Immunisation for All?
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A critical look at the first GAVI partners meeting
By Anita Hardon [1]
http://www.haiweb.org/pubs/hailights/mar2001/
Concerns about rational drug use, accountability and sustainability
have led HAI Europe members to scrutinise the growing number of pub-
lic/private interactions involving pharmaceuticals and health care
services. One of the largest and most publicised of these is the
Global Alliance for Vaccines and Immunization, better known as GAVI.
This new alliance was launched in early 2000. It was initially backed
by a US$750 million donation from computer magnate, Bill Gates. Since
then, it has received significantly smaller grants from a number of
governments. In its short history, the Alliance's structure and fund-
ing base have already altered the way in which vaccination policy is
developed and implemented. The financial resources at its disposal
have made it perhaps the most important actor in the vaccination
field today.
In this lead story, HAI member Anita Hardon analyses the impact that
GAVI has already had on vaccine policy and reports on the first GAVI
partners meeting held in The Netherlands late last year.
The road to GAVI
The global effort to immunise the world's children is a remarkable
success story. Building on the gains of the global smallpox eradica-
tion programme, the World Health Organization (WHO) launched the Ex-
panded Programme on Immunisation (EPI) in 1974. At the time less than
5% of the world's children were immunised against the six main target
diseases, diphtheria, tetanus, whooping cough, polio, measles and tu-
berculosis, though vaccines for them were inexpensive. The EPI effort
was accelerated when the Universal Childhood Immunisation (UCI) cam-
paign was adopted. At the 1990 World Summit for Children, the United
Nations Childrens Fund (UNICEF) declared that the UCI target of 80%
had been achieved.[2] When this success was announced in 1990, the
main actors initially planned to continue the effort to reach the
10%-20% of the population still lacking vaccine coverage. As the then
assistant Director-General of WHO stated:
"Vaccination coverage does not only need to be sustained, ... it
needs to be increased. The reason for setting a goal of 90% coverage
by the year 2000 is that this requires extending vaccination to the
currently unreached. These are the poorest of the poor, and those to
whom vaccination especially benefits, as they are at special risk
from disability and death from vaccine preventable diseases."[3]
Instead, the thirty year effort to immunise children and adults began
to break apart in the 1990s. The change happened for a number of rea-
sons including war, new diseases (such as HIV/AIDS), donor fatigue
and a change of leadership at WHO. (Dr Hiroshi Nakajima of Japan be-
came the organisation's new Director General, replacing Dr. Halfdan
Mahler, a staunch advocate of "Health for All" [4]) These changes in-
fluenced international agencies involved in immunisation programmes
and caused them to decrease their emphasis on reaching out to under-
served populations. In the 1990s, agencies followed more selective
approaches, including the eradication of polio and the development
and introduction of new and improved vaccines.
The results of immunisation efforts in the 1990s were dismal. Immuni-
sation coverage deteriorated in most of the world's poorest coun-
tries. By 2000, global coverage for the six traditional vaccines had
dropped to 75%[5]. More disturbing still, UNICEF identified 19 coun-
tries, mainly in Africa, where diphtheria, tetanus and polio (DTP3)
coverage dropped below 50%. In another 22 countries, fewer than 75%
of children receive DTP3 immunisation. Some countries were hit even
more severely: Nigeria's overall coverage went from 80% in 1990 to
27% in 1998; the Democratic Republic of Congo's immunisation rate
dropped from 46% to 25% for the same period, while Togo went from
100% coverage to little more than half of that (54%)[6]. The result
is an estimated 3 million unnecessary vaccine preventable deaths per
year[7].
How GAVI works
This deterioration of immunisation services is now being addressed by
a multi-million dollar Global Fund for Children's Vaccines launched
by the Global Alliance for Vaccines and Immunization (GAVI), a pub-
lic-private venture formally launched at the World Economic Forum in
Davos in January 2000. GAVI's strategy involves improving access to
sustainable immunisation services, expanding the use of all cost-
effective vaccines, accelerating the introduction of new vaccines,
speeding up efforts to create new vaccines and making immunisation a
central part of assessing international development efforts[8]. Its
founding partners include the WHO, UNICEF, the World Bank, The Bill
and Melinda Gates Children's Vaccine Program, the Rockefeller Founda-
tion, the International Federation of Pharmaceutical Manufacturers'
Associations (IFPMA) and some national governments.
The Global Fund and GAVI were created when the Bill and Melinda Gates
Foundation made a US$ 750 million donation to reach a "simple" goal:
"to fulfill the right of every child to be protected against vaccine-
preventable diseases of public health concern"[9]. Since this initial
donation, the Fund has received commitments from the governments of
the US (US$ 50 million), Norway (US$ 125 million), the United Kingdom
(US$ 5 million) and The Netherlands (US$ 100 million). This massive
monetary support to the Fund has revitalised global immunisation ef-
forts.
GAVI documents state that the Global Fund's Board decides on the al-
location of resources to projects and programmes that GAVI has recom-
mended. The Fund is not obliged to follow GAVI's recommendations. Re-
sponding to queries on the composition of the Global Fund's Board, a
communication officer for the Bill and Melinda Gates Vaccines Pro-
gramme explained that, at present, it had renewable and rotating mem-
bers.
A first assessment of GAVI
The Global Fund's operations and the GAVI were discussed at the first
biannual meeting of GAVI partners held in Noordwijk, The Netherlands
from 20-21st November 2000. At the meeting, members of GAVI's Board
and its task forces presented summaries of the progress made during
the past year. Through an independent review process, GAVI's Board
has recommended to the Global Fund that 23 countries receive support
to strengthen their national immunisation plans. Thirteen countries
were selected in September. An additional ten were chosen during the
Board meeting preceding the GAVI partners meeting.
Details of the first round of approvals reveal that a total of US$150
million in vaccines and funding[10] is to be given to the 13 coun-
tries already involved over a period of five years[11]. Details on
the first disbursements (2000/2001) reveal that approximately 10% of
these funds are earmarked to strengthen immunisation services, while
90% will go towards introducing new vaccines, mainly hepatitis B[12].
GAVI policy encourages the use of the newly developed DTP-hepatitis B
vaccine, especially in countries with a weak immunisation programme.
The emphasis on the introduction of new and under-used vaccines in
GAVI reflects a more general shift away from equity towards techno-
logical innovation and disease eradication in global health pro-
grammes. This appears to indicate a fundamental move in vaccine pol-
icy from the values of the Post Alma-Ata (Primary Health Care era).
The dominant themes in international health at that time included
community participation, the right to health, and equitable distribu-
tion of health resources. Now in the opening days of the new millen-
nium, international health policy makers involved in immunisation
programmes seem to view developing countries no longer primarily as
recipients of internationally procured essential vaccines, but
rather, as markets for new ones.
By spending such a large amount of its resources on new vaccines,
GAVI and the Global Fund run the risk of compounding health inequi-
ties in the poorest countries which they have prioritised for sup-
port. In nine of the countries selected for support in the first
round, immunisation coverage remains below 75%. However, under new
arrangements, the remaining 25% or more are likely to remain "un-
served". By introducing a hepatitis B vaccination in these countries,
children who are already being immunised with the traditional EPI
vaccines will be protected against yet another disease. The under-
reached children are most likely to be those living in the worst pov-
erty. Another concern, acknowledged at the Noordwijk meeting by a
spokesperson from the Vaccines Supply Division of UNICEF, is that the
rapid increase in demand for the hepatitis B-DTP combination vaccine
cannot be met.
GAVI's appeal for industry
The emphasis on the introduction of new vaccines makes GAVI an alli-
ance in which industry is willing to participate. The GAVI Board's
seats includes two for industry - one for an Organization of Economic
Cooperation and Development (OECD) industry representative and one
for an industry representative from a developing country. Jean Ste-
phenne, president of SmithKline Biologicals (a company producing the
combination DTP-hepatitis B combination which is now in great demand)
outlined in one of the meeting's keynote speeches the conditions for
industry participation in the Alliance. This included a guarantee for
"reasonable prices", support for a credible and sustainable market,
respect for international property rights, a tiered pricing system
including safeguards against re-export of products back from develop-
ing countries to high-priced markets, and a prohibition on compulsory
licensing[13]. In plenary discussions and breakout sessions in Noord-
wijk, industry representatives involved in vaccine development
stressed the need to rely on research-based companies to develop the
needed new vaccines, and said that they opposed technology transfer
proposals. They stressed that vaccine development is too complex for
public research institutes and local producers in developing coun-
tries. "Push and pull" mechanisms to accelerate vaccine development
were proposed, involving public sector subsidies to companies to con-
duct clinical trials and set up manufacturing plants.
The GAVI partners appeared unconcerned about some possible conflict
of interest between the large research-based companies' interest in
markets for new products and the public health objective of prevent-
ing childhood mortality in developing countries. In what is proposed
as the "win-win-win" paradigm, there is little room for critical
questions.
Asking critical questions
The problem with the new ideology governing public/private interac-
tions is the firm conviction that everyone benefits and no one loses.
In the programmes approved by GAVI, developing country governments
will join hands with multilateral and bilateral agencies to increase
the number of children reached by the services who receive new, ex-
pensive and under-used vaccines. Those children not reached by cur-
rent immunisation programmes will probably lose out again. As ineq-
uity in access to vaccines increases, they remain the losers.
While many developing countries have seemed eager to benefit from the
Alliance's support, some lone voices of dissent could be found in
Noordwijk. "We know what needs to be done," said Dr. Muga, a repre-
sentative of the Kenyan Ministry of Health, during the meeting's open
forum. "GAVI partners don't take the time to find out why we don't do
what we should be doing." He stressed the need to support local sys-
tems and enable people at country level to perform.
GAVI's effects on the UN
Have public/private interactions, such as GAVI, weakened or strength-
ened the role of UN agencies including the WHO and UNICEF? This ques-
tion must be asked remembering that they achieved near universal im-
munisation coverage by 1990. Other important questions arise from the
fact that, in GAVI, UN agencies are partners, and no longer the lead-
ers. WHO's Director General has been appointed the Board's chair for
its first two years and she will be followed by Carol Bellamy, UNI-
CEF's Executive Director for another two years. But it is unclear who
will lead the initiative after that. GAVI's structure also includes
no clear mechanisms for accountabilility nor is there transparency in
its decision-making. Decisions are made by the board which is domi-
nated by donors and Northern representatives (including the Gates
Foundation and representatives from the industrialised country gov-
ernments which have contributed to the Global Fund).
In Noordwijk, the GAVI Board first met with other partners and made a
number of key decisions including which diseases would be the focus
of the vaccine research and development programme. The first GAVI
partners meeting felt somewhat like a public relations event: part-
ners were told what was happening, but given little opportunity to
contribute to strategy development and decision-making. By contrast,
in the UN system, there are some mechanisms for accountability, e.g.
during General Assemblies. And importantly, in the UN structure, de-
veloping countries rather than donor countries and agencies, hold the
majority vote.
Further concerns involve the lack of sustainability. From 1990, in
the era of donor fatigue, developing country governments started to
develop mechanisms to become more independent in vaccine needs. They
were supported in this by the UNICEF Vaccine Independence Initiative.
Under GAVI, donor dependence for the procurement of vaccines is being
reinforced. What will happen in five years' time when the Gates Foun-
dation donation has been spent? Will the necessary global, political
will still exist to support immunisation programmes in the poorest
countries? Or will these countries be left to find resources for the
expanded, and more expensive, immunisation programmes that GAVI
brings? As William Muraskin, a writer who has studied the politics of
public health commented on the Gates initiative: "They are as bright
as hell, and I'm very impressed with the Gates people, but it doesn't
answer the question of sustainability." He continued, "Bandwagons can
stop as well as go." [14]
It is difficult to criticise a vaccine initiative. No one is against
increased immunisation coverage. That isn't the real issue. Rather,
what needs to be examined and discussed openly is the question of who
is going to direct these important efforts and make sure that they
reach the people who most need them. Who will ensure that public
health needs are addressed before the private sector agenda or that
of the research-based industry? Can private foundations, providing
the overwhelming majority of funds for such efforts, be held account-
able in the way that governments or UN agencies can? And is it really
their role to provide the financial support to vaccinate the world's
children? What responsibility do national governments have to con-
tinue their commitment to reach this crucial goal? As Jeffrey Sachs,
an international economist at Harvard University and chair of the
WHO's Commission on Macroeconomics and Health has said, "It's not a
year or two of help that we need, but it's 20 years of help. What
Gates has done is fantastic. But Gates by himself can't carry the
world on this."[15]
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REFERENCES
1. Anita Hardon is an Associate Professor at the University of Am-
sterdam, where she directs the Medical Anthropology Unit. She led the
transnational team "Global Immunization Policy and Technology Devel-
opment" of the Social Science and Immunization project (1994-1998),
and has also conducted policy-oriented research in other fields of
international health, including extensive field research on the use
and distribution of medicines in diverse health systems, and studies
on gender and reproductive health. She chairs the HAI Europe Founda-
tion Board.
2. The achievement is a global estimate: in many countries coverage
rates had not yet reached 80%; and within countries there were also
still disparities in immunisation coverage.
3. Henderson, 1994. P. 9.
4. The Health for All concept started in 1977 when the World Health
Assembly determined that the main social target for governments and
WHO should be "the attainment by all citizens of the world by the
year 2000 of a level of health that will permit them to lead a so-
cially and economically productive life", otherwise known as Health
for all by the year 2000" (resolution WHA30.43) taken from Implemen-
tation of the Global Strategy for Health for All by the year 2000,
Eighth report on the world health situation, Vol. 1, WHO, Geneva.
5. The State of the World's Children 2001, UNICEF.
http://www.unicef.org/sowc01/tables/table3.htm
6. Donnelly, J. Immunizations plummet in poorest nations wars, fund-
ing cuts blamed for decline, The Boston Globe, 13 Nov 2000, p. A1.
7.Brundtland, GH, Statement at GAVI symposium, Oslo, Norway, 13 June
2000
http://www.who.int/director-general/speeches/2000/20000613_oslo.html
8. Summary of GAVI strategy from its web page:
http://www.unicef.org/gavi
9. GAVI information, 26 Jan 2001
http://www.who.int/vaccines/aboutus/gavi.htm
10. Global vaccine fund commits US$150 million in vaccines and fund-
ing over five years to 13 developing countries, press release, WHO,
20 Sept 2000
http://www.who.int/inf-pr-2000/en/pr2000-GAVI13.html
11. The initial 13 countries include: Cambodia, Cote d'Ivoire, Ghana,
Guyana, Kenya, the Kyrgyz Republic, Laos, Madagascar, Malawi, Mali,
Mozambique, Rwanda, and Tanzania.
12. See GAVI, October 2000; Detail of first disbursement from the
Global Fund for Children's Vaccine.
http://www.vaccinealliance.org/reference/1stdisburs.html.
The Global Fund will provide three sub-accounts for:
* the development of immunisation services as part of the health sys-
tem
* introduction of new and under-used vaccines and associated safe in-
jection equipment
* research and development of vaccines for diseases which are preva-
lent in developing countries.
The last account is not yet operational. The first two sub-accounts
are only open for the 74 countries with per capita income below US$
1,000/year. Countries with an immunisation coverage below 50% can
only request support from the first sub-account - they are not enti-
tled to funds for new and under-used vaccines.
13. Compulsory licensing is a provision in the global trade agreement
on intellectual property rights (TRIPs) that can help address the
negative effect of patent monopolies. Compulsory licensing is the
granting of a license to a third party without the consent of the
patent holder. It can be issued on various grounds including public
health. The patent holder receive remuneration for the license. Com-
pulsory licensing is a legal option within the TRIPs agreement.
14. Donnelly, J. 2000.
15. Ibid.
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