COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 21.2.2001
COM(2001) 96 final
COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE
EUROPEAN PARLIAMENT
PROGRAMME FOR ACTION: Accelerated action onHIV/AIDS, malaria and
tuberculosis in the context ofpoverty reduction
2EXECUTIVE SUMMARY
This Commission’s Programme for Action develops the policy framework presented in the
September 2000 Communication on “Accelerated Action targeted at major communicable
diseases within the context of poverty reduction”1. It establishes a broad and coherent
Communityresponse, over the period 2001-2006,tothe globalemergencycaused bythe three
major communicable diseases, HIV/AIDS, malaria and tuberculosis, which most affect the
poorest populations and whichundermine global health.
The Programme, as part ofanexpanded globaleffort,targets actions to increase;the impact of
existing interventions, the affordabilityofkeypharmaceuticals, and research and development
ofspecificglobalpublicgoodstoconfrontthesediseases indevelopingcountries.
The Commission will prioritise investment in health, aids and population in the context of
poverty reduction. A greater focus on communicable diseases will be provided through
options including; redirection of unspent resources, guidance on future programming
exercises and the use of regional funds. More effective aid management processes will speed
up the disbursement of funds to improve health. While the overall approach will be
comprehensive, targeting the support for better health in developing countries, the
Commission will maintain a major focus on prevention. Investment in strengthening
pharmaceuticalpolicies will include the appraisalofopportunities to develop localproduction
capacities. The Commission will seek to work in close co-operation with the UN, the G8
partners, the World Bank, civil society and EU Member States to, based on each partner's
comparative advantage, promote the reform the international financial architecture to enable
greater co-ordination, complementarityand efficiencyof internationalfunding.
The European Community will seek to increase the affordability of key pharmaceuticals
through attention to issues related to taxes and tariffs in developing countries. The European
Community will work towards the introduction of tiered pricing as the norm for the poorest
developing countries2, while seeking to prevent re-importation to the EU market. Investment
will build capacity within developing countries on health and trade-related issues, including
implementationoftheTRIPsAgreement.
The European Community will support new approaches to stimulate the development of
global public goods targeting the three major communicable diseases. Action will include
increased public support to Research and Development, notably for clinical trials, appropriate
incentives to encourage private investment into Research and Development, attention to early
dialogue on regulatory aspects and ensuring participation of developing countries in the
research process. Building increased capacity for research in developing countries will be a
priority.
To meet these objectives, the Commission will explore the use of the full range of available
financial instruments to implement this Programme for Action. The framework presented
identifies main actions, potential partners and instruments, and will be further detailed within
specific work plans following endorsement ofthis Programme for Action.
1COM(2000) 585 of20.9.2000.
2In the context of this Programme for Action, the poorest developing countries include the Least Developed
Countries (currently48 countries (UNCTAD:2000) and the other low-income countries with a GNP percapita ofless than USD 765 (currently24 countries DAC:2000).
3Appropriate mechanisms, resources and partnerships will be put in place to monitor
implementation of this Programme for Action, and to participate in a global monitoring
system encompassing the efforts of all international partners. Successful implementation of
this initiative will make a major contribution to global efforts to address the communicable
diseaseemergency.
4TABLE OF CONTENTS
COMMUNICATION FROM THE COMMISSION TOTHE COUNCIL AND THE EUROPEAN
PARLIAMENT PROGRAMME FOR ACTION: Accelerated actiononHIV/AIDS, malaria and
tuberculosis inthecontext ofpovertyreduction......................................................................1
1. CONTEXT...............................................................................................................6
2. OBJECTIVESANDEXPECTEDOUTCOMESOFTHEPROGRAMMEFORACTION..63. THEPROGRAMME FORACTION........................................................................73.1. IMPACT...................................................................................................................83.1.1. Optimisingthe impact ofHealth,AIDSandPopulationinterventionstargetedat major
communicablediseasesand povertyreduction..........................................................8
3.1.2. Strengthening ofpharmaceuticalpolicies and capacity building ................................9
3.1.3. Developing localproductioncapacity.......................................................................93.2. AFFORDABILITY................................................................................................103.2.1. Tiered pricing.........................................................................................................103.2.2. Tariffsand taxes.....................................................................................................113.2.3. Intellectualpropertylegislation...............................................................................11
3.3. RESEARCH AND DEVELOPMENT....................................................................11
3.3.1. Strengthening and increasing support for Researchand Development.....................113.3.2. Capacitybuilding indeveloping countries...............................................................123.3.3. Incentives for thedevelopment ofspecificglobalpublic goods...............................123.4. PARTICIPATION IN GLOBALPARTNERSHIPS: POLICY AND POLITICAL
DIALOGUE...........................................................................................................13
4. INSTRUMENTS....................................................................................................14
4.1. Identifying the instruments for action......................................................................144.2. Partnership,ownershipandmonitoringofaneffectiveEuropeanCommunityresponse.....155. CONCLUSION......................................................................................................15
Annex1: Programme for Action– Matrix............................................................................17Annex2: BasicPrinciples for Health, AIDS and Populationsupport....................................22Annex3: Clarificationofterminology..................................................................................23
5Annex4: Acronyms..............................................................................................................24
61. CONTEXT
On 20 September 2000, the Commission adopted a new policy framework presented in the
C o m m u n i c a t i o no n“ Accelerated Action targeted at major communicable diseases within the
context of poverty reduction ”1. The European Community policy aims to respond to what is now
generally acknowledged as a global emergency: the death of five million people per year from three
major communicable diseases: HIV/AIDS, malaria and tuberculosis . Each disease kills more than
one millionpeople a year, mainlyin developing countries, posing a serious threat to globalhealth.
The policy framework identifies three objectives for targeted action and a coherent response to the
three diseases in the area of impact of existing interventions, affordability of key pharmaceuticals,
and research into and development of specific global public goods . This approach has received a
high level of political support from developing countries, EU Member States and international
development agency partners, civil society and industry. It combines a coherent and unique mix of
development, trade and research policy anddrawsonallavailableexpertisewithintheCommission.
Taking into account the outcome of the international ‘High-LevelRound Table’2onthe new European
Community policy, and following the conclusions by the Council3,t h eCommission has developed a
Programme for Action targeted at the three major communicable diseases over the coming five years
(2001 -2006).
2. OBJECTIVES AND EXPECTED OUTCOMES OF THE PROGRAMME FOR
ACTION
The main objective of European Community Development Policy4is to foster sustainable
development designed to eradicate poverty in developing countries and to integrate them into the
world economy . At the start of the twenty-first century, few investments are wiser than those in good
health. Investments in health can make a major contribution to poverty reduction welfare and
economic growth: countries with higher levels of health grow faster. In the poorest developing
countries5, communicable diseases, particularly HIV/AIDS, malaria and tuberculosis continue to limit
development.
The European Community policy framework and this Programme for Action targeted at the major
c o m m u n i c a b l ed i s e a s e s ,a r ee n t i r e l yi nl i n ew i t ha n da tt h es a m et i m eap r e - r e q u i s i t ef o ra c h i e v i n gt h e
objective ofthe European CommunityDevelopment Policy. They will allow the European Community
to contribute substantially and participate fully in global and country efforts to confront major
communicable diseases. In recognition of the pivotal role of developing countries in ensuring the
1Communication (2000) 585 of20.9.2000.
2In order to ensure a broad consultation on the new Communication, the EC, in partnership with WHO and UNAIDS,
convened a High-Level Round Table in Brussels on 28 September 2000. The Round Table brought together over170 stakeholders, including 25 developing countries, notably ACP states, EU Member States, the EuropeanParliament, international development agencies, civil society, researchers and leaders of major pharmaceuticalcompanies. A high degree of consensus was reached among stakeholders on the content of the Communication.Moreinformation can befound at www.europa.eu.int/comm/development/sector/social/table.
3Councilresolution of10.11.2000, 2304thCouncil meeting.
4COM (2000)212of26.4.2000.
5In the context of this Programme for Action, the poorest developing countries include the least developed countries
(currently 48 countries (UNCTAD:2000) and the other low-income countries with a GNP per capita of less than
USD 765 (currently24 countries DAC:2000).
7health of their people, this Programme for Action will pay particular attention to ensuring their full
participationand ‘ownership’ ofthe actions envisaged.
In line with the objectives of the policy framework, the expected outcomes of the European
Community’s Programme for Action are:
– optimal impact from existing interventions, services and commodities targeted at the
major communicable diseases affecting the poorest populations;
– increased affordabilityofkeypharmaceuticals througha comprehensive approach;
– increased investment inresearchanddevelopment ofspecificglobalpublicgoods.
All of these will make a substantial contribution to reducing the burden of the major communicable
diseases, in particular for the poorest developing countries, and will strengthen global poverty
reductionefforts.
3. THE PROGRAMME FOR ACTION
The European Community’s policy is designed to link country level actions aimed at increasing
people’s access to existing goods and services, with enabling global action on affordability and
investment in the development of specific global public goods (see Annex 3). Consequently ,a l lt h r e e
areas for action – impact, affordability and research – are inter-active and synergetic :t h e
development and financing of global public goods such as AIDS and malaria vaccines require more
effective research, financing and new partnerships. At the same time a real and sufficiently large
increase in financing for existing vaccines, for example at country level, will be needed to increase
confidence in future uptake of new vaccines. Similarly a reduction in prices and concessions from the
research and development industry will require a market of sufficient size, established public-private
partnerships and a substantial increase in production capacity. Implementing the European
Community Programme forAction will require coherent, collective and simultaneousaction .
This Programme for Action takes into account a number of basic principles for European
Community’s Health, AIDS and Population support in developing countries, as highlighted in Annex
2.
Progress willbemonitored at two levels. Impact and high-leveloutcome indicators will be monitored
as part of a joint gender sensitive and pro-poor global monitoring system to be developed with
internationalpartners. Annex1 outlines a frameworkto monitor implementation of this Programme for
Action within the direct areas for European Community action. The framework, which identifies
potential partners, instruments, will be further detailed within specific work plans and monitoring
tools, including yearly progress reports, to be developed by Commission services following
endorsement ofthis Programme for Action.
83.1. IMPACT
3.1.1. Optimising the impact of Health, AIDS and Population interventions6targeted at major
communicable diseases and poverty reduction
(1) The Commission will prioritise within the total development co-operation budget, health,
AIDS and population (HAP) interventions over the next five years (2002-2006). The
proportion allocated to HAP stood at 8% in 2000 (approximately Euro 800 million) and will be
steadily increased as delivery capacity improves. Within those interventions, increased support
will target HIV/AIDS, malaria and tuberculosis, and the actions identified in this Programme
for Action, inaccordance withthe needs ofeachcountryand region.
(2) The ongoing process of European Commission’s reform is establishing more effective aid
management processes and addressing bottlenecks to allow more rapid disbursement .T h e
European Community’s commitments to health, AIDS and population (HAP) totalled Euro 4.2
billion over the period 1990-1999 of which Euro 700 million was committed in 1998 alone.
Most of this supports, will continue to strengthen of the health sector. Measures are underway
to simplify payments and contracting procedures. In addition, the Commission will invite
developing countries to identify opportunitiesto direct unspent committed resources within
countryprogrammes to addressthe communicable disease burden.
(3) The Commission will provide guidance to developing countries on communicable disease
issues and options for accelerated action within the current country, regional and thematic
programming exercises7.Delegations and partner countries will be encouraged to address
froma povertyreductionand gender perspective, communicable diseases within the framework
of Country Strategy Papers (CSPs) and Poverty Reduction Strategy Papers (PRSPs)8.M e m b e r
States will be co-ordinated with and will be consulted in the competent committees. The
Commission will maintain a comprehensive approach within which preventive activities will
continue to receive major attention.
(4) The Commission will establish co-operative arrangements with WHO/UNAIDS, the World
Bank and Member States to provide necessary technical and normative input to country
programming and identificationexercises.
(5) The Commission will consider the use of "all ACP" and other regional funds9forrapid
resource transfers to partners to increase access and utilisation of existing approaches and
scale up innovative practices such as social marketing of bednets, condoms, prevention and
care of mothers with HIV, etc. Subject to the conditions contained in applicable instruments,
funds may include the possibility for transfers to UN agencies/NGOs and CBOs and non-
6EC 'Population interventions' are defined in Council Regulation on Population Policies and Programmes in Developing
Countries N°1484/97, 22 July1997.
7In the different elements in this Programme for Action will be adapted to 'unstable' situations or where the local
component is weak (absence of functional Ministries of Health, absence of proper national health strategies, lackof means to conduct a programme).
8TheEuropean Community’s DevelopmentPolicy’: COM(2000) 212 of26.4.2000.
9See section 4 on instruments.The legal bases for contributionsmayincludedevelopment co-operation (articles 177 et seq.
of the EC Treaty) including co-operation with international organisations (article 181), public health (article 152)and research policy (article 163 et seq.). Special instruments applicable in the field include Council regulationN°550/97, 24 March 1997, on HIV/AIDS in developing countries, and Council Regulation on Population Policies
and Programmes in Developing Countries N°1484/97, 22 July 1997. Commitments are subject the eligibility
conditionsspecified in theapplicableinstruments.
9traditional partners at the request of developing countries. Innovative practises will be
scrutinised froma povertyreductionand gender perspective before theyare used widely.
The Commissionwillcontinue to workwith global partners to develop new approaches through large
scale and more efficient resourcetransfersto developing countries. See section3.4 for specific actions.
3.1.2. Strengthening of pharmaceutical policies and capacity building
(1) Through national and regional co-operation, capacity building, and financial and technical
assistance, the Commission will support the strengthening of pharmaceutical policy and
practice. The Commission will build upon existing programmes10where possible. Particular
efforts will be directed to improving budgeting and financial management, planning, quality
assurance, purchasing, tendering, distribution and optimal use of pharmaceuticals. Commission
support will facilitate a review of the impact of import duties and taxation schemes on prices,
address regulatory aspects and ethical standards, and lead to improved information exchange.
The Commission will support the development of regional/sub-regional quality control
laboratory networks to ensure appropriate quality control of pharmaceuticals. This is
particularly important in the context of localproduction and use of generics in accordance with
WHO approved standards. Developing countries will be supported in their efforts to identify
actions and promote informed dialogue onpharmaceuticalpolicies.
(2) The Commission will enhance partnerships with regional technical resource networks,
notably with WHO as the lead technical agency in the pharmaceutical policy area.
Collaboration will be extended with UNICEF, UNAIDS, the pharmaceutical industry and other
partners.
(3) The European Community will work with WHO, to further refine essential drug policies in
favour of developing countries. Actions include the progressive inclusion of (non-generic)
key pharmaceuticals in the essential drug list and the implementation of appropriate, cost-
effective regulatory schemes at the regional and country levels. The aim will be to accelerate
registration and marketing approvals of key pharmaceuticals in developing countries based on
existing registration in developed countries. Moreover, the European Community will liase
with WHO for specific rules and regulatoryschemes, and the provision of key pharmaceuticals
in emergencysituations.
(4) The European Community will work with countries and regions to develop systems to protect
against diversion oftiered priced products (see 3.2.).
3.1.3.Developing local production capacity11
(1) The European Community will assist developing countries, at a regional or national level, to
develop high-quality, local production of key pharmaceuticals, many of which are off-patent
and could be produced immediately. Candidate-countries will be identified through sectoral
and market analyses, in conjunction with feasibility studies to identify and assess existing
business opportunities . In addition, dialogue between the private and state-owned
pharmaceutical sectors in both developing and developed countries will be encouraged, and
business links between them facilitated. Support for local production will go to countries
10For example theEC programmes ARIVA (Appui Régional a l’Indépendance Vaccinale en Afrique) and APPA (Appui a
laPolitiquePharmaceutiqueen Afrique).
11See Annex 3: Clarification of Terminology.
10that have pre-existing capacity and necessary infrastructure. Other countries may be considered
at alater stage.
(2)Viable projects will be supported by promoting business opportunities on the basis of sound
business plans andstudiesfocusing on public health benefits as well as profitability.
Financing may be through PROINVEST, the investment promotion programme for ACP
countries, the EC-ACP Business Assistance Scheme (EBAS)12, the private sector Investment
Facility of the Cotonou Agreement through the EIB, and other EC technical and financial co-
operation mechanisms (for ALA-MEDA- see section4 onInstruments).
(3) EU and non-EU generic and research-based industries will be encouraged to enter into
licensing agreements andjoint ventures with suitable developing country partners. This will
require adequate incentives , such as securing a high standard of protection for intellectual
property rights, obtaining access to developing country markets by mutual recognition of
marketing approvals, and ensuring that products destined for developing country markets are
not exported to the Communityor other developed country markets.
3.2. AFFORDABILITY
3.2.1. Tiered pricing13
(1) The EuropeanCommunity is at the forefront of internationalefforts to establish a global tiered
pricing system for key pharmaceuticals for the poorest developing countries. It remains
convinced that a firm, long-term commitment from manufacturers to supply these products at
the lowest possible prices would be a major contribution to the problem ofaccess to affordable
medicines. Further discussions will therefore be pursued with the pharmaceutical industry, and
with the public authorities in the poorest developing countries, with a view to setting up such a
system at the earliest opportunity. In future, tiered pricing for the poorest developing countries
should no longer betheexception, buttherule.
(2) A successful tiered pricing system targeted at the poorest developing countries must also be
able toprevent product diversion to other markets, thus undermining prices. It is essential, in
order to preserve confidence in such a system, that effective safeguards are in place to ensure
that all low-priced pharmaceuticals destined for specific markets are delivered to, and remain
in, those markets. Such safeguards include technical measures, such as differential labelling,
packaging and trademarks to identify preferentially priced products, special enforcement
procedures to be applied in the importing and/or exporting country, and contractual
arrangementsbetweentheexporter,importeranddistributorofthe medicines14.
(3)International concertation (e.g. under the auspices of the UN or the WTO) will be needed to
contain the risk of product diversion, but it will also require the full participation and co-
operation of governments in developed and developing countries, the public and private
12An ongoing programmefor ACP businesses, which provides support to individual companies or producer associations in
this sector.
13Tiered pricing describes a system whereby different prices are charged in different markets. In the context of this
Programme for Action, it refers to a pricing system by which producers of key pharmaceuticals, including bothpatented and non-patented medicines, make those products available to the poorest countries at significantly
discounted prices.
14Measuresforeseen inthisregardshouldnotaffectthefreemovementofgoodswithintheCommunity.
11sectors, and of NGOs. The European Community will continue discussions with its main
trading partners inorder to advance this debate.
3.2.2. Tariffs andtaxes
The European Community will continue to analyse the effects of other factors , besides the net import
price, on consumer prices in developing countries. Such factors, which include tariffs,taxes,and
importation, distribution and local registration fees , can significantly increase prices. Where
appropriate, importing countries shall be encouragedto reduceor abolishthese factors.
3.2.3. Intellectual property legislation
(1) The European Community is committed to supporting WTO developing country members
in implementing the TRIPs Agreement . The support available includes training, assistance
with legislative drafting, and setting up the appropriate institutional and administrative
structures.
(2) The EC recognises that, within the TRIPs Agreement, there exists a flexibility allowing
countries to issue, in certain circumstances, compulsory licenses15in order to address urgent
public healthconcerns.
For its part, the EC will promote discussions, within the WTO, WIPO or WHO, to address the link
between the TRIPs Agreement and public health protection issues, in order to an achieve international
consensus onthis issue.
3.3. RESEARCH AND DEVELOPMENT
3.3.1. Strengthening and increasing support for Research and DevelopmentUnder the current 5
thFramework Programme, the Commission is expected to commit Euro 130 million
for the research on HIV/AIDS, malaria and tuberculosis. More than Euro 80 million have been
committed under the 4thFramework Programme (1994-1998). Recent initiatives have increasingly
focused support on confronting communicable diseases in developing countries. The European
Research Area16provides a framework for Europeto develop co-operative Research and Development
strategies. Building on current investments in health research for the three major communicable
diseases, a new major initiative is envisaged to support and accelerate the clinical development of new
interventions. In this context, the Commission is elaborating in the first half of 2001, in consultation
with all relevant stakeholders, a European research strategy for global goods to confront HIV/AIDS,
malaria and tuberculosis. Guided by specific action plans for the three diseases, two directions for
Communitysupport areenvisaged:
(1) continued and increased support for basic and strategic research with greater co-
ordination at European andinternationallevel .
(2) the creation of a European Clinical Trials Platform to increase number, efficiency and
coherence of clinical trials carried out by the public and private sectors, and involving the
15The granting of a licence without the consent of the patent holder, but against adequate remuneration, on various
grounds ofgeneralinterest. SeealsoCOM (2000)585, 20 September 2000, paragraph 4.2.
16COM(2000) 6, 18 January2000 and COM(2000)612, 4 October 2000.
12developing countries. This platform will also function as an interface for research and
development with other global initiatives including those ofthe G8 partners.
3.3.2. Capacity building in developingcountries
Developing countries will be involved at all stages of the research and development process for new
public goods. Lasting impact is expected both from basic professional as well as advanced research
training onscience and technologycapacityand healthservices performance.
(1) Increased support to research activities will include support for collaborative molecular and
clinical, epidemiological, operational and social studies, strengthening the base for health-
related research. Emphasis will also be put on gender balance and poverty focus. Moreover,
support will be givento ensure appropriate ethicalstandards and review systems.
(2) Support will be provided for capacity building in developing countries to enable them to host
and conduct large-scale population trials. Three major activities are envisaged to be co-
ordinated through the clinical trials platform: a) human resources development, b) social
mobilisation and community empowerment as a support measure for population trials and c)
upgrading of facilities and services at research institutions and clinical institutions in
developing countries.
3.3.3. Incentives for the development of specificglobalpublic goods
(1) The EU will study and develop an incentive package to encourage more private investment
by the Research and Development based (R&D) industries in new products to confront the
major communicable diseases in developing countries. Following the adoption of the new
European Community’s policy framework, the UK Prime Minister’s office has established a
working groupto assess such potential incentives. The workofthe UK group will take place in
close consultation with the Commission and EU Member States. This will provide valuable
input to the EU’s examination of incentives such as the extension of marketing rights, venture
capital, low-cost loans, taxcredits, guaranteed markets, and so on.
(2) The Commission will encourage and support initiatives for an early dialogue on regulatory
aspectsin relation to new products for the three major communicable diseases. This will be
essential in avoiding delays in the approval of new products. The Commission will ensure
that regulatory bodies in developing countries where clinical trials are taking place or
envisaged are part ofsuch early dialogue inrespect ofthese new products.
(3) The Commission will increase its support for economic research into the demand for specific
global public goods for developing countries. The Commission is already involved with the
World Bank in research on public demand and willingness to pay for an AIDS vaccine. This
includes support for studies to improve market understanding and to assess the potential health
impact and affordability of an HIV vaccine. The results ofthis research will yield much-needed
information for policy makers indeveloping countries as wellas for donors.
(4) The Commission will participate in the development of financing mechanisms to address the
need for specific global public goods and to ensure that these become available to people in
developing countries as quickly as possible, particularly for AIDS and malaria vaccines,
tuberculosis diagnostics and vector controlproducts.
13(5) The work of the Commission AIDS Vaccine Task Team and co-operation with Member
States and other partners such as UNAIDS, IAVI, GAVI will be continued and
strengthened. The AIDS Vaccine Task Team is working on the various actions listed above
with the aim of accelerating the development and availability of an AIDS vaccine for
developing countries as soonas possible.17
(6) The European Clinical Trials Platform will act as an incentive by removing important
scientific, technological and operational hurdles to product development. It is intended to
extend the platformto developing countries.
3.4. PARTICIPATION IN GLOBAL PARTNERSHIPS: POLICY AND POLITICAL
DIALOGUE
The European Community will continue to participate in global initiatives targeting action against
the major communicable diseases in the context of poverty reduction. To this end, the European
Communitywill:
(1)promote the reform of the international financial architecture to foster increased
availability and development of specific global public goods (see Annex 3) and to support
greater co-ordination and efficiency of international funding. The European Community will
pay particular attention to ensuring that global support unites around comprehensive
approaches to health at country level and is based on the full participation and ownership of
developing countries. To this end, the Commission will continue to actively participates in
the working group of G8 members which will examine how best to organise increased
spending and targeting of global resources towards the three communicable diseases. In the
lead up to the Genoa G8 meeting (July 2001) the group evaluate the lessons learnt from
existing international mechanisms. These will provide important input to the Commission’s
ownexaminationoftheopportunitiesto fundglobalmechanisms;
(2)strengthen partnerships with the UN organisations, in particular with the WHO18and
UNAIDS. Particular aims will be to co-ordinate global efforts more efficiently and to monitor
the accelerated response throughresource flows and healthoutcomes;
(3)continue close co-operation with the US and Japan in order to garner support for adequate
global burden sharing, financing mechanisms and the development of a global tiered pricing
system for key pharmaceuticals for the poorest developing countries (see Section 3.2.1.). With
the US this should be part of the co-operation which has been set up by the EU-US Summit
Leaders on the three communicable diseases and will take place in the framework of the New
TransatlanticAgenda19and inthe context ofthe G8 discussions.
(4)this approach will benefit the European Community ,the international community and
recipient countries . It will facilitate more streamlined technicalsupport fromthe UN and other
important donors, establish a more effective financial mechanism to speed up delivery, and
17The EIB and EMEA are already part of the team and there is substantial interest from EU Member States and IAVI
participants.
18Over the past year the EC and WHO have intensified their co-operation. Letters have been exchanged covering a
memorandum with a framework for co-operation, signed in December 2000. The memorandum defines principles
and objectives, outlines areas of co-operation, establishes procedures and defines priority areas for action,
including those related to the threemajor communicable diseases.
19EU-US Summits Conclusions, Queluz May2000 and Washington D ecember 2000.
14reduce transaction costs for donor and recipient. At the same time, it will ensure a stronger
voice fortheEuropeanCommunityinglobalpolicysetting.
4. INSTRUMENTS
4.1. Identifying the instruments foraction
TheEuropeanCommissionhasa large arrayofpolicy, legislative, regulatoryand financialinstruments
which it willactivate insupport ofthe Programme for Action20.Whichofthese instruments come into
play for each action will depend on the various entry levels (national, regional, and global) and will
need to be defined further, following the procedures contained in the respective instruments. The
following development assistance instrumentswillbe used:
a) Unspent reserves fromthe 8thEDF, and resources fromgeographic budget lines (ALA-MEDA).
i) Specific actions in support of initiatives with existing or new partners. Specific Health,
AIDS and Populationprogramming guidelines are being developed to this end.
ii) Within this context the following interventions will be envisaged for financial support as
well:
– where countries agree to remove tariffs for pharmaceutical imports, technical support
for fiscalreformsandadditionalfinancialincentives for countries committedtothis will
beexamined;
– technicalsupport forthe implementationofthe TRIPs Agreement.
b) Resources fromthe 9thEDF21, ALA-MEDAand thematic budget lines.
i) It is proposed that a substantial amount would be allocated for partnerships with non-
traditional partners, such as the local private sector in developing countries, to use innovative
approaches inthe area ofsocialmarketing at countrylevel(see 3.1.1).
ii) It is further proposed that a substantial amount be allocated to form a partnership with
WHO for actions envisaged for the strengthening of pharmaceutical policies at regional and
countrylevel(see 3.1.2).
iii) While advocating adequate international burden-sharing and a consensus consistent with
the EuropeanCommunitypolicy spelt out in this Programme for Action, the Commission will
consider a contribution to a global mechanism providing technical know-how and
commodities inco-operationwithother partners (see 3.4).
20See footnote 9. Development assistance instruments which are proposed to be used in support of the Programme for
Action include:NIPs –RIPs and other EDF instruments, such as the Regional Economic Partnership Agreements(REPAs) and the new Investment Facility under the Cotonou agreement. Technical and financial co-operationprotocols for Asia, Latin-America and the Mediterranean, thematic budget lines, and Humanitarian Aid managedby ECHO should also be used. Commitments are subject the eligibility conditions specified in the applicableinstruments. In addition to the development assistance instruments, the European Research Area and research
framework Programmes willbeused for supportingthemeasures envisaged.
21From 2004 onwardsandas set out in the financial protocol tothe Cotonou Agreement.
15c) Severalsupport actions, such as feasibility studies, can be undertaken in support ofthe development
of production capacity in developing countries22. Business linkages may follow from the activities of
the ESIP programme that willstart in2001, inco-operationwiththe EuropeanInvestment Bank.
d) In relation to the current debate on untying aid, and with a view to enhancing local capacity and
affordability, the Commission proposes to replicate the ACP regime for non-ACP regional areas,
allowingpartner countries’ firms, aswellasEUfirms, tobid for tenders. Beyond that, the Commission
seeks to explore the opening of calls for tender for procurement of certain services or products, like
key pharmaceuticals for HIV/AIDS, malaria and tuberculosis, to all developing countries. The aim is
to encourage the production and access of such goods and services within developing countries or
regions, as appropriate, and to make available, with or without financial support from external
partners, suchgoods and services at anaffordable price to alldeveloping countries.
In addition to the development assistance instruments, Research Framework Programmes will be
used for supporting the measures envisaged under Section 3.3. in line with the objectives of the
EuropeanResearch Area.
The European Clinical Trials Platform (see Section 3.3.1) will seek to use, in addition to research
funds and where eligible, financial resources from Community development funds, public-private
partnerships and others, necessaryto carryout large-scale populationtrials.
4.2. Partnership, ownership and monitoring ofan effective European Community response
It must be noted that most of these development instruments and resources only become ‘activated’
following the request of developing country partners or international development partners. Many
internationaland developing countrypartners have expressed an interest inthe actions envisaged under
this Programme for Action. This interest in collaborating with the European Community is
accompanied by a clear call for ‘user-friendly’, ‘action-oriented’ instruments and partnership
arrangements . In order to ensure full ownership at country level it is crucial that developing country
partners continue to be involved inthe further identificationofspecific actions.
To date the Commission has not been successful in developing efficient financial instruments for
investing in global initiatives . The use ofsmall-scale thematic budget lines has onlypartiallyallowed
this gap to be addressed. Global mechanisms might well allow the Commission to increase
development spending and lower transactioncosts inco-operationwithMember States’ activities.
In addition to ‘responsive’ financing instruments a substantial amount of work needs to be done in
terms of ‘policy dialogue ’ and the use of instruments for policy development and dialogue.
Appropriate institutional arrangements and resources will be at the core of the implementation and
monitoringofthisProgramme forAction.
5. CONCLUSION
Successful implementation of this Programme of Action over the next five years (2002-2006) will
make a major contributionto globaleffortsto address the development crisis presented byHIV/AIDS,
malaria and tuberculosis. The Commission proposes a coherent policy framework to guide accelerated
Communityactionand has takena lead in efforts to co-ordinate a more effective response bycountries
and the international community. Developing countries and the poorest populations bearing the
22E.g. through theEBAS programme.
16greatest burden require co-ordinated support on an unprecedented scale. This will require a strong
commitment fromcountries, Member States, multilateraland bilateraldonors.
17Annex1:ProgrammeforAction–Matrix
IMPACT (1 of2)
ACTIVITIES GEOGRAPHICAL
FOCUSTIMELINE PARTNERSHIPS MONITORING/OUTCOMES
III1.1–Optimisingimpact ofHAPinterventions
targetedatmajorcommunicablediseasesand
povertyreduction .
Rapiddisbursement. Commissiontoidentify
opportunitiestodirectunspentresourcestoaddress
thethreecommunicablediseases.
1. Commission services will provide specific
guidance to EC Delegations. Partner countrieswill be encouraged to address thecommunicable diseases within the frameworkfor gender sensitive and pro-poor CountryStrategy Papers.
2. The Commission will establish co-operative
arrangementsfor programming.
3. The Commission will facilitate resources for
innovative partnerships.
4. The Commission will prioritise HAP
interventions within overall development aid.
5. The European Community will pursue greater
articulation between existing global
mechanisms and partner countries efforts.1) All developing
countries.
2) All developing
countries.
3) All developing
countries.
4) Mainly in Sub-
Saharan Africa andSouth Asia
5) All developing
countries
See3.4.1) March 2001-
December2001.
2)March 2001.
3) February 2001 –
July2001.
4) Continuous from
March 2001.
5) March 2001-
2006.
See3.4.1) All developing
countries.
2) All developing
countries, otherdonors.
3) WHO-UNAIDS -
MemberStates.
4) Civil society, private
sector, UN agencies.
5) All developing
countries, otherdonors.
See3.4.1.1HAP disbursementportfolioincreasedby50% by
end2001.
1.2 Dormant programmes (20) closed or re-oriented
byend 2001.
2.1 Programming guidelines established and used.
2.2. Number of gender sensitive and pro-poor CSPs
includingHAPinterventionsincreased.
2.3. Delegations staff reinforced andtrained.
3) Partnership and/or Financing Agreements
established.
4) Resourcesprogrammed,partnersidentified.
5) Increased HAP allocation from current 8% in
accordance withimproved deliverycapacity.
See3.4.
18Programme forAction – IMPACT (2 of2)
ACTIVITIES GEOGRAPHICAL
FOCUSTIMELINE PARTNERSHIPS
EC, developing
countriesMONITORING/OUTCOMES
III.1.2 Strengthening of pharmaceutical policies.
1. Regional co-operation, capacity building,
financial and technical assistance.
2. Enhanced and improved essential drug policy
andregulatoryschemes.
3. Refine global essential drug policy in favour
of the poorest developing countries.
4. Developing systems to prevent diversion of
tieredpriced products.Actions will primarily
take place at regionallevel and, due to thedevastating effect of thethree diseases and thepovertyfactors in the tworegions, be targeted atAfrica and South Asia.
See 3.2.3.June 2001-June
2002.
See 3.2.3.For all actions:
WHO
UNICEF, UNAIDS,Industry.
See 3.2.3.1. Partnershipsestablished.
2.1. Agreement with WHO established.2.2. Revision of EDL by WHO by end of
2002.
3. Partnership with UNICEF, UNAIDS,
Industryidentified.
4.See3.2.3.
III.1.3 Developing local production capacity
1. Support to sector and market analyses;
dialogue, identification of existing businessopportunities.
2. Support to the development of sound business
plans.
3. Promote licensing agreements and business
joint ventures through appropriate incentives.Actions will take place at
regional level with aspecific geographicalfocus on countries withpre-existing localproduction capacity (ineither private or public
sector).For all actions:
M a r c h2 0 0 2t o
January2006.Partnership will
simultaneouslyinvolve EU and non-EU generic andresearch-basedindustries andrelevant regional
bodies, the
Commission, the EUMember States, theEuropean InvestmentBank (EIB) and otherfinancinginstitutions.Industrialpartners.1. Pre-feasibilitystudies completed.
2.1Countriesidentifiedfor businessplans.
2.2 Business plans agreed.3. Licensing agreements and joint ventures
promoted.
19Programme forAction – AFFORDABILITY (1 of1)
ACTIVITIES GEOGRAPHICAL
FOCUSTIMELINE PARTNERSHIPS MONITORING/
OUTCOMES
III.2.1Tieredpricing
1. Lead international efforts to establish a global
tiered pricing system.
2. Set up effective safeguards against product
diversion.
III.2.2Tariffsandtaxes
Impact analysis.
III.2.3Intellectualpropertylegislation
1. Supportfor TRIPs implementation.
2. Discussion of links between TRIPs agreement
&publichealthprotection.Actions at global level for
thedevelopingcountries
1. EU, OECD and G8
countries.
2. Importing and
exportingcountries.
Developingcountries.1. Initiated in September 2000,
ongoing.2. FromMarch2001.
FromMarch 2001.
FromMarch 2001.
From November 2001.1. EU, generic and
research-based industry,G8, OECD anddevelopingcountries
2. EU, industry, OECD,
G8 anddeveloping
countries
EU, International
organisations, developingcountries
WTO, WIPO and
developingcountries.
FourthWTO
ministerial, WHO, WIPO,Civil Society, Industryplayers,EU.1. Commitments from the industry
players and developing countriesauthorities.
Lower consumer prices.
Provision of technical assistance where
required.
20Programme forAction – RESEARCH andDEVELOPMENT (1 of2)
ACTIVITIES GEOGRAPHICAL
FOCUSTIMELINE PARTNERSHIPS MONITORING/
OUTCOMES
III.3.1–Strengtheningsupportfor Research and
Development
1. Increasedsupport for basicandstrategic
research.
2. Creationofa EuropeanClinicalTrialsPlatform.
III.3.2–CapacitybuildinginDeveloping
Countries
1. Supporttogendersensitiveandpro-poor
research activities.
2. Capacitybuilding(equalopportunitiesfor
women and men).
III.3.3 – Incentives for the development of specific
global public goods
1. ECwillexamineand develop anincentive
package.
2. Earlydialogue on regulatoryaspects.
3. Economicresearchintodemand.
4. Development of joint financing mechanisms.
5. The AIDS Vaccine TaskTeamstrengthened.All actions will benefit all
populationsandinparticularthoseinthepoorestdevelopingcountries.Ongoing and to be continued
up to March 2001 – March2003.
1) Preparation as of 2001,
incentivesinplaceasof2002.
2)StartingJanuary2001 - and
taking account of February
WHO meeting.
3) 1-6 months from February
2001.
4) Starting January 2001-and
taking account of February
WHOmeeting.
5)FromJanuary2001.EU Member States, European
Community , G8, developingcountries, WHO, UNAIDS, in linewith the objectives of the EuropeanResearch Area..
1) Partnership with Member States,
developing countries, WHO andothers
2) Various financialpartnerships.
3) The UK Prime Minister's office
w o r k i n gg r o u pa n di nc l o s econsultation with other EU MemberStates.
4) Idem.
5) New operational partnership in
support of an AIDS vaccine (withUNAIDS and IAVI).All R& D activities will be
externally reviewedaccording to pre-determinedcriteria.
21Programme ForAction – GLOBALMECHANISMS(1 of1)
ACTIVITIES GEOGRAPHICAL
FOCUSTIMELINE PARTNERSHIPS MONITORING/
OUTCOMES
III.4. Participation in global partnerships
1. The EC will promote the reform of the
international financialarchitecture to fosterincreasedavailability and development of global public goods.
2. The EC will strengthen its partnership with the UN
organisations.
3. The EC will continue its co-operation with the US
&Japan,inparticularontiered pricing.For all actions. Global
actions in favour of thepoorest populations most
affected by the three major
communicablediseases.1. January 2001 and
continued.
2. ByJuly2001.
3. November 2000 and
continued.1.G8andEuropeanStates
2. UN organisations, and in particular
with the WHO and UNAIDS.
3. EU/US and Japan.1.1 Adequate burden-
sharinginplace.1.2 Coherent policy
between global partners.
2. Partnerships with UN
established.
3. Joint EU/US/Japan
position on tiered pricing inplace.
22Annex2: Basic PrinciplesforHealth, AIDS and Population support
(1) Build on the development agenda of each country, targeting poverty reduction and
equality between men and women, however it is expressed and whether within a
Comprehensive Development Framework, a Poverty Reduction Strategy or as a
nationaldevelopment plan. Thecountry’sstakeholders’ownership isvital.
(2) The approach to effectively address the burden of communicable diseases at country
level will be context specific. The ‘best fit’ for accelerated action will build on what is
inplace and willemploya range ofinterventions, funding mechanisms and partners.
(3) Countries where effective policies, institutions and on-or-off budget co-ordination are
in place will be supported through the mechanism of choice of the country. In
countries without coherent policies and mechanisms and/or where institutions are
weak, or in countries in crisis, support will be facilitated through partnerships with
NGOs and/or UN agencies.
(4) The health, AIDS and populationpolicyenvironment and practice will define potential
instruments and channels ofsupport.
(5) Efforts should support actions that strengthen health systems and further build national
capacity. Effective support willdeliver healthoutcomes whichwill be monitored.
(6) Coherent action will support a common framework, in partnership with all
stakeholders - governments and non-government actors, the public and private sector,
donorsandinternationalagencies.
(7) Effective pro-poor support will contribute to other important development outcomes
relating to crosscutting concerns such as the promotion of human rights, equality
betweenmenandwomen, children'srightsandtheenvironmentaldimension.
(8) Partners will need to employ imaginative approaches which can deliver equitable
health outcomes, are financially fair and responsive to people's demands and which
harness the resourcesofallpotentialcontributors.
(9) The Commission will invite Member States that are interested in working jointly on
short-term deliverables to develop flexible mechanisms to support interested partner
countries (co-financing, silent partners, technicalassistance, etc.).
23Annex3: Clarification ofterminology
a) Globalpublic goods
‘Public Goods’ are goods which benefit society as a whole. The concept of ‘national public
goods’ such as the maintenance of law and order is not new. But in an increasingly
interconnected and interdependent world much more attention is now being paid to ‘global
public goods’. Examples range fromthe controlofcommunicable diseases, to the provision of
globalfinancialstability, the protectionofthe environment and the preventionofconflict.1
The technical know-how necessary to support ‘global public goods’ will benefit allpopulations irrespective of who pays for their development. This creates a ‘free-rider’
problem, in that individuals and governments will be willing to pay less than the value of the
benefits they receive. Specifically with regard to for example HIV/AIDS and malaria
vaccines, the private sector is unlikely to recoup research and development costs for health
technologies that primarily benefit countries and populations with low ability to pay.
The solutionultimatelylies at global level with countries, donors and the private sectortaking
joint responsibility and sharing the cost related to the development and availability of ‘global
public goods’. A co-ordinated approach through a shared public facility may therefore be the
best answer.
b) LocalProduction
Local production refers to the manufacture of key pharmaceuticals (including global goods
such as new vaccines) in accordance with national legislation and with related international
obligations where applicable. It includes localproductionofpatented products under licensing
arrangements and joint venture agreements, as well as other activities such as re-labelling and
re-packaging.
In the context of this Programme for Action, supporting local production of low-cost key
pharmaceuticals means more thansimply boosting local manufacturing capacity. It is first and
foremost an industrial development issue involving a technology transfer between European
and developing country industries, as well as promoting South-South co-operation and
helping to integrate developing countries into the world economy. Indeed, those countries,
which are relatively advanced in terms of local production capacity and whose companies
receive support under this Programme for Action, should be prepared to provide technical
assistance and participate intechnologytransfer ventures for the benefit ofpoorer countries.
1Eliminating World Poverty: Making Globalisation Work for the Poor, White Paper on International
Development, UK Government; December 2000.
24Annex4: Acronyms
ACP Africa, CaribbeanandPacific
AIDS Acquired Immune DeficiencySyndrome
ALA Asia and Latin America development co-
operationprogramme
CBO CommunityBased Organisation
CSP CountryStrategyPaper
DAC Development AssistanceCommittee
DG DirectorateGeneral
EBAS EU-ACP BusinessAssistanceScheme
EC EuropeanCommunity
ECHO European Community Humanitarian Aid
Office
EDF EuropeanDevelopment Fund
EDL EssentialDrugs List
EIB European Investment Bank
EMEA EuropeanMedicines Evaluation Agency
ESIP EU SADC Investment Promotion Programme
EU EuropeanUnion
FP Framework Programme
G8 GroupofG7 most industrialised countries
and Russia
GAVI Global Alliance for Vaccines and
Immunization
HAP Health, AIDS and Population
HIV HumanImmuneDeficiencyVirus
IAVI InternationalAIDS Vaccine Initiative
LDC Least Developed Countries
MEDA Mediterraneancountriesdevelopment co-
operationprogramme
NGO Non-government Organisation
NIP NationalIndicativeProgramme
OECD OrganisationforEconomicCooperationand
Development
PRSP PovertyReductionStrategyPaper
R&D ResearchandDevelopment
REPA RegionalEconomicPartnershipAgreement
RIP RegionalIndicativeProgramme
SADC Southern Africa Development Community
TRIPs Agreement onTradeRelatedAspectsof
IntellectualPropertyRights
UN United Nations
UNAIDS UnitedNationsJoint Programmeon
HIV/AIDS
UNCTAD United Nations Conference onTrade and
Development
UNICEF United Nations Children's Fund
WHO World HealthOrganisation
WIPO World IntellectualPropertyOrganisation
25WTO World Trade Organisation