Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health
Date: 1994-11-09
Institutions: European Commission
Subjects: AIDS, action programme, disease prevention, dissemination of information, health policy, public health

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

COM(94) 413  final 
B r u s s e l s,  09.11.1994 

94/0222  (COD) 

COMMUNICATION  FROM THE  COMMISSION 

concerning  a Community  action  programme  on the  prevention 
of  AIDS  and  certain  other  communicable  diseases  in the 
context of the framework  for  action  in  the 
field  of public  health 

Proposal  for  a 
EUROPEAN  PARLIAMENT  AND COUNCIL  DECISION 

94/0222  (COD) 

adopting  a programme  of  Community  action  on the prevention  of 
AIDS  and  certain  other communicable  diseases within  the 
framework  for  action in the field  of  public  health 

(presented  by the  Commission) 

COMMUNICATION  FROM  THE  COMMISSION 

concerning  a Community  action  programme  on the  prevention 
of  AIDS  and  certain  other  communicable  diseases  in the 
context  of the framework  for  action  in  the 
field  of public  health 

CONTENTS 

I. 

INTRODUCTION 

1. 
2. 
3. 

. . .. 

BACKGROUND 
BASIC  CHARACTERISTICS  OF COMMUNICABLE  DISEASES 
SELECTION  OF  CERTAIN  COMMUNICABLE  DISEASES 
FOR  COMMUNITY  ACTIONS 

H.  THE  SITUATION  AS  REGARDS  COMMUNICABLE DISEASES  AT 

COMMUNITY  LEVEL 

' 

5 

5 
.6 

8 

9 

1. 
2. 
3. 
4. 

fflV 

ZOONOSIS  . 

INFECTION,  AIDS  AND  SEXUALLY  TRANSMITTED  DISEASES 

. 9 
. .  10 
COMMUNICABLE  DISEASES  PREVENTABLE  BY VACCINATION 
11 
COMMUNICABLE  DISEASES WHICH REQUIRE  SPECIFIC MEASURES  .  13 
(a)  Hepatitis 
13 
. 13 
(b)  Tuberculosis 
14 
(c)  Nosocomial  infections  . 

III.  OVERVIEW OF ACTIVITIES ALREADY UNDERTAKEN IN THE MEMBER 

STATES AND AT  COMMUNITY  LEVEL 

1. 

2. 

THE COUNCIL  . . .. 

THE EUROPEAN  PARLIAMENT  . .  . .  . 

IV.  COMMUNITY APPROACH 

L 
2. 

Objectives and means 
The Public Health Framework and the Community action programme 
on AIDS  and other communicable diseases 

3.  Other instruments of  Community action 
4. 
5. 

Cooperation between Member States 
Cooperation with International Organizations and  Third Countries 

V.  COMMUNITY ACTION  PLAN 

A.  Actions  on  HIV/AIDS  and sexually  transmitted  diseases  . 

1.  Data  collection 
2.  Measures for  children and young people 
3. 
4. 
5. 
6.  Combatting discrimination 

Prevention  of HIV  and STD transmission 
Safety of  blood and  blood products 
Social and psychological support 

.  . 

15 

15 

18 

19 

19 

20 
21 
22 
22 
24 

24 
24 
25 
26 
27 
28 
28 

B. 

Specific  Community  measures  for  certain  communicable  diseases 
/. 
2. 

Actions related to vaccination  . 
Creation and development of networks 
(a)  Surveillance 
(b)  Dissemination  of epidemiological  information 
Information, education and training 
Early  detection and systematic screening 

3. 
4. 

VI.  CONSULTATION,  ASSESSMENT AND  REPORTS 

1. 

CONSULTATION  AND PARTICIPATION  MECHANISMS 
(a)  Advisory  Committee 
(b)  Other participants 

2.  ASSESSMENT AND REPORTS 
3.  GENERAL  INFORMATION  ACTIVITIES 

29 
29 
30 
30 
32 
33 
35 

37 

. 37 
37 
37 
37 
38 

I. 

INTRODUCTION 

1.  BACKGROUND 

1. 

2. 

In its communication  of 24 November  1993 on the framework  for action in the field of public 
health(1)  the  Commission  defined  a framework  for  Community  action  in  order  to  attain  the 
objectives on health protection  laid down in Articles 3(o)  and  129 of the Treaty  establishing 
the European Community. The role of the Community is identified  as underpinning the  efforts 
of  the  Member  States  in  the  public  health  field,  assisting  in  the  formulation  and 
implementation  of  objectives  and  strategies,  and  contributing  to  the  provision  of  health 
protection  across  the  Community,  setting  as  a  target  the  best  results  already  obtained  in  a 
given  area anywhere  in the  Community. 

In  initiating  action  under  Article  129,  the  Community  has  to  address  itself  to  preventing 
disease  and  protecting  health.  Based  on  the  criteria  laid  down  in  the  Commission 
communication, AIDS and other communicable diseases have been identified  as a priority  for 
Community  action. 

3. 

These  are  diseases which  have the following  characteristics: 

they  cause  or  are likely  to  cause in  the  absence  of  intervention,  significant  premature 
death  and/or overall  high  death rates; 
they  cause  or  are  likely  to  cause  in  the  absence  of  intervention,  significant  ill  health 
including  high  morbidity  and/or  disability; 
they have significant implications for the quality of life as well as major  socio-economic 
effects,  such as high health care and treatment costs,  and  considerable absenteeism  and 
unfitness  for  work; 

and  for  which: 

practicable  measures  of  prevention  exist; 
there  would  be  added  value  from  the  Community  undertaking  actions,  particularly 
through  economies  of  scale. 

4. 

Furthermore,  AIDS  has  been  singled  out  by  the  Council,  the  European  Parliament,  the 
Economic  and  Social  Committee,  and  the  Committee  of  the  Regions,  as  a  major  scourge 
which deserves special  attention by the Community. A long series of resolutions,  conclusions 
and  opinions  by  these  institutions  culminated  in  June  1994  in  the  adoption  of  a  common 
position(2) by the Council,  following  favourable  opinions by the other bodies,  concerning the 
prolongation in  1994-1995 of the "Europe against AIDS" programme along the lines proposed 
by  the  Commission 

(1) 
(2) 

COM(93)  559 final. 
OJNo 

'X"< 

5. 

6. 

7. 

8. 

9. 

The  AIDS  crisis  has  aroused  interest,  from  the  public  health  point  of  view,  in  all  the  other 
diseases  in  this  category.  This  applies  first  and  foremost  to  the  other  sexually  transmitted 
diseases  (STDs)  which  can  often  accompany  the  HIV  (human  immunodeficiency  virus) 
infection  which  leads to ADDS. The occurrence of certain  STDs alongside HIV infection  has 
caused  the infectious  disease  experts to re-think  many  of  their  ideas,  obliging  them  to  adapt 
to a new, complex and constantly  evolving reality.  The renewed interest applies also to those 
infectious  diseases  which  accompany  the  onset  of  AIDS  proper,  and  which  are  known  as 
opportunistic  infections.  Some of these, which  have been  known  about for  a very  long time, 
now need to be monitored  more vigilantly,  such  as for  example tuberculosis. 

2. 

BASIC  CHARACTERISTICS  OF  COMMUNICABLE  DISEASES 

At  various  stages  in  our  history  there  have  been  epidemics  which  have  affected  and  even 
decimated  whole  populations.  The  plague  of  the  Middle  Ages  wiped  out  a  quarter  of  the 
population  of western Europe in a mere four years, and the  Spanish flu,  which ravaged  every 
continent at the start of this century, killed more than 20 million people in the space of a few 
months. But medical  advances such as the development of vaccines and new drugs, combined 
with  substantial  improvements  in  living  conditions  and  public  hygiene,  have  considerably 
reduced the threat from  infectious  diseases to the citizens of the European Union. Worldwide, 
however,  infectious  diseases  are  still  a  major  cause  of  death,  and  in  the  least-developed 
countries they  represent  more than  70% of the global  burden  of  disease. 

A  remarkable  success has recently  been  achieved  in the  fight  against  communicable  disease 
by the eradication  of smallpox. Through a combination  of active monitoring and an  effective, 
easy-to-use. vaccine,  the  health  authorities  managed  first  to  stem  the  spread  of  the  smallpox 
virus  and then  cause it to disappear altogether,  thus eradicating this  disease from  the  surface 
of  the  Earth.  In  the  same  period,  however,  infectious  diseases  which  were  thought  to  have 
disappeared  or  to  be  on  the  way  out  have  begun  to  re-appear,  and  have  reached  epidemic 
proportions  in  certain  places. 

Examples  are  diphtheria,  which  is  rampant  again  in  eastern  Europe,  and,  to  a lesser  degree, 
poliomyelitis,  which  was  thought  to  be  on  the  point  of  extinction.  Another  example  is 
tuberculosis,  the  resurgence  of  which  results  from  a  combination  of  factors,  such  as  the 
slackening of vaccination programmes, the inability of certain drugs to cope with resistant new 
strains,  and  poor  living conditions  - all factors  about  which  something  could  be  done. 

Moreover,  new  diseases  are  appearing  on  the  scene,  ranging  from  Lyme  borreliosis, 
transmitted  by  ticks  and  becoming  increasingly  prevalent,  to  chlamydiosis,  a  sexually 
transmitted  bacterial  disease  which  has  serious implications  for  female  fertility. 

*Zr •*•"*•'--

10. 

11. 

12. 

13. 

14. 

Of  particular  importance  has  been  the  appearance  of  HIV  infection,  which  has  become 
pandemic since its appearance at the start of the  1980s and which leads to AIDS. It has rightly 
given  great  cause for  concern because  it is fatal  in the long  term  and  because there is at yet 
no  serum,  vaccine  or  effective  treatment  available.  Its  nature  is  such  that  it  has  forced  the 
public  authorities to take measures guided by the circumstances to try  to  halt  its  progression 
and this  explains  why  so much  attention  is being  paid  to  it.  If  the weapons  deployed  so  far 
against  it  appear  ineffective,  there  can  be  no  doubt  that  they  have  nonetheless  borne  some 
fruit,  both in terms of checking somewhat its spread in certain countries and among particular 
groups, and also in terms of the beneficial  impact they have had on the fight against sexually 
transmitted  diseases in  general. 

All  communicable  diseases are caused by  a transmissible  agent,  such as a bacterium,  a virus, 
a parasite, a worm or a fungus.  To combat these infectious  diseases as effectively  as possible, 
it  is therefore  necessary  to find ways of preventing these  agents from  causing  disease. 

The  modes  of  transmission  of  infectious  agents  include:  water  (cholera,  hepatitis  A,  etc.); 
animals  which  transmit  various  zoonoses  to  man  (brucellosis,  trichinosis,  echinococcosis, 
rabies, tuberculosis, etc.); food (salmonellosis, listeriosis, etc.); the environment (legionellosis, 
etc.);  human  contact  (tuberculosis,  influenza,  etc.);  the  iatrogenic  route  (blood  transfusions 
which  can transmit  the HIV virus, the hepatitis  C virus, etc.). 

A distinction  needs to be made between infection,  i.e. the fact  that  one of these agents takes 
up residence in the body of an individual  and multiplies within it, very often  with no obvious 
clinical  manifestations,  and the  disease itself,  i.e.  it  produces  symptoms  and  signs which,  in 
most cases, is the only aspect which the general public worries about. Many more people carry 
an  infection,  all  too  often  without  realising  it,  or  are  exposed  to  a  source  of  infection,  than 
actually  contract  a  disease  and  become  ill.  Controlling  or  reducing  the  spread  of  any 
communicable  disease is usually  restricted  to measures  aimed  at containing  the  transmission 
of the infection  by the causal  agent. For example, chronic carriers of the hepatitis B virus or 
the HIV virus are not necessarily  ill but may,  in certain  circumstances,  transmit the  infection 
to other  unaffected  persons. In this respect,  such carriers are a potential risk to public health. 

The  severity  of a communicable  disease depends not  only  on the intrinsic  danger  constituted 
by  the  causal  agent but  also on whether  it is able or not to  spread  easily  in the  environment 
and  at  some  stage to  affect  the  state of  health  of  any  individual  contracting  it.  Furthermore, 
in the case of some communicable diseases the infection  process is due to toxins produced by 
the  causal  agents.  This  is the  case with  the  agents  responsible  for  botulism  and  tetanus,  for 
example. Finally,  certain agents responsible for  communicable  diseases are able to trigger an 
allergic  process within  man,  such  as Ascaris Suum and  Candida Albicans. 

15. 

Communicable diseases may affect  the general population, or be more prevalent in certain risk 
groups or in some types of situations. A distinction  is therefore  made between the  following: 

communicable  diseases  affecting  the  general  public,  such  as HIV,  hepatitis  (A,  B and 
C  especially),  tuberculosis,  sexually  transmitted  diseases,  gastrointestinal  diseases, 
communicable  diseases  (other  than  tuberculosis  and  hepatitis)  preventable  through 
vaccination,  and zoonoses; 

those  affecting,  more  particularly,  certain  categories  of  the  population  classifiable  as 
being  "at-risk";  these  communicable  diseases  can  become  dangerous  when  they  affect 
certain  constitutionally  or physiologically  fragile  categories  of the  population: 

Among  pregnant  women  these  are  rubella  (German  measles),  toxoplasmosis, 
listeriosis  and rickettsioses. 
Among children these are diseases which can be tackled through vaccination  such 
as diphtheria, whooping cough, poliomyelitis and tuberculosis, but also hyperacute 
communicable  diseases which have an adverse effect  on survival  prognosis (such 
as certain  meningococcal  infections). 
Among  old  people  this  is  influenza,  which  -  although  preventable,  in  particular 
through  vaccination  -  can  assume  serious  dimensions,  thus  adversely  affecting 
survival  prognosis. 
Among fragile  individuals, such as the immunodepressed,  alcoholics, the disabled, 
but  also  excluded  individuals  living  in  adverse  or  precarious  socio-economic 
conditions,  often  far  below  the  poverty  line,  such  as  the  homeless  or  migrant 
communities, certain mycotic or parasitic infections, anaerobic germ infections and 
opportunistic  infections. 

And,  finally,  those whose transmissibility  is increased  in  certain  situations: 

• • ' . .• 

this is particularly  the case for  hospitals where nosocomial  infections  are  causing 
an increasing  prevention  problem; 
in  communities  (nurseries,  armed  forces,  holiday  camps,  schools)  where 
gastrointestinal  diseases, hepatitis  and infections  preventable  through  vaccination 
are occurring  more and more  often; 
in  prisons,  where  there  is  a  clear  rise  in  the  number  of  sexually  transmitted 
diseases  and HIV  infection. 

3. 

SELECTION OF CERTAIN COMMUNICABLE DISEASES FOR COMMUNITY 
ACTIONS 

16. 

In  this  Communication  the  Commission  sets  out  the  measures  it  proposes  to  undertake  to 
prevent  communicable  diseases,  drawing  on  the  knowledge  and  experience  acquired  in  the 
course of its previous actions. The Community cannot tackle all communicable diseases in one 
go  since there are so many  of them. Nor is it possible to cover  all  communicable  diseases in 
this  Communication,  since there are far  too many  of  them  and  their  repercussions  on  public 
health  are  so variable. 

17. 

In  view  of  the  limited  resources  available  to  the  Community,  a  selection  has  to  be  made 
among  the  communicable  diseases  in  order  to  identify  those  which  would  be  the  object  of 
action  yielding  the  highest  Community  added  value;  moreover,  preference  will  have  to  be 
given to actions which can also benefit  the fight against the greatest possible number of such 
diseases.  Community  actions  must  primarily  encourage  cooperation  between  the  Member 
States,  and  aim,  where  appropriate,  at  coordinating  health  policies  and  programmes.  In this 
context,  the  fact,  for  example,  that  many  communicable diseases  can  be  treated  effectively 
with chemotherapy  or can be contained through tried-and-tested vaccination  programmes has 
been  followed  up  more  assiduously  by  some  Member  States  than  by  others,  and  has  thus 
resulted  in a widely  contrasting  situation which merits closer,  case-by-case  analysis. Finally, 
the  communicable  diseases  to  be  selected  must  include  those  for  which  the  Member  States 
themselves  and  the  Community  institutions  have  expressed  an  interest  or  preference  for  a 
contribution by the Community primarily on the basis of the perceived risks to individuals as 
well  as to the  society  as a whole. 

18. 

Applying this approach to communicable diseases involves selecting those diseases which are 
to be the main  focus  of this action, viz.: 

1.  HIV infection,  AIDS  and  sexually  transmitted  diseases; 
2. 
3. 

diseases which  can be prevented through vaccination;  and 
diseases which  can be tackled  through  certain  speciHc Community  measures. 

H.  THE  SITUATION  AS  REGARDS  COMMUNICABLE  DISEASES  AT 

COMMUNITY  LEVEL 

1. 

ZOONOSIS 

19. 

20. 

Zoonoses, i.e. infectious  diseases carried by animals and liable to be transmitted to man, have 
been  the  subject  of  close  attention  for  more  than  three  decades.  The  Community  has 
endeavoured,  to  contribute  to  safeguarding  public  health  in  general  by  adopting  and 
implementing a series of specific  programmes involving  substantial  funds  (for  instance,  over 
MECU  125  for  the  1987-1992  period)  and  aimed  at  combatting  or  eradicating  certain 
zoonoses. 

Since  1964  Community  programmes  have  focused  on  monitoring and  eradication  of  bovine 
tuberculosis,  as a result  of which many  herds in the Community  have been  declared  clear of 
this disease. The same applies to bovine brucellosis (B. abortus) and^. more recently, sheep and 
goat brucellosis, while the fight against B. melitensis continues.  Since  1989 the battle against 
rabies, in wild animals especially, has made good progress thanks to vaccination by means of 
aerial dropping of bait. Trichinosis is now under better control thanks to improved  processing 
of fresh  meat, especially horse meat. As for salmonellosis, this has received special attention -
over  and  above  that  stipulated  by  legislation  -  including  efforts  to  improve  the  quality  of 
livestock,  hygiene  in  abattoirs  and  undertakings  processing  and  transforming  products  of 
animal  origin into foods for human consumption. In this respect, significant  progress has been 
achieved through the establishment of microbiological  criteria (^signed to ensure the absence 
of salmonella or related contaminants, plus checks on application thereof in the case of minced 
meat,  meat-based  products,  shellfish,  milk  and  egg products. 

21. 

22. 

23. 

24. 

25. 

26. 

2.  HIV  INFECTION,  AIDS  AND  SEXUALLY  TRANSMITTED  DISEASES 

By  31  March  1994,  a  cumulative  total  of  105 446  AIDS  cases,  including  1 920  paediatric 
cases, had been reported  in the twelve countries of the European  Community  (EC) and 6 476 
(including 6 386 adults/adolescents and 86 paediatric cases) in the six COST(3) countries. The 
cumulative number of cases reported by country ranges from  79 in Luxembourg to 30 003 in 
France.  Three  countries  (France,  Italy,  and  Spain)  have  reported  over  20 000  cases  and 
account  for  72%  of  the  cases  reported  in  the  EC.  In  1993  over  20 000  new  cases  were 
reported,  and  6 000 for  the first three months of  1994. 

The  analysis  of  adult/adolescent  cases  by  transmission  group  from  1990  to  1993  shows  an 
increase in the proportion  of  cases attributed  to heterosexual  contact  (from  10.8% to  15.3%) 
and among intravenous  drug users (IDUs) (from  40.0% to 41.8%). In the  same period,  there 
were  gradual  decreases  in  the  proportions  of  homo/bisexual  males  (from  39.3% to  32.2%), 
haemophiliacs  (from  1.7%  to  1.1%)  and transfusion  recipients  (from  2.2% to  1.5%). 

A  preliminary  breakdown  of  the  transmission  category  "heterosexual  contact"  shows  an 
increase, from  1990 to  1993, in the proportion  of cases in several  groups: persons originating 
from  countries  where  heterosexual  transmission  is  common  (from  2.9%  to  3.7%  of  all 
adult/adolescent cases), persons with an IDU partner  (from  2.5% to 3.5%),  and persons with 
an  HIV-positive  partner without  a known risk factor  (from  1.2%  to 2.9%). 

The proportion  of infected  females  is  15.2% among adult/adolescent  cases but 46.7% among 
paediatric  cases.  This  proportion  varies  according  to  the  transmission  group:  among 
adult/adolescent  cases, it is highest in the transfusion  recipient group  (46.1% females)  and in 
the  heterosexual  contact  group  (43.0%  females).  Among  cases  in  the  heterosexual  contact 
group,  67.0% of  persons  with  an IDU partner  are  females. 

The  analysis  of  cases  by  period  of  diagnosis,  from  1990  to  1993,  shows  an  increase  in  the 
proportion  of females  among adult/adolescent  cases (from  14.9% to  18.3%). This increase is 
largely  correlated  to the  decrease  in the  proportion  of  homo/bisexual  cases,  but  also  reflects 
an  increase  (from  40.8%  to  45.4%)  in  the  proportion  of  female  cases  in  the  heterosexual 
contact  group.  This  latter  increase  is  observed  particularly  among  persons  originating  from 
countries where  heterosexual  transmission  is common  (36.8% to 46.0%)  and  among persons 
with  an  IDU  partner  (61.9% to 68.4%). 

The total  number  of  people  in the  Community  infected  with HIV  is unknown.  Nevertheless, 
application  of certain mathematical  models makes it possible to estimate the number of people 
who  are  currently  seropositive  - at  something  in the  region  of  half  a million  throughout  the 
Community, with major  variations from  one country to another.  Thus, there are thought to be 
some  200  000  seropositives  in  France  and  under  50 000  in  the  United  Kingdom.  If,  as the 
present state of knowledge indicates, all seropositive individuals eventually develop  full-blown 
AIDS,  this provides  some idea of the extent  of the public health  problem  faced,  all the more 
so given  that  prevention  by  vaccination  or effective  chemotherapy  are  not yet  possible. 

(3) 

Cooperation  in  Scientific  and  Technical  Research. 

10 

27. 

In each Community  country  one or more national  surveillance systems cover certain  sexually 
transmitted  diseases: gonorrhoea  and  syphilis are monitored  in all Member  States, but this is 
not so for genital herpes. Furthermore, case definitions vary from  one Member State to another 
depending  on  the  type  of  disease  monitored.  This  means  that  given  the  relatively  low 
prevalence  of the most  common  sexually transmitted  diseases - such  as gonorrhoea,  syphilis, 
chlamydiosis, Condylomata A infection,  genital herpes, soft chancre, granuloma inguinale and 
lymphogranuloma  venereum  -  we  currently  have  no  accurate  epidemiological  data  at 
Community  level. 

3. 

COMMUNICABLE  DISEASES PREVENTABLE  BY  VACCINATION 

28.  Many  communicable  diseases  can  be  contained  through 

tried-and-tested  vaccination 
programmes. Public health programmes to eliminate certain communicable infectious  diseases 
have often  based themselves on vaccination, which is the most effective  means of prevention 
for  many  of  them.  However,  the resurgence  of  certain  communicable  diseases  lends weight 
to  the  need  for  a re-examination  of vaccination  policies  used  by  Member  States to  assist in 
improving  their  control. 

29. 

Vaccination policies may  differ  in their aims, from  eradication to elimination  or to control of 
the  disease.  Eradication  means  bringing  about  the  total  and  definitive  disappearance  of  the 
causal  agent  and  the  disease,  but  it  can  only  be  successful  if  there  is  a  global  strategy  at 
international  level.  Elimination  means bringing  about  a  situation  in  which  the  causal  agent 
continues  to  exist  but  the  incidence  of  the  disease  is  extremely  low;  this  is  costly  for  the 
public  health  sector,  since  it  involves  regular  and  long-term  expenditure  on  vaccination 
programmes, permanent monitoring, and intervention whenever an epidemic flares up. On the 
other hand,  control  aims merely to bring about a situation where the existence of the disease 
does not constitute a major  health problem: the vaccination  policy  is directed towards certain 
groups  of the  population  considered  to be at high risk. 

30.  Member  States'  vaccination  policies  differ,  ranging  between  compulsory  vaccination,  either 
for everyone or for certain groups, and voluntary vaccination, with or without incentives such 
as  free  vaccines.  The  countries  with  the  most  similar  vaccination  policies  are  France, 
Luxembourg and the United Kingdom. All Member States vaccinate against diphtheria, tetanus 
and poliomyelitis,  and most vaccinate against whooping cough, measles, mumps and  rubella. 
Increasingly vaccination is also offered  against haemophilus influenza B. As concerns hepatitis 
B,  Italy  is  the  only  country  which  has  introduced  compulsory  vaccination  for  the  entire 
population,  since the incidence there is higher  than  in  any  other  country. 

11 

31. 

32. 

33. 

This  diversity  is  borne  out  by  WHO  statistics  (1991).  They  show  that  more  than  90%  of 
children  in the European  Community  are vaccinated  against  diphtheria  and tetanus, except in 
Ireland  (65%)  and  Spain  (86%).  Similarly  more than  90% are vaccinated  against  whooping 
cough,  except  in  Greece  (84%)  and  in  Italy  and  Ireland  (40%).  Child  vaccination  against 
measles  ranges  from  86% to  96% in the Member  States, with  the exceptions  of  Ireland  and 
Italy  (50%)  and  France  (77%). Finally,  the  child  vaccination  level  for  poliomyelitis  ranges 
between  88% and 99% in the European  Community, with the exception  of Ireland (63%) and 
Greece (77%). However,  caution  must be used in interpreting  these  statistics as the levels of 
vaccination  covet  are  calculated  differently  from  one  Member  State  to  another,  since  no 
common  criteria  are applied  and  the figures are  often  merely  estimates  rather  than  accurate 
calculations.  To  some  extent,  low  percentage  can  be  explained  by  the  absence  of  incentive 
measures when  immunization  was not  compulsory. 

Pursuing an effective vaccination policy at national level over a sufficiently  long period clearly 
pays off.  For  example, in the case of very  high  initial  incidence rates  of tetanus, it  has been 
possible to reduce them  considerably. Thus, the rate per  100 000 dropped from  2.21 to 0.4 in 
Portugal  between  1974  and  1991  as the  corresponding  vaccination  cover  rose  from  53% to 
over 94%; it went  from  1.33  to 0.14  in  Spain between  1980 and  1990; from 0.35  to 0.16  in 
Greece  between  1974  and  1990;  and  from  0.53  to  0.06  in  France  between  1974  and  1990 
where vaccination coverage grew from  79% to 92%. Where incidence rates were very low to 
begin with, a sustained vaccination effort  has made it possible either to keep the rate very low, 
as in  Great Britain  where  it  remained  at  0.03  between  1974  and  1989  or in  the  Netherlands 
where it decreased from 0.05 to 0.01 between  1974 and  1990, or to reduce it to virtually zero 
as  in  Denmark  and  Luxembourg.  The  results  are  even  more  spectacular  for  poliomyelitis, 
where maintenance  of extensive vaccination  cover during  a sufficiently  long period  - at least 
two  decades  -  has  led  to  extremely  low,  even  zero,  incidence  rates  in  the  European 
Community  nowadays, which  is more or less tantamount  to eradication  of the disease. 

The characteristic epidemiological features of influenza include the occurrence of frequent, but 
unpredictable  epidemics  and  periodic worldwide  pandemics.  Outbreaks  of  influenza  A  or B 
infection  are reported nearly every winter and vary in severity. Influenza  surveillance provides 
important information  on the timing and potential  of an influenza  outbreak.  This  information 
is  used  to  coordinate  an  appropriate  public  health  response,  including  issuing  guidelines  on 
vaccination  and  antiviral ^atment  and  assessing  the  need  for  additional  medical  resources. 
Vaccination  plays  an  important  role  in  reducing  mortality  and  morbidity  from  influenza, 
particulary  in groups at risk. It is most effective  when the influenza  strain  which is likely  to 
cause  an  outbreak  is identified  beforehand. 

34.  Mortality  from  influenza  increases  dramatically  with  age  and  the  presence  of  underlying 
medical  conditions. For instance, the  1989-90 epidemic in England  and Wales was the worst 
since  1976  and  was  thought  to  be  responsible  for  over  29  000  excess  deaths.  Increased 
numbers  of  deaths  from  cerebrovascular  or  cardiac  disease  were  also  recorded  during  the 
epidemic,  and  it  is probable that  influenza  played  a part  in  these  excess  deaths. 

12 

35. 

36. 

37. 

38. 

39. 

40. 

4. 

COMMUNICABLE  DISEASES  WHICH REQUIRE  SPECIFIC  MEASURES 

(a)  Hepatitis 

Hepatitis  is  a  condition  characterised  by  inflammation  of  the  liver  of  a  toxic  or  infectious 
origin,  provoking  a  change  in  the  hepatic  cells  and  consequently  a  change  in  normal  liver 
functions.  Viral  hepatitis  is  an  infectious  disease  common  throughout  the world  which  - on 
account  of  its  frequency,  severity  of  certain  forms  (acute,  chronic,  cancerous)  and  cost  of 
treatment  -  constitutes  a  serious public  health  problem.  Several  viruses  (A, B,  C,  D,  E  and 
others,  as yet unidentified)  may cause hepatitis, two of which  call  for  special  attention. 

Hepatitis B is one of the major human diseases against which safe and effective  vaccines have 
been  available  since  1982 in the Community.  A preliminary  analysis of a survey,  conducted 
by  the  WHO  Regional  Office  for  Europe,  estimates  that  900 000  to  1 000 000  people  in 
Europe  are infected  by hepatitis B  every year.  Of these, 24 000 will  die from the  effects  of 
the  chronic  disease,  cirrhosis  and  liver  cancer,  and  90 000  will  become  chronic  hepatitis  B 
carriers. About 85 000 cases of acute hepatitis B are reported every year to the WHO Regional 
Office  for  Europe.  The  carriers  also represent  a large reservoir  of  infection  which  serves  to 
perpetuate the infection^through various modes of  transmission. 

Among the types of viral hepatitis, hepatitis C - the virus causing it having been identified  in 
1989  -  warrants  special  attention  since its public  health  consequences  are  dire.  There  is  no 
vaccine  against  it  -  in  contrast  to A  and B  hepatitis  -  and  one  of  its  special  features  is that 
people  infected  by  the  C  virus  are  unaware  of  it  for  most  of  the  time,  with  the  disease 
developing quietly over one or two decades, without any obvious clinical signs in almost 95% 
of cases. 

The  specialists  acknowledge  that  in  the  natural  course  -  now  being  mapped  out  -  of  this 
disease  10% of those who have the C virus will  suffer  cirrhosis several years after  the initial 
infection,  and of those, 10 to 20% will develop cancer of the liver unless secondary prevention 
measures  are  taken.  Recent  epidemiological  studies,  undertaken  after  improvements  in 
screening  tests,  have  shown  that  some  16 million  people  are  infected  by  the  C virus  in  the 
Community.  This  gives  an  idea  of  the  size  of  the  problem  the  public  health  authorities  are 
facing  or will  face,  all  the  more  so given  the  fact  that  at  present  -  although  the  transfusion 
risk, i.e.  of infection  from  donated blood,  has been  substantially  reduced  - there  seems to be 
no plausible  explanation  for  50% of  infections. 

(b)  Tuberculosis 

Tuberculosis  has  been  a  major  affliction  of  man  since  ancient  times.  In  Britain  during  the 
industrial revolution of the eighteenth century, a tuberculosis epidemic claimed so many lives 
that  it  became  known  as  "the  white  plague".  Subsequently  the  disease  declined  steadily, 
probably  due to a combination  of  several  factors. 

The persistence of  a high level  of tuberculosis  in Europe  can be  attributed  to several  factors 
such as poor living conditions in certain regions of the world,  changing eating and  migratory 
patterns  and  resistance  to  some  strains  of  tuberculosis  bacteria  to  standard  treatments. 
Tuberculosis is a disease which can be prevented by vaccination,  yet there is less than  100% 
coverage by  current vaccination  programmes. 

13 

41. 

42. 

43. 

44. 

45. 

46. 

A retrospective WHO  survey in  1992 indicates that  50 000 new cases were registered  in the 
Community  in  1991, half  as many  as in  1974, and that the decline in tuberculosis has halted 
in most Member  States of the Community.  There was a steady  decline in the number of cases 
reported  in  Germany,  Belgium  and  France  between  1974  and  1991.  The  situation  had 
stabilised  in  Portugal  and  the  United  Kingdom,  while  increases  had been  observed  recently 
in Denmark,  Spain, Ireland, Italy  and the Netherlands.  There has been  a 5% annual  increase 
in France and the United Kingdom since 1992. These figures must be interpreted with caution, 
since  the  revival  of  interest  in  this  communicable  disease  could  have  led  to  more  diligent 
reporting  of  cases. Also, the definitions  used  are not  always the  same. 

In  some  countries  of  northern  Europe,  immigration  from  countries  where  tuberculosis  is 
endemic  seems  to  be  a  key  factor.  For  example,  in  Germany  the  number  of  cases  of 
tuberculosis  reported  in  nationals  continued  to  decline  between  1986  and  1989,  while  the 
number of cases reported among people coming from  countries where tuberculosis is endemic 
rose by an average of 7% each year during this period. Similarly, in the Netherlands there was 
a  5% annual  decrease in the number of cases reported  among Dutch  nationals between  1984 
and  1990, accompanied by an annual increase of  13% among the foreign  population. The rise 
in  cases  among, the  immigrant  population  does  not,  however,  seem  to  have  created  new 
outbreaks  of tuberculosis  infection  elsewhere. 

As regards possible links between the ADDS epidemic (and,  more widely, HIV infection)  on 
the  one hand,  and  the  resurgence  of tuberculosis  on the  other,  there  is no clear  evidence  of 
absolute  or  systematic links.  The proportion  of  AIDS  patients with tuberculosis  varies from 
2.3% in the United Kingdom to 23.9% in Portugal. This proportion is also higher among drug 
addicts  and  among those infected  via heterosexual  transmission. 

(c)  Nosocomial  infections 

Among  all  the  categories  of  communicable  disease  there  is  one  category  which  has  been 
known  about  for  some  time,  but  of  which  the  general  public  is  often  unaware.  This  is the 
category of nosocomial infections, i.e. infections which patients contract in hospitals and other 
health-care  establishments. 

Their importance is now recognised  and preventive measures, which are considered a priority 
in  all  health  establishments,  are underway.  This is essential  because the costs of  nosocomial 
infections  are  considerable  both  in  human  terms  (morbidity  and  mortality  rates)  and  in 
economic  terms  (they  cost  the  Community  tens  of  billions  of  ecus  each  year).  The  rate  of 
prevalence  of  nosocomial  infections,  i.e.  the ratio between  the  number  of  infections  and  the 
number  of  persons  present  in  health  care  establishments  varies but  averages  from  8 to  10% 
in the European  Community  as a whole. 

The  occurrence  of  these  infections  is  often  associated  with  invasive  procedures  during 
hospitalisation, such as surgery, catheter insertion or the use of artificial pulmonary ventilation. 
But  it  is  also  facilitated  by  a  patient's  advanced  age  or  reduced  resistance  to  infection 
(immunodepression).  This  explains,  for  example,  the  recent  occurrence  of  nosocomial 
tuberculoses  among  patients with HIV  infection. 

14 

47. 

In  order  of  frequency,  nosocomial  infections  occur  most  frequently  in  the  urinary  area 
(roughly  a half of all cases), then in the pulmonary area and in operation wounds. The germs 
most  often  isolated  are  Escherichia  coli,  staphylococci  and  Pseudomonas,  and  these  have 
developed  a much greater  multi-resistance to traditional  antibiotics. 

III.  OVERVIEW  OF  ACTIVITIES  ALREADY  UNDERTAKEN  IN  THE  MEMBER 

STATES AND AT COMMUNITY  LEVEL 

1. 

THE COUNCIL 

48. 

49. 

Council  Directive  92/117/EEC  of  17 December  1992  concerning  measures  for  protection 
against  specified  zoonoses  and  specified  zoonotic  agents in  animals  and  products  of  animal 
origin  in  order  to  prevent  outbreaks  of  food-borne  infections  and  intoxications(4)  provides 
among other things for  the collection of  data on the incidence  of  zoonoses  and the  presence 
of zoonotic agents in the human population, in domestic animals, in animal feeding  stuffs  and 
in  wildlife.  A  corresponding  Community  system  has  been  set  up  to  ensure  optimum 
implementation  of actions to combat  and prevent  such diseases. 

As regards other communicable diseases taking into consideration the existence of the single 
market  and the free  movement  of persons and foodstuffs,  the Council  specifically  addressed 
the need to take more account at Commumty level of the risks of the spread of  communicable 
diseases (including food-borne  diseases) by adopting  on  13 November  1992 a Resolution  on 
the  monitoring  and  surveillance  of  communicable  diseases(5) which  invited  the  Commission 
to  report  on  the  existing  transnational  surveillance  networks  in  this  field  and  to  submit 
proposals  for  improving  and  extending  such  networks  where  this  would  prove  useful. 
Moreover, the Council in its conclusions of  13 December  1993(6), stressed the need for  setting 
up  an epidemiological  network  in the Community, which, whilst it should  cover all  diseases 
whether communicable or not, should as a priority collect data on communicable diseases with 
a view to  acquiring better knowledge  of their causes and their epidemiological  context.  This 
emphasis  on  epidemiological  surveillance,  analysis,  and  training  was  also  shared  by  the 
European Parliament which in its resolution on public health policy  after Maastricht00, called 
on the Commission to set up an epidemiological  investigation  service and to collect,  analyse 
and  disseminate data on notifiable  diseases and to encourage the setting-up  and  operation of 
exchange  schemes for  health  professionals. 

50. 

On 3 May  1989 the Council adopted a Directive extending the scope of Directives 65/65/EEC 
and  75/319/EEC(8),  which  establishes  a number  of  specific  provisions  governing  the  placing 
of vaccines  on the  Community  market. 

(4) 

(5) 

(6) 

O J N o L 6 2,  15.3.1993, p. 38. 
O J N o C 3 2 6,  11.12.1992,  p. 1. 
O J N oC  15,  18.1.1994,  p. 6. 

(7)  OJ No 

(8) 

O J N oL  142, 25.5.1989, p.  14. 

15 

3) 

51. 

52. 

53. 

54. 

Active  medicinal  products  against  HIV  are  categorised  as  "high  technology  medicinal 
products",  and  as  such  qualify  to  be  dealt  with  under  the  centralised  procedure,  which 
facilitates and speeds up the process of obtaining authorisations for such products to be placed 
on the  market  at Community  level.  Since  1987,  high  technology  or  biotechnology-derived 
vaccines  have  been  covered  by  EC  pharmaceutical 
legislation  by  virtue  of 
Directive  87/22/EEC.  Other  vaccines  were  brought  into  the  scope  of  EC  pharmaceutical 
legislation  by Directive  89/342/EEC.  A  future  anti-AIDS  vaccine  would be  covered  by the 
same  legislation  and  would  benefit,  through  the  centralised  procedure,  from  provisions 
controlling its placing on the market at Community  level. 

Council Directive  89/381/EEC covers stable industrially  prepared blood derivatives intended 
for a large number of patients, such as albumin, coagulation factors and immunoglobulins, but 
does not apply to whole blood, plasma and blood cells of human origin.  These products are 
also subject to general provisions regarding manufacturing  and marketing authorisation.  The 
principles of good manufacturing practice laid down in Directive 91/356/EEC, as well  as the 
quality,  safety  and  efficacy  of  the  tests  referred  to  in  Directive  91/507/EEC,  are  thus 
applicable to these products. 

In  addition  to  these-general  provisions,  which  are  applicable  to  all  medicinal  products, 
Directive  89/381/EEC contains  several  elements which relate more specifically  to medicinal 
products  derived from human blood  or plasma.  The  measures  for  selection  and control  of 
blood donors recommended by the Council of Europe and the World Health Organization have 
become  compulsory  as a result  of this Directive.  Moreover,  for  these  particularly  sensitive 
products,  the  Council  has  demanded  the  application  of  validated  manufacturing  and 
purification  processes  in  order to  guarantee,  insofar  as the  state of  technology  permits,  the 
absence of  specific  viral  contamination (notably by HIV). 

In response to a request  from  the Council  which had expressed  concerns about the quality, 
safety  and supply of blood and plasma products in the Community following  the adoption of 
Council  Directive  89/381/EEC on medicinal  products derived from  human blood  or plasma 
in June  1989, the Commission submitted a Communication on "Blood Self-sufficiency  in the 
European  Community".  This  Communication 
issues  of  concern  to 
Member  States and specific  actions for consideration. 

identified  key 

55.  On 13 December 1993, following approval of the Commission's Communication on blood self-
sufficiency,  the Council adopted Conclusions on self-sufficiency  in the European Community 
which called inter alia for continued promotion of the quality  and safety  of blood  collection 
and of blood-derivative production(9). 

56. 

Council  Directive  93/43/EEC of  14 June  1993  on the hygiene  of  foodstuffs(10)  establishes a 
complete legal  context for taking any appropriate measure to combat health risks inherent in 
foodstuffs.  In dealing with every practical stage in the chain of use of foodstuffs,  from storage 
conditions to transport to supply to the consumer, this directive highlights the importance of 
food  hygiene  and, in use,  should contribute significantly  to ensuring that the requirement of 
a high level  of health is met. 

(9)  OJNoC  15,  18.1.1994,  p. 6. 
(10)  OJNoL  175,  19.7.1993, p. 1. 

16 

57. 

58. 

59. 

60. 

61. 

62. 

In its Resolution  of 29 May  1986, the Council  and the Ministers for Health  of the Member 
States,  meeting  within  the  Council,  requested  the  Commission  to  organize  an  exchange  of 
information  and experience  on AIDS(11).  As a result,  on  11 February  1987 the  Commission 
presented a Communication to the Council(12) laying down certain areas of action concerning 
AIDS prevention, information  and education. 

In the following years the Council and the Ministers for Health of the Member States, meeting 
within  the  Council,  adopted  a number  of  texts  dealing with  the  health  problems  posed  by 
AIDS,  the  most  important  of  which  was  the  Decision  of 4  June  1991  establishing  the 
"Europe against AIDS" programme. 

This health programme, scheduled to run from 1991 to 1993, focused principally on preventive 
actions such as information and education. As required by the Decision, the Commission sent 
to the  Council  on  10 March  1993  a report on the  implementation  of  the  plan  of  action in 
1991-1992. In this the Commission reported on the means deployed to achieve the objectives 
laid down in the Council Decision and commented on the early results obtained as well as on 
the relative weight and pertinence of the activities undertaken or requiring to be undertaken 
to give full  effect  to the aims of the Decision,  set against the backcloth of the spread of the 
epidemic.  The Commission also stated its view that there would be value in further actions 
on the public health aspects of HTV and AIDS being undertaken by the Community after the 
plan of action expired at the end of  1993. 

Following consideration of the Commission's report, the Council and the Ministers for Health, 
at their  meeting  of  27  May  1993,  agreed  to  invite  the  Commission  to  take  the  initiatives 
necessary for continuation of the actions of the "Europe against AIDS" programme in 1994, 
in anticipation of the entry into force of the Treaty on European Union, which provides in its 
Article  129 for Community action in the field of public health. 

The  subsequent  evaluation  in  the  Council  of  the  effectiveness  of  the  work  undertaken 
concluded  that the broad structure of  the areas of  action contained  in the  Council  Decision 
could  be  maintained,  but  with  a  number  of  modifications  in  the  objectives  pursued,  the 
introduction of new areas, and the deletion of others in order to reflect the changing needs of 
the Member States, increased knowledge of the problems posed by the disease, as well  as its 
evolution and trends. 

In order to avoid any break in the actions under the "Europe against AIDS" programme, and 
in order to respond to the wishes  of the Council,  the Commission  submitted to the Council 
on 29  September 1993 a Proposal for a Decision concerning the extension to the end of  1994 
of  the  1991-1993  plan  of  action  in  the  framework  of  the  "Europe  against  AIDS" 
programme(13). 

(11)  OJNoC  184, 23.7.1986. 
(12)  COM(87) 63. 
(13)  COM(93) 453 final. 

17 

63. 

Subsequent to the entry into force on 1 November 1993 of the Treaty on European Union, the 
Council  adopted on  13 December  1993  a Resolution  concerning the extension to the end of 
1994  of  the  1991-1993  plan  of  action  in  the  framework  of  the  "Europe  against  AIDS" 
programme(14). 

2. 

THE EUROPEAN PARLIAMENT 

64. 

65. 

66. 

67. 

68. 

As  long  ago  as  1984  the  European  Parliament,  in  adopting  a  number  of  Resolutions 
concerning the fight against ADDS, revealed its growing concern at the inexorable  spread of 
the epidemic and stressed the need for Community intervention. 

The European Parliament  has long taken interest in the frequency  and incidence  of  various 
communicable  infectious  diseases,  as reflected  by  the  numerous  written  and  oral  questions 
addressed to the Commission by MEPs. Two areas in particular have received attention and 
have  been  the  subject  of  reports  by  the  European  Parliament  Office  for  Scientific  and 
Technological  Options Assessment (STOA). 

The  first  of  these  reports,  published  in  1992,  concerns  the  protection  of  public  health  by 
vaccination.  The  conclusions  emphasise  the  need  for  more  information  on  the  levels  of 
vaccination cover in all Member States, advocate the establishment of a European programme 
for the surveillance of diseases preventable by vaccination  and call  for an aid policy to help 
European vaccine manufacturers in the face of international competition. Comprehensive, and 
sensitive  to  all  aspects  of  the  problem,  this  balanced  and  reasonable  report  constitutes  an 
important contribution to the public health debate, and one from which the Community could 
usefully  draw inspiration. 

The second report, at present in the course of being published, addressed the problems related 
to the resurgence of tuberculosis in Europe, and particularly its links with the AIDS epidemic 
and the movements of populations emigrating from places where tuberculosis is endemic and 
living in precarious socio-economic circumstances. The STOA's conclusions focus on the need 
to  facilitate  the  collection,  analysis  and  regular  dissemination  of  epidemiological  data 
concerning tuberculosis cases and setting up a network of laboratories for monitoring strains 
of bacillus tuberculosis which are multi-resistant to antibiotics. 

The European Parliament adopted two Resolutions during the July - December  1993  session 
dealing with  self-sufficiency  and the safety  of blood  and its derivatives.  The first requested 
the  Commission  and  Council  to  approve  an  action  plan  designed  to  improve  safety  and 
promote  self-sufficiency  through  voluntary  unpaid  donations.  The  second  called  for  the 
strengthening  of  controls  to  ensure  the  safety  of  blood  and  blood  products  and  for  the 
drawing-up  of  an instrument which  would  guarantee  the  monitoring  of  the  safety  of  blood 
from  donation to use,  and the setting up of a European blood  safety  authority. 

(14)  OJNoC  15,  18.1.1994,  p. 4. 

18 

IV.  COMMUNITY APPROACH 

1.  Objectives and means 

69.  As indicated in the Commission's Communication on the framework for action in the field of 
public health, Community action will, in particular, focus on encouraging cooperation between 
Member  States,  lending  support  to  their  action  and  promoting,  in  close  contact  with  the 
Member States, coordination of their policies and programmes. In practice, this will involve 
the  development  and  implementation  of  networks, joint  actions  and  information  exchange 
systems. 

70. 

Future  Community  action  in  the  public  health field must  take  account,  inter  alia,  of  the 
principle of subsidiarity  and the considerations set out in paragraph 27 of thé Commission's 
Communication. Activities should be selected on the basis of prior appraisal and should yield 
a Community added value while achieving maximum  cost-efficiency. 

71.  As  stated  in  the  introduction,  the  criteria  listed  in  paragraph  54  of  the  Commission's 
Communication  are  satisfied  from  a  public  health  perspective  since  AIDS  and  other 
communicable diseases undoubtedly can cause significant premature death, have a significant 
morbidity and potential to devastate unprotected populations, constitute a significant risk for 
each individual and for the society as a whole, have major socio-economic impacts, especially 
as regards intervention and treatment costs, and moreover practicable measures of prevention 
exist. The lessons of the first AIDS plan, as established in the evaluation process, show that 
there is substantial scope for added value from  Community actions, both from  economies of 
scale and from  dissemination of the results of projects. 

72. 

The  Commission  proposes,  in  paragraph  50  of  its  public  health  Communication,  four 
objectives which should form the basis of Commumty action: 

to prevent premature death which particularly affects the young and working population; 
to increase life expectancy without disability or sickness; 

(i) 
(ii) 
(iii)  to promote the quality of life by improving general health status and the avoidance of 

chronic and disabling conditions; 

(iv)  to  promote  the  general  well-being  of  the  population  particularly  by  minimizing  the 

economic and social consequences of ill health. 

This programme has to address all of these objectives. 

73. 

The following criteria in particular will be used in future in selecting projects for Community 
support in this  field: 

activities  on  a  scale which Member  States themselves  could  not,  or  could  only with 
difficulty,  implement; 
activities,  the joint  implementation  of which would  offer  obvious benefits  even  after 
taking account of the extra costs involved; 
activity which,  because of the complementary  nature of work being done at national 
level, enables significant results to be obtained in the Community as a whole; 
activity which leads, where the need is recognised, to the establishment of best practice 
norms and standards; 

19 

activities which contribute to the strengthening of solidarity and social cohesion in the 
Community, and promote its overall harmonious development. 

2. 

The Public Health Framework and the Community action programme on AIDS and 
other communicable diseases 

74. 

75. 

76. 

In  drawing  up  the  proposed  Community  programme the  Commission  has taken  fully  into 
account the substantial programmes that Member States already have. In accordance with the 
principles developed in the Commission's Communication on the public health framework, the 
proposed Community programme is intended to complement and enhance the effectiveness of 
Member States' actions and to avoid any duplication of work. 

The Commission seeks to ensure with its proposals that actions on the prevention of ADDS and 
other communicable  diseases enjoy  maximum priority  and adequate funding  and are given 
precise objectives. Priority will be given to large-scale wide-impact projects involving as far 
as possible  the  participation  of  governmental  and  non-governmental  organizations  with  a 
proven record in this  field. 

The  Community  -approach  must  be  designed  to  ensure  the  coherence  and  continuity  of 
preventive actions. The programme of activities has to address every stage of the prevention 
process,  including  information  and  data,  education,  specific  preventive  interventions* 
counselling  and  support.  It  must  also  include  all  parties  and  settings  involved  in  these 
activities, in order to promote the development of the necessary  skills, enhance cooperation 
between those undertaking actions, and foster coordination between those initiating preventive 
actions and the competent authorities. To achieve the maximum effect,  the Commission will 
give particular support to the creation of networks of organizations in the different  fields and 
to strengthening cooperation between existing networks. 

77.  As regards health education, health promotion, training, information,  and actions in relation 
to communicable diseases, these are to be conducted partly under the programme on health 
promotion, education and training and partly under the proposed programme focusing on two 
particular areas, namely: 

sexually  transmitted  diseases  (STDs),  with  special  emphasis  on  health  education 
initiatives  for  young  persons.  These  could  take  the  form,  for  example,  of 
education/information  campaigns, using appropriate communication  techniques, either 
for the general public or for particular groups in particular environments; 
diseases which can be prevented by vaccination. Information  on vaccination campaigns 
combination 
for 
measles/mumps/rubella,  aimed  at  parents  or  health  professionals,  especially  family 
doctors,  is  deemed  to  be  an  area  in  which  the  Community  can  make  a  substantial 
contribution. 

certain  diseases 

tuberculosis  or 

triple 

such 

the 

as 

20 

3.  Other instruments of Community action 

78. 

Special  attention  will  be  paid  to  the  obligation  contained  in  Article  129  which  states that 
health protection requirements shall form a constituent part of the Community's other policies. 
Many aspects of Community policy impinge on the prevention of communicable diseases and 
the Commission undertakes in its Communication on public health to ensure that full account 
is taken of health protection and communicable disease prevention issues.  The Commission 
has established  appropriate procedures to ensure that this  commitment  is  respected through 
adequate coordination and consultation in the development of relevant policies.  In addition, 
the  Commission  will  submit  on  a yearly  basis  a report  on the health protection  aspects  of 
policies which will  form part of the Commission's Annual Report. 

79. 

The following  are examples of  other Community  policies and instruments likely  to have an 
impact on the prevention of communicable diseases: 

certain instruments concerning the completion of the single market and consumer policy, 
particularly  as regards drug precursors, pharmaceutical  products in particular vaccines, 
medicinal products; 
social  affairs  policies  and  instruments,  particularly  concerning  migrants,  poverty, 
employment,  protection of workers' health and safety  and the European Social Fund; 
education and training for young people and health professionals, and activities targeted 
at young people in the field of culture, communication and information; 
instruments designed to protect citizens' rights and ensure free movement of information 
such as personal  data protection measures. 

80. 

The specific programme of research and technological development in the field of biomedicine 
and  health  (1994-1998)  lays  stress  on  the  integration  of  basic  and  clinical  research  and 
includes the following: 

viro-immunological research, genetics, and the molecular and structural biology of HIV 
and its variability; 
research towards the development of a safe and effective vaccine against AIDS, and of 
markers to evaluate its effectiveness  and to monitor the evolution of the disease; 
the  identification,  synthesis  and  evaluation  of  anti-viral  components  and  of  drugs 
designed to combat AIDS; 
clinical  research centred on clinical  trials, the treatment of AIDS and its opportunistic 
diseases, including research on the prognosis and progression of these diseases and the 
impact of treatment; 
studies of host response,  pathogenesis,  experimental  models and new pathologies, and 
of  resistance  to  conventional  forms  of  therapy,  taking  into  account  the  problem  of 
hospital  infections. 

81. 

Significant  progress  has been  achieved  in the fight against  AIDS  thanks to  AIDS  research 
supported and coordinated by the Community. 

21 

82. 

83. 

The establishment of the biomedicine and health research programme (BIOMED  1) under the 
third Framework Programme has enabled more than 6 000 research teams to collaborate with 
each  other  within  400  networks  set  up  to  encourage  cooperation  between  research  teams 
throughout the European Union and the European Economic Area and between complementary 
disciplines, with a view to tackling health problems which would be difficult  to resolve in a 
more limited context. 

As  regards  medical  and biomedical  research  specifically  into  communicable  diseases  other 
than  AIDS,  the  Commission  has  focused  on  a  certain  number  among  them  under  its 
BIOMED  1 programme and intends to do the same in the following phase, BIOMED 2. Even 
though  the  research  did  not  relate  particularly  to  public  health,  some  special  efforts  were 
undertaken by the European teams, for example in the field of tertiary prevention in the case 
of hepatitis C, this being a communicable infectious  disease which often  develops into liver 
cancer or exposes those infected to the risk of Lyme borreliosis. Also worth mentioning is the 
study concerning specific genetic markers in connection with the molecular epidemiology  of 
tuberculosis,  a new  discipline  which  needs  to  be  developed  much  further  but is  clearly  of 
significance for public health and the serious problem of the tuberculosis bacterium's multiple 
resistance to antibiotics. 

4. 

Cooperation between Member States 

84.  On the basis of previous work, potential priority fields for cooperation between Member States 

have already been identified.  These include: 

exchanges  of  information  on  management  regimes  for  people  with  HIV  and  AIDS, 
including  external maintenance and care in the community; 
cooperation on improving the methodology for evaluating care and therapeutic regimes, 
e.g.  drug utilisation-
consideration  of  access to treatment and care and how to meet the needs of particular 
groups,  such as children, pregnant women and migrants. 

85.  Where  appropriate,  the  Community  will  encourage  cooperation  between  Member  States  in 
these fields by supporting exchanges of information and experience and dissemination of best 
practice.  Cooperation  will  also  be  encouraged  through  the  development  of  networks  and 
support for programmes or pilot projects addressing objectives shared by the Member States. 

5. 

Cooperation with International Organizations and  Third Countries 

86. 

The activities of the Community programme should both add to the effectiveness of the global 
fight against AIDS and profit from relevant experiences gained in non-Community  states and 
the work  of  international  organizations.  The  activities  of the  Council  of  Europe  such as on 
ethical  questions and the World Health Organization's (WHO) work in many areas of public 
health has to be taken into account in the implementation of the programme. Equally, actions 
should  go  hand-in-hand  with  those  taken  by  non-Community  states  and  international 
organizations.  Cooperation in this field is therefore  necessary,  leading, where appropriate, to 
joint action. 

22 

87. 

The Commission intends to: 

build  upon  existing  cooperation  with  the  WHO,  the  Council  of  Europe  and  other 
international  bodies  by,  for  example,  developing  joint  actions  and  employing  their 
expertise in specific tasks; 
strengthen cooperation with third countries where possible, by promoting joint actions, 
involving them in Community  projects and providing  assistance for their programmes; 
contribute  to  the  WHO's  objective  of  eradicating  the  following  diseases:  measles, 
mumps, congenital  rubella, neonatal tetanus, diphtheria and poliomyelitis.  To this end, 
the Commission intends to establish an effective  partnership with the WHO Expanded 
Programme on Immunization (EPI), which includes those responsible for implementation 
of the EPI in each Member State; 
set  up  consultation  and  cooperation  with  the  WHO  for  the joint  production  of  an 
information 
instrument  based  on  the  diverse  surveillance  data  collected,  for 
dissemination to specialists. 

88. 

89. 

90. 

The PHARE programme,  set up in  1990, provides financial and technical  support for reform 
in the  countries  of  Central  and Eastern Europe.  In this  context  it  provides  support for the 
restructuring of health systems intended to improve their quality and effectiveness.  Activities 
against AIDS  can be  supported where they  are included in priority  action  areas such as the 
development  of training,  health promotion  and prevention  measures.  Similarly,  assistance 
may be available under the TACIS programme for the newly independent states of the former 
Soviet Union. 

The European  Community  has initiated AIDS  activities  for  developing  countries  under its 
development  programme,  on  the  basis  of  resolutions  by  Parliament  and  the  Council  of 
Ministers(15).  Drawing  on  the  lessons  of  7  years  experience  of  support  programmes  in 
developing  countries  the  Commission  has  presented  to  the  Council  a  Communication 
(COM(93) 479) defining main policy principles and priority strategies for the Community and 
the Member  States in the field of HIV/AIDS  in developing  countries.  The Communication 
was  endorsed  by  a  resolution  of  the  Council  in  May  1994.  The  Commission  has  also 
submitted a more general communication entitled "The Community and Member States' policy 
on cooperation with the developing  countries in the field of health" (COM(94) 77). 

Under the Lomé Conventions, very significative efforts have been, and are being, implemented 
to  support  ACP  countries  in  developing  health  care  systems  which  could  contribute  to 
efficiently  reduce  the  burden  of  communicable  diseases.  Special  attention  is  given  to  the 
development of preventive activities at peripheral level, the improvement of the physical and 
financial  accessibility  to  basic  health  care  and  essential  drugs,  particularly  antibiotics.  The 
EC/ACP AIDS programme was launched in 1987, with the collaboration of the ACP countries 
(the African,  Caribbean and Pacific  countries linked by the Lomé Convention). A year later, 
in  1988, the Community's ADDS programme was extended to cover all developing countries, 
and  the  accent  was  placed  specifically  on  prevention.  The  Commission's  total  financial 
contribution for the period  1987-1992 was ECU 74.8 million,  excluding funds  allocated for 

(15)  Parliament  Resolution  on  AIDS,  OJ No  C  88,  14.4.1986,  and  Council  Resolution, 

OJNoC  184, 23.7.1986. 

4) 

23 

91. 

92. 

research. The Member States contributed ECU  156.4 million over the same period, bringing 
the Twelve's total contribution to ECU 231.2 million. 

Since  1988 the European Community's research programme in the field of life  sciences and 
technologies for developing countries (EC-STD) has also focused  on specific  aspects of the 
ADDS  epidemic in developing countries. This programme contributes towards improving the 
balance between biomedical research and research on programmes, promoting socio-economic 
research,  developing  the  research  capacities  of  national  and  regional  research  institutes  in 
developing  countries,  and  making  more use of research  results in  order to  ensure that the 
findings  are rapidly put into practice. 

V.  COMMUNITY ACTION PLAN 

In many respects the Community's involvement in public health activities for the prevention 
of  communicable infectious  diseases other than  ADDS is relatively  new. The Community's 
contribution  complements  ongoing  work  in  this  field  by  the  Member  States  and  various 
international  organizations  competent  in  the  sphere  of  public  health,  notably  WHO.  The 
priority actions described here are based on the emerging needs in the Member States and for 
which there is value in undertaking activity at Community level. 

93. 

The general objectives are: 

to contribute to improving the prevention of communicable diseases in the Community 
by developing appropriate tools for the timely sharing of information  and for ensuring 
prior consultation  on communicable diseases and counter-measures, taking account of 
the existing situation; 
to develop and improve existing practical measures aimed at preventing the emergence 
or resurgence of such diseases. 

94.  As regards the HIV/AIDS epidemic, the following three broad aims are involved in particular: 

to contribute towards reducing the spread of HTV7AIDS in the Community; 
to  contribute  towards  minimizing  the  adverse  consequences  of  the  epidemic  for 
individuals and for  society; and 
to cooperate with the efforts  to combat AIDS and HIV outside the Community. 

A.  Actions on HIV/AIDS and sexually transmitted diseases 

I.  Data collection 

95.  National  epidemiological  data  are  currently  transmitted  to  the  European  Centre  for  the 
Epidemiological  Monitoring of AIDS in Paris which produces statistics for the Community. 
The data available for the Community as a whole are, however, confined to AIDS. Owing to 
differences  in Member States' approaches to HIV testing for  epidemiological  purposes, data 
on  the  prevalence  and  incidence  of  HIV  infection  in  the  Community  are  not  available. 
Moreover,  differences  in  Member  States'  collection  systems  and  in  the  application  of 
definitions  can delay  transmission  of the data to the Paris  Centre and  cause difficulties  in 
interpreting data from  different  sources. 

24 

96. 

97. 

In addition to epidemiological data, accurate information on people's knowledge, attitudes and 
behaviour  in  respect  of  HIV/AIDS  is  also  important  for  developing  policies  and  assessing 
preventive action. Member States' information varies, and that which is available is not always 
directly comparable. 

Finally,  the  measures  taken  to  combat  AIDS  and  HIV  in  the  Member  States  consume 
substantial  resources  of  finance  and  personnel,  and  these  are  likely  to  increase.  The 
development and promotion of objective parameters to assess the effectiveness  of prevention 
measures  is  important,  as  is  the  exchange  of  information  and  experience  which  enables 
Member States to compare actions, utilise the best practices developed so far and learn from 
each other about what has proved  effective. 

98. 

The objectives of Community actions could be: 

to improve the collection, analysis and dissemination of epidemiological  and other data 
on AIDS,  and increase the amount of data available on HTV infection while ensuring, 
insofar as identifiable personal data are concerned, that suitable safeguards are in place 
to protect the privacy of individuals; 
to  improve  the  available  information  on  AIDS-related  knowledge,  attitudes  and 
behaviour of the general public and target groups; 
to improve the quality of information on preventive measures and their effectiveness and 
promote its  diffusion. 

99. 

The actions to be taken to achieve these objectives could be: 

to  strengthen cooperation  and exchanges between Member  States in order to improve 
the quality, comparability and accessibility of ADDS data and to explore how more data 
on  HTV could  be  obtained,  in  this  context  the  establishment  of  equivalent  levels  of 
protection for personal  data at Member State level  is clearly a priority; support for the 
European Centre for the Epidemiological  Monitoring of ADDS to enable its work to be 
further developed; 
to collect, analyse and disseminate existing information on the knowledge, attitudes and 
behaviour of the general public and specific target groups and about preventive measures 
undertaken in the European Community: development of further Eurobarometer surveys 
of the general  public's knowledge  and attitudes concerning AIDS; 
to promote the development and use of assessment parameters to assess the effectiveness 
of the preventive measures, including the number and subject-matter of helpline calls, 
level  and kind of  media coverage,  and trends in the incidence of  sexually  transmitted 
diseases. 

2.  Measures for  children and young  people 

100.  Children and young people are best informed about the diseases at an appropriate time as part 
of  the  process  of  growing  sexual  awareness  and  personal  development.  Information  about 
HIV/AIDS and STDs provided to young people who may be tempted to experiment with high-
risk  activities relating to sex and drug abuse helps them to minimize the risks of infection and 
to comprehend  the impact  of the  diseases.  Such information  can be provided both within a 
formal educational setting and elsewhere, whether in youth and sports clubs, during organized 
holiday  activities or at entertainment venues. 

25 

101.  Wherever  the  information  is  provided,  it  must  take  account  of  age,  level  of  maturity  and 
cultural, religious and social background. Moreover, there are a number of  specific  settings, 
such as penal and military institutions, orphanages and residential homes for which tailor-made 
information  would  be  useful,  and  also  specific  groups  such  as  children  from  disrupted 
backgrounds, those with learning difficulties,  and drop-outs and 'streetkids' for whom special 
initiatives need to be developed. 

102.  General  health  and  sex  education  programmes,  which  cover  physical,  mental  and  social 
development and personal relationships, and also training for teachers and others involved are 
dealt with in the proposed programme on health promotion,  education and training. 

103.  The objectives to be pursued could be: 

to promote the provision of information  on HTV/ADDS and STDs to specific  groups of 
children and young people in specific  settings; 
to  strengthen  cooperation  and  exchanges  between  the  national  authorities  and  other 
organizations engaged in such work in order to improve the consistency of information 
provided in the different Member States. 

104.  The actions to be taken to achieve these objectives could be: 

promotion  of initiatives to provide information  relevant to specific  groups of  children 
and young  people  on  their  knowledge,  perceptions,  behaviour  and  needs  in  specific 
settings in relation to HTV/AIDS and  STDs  and to  exchange educational  and training 
materials and promotion of pilot projects; 
encouragement of studies and exchanges analysing current provision of HTV/AIDS and 
STD information to children and young people especially outside the educational setting, 
including issues  arising in  specific  settings and for  specific  groups,  and promotion  of 
pilot projects. 

3. 

Prevention of HIV and STD transmission 

105. 

Information  aimed  at  reducing  sexual  transmission  of  HIV  and  STDs  among  the  general 
population  must  be  complemented  by  specific  preventive  initiatives  targetted  at particular 
groups other than children an^*  young people who may be at higher risk or at settings where 
particular  problems  arise.  Experience  indicates  that  such  measures  would  be  of  value  to 
prostitutes and their clients, injecting drug users, travellers and tourists, for penal  institutions 
and for health service professionals. 

106.  The European Community  has already taken steps to ensure that condoms are manufactured 
to  the  highest  standards.  But  there  are  also  other  issues  to  address,  such  as  ensuring  that 
people use condoms properly and the need to develop and promote new methods of protection. 

107.  The objectives to be followed  could be: 

to reduce mother-to-child  transmission of HIV; 
to reduce HIV and STD transmission in specific  settings, such as penal institutions and 
hospitals, where there are particular problems; 

26 

to reduce HIV  and  STD transmission  among groups  whose members may  engage in 
high-risk behaviour, notably injecting  drug users and sex workers; 
to ensure that condoms available in the Community are as safe as possible when used 
correctly  and to promote other methods of protection for use by women. 

108.  The actions to be undertaken could include: 

information  on  transnational  tourism  and  travel  between  the  Community  and  non-
Community  states and promotion of appropriate pilot projects eg. in tourist resorts or 
frontier areas; 
information  for  pregnant  women,  in  particular  drug  users,  who  may  be  at  risk  of 
transmitting HTV infection to their children; 
information  for  people  with  HTV/AIDS  and  STDs  in  penal  institutions,  including 
information  for  prisoners  and  the  existence  of  harm-reduction  measures  such  as the 
provision of syringes for injecting  drug users; 
evaluation of the HTV/AIDS related knowledge, attitudes and behaviour of drug users 
and of HTV prevention strategies for them; exchange of information  on supplying safe 
injecting equipment and methadone programmes; 
exchanges of information  on the situation of those at particular risk of HIV and STD 
infection,  including sex workers and women involved with drugs, and on the actions 
being undertaken; 
exchange  of  information  on  the  development  and  promotion  of  new  methods  of 
protection. 

4. 

Safety of blood and blood products 

109.  The  administration  of  HEV-contaminated  blood  and  blood  products  to  haemophilia  and 
thalassaemia sufferers  and others requiring transfusions in recent years and the ensuing tragic 
consequences have underlined the potential hazards of blood transfusion  and highlighted the 
importance  of  ensuring  the  safety  of  blood  and  its  derivatives,  and  the  need  to  achieve 
Community  self-sufficiency 
in  blood  as  source  material  for  products  covered  under 
Directive 89/381/EEC, based on voluntary non-remunerated donations. 

110.  The control of blood and blood products to ensure that they are safe for use is a matter which 
is currently being examined by the Commission in close collaboration with the Member States, 
with a view to identifying  what further  common rules will be required. The results of this 
examination will be made available in a Communication which the Commission intends to 
transmit  to  Council  and  the  other  Community  institutions  in  due  course.  In  addition,  the 
Commission  is  pursuing  work  in  close  contact  with  the  Member  States,  concerning  the 
assessment of the situation in the Community as regards self-sufficiency,  survey of attitudes, 
behaviour and practices as regards donation and its promotion, optimal use of blood and blood 
products,  and assistance in creating networks so as to ensure exchange of  information  and 
facilitate transfers  of blood and blood products. 

27 

5. 

Social and psychological support 

111..  The  social  and  psychological  needs  of  the  rising  numbers  of  people  directly  affected  by 
HIV/AIDS are putting pressure on Member States' service provision. A particular problem is 
that  of  families  where  one  or  more  parents  and  children  are  infected.  Such  families  face 
enormous difficulties,  often  including  stigmatisation  and discrimination. 

112. 

In response  to these  problems one  significant  trend throughout the  Community  is  for non 
governmental bodies to play an increasing role in providing information, care and social and 
psychological  support. An accompanying  trend has been the growth  of  self-help  groups for 
people with HTV. Areas of non-medical support can profitably be addressed at the Community 
level  with a view to'assisting national  efforts. 

113.  The objectives in this field could be: 

to  assist Member  States to improve the  effectiveness  of their provision  for  social and 
psychological  support 
to  support the  activities  of  non-governmental  bodies,  including  self-help  groups,  and 
strengthen their capabilities. 

114.  The actions to be carried out could include: 

exchanges of experience about models of assistance and support, the promotion of pilot 
projects and of studies on the psycho-social  aspects of the disease 
exchanges on the needs of families with members infected with HTV; 
elaboration of manuals, bulletins and directories providing information on transmission 
of HTV, care and therapy, including organizations providing  advice and support; 
encouragement of networks of organizations, particularly in the voluntary sector, in these 
areas. 

6.  Combatting discrimination 

115.  Discrimination against people with HIV and ADDS and those close to them by, for example, 
excluding them from obtaining certain kinds of employment, housing, insurance, education or 
health care is both morally objectionable and undermines public health measures. In the face 
of prejudice and stigma HIV-infected individuals are more likely to conceal their seropositivity 
-  or even be deterred from discovering their sero-status -  and less likely to maintain contact 
with health and social  services which could assist them. 

116.  Unless people voluntarily come forward for such contacts, and unless people's  confidentiality 
and fundamental  freedoms are protected, the disease will  go undetected, making it harder to 
combat.  Moreover,  when  such- discrimination  is  combined  with  prejudice  against  people in 
marginalised  groups  and  minorities,  such  as  homosexuals  and  immigrants,  severe  social 
tensions and disruptions can result. 

28 

117.  Another  form  of  discrimination  is that  of forcing  certain  groups to be  screened  for  HIV  for 
reasons  unrelated  to  public  health  needs.  Practices  such  as the  mandatory  testing  of  certain 
groups  or  individuals,  such  as  prisoners,  the  armed  services,  people  seeking  or  holding 
particular  jobs  or  people  immigrating  to  or  entering  a  country,  exist  in  various  countries 
throughout  the  world.  Discrimination  may  also  occur  in  the  areas  of  HTV-testing  without 
consent, the violation of confidentiality  about someone's infection  and the compulsory tracing 
of  sexual  contacts. 

118. 

In the light  of this the objectives  could be: 

to increase people's understanding of AIDS and HTV and its effects  and reduce the fears 
and prejudices Tvnich can provoke  discrimination; 
to  assist Member  States' efforts  to combat  discrimination,  and to complement  these by 
Community  action, where appropriate. 

1.19.  The actions to be undertaken  could be: 

revision with Member States of the provisions on discrimination in the Resolution of the 
Council and the Ministers for Health of the Member States of 22 December  1989(16), and 
the measures taken in the Community  to avoid or reduce  discrimination; 
analysis of  actual  and potential  discriminatory  situations in the Community,  such as in 
the fields of employment, insurance, housing, education and health care and at  frontiers 
and  on  compulsory  screening  for  groups  such  as  immigrants,  prisoners,  employment 
seekers, patients and the armed  forces. 

B. 

Specific  Community  measures for  certain  communicable  diseases 

1.  Actions related to vaccination 

120.  One of the most  effective  methods of protecting^an individual  against certain  communicable 
diseases is vaccination, provided an effective vaccine exists, which unfortunately  is not always 
the case. Additionally, vaccination is one of the most cost-effective  health protection measures 
available for  both  populations and  individuals. 

121. 

In public health terms the risks of an epidemic are lowest when a sufficient  number of persons 
have  been  vaccinated  against  a  disease;  this  is  also  referred  to  as  the  level  of  vaccination 
cover,  the  ideal,  of  course,  being  100%  cover.  Obviously,  the  level  of  transmission  of  an 
infectious  agent responsible  for  a  disease  within  a given  population  depends  on the  level  of 
vaccination  cover within that  population. 

(16)  OJ No C  10,  16.1.1990, p. 3. 

-  u. 

29 

122.  Consequently, an effective public health policy in this field involves defining, perfecting and 
implementing  as  effective  a vaccination  programme  as possible,  and it  is for  the Member 
States  to  carry  out  such  a  programme.  Any  national  immunisation  programme  against  a 
particular disease will necessarily comprise two stages. The first is to build up stocks of the 
appropriate vaccine, provide personnel to perform the vaccinations, and encourage people to 
be  vaccinated.  The  second  is  to  verify  the  effectiveness  of  the  programme:  this  involves 
determining  the  level  of  vaccination  cover  and  changes  in  this  level  over  time  and  by 
geographical  area, monitoring the disease, and developing reference  laboratory  services for 
identifying  the strains responsible for the disease. 

123.  Coherent  and  reliable  data  on  levels  of  vaccination  cover  for  particular  diseases  or  on 
surveillance of such diseases do not generally exist. Additionally, the sources of information 
differ  widely from Member  State to  Member  State,  and  the  reliability  of  the  information 
concerning immunisation  schemes and the application  of  such  schemes is uncertain. These 
schemes are reflected in the vaccination schedules, which differ  in terms of dose, age of  first 
injection,  successive recalls, etc. The upshot is that there is no clear indication of the level of 
protection  of populations, and this poses a potential risk when imported  cases of  a disease 
appear in the population. 

124.  To  meet  the  requirement  of  a  high  level  of .health  protection,  a  vaccination  policy  at 

Community level could have the following  public health objectives: 

to  ascertain  as  accurately  as  possible  the  levels  of  vaccination  cover  for  particular 
diseases  in  each  Member  State,  so  as  to  provide  a  picture  of  the  overall  state  of 
immunisation in the European Community; 
to  contribute  towards  improving  vaccination  cover  wherever  necessary,  disease  by 
disease, by assisting in the launching of catch-up vaccination campaigns with a view to 
achieving a sufficiently  high level of vaccination cover to prevent the circulation of the 
infectious agents responsible for the disease. 

125. 

In this regard, the following  actions could be envisaged: 

publication of a document showing all the vaccination schedules at present available and 
in force in the Member States; 
definition  and  development  of  a  standard  methodology  for  assessing  levels  of 
vaccination cover; 
assessment  of levels of vaccination  cover in certain groups  of the population  such as 
children. 

2.  Creation and development of networks 

(a)  Surveillance 

126. 

Involving as it does the collection, recording and analysis of data on communicable diseases, 
and then communication  of the findings to the public health authorities, surveillance takes a 
number of forms,  depending on the type of communicable disease under investigation. 

30 

127. 

It can be carried out on the basis of clinical and/or biological criteria (the data being furnished 
by general practitioners and test laboratories) or on the basis of surveys (either exhaustive or 
via sampling, depending on the type of disease under investigation: rare and serious diseases 
require  exhaustive  surveys,  e.g.  obligatory  notifications  or  morbidity  registers,  whereas 
common  and  less  serious  diseases  require  sample  surveys  of  networks  of  doctors  or 
laboratories). Additionally, the validity  of the surveillance depends on the frequency of data 
collection, which may be continuous or periodic (but repeated at sufficiently  close intervals). 
Data may be collected passively  (i.e.  by awaiting the arrival  of the information)  or actively 
(i.e. through regular or permanent contact with the information source). 

128.  Surveillance  also  depends  on  the  administrative  level  involved  (i.e.  local,  national  or 
international),  and the  medium  selected  must be the  most  appropriate for the  requirements 
(particularly  as  regards  speed),  e.g.  written  questionnaire,  telephone  or  electronic  data 
transmission. Additionally,  a truly rigorous surveillance operation should feature at least two 
independent and complementary surveillance systems for the same disease: the exhaustiveness 
and representativeness of the data collected can then be verified by comparing the data from 
the different  systems. It requires adequate resources in order to ensure a satisfactory  level of 
operation and effectiveness. 

129.  All observations indicate that there is a need to improve, at Community level, the availability, 

quality, relevance and dissemination  of data on certain communicable diseases. 

130.  The diseases subject to such surveillance  can be grouped by category: 

diseases in which interest has been revived, tuberculosis (resistance to antibiotics) and 
blood transmission (hepatitis); 
diseases which can be prevented by vaccination,  which justify  a particular approach; 
nosocomial  infections; 
gastrointestinal  diseases (entero-haemorrhagic  E.  Coli,  salmonellosis,  etc.)  and certain 
other diseases (legionellosis, etc.). 

131.  The objectives of such surveillance can be stated as follows: 

- 

the early detection of  epidemic outbreaks; 
the  establishment  of  guidelines  for  epidemiological  intervention  to  contain  such 
outbreaks; 
identification  of the medium and long-term trends with regard to individual  diseases; 
identification  of at-risk groups; 
study of changes in modes of transmission; 
evaluation of prevention  strategies and corresponding measures; 
establishment  of  hypotheses  for  subsequent  research  and the  formulation  of  a public 
health plan. 

31 

132. 

In the light of these objectives at European Community level, the following  actions could be 
proposed: 

interlink Member  States' surveillance  systems, with the  emphasis on types  of  system: 
obligatory  notification  of  certain  agreed  diseases;  reporting  on  nosocomial  diseases; 
computer-linked  networks  of  doctors  and  laboratories;  one-off  studies;  surveys  on a 
given day; 
establish  a  consensus  for  the  adoption  of  a  case  definition  common  to  all  Member 
States,  as  well  as  on data collection  frequency  and the  nature  of  the  variables  to be 
collected; 
improve the quality of these systems by providing appropriate financial aid, to be jointly 
agreed with a group comprising  servers and users of these systems; 
offer  assistance  to  Member  States  requesting  it,  through  development  of  a  network 
structure based on pooled resources. 

133. 

In addition,  as regards nosocomial  diseases, the objectives of a Community policy could be: 

to improve awareness of the existence of nosocomial infections, which are often masked 
by  the  patient's  weakened  state  of  health,  through  establishing  consultation  and 
coordination between the few existing national or regional  surveillance networks in this 
field, with a view to achieving a minimum level of comparability of results recorded at 
local  level  and identifying  the role and distribution of risk factors; 
to  promote  exchanges  of  experience  on  the  ways  in  which  surveillance  results  are 
analyzed,  processed  and used  by  the  players  in  the  field,  with  a view  to  preventing 
nosocomial  infections and reducing the related hospitalisation costs; 

to promote and support the gradual creation of new surveillance networks so as to make 
the national  public health authorities more aware of the problem  and begin to include 
data  on  nosocomial  infections  in  their  routine  data  surveys  concerning  hospital 
conditions. 

134.  To achieve these objectives, the Commission  could carry out the following  specific  actions: 

production  of  standard  protocols  for  nosocomial  infection  surveillance,  to  include 
infection  definition  criteria, inclusion criteria and infection  coding conventions; 
creation of a reference database usable by all health care establishments in the network, 
showing the incidence of certain important nosocomial  infections by reference to types 
of risk factor and types of prevention practices used; by highlighting regional  differences 
in prevention and treatment practices, the database will  also make it possible to identify 
real  problems which the aggregated national  results tend not to reveal. 

(b)  Dissemination of epidemiological  information 

135.  The  data collected  in the surveillance  of  communicable  infectious  diseases  must,  of course, 
after  being  validated  and  interpreted,  be  disseminated  in  a  suitably  processed  form  to the 
public health authorities,  so that they  can define  and adopt appropriate preventive measures, 
and to the players in the field, such as general practitioners, who are often the original sources 
of the information. 

32 

136.  The information  in  question  may  serve one of two  purposes:  it  may  relate to an  emergency 
situation  where  outbreaks  or  epidemics  of  a  communicable  infectious  disease  have  been 
observed, in which case the public health authorities need to be alerted so that swift  action can 
be taken,  or it may relate to a routine situation,  i.e. be no more than a periodic transmission 
of the harmonised surveillance data produced by the national surveillance systems or networks. 

137. 

In  the  first  case,  succinct  and  validated  information  must  be  communicated  rapidly  using 
communication  systems  such  as  electronic  data  transmission.  In  the  second  case,  the 
information  is more elaborate in nature and transmitted to the health professionals and health 
authorities in the form  of  a specialist bulletin with  a suitable, but not  excessively long  time-
lag. In both  cases there is a requirement  for  the  existence  of  a combination  of  a  network of 
surveillance  systems with  validated  information  available  on  an  appropriate  communication 
medium. 

138. 

In the light of the above, the Community's objectives  in this area could  be: 

improved knowledge and wider dissemination (i.e. beyond the Member  State of origin) 
of  existing national  epidemiological  bulletins containing both  routine surveillance  data 
(quantitative information)  and  specific  original  articles (qualitative  information); 
creation of an epidemiological information  service open to health specialists and players 
in the public health field throughout the Community, the information being disseminated 
at intervals compatible with the requirements of  public health  action in the field. , 

139. 

In  order to achieve these objectives  the Commission  could  carry  out the following  actions: 

- 

a  pilot  study  to  establish  the  added  value  of  a  weekly  notice,  to  be  available  to  all 
existing national  communicable  disease  surveillance networks  electronically; 
a pilot study for the production of a two-monthly or three-monthly European Community 
bulletin  of  four  to  six  pages,  designed  for  the  same  public  as  above  and  comprising 
processed  data. 

3. 

Information,  education and training 

140. 

Increasing the population's  knowledge  and understanding  about  communicable  diseases  and 
their  implications  is  needed  to  prevent  transmission  and  reinforce  preventive  efforts.  The 
development  and  implementation  of  information  campaigns,  whether  aimed  at  the  general 
public  or  at  specific  groups,  are  a  key  instrument  in  prevention.  They  must,  however, 
essentially be undertaken by each Member State and what is appropriate and effective  in each 
State  varies  according  to  their  different  traditions  and  to  the  different  patterns  of  disease. 
Nonetheless,  the  Community  can  help  Member  States  to  draw  on the  results  of  experience 
elsewhere  as coordinating  campaigns  across the  Community  can  boost  the  overall  visibility 
and  impact  of national  activities. 

141.  There is also an increasing need for information  activities to respond to the growing mobility 
of  the  Community  population  and  for  specific  measures  to  be  targetted  at  groups  such  as 
tourists, migrants,  refugees  and  occupational  travellers. Moreover,  information  is needed by 
those working in the media to ensure accurate reporting in relation to HIV/AIDS and  certain 
other  communicable  diseases.  Activities  at  the  Community  level  can  help  to  supplement 
national  measures in this area. 

33 

142. 

Individuals with particular personal  concerns need access to specific  information  and advice 
with  proper respect  for their privacy  and confidentiality.  Together  with  specialised  advice 
centres, telephone helplines and other response mechanisms using modern technology  play a 
valuable role. However, such facilities do not exist everywhere in the Community, nor do they 
all provide the same high level  of service. 

143.  Those  involved  in  communicable  disease  prevention,  care  and  support  activities  and 
professionals whose work may bring them into contact with infected people with, for example, 
HTV and ADDS or hepatitis,  such as the emergency  services  and prison  staff,  need relevant 
information  and  training  about  the  disease,  basic  preventive  techniques,  but  also  how  to 
provide advice and counselling.  Initiatives to improve relevant training will  help ensure that 
the resources available are used to the best effect  in the whole  Community. 

144.  Because  of  a  shortage  of  manpower  in  the  field  of  epidemiology,  particularly  as  regards 
surveillance methodologies, and of the wide diversity of methods used to assess the extent of 
infectious diseases and control them, the use of comparative evaluation methods is at present 
difficult.  Any  attempt to improve this situation has also to take account of  the international 
dimension, and in particular the European Community dimension. This is particularly true with 
regard to grouping cases of a disease of unknown aetiology. 

145.  Field epidemiology  involves the application of  epidemiological  methods to the surveillance, 
data  production,  public  health  action  and  control  of  communicable  diseases,  so  that  all 
measures are taken to stop the spread of an epidemic outbreak and eventually  extinguish it. 

146.  At present the information emanating from Member States is not comparable because of the 
wide  diversity  of  their  surveillance  systems.  Added  to  this  is  the  fact  that  few  epidemic 
outbreaks are detected and properly investigated.  It is rare, when a public health problem of 
this nature arises, for a case investigation to be carried out and appropriate recommendations 
to be drafted,  often  because there is a lack  of  epidemiological  training which would enable 
those  serving the surveillance  systems to deal with this type of situation. 

147.  There is therefore  a need to provide  specific  training which would  involve not only  a basic 
academic element but also practical experience of approximately two years in several Member 
States. This is a model which has proved its worth in the USA and Canada but which cannot 
be found anywhere in Europe. The aim is to train a limited number of specialists who would 
then  be  capable  of  investigating  outbreaks  of  epidemics,  controlling  them  and  preventing 
communicable  infectious diseases. 

148.  Against this background,  the Community's  aim could  be to  improve  public health  practices 
with regard to the routine surveillance of infectious diseases and epidemic outbreaks whenever 
and wherever these occur in the Community. 

149.  The objectives in this area could be: 

to increase the level  of knowledge and understanding of the general public and specific 
groups about certain communicable  diseases and their impact; 
to maximise the effectiveness  of Member States' campaigns by  coordinating activities, 
where feasible,  and by complementing them with Community initiatives; 

34 

to  extend  the  existing  telephone  and  other  response  mechanisms  and  improve  their 
effectiveness  and  cooperation; 
to improve the skills and knowledge of those directly involved or whose work may bring 
them  into contact with  communicable  diseases; 
to monitor,  and help to improve existing training  courses  and  materials; 
to ensure  appropriate  awareness  of communicable disease prevention  and  other issues; 
to foster  a multi-sectoral  and multi-disciplinary  approach to  prevention. 

150.  With  a view to achieving these  objectives  the Commission  could: 

encourage exchanges between Member  States and improve cooperation  on  information 
campaigns  aimed  at the general  public and specific  groups, including the  development 
of ways  to/reinforce  and  link  information  campaigns by  using  Community  media  and 
producing  specific  materials to give campaigns  a Community  dimension; 
promote the provision of information  for use in the workplace and in the framework  of 
health  screening and  surveillance; 
investigate the  provision  of  telephone  and  other  response  mechanisms,  and  of  centres 
providing  information,  and  encourage  the  formation  of  networks  and  exchanges  of 
personnel  and expertise,  and  develop pilot  projects; 
facilitate an examination of the training programmes currently in use for health and other 
professionals  coming into contact with communicable diseases in order to identify  gaps 
and  help to devise further-training  programmes; 
promote  new  training  opportunities  for  those  directly  involved  with  communicable 
diseases  and  the  exchange  of  materials,  experience  and  personnel,  and  of  trainers  and 
students; development of pilot programmes involving exchanges between specific  kinds 
of  statutory  bodies  and  voluntary  organizations  and  implementation  of  pilot" further-
training programmes for  people whose work brings them into contact with HIV/AIDS, 

'  such  as personnel  in the emergency  services and penal  institutions; 

- 

facilitate an assessment of staff training in non-governmental  organizations and promote 
interchanges  for  the dissemination  of  expertise  and best  practice; 
create a steering group, comprising representatives from  the Member  States, to examine 
how  to  improve  the  training  for  field  epidemiologists  specializing  in  communicable 
diseases; 
help develop a network of public health  epidemiologists with  a view to defining  action 
objectives  and  common  methods. 

4. 

Early detection and systematic screening 

151.  Systematic  and  early  screening  for  communicable  diseases  is  an  important  element,  both  to 
limit the spread  of such diseases within the population  and  also to improve the prognosis  for 
affected  individuals, by making it possible to  start effective  treatment  as soon as possible. 

152.  Some communicable diseases give a clear and rapid indication  of their presence, thus making 
superfluous  any  approach  involving  systematic  and  early  screening  for  them.  The  situation 
is  different  for  the  communicable  diseases which  develop  quietly  in  a more  or  less  chronic 
manner  (hepatitis  C,  certain  parasitoses),  for  particular  forms  of  communicable  disease 
(tuberculosis), or, finally, for those with specific consequences among certain at-risk categories 
of  the  population  (toxoplasmosis  in  pregnant  women).  Due  to  the  hidden  nature  of  these 
communicable  diseases,  early  screening  for  them  must  include  supplementary  targeted 

35 

examinations: specific  serological analyses for hepatitis C and toxoplasmosis, lung X-rays for 
tuberculosis,  parasitological  examination  of  stools for  certain  helminthiases,  etc. 

153.  Analysis of the situation in the Member States shows that the methods of early and systematic 
screening  for  such  communicable  diseases  often  vary  and  that  it  would  be  beneficial  to 
promote exchanges of information  and experience in this field. Such exchanges could lead to 
the  start of  pilot projects  and the drawing-up  of recommendations  at Community  level.  The 
experience  gathered  from  early  and  systematic  screening  for  an  initial  number  of  specific 
communicable diseases could be applied to other diseases if the associated  feasibility  studies 
and  cost/benefit  analyses  showed mis to be  useful. 

154.  The  objectives  could be as follows: 

to  contribute  to  the  development  and  establishment  of  early  detection  and  effective 
screening  systems for  communicable diseases; 
to  spread  the  use  of  appropriate  practices  based  on  guidelines  to  be  drawn  up  at 
European  level in the quality  assurance protocols for  the screening and  early  diagnosis 
of  communicable diseases; 
to improve the quality of communicable  disease screening through the  development of 
continuing training of health personnel. 

155.  The  strategy  could include the following  key elements: 

the  promotion  of  investigations  on  the  effectiveness  and  feasibility  of  screening  for 
certain types of  communicable  disease (tuberculosis,  hepatitis, etc); 
support for the training of health personnel, in particular in the context of early detection 
and  systematic  screening of communicable  diseases; 
cost-benefit  analysis  of  screening  for  different  types  of  communicable  disease,  in 
particular  among pregnant  women. 

VI.  CONSULTATION, ASSESSMENT AND  REPORTS 

1.  CONSULTATION  AND PARTICIPATION  MECHANISMS 

(a)  Advisory  Committee 

156.  The experience of the "Europe against ADDS" programme between  1991 and  1993 has shown 
the value of having an appropriate consultation and coordination  structure. In order to permit 
the  fullest  possible  integration  of  the  various  partners  involved  in  the  Programme,  the 
Commission will propose the creation of an Advisory Committee composed of representatives 
from each Member State and chaired by the Commission. The composition of the Committee 
should ensure optimum representation of the interests and expertise of the national authorities, 
the  health  professionals  and  the  NGOs  competent  in  the  field  of  ADDS  and  other 
communicable  diseases.  The  Committee  will  assist  the  Commission  in  all  policy  questions 
relating  to  ADDS  and  other  communicable  diseases,  and  in  particular  relating  to  the 
programme's  development  and  approach. 

36 

(b)  Other participants 

157.  The Commission will encourage the Member States to set up national coordination committees 
for  the  programme  on  AIDS  and  other  communicable  diseases  in  order  to  enhance  the 
motivation  and  involvement  of  the  national  players.  These  national  committees,  the 
composition  and functions  of which will  be determined  locally,  have already  proven their 
worth,  in  other programmes, in improving the coherence  of  actions undertaken  at national 
level and in helping the national partners involved to work together more closely. 

158. 

In  the  past  few  years  of  the  Community  AIDS  programme,  the  NGOs  involved  have 
contributed generously to the realisation of Community actions, both in funds and in expertise. 
In view of the instrumental role in prevention, care and research played by these organizations, 
the Commission will maintain and strengthen its links with them, both through the Advisory 
Committee described above and through direct links with them. 

159.  The Commission will seek, in particular, to involve other partners, as justified  by the extent 
of its action on AIDS and communicable diseases and by the implications for other fields of 
action in the area of public health. In this context, the Commission will ensure that its action 
on AIDS and other communicable diseases is consistent with  "horizontal" actions and with 
actions under specific action programmes addressing other diseases. 

2.  ASSESSMENT AND REPORTS 

160.  The assessment of the action plan will comprise three main elements: 

a  mid-term  report  on the  execution  of  the Programme  to  the  Council,  the European 
Parliament, the Economic and Social Committee and the Committee of the Regions; 
an independent peer review evaluation of the major  actions and studies  funded; 
a  global  report  on  the  efficiency  and  effectiveness  of  projects  undertaken  under  the 
action plan to be submitted to the relevant Institutions by the Commission at the end of 
the execution of the Programme. 

161.  Mid-term  and global reports on the execution of the action plan 

The purpose of the mid-term report is to ensure that the institutions, and through them all the 
parties  concerned,  are kept fully  informed  of the progress  of the actions undertaken  in the 
context of this action plan. It will include an analysis of projects supported under the different 
actions and a detailed examination  of activities in other  sectors relevant to AIDS and other 
communicable diseases. The Commission will also submit a final global report at the end of 
the action plan. 

37 

162. 

Independent peer review evaluation of the major actions and studies funded 

Experience acquired in the actions between  1991 and 1993 under the "Europe against ADDS" 
programme has highlighted the need for more effective  evaluations of the Programme, both 
nationally and at European level. Such evaluations would facilitate the transferability of results 
of pilot projects from one country to another and hence increase the European added value of 
the Programme. In order to introduce effective  evaluations of this type, the Commission may 
consult  national  authorities  and  other  experts in  the  field  in  order to  establish  appropriate 
criteria and protocols. 

3.  GENERAL INFORMATION ACTIVnTES 

163. 

In addition  to the  information  activities  contained  in the Programme,  the Commission  will 
ensure that the general public and all parties concerned have access to the results of the most 
important actions,  studies and assessments undertaken. 

38 

Proposal  for a 
EUROPEAN PARLIAMENT AND COUNCIL DECISION 

94/0222 (COD) 

adopting a programme of Community  action on the prevention of 
ADDS and certain other communicable diseases within the 
framework for action in the field of public health 

39 

EXPLANATORY  MEMORANDUM 

1. 

2. 

3. 

4. 

5. 

In its Communication of 24 November  1993 on the framework  for action in the field of public 
health, the Commission  defined  a framework  for  future  Community  action  in order to attain 
the  objectives  on  health  protection  laid  down  in  Articles  3(o)  and  129  of  the  Treaty 
establishing  the  European  Community.  The  role  of  the  Community  is  identified  as 
underpinning  the  efforts  of  the  Member  States  in  the  public  health  field,  assisting  in  the 
formulation  and implementation of objectives and strategies, and contributing to the provision 
of health protection across the Community, setting as a target the best results already obtained 
in a given area anywhere in the Community.  Community  action is directed to the prevention 
of  diseases  and  the  provision  of  health  information  and  education.  Health  protection 
requirements must also be part  of  other Community  policies. 

Future  Commumty  action  in  the  public  health  field  must  take  into  account,  inter  alia,  the 
principle  of  subsidiarity  and  the  requirement  of  proportionality.  It  is  worth  noting  in  this 
context,  that  the  diversity  observed  within  and  between the  Member  States  in  respect  of 
geography, climate, lifestyles, culture, socio-economic conditions and the environment is such 
that,  generally  speaking,  no  detailed  requirements  can  be  proposed  by  the  Community. 
Activities  must  be  selected  on  the  basis  of  prior  appraisal  and  should  yield  a  Community 
added value while achieving maximum  cost  efficiency. 

The present proposal  sets out the objectives and action areas for  a programme on AIDS and 
certain other communicable diseases which is intended to run during the period  1995 -  1999. 
The  Community's  role  will  primarily  be  to  promote  cooperation  between  Member  States, 
support  their  actions promote co-ordination between their  policies and  programmes  in  close 
the  Member  States  themselves,  complement  their  actions,  where 
collaboration  with 
appropriate,  with  measures  at the  Community  level  and  ensure that Community  policies  in 
other  areas-such  as  education,  social  policy  and  the  implementation  of  the  single  market 
support the prevention  of these diseases. 

The  aims  of  the  programme  are  to  reduce  as  far  as  possible  the  spread  of  certain 
communicable diseases, including HTV and ADDS, in the  Community, to minimize the adverse 
consequences  for  individuals  and  for  society  and  to  cooperate with  efforts  to  combat  them 
outside the Community.  In the light of these aims, the Community approach must be designed 
to ensure the coherence and continuity of preventive action and thus must address every  stage 
of  the  prevention  process  including  information  and  data,  education,  specific  preventive 
interventions,  such as screening  and vaccination  where feasible  and  appropriate,  counselling 
and  support,  and  cover  all parties and  settings involved  at the various stages. 

A wide range of preventive measures will be needed to pursue these aims,  and some of these 
will have to be implemented in close liaison with other existing Community programmes such 
as those on research  and development assistance, or those currently  being developed,  such as 
those  on  drug  dependency;  health  promotion,  education  and  training;  and  health  data  and 
indicators,  and monitoring  and  surveillance  of diseases. 

40 

6. 

7. 

The previous  action programmes  on  ADDS emphasised  a number  of  fields  of  activity.  It is 
proposed to continue these actions whilst extending the programme to include  certain other 
communicable  diseases.  The  fields  of  activity  identified  in  the  communication  on  the 
framework  for  action  in  the  field  of  public  health  are:  epidemiological  data;  provision  of 
information to the public and specific target groups; health education; training; early detection 
and screening; research; and cooperation with international organizations and third countries. 
Other priority  areas  identified  are gathering and disseminating various kinds of  information 
on the spread of the diseases and the measures taken in response, measures for children and 
young  people,  specifically  targeted  preventive  interventions,  blood  transfusion  transmitted 
diseases,  social  and psychological  support, combating discrimination  and  screening tests. 

The Commission will transmit a mid-term and a final global report on the implementation of 
the programme to the Council, the European Parliament, the Economic and Social Committee 
and the Committee of the Regions. Moreover an indépendant peer review evaluation will  be 
conducted of the major actions and studies funded. These will enable the institutions to assess 
the  progress  and  impact  of  the. work,  and  of  the  actions  undertaken  and  the  methods  of 
implementation  could then be modified,  if required. 

41 

EUROPEAN PARLIAMENT AND COUNCIL DECISION 

94/0222  (COD) 

Proposal for a 

adopting a programme of Community action on the prevention of 
AIDS  and certain other communicable diseases within the 
framework  for action in the field of public health 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article  129 thereof, 

Having regard to the proposal from the Commission(1), 

Having regard to the opinion of the Economic and Social  Committee(2), 

Having regard to the opinion of the Committee of the Regions(3), 

Whereas the prevention of  diseases, in particular the major health  scourges, including drug 
dependence, is a priority for Community action, requiring a global and coordinated approach 
between Member States; 

Whereas AIDS is at present an incurable disease which, given its modes of transmission, can 
only be effectively  combated by preventive measures; 

Whereas  the  plan  of  action  adopted  by  Decision  91/317/EEC  of  the  Council  and  the 
Ministers for Health of the Member  States, meeting within the Council(4), in the framework 
of the "Europe against AIDS" programme expired at the end of  1993; 

Whereas,  in their conclusions  of 27 May  1993(5),  the Council  and the Ministers for Health, 
meeting  within  the  Council,  emphasised  the  need  to  continue  the  activities  of  the 
"Europe against AIDS" programme; 

| 

(1)  OJNo 
(2)  OJNo 
(3)  OJ No 
(4)  OJ No L  175, 4.7.1991, p. 26. 
(5)  Doc.  6946/93  SAN 36. 

42 

Whereas,  in  consequence,  the Commission  submitted  to the  Council  on 29  September  1993 
a Proposal  for  a Decision  concerning the extension to the end of  1994 of the  1991-1993 plan 
of  action  adopted  in  the  framework  of the  "Europe  against  ADDS" programme^,  to  ensure 
continuation  of  the  Community  actions  to  combat  AIDS  pending  the  adoption  of  a 
multiannual  action  programme;  whereas  the  Council  adopted  on  2  June  1994  a  common 
position  concerning  that  proposal(7),  with  a  view  to  extending  the  "Europe  against  AIDS" 
programme  to the period  1994-1995; 

Whereas, in its conclusions of  13 December  1993(8), the Council  agreed that it was necessary 
for the Community  as a whole to acquire a better knowledge of diseases on the basis of their 
causes and their  epidemiological  context; 

Whereas,  in  the  same  conclusions,  the  Council  emphasized  that  all  smooth  running  of  a 
network for  gathering epidemiological  data requires that theoretical  training in  epidemiology 
and practical preparation in epidemiology in the field be developed for the teams participating 
in the  network; 

Whereas in their resolution of  13 November  1992(9), the Council  and the Ministers for Health 
meeting  within  the  Council  invited  the  Commission  to  consider  the  existing  arrangements 
which provide for cooperation between Member States in the field of monitoring and control 
of communicable  diseases; 

Whereas  the  actions  undertaken  at  Community  level  in  the  field  of  ADDS  need  to  be 
continued  and  extended  to  cover  certain  other  communicable  diseases,  and  also  to  be 
consolidated  within  the framework  of the action  in the  field  of  public health  set  out  by  the 
Commission(10); 

Whereas  the  actions  must  take  into  account,  as the  Council  requested  in  its  Resolution  of 
27 May  1993(11), other actions undertaken by the Community  in the field of public health or 
having  an impact  on public  health; 

Whereas  in  its Resolution  of 2 June  1994 concerning  the framework  for  Community  action 
in the field of public health(12), the Council  agreed that priority  should be given  at present to 
AIDS  and  other  communicable  diseases; 

Whereas,  in  accordance with  the principle of  subsidiarity,  actions  on matters not within  the 
exclusive  competence  of  the  Community,  such  as  action  on  HIV/AIDS  and  communicable 
diseases, should be undertaken by the Community only when, by reason of its scale or  effects, 
its objectives  can be better  achieved  at Community  level; 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

COM(93) 453  final  of 29.9.1993. 
OJ No  C 213, 3.8.1994,  p. 220. 
O J N oC  15,  18.1.1994,  p. 6. 
O J N o C 3 2 6,  11.12.1992,  p.  1. 
COM(93)  559 final of 24.11.1993. 
O J N oC  174, 25.6.1993, p.  1. 
O J N oC  165,  17.6.1994,  p. 1. 

43 

Whereas  cooperation  with the  competent international  organizations  and with non-member 
countries should be strengthened; 

Whereas a multiannual programme is required, defining the objectives of Community action, 
the  priority  actions  for  the  prevenion  of  AIDS  and other  communicable  diseases,  and the 
appropriate evaluation mechanisms; 

Whereas  the  objectives  of  this  programme  must  be  to  contribute  towards  improving 
knowledge  concerning  the prevalence  and patterns  of  HIV/ADDS  and other  communicable 
diseases, improving recognition of risk situations and improving early detection and social and 
medical  support, with a view to preventing the transmission  of  communicable  diseases and 
thus reducing the associated mortality and morbidity; 

Whereas, from  an operational  point of view, past actions to establish European networks of 
non-governmental  organizations  and  to  mobilize  resources  should  be  maintained  and 
developed; 

Whereas possible duplication of effort  should be avoided by the promotion of exchanges of 
experience and by the development of information material  for the public, health educators 
and those who train the health professions; 

Whereas this programme should be of five-year duration in order to allow sufficient time for 
the various actions to be implemented and to achieve the objectives set, 

HAVE DECIDED AS FOLLOWS: 

Article 1 

A  Community  action  programme  on  ADDS  and  certain  other  communicable  diseases  is 
adopted for a five-year period. 

Article 2 

The  Commission  shall  ensure  implementation  of  the  actions  set  out  in  the  Annex  in 
accordance with Article 5 and in close cooperation and partnership with the Member States. 
The institutions  and  organizations  active  in the field of  the  prevention  of  AIDS  and other 
communicable  diseases shall take part in them as well. 

Article 3 

The budgetary authority  shall determine the appropriations available for each financial  year. 

Article 4 

The  Commission  shall  ensure  that  there  is  consistency  and  complementarity  between  the 
Community  actions to bè implemented under this programme and those implemented under 
other relevant Community programmes and initiatives. 

44 

Article 5 

For  the  implementation  of  the  programme  the  Commission  shall  be  assisted  by  an 
Advisory  Committee,  hereinafter  referred  to  as  "the  Committee",  comprising  two 
representatives from  each Member State and chaired by  a Commission representative. 

The representative  of the Comission  shall  submit to the Committee  a draft of the measures 
to be taken. The Committee shall  deliver its opinion on the draft, within a time limit which 
the chairman may lay down according to the urgency of the matter, if necessary by taking a 
vote. 

The opinion shall be recorded in the minutes; in addition, each Member State shall have the 
right  to ask to have its position recorded in the minutes. 

The Commission  shall take the utmost account of the opinion delivered by the Committee. 
It shall inform the Committee on the manner in which its opinion has been taken into account. 

Article 6 

1. 

2. 

1. 

2. 

The Community will encourage cooperation with third countries and with international 
public health organizations, in particular the World Health Organization. 

The EFTA countries, in the framework  of the EEA Agreement and the countries  from 
Central  and  Eastern  Europe  with  whom  the  Community  has  concluded  association 
agreements may be associated with the activities described in the Annex, according to 
the provisions of those agreements. 

Article 7 

The  Commission,will  regularly  publish  information  on  the  actions  undertaken  and 
opportunities for Community  support in the various fields  of action. 

The  Commission  will  submit  to  the  European  Parliament,  the  Council,  the 
Economic  and Social Committee, and the Committee of the Regions a mid-term report 
on the actions undertaken, as well  as an overall  report at the end of the programme. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

45 

ANNEX 

COMMUNITY  ACTION  PROGRAMME  CONCERNING  THE  PREVENTION 
OF AIDS AND  OTHER COMMUNICABLE  DISEASES 

h 

ACTIONS  ON HIV/AIDS AND SEXUALLY  TRANSMITTED  DISEASES 

A.  Data  collection 

1. 

Exploration with Member  States of ways to increase and improve AIDS  and HTV data 
at  the  Community  level,  and  provide  support  to  strengthen  the  work  of  the  national 
epidemiological  surveillance systems and the European Centre for the Epidemiological 
Monitoring  of AIDS. 

2.  Gather, analysis and dissemination information  concerning preventive measures and the 
knowledge, attitudes and behaviour of the general public and target groups; promotion 
of  the  development  and use of  measures for  assessing effectiveness  and new  surveys 
where existing information  is inadequate, including Eurobarometer  surveys. 

B.  Measures for children  and young  people 

3. 

4. 

5. 

Encouragement  of  initiatives to ascertain and disseminate information  about  children's 
and  young  people's  knowledge,  attitudes  and  behaviour  in  relation  to  HIV/AIDS  and 
STDs, to examine current practice in providing them with information  both within and 
outside  formal  settings  such  as  schools and  training  institutions  and  to promote  the 
exchange  of  educational  and training material,  and the setting up of pilot projects  and 
networks. 

C.  Prevention  of HIV and  STD transmission 

Examination and exchanges of  information on problems and situations related to groups 
at  risk  (drug  users,  sex workers,  homosexuals  and  bisexuals),  risk  situations  (mobile 
populations and border areas, penal institutions); and modes of transmission;  exchange 
of  experience  on  harm-reduction  measures  and  preventive  actions;  and  promotion  of 
appropriate  preventive measures and of pilot  projects. 

Promotion  of information,  advice and  counselling  to  pregnant women  who may  be at 
risk of transmitting HIV to their babies; exchange of views and experience on screening 
pregnant  women;  and  co-ordination  of  research  on  minimizing  mother-child 
transmission. 

46 

D. 

Social  and  psychological  support  and combatting  discrimination 

Exchanges of experience and information  concerning models of assistance and  support, 
including  the  particular  difficulties  facing  families  with  infected  members,  and 
concerning  policies and practices on screening and discriminatory situations, promotion 
of  analysies  and  pilot  projects  on  the  psycho-social  aspects  of  the  disease,  and  the 
setting up  of networks of organizations providing information  and  assistance. 

H.  SPECIFIC  COMMUNITY  MEASURES  FOR  CERTAIN  COMMUNICABLE 

DISEASES 

A.  Actions  related  to  vaccination 

7. 

8. 

9. 

Support  for  initiatives designed  to produce information  on  levels of vaccination  cover 
in  the  Community,  especially  among  children,  at-risk  groups  and  persons  living  in 
certain  risk  situations,  against  communicable  diseases  preventable  by  vaccination; 
promotion of initiatives designed to improve the vaccination cover of the general public, 
and  especially  of  at-risk  groups  and  persons  living  in  certain  risk  situations; 
encouragement  of  measures  designed 
the 
epidemiological  context. 

to  match  vaccination  schedules 

to 

B.  Creation  and  development  of  networks 

1°.  Surveillance 

Contribute to improving the quality of Member States' surveillance systems, taking into 
account  the  views  of  servers  and  users,  and  assist  in  the  development  of  networks, 
based  on  agreed  methodologies  and  conditions  of  transmission  of  information,  prior 
consultation  and  coordination  of  responses. 

Promote  knowledge  and  exchanges  of  experience  on  the  ways  in  which  surveillance 
results  of nosocomial  infections  are analysed,  processed  and  used  by  the actors  in the 
field,  and  encourage  actions  to  increase  awareness  of  the  problems  and  inclusion  of 
comparable  and  reliable  data  on  nosocomial  infections  in  routine  surveys  concerning 
hospital  conditions,  and  support  the  creation  of  new  surveillance  networks  for  such 
infections. 

2°.  Dissemination  of epidemiological  information 

10.  Contribute,  in  particular  by  the  provision  of  the  logistical  support  necessary,  to  the 
production  and  dissemination  of  a  regular  information  notice  and  of  a  European 
Community  bulletin  on  communicable  diseases  surveillance,  comprising  both  routine 
surveillance  data  and  reports  on  specific  investigations. 

47 

C. 

Information,  education  and  training 

11.  Encouragement of exchanges between Member States on information campaigns at all 
levels, development of ways of linking and reinforcing campaigns, such as provision of 
specific  materials;  and utilisation  of  telephone  and  other response  mechanisms,  and 
development and promotion of activities to complement national efforts,  including the 
setting up of networks and the exchange of experience and expertise. 

12.  Examination of current training programmes for health and other professionals, and for 
those  whose  work  brings  them  into  contact  with  certain  communicable  diseases; 
identification  of  weaknesses  and gaps,  and  devising  and  promotion  of  new  further 
training opportunities and programmes. 

13. 

Improvement  of  public  health  practices  with  regard  to  the  routine  surveillance  of 
infectious  diseases and epidemic outbreaks whenever and wherever these occur in the 
Community;  development  of a Community  network  of  public health  epidemiologists 
with  a view  to  defining  common  methods  and tools  and  enhancing  the  capacity  for 
coordinated response. 

D.  Early  detection  and systematic  screening 

14.  Promotion of investigations on the effectiveness  and feasibility  of screening for certain 

types of communicable diseases (tuberculosis, hepatitis, etc). 

15.  Support  for  the  training  of  health  personnel,  in  particular  in  the  context  of  early 
detection  and systematic  screening of communicable  diseases; cost-benefit  analysis of 
screening  for  different  types  of  communicable  disease,  in  particular among  pregnant 
women. 

48 

FINANCIAL  STATEMENT 

TITLE  OF  OPERATION 

Proposal  for  a European Parliament  and Council Decision  adopting a programme of 
Community  action  on  the  prevention  of  AIDS  and  certain  other  communicable 
diseases within the framework  for  action  in the field  of public health 

BUDGET  HEADING  INVOLVED 

B3-4305 (former item B3-4301): Combating AIDS and other communicable diseases. 

LEGAL  BASIS 

(a) Actual  legal  basis 

Article 3(0)  and Article  129 of the Treaty  on European  Union. 

(b)  References 

Resolutions  of the European Parliament  on measures to combat AIDS (OJ No  C 46, 
20.2.1984  and OJNo  C 88,  14.4.1986). 

Resolution  of the representatives of the Governments of the Member  States, meeting 
within  the Council  of 29 May  1986, on AIDS (OJ No C  184, 23.7.1986,  p. 21) 

Communication from the Commission of 11 February  1987 on the fight against AIDS 
(COM(87) 63 final). 

Conclusions  of  the  Council  and  of  the  representatives  of  the  Governments  of  the 
Member  States,  meeting  within  the  Council  of  15  May  1987,  concerning  AIDS 
( O J N oC  178, 7.7.1987, p.  1). 

Conclusions  of  the  Council  and  of  the  representatives  of  the  Governments  of  the 
Member  States,  meeting  within  the  Council  of  31  May  1988,  concerning  AIDS 
(OJ No  C  197, 27.7.1988, p. 8). 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting  within  the  Council  of  15 December  1988, concerning  AIDS  (OJ No  C 28, 
3.2.1989,  p.  p. 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting within the Council of  15 December  1988, concerning AIDS and the place of 
work  (OJ No  C 28, 3.2.1989,  p. 2). 

Resolution  of the European Parliament  of 30 March  1989 on the fight  against  AIDS 
(OJ No  C  158, 26.6.1989, p. 477). 

49 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting  within  the Council  of  16 May  1989,  regarding the  prevention  of  AIDS  in 
intravenous drug users (OJ No  C  185, 22.7.1989,  p. 3). 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting within the Council  of  16 May  1989,  on awareness measures for health care 
personnel  (OJ No  C  185, 22.7.1989,  p. 6). 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting  within  the  Council  of  16 May  1989,  on  the  improvement  of  the  general 
system  for  collecting  epidemiological  data,  including  the  application  of  the  new 
definition  of AIDS  cases (OJ No  C 185, 22.7.1989, p. 7). 

Conclusions  of  the  Council  and  the  Ministers  for  Health  of  the  Member  States, 
meeting  within  the  Council  of  16 May  1989,  regarding  future  activities  on  AIDS 
prevention and control  at Community level  (OJ No  C  185, 22.7.1989,  p. 8). 

Resolution of the Council and the Ministers for Health of the Member States, meeting 
within the Council  of 22 December  1989,  on the fight against AIDS  (OJ No  C 10, 
16.1.1990,  p. 3). 

Conclusions of the Council and the Ministers for Health, meeting within the Council 
of  17 May  1990,  concerning medical  and psychosocial  support for persons  affected 
by the AIDS  epidemic (Doc.  7264/90  SAN 45). 

Conclusions  of  the  Council  and  of  the  Ministers  for  Health,  meeting  within  the 
Council  of 3 December  1990,  on AIDS  (OJ No C 329,  31.12.1990,  p. 21). 

Decision  91/317/EEC  of  the  Council  and  the  Ministers  for  Health  of  the 
Member States, meeting within the Council of 4 June 1991, adopting a plan of action 
in  the  framework  of  the  1991  to  1993  "Europe  against  AIDS"  programme 
(OJ No L  175, 4.7.1991,  p. 26). 

Resolution  of the Council  and the Ministers for Health, meeting within the Council 
of  13 November  1992, on the monitoring and surveillance of communicable diseases 
(OJ No  C 326,  11.12.1992,  p.  1). 

Report  from  the  Commission  on  the  implementation  of  the  plan  of  action 
(Europe Against AIDS) in  1991-1992  (COM(93) 42 final, 10.3.1993). 

Conclusions of the Council  and the Ministers for Health, meeting within the Council 
of  27  May  1993,  on  the  implementation  and  continuation  of  the  "Europe  Against 
AIDS" programme (Doc.  6946/93  SAN 36). 

Proposal  for  a  Decision  of  the  Council  and  the  Ministers  for  Health  of  the 
Member  States, meeting within the Council,  concerning the extension to the end of 
1994 of the  1991-1993  plan of action in the framework of the Europe Against AIDS 
programme (COM(93) 453 final, 29.9.1993). 

50 

Commission communication on the framework  for action in the field of public health 
(COM(93)  559 final). 

Council  conclusions  of  13 December  1993  on  the  setting  up  of  an  epidemiological 
network in the Community  (OJ No  C  15,  18.1.1994, p. 6). 

Council Resolution of 13 December  1993 concerning the extension to the end of 1994 
of the  1991 to  1993 plan  of action in the framework  of the  "Europe Against AIDS" 
programme  (OJ No C  15,  18.1.1994, p. 4). 

Council  Resolution  of  2 June  1994  on the framework  for  Community  action  in  the 
field  of public health  (OJNo 

.....). 

DESCRIPTION  OF  OPERATION 

4.1  General  objective 

Implementation  of  a  programme  of  Community  operations  to  prevent  AIDS  and 
other communicable  diseases. Parliament,  the Council  and the Ministers for  Health 
of the  Member  States meeting  within  the  Council  have,  since the beginning  of  the 
epidemic, adopted a number of texts dealing with the public health problems  posed 
by  AIDS  (see  list  above),  the  most  important  of  which  is  the  Decision  of  4  June 
1991 establishing the  "Europe Against AIDS" programme. 

The  aim  of  this  communication  is  to  establish  the  necessary  basis  for  extending 
Community operations against AIDS and expand them to cover other communicable 
diseases  while  taking  into  account  the  entry  into  force  of  the  Treaty  on 
European  Union,  particularly  Article  129, which  makes  provision  for  Community 
action  in  the  field  of  public  health  and,  in  particular,  against  the  major  health 
scourges. 

The  aim  of  this  programme  is  to  encourage  cooperation  between  Member  States, 
support  their  operations  and  promote  coordination  between  their  policies  and 
programmes  within  the  framework  of  the  prevention  of  HIV/AIDS  and  other 
communicable  diseases. 

Intermediate  objectives:  these  include  reducing  mortality  and  morbidity  due  to 
communicable diseases and reducing the risk of infection by the AIDS virus or other 
infectious  agents. 

Methods  for  achieving  this  objective:  stimulating  Member  States  to  develop  their 
own  resources  for  the  prevention  of  AIDS  and  other  communicable  diseases, 
prevention strategies and intra-Community  cooperation, particularly through  support 
for  exchanges, identification  and  dissemination  of best practice  and the creation  of 
networks; development of guidelines and financial assistance for programmes or pilot 
projects aimed at improving the effectiveness  of prevention both among professionals 
in the  social  and  health  fields  and  among the general  public. 

51 

4.2 

Period  covered  and  arrangements  for  renewal  or  extension 

5 years:  1995-1999 
Report  on  implementation  to  be  transmitted  to  the  Council  and 
European Parliament during the third year of the programme: any 
modifications  necessary 
Report to the Council  and European Parliament  at the end of the 
programme: renewal  or adaptation procedures. 

5 

CLASSIFICATION  OF  EXPENDITURE  OR  REVENUE 

Non-compulsory  expenditure 

Differentiated  appropriations 

6 

TYPE OF EXPENDITURE OR REVENUE 

Subsidies  for  co-financing  with  other  public  and/or  private  sector  bodies 
(not exceeding  a certain percentage of the total  cost of  such projects). 

7 

FINANCIAL  IMPACT 

7.1  Method of calculating total cost of operation (definition  of unit costs) 

The  method  of  calculation  is  the  result  of  experience  acquired  in 
implementing  operations to combat AIDS and other communicable  diseases 
(items  B3/4301,  later  B3-4305)  over  recent  years,  taking  into  account 
medium-term  prospects  set  out  in  the  Commission  communication  on  the 
framework for action in the field of public health. A total amount rounded off 
to ECU 50 million during the period  1995-1999 appears to be necessary for 
these activities. The yearly allocation will be decided in accordance with the 
normal budgetary procedures. 

52 

7.2 

Itemized breakdown of cost (in ECU million) 

DISEASES 

ACTION 
AREA 

HIV/AIDS AND 
OTHER 
COMMUNI 
CABLE 
DISEASES 

Collection of 
epidemiological 
data; establishment 
of networks 

YEARS 

1996 

1997 

1998 

1999 

TOTAL 
1995-1999 

Indicative  programming 

PDB 
1995 

Indicative 
break 
down 

0.2 

0.3 

0.3 

0.3 

0.3 

1.4 

Specific  prevention 
measures 
(vaccination, 
safety of blood 
and blood 
products) 

Information  and 
awareness-raising 
for general public 
and target groups 

Training and 
promotion of 
human resources 

Measures for 
children and 
young people 

Health and social 
support and 
assistance 

Measures to 
combat 
discrimination 

Early detection 
and systematic 
screening 

2 

2.2 

2.3 

2.4 

2.6 

11.5 

0.5 

0.5 

0.5 

0.6 

0.6 

2.7 

1.6 

1.7 

1.7 

1.8 

1.9 

8.7 

1.3 

1.3 

1.4 

1-5 

1.5 

1.7 

!-7 

1.8 

1.9 

2 

0.4 

0.4 

0.5 

0.5 

0.5 

1.3 

1.3 

1.4 

1.4 

1.5 

7 

9.1 

2.3 

6.9 

TOTAL 

9 

9.4 

9.9 

10.4 

10.9 

49.6 

% Variation  1.05  (see communication  on public health) 

HTV/AIDS 

OTHER 
COMMUNI 
CABLE 
DISEASES 

53 

7.3 

Indicative  schedule  of  appropriations 

1995 

1996 

1997 

9 

9.4 

9.9 

1998 

10.4 

1999 

10.9 

TOTAL 

49.6 

Commitment 
appropriations 

Payment 
appropriations 

50% 

1995 

35% 

1996 

15% 

1997 

1998 

1999 

Subsequent  years 

3.2 

4.3 

1.5 

4.7 

3.3 

1.4 

. 

5 

3.4 

1.5 

5.2 

3.7 

1.5 

5.4 

5.5 

3.2 

9.0 

9.8 

10 

10.6 

7 

49.6 

TOTAL 

9 

9.4 

9.9 

10.4 

10.9 

8 

FRAUD PREVENTION MEASURES; RESULTS OF MEASURES TAKEN 

The grant application forms will require information  on the identity and nature of potential 
beneficiaries  so that their reliability  can be  assessed  in  advance. 

Fraud  prevention  measures  (checks,  intermediate  reports,  final  report)  are included  in  the 
agreements  or  contracts between the Commission  and beneficiaries.  The Commission  will 
check  reports  and  ensure that work  has been properly  carried  out before  intermediate  and 
final payments  are made. 

In  addition,  spot checks are carried  out by the Commission to verify  how funds  have been 
used. Checks have already been carried out in relation to the financial  years 1991, 1992 and 
1993  and  have  shown their  effectiveness. 

ELEMENTS  OF  COST-EFFECTIVENESS ANALYSIS 

9.1 

Specific  and  quantifiable  objectives;  target  population 

The  Community  measures  are intended  to  encourage: 

- 

- 

- 

improved  knowledge  of  communicable  diseases,  including  HIV  infection, 
among the general  public  and risk groups; 
prevention  of  communicable  diseases  and  HIV/AIDS  among  the  general 
public  and risk groups; 
guidance  and  advice: professionals  in the  social  and health  fields; 

54 

- 

social  and  health  care:  professionals  in  the  social  and  health  fields,  work 
environment,  risk  groups  (drug  abusers,  homosexuals,  prostitutes,  risk 
situations). 

9.2  Grounds for  the  operation 

Rational  use of budget provision based on: 

(a) 

(b) 

(c) 

identifying 

specific  application  of  the  principle  of  subsidiarity  when 
measures to be undertaken  and  co-financed; 
identification  and selection of projects for co-financing in the fields of health 
education,  improving knowledge  among the public  and  certain risk groups, 
training and stimulation  of cooperation  between Member  States in the field 
of  prevention.  These  projects  will  be  selected  and  implemented,  where 
necessary,  with  national  coordinating  committees  to  be  established  at  the 
request  of  Member  States,  with  participation  by  all  those  involved  in  the 
prevention  of HTV/AIDS and  other  communicable  diseases; 
the concept  of added  Community  value, which  will  continue to be  realised 
through  the  coordination  of  national  measures,  the  dissemination  of 
information  and experiences, the establishment of priorities, the extension of 
existing  European  networks,  selection  of  European  projects  and  the 
motivation  and mobilisation of all  involved. 
The  main  method  of  implementation  for  the  programme  is  to  support 
projects  carried  out in Member  States.  The  selection  of priority  projects  is 
based largely on general and intermediate objectives, and implementation  of 
the  measures  themselves  depends  on  the  quality  and  reliability  of  projects 
submitted  to the competent  department  during the course of the year. 

The  selection  criteria for  projects  are as  follows: 

Compatibility  with  the  objectives  and  conformity  with  at  least  one  of  the 
established  objectives; 
Examination  of the "added Community value" of the projects  (transnational 
participation,  development  of  a  model  applicable  in  other  Member  States, 
information  usable in other Member  States, etc.); 
Presumed  effectiveness  and  profitability; 
Clarity  and justification  of  requirements; 
Population  targeted  or affected  by the  measure; 
Relevance  of the  selected  methodology; 
Organizational  competence  and  experience; 
Suitability  of budget  for  objectives; 
Support for  projects  from  national  partners; 
Objective  assessment; 
Opinion  of the advisory  committee  involved. 

55 

9.3  Monitoring  and  evaluation  of the  operation 

9.3.1  Monitoring  of  the  operation: 

Monitoring at Community  level is by the Commission, which will  submit an 
annual report on the operation of the programme to the Council, the European 
Parliament, the Economic  and  Social  Committee  and the  Committee  of the 
Regions,  and  at  national  level  by  national  coordinating  committees,  if 
Member  States  choose to  establish  such  committees,  by  the  ministries  with 
responsibility  for  the prevention  of AIDS and  other  communicable  diseases, 
NGOs and those responsible for  the implementation  and conduct  of  specific 
projects. 

9.3.2  Evaluation 

Evaluation  will be by means  of: 

- 

An  annual  report  on the execution  of the programme to the  Council, 
the European Parliament, the Economic and Social Committee and the 
Committee  of the Regions; 
An  independent  evaluation  of  the  main  measures  and  of  subsidised 
studies; 
An  overall  report  on  the  reliability  and  effectiveness  of  projects 
the 
implemented  under  the  action  plan,  to  be  submitted  by 
Commission  to  the  competent  institutions  during  the  second  half  of 
1997. 

Performance  indicators selected for  this evaluation: 

those 

Estimate  of the target  population  reached  and  any media  coverage; 
Evaluation  of  projects  by  Commission  officials  and/or 
cooperating  with  them; 
Analysis of intermediate reports on measures scheduled and  financed, 
allowing  a  shifting  of  emphasis where  possible; 
Impact  studies by  external  bodies; 
Relevance  of the  methodology  used by  organizers; 
Suitability  of the budget  for  the  objectives; 
Clarity  of  original  objectives; 
Skills anc1 
Dissemin 

ence of bodies; 

of results. 

Evaluation t  'ocedures and  intervals: 

Drawing  up of intermediate and final reports on the various measures 
undertaken  in the field; 
Development  of  a  "standard"  evaluation  form  for  the  measure,  to be 
forwarded  by  the beneficiaries  with  their  final  reports,  and  checking 
of  these  documents  by  officials  either  at  the  Commission  or  in  the 
field. 

56 

9.4 

Coherence  with  financial  programming 

Is  the  operation  incorporated 
years?  Yes. 

in  the  DG's  financial  programming  for  the  relevant 

To  which  broader  objectives  defined  in  the  DG's  financial  programming  does  the 
objective  of  the proposed  operation  correspond? 
"To  contribute  towards  ensuring  a  high  level  of  human  health  protection"  -
Article  129  of  the  Treaty. 

10 

ADMINISTRATIVE  EXPENDITURE  (PART  A  OF  THE  BUDGET) 

The  new  action  programme  referred  to  in  this  financial  statement  comes 
under the new responsibilities  of the  Community  in the  field  of public  health 
following  entry  into  force  of  the  Maastricht  Treaty  (Article  129). 
In  addition  to  the  staff  currently  carrying  out  similar  and  preparatory  work, 
implementation  of  the  programme  will  necessitate  the  following  additional 
staff:  one  grade  A  official,  one  grade  B  official  and  one  grade  C  official  -
subject  to  the  outcome  of  the  1995  budget  procedure  and  the  Commission 
Decision  on the  allocation  of funds.  This  additional  personnel  could  be  made 
available  either  by  internal  deployment  of  staff  within  the  Commission  or  as 
part  of the  decision  on  the  allocation  of  human  resources  to  be  taken  by  the 
Commission  in  1995. 
The  following  meetings  and  missions  are  planned  for  1995  in  conjunction 
with  the  launching  and  implementation  of  the  new  action  programme  (the 
budget  headings  relating  to  meetings  and  missions  are  A  2500  and  A  1300 
respectively): 

57 

Meetings: 

2  meetings  of  the  Advisory  Committee  (two  representatives  per 
Member  State) 
( 2 x 2 4 x 6 58  =  31  584) 

32  000 

4 meetings  of  experts 
(4 x  6 x  658 =  15.792) 

16 000 

Conferences  and  seminars for  presentation  and  implementation 
( 4 x 4 8 x 6 5 8 = 1 26  336) 

126 000 

TOTAL  MEETINGS: 

ECU  174  000 

Missions: 

Luxembourg-Brussels  (5 missions  per  month) 
( 6 0 x 2 0 0 = 12  000) 

Other missions  (Member  States) 
(25 x  1000 =  25  000) 

TOTAL  MISSIONS: 

ECU  37  000 

58 

ISSN 0254-1475 

COM (94) 413  final 

DOCUMENTS 

EN 

05 

Catalogue number : CB-CO-94-443-EN-C 

ISBN 92-77-80902-7 

Offîce for Official Publications of the European Communities 

L-2985 Luxembourg