INDEXED
An addendum to document E B 5 7 / 3 , c o n t a i n i n g the D i r e c t o r - G e n e r a l 's r e p o r t on f u r t h e r E x p e r t Committee m e e t i n g s , for which the r e p o r t s w i l l be r e a d y i n p r i n t i n E n g l i s h and F r e n c h by the end o f November, w i l l be d e s p a t c h e d to Members o f the E x e c u t i v e Board at the b e g i n n i n g o f December.
^ ^ ^ ^ ORGANISATION M O N D I A L E D E L
EXECUTIVE BOARD
F i f t y - s e v e n t h S e s s i o n P r o v i s i o n a l a g e n d a i t e m 4
REPORT ON EXPERT COMMITTEE MEETINGS Report of the Director-General
INTRODUCTION
In compliance with paragraph 10.6 of the Regulations for Expert Advisory Panels and Committees， the Director-General submits herewith his report on expert committee meetings.
At its fifty-sixth session the Board decided to postpone until the current session the discussion of the report on expert committee meetings then before i t a s the late distribution of that report did not give the Board time to consider it in sufficient depth. The present report, therefore, includes the contents of that report. It now reviews eight expert committee meetings, for which the reports have become available in English and French since the fifty-fifth session of the Board.^
Following a suggestion made by the Executive Board at its fifty-fifth session, when discussing the Director-General‘s report on expert committee m e e t i n g s s h o r t comments have been added, when appropriate, under the relevant sections.
I t is realized that this is only a first step towards assessing expert committee meetings.
Efforts w i l l be made to improve this evaluation for future Board sessions.
The eight meetings and their reports are reviewed hereunder in the following order:
1. SERVICES FOR CARDIOVASCULAR EMERGENCIES Report of a WHO Expert Committee
2. ECOLOGY AND CONTROL OF VECTORS IN PUBLIC HEALTH
Twenty-first Report of the WHO Expert Committee on Insecticides 3. ORGANIZATION OF MENTAL HEALTH SERVICES IN DEVELOPING COUNTRIES
Sixteenth Report of the WHO Expert Committee on Mental Health
4. WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Twenty-fifth Report
5. EVALUATION OF FAMILY PIANNING IN HEALTH SERVICES Report of a WHO Expert Committee
1 WHO Basic Documents, 25th e d . , 1975， p. 93.
2
Document EB56/5.3
For easy reference, copies of these eight reports are annexed to this document (for members of the Executive Board only).
4 WHO O f f i c i a l Records, No. 224, 1975, pp. 6-15, document EB55/4.
6 . P E S T I C I D E RESIDUES IN FOOD
R e p o r t o f the 1 9 7 4 J o i n t Meeting o f t h e FAO Working P a r t y o f E x p e r t s on P e s t i c i d e R e s i d u e s and the WHO E x p e r t Committee on P e s t i c i d e R e s i d u e s
7 . SMOKING AND I T S EFFECTS ON HEALTH R e p o r t o f a WHO E x p e r t Committee
8 . WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION T w e n t y - s i x t h R e p o r t
1 . SERVICES FOR CARDIOVASCUIAR EMERGENCIES R e p o r t of a WHO E x p e r t Committee
G e n e v a , 2 2 - 3 0 A p r i l 1 9 7 41
1 . 1 Background i n f o r m a t i o n
V a r i o u s WHO b o d i e s h a v e a l r e a d y d i s c u s s e d c e r t a i n a s p e c t s o f c a r d i o v a s c u l a r e m e r g e n c i e s a s w e l l a s o t h e r e m e r g e n c i e s o c c u r r i n g i n t h e community. The a i m o f t h e p r e s e n t Committee was to p r o v i d e g u i d e l i n e s f o r e s t a b l i s h i n g or promoting s e r v i c e s f o r c a r d i o v a s c u l a r
e m e r g e n c i e s i n the l i g h t o f c u r r e n t knowledge and e x p e r i e n c e , and a l s o to d e f i n e methods o f p r e v e n t i n g c a r d i o v a s c u l a r e m e r g e n c i e s , whenever p o s s i b l e .
R e c e n t i n f o r m a t i o n from a WHO p r o j e c t f o r t h e r e g i s t r a t i o n o f a c u t e i s c h a e m i c h e a r t d i s e a s e i n the community has shown t h a t the problem i s v e r y e x t e n s i v e . I t h a s a l s o shown t h a t t h e sequence o f e v e n t s i n a c u t e m y o c a r d i a l i n f a r c t i o n i s much more d r a m a t i c t h a n was thought e a r l i e r when o n l y h o s p i t a l s t a t i s t i c s were a v a i l a b l e . On the o t h e r hand3 t h e h e a l t h s e r v i c e s d i d not seem i n many p l a c e s to cope a d e q u a t e l y w i t h the t a s k s t h e y were c o n f r o n t e d w i t h . A c u t e m y o c a r d i a l i n f a r c t i o n , though c e r t a i n l y a c a r d i o v a s c u l a r emergency o f l e a d i n g i m p o r t a n c e , i s o n l y one o f a l a r g e group o f c o n d i t i o n s t h a t i n c l u d e s , f o r example, s t r o k e ^ pulmonary embolism, h y p e r t e n s i v e c r i s e s , v a r i o u s d y s r h y t h m i a s and trauma o f t h e h e a r t . T h e r e i s thus a d e f i n i t e need f o r emergency c a r e o f c a r d i o v a s c u l a r p a t i e n t s a n d i t i s p o s t u l a t e d t h a t a s u b s t a n t i a l number o f l i v e s c o u l d be s a v e d by e s t a b l i s h i n g e f f i c i e n t c a r d i o v a s c u l a r emergency s e r v i c e s , and even more by promoting p r e v e n t i v e a p p r o a c h e s . 1 . 2 The r e p o r t
U s i n g u p - t o - d a t e e p i d e m i o l o g i c a l e v i d e n c e , t h e Committee r e v i e w e d t h e e x t e n t o f the problem. N a t i o n a l3 r e g i o n a l and l o c a l needs f o r emergency c a r e o b v i o u s l y v a r y , among o t h e r r e a s o n s a c c o r d i n g to the a b s o l u t e and r e l a t i v e f r e q u e n c y o f t h e c o n d i t i o n s p r e s e n t i n g a s e m e r g e n c i e s . A l t h o u g h r e l i a b l e e p i d e m i o l o g i c a l d a t a a r e d e s i r a b l e f o r d e s i g n i n g a n emergency c a r e s e r v i c e i n a p a r t i c u l a r community, t h e Committee c o n s i d e r s t h a t t h e
e s t a b l i s h m e n t o f s u c h s e r v i c e s s h o u l d n o t be d e f e r r e d b e c a u s e of l a c k o f d a t a b u t t h a t an i n f o r m a t i o n system s h o u l d be b u i l t i n t o t h e emergency s e r v i c e s . A s e x p e r i e n c e i s g a i n e d , t h e s e r v i c e s c a n be improved.
T h e Committee d i s c u s s e d t h e most a p p r o p r i a t e measures to be u n d e r t a k e n i n v a r i o u s c a r d i o v a s c u l a r emergency s i t u a t i o n s p a y i n g p a r t i c u l a r a t t e n t i o n to t h e o r g a n i z a t i o n a l , e d u c a t i o n a l and p r e v e n t i v e a s p e c t s . I t h a s been p o i n t e d out t h a t c a r d i o v a s c u l a r emergency s e r v i c e s must be v i e w e d a s a system t h a t r e s p o n d s to an a c u t e need f o r h e l p by p r o v i d i n g f a s t and e f f e c t i v e a c t i o n , and t h a t i t i s i t s e l f p a r t o f an o v e r a l l h e a l t h c a r e s y s t e m .
P r o t o t y p e s f o r d i f f e r e n t k i n d s o f c a r d i o v a s c u l a r emergency s e r v i c e systems e x i s t i n v a r i o u s c o u n t r i e s . C l e a r l y3 t h e s y s t e m c a n o n l y be f u l l y e f f e c t i v e i f a l l i t s l i n k s f u n c t i o n o p t i m a l l y� Means to a c h i e v e t h i s v a r y w i t h t h e demographic, s o c i o e c o n o m i c and c u l t u r a l s i t u a t i o n s and w i t h t h e way i n w h i c h m e d i c a l c a r e i s p r o v i d e d i n t h e community.
1
WHO Technical Report Series, No. 562, 1975.
The r e p o r t p o i n t s to t h e n e e d f o r f u r t h e r e x p e r i e n c e a n d r e s e a r c h i n c e r t a i n a r e a s . F i r m a n s w e r s to a l l t h e q u e s t i o n s i n t h i s f i e l d a r e o b v i o u s l y n o t p o s s i b l e ; y e t t h e p r o b l e m i n many p a r t s o f t h e w o r l d i s so g r e a t t h a t a c t i o n i s recommended now on t h e b a s i s o f t h e b e s t
k n o w l e d g e a v a i l a b l e .
Some m e a s u r e s , e s p e c i a l l y t h o s e u s i n g a d v a n c e d t e c h n o l o g y , a r e c o s t l y . O t h e r s , s u c h a s e d u c a t i o n or c o o r d i n a t i o n o f e x i s t i n g s e r v i c e s , may h a v e a g r e a t i m p a c t on t h e improvement o f h e a l t h c a r e a n d y e t do n o t s i g n i f i c a n t l y compete f o r f u n d s w i t h o t h e r h e a l t h n e e d s . T h e C o m m i t t e e e m p h a s i z e d t h a t t h e s e c o n s i d e r a t i o n s s h o u l d be t a k e n i n t o a c c o u n t , p a r t i c u l a r l y s i n c e d i f f e r e n t c o m m u n i t i e s h a v e w i d e l y d i f f e r i n g n e e d s a n d r e s o u r c e s .
1 . 3 T h e r e c o m m e n d a t i o n s
T h e Committee recommends t h a t emergency s e r v i c e s s h o u l d be t a i l o r e d to p a r t i c u l a r community n e e d s , r e s o u r c e s a n d l e v e l s o f p r o f e s s i o n a l t r a i n i n g o f h e a l t h p e r s o n n e l .
C o n t i n u o u s e v a l u a t i o n i s s u g g e s t e d i n o r d e r to e n s u r e improvements b a s e d on f e e d b a c k i n f o r m a t i o n .
A number o f more s p e c i f i c o r g a n i z a t i o n a l r e c o m m e n d a t i o n s a r e g i v e n a s w e l l , s u c h a s s i m p l e , e a s i l y remembered, n a t i o n a l l y u n i f o r m t e l e p h o n e numbers f o r emergency c a l l s， to w h i c h w i d e p u b l i c i t y s h o u l d be g i v e n . Recommendations a r e g i v e n a l s o on t h e p r e v e n t i v e and
c l i n i c a l a s p e c t s o f c a r d i o v a s c u l a r e m e r g e n c i e s and e m p h a s i s i s l a i d on b o t h p r o f e s s i o n a l a n d l a y e d u c a t i o n i n t h e p r e v e n t i o n , r e c o g n i t i o n a n d management o f c a r d i o v a s c u l a r e m e r g e n c i e s .
Comment： A c r i t i c a l a p p r a i s a l o f t h e r e c o m m e n d a t i o n s shows t h a t t h e y a r e m a i n l y a d d r e s s e d to c o m m u n i t i e s w i t h a d e f i n i t e p u b l i c h e a l t h b u r d e n o f c a r d i o v a s c u l a r
e m e r g e n c i e s a n d t h u s a r e n o t o f a u n i v e r s a l c h a r a c t e r . However, t h i s i s a l s o c l e a r l y s t a t e d i n t h e C o m m i t t e e ' s r e c o m m e n d a t i o n s , i n w h i c h i t " i s recommended t h a t emergency s e r v i c e s b e a p p r o p r i a t e f o r t h e p a r t i c u l a r n e e d s , r e s o u r c e s and a v a i l a b i l i t y o f t r a i n e d m e d i c a l a n d a u x i l i a r y h e a l t h p e r s o n n e l o f e a c h c o m m u n i t y " .
I t i s f e l t t h a t n o t enough a t t e n t i o n i s drawn to t h e l i m i t a t i o n s t h a t make t h e emergency s e r v i c e s l e s s e f f e c t i v e . E x p e r i e n c e shows t h a t , b e c a u s e o f t h e d e l a y i n r e c e i v i n g s k i l l e d m e d i c a l a t t e n t i o n ( w h i c h , i n t h e WHO m y o c a r d i a l i n f a r c t i o n r e g i s t e r s t u d y , i s on a v e r a g e one h o u r ) , i t i s v e r y d i f f i c u l t to i n f l u e n c e t h e g e n e r a l m o r t a l i t y from a c u t e m y o c a r d i a l i n f a r c t i o n i n t h e c o m m u n i t y , even w i t h s o p h i s t i c a t e d t r a n s p o r t a t i o n s y s t e m s . As i n g e n e r a l l y known, t h e h i g h e s t m o r t a l i t y r a t e from a c u t e m y o c a r d i a l
i n f a r c t i o n o c c u r s d u r i n g t h e f i r s t h o u r a f t e r t h e a t t a c k .
I t s h o u l d be s t r e s s e d t h a t some o f t h e r e c o m m e n d a t i o n s ( a s m e n t i o n e d u n d e r i t e m 30 on page 60 o f t h e r e p o r t ) may n e e d to be t r i e d o u t i n p r a c t i c e on a l i m i t e d s c a l e b e f o r e b e i n g i m p l e m e n t e d . T h i s a p p l i e s , f o r e x a m p l e , t o i n t r o d u c i n g a n i n t e r n a t i o n a l i d e n t i t y c a r d f o r p e r s o n s a t h i g h r i s k o f becoming a c a r d i o v a s c u l a r emergency.
1 . 4 I m p l i c a t i o n s f o r t h e O r g a n i z a t i o n ' s programme
The r e p o r t i s l i n k e d w i t h o t h e r p a r t s o f t h e O r g a n i z a t i o n1 s l o n g - t e r m programme f o r t h e c o n t r o l o f c a r d i o v a s c u l a r d i s e a s e s i n t h e community. I t c o v e r s t h e community a s p e c t s o f c a r e i n a c u t e e m e r g e n c i e s a n d t h e p a r t s d e a l i n g w i t h t h e p r e v e n t i o n o f e m e r g e n c i e s f i t i n t o t h e g e n e r a l p r o p h y l a c t i c t r e n d towards p r e v e n t i o n i n t h e c a r d i o v a s c u l a r programme a s a w h o l e . I t a l s o i n t e g r a t e s w e l l w i t h t h e O r g a n i z a t i o n ' s p r o s p e c t i v e programme on t h e c o m p r e h e n s i v e
c o n t r o l o f c a r d i o v a s c u l a r d i s e a s e s i n t h e community. T h u s3 i t w i l l be u s e f u l i n h e l p i n g t h e O r g a n i z a t i o n to a d v i s e and a s s i s t n a t i o n a l h e a l t h a u t h o r i t i e s i n t h e i r e f f o r t s to a c h i e v e c o n t r o l o f c a r d i o v a s c u l a r d i s e a s e s a t t h e community l e v e l .
2 . ECOLOGY AND CONTROL OF VECTORS IN PUBLIC HEALTH
Twenty-first report of the WHO Expert Committee on Insecticides Geneva 3 7-11 October 19741
2 . 1 Background information
The control or eradication of many widespread vector-borne diseases of man became a practical proposition with the advent of modern pesticides and new forms of application equipment in the years immediately following the Second World War. Insecticides enabled programmes to be undertaken to control the vectors of malaria, f i l a r i a s i s , dengue and leishmaniasis among others; the result in many of these programmes was an impressive
reduction in morbidity and mortality. However, a number of serious impediments have arisen in most disease vector control programmes； among them the development of vector resistance to i n s e c t i c i d e s , the limited number and high cost of alternative compounds to combat resistance, and the rapidly increasing cost and short supply of pesticides.
I n a d d i t i o n t o t h e t e c h n i c a l i m p e d i m e n t s l i s t e d a b o v e , a d m i n i s t r a t i v e a n d f i n a n c i a l d i f f i c u l t i e s and concern about the possible effects on the environment of the insecticides applied have acted as constraints to the progress of most current vector control operations.
The Expert Committee was convened to consider the various impediments, review technical progress and consider how improved methods and materials could be best used to overcome the above impediments.
2 . 2 The report
The Committee called for a better understanding of the ecology of the target species so as to enable more selective application of pesticides to be carried out with maximum impact.
Lack of trained personnel, especially professional, in the developing countries has seriously hampered the ability of these countries to organize programmes effectively against the
v e c t o r - b o r n e d i s e a s e s t h a t i n some c a s e s a r e among t h e i r m a i n p u b l i c h e a l t h p r o b l e m s . T h e Committee recognized that greater emphasis must be placed on the training of nationals in these countries so as to ensure efficient management and supervision of vector control operations.
L i t t l e a t t e n t i o n was g i v e n i n t h e p a s t to p r o j e c t c o s t s a n d to assessing t h e economic a s well as the health benefits of control programmes. The Committee stressed the need for a vigorous socioeconomic appraisal of future projects. This should include a cost/benefit analysis taking into consideration both classical pesticide-based vector control methods and alternative long-term solutions, including environmental improvement such as sewage disposal systems•
Information exchange has not been satisfactory as many of the public health workers in the developing countries who are most in need of information on new methods and materials are n o t r e c e i v i n g them. T h e C o m m i t t e e c o n s i d e r e d how t h e d i s s e m i n a t i o n o f t h i s i n f o r m a t i o n could be improved.
New developments in vector control techniques, including environmental control, chemical control, modern application techniques and genetic and biological control were reviewed to determine which could most effectively be applied to existing and planned programmes.
1 WHO Technical Report Series, No. 5 6 1 , 1975.
5•3 The recommendations
Among o t h e r s r e l a t e d to r e s e a r c h needs under v e c t o r c o n t r o l and t h e improvement o f o p e r a t i o n programmes the Committee made t h e f o l l o w i n g recommendations.
( a ) A systems a n a l y s i s approach to v e c t o r - b o r n e d i s e a s e s s h o u l d be d e v e l o p e d i n o r d e r t h a t a v a r i e t y o f s u p p r e s s i v e measures can be i n t e g r a t e d and t h e e f f e c t s o f changes o f s t r a t e g y a s s e s s e d .
(b) T h e r e s h o u l d be d e t a i l e d advanced p l a n n i n g o f a l l phases o f p r o j e c t e d v e c t o r c o n t r o l programmes and p i l o t programmes to s i m u l a t e a l l phases o f a l a r g e - s c a l e programme so t h a t any p o t e n t i a l weaknesses can be d e t e c t e d and d e a l t w i t h b e f o r e t h e i n i t i a t i o n o f a l a r g e - s c a l e campaign.
( c ) S y s t e m a t i c s t u d i e s s h o u l d be c a r r i e d out to e v a l u a t e t h e e f f e c t s of c o n t r o l a g e n t s and t e c h n i q u e s on the components and dynamics o f d i f f e r e n t e c o s y s t e m s .
(d) New v e c t o r c o n t r o l p r o j e c t s and programmes s h o u l d be s u b j e c t e d to r e a l i s t i c c o s t / b e n e f i t a n a l y s e s , i n c l u d i n g a p p r a i s a l of t h e m e r i t s and d e m e r i t s o f s o c i o e c o n o m i c changes a r i s i n g
from t h e t e c h n i q u e s employed and the r e s u l t s a c h i e v e d ,
(e) The world c h e m i c a l i n d u s t r y s h o u l d be encouraged by a l l a p p r o p r i a t e means to i n t e n s i f y i t s s e a r c h for new s e l e c t i v e i n s e c t i c i d e s , r o d e n t i c i d e s and m o l l u s c i c i d e s w i t h n o v e l modes o f a c t i o n .
( f ) S t r i n g e n t r e q u i r e m e n t s s h o u l d be developed for e v a l u a t i o n o f t h e s a f e t y of a l l proposed bio l o g i c a l , g e n e t i c a l and c h e m i c a l c o n t r o l a g e n t s .
(g) I n c r e a s e d and improved t r a i n i n g for v e c t o r c o n t r o l p e r s o n n e l o f a l l grades s h o u l d be supported and s c i e n t i s t s o f r e l a t e d d i s c i p l i n e s encouraged to p l a y a p a r t i n v e c t o r - b o r n e d i s e a s e problems.
(h) A more e f f i c i e n t and r a p i d means s h o u l d be d e v e l o p e d f o r t h e exchange o f t e c h n i c a l i n f o r m a t i o n on v e c t o r c o n t r o l programmes e s p e c i a l l y to f i e l d w o r k e r s .
( i ) E v e r y e f f o r t s h o u l d be made to s t r e n g t h e n r e s e a r c h on and t h e development o f n o n - c h e m i c a l methods of c o n t r o l w hi c h would be i n t e g r a t e d w i t h t h e u s e o f p e s t i c i d e s .
Comment: The above recommendations were made on t h e b a s i s o f e x t e n s i v e d i s c u s s i o n s by t h e group i n which members o f the S e c r e t a r i a t p a r t i c i p a t e d . They r e p r e s e n t t h e v i e w s o f some o f t h e w o r l d ' s foremost e x p e r t s i n t h e f i e l d , among them i n d i v i d u a l s who h a v e long been a s s o c i a t e d w i t h t h e WHO programme.
2 . 4 I m p l i c a t i o n s for t h e O r g a n i z a t i o n ' s programme
Steps have been taken to p r e p a r e and d i s s e m i n a t e a s e r i e s o f documents among r e g i o n a l o f f i c e s and WHO r e p r e s e n t a t i v e s d e a l i n g w i t h t h e b i o l o g y and c o n t r o l o f i n s e c t v e c t o r s and r o d e n t r e s e r v o i r s o f d i s e a s e . I n view o f t h e c o n c e r n o f t h i s E x p e r t Committee and p r e v i o u s groups t h a t have met, c l o s e s c r u t i n y has been g i v e n to a l l t h e p o s s i b l e b i o l o g i c a l , g e n e t i c and c h e m i c a l t e c h n i q u e s to e n s u r e t h e i r s a f e t y b o t h to man and to o t h e r n o n - t a r g e t o r g a n i s m s . An i n c r e a s i n g e f f o r t i s b e i n g made to encourage t h e c h e m i c a l i n d u s t r y to develop new
s e l e c t i v e and s a f e p e s t i c i d e compounds u n l i k e l y to h a v e c r o s s - r e s i s t a n c e to p r e v i o u s l y e x i s t i n g compounds.
3. ORGANIZATION OF MENTAL HEALTH SERVICES IN DEVELOPING COUNTRIES Sixteenth Report of the WHO Expert Committee on Mental Health Genevaд 22-28 October 19741
3 . 1 Background information
T h e r e h a v e b e e n s u b s t a n t i a l a d v a n c e s i n t h e management o f m e n t a l i l l n e s s d u r i n g t h e p a s t 25 years. As a result effective methods of treatment are now available that modify the course and improve the prognosis of most mental disorders. It is now realized that mental disorders constitute a major public health problem in a l l parts of the world, but in the
developing countries effective mental health care exists only on a very limited scale. This has led to increasing concern with the question of delivery of mental health services, which has been reflected in several WHO a c t i v i t i e s . Since 1971 WHO regional offices have held a seminar on the organization and future needs of mental health services, New D e l h i , February 1971, a seminar on community action for mental health care. Bangalore， India, October 1973, an interregional seminar on the organization of mental health services, Addis Ababa, November 1973, and technical discussions at the Regional Committee for A f r i c a ,
September 1973.
The Expert Committee was convened to consider the reasons for the failure to provide adequate mental health care in developing countries and to advise how services could be organized to provide such care effectively with wide coverage and at low cost.
Comment: The value of the Expert Committee meeting was undoubtedly increased by deciding to narrow the focus of its work and concentrate on the organization of mental health studies in developing countries. This decision involved a change in the Committeefs t i t l e from that originally approved, in which developing countries were not mentioned.
This i n i t i a t i v e was taken in response to comments made by members of the Executive Board at its fifty-first session.^
3 . 2 The report
T h e C o m m i t t e e b e g a n w i t h two b a s i c a s s u m p t i o n s :
( i ) mental health cannot be considered in isolation from the wider problems of public health; and
( i i ) the planning of mental health services should take place in the context of overall country health planning.
Evidence on the prevalence and consequences of mental disorders was reviewed and it was concluded that such disorders constitute a major public health problem responsible for a considerable proportion of serious d i s a b i l i t i e s . Particular attention was drawn to:
- the adverse effects of untreated mental illness on the family working l i f e , farming efficiency and child care
- the importance of childhood disorders in educational failure, delinquency and long-term handicap
- the significant number of patients attending a l l curative services suffering from psychiatric disorders (often with somatic symptoms), mismanagement of which has adverse effects on both the patients and the service.
1 WHO Technical Report S e r i e s , No. 5 6 4 , 1975.
2 WHO O f f i c i a l Records3 No. 2 0 7 , 1973, p. 16.
V e r y few p s y c h i a t r i s t s and p s y c h i a t r i c n u r s e s a r e a v a i l a b l e i n d e v e l o p i n g c o u n t r i e s . I n many c o u n t r i e s a c e n t r a l i z e d c u s t o d i a l m e n t a l h o s p i t a l i s the o n l y p s y c h i a t r i c f a c i l i t y and
copes m a i n l y w i t h p a t i e n t s who d i d not r e c e i v e e f f e c t i v e treatment i n the e a r l y s t a g e s o f t h e i r i l l n e s s . N e g a t i v e a t t i t u d e s to m e n t a l h e a l t h a r e w i d e s p r e a d among both t h e p u b l i c and h e a l t h w o r k e r s , and a r e u n l i k e l y to change u n t i l e f f e c t i v e m e n t a l h e a l t h c a r e i s e s t a b l i s h e d . The Committee t h e r e f o r e c o n s i d e r e d t h e s t e p s t h a t s h o u l d be taken to i n t e g r a t e m e n t a l h e a l t h c a r e i n t o t h e g e n e r a l h e a l t h s e r v i c e s , to d e c e n t r a l i z e t h e m e n t a l h e a l t h s e r v i c e s and to p r o v i d e c a r e i n the community. The c r u c i a l element i n t h i s p r o c e s s w i l l be t h e s h a r i n g o f m e n t a l h e a l t h t a s k s by a wide r a n g e o f h e a l t h workers and o t h e r s , and t h e r e i s t h e r e f o r e s p e c i a l
emphasis i n the r e p o r t on t r a i n i n g n e e d s . The i n v o l v e m e n t o f b a s i c h e a l t h w o r k e r s ,
t r a d i t i o n a l h e a l e r s and n o n - m e d i c a l community workers ( s u c h a s t e a c h e r s and t h e p o l i c e ) i n m e n t a l h e a l t h c a r e i s d i s c u s s e d i n d e t a i l .
3 . 3 The recommendations
T h e r e s h o u l d be i n c r e a s e d and w e l l p l a n n e d e f f o r t s to a p p l y e f f e c t i v e methods o f t r e a t m e n t f o r m e n t a l d i s o r d e r s . H i g h p r i o r i t y s h o u l d be g i v e n to ( a ) t h e management o f p s y c h i a t r i c emergenciess ( b ) t r e a t m e n t f o r t h o s e w i t h s e v e r e p s y c h o t i c d i s o r d e r s , a s f a r a s p o s s i b l e i n t h e community, ( c ) i n t e r v e n t i o n s to p r e v e n t d i s a b i l i t y i n e p i l e p s y , m e n t a l r e t a r d a t i o n and o r g a n i c b r a i n d i s e a s e s , (d) t h e r e c o g n i t i o n and a p p r o p r i a t e management o f m e n t a l h e a l t h problems p r e s e n t i n g a t h e a l t h c e n t r e s and g e n e r a l c l i n i c s , and ( e ) the problems o f h i g h r i s k groups such a s homeless c h i l d r e n , r e f u g e e s and t h o s e w i t h c h r o n i c p h y s i c a l d i s e a s e .
C l e a r l y d e f i n e d and r e a l i s t i c o b j e c t i v e s on m e n t a l h e a l t h s h o u l d be f o r m u l a t e d i n each c o u n t r y a s p a r t of a n a t i o n a l h e a l t h p o l i c y . E a c h n a t i o n a l or r e g i o n a l h e a l t h a d m i n i s t r a t i o n s h o u l d i n c l u d e a m e n t a l h e a l t h u n i t . S e r v i c e s s h o u l d be d e c e n t r a l i z e d and p s y c h i a t r i c
treatment ( o u t - p a t i e n t and i n - p a t i e n t ) s h o u l d be a v a i l a b l e i n d i s t r i c t h o s p i t a l s . B a s i c m e n t a l h e a l t h c a r e , i n c l u d i n g t h e r e c o g n i t i o n o f emergencies and the f o l l o w up o f c h r o n i c p a t i e n t s , s h o u l d be i n c l u d e d i n t h e work o f p r i m a r y h e a l t h w o r k e r s . T r a i n i n g o f h e a l t h worker s i n m e n t a l h e a l t h s h o u l d be o r i e n t e d to t h e t a s k s t h e y a r e expected to p e r f o r m , which
s h o u l d be c l e a r l y d e f i n e d . P s y c h i a t r i c n u r s e s and p s y c h i a t r i s t s s h o u l d p l a y a s u p e r v i s o r y and s u p p o r t i v e r o l e and be a c t i v e l y i n v o l v e d i n t h e p l a n n i n g and a d m i n i s t r a t i o n o f s e r v i c e s • S i m p l e and u s a b l e m e n t a l h e a l t h s t a t i s t i c s s h o u l d be c o l l e c t e d from a l l p a r t s o f t h e h e á l t h s e r v i c e s . R e l e v a n t r e s e a r c h i n m e n t a l h e a l t h s h o u l d be encouraged by t h e e s t a b l i s h m e n t o f r e s e a r c h c e n t r e s i n d e v e l o p i n g c o u n t r i e s w i t h h i g h s t a n d a r d s and o f f e r i n g t r a i n i n g i n r e s e a r c h methods.
Comment: The recommendations c o n c e r n i n g t h e a v a i l a b i l i t y o f mental h e a l t h a d v i c e i n h e a l t h m i n i s t r i e s i n d i c a t e t h e need f o r f u r t h e r c o n s i d e r a t i o n o f mechanisms for such a d v i c e i n d i f f e r e n t m i n i s t r i e s and a t v a r i o u s a d m i n i s t r a t i v e l e v e l s . Mental h e a l t h i s s u e s r e l a t i n g to e d u c a t i o n ( f o r example, t h e problem o f e d u c a t i o n a l f a i l u r e ) , s o c i a l w e l f a r e , n u t r i t i o n and s o c i a l and economic p l a n n i n g have not been d e a l t w i t h i n any
^ d e t a i l i n t h i s r e p o r t ; i n view o f t h e i r g r e a t importance to d e v e l o p i n g c o u n t r i e s , t h e r e i s a need for new methods for c o o r d i n a t i n g a d v i c e i n t h e s e a r e a s .
3 . 4 I m p l i c a t i o n s f o r the O r g a n i z a t i o n ' s programme
The r e p o r t p r o v i d e s g u i d a n c e f o r f u t u r e WHO a c t i v i t y i n the f i e l d o f m e n t a l h e a l t h s e r v i c e s . T h e r e i s a need for model t r a i n i n g programmes and s i m p l e manuals to be developed and for i n t e r n a t i o n a l c o l l a b o r a t i o n i n e v a l u a t i v e s t u d i e s o f a l t e r n a t i v e approaches to mental h e a l t h c a r e . Such s t u d i e s would r e q u i r e s t a n d a r d i z e d methods for c a s e d e t e c t i o n and
assessment o f s o c i a l f u n c t i o n . WHO s h o u l d develop i t s t r a i n i n g a c t i v i t i e s i n the f i e l d s o f t e a c h i n g methods, a d m i n i s t r a t i o n and d a t a c o l l e c t i o n through seminars and f e l l o w s h i p s .
C r i t e r i a and g u i d e l i n e s s h o u l d be e s t a b l i s h e d for t h e a p p r o p r i a t e use of p s y c h o t r o p i c d r u g s , and g u i d e l i n e s reviewed and p u b l i s h e d i n p r e p a r a t i o n f o r m e n t a l h e a l t h l e g i s l a t i o n .
Comment： The recommendations r e l a t i n g to mental health care at community level are e x p l i c i t and far-reaching. The great emphasis placed on the integration of mental health into the general health services and on the mobilization of community resources involves a significant shift from previous p o l i c i e s , and the definition of priority areas in public health terms is seen as most u s e f u l . The Committee could not consider in d e t a i l a l l the implications of these recommendations in terms of administrative structure and training requirements； there is a need for further work by WHO in this area.
4 . WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS T w e n t y - f i f t h R e p o r t
Geneva. 4-9 November 1 9 7 41
4 . 1 Background information
The present report is the twenty-fifth of a series dealing with various aspects of the quality control of drugs。 The majority of previous reports dealt with the efforts directed toward the establishment and improvement of recommended international specifications for the identity and purity of drugs. These efforts resulted in the publication of two editions of the International Pharmacopoeia (second edition in 1 9 6 8 ) , and of a supplement to the second edition in 1971.
Starting with the twenty-second report, the Expert Committee on Specifications for Pharmaceutical Preparations has taken up another important aspect of the quality control of drugs. This is the establishment of requirements for "Good Practices in the Manufacture and Quality Control of Drugs". A document containing these requirements was proposed in 1968 in the twenty-second report and adopted by the Twenty-second World Health Assembly in
resolution WHA22.50.
The Twenty-third World Health Assembly, in resolution WHA23.453 requested the Director-General to continue to review the requirements in the light of the information obtained. In its twenty-fourth report, the Expert Committee on Specifications for Pharmaceutical Preparations after receiving comments from Member States, proposed textual revisions and alterations to the requirements for "Good Practices in the Manufacture and Quality Control of Drugs". The revised text was circulated in January 1974 to a l l Member States for further comments. At this stage comments were received from some 40 Member States, including the majority of countries that manufacture drugs for export.
In resolution WHA17.41, the Seventeenth World Health Assembly invited Member States to consider the f e a s i b i l i t y of ensuring that drugs which are exported comply with the same drug control requirements as apply to drugs for domestic use. The underlying idea was to use the control f a c i l i t i e s and inspection system of health authorities in developed countries that export drugs to ensure the adequate quality of drugs imported by developing countries. This idea evolved further into a proposed " C e r t i f i c a t i o n Scheme on the Quality of Pharmaceutical Products moving in International Commerce" which was adopted by the Twenty-second World Health Assembly in resolution WHA22.50. A revised text of the Scheme was circulated in January 1974 to a l l Member States and the comments were received together with those on the revised text of
"Good Practices in the Manufacture and Quality Control of Drugs".
4 . 2 The report
The Committee took into consideration a l l the comments made on the last version of the requirements for "Good Practices in the Manufacture and Quality Control of Drugs" and noted that although no new points of principle were involved, there were several recommendations for changes in the text. Due note was taken of comments that revealed ambiguities or vagueness in the text that might lead to misunderstandings, and suitable corrections were proposed. I t
1 WHO Technical Report S e r i e s , No. 5 6 7 , 1975.
was considered necessary to define more clearly the role of the quality control laboratory of the manufacturer. It was also recommended that a formal act of release of batches by the quality control department should be mandatory instead of an informal release linked solely to the analytical report. The revised text is attached to the report as Annex I .
T h e C o m m i t t e e a l s o c o n s i d e r e d t h e comments r e c e i v e d i n r e s p e c t o f t h e " C e r t i f i c a t i o n Scheme on t h e Q u a l i t y o f P h a r m a c e u t i c a l P r o d u c t s moving i n I n t e r n a t i o n a l Commerce". I t was noted that substantial changes have to be made in the Scheme in order to distinguish more clearly between the general certificate of pharmaceutical products and the issue of batch certificates.
I t was r e a l i z e d t h a t t h e l e g i s l a t i o n i n f o r c e i n some Member S t a t e s may l e a d them t o h a v e reservations regarding their participation in the Scheme and that this has to be recognized by suitable additions. It was also considered necessary to revise the specimen certificate to recognize that "authorization11 for placing on the market is not necessarily accompanied by the issue of permits. The revised text is attached to the report as Annex I .
T h e C o m m i t t e e d i s c u s s e d f u r t h e r work on t h e I n t e r n a t i o n a l P h a r m a c o p o e i a , a n d i n p a r t i c u l a r procedures which, in accordance with resolution WHA20.34, should produce an increased flow of specifications for international acceptance. The Committee considered that specifications should be developed primarily in respect of pharmaceutical raw materials, comprising both active and inactive ingredients, as well as general methods and tests necessary to support such specifications. When adequate consultations have been carried out amongst members of t h e E x p e r t A d v i s o r y P a n e l , P h a r m a c o p o e i a C o m m i s s i o n s a n d o t h e r a p p r o p r i a t e i n t e r e s t e d p a r t i e s , the specifications should then be published.
The Committee considered the reports from the WHO Collaborating Centre for Chemical Reference Substances for 1971, 1972 and 1973, and noted that 24 new chemical reference
substances have been established in that period and a number of existing chemical reference substances replaced by new batches. The Committee also discussed general guidelines for the establishment, maintenance, and distribution of chemical reference substances, as well as means of promoting an effective exchange of information and ensuring collaboration between
organizations establishing reference substances. The text of the guidelines is attached to the report as Annex I I I .
The Committee considered the revised text of Appendix 13, "Radioactivity1 1, of the I n t e r n a t i o n a l P h a r m a c o p o e i a , t h e r e v i s e d t e x t s o f a l l e x i s t i n g monographs on r a d i o a c t i v e pharmaceuticals, and specifications for five new radioactive agents, which are attached to the report as Annex I I . It was noted that the revision and the work on new monographs were carried out in collaboration by a number of institutions engaged in studies on radioactive pharmaceuticals, consultation taking place with appropriate experts and with the International Atomic Energy Agency.
T h e C o m m i t t e e e x a m i n e d a s t u d y made o f i n f o r m a t i o n a n d d a t a a v a i l a b l e on t h e s u i t a b i l i t y of plastics as materials for containers for drugs, and noted that, because of a wide variety of container types, it was necessary to select certain categories for i n i t i a l attention.
Provisional requirements for plastic containers for pharmaceuticals were therefore agreed upon with a view to seeking comments among specialists in this f i e l d . The text of these
requirements is attached to the report as Annex IV.
In accordance with the request made in the course of the f e a s i b i l i t y study on an International Information System on the Registration of Drugs, the Committee examined the pharmaceutical aspects of drug evaluation for registration. The Committee noted that the development of information on drugs is a cumulative process as the primary drug substance evoIves into a pharmaceutical preparation. The text of proposed principles of drug evaluation for registration is attached to the report as Annex V.
4.3 The recommendations
The Committee recommended：
( a ) A r e v i s e d text of the requirements for "Good Practices in the Manufacture and Quality Control o f Drugs" based on comments and proposals obtained from Member States. I t is
intended to submit the text to the World Health Assembly.
( b ) A r e v i s e d and amended text of the " C e r t i f i c a t i o n Scheme on the Quality of Pharmaceutical Products moving in I n t e r n a t i o n a l Commerce", based on comments and proposals obtained from Member S t a t e s . I t i s intended to submit the text to the World Health Assembly.
( c ) A procedure to be followed up for the development of a n a l y t i c a l control s p e c i f i c a t i o n s for drugs. These procedures lead to a more rapid publication of new specifications and of general methods and texts necessary to support such s p e c i f i c a t i o n s .
( d ) The establishment of a n a l y t i c a l control s p e c i f i c a t i o n s in the f i r s t place for raw
m a t e r i a l s , comprising a c t i v e and i n a c t i v e ingredients present in pharmaceutical products, a n d , when s e l e c t i n g drugs, p r i o r i t y to drugs that are widely used throughout the world, adequate weight to the therapeutic v a l u e of the selected drugs, and high p r i o r i t y to drugs important
to WHO health programmes.
( e ) A procedure to be followed up for the establishment of chemical reference substances necessary to support a n a l y t i c a l control s p e c i f i c a t i o n s .
( f ) Annexing of the r e v i s e d text of Appendix 1 3 , " R a d i o a c t i v i t y " , of the International Pharmacopoeia, the r e v i s e d texts of a l l e x i s t i n g monographs on radioactive pharmaceuticals3
and s p e c i f i c a t i o n s for f i v e new r a d i o a c t i v e agents to the twenty-fifth report of the Expert Committee on S p e c i f i c a t i o n s for Pharmaceutical Preparations.
4 . 4 Implications for the O r g a n i z a t i o n ' s programme
The recommendations concerning the " C e r t i f i c a t i o n Scheme on the Quality of Pharmaceutical Products moving in I n t e r n a t i o n a l Commerce" and "Good Practices in the Manufacture and Q u a l i t y Control of D r u g s " , i f adopted by the World Health Assembly, w i l l necessitate the establishment and recording by Headquarters of up-to-date l i s t s of the countries participating in the
C e r t i f i c a t i o n Scheme, of names and addresses of competent a u t h o r i t i e s , and of reservations made by the p a r t i c i p a t i n g Member S t a t e s .
The recommendations concerning further work on quality control specifications w i l l c o n s t i t u t e a b a s i s for the preliminary work on the new edition o f the International
Pharmacopoeia and for further work on general requirements for dosage forms as well as other questions of broader general application in the f i e l d of drug control s p e c i f i c a t i o n s .
Comment: The items discussed by the Expert Committee were selected to implement
s p e c i f i c requests of the World Health Assembly (resolutions W H A 2 0 . 3 4 , WHA22.50, W H A 2 3 . 4 5 , WHA.25.61) . As the result of the Expert Committee's work, revised texts of "Good
Practices in the Manufacture and Quality Control of Drugs" and the " C e r t i f i c a t i o n Scheme on the Q u a l i t y of Pharmaceutical Products moving in International Commerce" were presented to the Executive Board at its f i f t y - f i f t h session and subsequently to the Twenty-eighth World Health Assembly which adopted the text (resolution W H A 2 8 . 6 5 ) .
1 WHO Official Records, No. 226, 1975, p. 35.
5. EVALUATION OF FAMILY PIANNING IN HEALTH SERVICES Report of a WHO Expert Committee
Geneva3 18-22 November 1 9 7 41
5 . 1 Background information
I n recent years the Organization has taken great interest in the development of c r i t e r i a and measures for the planning and evaluation of public health programmes, and several expert committee and s c i e n t i f i c group meetings have produced reports on the t o p i c . ^ The Expert Committee meeting on Family Planning in Health Services which was held in 1970 recommended the convening of a meeting of experts to study "procedures for the e f f e c t i v e planning and evaluation of family planning a c t i v i t i e s in health s e r v i c e s " . ^
Although much has been written about methods and procedures for evaluating family planning programmes, l i t t l e has been subjected to expert judgement. Much of the l i t e r a t u r e deals with survey research r e l a t i n g to the knowledge, attitudes and practice of contraception and the measurement of the demographic e f f e c t s of family planning programmes. There is much
less information a v a i l a b l e to the public health practitioner on the evaluation of the operational aspects of family planning programmes in health services and the measurement of the health e f f e c t s of such programmes.
The need e x i s t s to compile methodologies for evaluation that are relevant to public health p r a c t i t i o n e r s , to analyse them for their u t i l i t y and to recommend the most u s e f u l approaches for the evaluation o f family planning in health services. The Expert Committee, t h e r e f o r e , had as its objectives " t o review experience in evaluating family planning
programmes in health services； outline systematic approaches to measuring their e f f i c i e n c y , effectiveness and ultimate impact； and determine the organizational structure and s t a f f i n g needed for such an assessment".
5 . 2 The report
The Committee was concerned i n i t i a l l y with a discussion of concepts and d e f i n i t i o n s relating to family planning and evaluation, with a review of current experiences in evaluating family planning in health services， including techniques and procedures for evaluating the health need for family planning s e r v i c e s , the operational aspects and the health impact of these services, and the interaction of family planning and other health a c t i v i t i e s . The Committee developed general guidelines for the systematic selection of evaluation topics, the design of evaluation procedures and the organization and administration of evaluation, including l i s t s of practical measures of health impact, e f f e c t s , and outputs and inputs of family planning in health services.
Comment: The Committee was representative of the many d i s c i p l i n e s with an interest in evaluation of family planning, including public health administration, community h e a l t h , n u r s i n g , maternity health and p a e d i a t r i c s , s t a t i s t i c s , demography and behavioural
science. It was attended by representatives of the relevant organizations of the United Nations system and of nongovernmental organizations. I t approached the subject pragmatically and produced a report which, while comprehensive, is at the same time precise and clearly i n s t r u c t i o n a l .
WHO Technical Report S e r i e s , No. 569， 1975.
WHO Technical Report S e r i e s , No. 4 0 9 , 1969.
WHO Technical Report S e r i e s , No. 472， 1971.
WHO Technical Report S e r i e s , No. 5 2 8 , 1973.
WHO Technical Report S e r i e s , No. 4 7 6 , 1 9 7 1 , 65.
5•3 The recommendations
The Committee c o n s i d e r e d t h a t e a r l y a c t i o n s h o u l d be taken to f o l l o w up t h e r e p o r t , a s t h e need was p r e s s i n g f o r a s y s t e m a t i c e v a l u a t i o n o f f a m i l y p l a n n i n g i n h e a l t h s e r v i c e s . I t t h e r e f o r e recommended t h a t i n a d d i t i o n to the g e n e r a l recommendations i n c o r p o r a t e d i n t h e
g u i d e l i n e s , WHO s h o u l d u r g e c o u n t r i e s t o :
( a ) s t r e n g t h e n t h e i r e v a l u a t i o n a c t i v i t i e s p a r t i c u l a r l y those o f t h e i r m a t e r n a l and c h i l d h e a l t h s e r v i c e s；
( b ) d e v e l o p and t e s t the e v a l u a t i o n g u i d e l i n e s d e s c r i b e d i n the r e p o r t a t the d i f f e r e n t a d m i n i s t r a t i v e l e v e l s； and
( c ) i n i t i a t e t r a i n i n g programmes to be o f f e r e d to h e a l t h p e r s o n n e l a t a p p r o p r i a t e l e v e l s to p r o v i d e them w i t h c o n c e p t u a l and t e c h n i c a l t o o l s needed to c a r r y out the e v a l u a t i o n o f f a m i l y p l a n n i n g i n h e a l t h s e r v i c e s .
I n t h e a r e a o f r e s e a r c h the Committee c o n s i d e r e d the f o l l o w i n g to be p r i o r i t y a r e a s : ( a ) the development o f p r o c e d u r e s f o r e v a l u a t i n g t h e h e a l t h need and demand for f a m i l y p l a n n i n g i n t h e h e a l t h s e r v i c e s a s w e l l a s t h e e f f e c t s o f i n t r o d u c i n g f a m i l y p l a n n i n g i n t o t h e h e a l t h s e r v i c e s；
( b ) t h e development o f p r a c t i c a l and u s e f u l measures o f t h e h e a l t h impact of and the need f o r f a m i l y p l a n n i n g s e r v i c e s , p a r t i c u l a r l y w i t h r e f e r e n c e to the t a r g e t p o p u l a t i o n ; ( c ) t h e development o f measures and p r o c e d u r e s for e v a l u a t i n g t h e i n t e r a c t i o n between f a m i l y p l a n n i n g and o t h e r h e a l t h s e r v i c e s .
5 . 4 I m p l i c a t i o n s for t h e O r g a n i z a t i o n ' s programme
To s u p p o r t the g u i d e l i n e s for the e v a l u a t i o n o f f a m i l y p l a n n i n g recommended by the Committee, the O r g a n i z a t i o n w i l l have to e l a b o r a t e a s e t o f g e n e r a l d e f i n i t i o n s and concepts o f f a m i l y p l a n n i n g and e v a l u a t i o n for a c c e p t a n c e i n c o u n t r y programmes； to produce
a p r o c e d u r a l manual and t r a i n i n g m a t e r i a l s to support them and to develop a f e l l o w s h i p programme to t r a i n m e d i c a l demographers and h e a l t h s t a t i s t i c i a n s i n t h e t e c h n i c a l a s p e c t s of e v a l u a t i o n .
I n i t s recommendations, the Committee c o n s i d e r e d t h a t the O r g a n i z a t i o n s h o u l d g i v e s u p p o r t to e f f o r t s by o t h e r a g e n c i e s i n t h e f i e l d o f f a m i l y p l a n n i n g by t r a n s l a t i n g ,
a b s t r a c t i n g , p u b l i s h i n g and d i s s e m i n a t i n g the r e l e v a n t l i t e r a t u r e on t h e e v a l u a t i o n o f f a m i l y p l a n n i n g i n h e a l t h s e r v i c e s , w i t h p a r t i c u l a r a t t e n t i o n to work done i n d e v e l o p i n g c o u n t r i e s and to a r t i c l e s p u b l i s h e d i n n o n - i n t e r n a t i o n a l j o u r n a l s and languages and to m e t h o d o l o g i e s developed f o r a s s e s s i n g the h e a l t h impact o f f a m i l y p l a n n i n g and m a t e r n a l and c h i l d h e a l t h p r o j e c t s .
Comment: The g u i d e l i n e s for t h e e v a l u a t i o n o f f a m i l y p l a n n i n g produced by t h e Committee w i l l be u s e f u l i n a s s i s t i n g c o u n t r i e s w i t h t h e development o f an e v a l u a t i o n system.
C o n s i d e r a t i o n o f t h e recommendations has a l r e a d y been i n i t i a t e d i n t h a t t h e r e p o r t was r e v i e w e d a t a r e c e n t t r a i n i n g workshop on f a m i l y h e a l t h . The g u i d e l i n e s were c o n s i d e r e d to be of p r a c t i c a l v a l u e and implementable.
6 . PESTICIDE RESIDUES IN FOOD
Report of the 1974 Joint Meeting of the FAO Working Party of Experts on Pesticide Residues and the WHO Expert Committee on Pesticide Residues
Rome， 2-11 December 1 9 7 41
6 • 1 Background information
This meeting was the twelfth of a series of meetings convened annually by WHO and FAO in pursuance of the recommendations made in 1961, at a meeting of a WHO Expert Committee on Pesticide Residues held j o i n t l y with the FAO Panel of Experts on the Use of Pesticides in
A g r i c u l t u r e , 2 that studies be undertaken to evaluate possible hazards to man arising from the occurrence of residues of pesticides in foods. The reports of previous meetings contain information on acceptable daily intakes (ADIs) established, residue limits recommended, and methods of analysis suggested for the various pesticides considered.
6 . 2 The report
The terms of reference of this Meeting were:
( a ) to review toxicological and other relevant data on certain pesticides and their residues in agricultural products；
( b ) to establish where possible, acceptable daily intakes ( A D I s ) for man for the pesticides examined;
( c ) to propose pesticide residue limits and recommend methods for their a n a l y s i s . The Meeting discussed a number of principles and guidelines laid down in reports of previous Meetings as well as those of other expert meetings, especially the report of the WHO S c i e n t i f i c Group on the Assessment of the Carcinogenicity and Mutagenicity of C h e m i c a l s . 3
One of the recommendations of the S c i e n t i f i c Group was that threshold doses exist for
compounds whose carcinogenic action is secondary to certain hormonal e f f e c t s . Following that recommendation, the Meeting allocated acceptable daily intakes to amitrole and certain
dithiocarbamates (whose main degradation product is ethylenethiourea) which have been shown to produce hormone-mediated tumours in laboratory animals.
A number of N-nitroso compounds have been shown to exert a carcinogenic effect in animals. Recent experiments have demonstrated that N-nitroso compounds are formed from a number of nitrogen-containing pesticides in vivo as well as in vitroa and that in vivo formation may occur in man. Of the N-nitroso compounds formed from certain agricultural pesticides some are known to have a carcinogenic action in rodents. The extent of formation of N-nitroso compounds in man i s probably very limited, and it is not yet possible to predict the effect in man of low doses of these substances. The Committee therefore suggested that further research be conducted on the formation of N-nitroso compounds from pesticides under conditions and at concentrations that include those to which man might be exposed.
The Committee also allocated acceptable daily intakes for a number of other pesticides and discussed tolerances for the levels of their residues in specific foods. These pesticides were considered because of their potential health hazards and/or economic importance in agriculture and in the international movement of food, and most of them were recommended by the Codex Committee on Pesticide Residues.
WHO Technical Report S e r i e s , No. 5 7 4 , 1975.
WHO Technical Report S e r i e s , No. 2 4 0 , 1962.
WHO Technical Report S e r i e s , No. 5 4 6 , 1974.
6 • 3 The recommendations
( a ) In the l i g h t of the need of research workers, government o f f i c i a l s , members of the Codex A l i m e n t a r i u s Commission， and others for f u l l and early knowledge o f the matters
d i s c u s s e d at m e e t i n g s , the Directors-General of FAO and WHO were requested to review procedures for the p u b l i c a t i o n o f reports and monographs with a view to decreasing the length of time between Meetings and the i s s u e of the p u b l i c a t i o n s .
( b ) To provide more time for the c o l l e c t i o n o f data from various sources and for their c o n s i d e r a t i o n by the appropriate s p e c i a l i s t s , an agenda for the next Meeting l i s t i n g the compounds to b e considered should be issued immediately a f t e r the present Meeting.
( c ) When attempting to re-évaluate c e r t a i n p e s t i c i d e s about which s u f f i c i e n t information had not been a v a i l a b l e at previous sessions3 the Meeting once a g a i n found that the necessary research had not been c a r r i e d out. As t h i s information i s e s s e n t i a l to obtaining assurance concerning the safety of these products, some of which a r e used on a large scale and w i l l be needed for currently planned increases in world food production, the Meeting strongly
recommended that new and vigorous e f f o r t s , coordinated on an i n t e r n a t i o n a l b a s i s , should be made to provide f i n a n c i a l support for such r e s e a r c h .
( d ) In v i e w of the v a l u e of observations of the e f f e c t s of p e s t i c i d e s in man, WHO should seek the cooperation of the I n t e r n a t i o n a l Federation of Poison Control Centres and other o r g a n i z a t i o n s in developing the relevant data banks.
( e ) WHO should take steps to obtain the a d d i t i o n a l information needed for the evaluation o f certain p e s t i c i d e s .
6 . 4 Implications for the O r g a n i z a t i o n 1 s programme
D i s c u s s i o n s a r e taking p l a c e between the r e s p o n s i b l e services in FAO and WHO to seek speedier means for p u b l i s h i n g the reports and monographs a r i s i n g from meetings.
In order to s o l i c i t the r e l e v a n t data from a wider range o f sources, a tentative l i s t of p e s t i c i d e s to be considered by the next Meeting has a l r e a d y been c i r c u l a t e d to various
i n s t i t u t i o n s j i n c l u d i n g the I n t e r n a t i o n a l Federation of Poison Control Centres and other i n t e r n a t i o n a l o r g a n i z a t i o n s .
P o t e n t i a l sources of funds a r e being explored for the support of investigations designed to provide the information considered e s s e n t i a l for the safety evaluation o f p e s t i c i d e s as requested by the Meeting.
Comment: The recommendations of the J o i n t Meeting a r e intended to provide an even broader data base for evaluation and to disseminate the results of the evaluation to those concerned w i t h the minimum of delay. I t should however be r e a l i z e d that the checking of r e f e r e n c e s , e d i t i n g , t r a n s l a t i o n , a p p r o v a l , and d i s t r i b u t i o n take time.
7. SMOKING AND ITS EFFECTS ON HEALTH Report of a WHO Expert Committee Geneva. 9-14 December 19741
7. Background information
Smoking i s one of the greatest avoidable health hazards of modern times»» The adverse h e a l t h e f f e c t s of smoking a r e w e l l known, p a r t i c u l a r l y in r e l a t i o n to cardiovascular d i s e a s e s , c e r t a i n forms o f cancer and other d i s e a s e s . Curbing smoking i s , however, a d i f f i c u l t t a s k ,
1 WHO Technical Report Series, No. 568, 1975.
for not only are the public health authorities involved but economic and social factors also play an important r o l e , usually in opposition to health oriented efforts. Following resolution E B 5 3 . R 3 1 , 1 an Expert Committee on Smoking and its Effects on Health was convened to summarize present evidence on the adverse health effects of smoking and to suggest action WHO might commend to Member States and interested health organizations.
7 . 2 The report
Evidence of the adverse effects of smoking on health has been comprehensively reviewed already in previous WHO publications. The present report therefore deals mainly with additional evidence that has been accumulated since. This evidence deals with the relationship of smoking habits to total mortality, to lung cancer, to other respiratory
diseases, to ischaemic heart disease, to cerebrovascular diseasesy and to peptic u l c e r , as well as with the harmful effects on the foetus from smoking during pregnancy, and the higher
susceptibility of young children to chest illnesses when they are exposed to tobacco smoke.
Smoking trends in various countries are also discussed. It seems well established that, although tobacco production and consumption in most countries provide a substantial source of
income, the heavy demands upon health care f a c i l i t i e s and the economic loss due to the
absenteeism from work that results from smoking-related illnesses usually offset the economic value of tobacco products. Apart from the saving that could be obtained merely in monetary
terms, the true gain from reducing smoking would be in human terms and in the reduction of i l l health and of premature death.
One way of reducing exposure to smoke that is suggested is to reduce the concentration of the harmful components of tobacco smoke by producing new types of cigarettes having lower concentration of these components.
One of the mainstays of a successful campaign to curb smoking is a sound health educational approach aimed at children and adolescents as well as adults. Teachers,
physicians and other health workers could play a most important role in this respect. The educational approach should be backed by appropriate legislative action.
Since the psychosocial and pharmacological components of the smoking habit are s t i l l incompletely known, research should be carried out to c l a r i f y the mechanisms by which smoking habits and the various constituents of tobacco smoke cause their pathological e f f e c t s .
7 . 3 The recommendations
The Committee recommended that：
( a ) as few young people as possible should start smoking, and those doing so should start as late as possible;
( b ) as many smokers as possible should be encouraged and assisted to stop smoking;
( c ) those who are unable to stop smoking should try to reduce their exposure to such harmful substances in smoke as tar, nicotine and carbon monoxide.
These recommendations are considered only as guidelines. Countries may differ in their readiness to implement them, or they may find that the same ends can be accomplished by other means more appropriate to the local public health interests and to traditional ways of
dealing with health problems.
1 WHO Official Records, No. 215, 1974, p. 25.
I t was f u r t h e r recommended t h a t :
governments should consider the establishment of a committee or other appropriate machinery to coordinate programmes for the control and prevention of tobacco smoking, if
serious health problems associated with smoking exist in the country.
T h r e e m a i n l i n e s o f a c t i o n s h o u l d be c o n s i d e r e d：
( 1 ) Anti-smoking health education of children should start as early as possible and be appropriately reinforced at different stages during the whole educational period. I t should emphasize the favourable aspects of non-smoking and emphasize the rights of non-smokers, especially children and pregnant women, to be protected from involuntary exposure to tobacco smoke. K e y g r o u p s l i k e t e a c h e r s , women a t t h e c h i l d - b e a r i n g a g e , p a r e n t s w i t h young
children, and health workers should be appropriately informed and should set an example.
( 2 ) The rights of the non-smoker should be secured and smoking and non-smoking areas in p u b l i c p l a c e s s h o u l d t h e r e f o r e be p r o v i d e d . I n p u b l i c p l a c e s s u c h a s h o s p i t a l s a n d o t h e r health care institutions smoking should be strongly discouraged.
( 3 ) Legislation should be enacted to restrict or prohibit advertising and the sales
p r o m o t i o n o f t o b a c c o . P a c k e t s o f c i g a r e t t e s and a d v e r t i s e m e n t s s h o u l d c a r r y h e a l t h w a r n i n g s and/or other information that may be used by smokers to assess the degree of this exposure to health hazards. A system of d i f f e r e n t i a l taxation should be established to discourage c i g a r e t t e c o n s u m p t i o n . I t s h o u l d be i l l e g a l t o s e l l o r o f f e r t o b a c c o to c h i l d r e n , adolescents3 etc.
Comment： T h e p r e s e n t r e c o m m e n d a t i o n s c o n f i r m a n d s t r e n g t h e n t h o s e made i n t h e r e p o r t s p r e s e n t e d t o t h e T w e n t y - t h i r d a n d T w e n t y - f o u r t h W o r l d H e a l t h A s s e m b l i e s . I m p l e m e n t a t i o n of the recommendations depends to a great extent on the readiness of governments to take action, which in turn depends on whether or not tobacco smoking is a main health problem in the country. It also depends on whether public health measures and anti-smoking a c t i v i t i e s can be best undertaken in ways that are more suitable to local conditions but may be different from those envisaged by the Expert Committee. Economic and social
factors w i l l also have to be taken into consideration.
7 , 4 Implications for the Organization's programme
It was also recommended that WHO should assist Member States with their smoking and health problems by, e.g., collating and disseminating relevant information, working out standard definitions for measuring smoking behaviour, facilitating the exchange of
information and of health education material in different countries as well as recruiting experts to help countries in identifying smoking-related health hazards and in dealing with them, and establishing contact with other agencies and appropriate nongovernmental
organizations concerning the educational approaches of anti-smoking campaigns and study of the problem of agricultural and economic changes possibly occurring in some countries as
a consequence of the anticipated reduction of smoking. WHO has already applied some of the r e c o m m e n d a t i o n s o f t h e C o m m i t t e e to i t s own work e n v i r o n m e n t .
8. WHO EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION T w e n t y - s i x t h R e p o r t
Geneva, 26 November - 2 December 19741
8 • 1 Background information
This twenty-sixth meeting continued the work supervised by the previous Expert Committee meetings which have been held since 1947. The Committee considered international bio logical
1 WHO Technical Report Series, No. 568, 1975.
standards and reference preparations for a number of hormones and certain international requirements for hormones which had been prepared by experts in collaboration with the WHO Secretariat.
8 . 2 The report
International standard^ international reference preparation and international units The f i r s t international Standards for Human Urinary F o l l i c l e Stimulating Hormone (FSH) and Human Urinary Luteinizing Hormone ( I n t e r s t i t i a l C e l l Stimulating Hormone) ( L H ( I C S H ) ) , for Bioassay were established and the international unit d e f i n e d . A number of international reference preparations for bioassay were established: these were porcine and salmon c a l c i t o n i n s , bovine parathyroid hormone, human p i t u i t a r y FSH and LH, and r e n i n .
International units were defined in these cases. A number of international reference preparations for immunoassay were established： these were parathyroid hormone, human chorionic gonadotrophin ( i n t a c t hormone) and preparations of the alpha and beta subunits, human pituitary LH, human thyroid stimulating hormone ( T S H ) , human placental lactogen, human insulin and a preparation of porcine glucagon for assay of human glucagon. International units were defined in most cases and the International Laboratory for B i o l o g i c a l Standards in London was authorized to determine the figure for the international unit in the remaining cases according to the weight of contents of each ampoule. A number of preparations were discussed for further consideration. These were mainly for immunoassay and included human calcitonin, angiotensins, human pituitary FSH, subunits of the p i t u i t a r y hormones FSH, LH and TSH, human i n s u l i n С peptide, human vasopressin, at least three gastrointestinal hormones, at
least three hormone releasing and release-inhibiting substances, human prolactin and human adrenal corticotrophic hormone (ACTH).
Requirements and recommendations of reagents used in hormone assays and in assay performance
The Committee adopted guidelines for the formulation of requirements for assay reagents and assay k i t s for immunoassays, receptor bioassays and cytochemical bioassays. I t adopted a proposed model plan for the development of national assay services for human hormones and other substances by the newer immunoassays and other assay techniques. I t also discussed some recurring problems in the standardization of hormones which would be u s e f u l for the national control of hormone preparations, whether manufactured in the country or imported;
this would be particularly useful for developing countries.
8 , 3 The recommendations
The Committee made a number of recommendations on technical aspects of the various
substances already mentioned, rioted the progress of work in accordance with the recommendations of previous expert committees and made further recommendations.
The international standards and reference preparations that have been established and replaced are now recommended for further use in the control of hormones and reagents used in hormone assays in various countries. The recommendations for the control of assay reagents considered by the Committee are also recommended to national control a u t h o r i t i e s ,
manufacturing establishments and control laboratories for their regulatory a c t i v i t i e s . The model national assay service document contains a complete set of recommendations to enable countries to implement this important public health a c t i v i t y within community health care services.
8 , 4 Implications for the O r g a n i z a t i o n ’ s programme
The implications of the present report for the WHO programme of b i o l o g i c a l
standardization w i l l be considered by the Secretariat in conjunction with the International Laboratory for Biological Standards in London. Many of the items are also of interest to
