidelines for derived intervention levels concerning radioactive contamination of food; Concerned by the potential hazards to health due to contamination of the food supply with radionuclides; Recognizing the problem that such contamination poses to international trade in food; Aware that the action undertaken by national authorities to protect the public following the serious nuclear accident in 1986 varied widely and caused considerable public confusion and concern; Noting that most developing countries lack the means necessary for evaluation and control of radionuclide contamination of their environment and foodstuffs; 1. CALLS UPON Member States to utilize the WHO guidelines for derived intervention levels regaroing radionuclides in food when deve1op1ng their own plans and procedures for the protection of public health following accidental radioactive contamination of food supplies; 2. REQUESTS the Director-General: (1) to continue to cooperate with Member States in the development and strengthening of national capabilities for the protection of public health following radioactive contamination of food supplies, including the development of derived intervention levels regarding radionuclides in food on the basis of the recommendations contained in the WHO guidelines, and the monitoring of food supplies; (2) to provide support through WHO collaborating centres to Member States in case of radiological emergencies and in the preparation of plans and procedures for dealing with such emergencies;
1 Document EB8ljl988/REC/l, Annex 11.
WHA41. 29
page 2
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Fifteenth plenary meeting, 13 May 1988 A41/VR715