SECOND REPORT FROM THE COMMISSION to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the integration of health protection requirements in Community policies (1995)
Date: 1996-09-04
Institutions: European Commission
Subjects: EU policy, EU situation, activity report, health policy, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  04.09.1996 
COM(96) 407  final 

SECOND  REPORT FROM THE COMMISSION 

to the  Council,  the European Parliament, 
the Economic  and  Social  Committee  and the  Committee  of the Regions 
on the integration  of  health  protection  requirements  in  Community  policies 

(1995) 

Executive Summary 

1. 

This  second  report  on  the  integration  of  health  requirements  in  Community 
policies gives an overview of Community  activities in  1995 with repercussions on 
health. Building  on the first report, published  in  1995, which took  stock of health 
dimensions in all areas of Community policy, this report concentrates on a number 
of  key  policy  areas.  It  is  in  these  areas  that  the  most  important  health-related 
developments  have  taken  place: 

-  social  policy, 
-  internal  market, 
-  agriculture,  food  and  fisheries, 
-  research  and  development, 
-  environment  and  energy, 
-  transport, 
-  international  cooperation. 

2. 

3. 

It  includes  the  work  of  relevant  agencies  and  other  outside  bodies  connected  to 
the  Community  which  are working  in these  areas. 

This  annual  report  is one  of  the instruments  the  Commission  has  set up  in  order 
to  monitor  how  the  Community  is  meeting  the  obligation  in  Article  129  of  the 
Treaty  that health  requirements  shall form  a constituent part  of  other  Community 
policies.  As  set  out  in  detail  in  the  first  report  in  1995, this  Treaty  obligation  is 
supplemented  by  a range of other references  to health protection  in the context of 
other Community  policies. Their  common  aim is to ensure  a high  level  of  human 
health  protection  (Article  3  (o)  of the Treaty). 

In the light of this goal, the Commission  has also put into place other  instruments 
which  have more influence  on the preparation  of Community  legislation  and other 
activities  than  a  retrospective  report.  These  include  the  procedures  of  full 
interservice  consultation  on proposals in other fields  which  could  have  an  impact 
on  health  being  put  forward  by  the  Commission.  In  addition,  the  Interservice 
Group  on  Health  provides  opportunities  for  more  general  discussions  of  health-
related topics among Commission  services, while ad hoc groups have been created 
to  allow  more  detailed  examinations  of  particular  problems  or  areas  of  policy 
from  the  health  point  of  view. 

Some  progress  has  been  made  in  raising  awareness  of  the  numerous  links  with 
and  effects  on  health  which  the vast  majority  of  Community  policy  areas have  -
and  therefore  of  the  importance  of  an  early  integration  of  health  issues  into  the 
preparatory work for drawing up policies and action programmes - both within the 
Community  institutions  as  well  as  in  Member  States.  Moreover,  the  fact  that 
health  issues  also  tend  to  generate  considerable  media  attention  and  raise  major 
concerns  among  the  population  is another  reason  why  they  need  to be taken  into 
account  at  an  early  stage  of  policy  formation. 

It is not always evident how best to integrate health requirements in a given area 
of  policy,  or  how  and  according  to  which  criteria  to judge  success  or  failure. 
Work will  have to continue to develop thinking on these areas. In publishing this 
report,  the Commission  wishes to  stimulate public  debate on these  questions.  In 
this sense, this report is an instrument to promote transparency  and discussion on 
health issues within  the Community. 

Table of Contents 

1. 

2. 

3. 

Introduction 

Public  health  programmes  and  activities 

Integration  of  health  requirements  in  Community  policies 

Social  policy 

3.1 
3.1.1  Social  protection 
3.1.2  European  Social  Fund 
3.1.3  Solidarity  -  social  exclusion 
3.1.4  Free  movement  of  workers 
3.1.5  People  with  disabilities 
3.1.6  Health  and  safety  at  work 

Internal  market  -free  circulation  of persons  and goods  -  taxation 

3.2 
3.2.1  Medicinal  products 
3.2.2  Medical  devices 
3.2.3  Consumer  protection  -  cosmetics 
3.2.4  Taxation 
3.2.5 
3.2.6  Free  movement  of  persons,  recognition  of  diplomas  -health  professions 
3.2.7  Data  protection 
3.2.8  Education  and  training  -  KAROLUS 

Jurisdiction  on  free  movement  of  goods 

Agricultural  and foods  Policy,  fisheries 

3.3 
3.3.1  Veterinary  sector 
3.3.2  Pesticide  residues 
3.3.3  Tobacco 
3.3.4  Foodstuffs 
3.3.5  Milk  promotion  campaigns 
3.3.6  Fisheries 

Research  and  development 

3.4 
3.4.1  BIOMED 
3.4.2  Telematics 
3.4.3  G  7 Global  Information  Society  Initiative 
3.4.4  Targeted  socio-economic  research 
3.4.5  Research  on  agriculture,  fisheries  and  agro-industrial  processing 
3.4.6  Transport  research 
3.4.7  Environment  and  Climate 
3.4.8 
Industrial  and  Material  Technologies 
3.4.9  Standards,  Measurements  and  Testing 

Environmental  policy,  energy 

3.5 
3.5.1  Air  pollution 
3.5.2  Radiation  protection 
3.5.3  Chemical  products 
3.5.4  Civil  protection 

m 

3.5.5  European  Environment  Agency 
3.5.6  Energy  policy 

Transport 

3.6 
3.6.1  Ships 
3.6.2  Transport  of  dangerous  goods 
3.6.3  Road  transport 

3.7 

International  cooperation,  relations  with 
organisations 
3.7.1  EC-USA  cooperation 
3.7.2  Cooperation  with  Central  Europe  and  the  Community  of  Independent  States  -

third  countries  and 

international 

Phare/Tacis 

3.7.3  Cooperation  with  international  organisations 
3.7.4  Cooperation  with  ACP  countries  in  the  health  field 
3.7.5  Co-operation  with  South  and  South  East  Asia,  Latin  America 
3.7.6  Fight  against  drugs 
3.7.7  Humanitarian  aid 
3.7.8  Environment  and  health 

Integration  of  health  requirements  in other  Community  policies 

3.8 
3.8.1  Statistics 
3.8.2  Youth  and  education 
3.8.3 
Information  activities 
3.8.4  Regional  policy 
3.8.5  Drugs 

4. 

Conclusions 

iv 

1. 

1. 

2. 

3. 

4. 

5. 

Introduction 

This  second  report  on  the  integration  of  health  requirements  in  Community 
policies  aims  to  provide  an  overview  of  developments  in  European  Community 
policy  pertaining to health. Read  as a whole, it shows that a wide range of  policy 
areas  in  the  Community  have  considerable  repercussions  on  health. 

Article  129  of  the  Treaty  stipulates  that  health  considerations  should  form  a 
constituent  part of the Community's  other policies. This annual  report -  following 
a  Commission  decision 
the  Commission 
Communication  on  the  Framework  of  Action  in  the  field  of  public  health1  -  is 
designed  to  give  an  overview  on  how  this  obligation  of the  Treaty  is taken  into 
account  in  the  different  areas  of  Community  policy. 

the  context  of  adopting 

in 

This report is supplemented by other instruments of consultation  and  concertation 
within  Commission  services  which  aim  to  ensure  that  health  requirements  are 
properly  taken  into  account.  An  Interservice  Group  on  Health  has  been  created 
which  includes  representatives  from  relevant  Commission  services  and  meets  in 
plenary  several  times  a  year.  Several  subgroups  follow  specific  issues.  In 
application  of  regular  Commission  internal  procedures,  Commission  services  are 
required  to  consult  on  all  proposals  with  a  potential  bearing  on  health  with  the 
responsible  services for  public health  in the Directorate  General  for  Employment, 
Industrial  Relations  and  Social  Affairs. 

, The  first  report  on  the  integration  of  health  requirements  in  other  Community 
policies,  covering  activities in  1994, was adopted  by the Commission  on 29 May 
19952.  As  a  first  report  of  its  kind,  it  aimed  to  give  a  complete  overview  of 
Community  activities  related  to  health.  This  second  report  focuses  on  health-
related  activities  during the course of  1995. It does not include the recent  debates 
on  BSE  and  CJD  which  occurred  in  1996  and  will  be  dealt  with  in  the  third 
report. For a broader picture, it should be read in conjunction  with the first report, 
particularly  with  its  introduction,  which  includes  a  history  of  health-related 
activities  at  Community  level. 

The  first  report  was  met  with  great  interest  by  the  other  Community  Institutions 
and  the  public,  while  there  was  recognition  of  the  difficulties  associated  with 
presenting  such a wide range of topics in a coherent manner. The Council  adopted 
a  resolution  on  the  integration  of  health  requirements  in  Community  policies 
which  took  the  1994  report  as  a point  of  departure. 

The  Council  welcomed  the  initiative  taken  by  the  Commission  to  present  such 
reports,  and  invited  the Commission  to pay  particular  attention,  in future  reports, 
to certain  areas of Community  activity,  namely,  economic  and  in particular  fiscal 
policy, social policy, including questions of employment, free movement of goods 
and  persons,  agricultural  and  food  policy,  consumer  policy,  research  and 
technological  development,  environment  and  transport.3 

COM  (93)559  fin.  of  24.11.1993 
COM  (95)196  fin. 
Council  Resolution  of  20.12.1995, OJ  C  350/2,  30.12.1995 

1 

6. 

7. 

8. 

This  report  seeks  to  present  an  overview  of  all  relevant  activities  whilst  giving 
particular  attention to the abovementioned  areas of  policy. 

The  European  Parliament,  in  its  Resolution  on  the  medium-term  social  action 
programme,  asked the Commission  to present guidelines  on incorporating  health 
protection  requirements  in the other Community  policies4. 

This year's report starts off with an overview of the public health programmes and 
activities  of  the  Community,  which  in  1995  have  been  advanced  considerably. 
This is followed  by a summary  of activities in a number of priority  areas - areas 
which  are important  either because  of  the major activities which  took  place  last 
year  or  because  of  the  major  impact  they  have  on  health  in  general.  In  a third 
section,  the  report  outlines  other  health-related  activities  in  additional  areas  of 
Community policy. In addition, some specific  subjects (drugs, AIDS and tobacco) 
are presented  in  "boxes" inserted into the text.  Legislative  measures  proposed or 
adopted  in  1995  are summarised  in an annex. 

As in the first report, this report demonstrates that there is a diversity  of areas of 
activity with an impact on health in the Community. In some areas, a remarkable 
degree of  coherence  has been achieved between the objectives in their own right 
and their impact on public health. In other areas, there is still progress to be made. 

This  report  is  designed  to  present  as  broad  a  picture  as  possible  of  political 
initiatives  with  a health perspective.  It could  serve to raise  awareness  on health-
related  issues  and  their  likely  impact,  as  well  as  to  stimulate  efforts  aimed  at 
ensuring  that  health  becomes  a  fundamental  consideration  in  the  design  and 
implementation  of policies. 

Report on the Medium-Term  Social Action Programme (HUGHES), Doc. A4-0311/95, p. 12 

2 

2. 

9. 

10. 

11. 

12. 

Public  health  programmes  and  activities 

The  Commission's  Communication  on  the  Framework  of  Action  in  the  field  of 
public  health5  identified  eight  policy  areas  necessitating  particular  attention  and 
the development of specific programmes. As outlined in the 1994 report, proposals 
have  been  presented  in  the  areas  of  the  fight  against  cancer  (Proposal  for  a 
European Parliament  and  Council  Decision  adopting an action plan  1996-2000  to 
combat  cancer6), prevention  of AIDS and other communicable  diseases  (Proposal 
for  a European  Parliament  and  Council  Decision  adopting  a  Community  action 
programme  on  the  prevention  of  ADDS  and  other  communicable  diseases7), 
prevention  of drug  dependence  (Proposal  for  a European  Parliament  and  Council 
Decision  adopting  a programme  of  Community  action  on the prevention  of  drug 
dependence8) and health promotion, information,  education and training  (Proposal 
for  a  European  Parliament  and  Council  Decision  adopting  a  programme  of 
Community  action9). 

On  the  programmes  on  cancer,  AIDS  and  other  communicable  diseases,  and 
health promotion,  agreement was reached in the Conciliation  Committee  between 
Council and the European Parliament in December  1995 which led to the adoption 
of the relevant decisions in  1996. The Council adopted a Common Position  on the 
Community  action  on  drug  dependence  in  December  199510. 

In  October  1995, the  Commission  adopted  a  Communication  and  Proposal  for  a 
Community  action  programme  on health  monitoring11, which  aims  at  developing 
a  framework  for  the  establishment  of  common  health  indicators  among  Member 
States and should establish a comparable basis for  collecting and evaluating health 
data  in  the  Community. 

In  addition  to  the  1994  report  on  the  integration  of  health  requirements  in 
Community  policies, the Commission  adopted in July  1995 the first Report on the 
State of Health in the European  Community12, which gives an overview of  health 
status in the Community,  including  a description  of the main  demographic  trends 
and  patterns  of  mortality  and  morbidity  as  well  as  the  major  determinants  of 
health.  The  Commission  intends  to present  annual  health  status  reports,  focusing 
on  specific  issues  and  population  groups.  At  regular  intervals,  a  general  health 
status  report  will  be  produced. 

5 

6 

7 

8 

9 

10 

11 

12 

COM  (93)  559  fin.  of  24.11.1993 
OJ  C  139, 21.05.1.994, p.  12, decision  646/96/EC  of  29.03.1996, OJ L  95,  16.04.1996, p.  9 
OJ  C  333, 29.11.1994, p.  34, decision  647/96/EC  of  29.03.1996, OT L  95,  16.4.1996, p.  16 
O J C 2 5 7,  14.09.1994, p. 4 
OJ  C  252, 09.09.1994, p.  3, decision  645/96/EC  of  29.03.1996,  OJ L  95,  16.4.1996, p.  1 
Common Position (EC) n* 1/96  adopted by the Council  on 20.12.1995, OJ C  37, 09.02.1996, p.  1 
COM  (95)  449  fin.  of  16.10.1995 
COM  (95)  357  fin.  of  19.07.1995 

13. 

In  the  context  of  its  activities  in  the  field  of  cancer  prevention  in  1995,  the 
Commission  supported  the  European  Week  against  Cancer  intended,  notably,  to 
promote  the  European  Code  against  Cancer,  a  set  of  10  simple  but  essential 
cancer  prevention  recommendations  established  by  Europe's  leading  cancer 
experts. 

During  the  week,  a campaign  aiming  at the widest  possible  dissemination  of  the 
Code  was  carried  out  in  all  Member  States,  in  close  collaboration  with 
organisations  working  in  the  field.  The  campaign  was  based  on  a  common 
European  concept and common  supporting material  (posters, leaflets,  video spots, 
advertisements). 6.5 million information  leaflets on the Code were distributed, and 
more than 250 million contacts were achieved through articles in the press and TV 
features  as well  as through  (free)  advertising  space. 

In  parallel,  a  brochure  on  the  Code  was  prepared  geared  to  the  particular 
information  requirements  of general  practitioners,  who play  a vital  role in  raising 
their  patients'  awareness  of  the  possibilities  for  cancer  prevention;  this  brochure 
was  mailed  to  all  of  Europe's  325  000  GPs  and  was widely  welcomed. 

Mental  health 

14. 

In  1995,  the  specific  Community  action  providing  exceptional  financial  support 
for  Greece inter alia in the field of mental  health  from  the European  Social Funds 
was concluded.  This was the first Community  involvement  in the field of  mental 
health. The operations, involving 60 million ecus over eleven years, were designed 
to  deal  with  the  need  to  reform  the  Greek  psychiatric  care  system  through  the 
development  across the country  of new structures and  services aimed  at the  social 
and vocational  rehabilitation  of mentally ill and mentally handicapped  persons and 
the  improvement  of  care  conditions  for  patients  in  public  psychiatric  hospitals. 
The  impact  of  the  programme  has been  significant.  It  led  to  the  development  of 
a structure for  psychosocial  rehabilitation  services in Greece as well  as a reduction 
in  the  size  of  the  large  psychiatric  centres  and  hospitals  and  an  improvement  in 
the  conditions  found  there13. 

13 

cf.  Final  report, COM (95) 668 fin. of  15.12.1995 

4 

3. 

Integration  of  health  requirements  in  Community  policies 

3.1 

Social  policy 

15. 

Social  and health policies are linked in many ways. Questions of employment  and 
unemployment,  labour  laws,  social  protection  systems  and  insurance,  policy 
towards  specific  marginalised  or vulnerable groups and  regulations  on health  and 
safety  at work  all  have broad  repercussions  on  health. 

The main  orientation  document for the Community's  social policy is the Medium-
Term  Social  Action  Programme  1995-199714,  which  defines  the  creation  of jobs 
and  the  fight  against  unemployment  as the  main  priority  of  Community  action. 

A  number  of  areas  of  social  policy  have  a  particular  health  dimension,  i.e.  the 
future  of  social  protection,  questions of solidarity  and  social  exclusion,  disability, 
questions of migration  and of workers' mobility  inside the Community,  as well  as 
the very  concrete  concerns  on  health  and  safety  at  work. 

3.1.1  Social  protection 

16. 

In  the  debate  on  future  orientations  of  social  policy,  social  protection  plays  a 
central  role.  On  31  October  1995, the  Commission  adopted  its  Communication 
"The  future  of  social  protection  -  a framework  for  a European  debate"15,  which 
identifies  social  protection  as  a  fundamental  component  and  a  distinguishing 
feature  of European  societies. This is a contribution to the European  debate on the 
future  of  social  protection  in  the  light  of  demographic  changes  as  well  as  the 
economic  and  social  challenges  Europe  is  facing.  An  important  factor  in  this 
debate  is  the  future  of  health  care  systems,  where  the  Community  can  help  to 
exchange  experiences  on  how  to  reconcile  the  objective  of  providing  universal 
access  to  all  necessary  health  care  and  prevention  facilities  with  the  need  to 
contain  rising  costs. 

Reforms  in  health  care  are  also a specific  topic  in the  report  on  social  protection 
in  Europe16,  which  reports  on the  developments  in  this  area  in  Member  States. 

3.1.2  European  Social  Fund 

17. 

As  outlined  in  the  previous  report,  the  European  Social  Fund  supports  projects 
both  to encourage  active measures in the labour market  as well  as to improve  the 
general  conditions  for  developing  the  full  potential  of  participants  in  the  labour 
market.  Operations  under  Community  Support  Frameworks  (CSFs)  agreed  with 
the  Commission  have  started  in  the Member  States.  Results  from  the  evaluation 
of these  projects  will  be  presented  in  later  reports. 

14 

15 

16 

COM  (95)  134 fin.  of  12.04.1995 
COM  (95)  466  fin.  of  31.10.1995 
Social  protection  in Europe,  1995 

18. 

19. 

A  first  set  of  projects  was  selected  for  the  Community  Initiative  "Employment" 
in  December  1995  and  will  be  carried  out  over  the  coming  years.  The 
Employment  programme  includes  initiatives  on  the  integration  of  people  with 
disabilities  (HORIZON)  and  people  from  excluded  backgrounds  (INCLUSION) 
into the labour  market.  In  both  initiatives,  a number  of  projects  selected  involve 
a  health  dimension. 

A  certain  amount  of  funds  was  set  aside  from  general  Social  Fund  financing  to 
support  innovative  measures  to  achieve  a  more  employment-intensive  pattern  of 
growth, to improve the workings of the labour market and to reinforce  the training 
system.  This  includes  specific  measures  for  groups  in  danger  of  exclusion  from 
the  labour  market.  Of  the  more  than  60  projects  selected  in  1995,  four  projects 
were particularly  related to health, covering the integration  of physically  disabled 
people,  health  informatics  and  adapted  workplaces  for  people  with  disabilities. 

3.1.3  Solidarity  -  social  exclusion 

20. 

21. 

Health  and  social  exclusion  are inextricably  linked.  Poor  health  can be  the  cause 
of  social  exclusion  (e.g.  in  the  case  in  chronic  sickness  or  invalidity  leading  to 
long-term  unemployment,  or in the case  of  the  stigmatisation  of  a chronically  ill 
or disabled person); it can be the consequence of social exclusion  (e.g.  depression, 
psychosomatic  illness); it can be part of social  exclusion  (e.g. unhealthy  housing, 
lack  of  running water,  of  accessible  toilets,  of  a well-balanced  diet, -of  access  to 
quality  health  services),  or 
it  can  be  a  factor  preventing  reintegration  (e.g. 
depression,  psychosomatic  illness, lack of  self-confidence  if the person's  physical 
health  is  weakened).  Social  exclusion  may  make  access  to  health  services  more 
difficult. 

The  scheme  of  European  funding  for  projects  seeking  to  overcome  social 
exclusion (1995) received  some 2000 applications, many of which were concerned 
with different  aspects of health. The aspects most frequently  included  were  : drug 
and  alcohol  abuse,  mental  health  and  well-being  (particularly  of  immigrants  and 
refugees),  disability  (both mental and physical). Of the 86 projects finally  adopted 
in  December  1995,  15  concerned  health,  touching  on  the  following  areas: 
drug/alcohol  addiction  (8  projects),  integration  of  sick  and  healthy  people  in 
housing  development  (2),  help  for  women  who  have  experienced  violence  (2), 
information  about  health  services  in  immigrants'  own  languages  (1),  integration 
of prostitutes  (2), integration  of schizophrenics  and their carers  (1),  improvement 
of  mental  health  and  well-being  (1). 

22. 

The European  Initiative  for  the Prevention  of Urban  Delinquency  and  the  Social 
Reintegration  of Ex-Offenders  (1995)  included  numerous  health-related  projects, 
in particular  as regards drug abuse. Drug abuse is a health  problem  needing to be 
tackled  among  potential  delinquents,  and/or  prisoners  or  ex-offenders.  But  it  is 
also  in  many  cases  a crime  itself,  and  often  a major  cause  of  further  crime. 

3.1.4  Free  movement  of  workers 

23. 

On 28 June  1995, the Commission  submitted  a proposal  for  a Council  Regulation 
amending  Regulation  (EEC)  1408/7117.  In  particular,  this  proposal  provides  that 
the  entitlement  to urgently  needed  health  care  of  a person  who  is  insured  in  one 
Member  State  and  temporarily  resident  in  another  be  extended  to  all  persons 
regardless  of  their  nationality. 

3.1.5  People  with  disabilities 

24. 

As in health  matters, policies concerning  disabled  people are tending  increasingly 
to  move  away  from  strictly  medical  considerations  towards  the  area  of  social 
welfare.  While it is still important to look at how disabilities develop  and at ways 
of  preventing  them,  it  is  now  essential  to  have  a  better  understanding  of  their 
social  effects.  In  this  connection,  we  are  now  seeing  the  emergence  of  a  new 
approach based on the need to take action directed not only at disabled  individuals 
but  also  at  the  environment  in which  they  live. 

The third Community  Action Programme to assist disabled people (HELIOS  II)18, 
covering  the  period  January  1993-December  1996,  is  in  line  with  this  approach 
in  that  it  develops  exchanges  and  disseminates  information  at  Community  level 
so as to  promote  equality  of  opportunity  for  the  disabled.  Activities  taking  place 
under  the  programme  in  1995  mainly  concerned  the  following  areas:  anti 
discrimination measures, raising public awareness, independent living, the creation 
of  suitable jobs,  and  the  role  of NGOs. 

3.1.6  Health  and  safety  at  work 

25. 

The  Communication  from 
concerning  safety,  hygiene  and  health  at work  (1996-2000)  was  adopted  on 
12  July  199519,  and  included  a  proposal  for  a  Council  decision  adopting  a 
programme  of  non-legislative  measures  to  improve  health  and  safety  at  work. 

the  Commission  on  a  Community  programme 

The  Commission  intends  that  this  programme  should  provide  a  sufficiently 
flexible,  dynamic  and  realistic  framework  to  enable  the  Community  to  meet  the 
challenges posed by the profound  economic, technological  and social  changes that 
are  occurring.  It  includes  non-legislative  measures,  a legislative  programme  and 
in  other  policies.  As  part  of  the 
provisions  concerning  health  and  safety 
programme  the  Commission  has  included  SAFE  (Safety  Action  for  Europe), 
aimed  at  improving  safety,  hygiene  and  health  at  work  especially  in  small  and 
medium-sized  enterprises. 

Amended proposal for a Council Regulation of 28.06.1995, OJ C 242 of 19.09.1995 
Council Decision of 25.02.1993 establishing a third Community Action programme to promote 
equal opportunities and the integration of disabled people (HELIOS II), 93/136/EEC, OJ C  56, 
09.03.1993, p.  30 
COM(95) 282 final of 12.07.1995 

19 

The  proposed  decision  of  the  Commission  deals  with  the  development  of  non-
legislative  measures  such  as  guidance  notes  and  information,  education  and 
training  material  and  the  SAFE  programme. 

26. 

In  setting  Occupational  Exposure  Limits  (OELs)  for  the  control  of  exposure  to 
chemical  substances  the  aim  is to  identify  a level  of  exposure  at  which,  according 
to  the  most  up-to-date  knowledge,  the  exposed  worker's  health  should  not  be 
affected. 

To  further  support  the  work  of  developing  harmonized  OELs,  the  Commission 
Decision  on  setting  up  a  Scientific  Committee  for  Occupational  Exposure  Limits 
to  Chemical  Agents  (SCOEL)20  established  a  formal  basis  for  the  scientific 
evaluation  of  the  risk  at  the  workplace  related  to  chemical  substances.  By  giving 
the  Committee  a  formal  basis,  the  European  Commission  has  acknowledged  the 
work  already  performed  and  significantly  advanced  its  role  in  the  European 
process,  contributing  to  the  global  aim  on  the  harmonisation  of  conditions  in  the 
working  environment  as  specified  by  Article  118a  of  the  European  Community 
Treaty. 

In  September  1995  the  Commission  presented  a proposal  for  a  Council  Directive 
amending  for  the  first  time  Directive  90/394/EEC  on  the  protection  of  workers 
from  the  risks  related  to  exposure  to  carcinogens  at  work.21  The  main  purpose  of 
this  proposal  is  to  set  limit  values  for  occupational  exposure  to  carcinogens, 
starting  with  benzene. 

On  29  June  199522  the  Council  adopted  a  Regulation  which  amended 
the 
Regulation  establishing  a  European  Agency  for  Safety  and  Health  at  Work, 
located  in  Bilbao.  The  Agency's  main  tasks  will  be  to  collect  and  disseminate 
technical,  economic  and  scientific  information  on  health  and  safety  at  work  and 
to promote  and  support  exchanges of information  and  experience between  Member 
States. 

The  Agency  became  operational  in  1995.  Two  meetings  of  its  Administrative 
Board  were  held.  The  recruitment  of  staff  began  with  the  publication  of  the  Call 
for  Applications  for  the  post  of  Director23. 

In July  1995, ilie Commission  decided  to officially  set up the  Committee  of  Senior 
Labour  Inspectors  (SLIC)24,  which  has  existed  informally  since  1982.  In  1995,  the 
Committee  discussed  inter  alia  issues  of  free  movement  of  workers,  services  and 
enterprises  engaged  in  health  and  safety,  and  informatics  support  for  labour 
inspectorates.  SLIC  has  agreed  on  common  principles  of  labour  inspection.  A 
process  of  evaluation  of  national  systems  was  launched  on  the  basis  of  these 
principles.  Observers  from  Central  and  Eastern  European  countries  and  the  Baltic 
States  participated  in  parts  of  the  Committee  meetings. 

27 

28. 

29. 

20 
21 
22 

23 

24 

Commission  Decision  95/320/EC  of  12.07.1995  - O.J. N°  L  188,  9.8.1995 
O.J. N°  C  317,  28.11.1995 

Council  Regulation  N°  1643/95, OJ N°  L  156, 07.07.1995, p.l 
OJN°  C  338,  16.12.1995 
Commission  Decision  95/319/EC  of  12.07.1995, OJ  L  188/11,  09.08.1995 

Drugs 

1. 

2. 

3. 

Actions  to  combat  drug  dependence  focus  on  reducing  the  supply  of  drugs 
(through  measures  such  as  police  cooperation  and  border  controls  and 
incentives  to  producers  to  grow  alternative  crops)  and  on  addressing  the 
problems  of  drug  users  (through  health  and  social  support  measures).  Both 
approaches are  prominent  in  the  Community  actions  in the  drugs  sector,  and 
are  combined  in  the  Community  Action  plan  to  combat  drugs  (1995-99)25. 

The reduction  of drug  dependence  is a priority  area for  Community  activities 
in  the  field  of public  health  and  is  specifically  mentioned  in  Article  129  of 
the  Treaty.  A  corresponding  Community  action  programme  is  currently 
under  discussion.  This  is  supplemented  by  high  profile  events,  such  as 
European  Weeks  against  Drug  Dependence. 

Social policy  actions  aimed  at  marginalised  groups  in  society  also  reinforce 
preventive  and  support  activities  concerning  potential  and  actual  drug users. 

These  actions  are  supplemented  by  other  activities,  e.g.  research,  education 
and  training  activities  (particularly  aimed  at  young  people).  Another 
important  area  is medicinal products,  where  issues  of  dependence  are  raised. 

Drug  supply  reduction  and  activities preventing  drug trafficking  often  extend 
beyond  the  territory  of  the  Community  and  are  therefore  conducted  in 
cooperation  with  third  countries  and  international  organisations.  These  issues 
are  covered  in  several  programmes  of  cooperation  with  third  countries,  e.g. 
Tacis/ Phare  and  the Lomé  convention. 

Internally,  drug  supply  reduction  is  a  major  topic  in  the  area  of  cooperation 
between  Member  States  in judicial  and  home  affairs,  particularly  concerning 
police  cooperation.  Implementation  of  the  first  phase  of  EUROPOL  also 
covers this  topic. 

The  Community  is  supporting  relevant  activities  by  the  United  Nations,  its 
agencies  and  other  international  organisations. 

See  the  relevant  sections  of  this  report  for  further  information  on  1995 
activities  in  these areas  of policy. 

3.2 

Internal  market  -free  movement  of  persons  and goods,  taxation 

30. 

Community  activities regarding the creation of the internal market have numerous 
consequences  for  health.  These  include  the  development  of  common  rules  and 
regulations  concerning  the  markets for  specific  products,  e.g.  pharmaceuticals  or 
medical  devices,  as  well  as  the  rules  on  free  movement  of  goods  as  such.  A 

25 

COM (94)  234  fin. 

specific  area of  activity  - under the  auspices  of consumer  protection  - is the field 
of  cosmetics.  Indirect  taxation  of  goods  such  as  tobacco  or  alcohol  can  have 
immediate  health  effects.  An  important  requisite  enabling  the  free  movement  of 
persons  is the  recognition  of  diplomas,  e.g.  in  medical  professions.  Finally,  data 
protection  is  an  area  of  Community  policy  where  health-related  concerns  -  both 
of  the  citizen  interested  in  protecting  his/her  medical  and  other  data  and  the 
medical  researcher  - need  to be taken  into  account. 

3.2.1  Medicinal  products 

31. 

Starting with the first directive in 1965, Community legislation on pharmaceuticals 
has  usually  been  designed  to  promote  and  protect  public  health.  By  1993  there 
was a harmonised  legal  framework  for  marketing  authorisations. Under the rules, 
every  medicinal  product  must  meet  strict  quality,  safety  and  efficacy  criteria 
before  it  can  be  authorised.  This  legislation  covers  all  industrially-manufactured 
medicinal  products:  vaccines,  blood  products,  radiopharmaceuticals.  The  criteria 
are  regularly  revised  to take  account  of  scientific  and  technical  progress. 

1995  saw  the  introduction  of  the  new  European  system  for  authorising  and 
monitoring  medicinal  products  in  the  European  Community.  Under  this  new 
system  the  Commission  has already  authorised  the  marketing  of three  innovative 
products. 

This  new  system  for  registering  medicinal  products  in the European  Community 
represents a decisive step towards the establishment  of the Single Market. It helps 
to  promote  the  free  movement  of  medicines  within  the  European  Community 
while  ensuring  optimum  protection  for  public  health. 

32. 

The main  innovation  in  this  area  in  1995  was the  establishment  of the  European 
Medicines  Evaluation  Agency  (EMEA)  in  London,  whose  aim  is  to  encourage 
cooperation  between,  and  coordinate  the  resources  of,  national  drug  registration 
agencies. 

There  are  now  two  licensing  procedures  for  medicinal  products:  a  centralised 
procedure,  which  is  compulsory  for  high-technology  products  and  optional  for 
innovatory  new  medicines,  and  a  decentralised  procedure  that  is  based  on  the 
principle  of  mutual  recognition  of  national  authorisations.  Under  the  latter 
procedure, the  Agency  intervenes if there are conflicting  scientific  evaluations by 
national  authorities  when  application 
is  made  for  mutual  recognition  of 
authorisations. 

Once  the  evaluation  process  has  been  completed,  the  European  Commission  is 
responsible for  making the  scientific  opinions binding  (for  human  and  veterinary 
uses). 

This  new  system  provides  all  patients  in  the  European  Community  with  more 
rapid,  and  simultaneous,  access  to  innovatory  medicines.  When  an  authorisation 
is issued,  health professionals  and  consumers are provided  with  clear and  reliable 
information  in the form  of labels and package leaflets.  In addition, the monitoring 
of  medicinal  products  after  their  authorisation  is  being  improved 
through 
coordination  by  the  Agency  of  national  pharmacovigilance  activities. 

10 

By coordinating national resources devoted to drugs registration, this system helps 
to  ensure  that  the  quality,  safety  and  efficacy  of  medicines  which  are  to  be 
marketed  in  the  European  Community  or  exported  to  third  countries  are  of  an 
optimum  standard. 

Finally,  this  system  coincides  with  the  emergence  of  the European  Community 
onto  the  international  scene.  It  provides  third  countries  with  a  public  health 
guarantee for evaluations carried out in the Community and strengthens the latter's 
position  vis-à-vis  these countries. 

33. 

In  1995,  the  institutions  discussed  the  Communication  from  the  Commission  to 
the  Council  and the European Parliament  on the  outlines  of  an industrial  policy 
for  the  pharmaceutical  sector  in  the European  Community26.  Although  in  other 
areas the Commission  advocates a global  approach to industrial  policy,  a sectoral 
approach  seemed  appropriate  in  this  particular  area given  the  public  health  and 
social policy issues that it raises. In its communication, the Commission proposes 
a  set  of  guidelines  reconciling  effective  control  of  health  care  expenditure  with 
continuation  of the long-term  efforts by the European pharmaceutical  industry to 
develop  therapeutically  innovative  medicines.  However,  it  is  the  Council  which 
should take the lead here since most of the subjects discussed in the Commission's 
communication  lie within  the competence  of the Member States. 

34. 

The  Commission  has  launched  an  information  society  programme  for  the 
pharmaceutical  sector  to  encourage  transparency  and  the  rapid  exchange  of 
information.  This  is  particularly  important  as  regards  pharmacovigilance.  The 
databases  to  which  the  network  will  give  access  will  include  scientific  and 
economic  information  on all  medicines  sold  on the Community  market. 

3.2.2  Medical  devices 

35. 

36. 

Community  legislation  on  medical  devices  removes  technical  barriers  to  trade, 
thus enabling the single market to be brought about in this particular sector.  It is 
also designed  to ensure  a high level  of  safety  and health in the  Community  and, 
for  this  purpose,  introduces  a  coherent  approach  to  the  establishment  and 
implementation of requirements for the design, manufacture and marketing of such 
devices.  The  gains  in  terms  of  protection  of  public  health  are  real  and  quite 
considerable. 

1  January  1995  saw  the  compulsory  application  -  following  the  end  of  the 
transition period - of Council Directive 90/385/EEC on active implantable medical 
devices. It also marked the optional  application - at the beginning of the transition 
period - of Council  Directive  93/42/EEC, which covers all  other medical  devices 
(except thbse used for in vitro diagnosis). During  1995, the  Commission's  efforts 
aimed  at implementing  these  two  directives bad  a positive  effect  as  regards the 
protection  of  public  health.  Its activities included: 

consultations with authorities in the Member States which  are responsible 
for  implementing  the two directives; 

26 

COM  (93)  718  fin.  of  02.03.1994 

11 

to 

the 

tasks  assigned 

coordination  and  monitoring  of  the  activities  of  the  certification  bodies 
concerned  (notified  bodies)  to  ensure  that  the  latter  adopt  a  uniform, 
consistent  approach27 
monitoring  performance  of 
international 
standardisation  organisations  (CEN  and  CENELEC).  In  this  connection, 
the  titles  and  references  of  important  "horizontal"  standards  have  been 
published  in  the  OJ,  giving  them  the  status  of  European  harmonised 
standards28 
encouraging  and  coordinating  work  to  set  up  a  Community  monitoring 
system  so  as  to  avoid  the  occurrence  and/or  recurrence  of  events  with 
negative  repercussions  on  public  health;  in  1995,  the  issuing  of  public 
warnings  concerning  certain  types of devices and the use  of the  safeguard 
clause by  certain Member  states, as provided  for  in the directives,  showed 
how  valuable  and  important  the  concept  of  Community  monitoring  is  in 
an  area  as  sensitive  as that  of  health. 

37. 

Finally,  mention  should  be made of the Commission's  proposal  for  a directive  on 
in  vitro  diagnostic  medical  devices29,  which  completes  the  set  of  directives 
covering  all  medical  devices.  This  proposal  has  received  a  favourable  opinion 
from  the  Economic  and  Social  Committee.  It  is  currently  undergoing  the  initial 
consultation  procedure  at  the  Parliament  and  will  be  discussed  by  the  Council's 
Working  Party  on  Economic  Questions  at the beginning  of  1996. 

3.2.3  Consumer  protection  -  cosmetics 

38. 

In  July  1995,  the  Commission  adopted  the  18th  Directive  adapting  to  technical 
progress the annexes of the basic directive on cosmetic products30. These  annexes 
contain  lists  of  substances  which  must  not  form  part  of  the  composition  of 
cosmetic  products,  substances  which  cosmetic  products  can  contain  only  subject 
to restrictions  or special  conditions,  and  substances which  cosmetic products  may 
contain  (UV-filters,  preservatives  and  colouring  agents).  Before  being  added  to 
one of these  lists, the  safety  of the  substance for  human  health  is assessed  by  the 
Scientific  Committee  on Cosmetology,  which  gives an opinion.  The  Commission 
takes  this  opinion  into  account  when  preparing  its  draft  proposal,  which  is 
subsequently  submitted  to  the  Committee  for  Adaptation  to  Technical  Progress. 
In July  1995, the Commission  adopted  a 6th Directive on methods of analysis  for 
checking  the  composition  of  cosmetic  products31. 

39. 

The  Commission  has  adopted  a  directive  establishing  the  criteria  and  conditions 
under  which  a  manufacturer  may,  for  reasons  of  trade  secrecy,  apply  not  to 
include  one  or  more  ingredients  in  the  list  of  ingredients  to  be  indicated  on  the 
packaging of cosmetic products32. These criteria take into account the safety  of the 
consumer  as well  as the justified  commercial  interests  of  the  manufacturer. 

27 

28 

29 

30 

31 

32 

OJ  C  280/12  of  25.10.1995 
OJ  C 277/6  of  4.10.1994,  C  204/22  of  9.8.1995,  C  307/14  of  18.11.1995 
OJC  172/21  of  7.7.1995,  p.  21 
Commission  Directive  95/34/EC  of  10.07.1995, OJ L  167 of  18.07.1995, p.  19 
Directive  95/32/EC  of  07.07.1995, OJ L  178, 28.07.1995, p.  20 
Directive  95/17/EC  of  19.06.1995, OJ L  140, 23.06.1995, p. 26 

12 

40. 

The  Commission  is  currently  finalising  an  inventory  of  ingredients  employed  in 
cosmetic  products  and  a  common  nomenclature  of  these  ingredients.  These  are 
linked  with  the  full  labelling  of  ingredients  in  cosmetic  products  required  after 
January  1997. The idea is to enable the consumer to identify  substances he should 
avoid,  e.g.  because  of  personal  allergy,  when  buying  a cosmetic  product. 

3.2.4  Taxation 

41. 

Fiscal  policy  concerning  the  indirect  taxation  of goods  has  an  effect  on the  price 
of goods  such as tobacco, alcoholic beverages and petrol. On  13 September  1995, 
the  Commission  adopted  a report  on the  approximation  of  excise  duties33.  In this 
report,  the  Commission  clearly  demonstrates  how  fiscal  policy  has  to  take  into 
account  the  general  objectives  of  the  Treaty,  including  health  protection 
requirements  as well  as  environmental  questions. 

Regarding  the  consumption  of  tobacco  products,  the report  underlines  that  fiscal 
measures represent a means of dissuasion. The revenue generated  could  contribute 
towards  compensation  for  the  "social  cost"  of  smoking,  i.e.  health  care  costs and 
costs of scientific  research.  On alcohol  and alcoholic beverages, from  a social  and 
health  policy  point  of view,  taxation  could  be  a means of  discouraging  excessive 
consumption.  It could  contribute to reduce the problems associated  with the abuse 
of  alcohol. 

3.2.5 

Jurisdiction  on  free  movement  of  goods 

42. 

Protecting  public  health  is  one  of  the  legitimate  objectives  recognised  by  the 
Treaty as justifying,  where necessary  and appropriate, measures that do not accord 
with  one  of  the basic  principles  of the  internal  market,  i.e. the  free  movement  of 
goods.  It  is,  in  fact,  often  invoked  by  Member  States  to justify  the  adoption  of 
national  regulations  laying  down  technical  specifications  that  affect  the  free 
movement  of  goods  within  the  single  market. 

43. 

In  1995,  the  Court  of  Justice  delivered  two judgments  regarding  the  application 
of  the  rules  on  free  movement  in  the  light  of  health  protection  requirements. 

In  its  judgment  of  23.02.199534,  the  Court  ruled  that  Council  Directive 
90/642/EEC of 27 November  1990 on the fixing  of maximum  levels for  pesticide 
residues  in  and  on  certain  products  of  plant  origin  does  not  preclude  national 
legislation  -  in  this  instance,  Italian  regulations  -  from  setting  maximum 
permissible  levels  for  residues  of  Chlorpropham  and  Propham  and  providing  for 
procedures  for  checking  compliance  with  those  levels,  on  condition  that  such 
provisions  do  not  contravene  Articles  30  and  36  of  the  Treaty. 

In  its judgment  of  28.03.199535,  the  Court  held  that  a  national  practice  -  in  this 
instance, a British  one - of prohibiting importation  of narcotic drugs (diamorphine, 
in this particular case) is covered by Article 30 of the Treaty. Moreover,  an import 

33 

34 

35 

COM  (95)  285  fin.  of  13.09.1995 
Judgment  of  23.02.1995, Joined  Cases  C-54/94  and  C-74/94,  [1995]  ECR  I  -  391 
Judgment  of  28.03.1995,  Case  C-324/93,  [1995]  ECR  I  -  563 

13 

ban  would  not  be  admissible  under  Article  36  if  it  were  based  on  the  need  to 
safeguard  an  undertaking's  survival.  On  the  other  hand,  such  a ban  may  benefit 
from  the derogation  provided  for  in Article 36 of the EEC Treaty  if protection  of 
the  health  and  life  of  humans  is at issue and this objective  cannot be  achieved  as 
effectively  by  measures  less  restrictive  of  intra-Community  trade. 

3.2.6  Free  movement  of  persons 

Recognition  of  diplomas  in  health  professions 

44. 

Health  protection  has  always  been  an  important  consideration  when  it  comes  to 
the  mutual  recognition  of  diplomas  in  the  health  professions  (doctors,* nurses, 
midwives,  pharmacists,  dentists  and  veterinarians,  in  particular).  The  directives 
concerning these diplomas are based  on the free-movement  articles of the Treaty, 
49,  54 and 63, and aim to facilitate  the free  movement of professionals  trained  in 
the  Community  in  accordance  with  comparable  standards  of  training.  These 
standards  are being  harmonised  by  drawing up  common  minimum  requirements. 

45. 

In  addition,  advisory  committees  on the training  of these professionals,  set up  to 
support  the  directives,  help  to  ensure  comparably  high  skill  levels  by  issuing 
opinions  and  recommendation  on training  matters. 

In  so  doing,  they  also  contribute  to  the  framing  of  health  policies  in  the 
Community. 

Finally,  the Committee  of  Senior  Officials  on Public Health,  consisting  of  senior 
officials  from  the Member  States with  direct responsibilities  in the public  health 
field,  has the task  inter alia  of gathering  any useful  information  on  arrangements 
for  providing  medical  and  general  care  in  the  Member  States  and  of  issuing 
opinions  that  help  to  guide  the  Commission's  work  as  far  as  doctors,  dentists, 
nurses and  midwives  are concerned. For pharmacists  and veterinaries, this task is 
assured  by  two  specific  bodies.  A  proposal  for  a  directive  submitted  by  the 
Commission  to  the European  Parliament  and  the  Council  on  16 December  1994 
is  designed  to  enable  this  committee  to  assist  the  Commission  by  means  of  a 
special  committee  procedure  with  a  view  to  amending  the  lists  of  medical 
specialisations  and  the  length  of  the  corresponding  training  courses  set  out  in 
the  free  movement  of  doctors.  The 
Directive  93/16/EEC  on  facilitating 
Commission  has  presented  a  modified  proposal  of  the  directive  following  the 
opinion  of  Parliament36. 

36  27.11.1995,  JOC  C  28,  01.02.1996 

14 

3.2.7  Data protection 

46. 

1995 saw the final adoption of the European Parliament and Council directive on 
the protection of individuals with regard to the processing of personal data and on 
the free  movement  of  such  data37.  The text  establishes  a  framework  of  general 
principles  for  the  processing  of  data  relating  to  individuals,  and  will  apply 
generally to all data processing covered by Community law, including that in the 
health  sector. 

The needs of public health are recognised  specifically  in the text in a number of 
places,  most notably  in  a recital  which  cites public  health  as an  area  where an 
exemption  to the prohibition  on the processing of certain  sensitive categories of 
data may be granted  on grounds of important public interest. 

The  overall  effect  of  the  directive,  which  Member  States  have  3  years  to 
transpose into national law, will be to harmonise data protection legislation so that 
personal data may move freely  within the European  Community  on the basis of 
a  shared  framework  of  rules.  In  the public  health field this  will  facilitate  data 
processing  which  involves  bringing  together  personal  data  from  a  number  of 
different  Member States. Epidemiology and clinical trials are two areas which are 
likely to be particularly  affected  in this regard. 

3.2.8  Education  and  training  - KAROLUS 

47. 

The KAROLUS Programme is a scheme for  training officials  from  the Member 
States  through  the  exchange  of  national  officials  between  Member  State 
administrations.  Its  purpose  is  to  facilitate  cooperation,  and  promote  mutual 
confidence, between national administrations, and to ensure a uniform and proper 
application  of Community legislation on the internal  market.  Among the sectors 
covered  by the exchange programme are some with a direct or  indirect  bearing 
on health,  such as medicinal products,  foodstuffs,  product  safety,  etc. 

3.3  Agricultural and foods policy,  fisheries 

48. 

The  links  between  the  quality  of  food  and  health  are  obvious.  Therefore,  the 
different  aspects of agricultural, fisheries and foodstuffs  policies are crucial areas 
where  health  requirements  need  to be  integrated  into  Community  policy.  It  is 
impossible  to  give  a  complete  overview  of  all  day-to-day  activities  of  the 
Commission in this field. In this section, major developments in 1995 concerning 
the veterinary sector, pesticides, tobacco, wine and alcohol, foodstuffs,  milk, and 
the fisheries  sector will be presented. 

37  EP and  Council  Directive  95/46/CE  of  24.10.1995, OJ L  281  of  23.11.1995 

15 

3.3.1  Veterinary  sector 

49. 

50. 

A series of decisions were taken during  1995 by the Council  and the  Commission, 
developing  legislation  on health  and hygiene, concerning  animals and products of 
animal  origin. 

In  June,  the  Council  adopted  a  directive  amending  Directive  64/433/EEC 
concerning  health  conditions  for  the production  and marketing  of fresh  meat38.  It 
also  adopted  a  series  of  decisions  concerning  tests  for  salmonella  in  certain 
animals  and  animal  products  destined  for  Finland  and  Sweden39. 

The  Commission  adopted  a number  of  proposals  for  presentation  to  the  Council 
including  in  particular  a  proposal  on  the  marketing  of  meat  products40  and  a 
proposal  for  a  Council  directive  amending  Directive  92/117/EEC  concerning 
measures  for  protection  against  certain  zoonoses  (diseases  transmissible  between 
animals  and  man,  such  as rabies)41. 

51. 

The  Commission  took  many  decisions  to  establish  common  health  requirements 
to  be  applied  to  the  import  of  animals  and  products  of  animal  origin  from  third 
countries. 

In  addition,  it was  necessary  to take  a number  of  emergency  safeguard  measures 
to limit imports of products from  certain third  countries where the health  situation 
was  considered  unsatisfactory.  The import  offish  from  Japan  was restricted  after 
an inspection  revealed  serious deficiencies  in inspections  and controls of products 
to  be  exported  to  the European  Community42.  A  Commission  decision  based  on 
a  report  from  the  Scientific  Veterinary  Committee  authorised  special  heat 
treatment  to  decontaminate  bivalve  molluscs  in  southern  Spain  containing  low 
levels  of  the  PSP  toxin.  This  decision  applies  only  to  Spain  and  is  limited  to  a 
particular  species. Its purpose is ensure that this type of product is safe for  human 
consumption.  Following  the  outbreak  of Ebola  disease in Zaire,  the  Commission 
banned  the importation  of apes originating  in or coming  from  Zaire43. Both  these 
decisions  form  part  of  the  measures  to  protect  human  and  animal  health  in  the 
Community. 

52. 

The  veterinary  and  phytosanitary  office  continued  its  programme  of  inspections 
within  the  Community  and  in  third  countries  to  monitor  the  application  of  and 
compliance with  Community  health  rules in the veterinary  sector.  Apart from  the 
fresh  meat and meat products sector,  checks were also initiated  in the  poultrymeat 
and  fish  and  fishery  products  sector.  In  addition,  special  visits were  also  made  in 

38 

39 

40 

41 

42 

43 

Directive  95/23/EC,  OJ L  243,  11.10.1995, p.7 
Directives  95/409  to  411/EC,  OJ  L  243,  11.10.1995, pp.  21, 25, 29 
O JC  269,  16.10.199 
COM  (95)  491  fin.  of  23.10.1995 
95/119/EC  of  07.04.1995 
Decisions  95/171/EC of  18.05.1995, OJL  112 of  19.05.1995, p. 30, and 95/313/EC of 24.07.1995, 
O JL  187, 08.08.1995, p. 23 

16 

Member  States and third  countries in case of outbreaks of certain diseases to study 
the  epidemiology  and  check  the  health  controls  applied. 

53. 

From  30  November  to  1 December  1995,  the  Commission  organised  a  major 
scientific  conference  on  growth  promotion  in  meat  production.  The  conference 
came  to  the  conclusion  that  the  accumulation  of  experiences  and  published  data 
on  the  use  of  natural  and  sex  hormones  and  related  compounds  (Zeranol  and 
Trenbolene)  has  shown  no  evidence  of human  health  risk  arising  from  their use, 
when  used  under  prescribed  conditions.  Further  scrutiny  is  required  to  evaluate 
effects  on  animal  health.  Substantial  concerns  about the potential  risk  for  human 
and  animal  health  remain  concerning  the  possible  use  of  beta-2-antagonists  as 
growth  promoters.  The  conference  concluded  in  addition  that  the  illicit  use  of  a 
variety  of  growth  promoters  has  become  a  serious  problem.  It  saw  therefore  a 
need for coordinating national control systems, to target surveillance systems more 
effectively,  and  to  enhance  the  efficacy  of  detection  systems  and  methods. 

3.3.2  Pesticide  residues 

54. 

In  1995,  as  part  of  the  ongoing  harmonisation  of  maximum  levels  of  pesticide 
residues in and on certain  products of plant or animal  origin, the Council  adopted 
three  directives  harmonising  maximum  residue  levels  for  nine  pesticide  active 
substances  and  amending  existing  maximum  residue levels for  some 20  pesticide 
active  substances44 

3.3.3  Tobacco 

55. 

The  Community  fund  for  tobacco  research  and  information  decided  to  fund  a 
number  of  projects,  to  commence  in  March  1996,  both  on  informing  the  public 
about the health  effects  of tobacco and  on agricultural  research  aimed  at  reducing 
the  harm  caused  by  tobacco45. 

44 

45 

Coimcil directives 95/38/EC, OJL  197, 22.08.1995, p. 14; 95/39/EC, OJL  197, 22.08.1995, p. 29. 
95/61/EC,  OJ L  292, 07.12.1995, p. 27 
cf.  call  for  tenders  published  in  OJ  C  179/8  of  01.07.1994 

17 

Tobacco  and  alcohol 

1. 

2. 

3. 

4. 

Tobacco  and  alcohol  abuse  are  among  the  major  determinants  for  important 
health  scourges  such  as  cancer  and  cardio-vascular  diseases.  In  addition, 
excessive  consumption  of  alcohol  is a  major  factor  in  accidents,  be  it  on  the 
road,  in  the  workplace  or  at  home.  Several  areas  of  Community  policy 
address  tobacco  and  alcohol  issues. 

In public  health,  there  is  a  strong  focus  on  the  need  to  stop  smoking  and 
moderate  alcohol  consumption  in  the  context  of  activities  to  combat  cancer. 
Alcohol  and  tobacco  were  two  major  focuses  of  European  Cancer  Week  in 
October  1995. 

Specific  social policy  actions  aim  at improving  the  situation  of  excluded  and 
disadvantaged  groups  in  society.  This  may  involve  victims  of  severe  alcohol 
abuse. 

Community  agricultural  policy  covers  tobacco,  which  is  as  an  important 
agricultural  product  of  southern  Member  States.  It  has  taken  steps  to 
encourage  the  production  of less harmful  products,  e.g.  tobacco  yielding  low 
levels  of  nicotine.  The  Community  funds 
tobacco  research  and 
information  will  become  operational  in  1996  to  support  research  and  public 
awareness  campaigns  in  this  area. 

for 

The  production  of  alcoholic  beverages  also  involves  agricultural  products 
(grapes,  hops,  malt,  etc.),  and  common  market  regulations  exist  for  hops, 
wine  and  spirits. 

Fiscal policy,  particularly  concerning  indirect taxation,  has  a major  effect  on 
the  pricing  of  tobacco  and  alcohol  products  and  on  choices  made  by 
consumers.  While  indirect  taxation  levels  have  not  been  harmonised  at  the 
EC  level,  there  is  an  awareness  that  tax  revenues  from  the  sale  of  alcohol 
and  tobacco  could  provide  important  resources  for  preventive  activities. 

5. 

Alcohol  and  driving  is  a major  concern  for  transport policy  in the  context  of 
road  safety  campaigns. 

the  relevant  sections 

See 
developments  in  these sectors in 1995. 

in  this  report  for  more  details  on  policy 

18 

3.3.4  Foodstuffs 

56. 

57. 

In the area of foodstuffs  legislation, the Commission adopted a directive amending 
Directive  90/128/EEC  relating  to  plastic  materials  and  articles  intended  to  come 
into  contact  with  foodstuffs46. 

The  Commission  also  adopted  the  updated  inventory  of  scientific  cooperation 
tasks on questions related  to food47.  Scientific  cooperation  provides  a  mechanism 
allowing  the  Member  States  to  assist  the  Commission  with  the  scientific 
examination  of  questions  related  to food.  Many  of the tasks undertaken  relate  to 
subjects  of  direct  relevance  to  public  health. 

The  Scientific  Committee  for  Food  delivered  a  substantial  number  of  opinions 
relating to food  safety  covering  additives,  contaminants,  materials  and  articles  in 
contact  with  foods  and  adverse  reactions  to  food  and  food  ingredients.  Their 
opinions and  reports will  serve as the basis for  future  legislative  initiatives  of the 
Commission. 

3.3.5  Milk  promotion  campaigns 

58. 

Under the EC's school milk  scheme, subsidies are provided  so that  schoolchildren 
can receive certain  milk products at reduced  prices. Although the prime  objective 
of  this  programme  is  to  promote  the  consumption  of  milk  products,  its 
contribution  to  achieving  a  balanced  diet  for  schoolchildren  has  proved  to  be 
equally important. In recent years, Member States have been encouraged to supply 
suitable  nutritional  information  on milk  and milk products in  schools, in  order  to 
enhance  the  efficiency  of  the  school  milk  scheme. 

The  range  of  milk  products  eligible  for  subsidy  is  sufficiently  wide  to  comply 
with  the  need  for  a  varied  and  balanced  diet  in  different  circumstances.  Within 
this range, there is a clear trend towards those products with a reduced  fat  content. 
In the school year  1988/89, whole milk products  still accounted  for  some  77% of 
the total  quantity  distributed  ; for  the  1994/95  period,  this figure  was reduced  to 
less than 65%. 

3.3.6  Fisheries 

59. 

There  is  a  general  consensus  that  the  consumption  of  fish  contributes  to  the 
the  Commission  has 
prevention  of  cardio-vascular  diseases.  Accordingly, 
continued  its  efforts  to  promote  the  consumption  of  fisheries  products  and  to 
improve  the  quality  of  products  sold  to the  public. 

60. 

After  the  merging  (in  late  1993)  of  all  the  structural  financial  tools  in  a  unique 
financial  instrument  for  fisheries  guidance  (FIFG),  the  Community  action  in 

46 

47 

Directive  95/3/EC of  14.02.1995, OJ L 41, 23.02.1995, p. 44 
Commission decision amending Decision 94/652/EC establishing the inventory and distribution of 
tasks to be undertaken within the framework  of cooperation by Member States in the  scientific 
examination of questions related to food  (95/492/EC of  15.11.1995) 

19 

supporting these measures is carried  out in the framework  of the  Structural  Funds 
reform,  i.e.  in  integrated,  coherent  structural  development  plans  covering  the 
period  1994-99, established  in partnership  between the Commission  and Member 
States,  and  implemented  at local  level.  The  new financial  instrument  has  special 
provisions for the promotion of consumption, including operations associated with 
quality  certification,  promotion  campaigns  based  on  quality,  and  studies. 
Moreover,  all  physical  investment  intended  to  improve  conditions  of  hygiene  or 
human  or  animal  health  and  to  improve  quality  is  eligible  for  aid  in  the  sectors 
of  aquaculture,  fish  processing  and  marketing  of  fisheries  products. 

The total FIFG budget allocated to national  plans for the period  1994-99 is 2 671 
million  ecus.  Of  this,  84  million  is  allocated  to  promotion  and  859  million  to 
aquaculture,  processing  and  marketing  (this sum  includes financing  for  measures 
not  directly  linked  to  health  requirements). 

The  FIFG  also  finances  studies  on  an  annual  basis;  in  the  period  1994-95,  six 
studies  directly  relating  to  quality  or  health  matters  were  financed,  with  a 
Community  contribution  in  excess  of  530  000  ecus. 

3.4 

Research  and  development 

61. 

Research and development activities in the European  Community take place in the 
context  of  Framework  Programmes  for  research  and  technological  development 
(RTD).  The  4th  Framework  Programme48,  which  currently  is  the  basis  of  RTD 
activities,  encompasses  a  number  of  specific  RTD  programmes  which  are  either 
health-related  or  include  projects  with  a health  dimension. 

3.4.1  BIOMED 

62. 

Health-related  research  and  development  activities  take  place  mainly  within  the 
Biomedicine  and  Health  Programme  (1994-1998  -  BIOMED  2)  within  the  4th 
RTD Framework Programme49. With  a total budget  of 336 million  ecus, it  covers 
the  following  eight  target  areas: 

Area  1: Pharmaceuticals  research; 
Area  2: Research  on biomedical  technology  and  engineering; 
Area  3: Brain  research; 
Area  4:  Research  on  other  diseases with  a major  socio-economic  impact; 
Area  5: Human  genome  research; 
Area  6:  Public  health  research,  including  health  services  research; 
Area  7:  Research  on  biomedical  ethics; 
Area  8: Ethical,  legal  and  social  aspects. 

49 

Decision  94/1110/EC  of  26.04.1994,  OJ  L  126,  18.05.1994,  p.  1,  as  amended  by  Decision 
96/616/EC  of  25.03.1996,  OJ L  86, 04.04.1996,  p. 69 
Council  decision  94/913/EC  of  15.12.1994  adopting  a  specific  programme  of  research  and 
technological development, including demonstration, in the field of biomedicine and health (1994-
1998),  OJ  L  361, 31.12.1994,  p.40 

20 

63. 

A first call for  proposals was launched  in January  1995 with  all thematic areas of 
the  work  programme  open  to  submission  of  research  proposals.  After  scientific 
and technical  evaluation  by  independent  experts,  307 out of  1709  proposals  have 
been  selected for Community  support with  a financial  contribution totalling  153.7 
million  ecus. 

The selected proposals, notably  in the fields  of AIDS,  cancer,  occupational  health 
research  and  in  particular  public  health  research,  are  expected  to  underpin  the 
public  health  initiatives  in  the  context  of  Article  129  of  the  Treaty. 

Likewise,  the  BIOMED  2 programme  will  be  supporting  demonstration  projects 
in order to prove the techno-economic  viability  of new medical  practices  (e.g.  ex 
vivo AIDS treatment,  restoration  of movement of paraplegic patients by  electrical 
stimulation)  and  to  disseminate  these  practices  to  users,  industry,  public  entities 
and  other  targeted  interest  groupings. 

64. 

Vaccination  is  widely  recognised  as  one  of  the  most  efficient  tools  of  public 
health policy showing evident cost-benefit  advantages for all the target populations 
involved. 

With  more  than  5  million  patients  in  western  Europe,  hepatitis  C  is  the  most 
important  chronic  viral  infection  in  the  region.  Development  of  a  vaccine  for 
hepatitis  C is extremely  complicated  because  of the lack  of  knowledge  regarding 
immunological  parameters, and can be accomplished  only through  a collaborative 
effort  of  multidisciplinary  approaches 
laboratories.  The 
BIOMED 2 programme is currently  supporting a project for  developing a vaccine 
in  which  laboratories  from  five  countries  are  participating. 

involving  several 

It  now  appears  feasible  to  develop  cancer  vaccines  that  induce  cancer  rejection 
responses  and  stimulate the  immune  system  to produce  antibodies  against  cancer 
cells.  The BIOMED  2 programme  is supporting  a transnational  project  involving 
seven  leading  laboratories,  the  main  aim  of  which  is  to  identify  antigens 
recognised  by  T-lymphocytes  on  human  tumours. 

A number of research teams are devoting their efforts  to develop vaccines  against 
chronic diseases by the development  of highly immunogenic  recombinant/peptide 
vaccines  and  generation  of  new  adjuvants. 

The Task Force  on Vaccines  and Viral  Diseases which  has been  established  aims 
at  strengthening  the  European  effort  on  vaccine  development  by  fostering 
partnership  and  cooperation  in  research  and  transposing  the  latest  scientific 
advances. 

65. 

Research  on  the human  genome  - the genetic  material  contained  in  every  cell  in 
the  human  body  -  aims  at  determining  the  structure  of  human  DNA  and  the 
identification  and  function  of  all  the  genes.  The  rationale  for  coordinated 
European  activities  related  to  human  genome  research  is  based  on  its  potential 
contribution  to  the  understanding  of  the  processes  underlying  human  disease, 
hence  to  improve  diagnostics,  treatment  and  eventually  disease  prevention.  This 
objective  is  met  through  the  improvement  of  research  infrastructure,  availability 

21 

of resources and cooperation  of leading research groups in Europe in order to put 
Europe  on  the  map  of  the  international  human  genome  programme. 

Particular  progress  was  achieved  through  EUROGEM,  the  European  Gene 
Mapping Project,  which  includes 23 laboratories. This network enabled  European 
researchers  from  all  Member  States,  in  particular  those  without  national 
programmes, to organise human genome research at a European level and to come 
up  with  a European  Genetic  Map  based  on  the  CEPH  reference  families.  At  the 
international  level,  the  work  on  chromosomes  11  and  21  has  been  particularly 
successful. 

Thanks  to  a  European  initiative  there  are  the  so-called  "Single  Chromosome 
Workshops"  for  exchange  of  information  and  data  and  reaching  agreement  on 
nomenclature with regard to progress in the study of individual chromosomes. The 
EC  pays  for  the  European  organisers  and  participants;  the U.S.  (DOE  and  NIH) 
eventually  agreed  to  follow  the  scheme  and  pay  for  the  U.S.  participants  or 
organisers.  These  workshops  turned  out  to  be  extremely  valuable  in  the 
development  of  scientific  collaboration  and the establishment  of research  policies 
in this  field. 

66. 

From  a broader health perspective, a meeting was held in  1995 under the auspices 
of the BIOMED programme in Delft/NL  on "Individual  responsibility  for  health -
moral  issues  regarding  lifestyle  and  a just  distribution  of  medical  resources", 
bringing  together  experts  from  different  Member  States  in  the  fields  of  public 
health,  sociology  and  ethics. 

3.4.2  Telematics 

67. 

Another  area  of RTD  activities with  an important  health  dimension  is telematics. 
The telematics applications programme50 includes specific activities on health care 
telematics  as well  as for  the  disabled  and  the elderly  among the  15 sectors  in the 
programme. It has an overall budget  of 843 million  ecus for  1994 to  1998. Health 
care  telematics  has  an  indicative  budget  of  135  million  ecus,  while  the  sector 
concerning  the  disabled  and  elderly  has  an  indicative  budget  of  65  million  ecus. 

68.  Most of the 42 health telematics RTD projects  initiated during the 3rd  Framework 
Programme  came  to  an  end  in  1995.  Seventy  new  projects  with  a  total 
Community  contribution  of 77 million ecus were negotiated  in  1995 under the 4th 
framework  programme  budget.  As  in  other  sectors  of  the  telematics  application 
programme, stress is now put on actual validation  of applications by  "user groups" 
in  order to have effective  up-take and  deployment  of results once the  programme 
has been  completed. 

Some  of  the  fields  covered  by  the  programme  are:  development  and  inter-
operation  of  regional  networks  for  a  better  integration  and  continuity  of  care, 
cooperation  of  professionals  in  areas  important  for  public  health  such  as  cancer, 

50  Council  Decision  94/801/EC  of  23.11.1994,  adopting  a  specific  programme  of  research  and 
technological  development,  including  demonstration  in the  field  of  telematics  applications  of 
common interest, OJ L 334 of 22.11.1994, p.l 

22 

cardio-vascular  diseases  and  chronic  illnesses.  Inter-operability  of  telematics 
services on a European scale is also covered, for example concerning emergencies. 
In all  cases, the objective  is to increase the efficiency  of the natural  circulation  of 
information  in the health  sector, improving access while maintaining  security  and 
strict  confidentiality.  Management  of  feasibility  studies  in  support  of  national 
policies and of other Community policies is also a significant  part of the activities. 

3.4.3  G-7  Global  Information  Society  Initiative 

69. 

In February  1995, the G7 group of major industrialised nations launched a "Global 
Information  Society" initiative in Brussels. Among the  11 projects included  in this 
initiative,  the  project  on  Global  Healthcare  Applications  consists  of  six  sub-
projects: 

1. 
2. 

3. 

4. 

5. 
6. 

Towards  a Global  Public Health  Network 
Improving  prevention,  early  detection,  diagnosis  and  treatment  of 
cancer 
Improving  prevention,  diagnosis  and  treatment  of  cardiovascular 
diseases 
A  24  hour  multilingual  telemedicine  surveillance  and  emergency 
service  around  the world 
Enabling  mechanisms  for  global  health  networks 
International  harmonisation  of the use of data cards in health care. 

A  global  healthcare  project  meeting  in  Ottawa/Canada  in  November  1995 
launched  a  number  of  European  feasibility  studies  in  preparation  for  these 
initiatives. 

3.4.4  Targeted  socio-economic  research 

70. 

The  programme  on  targeted  socio-economic  research  is  divided  into  three  main 
areas:  research  into  science  and  technology  options  in  Europe,  research  on 
education  and training,  and  research  on social  integration  and  social  exclusion  in 
Europe51.  A number  of projects  funded  under these  headings  - particularly  in  the 
third  area  of  action  -  are  related  to  health. 

3.4.5  Research  on  agriculture,  fisheries  and  agro-industrial  processing 

71. 

The work programme of the FAIR (food  and agro-industrial  research)  programme 
for  1994-1998,  which  is  the  specific  RTD  programme  for  agriculture  and 
fisheries52,  includes  a  number  of  references  to  health  issues.  The  section  on 
agricultural  environmental  interaction  also  foresees  health-related  research,  such 
as  minimising  the  passage  of  agrochemicals  into  the  water  table  and  thence  to 

51 

52 

Council  decision  94/915/EC  of  15.12.1994  adopting  a  specific  programme  of  research  and 
technological  development,  including  demonstration,  in  the  field  of  targeted  socio-economic 
research (1994-1998), OJ L 361 of 31.12.1994, p.77 
Council  Decision  94/805/EC  of  23.11.1994  adopting  a  specific  programme  of  research  and 
technological development and demonstration in the field of agriculture and  fisheries...(1994-1998), 
OJL  334 of 22.11.1994, p. 73 

23 

human  drinking-water  supply.  A large part of the programme  is dedicated  to  the 
role  of  food  in  consumer  nutrition  and  well-being. 

In  addition,  four  research  projects  in  the  field  of  fisheries  products  upgrading, 
which  have  connections  to  human  health  requirements,  have  been  financed  in 
1995. The  Community  contribution  to these projects  exceeded  two million  ecus. 

3.4.6  Transport  research 

72. 

issues  are  particularly  noteworthy: 

The  Specific  Programme  for  research  and technological  development  in the  field 
of Transport  within  the 4th Framework  Programme53  continues  to  address  safety 
issues  in  all  modes  of  transport.  From  an  extensive  list  of  tasks,  the  following 
'the  safety  aspects  of  human 
safety 
management'  (rail),  'passenger  survivability'  (air),  'methodology  of  safety  in 
maritime  operations',  and 
traffic  system' 
(waterborne)  as  well  as  'improvements  in  passive  vehicle  safety'  and  'driver 
behaviour'  (road). 

'traffic  management  and  vessel 

3.4.7  Environment  and  climate 

73. 

The Environment  and climate programme (1994-1998)54 has a total budget of 532 
million  ecus  and  covers  four  themes: 
1. 

Research  into  the  natural  environment,  environmental  quality  and  global 
change, 
Environmental  technologies, 
Space  technologies  applied  to  environmental  monitoring  and  research, 
Human  dimensions  of  environmental  change. 

2. 
3. 
4. 

A first call  for  proposals was launched  for themes  1, 2 and 4 in January  1995 and 
after  scientific  and  technical  evaluation  by  independent  experts,  315  out  of  1601 
proposals  were  selected  for  Community  support  with  a  Community  financial 
contribution  totalling  216  million  ecus.  18  of  88  health-related  proposals  were 
retained  with  a  Community  financial  support  of  12 million  ecus.  These  projects 
complemented 
the  preceding 
in 
ENVIRONMENT  Programme  which  were  still  running  in  1995. 

the  46  health-related  projects  financed 

Health-related  research  underpins  the  environmental  health  policies  of  the 
Community  and  is  consistent  with  the  conclusions  of  the  Intergovernmental 
Conference  on  Chemical  Safety  (Stockholm,  April  1994)  and  the Declaration  of 
the Ministers  of Health  and  the Environment  (Helsinki,  June  1994). 

74. 

The main research  priorities are to assess the impact of environmental  factors  (e.g. 
ozone  depletion,  air  quality  pollutants)  on  the  health  status  of  populations 

53 

54 

Council  Decision  94/914/EC  of  15.12.1994  adopting  a  specific  programme  for  research  and 
technological  development,  including demonstration  in the field  of transport  (1994  to  1998), OJ 
L  361, 31.12.1994,  p.  56 
Council  Decision  94/911/EC  of  15.12.1994  adopting  a  specific  programme  of  research  and 
technological  development  in  field  of  environment  and  climate  (1994-1998),  OJ  L  361  of 
31.12.1994,  p.  1 

24 

(neurological,  immunological,  genotoxic,  endocrine-disrupting  effects,  etc.)  and 
to improve risk management  of chemical  substances by  developing  more  efficent 
testing  methods  (with  an  emphasis  on  reducing  the  number  of  animals  required 
for  testing),  by  critically  appraising  the  risk  assessment  process  itself,  by 
developing new methodologies for  hazard  identification  and  exposure  assessment 
and  by  identifying  vulnerable  or  susceptible  groups  in  the  population.  The 
research  is  implemented  in  close  cooperation  with  international  organisations  in 
the  field.  More  than  200 European  laboratories  are  currently  involved. 

3.4.8 

Industrial  and  Material  Technologies 

75. 

76. 

77. 

Concerning  the  production  technologies  area,  the  Industrial  and  Material 
Technologies  Programme55  deals  with  the  development  of  clean  production 
technologies  emphasizing  the efficent  use of  material  and  energy  ressources,  and 
reduction  or  elimination  of  polluting  wastes  at  their  source.  Reduction  of 
emissions  is  also  a  high  priority  within  research  related  to  transport  means. 
Specific  attention  is  given  to  the  health  of  the  workforce  employed  in  the 
manufacturing  industries  by developing  safe  and  reliable  production  systems  and 
paying  attention  to  human  and  organisational  factors. 

The research area on Materials and technologies for product innovation  contributes 
on  a  more  long  term  scale  to  health,  as  it  deals  with  basic  research  in  materials 
(e.g.  surface  behaviour,  biocompability  and  strength  of  materials  for  implants), 
development  of  special  coatings  (e.g.  for  targeted  drug  release  and  dental  or 
orthepeadic  applications),  research  on  medical  devices  and  instruments  for 
diagnosis.  The  result  will  produce  new  applications  and  new  methods  (diagnosis 
and  treatment)  for  medicine. 

A  third  area  of  the  programme  covers  technologies  for  means  of  transport, 
including  all  aspects  of  design,  integration,  production,  efficency,  environment, 
safety  and  operation  of  the  transport  vehicle,  be  it  an  aircraft  or  any  form  of' 
surface  vehicle.  The  aim  of  projects  selected  is  to  contribute  to  reduce  the 
environmental  impact of production  systems, products and means of transport and 
to  improve  the  safety  of  products  and  vehicles.  This  includes  the  reduction  of 
noise  and  pollutant  emission  from  engines  as  well  as  primary  vehicle  safety 
technologies  -  accident  prevention  -  and  secondary  safety  -  the  mitigation  of 
effects  of  accidents.  Other  projects  aim  to  prevent  contamination  caused  by  the 
exit  of  goods  being  transported  in  case  of  an  accident. 

3.4.9  Standards,  Measurements  and  Testing 

78. 

The  Standards,  Measurements  and  Testing  Programme56  has  set  up  a  specific 
management  tool  -  the  Dedicated  Call  -  to  allow  targeted  research  on  some 

55 

56 

Council  Decision  94/571/CE  of  27.07.1994  adopting  a  specific  programme  for  research  and 
technological  development,  including  demonstration,  in  the  field  of  industrial  and  materials 
technologies (1994-1998), OJ L 222 of  26.08.1994, p. 19 
Council  Decision  94/803/CE  of  23.11.1994  adopting  a  specific  programme  for  research  and 
technological development, including demonstration, in the field of standards, measurements and 
testing  (1994-1998), OJ L 334, 22.12.1994, p. 47 

25 

specific  subjects  in  support  of European  policies  on  standardisation.  In  1995,  15 
projects  related  to  health,  safety  and  environmental  topics  have  been  selected, 
amounting  to  some  13 million  ecus. 

3.5 

Environmental  policy,  energy 

79. 

In the framework  of the Community Programme on Environment  and  Sustainable 
Development57,  Community  policy  in  the  environmental  field  aims  to  integrate 
environmental  considerations into Community policies. Among the environmental 
challenges and priorities of the programme, the improvement  of public health and 
of health and safety  (particularly the evaluation of industrial risks, nuclear  security 
and  radiation  protection)  are  explicitly  mentioned. 

The  direct  and  indirect  effects  of  the  environment  on  health  are  becoming  more 
and  more  evident.  A  number  of  interrelated  factors  have  already  been  identified 
as influencing  health: 

climate  changes  and  global  warming, 
shrinking  of  the  ozone  layer, 
atmospheric pollution (concentration of ozone in the atmosphere, increased 
concentration  of  sulphur  and  nitrogen  oxides,  particulate  matter), 
soil  pollution  and  acidification, 
surface  and  ground  water  pollution, 
exposure  to  man-made  chemical  agents  and  substances. 

In the majority  of cases,  legislation  in these  areas takes health  considerations  into 
account. 

3.5.1  Air  pollution 

80. 

A proposal  for  a European  Parliament  and  Council  directive was  adopted  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  the  measures  to  be 
taken  against  the  emission  of  gaseous  and  particulate  pollutants  from  internal 
combustion  engines  to  be  installed  in  non-road  mobile  machinery58.  In  addition, 
a number  of proposals were considered  by the institutions in  1995: a  directive on 
the quality  of ambient  air59, a revision  of the directive on air pollution  from  motor 
vehicle emissions60 and  a directive on diesel  motor emissions in heavy vehicles61. 

Apart from  legislation,  reports on the implementation  of the ambient air  directives 
and  on  developments  concerning  ozone  were  published. 

57  Fifth  Programme  - OJ  C  138  -  17.05.1993 
58  COM  (95)  350  fin.  of  06.09.1995 
59 
COM  (94)  109 fin.  of  04.07.1994 
COM  (94)  558  fin.  of  16.12.1994 
COM  (94)  559  fin.  of  16.12.1994 

61 

60 

26 

3.5.2  Radiation  protection 

81. 

In  the  framework  of  Chapter  III  (Health  and  Safety)  of  the  Euratom  Treaty  the 
revision  of two important directives directly related to health protection  continued 
in  1995. 

First,  a revision  of the Basic  Safety  Standards Directive (80/836/EURATOM)  for 
the protection  of workers and the public against the dangers arising from  ionising 
radiation  was  made,  in  order  to  take  into  account  the  latest  scientific  data.  The 
revision  reinforces  radiation  protection,  for  example  by  reducing  dose  limits  for 
workers  and  the  public,  and  by  including  in  the  scope  of the  directive  exposure 
to natural  sources of radiation  at work.  The  Commission's proposal  was  accepted 
by  the  Permanent  Representatives  on  21  December  1995  and  was  formally 
adopted  at  the  beginning  of  1996. 

82. 

83. 

or 

treatment 

examination 

Secondly,  the  revision  of  the  Directive  on  the  protection  of  persons  undergoing 
medical 
radiation 
(84/466/EURATOM) continued.  A formal  opinion  of the group  of experts  set up 
under  Article  31 of  the Euratom  Treaty  was  obtained  on  a Commission  proposal 
for  revision  of  the  directive.  This  proposal  largely  extends  the  existing  directive 
in  order  to  take  account  of  new  techniques  used  in  medicine  and  to  clarify  and 
specify  radiation  protection  aspects  in  this  field. 

involving 

ionising 

Chapter  III (Health  and  Safety)  of the Euratom  Treaty  was applied  to the  nuclear 
tests in French Polynesia: the Commission,  in accordance with its responsibilities, 
asked the French  authorities  for  information  on the radiation  protection  measures 
taken  to  protect  both  workers  at  the  nuclear  site  and  the  public,  and  visited  the 
area. 

The  Commission  asked  the  French  authorities  to  continue  the  monitoring  of 
environmental  radioactivity  in the area  on  a long-term  basis and  to  communicate 
the  results  to  the  Commission.  It  also  asked  an  independent  institute  to  make an 
evaluation  of  the  worst  case  scenario  as  regards  geological  accidents,  which 
confirmed  the  sound  basis  of  the  calculations  made  by  the French  authorities. 

84. 

Besides these regulatory  activities, the Commission  is participating in research  on 
optimisation  of  radiation  protection  of  the  patient  in  diagnostic  radiology. 
Scientifically  based  guidance  is  established  to  fulfil  clinical  and  technical 
requirements  for  adequate  diagnostic  information  obtained  at  reasonable  dose  to 
the  patient.  The  principle  of  safety  culture  is  thus  promoted  both  in  the  clinical 
environment  and  on  the  manufacturer's  side. 

3.5.3  Chemical  products 

85. 

Concerning  chemical  products, the Commission put forward  an amended  proposal 
for  a Council  Directive  concerning  integrated  pollution  prevention  and  control62. 
An amendment was also proposed  concerning the draft  directive on the marketing 

62  COM  (95)  88  fin.  of  15.05.1995 

27 

of  biocidal  products63,  which  provides  for  an  authorization  procedure  for  each 
biocidal  product  put  on  the  market,  based  on  an  evaluation  of  risks  for  human 
health  and  the  environment. 

3.5.4  Civil  protection 

86. 

A  process  of  reflection  has  been  launched  in  the  area  of  civil  protection 
concerning,  on  the  one  hand,  emergency  medicine  in  cases  of  disasters 
(organisation at the moment of disaster, psychological follow-up)  and, on the other 
hand, the environmental  impact of natural  and technological  disasters with  a view 
to  reducing,  or  even  avoiding,  their  serious  consequences  for  human  health  and 
the  environment. 

3.5.5  European  Environment  Agency 

87. 

The  European  Environment  Agency  based  in  Copenhagen  has  recently  become 
operational.  It  has  now  published  a  monograph  "Environment  &  Health  (1): 
Overview  and main European Issues" in the framework  of the  "Threats to Human 
Health"  project. 

3.5.6  Energy  policy 

88. 

The relationship  between  energy  and  health  is mainly  based  on the  direct  effects 
which  production  and the use of energy  have on the environment,  since pollution 
directly  influences  individuals'  health.  At  the  end  of  1995,  the  Commission 
presented  a White Paper  on  "An Energy  Policy  for  the European  Community"64; 
Among  the  common  objectives  outlined,  the  objective  of  the  protection  of  the 
environment  will  have  a positive  and  direct  impact  on  human  health.  Moreover, 
an integrated  energy/environmental  framework  will contribute to the  achievement 
of  sustainable  development. 

The  White  Paper  states  that  all  problems  related  to  spills,  waste,  noise,  amenity 
damage  and  atmospheric  pollution  produced  by  local  emissions  or  the  increased 
emissions  of  C02  and  other  greenhouse  gases  must be  dealt  with  increasingly  at 
the Community  level, as their direct negative effects  on public health  are obvious. 
This  will  particularly  be  done by  making  use  of  new  technologies. 

89. 

The  Commission's  proposals  for  two new  programmes  under  discussion  in  1995 
-  THERMIE  II for  the  promotion  and  dissemination  of  new  clean  technologies65 
and  SAVE  II concerning  a multi-annual  programme  for  the promotion  of  energy 
efficiency  in  the  Community66  -  will,  when  adopted  by  the  Council,  greatly 
contribute  to  alleviating  global  environmental  problems. 

63 

64 

65 

66 

COM  (95)  387  fin.  of  20.07.1995 
COM  (95)  682  fin.  of  13.12.1995 
COM  (94)  654  fin.  of  12.12.1994 
COM  (95)  225  fin.  of  31.05.1995 

28 

3.6 

Transport 

90. 

The  importance  of  transport  safety  was  reinforced  by  the  Treaty  on  European 
Union,  which  amended  Article  75  to  extend  Community  activities  to  "measures 
to  improve  transport  safety".  All  measures  increasing  transport  safety  contribute 
to attaining  a high level  of health  protection  in the Community.  In July  1995, the 
Commission  adopted a Communication  on the Common Transport Policy: Action 
Programme  1995-200067.  Elaborating  on  the  White  Paper  on  the  Future 
Development of the Common Transport Policy68, the Action programme maintains 
safety  as  an  integral  component  of  the  Common  Transport  Policy. 

The  Action  Programme  sets  out  in  detail  proposals  and  actions  for  the  period 
1995-1996  and  identifies  issues  to  be  addressed  in  the  period  1997-2000  and 
beyond.  Safety  is prominent  in  the  list  of these  measures. 

3.6.1  Ships 

91. 

92. 

The loss of the "Estonia" with  over 900 lives in the Baltic  Sea in  September  1994 
highlighted  the urgent  need  to  improve  the  safety  of  roll-on/roll-off  ferries.  The 
Commission  prepared  a  proposal  for  a  Council  Regulation  on  the  Safety 
Management  of  Ro-Ro  Passenger  Vessels,  which  was  adopted  by  Council  on  8 
December  199569. The Regulation  seeks mandatory  application  by  1 July  1996 of 
the International Maritime Organisation's "International  Safety Management Code" 
(ISM  Code)  for  regular  ro-ro  passenger  ferry  services  to  and  from  ports  of  the 
Community.  In  addition,  it  includes  a  provision  for  strict  verification  of 
compliance  by Member  States.  The  development  of  a safety  culture by  means  of 
a  Safety  Management  System  under the ISM code can  only  have positive  effects 
on the  safety  of  passengers  and  seafarers  alike. 

Although  it  is  recognised  that  some  80% of  accidents  at  sea  can  be  attributed  to 
human  factors,  it  remains  the  case  that  vessels  and  equipment  on  board  vessels 
may  also  be  at  fault.  Conversely,  safe  and  reliable  equipment  can  often  be  the 
very  factor  which  prevents  tragedy  at  sea.  In  June,  the  Commission  adopted  a 
proposal  for  a Council Directive  on Marine Equipment70 which  aims to  submit an 
extensive  range  of  equipment  to  compliance  with  existing  international  testing 
standards,  or where these  do  not  exist,  with  future  standards  to be  agreed  within 
the  EMO.  Compliance  would  have  to  be  verified  by  notified  bodies  fulfilling 
common  quality  criteria. 

3.6.2  Transport  of  dangerous  goods 

93. 

During  1995, the  European  Parliament  and  Council  discussed  the  Commission's 
proposal  for  a  Council  Directive  on  the  approximation  of  laws  of  the  Member 
States with regard  to the transport of dangerous goods by rail. In December  1995, 

67 

68 

69 

70 

COM  (95)  302  fin.  of  12.07.1995 
COM  (92)  494  fin.  of  02.12.1992 
Council  regulation  3051/95/EC  of  08.12.1995  - OJ L  320/14  of  30.12.1995 
COM  (95)  269  fin.  of  21.06.1995 

29 

Council  adopted its Common Position on the proposal71. The potential  health  risks 
associated  with  the  transport  of  such  goods  by  rail  are  significant,  particularly 
given  the  fact  that  these  goods  are  often  transported  in  quantity  through urban 
areas.  Moreover,  the  gradual  opening  of  rail  transport  markets  requires  the 
development  of  a  framework  of  safety  legislation  to  cover  the  transport  of 
dangerous  goods by rail. 

94. 

In  October  1995,  the  Council  adopted  a  Common  Position  on  a  long-standing 
proposal  for a Council  Directive on the appointment and vocational  qualification 
of  a safety  advisor for the transport of dangerous goods72. This proposal  seeks to 
ensure that undertakings carrying out the transport of dangerous goods and related 
activities  appoint  advisors to  safeguard  against risks to  public  health  and  safety, 
property  and  the  environment,  who  would  facilitate  the  carrying-out  of  the 
undertaking's  activities  in the  safest  possible way. 

3.6.3  Road transport 

95. 

3.7 

96. 

97. 

98. 

The  Commission  brought  forward  a  proposal  for  a  Council  Directive  on  the 
approximation  of  laws  of the Member  States relating to roadworthiness  tests for 
motor vehicles and their trailers73. Its purpose includes the amendment of the basic 
Directive 77/143/EEC74 to include effective  and regular testing of speed limitation 
devices on certain heavy goods vehicles and buses, thereby contributing to general 
road  safety  and  to  the  health  of  the  population.  Opportunity  was  also  taken  to 
consolidate  the texts  of this Directive,  which  guarantees that vehicles  concerned 
are  sufficiently  regulated  and maintained to  ensure road  safety. 

International  cooperation,  relations  with  third  countries  and 
organisations 

international 

Provisions  on cooperation in the areas of health and health and safety  at work are 
included  in  cooperation  agreements between the EC and third countries. 

The  Euro-Mediterranean  Conference  in  Barcelona  identified  health  in  its final 
declaration  as  one  of  the  areas  of  future  cooperation  in  the  region.  In the work 
programme  adopted in Barcelona,  the partners agreed to cooperate,  in particular, 
on  information  and  prevention  activities,  the  development  of  public  health 
services,  the training of  personnel,  and medical  assistance in the event  of natural 
disasters75. 

In the trade relations between the European Community and third countries, health 
protection  is  included  in  both  bilateral  and  regional  programmes,  including  the 
transatlantic dialogue and activities in the framework of the Community's  Specific 
Commitments to the  General  Agreement  on Trade in  Services. 

71 

72 

73 

74 

75 

COM  (94)  573  fin.  of  09.12.1994 
COM  (91)  4  fin. 
COM  (95)  415  fin  of  08.09.1995 
O JL  47  of  18.02.1977 
Barcelona  Declaration,  adopted  at  the  Euro-Mediterranean  Conference  (27/28.11.1995),  final 
version,  Barcelona,  28.11.1995 

30 

99. 

In  research  cooperation  with  third  countries,  and  international  organisations76, 
significant  progress  has  been  made  on  drug,  diagnostic  and  vaccine  research 
aimed at providing the tools to combat the predominant disease problems of many 
developing countries. For studies of malaria, the STD-3 programme involved the 
participation of over 80 teams in 33 different  countries. Reflecting the importance 
of this disease,  malaria research,  and in particular  malaria vaccine studies, also 
feature within the new INCO-DC programme. Discussions on possible cooperation 
with the United  States on malaria vaccine development are underway. 

3.7.1  EC-USA  cooperation 

100. 

In  the  framework  of  the joint  EC-USA  Action  Plan  adopted  at  the  EC-USA 
summit in  Madrid  on 9 December  1995, the two parties pledged  to establish  a 
task force to develop and implement an effective global early warning system and 
response network for communicable diseases. Furthermore, they have undertaken 
to  cooperate,  bilaterally  and  within  the  framework  of  the  WHO  and  other 
international  organisations  as  appropriate,  on  programmes  on  health-related 
matters (AIDS and other communicable diseases, cancer, drug addiction), and to 
identify  specific  areas for  cooperation,  especially  in the research field. 

101.  The two parties have also pledged to explore the scope for  an agreement  for  the 
exchange of  information  on  issues affecting  health  and  safety  at  work,  such as 
occupational  safety  and health  standards,  the development  of  regulations,  high-
risk  activities,  carcinogenic  substances  at  the  workplace,  toxicology,  testing 
programmes,  education  and  information  programmes,  and  the  collection  of 
statistics and data. In addition, they are expected to explore the establishment of 
improved  mechanisms  for  the  timely  exchange  of  information  related  to  the 
general safety of products, including the withdrawal of products from the market. 

102. 

In the area of the environment  - directly related  to the protection  of health  - the 
Community and the USA have pledged to strengthen the exchange of information 
and reporting on global environmental issues such as climate change, biodiversity, 
ozone layer depletion,  persistent organic pollutants,  desertification  and  erosion, 
water  quality  and  quantity,  land-based  sources  of  marine  pollution,  hazardous 
wastes and contaminated  soils,  and forests.  Furthermore,  they have undertaken 
to enhance their bilateral  dialogue on regulatory  cooperation,  including: 

extending cooperation  on chemical issues; 
continuing  work on biotechnology  issues,  such as the mutual  acceptance 
of data for assessment and the release of genetically modified  organisms; 
enhancing  work on air pollution. 

76  Council  Decision  94/807/CE  of  23.11.1994  adopting  a  specific  programme  of  research  and 
technological  development,  including demonstration  in the field  of cooperation  with third  countries 
and  international  organisations,  OJ  L  334,  22.12.1994,  p.  109 

31 

3.7.2  Cooperation with  Central  Europe  and  the  Community  of  Independent  States  -

PHARE/Tacis 

103.  Phare  has  concentrated  its  support  on  key  areas  of  reform  along  the  lines  of  the 
Health  Strategy  Paper  revised  in  1994 (health  financing,  reorganisation  of  health 
services  with  special  emphasis  on  primary  health  care,  pharmaceuticals  policy, 
human resources management and training, and preventive measures), areas which 
were  already  mentioned  in  the  first  strategy  paper.  In  programme  design  and 
adaptation  of  ongoing  programmes,  while  pursuing  the  specific  objectives  of 
health  sector  reform,  Phare  has  paid  special  attention  to  the  wider  objective  of 
integrating  countries  with  association  agreements.  A  total  amount  of  over  130 
million ecus was committed to health sector restructuring in the period  1991-1995. 
During  1995, implementation  of the ongoing programmes in all the Phare-eligible 
CEECs,  except  Slovenia,  continued,  while  new  programmes  were  approved  for 
four  other  CEECs. 
With regard to Tacis, in  1995 a start was made on work under the 4.5  million  ecu 
programme  for  Russia  approved  in  1994  involving  support  for  health  sector 
reform  in  4  pilot  areas. 
In  1995,  new  programmes  with  a  health  component  were  developed  for  Russia 
and  Moldova. 

104. 

a)  Ongoing  Phare/Tacis  activities  in  1995 

In  Albania,  ongoing  activities  are taking  place under two programmes  (1993  and 
1994)  and  concern:  i)  primary  health  care  development  through  strategy  design 
and  re-training  of  500  general  practitioners  and  1800  nurses;  ii)  reform  of  the 
hospital  system  through  twinning  with  EC  hospitals  and  training  to  streamline 
management  practices,  the  creation  of  a  maintenance  service  for  biomedical 
the  diagnostic  and  follow-up  capacity  of  hospital 
equipment, 
laboratories,  and  restructuring  the  emergency  services;  iii)  technical  assistance 
with  setting  up  a  legal  framework  for  the  health  sector;  iv)  restructuring  of  the 
pharmaceuticals  sector  involving the creation  of  an infusion  fluid  production  line 
and  assistance  in  establishing  a  pharmaceuticals  inspectorate;  v)  preventive 
medicine, with the restructuring  of the network of public health laboratories. Most 
of  the  work  under  the  1993  programme  was  completed  during  1995. 

improving 

In  Bulgaria,  activities  comprise  two  programmes  (1992  and  1993)  and  concern: 
i)  health  financing,  including  assessment  of  costs  for  medical  procedures,  and 
health  insurance  issues;  ii)  training  in  devising  a training  policy  for  medical  and 
para-medical  staff,  training  of  medical  personnel  and  officials  involved  in  the 
decentralisation  process,  creating  a faculty  of  nursing  in  the University  of  Sofia, 
improving training in general  medicine (post-graduate  and  continuing  education); 
involving  inter  alia  harmonisation  of  national 
iii)  pharmaceuticals  policy 
legislation  and  practice with  those found  in the EC;  iv) a framework  for  private 
practice aimed  at the development  of a well-balanced  mixed  public/private  health 
care system; vi) health and safety  at work with collaboration between the Ministry 
of  Health  and  the  Ministry  of  Labour.  Most  of  the  activities  under  the  1992 
programme  were  completed  in  1995. 

32 

In  Hungary,  the  1993  programme  aims  at:  i)  the  development  of  a  modern 
primary  health  care  system  covering  all  aspects  (legislation,  policy  and 
implementation  strategy,  training,  operational  research,  communication  strategy, 
etc.),  combined  with  an  innovation  fund  providing  grants  for  public  or  private 
PHC  initiatives;  ii)  harmonisation  with  EC  legislation  and  best  EC  practices  as 
regards  health  and  safety  at work  and  the  training  of  health  professionals.  Work 
is  still  continuing. 

In  Romania,  some  work  on  health  financing  reform  was  continued  under  the 
health  component  of  the  social  programme. 

In  FYROM,  assistance  in  preparing  a  pharmaceuticals  policy  was  continued  as 
part  of  a  humanitarian  aid  package  which  initially  included  the  supply  of 
pharmaceuticals. 

Existing programmes were completed in the Czech Republic (health care financing 
and  health  insurance  administration,  health  information  system)  and  Slovakia 
(devising  methods  for  assessing  and  managing  medical  equipment,  designing  a 
strategy  for  primary  health  care  development  and  for  health  care  management 
including coverage  of the immediate continuing  education needs  of existing  staff) 
as well  as  in  the Baltic  States. 

In Russia,  the activities  initiated  in  1995 under the  1994 programme  covered  the 
development  of primary  health  care (PHC) services in the form  of  "pilot oblasts", 
the  modernisation  of  hospital  practices  and  management  as  well  as  a 
demonstration  project  on  maternal  and  child  health  in  one  pilot  area. 

105. 

b)New  Phare/Tacis  programmes  in  1995 

New  Phare  programmes  were  prepared  for  Slovakia  and  the  three  Baltic  States, 
partly  as  a  continuation  of  previous  support: 

In  Slovakia,  the  programme  focuses  on  4  areas:  i)  health  financing  reform 
addressing  issues  such  as  pricing  and  payment  systems,  accountancy  and 
information  flow between care providers and financing bodies, resource allocation 
criteria and the development of investment strategies for health care  infrastructures 
and  equipment;  ii)  preparation  of  a framework  for  private  practice  with  a  view 
to  developing  a  well-balanced  mixed  public/private  health  care  system;  iii) 
implementation  of  a PHC  strategy;  iv)  implementation  of  a  health  management 
strategy. 

In  the  Baltic  States  the  focus  remains  mainly  on  previous  priority  areas:  health 
care  financing  reform  in  all  3 countries;  in  Latvia  and  Lithuania  support  is  also 
given  to  human  resources  and  training,  primary  health  care  development  and 
pharmaceuticals policy,  while in Estonia  support is also provided  for  information 
systems. 

In  all  these  new  programmes,  it  is  planned  to  devise  and  implement  a 
communication  strategy  on health  reform  directed  at health  professionals  and  the 
general  public. 

33 

106. 

In  addition  to  these  national  programmes,  a  10  million  ecu  multi-country 
programme  initiated  by the Commission,  named  CONSENSUS, was launched  in 
1995 to provide policy  advice and  support  for  social  protection  reform  in Phare-
eligible  countries.  Inter-Institutional  Reform  Committees  have been  set up  in  the 
CEECs  and  a  Programme  Advisory  Board,  composed  of  the  15  EC  Members 
States  and  all  the  Phare-eligible  CEECs,  advises  on  programme  policy  and 
selection  of  project  proposals.  The  scope  of this programme  includes health  care 
financing  issues  and  health  care  delivery.  It  is  being  implemented  in  close 
collaboration  with  DGV. 

With  regard  to  Tacis,  in  1995  new  programmes  with  a  health  component  were 
drawn  up  for  Russia  and  Moldova: 

Russia:  two  actions  were  initiated 
*  A 2.6  million  ecu  programme,  aimed  at the  coherent implementation  of  social 
and  health  care reforms,  was finalised for  the Republic  of Karelia.  It  deals with 
the  management  of  social  protection  by  the  Ministry  of  Social  Welfare  in 
cooperation  with other ministries such as the Ministry  of Labour and the Ministry 
of Health, as well as management of the health care systems, which remains under 
the  responsibility  of  the  Ministry  of Health  but  is  in  practice  exercised  by  local 
government  agencies. 
*  500  000  ecus  were  made  available  for  policy  advice  for  the Russian  Govern 
ment  concerning  both  the  demand  and  the  supply  side  of  pharmaceuticals,  with 
a view  to  improving  their  distribution  and  production. 

Moldova:  In  the  framework  of  the  programme  "Technical  Assistance  on  Human 
Resource  Development"  a sum  of  500  000  ecus was  approved  to  cover  primary 
health  care  development  and  health  care  management. 

107.  Furthermore,  health  considerations  played  an  important  role  in  the  ongoing 
contacts  and  cooperation  activities with  Central  and  Eastern  European  countries, 
aimed  in  particular  at  evaluating  the  situation  and  specific  needs  as  well  as  the 
scope  for  cooperation  in  the  social  and  health  fields,  including  the  possibility  of 
opening Community programmes in the field of health to the participation of these 
countries. 

108.  The  Link  Inter-European  NGOs  (LIEN)  programme,  initiated  in  1994  and 
covering  both  Phare  and  Tacis  countries,  is  aimed  at  stimulating  activities  of 
NGOs  in  favour  of  deprived  communities.  In  the  health  field,  the  actions  can 
cover: 

assistance  to women  having  limited  access to  health  and  social  services; 
sustainable  health  and  social  support  for  the  most  disadvantaged  target 
groups, such as the disabled, victims of addiction, people with HIV/AIDS, 
street  children,  the  elderly,  etc. 

Health  projects  for  over  1  million  ecus have been approved  in Bulgaria,  Hungary, 
Lithuania,  Poland  and  Slovakia.  Among  these  projects  the  following  deserve 
mention: 

34 

establishment  of  a centre  providing  palliative  home  care  in  the  region  of 
Sofia  (for  persons  suffering  from  incurable  illnesses  such  as  cancer  and 
AIDS); 
professional  training  for  young  people with  drug  problems  and  criminal 
records; 
improving  women's  health  in  Slovakia  through  the  development  of 
sustainable  reproductive  health  care  services; 
rehabilitation  of  children  with  cerebral  palsy; 
AIDS  centre:  assistance,  education,  information  and  documentation; 
model  for  community-based  health  care  for  vulnerable  older  people 
(mental  illness  and  dementia). 

Coordination  and  coherence  is  maintained  between  these  activities  and  the 
European  Community  programmes  in  public  health  such  as  cancer,  AIDS,  drug 
dependence  and  health  promotion. 

3.7.3  Cooperation  with  international  organisations 

109.  The  European  Community  continued  to  follow  health-related  activities  in  the 
Council  of  Europe  and  was  represented  on  several  relevant  committees  and 
groups.  In  1995,  the  major  items  under  consideration  related  to  blood  (blood 
safety  and  self-sufficiency, 
including  the  proposed  revision  of  the  technical 
protocol to Agreement No. 26), the proposed Bioethics Convention  and a number 
of  other  subjects,  including  organ transplantation,  the  organisation  of  health  care 
services  for  persons  in  custody,  recommendations  on  nursing  research,  health 
information  in  hospitals,  health  problems  of  single-parent  families,  and  health, 
dignity  and  social  exclusion. 

110.  Cooperation with the World Health Organisation  (including the European  Region 
and  the  International  Agency  for  Research  on  Cancer)  has  continued  at  a 
satisfactory 
the 
Commission  in  June  1995. 

level.  The  WHO  Director  General,  Dr  Nakajima,  visited 

The Commission participated in the World Health Assembly, the Executive Board 
of  WHO  and  the  European  Regional  Committee  meetings.  The  meeting  of  the 
Regional  Committee in Jerusalem  (September  1995) recognised the importance of 
placing  statements  from  the European  Commission  on  its  activities  in  the  health 
field  high  on  its  agenda. 

3.7.4  Cooperation  with  ACP  countries  in the  health  field 

111. 

1995  saw  the  revision  of  the  Fourth  Lomé  Convention,  which  since  1990  has 
governed  cooperation  between  the European  Community  and  African,  Caribbean 
and  Pacific  (ACP)  countries.  The  new  agreement,  signed  on  Mauritius  on  4 
November  1995,  does  not  represent  a  new  departure  but  strengthens  and  partly 
recasts  a convention  that  will  remain  in  force  until  the year  2000. 

In  this  connection,  a  start  has  been  made  on  work  preceding  the  negotiations 
leading  to the  adoption  of the indicative  programmes.  In  1995, this work  mainly 
involved  an  examination  of  cooperation  strategies  at  region  and  country  level. 

35 

In  the  course  of  this  examination,  questions  of  health  and  AIDS  were  given 
greater consideration  than in the past. Thus, even though it is of course  impossible 
to  anticipate  the  results  of  the  negotiations  on  the  indicative  programmes,  the 
signs  are  that  funding  for  the  health  sector  will  continue  to  rise  when  the  8th 
Lomé  financial  protocol  is  implemented. 

112.  The  work  carried  out  over  the  past  few  years  in  the  fields  of  health  and  AIDS 
continued  in  1995. Apart from  the monitoring of the development projects  funded 
under  the  7th  EDF  which  are  now  underway  and  assistance  given  under  the 
structural  adjustment  facility,  several new and important  financing  decisions were 
taken.  Particular  mention  should  be  made  of  those  relating  to: 

* 

* 

Mozambique,  where  22  million  ecus  were  allocated  to  a  programme  for 
improving  the  health  system  in  rural  areas 

Kenya,  for  a  "family  health"  programme  (drawn up jointly  with the  ODA 
in  the  UK)  to  which  the  Commission  contributed  14.8  million  ecus. 

A  number  of  other  operations  were  decided  upon,  Burkina  Faso  (support  for 
reform  of the pharmaceutical  sector,  1.6 million ecus)  and Central  Africa  (support 
to  improve  primary  health  care,  1.8  million  ecus)  deserving  particular  mention. 

113.  As  regards  STDs/HIV/AIDS,  the  Commission  continued  to  implement  its  main 
strategies  by  focusing  on  prevention,  the  strengthening  of  health  services, 
consideration  of  the  socio-economic  impact  of  the  epidemic,  and  scientific 
training. 

in  particular 

in  1995,  relating 

Major  programmes  were  adopted 
the 
incorporation  of  the  STD/HIV/AIDS  strategy  into  health  systems  (including  a 5 
million  ecu  project  in Mozambique  and  a 4 million  ecu  scheme  in Tanzania).  As 
for  operational  research,  1995  saw  the  completion  of  an  important  project  at 
Mwanza  in  Tanzania  showing  how  treating  STDs  reduces  HIV  transmission. 
Finally,  at  regional  level,  a number  of HIV/AIDS  awareness  campaigns  aimed  at 
the  general  public  were  organised  via  the  mass  media.  These  included  radio 
campaigns  in  some  Asian  countries  as well  as television  campaigns  (advertising 
spots  during  the  African  Nations  Cup). 

to 

114.  Meetings  of technicians  and  national  experts from  ACP  countries were  organised 

in Brussels  to  discuss  "decentralisation  of  health  systems". 

The  first  of  these,  held  in  November  1995  and  dealing  with  the  situation  in 
French-speaking  countries,  brought  together  over  30  participants  from  west  and 
central  Africa. 

Its  purpose  was  to  review  the  situation  in  these  countries  and  to  examine  the 
constraints,  limits  and  consequences  associated  with  the  decentralisation  process, 
which  is  an  important  factor  in  the  health  system  reforms  now  taking  place. 

115.  The process of improving coordination  with the Member  States, the main  features 
of which  were  decided  upon  by  the  Council  in  1994,  continued  in  1995. 

36 

Activities  in this  area  included  further  meetings  of the  expert groups  "health  and 
development"  and  "STD/AIDS"  as  well  as  efforts  to  progressively  improve 
operational  coordination  in  the  countries  themselves. 

Action  was  also  taken  to  extend joint  consultation  on  policies  and  strategies  and 
to  improve  operational  coordination  with,  in  particular,  USAID  and  the  World 
Bank. 

116. 

1995  also  saw  the  convening  of  the  second  meeting  of  health  ministers  of 
countries  in  the  franc  area  and  associated  countries  on  medicines  policy,  which 
was  held  in  Brussels  in  April. 

This meeting  is part  of  a process  initiated  by  the Ivory  Coast with  the  support  of 
the  EC  following  the  devaluation  of  the  CFA  franc  in  1994,  the  aim  being  to 
promote joint  discussion  and  action  with  regard  to  policies  on  medicines. 

The  meeting  adopted  an  action  plan  with  the  following  objectives: 

* 
* 
* 
* 
* 

setting up an information  network on medicines and their prices in  Africa; 
strengthening  mechanisms  for  the  quality  control  of  medicines; 
speeding  up  the  introduction  of  generic  medicines  in  the  private  sector; 
harmonising  legislation; 
improving  the  way  in  which  medicines  are  prescribed  and  dispensed. 

37 

AIDS 

1. 

HIV/AIDS  today  poses  a major  scientific  and  social  challenge. 

Addressing  the  problem  of HIV/AIDS  calls for  a multi-disciplinary  response 
that  combines  the  best  of  biological  and  medical  research,  effective 
interventions  to  deal  with  the  socio-economic  causes  and  consequences, 
particularly  for  the  most  disadvantaged  groups  and  the  poorest  countries, 
actions  to  monitor  and  reduce  the  spread  of  HIV  infection,  notably  by 
education  and  information,  and  provision  of  support  for  those  living  with 
HIV/AIDS  and  their  families. 

The  European  Community  has  played  and  continues  to  play  a  major  part  in 
the international  HIV/AIDS effort.  The actions implemented  by the European 
Commission  range  across  the  whole  span  of  the  responsibilities  of  the 
. Community,  but  focus  mainly  on  the  following  three  areas  of  activity: 
research,  development  assistance,  and  public  health. 

2. 

HIV/AIDS  prevention  in  Europe  : the European  Community's  priorities 

By  31  December  1995,  a  cumulative  total  of  159  343  AIDS  cases  had  been 
reported  in  the  fifteen  countries  of  the  European  Community  since  the 
epidemic  began.  Cases  tend  to  be  geographically  clustered  with  a  gradient 
of  decreasing  incidence  rates  from  the  south-western  to  the  north-eastern 
countries.  Against  the  background  of  rapid  increase  of  AIDS  cases,  a 
consensus  has  emerged  that  the  Community  needs  to  play  a  significant  role 
in  the  response  to  the  epidemic. 

Since  1988  the  European  Community  has  tackled  the  issue  of  AIDS  in  the 
framework  of  public  health.  A  "Europe  against  AIDS"  programme  was  set 
up  in  June  1991.  Under  the  Treaty  on  European  Union  of  1993,  the 
European  Community  was given  a new  competence  in public  health,  namely 
that  Community  action  should  be  directed  towards  "the  prevention  of 
diseases",  in  particular  the  major  health  scourges.  Up  to  1995  about  360 
transnational  projects  involving  NGO's  have  been  funded  for  approximately 
40  million  ecus. 

A  new  draft  programme  of  Community  action  on  the  prevention  of  AIDS 
and  certain  other  communicable  diseases  for  the  years  1996-2000  was 
discussed  by  the  institutions  in  1995, with  a view  of  adoption  in  1996' :77 

This  new  programme, with  a budget  of  49.6  million  ecus, will  have  four  key 
priorities: 

77  The programme was adopted on 29.03.1996 - Decision 645/96/EC - cf.  OJ L 95 of  16.04.1996 

38 

surveillance  and  control  of  AIDS  and  certain  other  communicable 
diseases, 
combatting  transmission  of HIV, 
information,  education  and  training, 
support  for  persons  with  HIV/AIDS  and  combatting  discrimination. 

The  programme  is implemented  through: 

support  for  Community  wide  projects, 
support  for  innovative  projects, 
support  for  NGOs'  activities,  including  the  establishment  of  inter-
country  links, 
setting  up  of  networks. 

This  programme  is  open  to  the  participation  of  countries  in  association 
agreements  with  the  European  Community  and  promotes  cooperation  with 
international  organisations  active  in  this  field. 

The HIV/AIDS  programme  for  developing  countries 

The  Commission  began  its  work  concerning  HIV/AIDS  in  developing 
countries  back  in  1987  and  has  endeavoured  from  the  start  to  ensure  that  its 
activities  are  closely  coordinated  with  the  WHO's  special  programme  dating 
from  the  same  year. 

Over  the  years,  the  programmes  have  evolved  from  preventive  measures 
taken  in  an  emergency  situation  towards  strategies  and  policies  which  deal 
with  HIV/AIDS  as  a  structural  problem  requiring  a long-term  strategy  and  a 
multisectoral  response. 

This  response  must  first  come  from  the  health  and  welfare  sectors,  which  in 
many  countries  are  undergoing  reforms  aimed  at  greater  efficiency  in  the 
provision  of  services  while  at  the  same  time  having  to  cope  with  a 
significant  increase  in the  demand  for  HIV/AID S-related  care.  However,  the 
consequences  of  the  epidemic  and  the  responses  called  for  go  well  beyond 
the  health  sector,  involving  as  they  do  respect  for  human  rights,  non 
discrimination  towards  persons  with  HIV/AIDS,  and  the  social  and  family 
structures  affected  by  the  epidemic. 

39 

It  is  against  this background  that  the  Commission  has,  in  close  collaboration 
with  the  EC  Member  States,  endeavoured  to  develop  an  appropriate  policy 
and  strategy  for  dealing  with  the HIV/AIDS  problem.  If  Community  support 
and  bilateral  aid  are  taken  together,  the  EC  is  the  largest  contributor  to  the 
fight  against  HIV/AIDS 
improve 
coordination  led  in  1994 to  the  submission  of  a Commission  communication 
to the  Council  and the European  Parliament  on policies  and  strategies to deal 
with  HIV/AIDS.  On  the  basis  of  this  communication,  a  Council  resolution 
was  adopted  in  1994  followed  by  a  Parliament  resolution  in  1995.  Four 
action  priorities  were  identified: 

in  developing  countries.  Efforts 

to 

controlling  the  spread  of  the  epidemic  by  means  of  preventive 
measures; 
strengthening  the  health  sector to  enable it to cope with  the  additional 
burden  resulting  from  the  epidemic; 
helping  countries  to  pay  more  attention  to  the  social  and  economic 
consequences  of  AIDS; 
developing  scientific  knowledge  and  skills. 

Close  coordination  is taking  place both  with  the Member  States  and with  the 
UN  AIDS  programme  as  well  as  with  other  international  organisations 
working  in  this  field. 

In  overall  terms,  when  all  countries  and  all  financial  resources  are  included 
(excluding  co-funding  by  NGOs  and  research),  Community  spending  in  this 
area  since  July  1987  amounts  to  over  160 million  ecus. 

The  Biomedical  and  Health  Research  Programme 

The European  Commission's  activities  in  the  area  of  research  in  biomedicine 
and  health  dates  back  to  the  launching  of  the  First  Medical  and  Health 
Research  Programme  in  1978.  It  has  ever  since  steadily  grown  both  in  its 
research  ambitions  as well  as in its budget  available  for  supporting  European 
research  in  areas  of  high  priority. 

Medical  research  at  the  EC  level  aims  at:  pooling  of  data,  avoiding 
duplication  of  effort,  standardization  of  methods  and  reagents,  better 
selection  of  cohorts for  clinical  trials, bringing  together  complementary  skills 
in  multi-faceted  projects, 
for  young 
researchers  in  specialized  fields,  better  utilisation  of  results  in  the  public 
health  sector,  creating  better  access  to  research  results  for  all  parts  of 
Europe, 
animal 
experimentation  in  order  to  reduce  the  overall  number  of  animals  used  in 
experimentation  and  increase  cost-effectiveness. 

training  possibilities 

of  European 

establishment 

improved 

facilities 

shared 

for 

40 

Ever  since  1983, only  two  years  after  the  first  case  of  AIDS  was  diagnosed, 
the European  Commission  has taken  on  an active  role in the  fight  against  the 
AIDS  epidemic.  Funding  of  research  on  AIDS  began  in  1987  under  the 
Fourth  Medical  and  Health  Research  Programme.  The  ambitions  of  the 
programme  as well  as the budget  available  have been  significantly  increased 
over  the  years.  At  present,  the  programme  is  supporting  a  total  of  51 
projects  including  over  600  research  teams  with  a budget  of  32  million  ecus 
under  the  BIOMED  1  and  BIOMED  2  research  work  on  AIDS  -  figures 
which  will  grow  shortly  as  the  Commission  has  made  its  selection  for 
funding  among  the  recently  submitted  project  proposals. 

The  projects  are  all  closely  related  to  the  three  main  priorities  of  the 
programme: 

development  of  safe  and  effective  vaccines  against  HIV  infection 
development  of  therapeutic  agents  suppressing  progression  of  the 
disease  in  infected  individuals 
research  on  the  epidemiology  of  the virus  in  Europe 

The  International  Scientific  Collaboration  Programme  - Health  Research  for 
Development 

This  programme,  concerning  research  collaboration  between  European 
groups  and  scientists 
important 
component  on  health  research  in  which  some  activity  on  HIV  takes  place  as 
well. 

in  developing  countries,  contains  an 

16 joint  research  projects  have been  funded  with  partners  in Africa  and  Asia 
with  a budget  over  5 million  ecus. 

invests  in  research  on  the  epidemiology  of  HIV 

The  programme 
in 
developing  countries,  mechanisms  of  vertical  HIV  transmission,  longitudinal 
studies  of  HIV  infection  profiles,  biology  and  epidemiology  of HTV7IBC co-
infection,  role  of  other  STDs  in  the  epidemiology  of  HIV,  international 
research  against  STDs  and  HIV  with  particular  regard  to  evaluation  of 
upgraded  STD  patient  and  clinical  services. 

See  the  relevant  sections  of  this  report  for  further 
activities  in  these areas  of policy. 

information  on  1995 

3.7.5  Cooperation  with  South  and  South  East  Asia,  Latin  America 

117. 

In Asian countries, a number of important health programmes have been  launched. 
They  were  concentrated,  on  the  one  hand  on  an  extensive  malaria  control 
programme (Cambodia, Laos and Vietnam, 29 MECU) and on women's health and 
safe  motherhood  (Philippines,  17  MECU)  on  the  other.  Two  smaller  projects 
concerned  primary  health  care (Bangladesh,  9.95 MECU) and reproductive  health 
(Nepal,  0.9  MECU). 

41 

118.  Support to the health  sector is increasing rapidly with Latin America. In  1995, the 
health sector represented 6 % of the total  amount of all the on-going projects  from 
this budget  line, and there will be  a significant  increase in the future.  Among  the 
financial  proposals  approved  in  1995,  30  %  constituted  support  to  the  health 
sector.  This  implies that  in  1996 the  share will  raise to 9 %  of  all  projects  under 
implementation.  In  addition,  the  majority  of  rural  development  programmes 
include  components  related  to  health,  such  as  water  and  sanitation  and 
construction  of  health  centres, etc. 

In  1995,  the  total  amount  disbursed  to  the  health  sector  was  54,5  MECU,  the 
support  being  mainly  concentrated  to  Central  America  (27  MECU  to  health 
projects  in El  Salvador  and  21 MECU to regional  projects);  Among  the  regional 
projects it is worth mentioning the Project  "Salud materno-infantil" (16,0 MECU), 
which  is  addressing  specific  problems  related  to  reproductive  health. 

3.7.6  Fight  against  drugs 

119.  The  Phare  Multi-country  Drugs  Programme  covers  all  countries  of  Central  and 
Eastern  Europe  (11  countries)  and  has  been  operational  since  1993.  Health 
education,  training  and  other  preventive  measures,  as  well  as  treatment  and 
rehabilitation  components  represent  a  significant  part  of  the  programme.  It  is  a 
multidisciplinary  programme  promoting  cooperation  among  the  Phare  partner 
countries  in the fields  of drug demand  and  supply  reduction  and  the  development 
of a global  approach  towards the drugs phenomenon.  The programme  has helped 
to raise  official  awareness  of the problem  of  drug use  and  to  initiate  the  creation 
of  structures  at  national  level  to  coordinate  actions  and  bring  together  all  actors 
in the  field. 

Regional  training  activities  have  been  organised  on  topics  such  as  schools,  the 
family,  the  community  and  the  media. 

A  second  regional  report  on  drug  demand  reduction  was  prepared  in  1995;  it 
shows both  an  increase  in  drug  use  and  the  development  of  local  awareness  and 
facilities  to  deal  with the problem.  The report  was discussed  at  a joint  CEEC-EC 
seminar in Luxembourg in September  1995, thus enhancing the cooperation which 
was  established  in  1994  between  this  programme  and  the  drug-related  activities 
carried  out  inside  the  Community. 

Approximately  2  million  ecus  have been  spent  so far  on this  activity. 

120. 

In the context  of North-South  activities, particular emphasis is placed  on the fight 
against  drugs  and  drug  dependence.  A  total  of  8.7  million  ecus  was  utilised  to 
support  actions 
to  reduce  drug  supplies  (trafficking  controls,  alternative 
developments)  and  demand  (prevention,  treatment  and  rehabilitation). 

3.7.7  Humanitarian  aid 

121.  The European Community Humanitarian Office,  ECHO, which has been operating 
since  1992,  plans,  implements,  finances,  monitors  and  evaluates  operations  and 
decisions  concerning  humanitarian  aid.  When  health  systems  are  clearly 

42 

inadequate, preventive humanitarian  measures may be taken to stop epidemics and 
assist the population.  Given the limited  resources available to ECHO, this type of 
assistance  is  only  provided  in  a  serious  situation. 

122. 

In  1995, man-made  disasters  accounted  for  96% of ECHO'S work,  the  remaining 
4% relating to epidemics or natural disasters and their prevention. During the year, 
ECHO  followed  the  same approach  as in  1994 in respect  of its emergency  health 
protection  measures: 

supply  of  medicines  and  medical  equipment  (the  most  important  health 
measure  taken  by  the  Office); 
vaccination  campaigns; 
checking  the  quality  of  distributed  foodstuffs; 
infrastructure  work to improve the general  standard  of health,  and training 
of  local  medical  personnel. 

123.  The main  emergency  operations undertaken by ECHO in  1995 in the health field 
were  predominantly  directed  at the  Great  Lakes Region  (Rwanda,  Burundi).  But 
they also concerned the vaccination of,  and support for,  cholera victims in Liberia, 
Guinea,  Nicaragua  and  Peru.  In  addition,  a  major  contribution  (15  million  ecu) 
mainly  in form  of  medicines  and  food,  was made to a global  campaign  launched 
by  UNICEF  aimed  at  combatting  a  renewed  outbreak  of  diphtheria  and 
tuberculosis in Russia, the Community of Independent  States and the Baltic States. 

3.7.8  Environment  and  health 

124.  The  Community  plays  an  important  international  role  also  in  the  area  of 
environment  and  health.  It  is  participating  in  the  activities  of  the  UNCED 
Commission  on  Sustainable  Development  and  is  represented  on  the  European 
Committee  for  Environment  and  Health  (ECEH),  which  is  responsible  for  the 
follow-up  of the  Second  European  Conference  on Environment  and Health  held 
in Helsinki  in  1994.  The  next  meeting  is  due to take  place  in  London  in  1999. 

3.8 

Integration  of  health  requirements  in  other  Community  policies 

3.8.1  Statistics 

125.  A  condition  for  Community  action  in  any  field  is  the  existence  of  reliable, 
accurate and accessible data. Under the Framework programme for priority  actions 
in  the  field  of  statistical  information  1993-199778 and  with  close  involvement  of 
the  Statistical  Programme  Committee79,  sectoral  programmes  for  social  policy 
statistics  are being  further  developed. 

126. 

In  close  cooperation  with  the  Member  States,  Eurostat  (the  Statistical  Office  of 
the  European  Community)  is  collecting,  analysing  and  disseminating  statistical 
information  on a wide range of items related to social and economic aspects, such 

78 

79 

Council Decision  93/464/EEC, 22.07.1993, OJ L 219, 28.08.1993, p.l 
Established by  Council Decision 94/382/EEC, Euratom, OJ  L  181, 28.06.1989, p.47 

43 

as  demography,  environment,  poverty  and  social  exclusion,  social  protection, 
public health,  and health  and safety  at work.  A number of publications  containing 
inter  alia  statistical  information  on  health  and  safety  were  published  in  1995 
(Eurostat  Yearbook,  Social  Portrait  of  Europe,  Women  and  Men  in  the  EC, 
Disabled  persons:  Statistical  data  -  second  edition). 

127.  Data on accidents at work (ESAW: European  Statistics on Accidents at Work) are 
collected  on  a  regular  basis  and  a  database  has  been  designed.  A  task  force  has 
been  set  up  to  discuss  methodological  issues  such  as  coverage  and  under 
reporting,  as well  as changes to  certain  classification  systems.  A pilot  project  on 
developing  comparable  studies  on  occupational  diseases  (EODS:  European 
Occupational Diseases Statistics) for 31 substances and diseases has been launched 
and  a prototype  database  has been  created.  A technical  sub-committee to  develop 
new  classification  systems  for  factors  on  biological,  physical  and  chemical 
exposure  has  been  established.  The  basic  variables  for  which  data  are  being 
collected  will  provide  the  first  reliable  Community-wide  statistics  on  working 
conditions. 

128.  On  the  collection  at  Community  level  of  data  on  home  and  leisure  accidents 
(EHLASS),  Eurostat  has  provided  assistance  in  the  preparation  of  summary 
reports  and  the  revision  of  methodologies. 

129. 

In  1995,  the  second  wave  of  the  European  Community  household  panel  took 
place.  The  first  wave  (1994)  data  of  this  multidimensional  panel  survey,  which 
provide  information  on  a  wide  range  of  socio-economic  issues  including  health 
and  medical  consumption,  are  currently  being  analyzed. 

130.  These  health-related  activities  will  be  coordinated  with 

forthcoming 
programme  on  health  monitoring80.  In  close  cooperation  with  other  Commission 
services and with  international  organisations  active  in the field of health  statistics 
(WHO,  OECD),  existing  projects  on 'causes of death  statistics',  'health  interview 
surveys'  and  'health  resources'  will  be  further  improved  in  view  of  this  coming 
programme. 

the 

3.8.2  Youth  and  education 

131.  The  SOCRATES  Community  action  programme  (1995-1999)  is  designed  to 

contribute  to  the  development  of  quality  education  and  training. 

Chapter  I,  relating  to  higher  education  (ERASMUS),  provides  for  measures  to 
promote student and teacher mobility, the setting up of thematic networks, and the 
development  of  curricula  for  various  subject  areas.  The  latter  include  medical 
sciences  such  as  medicine,  psychiatry,  dentistry,  public  health,  pharmacology, 
medical  technologies,  etc. 

Chapter  II,  covering  school  education  (COMENIUS),  has  a  section  on 
"partnerships  between  schools"  (Action  1)  that  is  aimed  at  encouraging  the 
creation of partnerships between  several schools in different  Member  States which 

80  COM (95) 449 fin. of  16.10.1995 - see above, Public health 

44 

will  cooperate  on  European  education  projects  (EEP).  The  latter  aim  to  develop 
subjects  of  European  interest  (culturage  heritage,  the  environment,  science  and 
technology,  etc.).  One  such  subject  could  be  health  promotion  in  schools. 

132.  The  Youth  for  Europe  programme  gives  financial  support  to  projects  and 
.exchanges  organised  by  youth  initiatives  and  organisations.  Specific  actions 
support  periods  of  voluntary  service  and  exchanges  outside  the  European 
Community,  including  CEECs,  the  NIS,  Latin  America  and  the  Mediterranean 
region. 

While  health  is  not  a  specific  programme  target,  a number  of  projects  receiving 
financial assistance  in  1995 had  a health  dimension,  relating for  example to  drug 
prevention  and  abuse,  alcohol,  AIDS  prevention  and  the  provision  of  care  and 
support-for  people  with  HIV/AIDS,  health  education  and  young  people  with 
disabilities. One project  relates to health in the context  of basic youth rights to be 
accorded  to  all  young  people81. 

3.8.3 

Information  activities 

133.  The  Citizens  First  campaign,  designed  to  help  to  bring  Europe  closer  to  the 
individual  citizen,  was  adopted  by  the  Commission  in  October  1995. In  the  run 
up  to  the  Intergovernmental  Conference,  the  Commission  intends  this  campaign 
to  demonstrate  the  benefits  of  the  internal  market  to  citizens.  This  general 
objective  will  be  developed  in  the  context  of  ten  specific  themes.  When  the 
information  campaign  on  one  of  the  themes  is  launched,  the  Commission  will 
publish  both  a  guide  and  a  factsheet.  Two  of  the  themes  have  a  particular 
relevance for  health:  health  provisions in the single market,  and  health  and  safety 
at the  workplace. 

3.8.4  Regional  policy 

134.  As outlined  in  the  1994  report,  investments  in  education  and  health  in  objective 
I  regions  are  now  included  in  the  scope  of the European  Regional  Development 
Fund  (ERDF).  While  it  is  too  early  to  provide  any  detailed  assessment  of  the 
effect  on health of this expenditure (the Commission  does not yet have a complete 
overview  of  all  projects  funded  according  to  target  area),  it  is  clear  that,  in 
qualitative  terms,  significant  health  benefits  are  expected  from  improvements  in 
the  overall  environment  and  infrastructure  of  the  regions  concerned. 

3.8.5  Drugs 

135.  The European  Monitoring  Centre  for  Drugs  and  Drug  Addiction  (EMCDDA)  in 
Lisbon  became  operational  in  the  first  half  of  1995.  As  the  centre's  physical 
infrastructure  was not in place before  mid-year,  activities concentrated  on gearing 
up for  the tasks assigned  to the Centre and on launching work in the main  priority 
areas  defined  by  the  Centre's  1995-97 work  plan. 

!1  cf.  Youth  for  Europe  statistics  1995, DG  XXII, Doc. YIE-D95-006E 

45 

136.  The Centre has concentrated  on the following  objectives:  1. Definition  of a set of 
principles for  information  collection,  2. Identification  of key  indicators  and core 
data,  3.  Identification  of  mecnanisms  for  providing  appropriately  analyzed 
information,  4.  Establishment  of  effective  working  relationships  with  competent 
international  institutions  and  bodies,  5.  Establishment  of  working  relationships 
with the main research groups and centres in the Member  States,  and, finally,  6. 
Establishment  of recommendations for the Management Board concerning action 
to  be  taken  in  these  fields.  The  completion  of  this  work  is  a  precondition  for 
preparing  the  Annual  Report  on the Drugs  Situation  in Europe. 

137.  Taking  into account these  objectives,  the centre focused  its activities in  1995  on 
reviewing  the  diverse  studies and initiatives undertaken by the  Community  prior 
to  its  creation.  These  covered  three  main  areas:  demand  reduction  and 
epidemiology,  implementation  and coordination  of the REITOX network and the 
national focal  points, and a restructuring of relations with the Centre's institutional 
and scientific  partners. The work of the REITOX network was reviewed  in 1995, 
with  a  view  to  improving  this  successful  cooperation  between  Member  States 
concerning  drugs questions. 

46 

4. 

Conclusions 

138.  This second annual report on the integration of health requirements in  Community 
policies  shows  clearly  how  almost  all  main  policy  areas in  the  Community  have 
repercussions  on  health  and  take  health  considerations  into  account. 

139. 

It shows that a number of subjects  are being addressed by  several  different  policy 
areas: work  on tobacco, for  example, takes place in the context  of the  preventive 
activities of the Europe against cancer programme. In addition, agricultural  policy 
deals  with  the  growth  of  tobacco  plants;  research  is  being  conducted  on  less 
harmful  tobacco  varieties  and  indirect  taxation  of  tobacco  products  is  being 
considered  within  the  context  of  taxation  policy.  A  similar  situation  exists 
concerning drugs, which  are a topic for action in public health (with a programme 
proposal  being  discussed  by  Council),  for  cooperation  in  internal  and  justice 
affairs,  or  in  North-South  work.  Drugs-related  projects  are  also  funded  by 
programmes  directed  at  the  fight  against  social  exclusion  and  by  the  Youth  for 
Europe  programme.  The  specific  programmes  targeted  at  Central  and  Eastern 
Europe  all  include  a health  dimension. 

140.  Several  important health-related  issues on the EC level are not being  administered 
by  the  Community  institutions  themselves,  but  have  become  the  task  of 
independent  agencies.  In  this report,  there have been  references  to  the  European 
Agency  for  Safety  .and  Health  at  Work  (Bilbao),  the  European  Medicines 
Evaluation  Agency  (EMEA)  in  London,  the  European  Environment  Agency 
(Copenhagen), and the European Monitoring Centre for Drugs and Drug Addiction 
(EMCDDA) in Lisbon. In their work, these agencies, while formally  independent, 
are  still  required  to  respect  the  provisions  of  Article  129  of  the  Treaty. 

141.  The emphasis which  the first report put on the need for  complementarity  - public 
health  policy  needs to be complementary  to other policies,  and  other  Community 
policies  may  need  to  be  complemented  by  public  health  measures  -  remains  a 
continual  challenge  for  Community  policies82.  Particularly  in  areas  where  the 
legislative  groundwork  has been  laid,  it  is  important  to  realise  that  legislative  or 
other  measures  in  that  context  may  also  have  important  public  health  aspects 
which  need  to be  considered. 

142.  All  in  all,  health  protection  and  disease  prevention  requirements  are  steadily 
taking  on more importance both  as a result of the consultation  processes  installed 
inside the Commission  - including the Interservice Group on Health  - and because 
of  growing  public  awareness  of the health  implications  of  other  areas  of  policy. 

82  Report on the integration of health requirements in Community policies (1994), COM (95)  196 fin. 

of  29.05.1995, p.  40f. 

47 

143.  This report is intended  to be a contribution  to the  transparent functioning  of the 
Community.  This  is,  however,  a  two-way  process.  The  Commission  would 
therefore  hope  that  the  publication  of  this  report  will  also  provide  important 
pointers to all those involved  and interested in decision-making  in various policy 
areas  to  ways  and  directions  of  intervention  aiming  at  ensuring  that  health 
requirements  are properly  integrated  into the various  Community  policies. 

Article  129 of the Treaty places the obligation to integrate health requirements in 
Community  policies  on  all  the  institutions  involved  in  the  shaping  and 
implementation  of  Community  policies.  Some Member States and regions  in the 
Community  have  launched  similar  initiatives.  The  Commission  hopes  that  this 
report will  stimulate  other Member  States and regions to follow  suit. 

48 

A N N EX 

Proposals  for  and  adoption  of  major  health-related  legislation  in  1995 

Legislation  proposed  in  1995 

Public  health 

Communication  and Proposal for  a European Parliament  and Council Decision  on Health 
Monitoring,  COM  (95)  449  fin.  of  16.10.1995 

Social  policy 

Amended  proposal  for  a Regulation  amending  Council  Regulation  (EEC)  1408/71,  OJ C 
242,  19.09.1995 

Proposal  for  a  Council  Directive  amending  Directive  90/349/EEC  on  the  protection  of 
workers  from  the  risks  related  to  the  exposure  to  carcinogens  at  work,  OJ  C  317, 
28.11.1995 

Environment 

Proposal  for  a European  Parliament  and  Council  Directive  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  the  measures  to  be taken  against  the  emission  of 
gaseous  and  particulate  pollutants  from  internal  combustion  engines  to  be  installed  in 
non-road  mobile  machinery,  COM  (95)  350  fin.  of  06.09.1995 

Amended proposal for a Council Directive concerning integrated pollution prevention  and 
control,  COM  (95)  88  fin.  of  15.05.1995 

Amended  proposal  for  a Council  Directive  on the  marketing  of biocidal  products,  COM 
(95)  387  fin.  of  20.07.1995 

Agriculture 

Proposal  for  a Council  Directive in relation  to the marketing  of meat  products, OJ C 269 
of  16.10.1995 

Proposal  for  a  Council  Directive  amending  Directive  92/117/EEC  concerning  measures 
for  protection  against  certain  zoonoses,  COM  (95)  491  fin.  of  23.10.1995 

Transport 

Proposal  for  a  Council  Directive  on  maritime  equipment,  COM  (95)  269  fin.  of 
21.06.1995 

Proposal  for  a  Council  Directive  on  the  approximation  of  laws  of  the  Member  States 
relating  to  roadworthiness  tests  for  motor vehicles  and  their trailers,  COM  (95)  415  fin. 
of  08.09.1995 

14*3 

Energy 

Proposal  for  a Council Decision  concerning a multi-annual  programme for the promotion 
of energy efficiency  in the European Union - SAVE II, COM (95) 225 fin. of  31.05.1995 

Legislation  adopted  in  1995 

Social  policy 

Medium-Term  Social  Action  Programme,  COM  (95)  134  fin.  of  12.04.1995 

The Future of Social Protection - a framework  for  a European  debate, COM (95) 466 fin. 
of  31.10.1995 

Commission Communication on a Community programme concerning safety, hygiene and 
health  at work  (1996-2000),  COM  (95)  282  fin.  of  12.07.1995 

Commission  Decision  95/230/EC  of  12.07.1995  setting  up  a  Scientific  Committee  for 
Occupational  Exposure  Limits  to  Chemical  Agents,  OJ L  188,  09.08.1995 

Commission Decision 95/319/EC of  12.07.1995 setting up a Committee of Senior Labour 
Inspectors,  O JL  188,  09.08.1995 

Single  Market 

18th  Directive  adapting  to  technical  progress  the  annexes  of  the  basic  Directive  on 
cosmetics  products,  Commission  Directive  95/34/EC  of  10.07.1995,  OJ  L  167  of 
18.07.1995 

6th Directive  on methods  of analysis for  checking the composition  of cosmetic products, 
Commission  Directive  95/32/EC  of  07.07.1995,  OJL  178,  28.07.1995 

Directive  establishing the criteria  and  conditions under which  a manufacturer  may  apply 
not  to  include  one  or  more  ingredients  on  the  list  of  ingredients  to  be  indicated  on  the 
packaging  of  cosmetic  products,  Commission  Directive  95/17/EC  of  19.06.1995,  OJ  L 
140,  23.06.1995 

Directive  95/46/EC of the European  Parliament  and  of the Council  of  24.10.1995  on the 
protection  of  individuals  with  regard  to the  processing  of  personal  data  and  on  the  free 
movement  of  such  data,  OJ L  281, 23.11.1995 

Agriculture 

Council Directive 95/23/EC of 22.06.1995 amending Directive 64/433/EEC on conditions 
for  the  production  and  marketing  of  fresh  meat,  OJ L  243,  11.10.1995 

Council  Directives  harmonising  maximum  residue  levels  for  nine  pesticide  active 
substances  and  amending  existing  maximum  residue  levels  for  other  pesticide  active 
substances,  Council  Directives  95/38/EC,  OJ  L  197,  22.08.1995;  95/39/EC,  OJ  L  197, 
22.08.1995;  95/61/EC,  OJ L  292,  07.12.1995 

SO 

Commission  Directive  95/3/EC of  14.02.1995  amending Directive  90/128/EEC relating 
to plastic materials  and articles intended to come  into contact with foodstuffs,  OJ L 41, 
23.02.1995 

Commission  Decision  95/492/EC  of  15.11.1995  amending  Decision  94/652/EC 
establishing the inventory and distribution of tasks to be undertaken within the framework 
of  cooperation  by  Member  States  in  the  scientific  examination  of  questions  related  to 
food,  OJL  282,  24.11.1995 

Transport 

Commission  Communication  on  a common  transport  policy:  Action  programme  1995-
2000,  COM (95)  302  fin.  of  12.07.1995 

Council  Regulation  (EC) No  3051/95  of  08.12.1995  on the  safety  management  of  roll-
on/roll-off  passenger  ferries,  OJ L  320,  30.12.1995 

S'l 

ISSN  0254-1475 

COM(96) 407 final 

DOCUMENTS 

EN 

05 

Catalogue  number  :  CB-CO-96-406-EN-C 

ISBN  92-78-07766-6 

Office for Official  Publications of the European Communities 

L-2985 Luxembourg 

?2.