Proposal for a Regulation of the European Parliament and of the Council On aid for poverty diseases (HIV/AIDS, malaria and tuberculosis) in developing countries
Date: 2002-03-04
Institutions: European Commission
Subjects: AIDS, cooperation policy, developing countries, financial aid, health policy, infectious disease, medicinal product, poverty, research and development

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 04.03.2002
COM(2002) 109 final

2002/0051 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

On aid for poverty diseases (HIV/AIDS, malaria and tuberculosis) in developing
countries

(presented by the Commission)

EXPLANATORY MEMORANDUM

The co-operation and development policy referred to in Article 179 of the Treaty establishing
the European Community highlights the need for the Council, acting in accordance with the
procedure referred to in Article 251, to adopt the measures necessary to further the objectives
referred  to  in  Article  177  of  the  Treaty.  Community  policy  in  this  area  shall  foster  the
sustainable and economic development of developing countries, the integration of developing
countries into the world economy and the fight against poverty.

Despite  the  impressive  achievements  of  health  investments,  the  burden  of  preventable
communicable diseases such as HIV/AIDS, malaria and tuberculosis, in developing countries
is  still  very  high,  resulting  in  profound  human  and  economic  costs.  In  1997,  the  Council
adopted Regulation (EC) No 550/97 on HIV/AIDS-related operations in developing countries,
which was set for an indefinite period. The Regulation aimed at reducing the transmission of
HIV/AIDS,  reinforcing  health  and  social  services,  strengthening  governments  and
communities  capacities  to  fight  the  epidemic,  developing  scientific  understanding  of  the
epidemic,  and  combating  the  social  and  economic  exclusion  of  persons  infected  with
HIV/AIDS.

This Regulation replaces Council Regulation (EC) No 550/97, to provide for a comprehensive
package  targeting  simultaneously  interventions  related  to  development  co-operation,  trade
relations  and  research  for  new  pharmaceutical  products,  for  the  three  major  communicable
diseases:  HIV/AIDS,  malaria  and  tuberculosis.  The  European  Community  Programme  for
Action on accelerated action targeting the three major communicable diseases in the context
of  poverty  reduction,  adopted  by  the  General  Affairs  Council  of  14  May  2001,  presents  an
ambitious framework for action, which needs substantial additional financial resources from
now until 2006.

the  activities  carried  out  under 

The  objectives  of 
to:
optimise the impact of existing interventions, services and commodities targeted at the major
communicable  diseases  affecting  the  poorest  populations;  increase  the  affordability  of  key
pharmaceuticals;  increase  the  research  and  development  of  vaccines,  microbicides  and
innovative  treatments.  Budget  heading  B7-6211  on  aid  for  poverty  diseases  (HIV/AIDS,
malaria and tuberculosis) in developing countries, provides for a vast set of coherent measures
to reach these objectives.

this  Regulation  shall  be 

Under this Regulation and based on the existing rules of the Community, contractors from all
developing countries shall be allowed, on a case by case basis, to bid for the procurement of
services  and  products  essential  in  the  fight  against  the  major  communicable  diseases:
HIV/AIDS, malaria and tuberculosis.

The  budget  heading  reflects  as  well  recently  adopted  Community  policy  on  enhanced  co-
operation between the EC and other donors and international institutions, including the United
Nations  and  the  World  Bank.  Use  will  be  made  of  the  possibility  to  create  new  innovative
partnerships with different actors, and to contribute, where appropriate and duly justified, to
global  initiatives  in  an  attempt  to  scale  up  resources  needed  for  health  in  developing
countries.

2

Compared to the previous Regulation, the financial framework for the implementation of this
Regulation  reflects  a  substantial  increase  needed  for  the  successful  implementation  of  the
European Community Programme for Action. The final amount shall be decided based on the
APS  2003  decision,  expected  by  the  end  of  February  2002,  and  shall  include  yearly
contributions to the Global Fund to fight HIV/AIDS, tuberculosis and malaria.

Operations  under  this  Regulation  form  part  of  the  Community's  overall  health  and  poverty
policy  within  development  co-operation.  In  this  context,  co-ordination,  coherence  and
complementarity  with  other  aid  instruments  and  with  the  policies  at  national,  regional  and
international levels, remain essential.

There  is  clearly  a  need  for  a  revised  legal  instrument  enabling  operations  to  reflect  most
recently  adopted  policies  and  principles.  For  this  reason,  the  Commission  proposes  to  the
Council and the European Parliament to adopt this Regulation.

3

2002/0051 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

On aid for poverty diseases (HIV/AIDS, malaria and tuberculosis) in developing
countries

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission1,

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

The right to good health is a fundamental human right recognised by Article 25 of the
Universal Declaration of Human Rights.  This right is being denied to  over a fifth of
the world's population,

Article  35  of  the  Charter  of  Fundamental  Rights  of  the  European  Union  calls  for  a
high  level  of  human  health  protection  in  the  definition  and  implementation  of  all
Union policies and activities,

HIV/AIDS,  malaria  and  tuberculosis  cause  the  deaths  of  more  than  five  and  a  half
million people each year, their greatest impact being on morbidity and life expectancy
in developing countries,

The failure to reduce the burden of these diseases and the evidence of their increasing
impact has brought them to the centre of the development debate and has led to calls
for  urgent  action  and  a  series  of  national,  regional  and  international  initiatives,  all
meant  to  achieve  the  Millennium  Development  Goals  which  include  clear  targets  to
fight HIV/AIDS, malaria and tuberculosis, and to which the European Community and
its Member States committed themselves,

The international community,  represented by  United  Nations  Secretary  General  Kofi
Annan, calls for an additional minimal investment of 7 - 10 billion USD per year for
HIV/AIDS, malaria and tuberculosis,

HIV/AIDS, malaria and tuberculosis require an appropriate structural response, which
is  both  comprehensive  and  coherent  and  which  is  beyond  the  financial  and  human
resources of most developing countries,

1

OJ C […], […], p. […].

4

                                                
(7) 

(8) 

(9) 

The effectiveness of programmes to support national strategies to combat HIV/AIDS,
malaria and tuberculosis partly depends on the improved co-ordination of aid at both
the European and the international level, including partnerships with the private sector,
and  on  the  use  of  procedures  tailored  to  the  specific  nature  of  the  strategies  and
partners concerned,

For the partner countries and populations in question, the type of assistance provided
for  by  this  Regulation  is  a  pre-requisite  for  development  and  thus  contributes
significantly to the Community's development co-operation policy,

In its Communications to the Council and the European Parliament  of  20 September
2000  and  21  February  2001  on  Action  related  to  Communicable  Diseases  in  the
Context  of  Poverty  Reduction,  the  Commission  outlined  the  policy  principles  and
strategic  priorities  needed  to  enhance  the  effectiveness  of  action  by  the  Community
and the Member States in this field,

(10) 

In  its  Resolutions  of  10  November  2000  and  14  May  2001,  the  Council  emphasised
the gravity of the HIV/AIDS, malaria and tuberculosis epidemics and the need to step
up efforts to give more support at national, regional and global levels,

(11)  The European Parliament has adopted several Resolutions and reports on this subject,
including  the  Khanbhai  report  adopted  on  4  October  2001  on  the  Commission’s
Communications  on  accelerated  action  targeted  at  major  communicable  diseases
within the context of poverty reduction,

(12) 

In  its  Resolutions  of  September  1998  and  October  2000,  the  ACP-EU  Joint
Parliamentary Assembly underlined the threat posed by HIV/AIDS to all development
efforts and the need for rapid action,

(13)  The  present  Regulation  renders  obsolete  Council  Regulation  (EC)  No  550/97  of  24
March  1997  on  HIV/AIDS-related  operations  in  developing  countries,  which  should
therefore be repealed2,

(14)  The  present  Regulation  lays  down,  for  the  entire  duration  of  the  programme  it
establishes,  a  financial  framework  constituting  the  prime  reference,  within  the
meaning  of  point  33  of  the  Interinstitutional  Agreement  between  the  European
Parliament, the Council and the Commission of 6 May 1999 on budgetary discipline
and improvement of the budgetary procedure3, for the budgetary  authority during the
annual budgetary procedure,

(15)  Since  the  measures  necessary  for  the  implementation  of  this  Regulation  are
management  measures  within  the  meaning  of  Article  2  of  Council  Decision
1999/468/EC  of  28  June  1999  laying  down  the  procedures  for  the  exercise  of
implementing powers conferred on the Commission4, they should be adopted by use of
the management procedure provided for in Article 4 of that Decision,

2

3

4

OJ L 85, 27.3.1997, p.1.
OJ C 172, 18.6.1999, p. 1.
OJ L 184, 17.7.1999, p. 23.

5

                                                
(16) 

In accordance with the principles of subsidiarity and proportionality set out in Article
5 of the Treaty, the objective of the proposed action, namely to combat the three major
communicable  diseases  within  the  context  of  poverty  reduction,  with  particular
reference  to  developing  countries,  cannot  be  attained  by  the  Member  States  acting
alone and, by reason of the scale and effects of the proposed action, can therefore only
be  achieved  by  the  Community.  This  Regulation  confines  itself  to  the  minimum
required to achieve that objective and does  not go beyond what  is necessary for that
purpose,

6

HAVE ADOPTED THIS REGULATION:

Chapter I

Purpose and scope

Article 1

(1) 

(2) 

The  Community  shall  implement  the  European  Community  Programme  for  Action
targeting  the  three  major  communicable  diseases,  namely  HIV/AIDS,  malaria  and
tuberculosis, in developing countries.

Under  that  Programme  the  Community  shall  provide  financial  assistance  and
appropriate  expertise  with  a  view  to  promoting  investments  in  health,  poverty
reduction and equitable economic growth in developing countries.

(3) 

In the allocation of such funding and expertise, priority shall be given to:

(a)

(b)

the poorest and least developed countries and the most disadvantaged sections
of the population within developing countries;

action  that  complements  and  reinforces  both  the  policies  and  capacities  of
developing countries and the assistance provided through other instruments of
development co-operation.

The purpose of activities carried out under this Regulation shall be to:

Article 2

optimise  the  impact  of  existing  interventions,  services  and  commodities

(a)
targeted at the major communicable diseases affecting the poorest populations;

(b)

increase the affordability of key pharmaceuticals;

increase  research  and  development,  including  vaccines,  microbicides  and

(c)
innovative treatments.

Article 3

Community  financial  support  shall  be  given  to  specific  projects  designed  to  further  the
objectives described in Article 2(1) and, in particular, to those which aim to:

(a) 

provide  the  necessary  technical,  scientific  and  normative  input  in  order  to
prioritise health interventions within the total development co-operation budget
and  improve  health  outcomes  related  to  the  three  major  communicable
diseases, keeping a balanced approach between prevention, treatment and care,
with a primary focus on prevention;

(b) 

improve  the  performance  of  health  interventions  targeted  at  the  three  major
communicable diseases within the context of a comprehensive health system;

7

(c) 

improve  pharmaceutical  policies  and  practice,  and  help  developing  countries,
at  regional  or  national  level,  to  develop  high-quality  local  production  of  off-
patent and / or licensed key pharmaceuticals;

(d) 

promote global tiered pricing for key pharmaceuticals for developing countries;

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

analyse  the  effects  of  factors,  such  as  the  level  of  net  import  price,  tariffs,
taxes,  and  importation,  distribution  and  local  registration  fees,  on  consumer
prices of medical goods in developing countries;

provide, where appropriate, technical assistance to developing countries to help
them  address  public  health  issues  in  accordance  with  the  provisions  of  the
Agreement  on  Trade  Related  Aspects  of  Intellectual  Property  Rights  (TRIPs)
as  clarified  in  the  Doha  Declaration  on  the  TRIPs  Agreement  and  Public
Health;

develop  an  incentive  package  to  encourage  more  private  investment  by  the
Research  and  Development  based  industries  in  new  products,  particularly
vaccines and microbicides, designed to fight the major communicable diseases
in developing countries;

support  collaborative clinical, epidemiological, operational and  social  studies,
so as to enable health-related research to be conducted on a sounder basis;

encourage  capacity  building  in  developing  countries,  to  enable  them  to  co-
ordinate, host and conduct large-scale population trials;

support  global  initiatives  targeting  the  major  communicable  diseases  in  the
context  of  poverty  reduction,  including  the  Global  Fund  to  fight  HIV/AIDS,
tuberculosis and malaria which came into operation on 29-01-2002.

Article 4

(1) 

In the context of the operations referred to in Article 3, Community support may take
the form of:

(a)

(b)

(c)

(d)

financial assistance;

technical assistance, training or other services;

supplies, such as medical supplies and commodities, and works;

audits and evaluation and monitoring missions.

Priority shall be given to enhancing national capacity with a view to long-term viability.

(2) 

Community financing may cover both investment expenditure, excluding the purchase
of real estate, and, in exceptional and duly substantiated cases, taking into account the
fact that the operation must, as far as possible, aim at medium-term viability, recurring
expenditure  as  well  (including  administrative  expenditure,  maintenance  and  running
costs), the operation of which temporarily represents a burden for the partner, so that
the maximum use is made of the support referred to in paragraph 1.

8

Chapter II

Procedures for the implementation of aid

Article 5

(1) 

(2) 

(3) 

(4) 

Community financing under this Regulation shall take the form of grants.

A financial contribution from the partners defined in Article 6 shall be sought for each
co-operation operation. In specifying the amount of the contribution requested, regard
shall be had to the capacity of the partners concerned and the nature of the operation in
question. In certain circumstances, the contribution may be made in kind if the partner
is either a non-governmental organisation (NGO) or a community-based organisation.

The  provision  of  financial  assistance  under  this  Regulation  may  entail  co-financing
with  other  donors,  in  particular  with  Member  States,  the  United  Nations,  and
international or regional development banks or financial institutions.

In the context of the operations referred to in Article 3 (1) (g)-(i), financial assistance
shall  be  granted  in  co-ordination  with  the  new  instruments  for  product  research  and
development  on  poverty-related  communicable  diseases  implemented  under  the
Community Framework Programme of Research and Development 2002 – 2006.

(1) 

The partners eligible for financial assistance under this Regulation include:

Article 6

(a) 

administrative  authorities  and  agencies  at  national,  regional  and  local
government level;

(b) 

local authorities and other decentralised bodies;

(c) 

local communities, NGOs, community-based organisations and other non-for-
profit natural and legal persons from the private sector;

(d) 

regional organisations;

(e) 

international organisations, such as the United Nations and its agencies, as well
as  development  banks,  financial  institutions,  global  initiatives,  international
public/private partnerships;

(f) 

research institutes and universities.

(2)  Without  prejudice  to  paragraph  1(e),  Community  financial  assistance  shall  be
available  to  partners  whose  head  office  is  located  in  a  Member  State  or  in  a  third
country that  is  a  beneficiary  of  potential  beneficiary  of  Community  assistance  under
this  Regulation,  provided  that  this  office  is  the  actual  centre  directing  business
operations. In exceptional cases, this office may be located in another third country.

(1)  Where operations are the subject of financing agreements between the Community and
countries  which  benefit  from  operations  financed  under  this  Regulation,  the

Article 7

9

(2) 

(3) 

(1) 

(2) 

(1) 

agreements  shall  stipulate  that  the  payment  of  taxes,  duties  and  charges  shall  not  be
financed by the Community.

Any  financing  agreement  or  contract  concluded  under  this  Regulation  shall  stipulate
that it is subject to the supervision and financial control of the Commission which may
carry  out  spot-checks  and  inspections,  and  to  audits  by  the  Court  of  Auditors,  in
accordance  with  the  usual  arrangements  laid  down  by  the  Commission  under  the
provisions  in  force,  particularly  those  in  the  Financial  Regulation  applicable  to  the
general budget of the European Communities.

The necessary measures shall be taken to emphasise the Community character of  aid
provided under this Regulation.

Article 8

Participation in invitations to tender for the award of contracts shall be open on equal
terms  to  all  natural  and  legal  persons  in  the  Member  States  and  in  all  developing
countries. It may be extended, in exceptional cases, to other third countries.

Supplies shall  originate in the  beneficiary  country,  other  developing  countries  or  the
Member  States.  In  exceptional  cases,  supplies  may  originate  from  other  third
countries.

Article 9

In order to secure the objectives of consistency and complementarity referred to in the
Treaty  and  to  ensure  maximum  effectiveness  of  these  operations  as  a  whole,  the
Commission may take all necessary coordination measures, including:

(a) 

(b) 

establishing a system for the systematic exchange and analysis of information
on  the  operations  financed  and  those  which  the  Community  and  the  Member
States propose to finance;

on-the-spot  coordination  of  the  implementation  of  operations  through  regular
meetings  and  exchanges  of  information  between  the  representatives  of  the
Commission and the Member States in the recipient country.

(2) 

The Commission, in liaison with the Member States, may take any initiative necessary
for ensuring proper co-ordination with the other donors concerned, in particular those
forming part of the United Nations system.

Chapter III

Decision-making procedures

Article 10

(1) 

(2) 

The financial framework for the implementation of this Regulation for the period from
2003 to 2006 is hereby set at …. million Euro [to be decided APS 2003].

The  annual  appropriation  shall  be  authorised  by  the  budgetary  authority  within  the
limits of the financial perspective.

10

Article 11

(1) 

(2) 

(1) 

(2) 

(3) 

(1) 

The  Commission  shall  be  responsible  for  drafting  strategic  programming  guidelines,
defining  the  Community's  co-operation  in  terms  of  measurable  objectives,  priorities,
deadlines  for  specific  areas  of  action,  assumptions  and  expected  outcomes.
Programming is annual and indicative.

An  exchange  of  views  with  the  Member  States  shall  take  place  on  the  basis  of  a
presentation  by  the  representative  of  the  Commission  of  the  strategic  programming
guidelines  for  the  operations  to  be  carried  out,  within  the  Committee  referred  to  in
Article 13 paragraph 1.

Article 12

The  Commission  shall  be  responsible  for  appraising,  deciding  and  administering  the
operations  covered  by  this  Regulation  in  accordance  with  the  budgetary  and  other
procedures  in  force,  in  particular  those  laid  down  in  the  Financial  Regulation
applicable to the general budget of the European Communities.

Decisions concerning operations for which financing under this Regulation exceeds 5
million  Euro  and  any  changes  to  these  operations  that  entail  a  cost  overrun  of  more
than 20% of the amount initially fixed for the operation concerned, shall be adopted in
accordance with the procedure referred to in Article 13, paragraph 2.

For decisions and changes to these operations amounting to 5 million Euro or less, the
Commission will inform the Member States.

The  Commission  shall  be  assisted  by  the  geographically  determined  committee
competent for development.

Article 13

(2)  Where  reference  is  made  to  this  paragraph,  the  management  procedure  laid  down  in
Article  4  of  Decision  1999/468/EC  shall  apply,  in  compliance  with  Article  7  and
Article 8 thereof.

(3) 

The period provided for in Article 4, paragraph 3, of Decision 1999/468/EC shall be
set at 45 days.

Chapter IV

Reporting and financial provisions

Article 14

(1) 

After  each  budget  year,  the  Commission  shall  submit  in  its  annual  report  on  EC
development policy to the European Parliament and to the Council, information on the
operations financed in the course of that year and the Commission's conclusions on the
implementation of this Regulation over the previous budget year. The summary shall
in  particular  provide  information  about  the  strengths  and  weaknesses  of  operations,
those  with  whom  contracts  have  been  concluded  as  well  as  the  results  of  any
independent evaluations of specific operations.

11

(2) 

One  year  before  the  expiry  of  this  Regulation,  the  Commission  shall  submit  an
independent appraisal report on the implementation of this Regulation to the European
Parliament  and  the  Council  with  a  view  to  establishing  whether  its  objectives  have
been  achieved  and  providing  guidelines  for  improving  the  effectiveness  of  future
operations. On the basis of this appraisal report the Commission may make proposals
for the future of this Regulation and, if necessary, proposals for its amendment.

Council  Regulation  (EC)  No  550/97  is  hereby  repealed.  Operations  that  have  been  decided
under Regulation No 550/97 shall continue to be implemented under that Regulation.

Article 15

(1) 

This Regulation shall enter into force on the third day following that of its publication
in the Official Journal of the European Communities.

Article 16

(2) 

It shall apply until 31 December 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, […]

For the European Parliament
The President

For the Council
The President

12

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Development and Relations with ACP countries

Activity(ies): Development co-operation policies and sectoral strategies

TITLE OF ACTION: COMMUNICABLE DISEASES IN DEVELOPING COUNTRIES

1.

2.

2.1.

2.2.

2.3.

BUDGET  LINE  +  HEADING  -  B7-6211  –  ON  AID  FOR  POVERTY  DISEASES
(HIV/AIDS, MALARIA AND TUBERCULOSIS) IN DEVELOPING COUNTRIES

OVERALL FIGURES

Total  allocation  for  action  (Part  B):  to  be  decided  -  following  the  APS  2003
decision

Period of application: 1.1.2003 - 31.12.2006

Overall multi-annual estimate on expenditure*

a) Schedule of commitment appropriations / payment appropriations (financial intervention)

€ thousand (to 3rd decimal place)

Commitments

Payments

2002
25,270

18,080

b) Technical and administrative assistance and support expenditure

€ thousand (to 3rd decimal place)

€ thousand (to 3rd decimal place)

Commitments

Payments

Subtotal a+b

Commitments

Payments

852.300

720.000

26,122.300

18,800.000

c) Overall financial impact of human resources and other administrative expenditure

€ thousand (to 3rd decimal place)

Commitments/
payments

507.000

13

TOTAL a+b+c

Commitments

Payments

26,629.300

19,307.000

* to be decided - Budget 2002 for information purposes

2.4

Compatibility with the financial programming and the financial perspective

(cid:1)

Proposal compatible with the existing financial programming

This  proposal  will  entail  reprogramming  of  the  relevant  heading  in  the

X
financial perspective

(cid:1)
Agreement.

This  may  entail  application  of  the  provisions  of  the  Interinstitutional

2.5

Financial impact on revenue:

No financial implications (involves technical aspects regarding implementation

X
of a measure)

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
participation

Participation
applicant
countries

Non-comp

Diff

YES

NO

NO

Heading
Financial
Perspective

Heading 4

4.

LEGAL BASIS

Attached in Commission proposal.

14

5.

DESCRIPTION AND GROUNDS

5.1.

Need for Community intervention

5.1.1. Objectives pursued

The  objectives  of  activities  carried  out  under 

this  Regulation 

shall  be 

to:

optimise  the  impact  of  existing  interventions,  services  and  commodities

(a)
targeted at the major communicable diseases affecting the poorest populations;

(b)

increase the affordability of key pharmaceuticals;

increase  research  and  development,  including  vaccines,  microbicides  and

(c)
innovative treatments.

5.1.2. Measures taken in connection with ex ante evaluation

The Commission has been  involved in support  for  the health sector  in  developing  countries
since  1987.  Lessons  from  the  past  reflected  in  recommendations  from  in-house  evaluations
and audits of this special budget line and support to Health, AIDS and Population in general,
and  lessons  from  other  donors  and  international  organisations,  have  shown  that  a  coherent,
comprehensive, timely and bold approach is needed, based on new ways of working with and
within  partner  countries  and  ultimate  beneficiaries,  and  amongst  donors,  the  private  sector,
politicians and other stakeholders.

The Programme for Action on communicable diseases adopted in 2001 has lead to long and
extensive consultations being held with all stakeholders. Council and Parliament have agreed
that the Programme for Action  is  an  appropriate  basis  for  future  support  and  that  additional
resources  are  needed.  Before  any  programming,  identification  and  commitment  from  this
budget  line  takes  place,  the  Commission  will  develop  a  coherent  framework  on  expected
results/outcomes and indicators to measure them, on assumptions and risks and on the volume
of appropriations.

Specific  targets  and  indicators  will  follow  the  Millennium  Development  Goals  defined  for
HIV/AIDS, malaria and tuberculosis. Proposed indicators are: HIV prevalence among 15-24
year old women; contraceptive prevalence rates; number of children orphaned by HIV/AIDS;
prevalence and  death  rates  associated  with malaria;  proportion of population in malaria risk
areas using effective malaria prevention and treatment measures; prevalence  and death  rates
associated  with  tuberculosis;  proportion  of  TB  cases  detected  and  cured  under  DOTS
(Directly Observed Treatment Short Course).

5.1.3. Measures taken following ex post evaluation

The  implementation  of  the  Programme,  i.e.  the  management  of  the  interventions  financed
from  the  budget  line,  will  be  continuously  monitored  by  means  of  a  monitoring  system
involving  relevant  DGs  and  Delegations,  partners  and  actors  concerned  and  working  with
clear  progress  and  outcome  indicators  (as  referred  to  in  5.1.2.).  All  programmes  or  actions
financed from this budget line shall be subject to an ex post evaluation in terms of the human
and financial resources allocated and the results obtained in order to verify that they were in
keeping  with  the  objectives  set.  To  this  end,  a  timetable  shall  be  set  which  will  allow  the

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findings  of  the  evaluation  to  be  taken  into  account  for  any  decision  on  the  continuation,
modification or suspension of the programme or action.

5.2.

Actions envisaged and arrangements for budget intervention

Financial support shall be given to operations following the objectives described above, and
in particular, to those which aim to:

(a) 

(b) 

(c) 

provide  the  necessary  technical,  scientific  and  normative  input  in  order  to  prioritise
health  interventions  within  the  total  development  co-operation  budget  and  improve
health  outcomes  related  to  the  three  major  communicable  diseases;  keep  a  balanced
approach between prevention, treatment and care, with a primary focus on prevention;

improve  the  performance  of  health  interventions  targeted  at  the  three  major
communicable diseases within the context of a comprehensive health system;

improve  pharmaceutical  policies  and  practice,  and  help  developing  countries,  at
regional or national level, to develop high-quality local production of off-patent and /
or licensed key pharmaceuticals;

(d) 

promote global tiered pricing for key pharmaceuticals for developing countries;

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

analyse the effects of factors, such as the level of net import price, tariffs, taxes, and
importation,  distribution  and  local  registration  fees,  on  consumer  prices  of  medical
goods in developing countries;

provide, where appropriate, technical assistance to developing countries to help them
address  public  health  issues  in  accordance  with  the  provisions  of  the  Agreement  on
Trade Related Aspects of Intellectual Property Rights (TRIPs) as clarified in the Doha
Declaration on the TRIPs Agreement and Public Health;

develop an incentive package to encourage more private investment by the Research
and  Development  based  industries  in  new  products,  particularly  vaccines  and
microbicides,  designed  to  fight  the  major  communicable  diseases  in  developing
countries;

support collaborative clinical, epidemiological, operational and social studies, so as to
enable health-related research to be conducted on a sounder basis;

encourage  capacity  building  in  developing  countries,  to  enable  them  to  co-ordinate,
host and conduct large-scale population trials;

support global initiatives targeting the major communicable diseases in the context of
poverty  reduction,  including  the  Global  Fund  to  fight  HIV/AIDS,  tuberculosis  and
malaria which came into operation on […]

5.3.

Methods of implementation

In the context of the operations referred to above, Community support may take the form of:

(a) 

financial assistance;

(b) 

technical assistance, training or other services;

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(c) 

supplies, such as medical supplies and commodities, and works;

(d) 

audits and evaluation and monitoring missions.

Priority shall be given to enhancing national capacity with a view to long-term viability.

Community financing may cover both investment expenditure, excluding the purchase of real
estate, and, in exceptional and duly substantiated  cases, taking into account the fact that  the
operation must, as far as possible, aim at medium-term viability, recurring expenditure as well
(including administrative expenditure, maintenance and running costs), the operation of which
temporarily  represents  a  burden  for  the  partner,  so  that  the  maximum  use  is  made  of  the
support referred to in paragraph 1.

The  effectiveness  of  programmes  to  support  national  strategies  to  fight  HIV/AIDS,  malaria
and tuberculosis partly depends on improved co-ordination of aid both at European level and
at  international  level,  including  partnerships  with  the  private  sector,  and  on  the  use  of
procedures tailored to the specific nature of the activities and the partners concerned.

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - NOT APPLICABLE pending on APS 2003

6.2.Calculation of costs by measure envisaged in Part B (over the entireprogramming period)

- NOT APPLICABLE pending on APS 2003

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources - current status

Types of post

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of
permanent posts

Number of
temporary posts

Total

Permanent
officials 
Temporary staff

or

A

B

C

Other human resources

Total

2.5

1.5

4

Description of tasks deriving from the
action

Policy - Programming - Management
budget line - identification
interventions, monitoring impact,
liasing with partners, representing
Commission etc.

7.2.

Overall financial impact of human resources

Type of human resources

Officials (4)

Temporary staff

Other human resources (give budget line)

Amount €

108 000

Method of calculation *

4 x € 108 000

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The  amounts  are  total  expenditure  for  twelve  months.  The  needs  for  human  and
administrative resources shall be covered within the allocation granted to the managing DG in
the framework of the annual allocation procedure.

Total

432 000

7.3.

Other administrative expenditure deriving from the action

Budget line

(number and heading)

Overall allocation (Title A7)

A0701 – Missions

A07030 – Meetings
A07031 – Compulsory committees (1)
A07032 – Non-compulsory committees (1)

A07040 – Conferences

A0705 – Studies and consultations

… Other expenditure (state which)

Information systems (A-5001/A-4300)

Other expenditure - Part A (state which)

Amount €

Method of calculation if available

40 000

5 000

30 000

Total

75 000

The amounts are total expenditure for twelve months.

(1) Specify the type of committee and the group to which it belongs.

I.

II.

III.

Annual total (7.2 + 7.3)*

Duration of action

Total cost of action (I x II)

€ 507 000

1 Year

€ 507 000

* amounts referring to the present situation (only for 2002)

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

After each budget year, the Commission shall submit in its annual report on EC development
policy to the European Parliament and to the Council, information on the operations financed
in  the  course  of  that  year  and  the  Commission's  conclusions  on  the  implementation  of  this
Regulation  over  the  previous  budget  year.  The  summary  shall  in  particular  provide
information  about  the  strengths  and  weaknesses  of  operations,  those  with  whom  contracts
have  been  concluded  as  well  as  the  results  of  any  independent  evaluations  of  specific
operations.

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8.2.

Arrangements and schedule for the planned evaluation

A  mid-term  exchange  of  views  shall  take  place  on  the  basis  of  a  presentation  by  the
representative of the Commission of the multi-annual strategic guidelines for the operations to
be carried out in the years ahead, within the geographically competent Committee. Guidelines
will  include,  as  far  as  possible,  measurable  objectives  and  deadlines  for  specific  actions.

One  year before the expiry of this Regulation, the Commission shall submit an independent
appraisal report on the implementation of this Regulation to the European Parliament and the
Council with a view to establishing whether its objectives have been achieved and providing
guidelines for improving the effectiveness of future operations. The appraisal will assess the
effectiveness of action taken following performance audits and independent evaluations.

9.

ANTI-FRAUD MEASURES

Joint evaluations and reviews will be carried out in agreement with the community of donors
and partner countries according the agreed Community rules and standards.

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