NEW MODELS FOR PUBLIC- PRIVATE PARTNERSHIPS IN HEALTH PROMOTION
The Road to Universal Health Coverage. 12th India Infrastructure Report. 2013-14. Chapter 16 Page 203 to 212 IDFC FoundationOrient BlackSwan New Delhi ISBN 978 81 250 5610 2 http://www.idfc.com/pdf/report/2013-14/Chapter-16.pdf
The last two decades have been the era of public-private
partnerships (PPPs). The Saskatchewan Institute of
Public Policy defines PPPs as co-operative ventures
between public and private sectors, built on the expertise
of each partner which meets clearly defined public needs
through appropriate allocation of resources, risks and
rewards (Allan 2001).
A particularly important element is the emphasis upon
risk-sharing, joint investment of resources, and sharing
of authority. These factors differentiate a PPP from
contracting-out and also privatisation. In all the three
models, the public sector ceases to be a direct provider
of services to the public, but instead becomes a procurer
of services and a regulator. With contracting-out, the
private-sector party provides the service in return for
payments, but it is not involved in the decision-making
nor is there transfer of responsibility. In privatisation,
the public sector hands over the responsibility for
the project to the private party, and subsequently the
government’s role is minimal. The partnership aspect is
what is crucial to the PPP.
The concept of PPP evolved in the context of
ballooning public debt in the 1970s and 1980s. The first
systematic programme in the United Kingdom (UK)
aimed at encouraging PPPs was the private finance
initiative (PFI) introduced in 1992 by the Conservative
Government. It was structured in a manner so that a
public sector body seeking to make capital investments
did not incur any borrowing. The borrowing was incurred by the ‘private sector vehicle’ implementing the project
and therefore, from the public sector’s perspective, a
PPP was an ‘off-balance sheet’ method of financing the
delivery of new or refurbished public sector assets (Tan
2012). It was argued that the expertise and efficiencies
of the private sector could be harnessed by this contract
for services traditionally procured and delivered by the
public sector (Allan 2001).
A large number of hospitals
were refurbished under this scheme.
PFI: T
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The PFI for hospitals failed miserably. Allyson et al.
(2002) show that using the PFI to build the UK
National Health Service (NHS) hospitals is an
expensive way of building new capacity that constrains
services and limits future options. PFI have also had
a negative impact on levels of service. Crucially it has
been shown that hospitals financed through PFIs had
reduced their bed capacity by 30 per cent and hospital
staffing by 20 per cent (Gaffney et al. 1999, Pollock et
al. 1999). It was shown that one PFI hospital replaced
two or three hospitals. The new hospitals were built in
out-of-town sites using proceeds from the sale of land
of the original hospitals in prime locations (Pollock et
al. 2002), and so adds to the inconvenience faced by
the public.
Allyson et al. (2002) demonstrated that PFI brings
no new capital investment into public services and it creates a debt which has to be serviced by the future
generations. The PFI costs are almost double the
estimated costs of a similar scheme funded by public
finance. In spite of all the tall-talk of sharing risks in a
PPP, where a trust wishes to terminate a contract either
because of poor performance or due to insolvency of the
private consortium, it still has to pay the consortium’s
financing costs, even though the latter is in default. It
would otherwise have to take-over the consortium’s
debts and liabilities, given that the lending institutions
make their loans to the consortiums conditional on
NHS guarantees. In such cases, ‘the attempt to shift
financial responsibility from the public to the private
sector fails’ (ibid.).
The UK Treasury Select Committee has now
added its criticism. It examined PFIs funding for new
infrastructure, such as schools and hospitals, and
concluded that it does not provide taxpayers with good
value for money, and stricter criteria should be introduced
to govern its use (Commons Select Committee 2011).
The Chairman of the Treasury Select Committee,
Andrew Tyrie, Member of Parliament, observed that the
average cost of capital for a low-risk PFI project is over 8
per cent—double that of government gilts.
The Committee observed that the higher borrowing
costs resulting from the credit crisis meant that PFIs
are now an ‘extremely inefficient’ method of financing
projects. The Committee has not seen any convincing
evidence that savings and efficiencies during the
lifetime of PFI projects offset the significantly higher
cost of finance. Indeed, the report raises concerns that
the current ‘value for money’ appraisal system is biased
to favour PFIs. It identified a number of problems
with the way costs and benefits for such projects are
calculated.
The Treasury Sub-Committee Report of 2011
is telling and begs to be quoted verbatim, ‘... PFI
means getting something now and paying later. Any
Whitehall department could be excused for becoming
addicted to that. We can’t carry on as we are, expecting
the next generation of taxpayers to pick up the tab. PFI
should only be used where we can show clear benefits
for the taxpayer. PFI should be brought on balance
sheet. The Treasury should remove any perverse
incentives unrelated to value for money by ensuring
that PFI is not used to circumvent departmental
budget limits’.
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Interestingly, the spectacular failure of the original
programme did not hinder replication of this grand
scheme. The concept of PPP has spread both in the
developed and in the developing countries. Initially they
were used for infrastructure development, e.g. ports, rail,
power, roads and hospitals. Over the past two decades,
more than 1,400 PPP deals were signed in the European
Union (EU), representing a capital value of approximately
€260 billion (Kappeler and Nemoz 2010). In Pakistan,
economic advisors advised the public sector to ‘mend its
ways’ and promote PPPs as the only way forward for
the development of the infrastructure and power sectors
(Ahmad 2013). Today, Monsanto with no infrastructure
development in the traditional sense of the term advertises
its involvement in a PPP
1
with state governments in
India reaching farmers with their seeds that are modified,
patented and genetically locked (Shiva 2013),
leading
to farmers being forced to buy more every season.
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It is now widely recognised that the problem with most
PPP is that the private investor makes all the profit
(with returns higher than the government bond rate)
and nearly all the income risk is borne by the public
partner. It is suggested that PPP can survive if the focus
of evaluation is changed from reduction in debt of the
public sector partner, to looking at ‘value for money’
after appropriate allocation of risk. The New Zealand
Treasury released a report in 2006 by Katz (2006)
suggesting that ‘... there is little empirical evidence about
costs and benefits of PPP’ and that any ‘... advantages
of PPP must be weighed against the contractual
complexities and rigidities they entail’. It suggested that
the decision whether to proceed with a PPP rather than
with a conventional procurement process should be
hinged on the following three questions:
1.
Is the public agency able to specify outcomes in
service-level terms, thereby leaving scope for the PPP
consortium to innovate and optimise?
2.
Is it easy for the public agency to specify outcomes in
a way that performance can be measured objectively
and rewards and sanctions applied?
3.
Are the public agency’s desired outcomes likely to be
durable, given the length of the contract?
If the answer to any of these three questions is ‘no’,
then conventional procurement is likely to be preferable
to a PPP (ibid.).
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An offshoot of the traditional PPP for infrastructure
development is Product Development Partnerships
(PDPs). This is a form of PPP that develops drugs
especially for neglected diseases like tuberculosis (TB)
and tropical diseases of the developing countries. Not-
for-profit organisations provide industry cash incentives
needed to develop these interventions and market
them. An example of this is ‘The Global Fund to fight
AIDS, Tuberculosis and Malaria’, which was established
to finance interventions against these three diseases.
Similarly, the ‘Roll Back Malaria Partnership’ mobilises
resources to fight malaria in endemic countries. The
Global Alliance for Vaccines and Immunisation (GAVI)
is a product development partnership for vaccines.
PDPs and Vaccines
The vaccine marketing enterprise is now a PPP. Most
modern vaccines are produced by private manufacturers, and profits from sales of these vaccines accrue to them.
However, publicly-funded international organisations
and tax-free charities—the World Health Organisation
(WHO)/United States Agency for International
Development (USAID)/GAVI invest in research to
develop new vaccines and for field trials to promote
its use. The target vaccine market is usually publicly
funded. This chapter examines PPPs broadly in the
context of health and looks more specifically at PPP
in vaccines. The chapter argues that this scheme puts
international organisations in an unenviable position
of selling vaccines—some of doubtful utility—and this
erodes the very credibility of the organisations.
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Research and Development (R&D) on vaccines is
considered a public good (Kremer 2002). Efforts to
encourage research on vaccines can adopt one of the
three strategies. The first two have their advantages and
disadvantages while there are no takers for the third.
a)
Research grants and tax credits can be given to
research organisations to promote research. Such
research is done mostly in academic and research
organisations which are not directly involved in
manufacture or marketing of the products. This is called the ‘push’ strategy—paying for research in
the hope that the industry will find it useful. Quite
often the projects supported by taxpayer funds
do not result in new vaccines or other tangible
results. The ‘push’ method has been criticised as
being wasteful and inefficient.
b)
‘Pull’ mechanisms on the other hand, incentivises
the development of actual vaccines. The research
is usually done by the pharmaceutical industry.
Industry does its own research and develops
useful and marketable vaccines and this is
rewarded. Here, the public pay nothing unless
a viable vaccine is developed. This encourages
researchers to self-select projects that yield viable
products. If an acceptable vaccine is developed,
the ‘pull’ programme is committed to purchase the
vaccine for use the world over. An annual market
of $330 to $660 million is considered necessary to
stimulate research. This market is guaranteed by
a purchase commitment—the Advance Market
Commitment (AMC) which is integral to the ‘pull’
mechanism (ibid.). However, the pull mechanism
is criticised because the commitment to purchase
vaccines at a fixed price violates the laissez-faire
principle allowing the market forces to determine
prices. This removes the basic incentive to innovate
and bring good quality vaccines to the market.
These days, the pull mechanism is preferred by
the international funding agencies.
For this purpose, the Global Fund for
Vaccines was launched by GAVI, a public-private
venture formally launched at the World Economic
Forum (WEF) in Davos in January 2000. GAVI’s
founding partners include WHO, United Nations
Children’s Fund (UNICEF), World Bank, Bill &
Melinda Gates Children’s Vaccine Programme,
the Rockefeller Foundation, International
Federation of Pharmaceutical Manufacturers’
Associations (IFPMA), and a few other national
governments. It was created starting with a $750
million donation by the Bill & Melinda Gates
Foundation. Since this initial donation, the Fund
has received commitments from the governments
of the US ($50 million), Norway ($125 million),
the United Kingdom ($5 million) and The
Netherlands ($100 million) (Hardon 2001).
c)
There is a third strategy which is to allow the
market forces to control both supply and demand
for vaccines. Paradoxically, votaries of the free
market are strangely silent where vaccine markets
are concernedThis chapter will dwell mostly on the ‘pull strategy’ of
the PPPs.
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As explained above, GAVI utilises AMC to incentivise
vaccine development. AMC was launched in 2005
(Center for Global Development 2005). Poor countries
cannot afford to buy expensive vaccines and the vaccines
meant for them have to have their prices marked
down. To encourage multinational companies to make
these vaccines for the poor, the AMC underwrites the
losses they incur in this way. Donors (donor countries
and philanthropic organisations) put up the monitory
equivalent of sales proceeds that a multinational
pharmaceutical company would make from developing
and testing a new drug for the western market, for
making a drug for a neglected disease in poor countries
(Kremer and Glennerster 2004). The normal profit for
a new drug in the West is considered to be $400 million.
The donors make a binding commitment to buy a few
hundred million doses of a new vaccine for a neglected
disease at a buy-out price that will yield about $400
million in profits for the manufacturer. In return, the
manufacturer would commit to making the vaccine
available to low-income countries thereafter, at a low ‘tail
price’ on a no-profit basis (Light 2011).
The manufacturer who accomplishes the task of
making an acceptable vaccine first, takes the prize of the
AMC. Light (2011),
has suggested that this is a vaccine
developer’s nightmare as they have to bear all the risks
and costs of discovering and testing the drug without
financial support if they are pipped at the finish line. All
their efforts would be a total loss to the company. The
AMC scheme would in fact also work as a disincentive
for competitors wanting to develop a more efficacious or
less expensive products as there would be no buyers for
the product in the face of the highly subsidised AMC
funded product. Light notes that despite the proposed
buy-out worth billions of dollars, the AMC design
included no arrangement for acquiring intellectual
property rights or for technology transfer (ibid.).
AMC and Pneumococcal Vaccine
One of the first vaccines awarded the AMC was the
pneumococcal conjugate vaccine (PCV). When the
AMC for the vaccine was agreed in 2008, it was clear
that the subsidy would initially be exclusively granted
to Pfizer and GlaxoSmithKline (GSK) for a vaccine.that was already in the market. In 2008, Pfizer reported
$2.72 billion in revenue for the first generation
pneumococcal vaccine, Prevnar. According to Berman
and Malpani (2011), presenting the pneumococcal
AMC as a cost-effective mechanism was ‘disingenuous’.
They argue that at the agreed price of $3.50 per dose of
pneumococcal vaccine, Pfizer and GSK will be given a
‘subsidy’ of $225 million.
Berman and Malpani (2011) suggest that GAVI
needs to eliminate the conflicts of interest that have
led to advantageous arrangements for multinational
pharmaceutical companies.
Four points need to be highlighted with regard to the
PCV AMC (Birn and Lexchin 2011):
(1)
The vaccine is of questionable benefit, since it
assumes that the prevalence of disease strains
(serotypes) is the same worldwide, an assumption
that is not necessarily valid (also see Puliyel et al.
2011);
(2)
The AMC was extended to an existing vaccine
developed for a high-income market rather than
for its stated purpose of developing new vaccines
for low-income settings;
(3)
The PCV AMC is financing exorbitant
pharmaceutical company profits;
(4)
The efficacy and cost-effectiveness of PCVs,
as opposed to other vaccines and child health
interventions—or integrated socio-political
primary healthcare approaches—are dubious.
Conflicts of Interest at GAVI
Birn and Lexchin (2011) note that GAVI has been
accused of practising ‘scientific imperialism’. According
to them, the interests of almost three-fourths of GAVI
members are aligned with profit-making rather than
people’s health. Of the 20 members, two represent
pharmaceutical companies themselves; five of the donor
countries are heavily influenced by corporate lobbying;
two are involved in PPPs with pharmaceuticals
(WHO and UNICEF); two consider profit-making
as compatible with addressing global inequality (Bill
& Melinda Gates Foundation and World Bank); and
four are ‘private citizens’ who are connected to finance,
banking and insurance industries.
Hardon (2001) records that at the first GAVI-
partners meeting, the Head of SmithKline Biologicals
outlined the conditions for industry participation; ‘... a
guarantee for reasonable prices, support for a credible
and sustainable market, respect for intellectual property
rights, a tiered pricing system including safeguards against re-export of products back from developing
countries to high-priced markets, and a prohibition
on compulsory licensing.’
Industry representatives
opposed technology transfer arrangements, ‘ ...
claiming that vaccines were too complex for public
research institutes and local production’ Birn and
Lexchin (2011). Hardon (2001) notes that GAVI
partners appeared unconcerned about possible conflict
of interest between the large research-based companies’
interest in markets for new products and the public
health objective of preventing childhood mortality in
the developing countries.
Light (2007) agrees that the so-called G8 ‘AMC
pilot’ for pneumococcal vaccine was really a large long-
term procurement and it was not an AMC. In 2007,
several affluent countries—the UK, Italy, Canada,
Russia and Norway—and the Bill & Melinda Gates
Foundation announced donations totalling $1·5 billion
to buy new vaccines to ease the burdens of disease
that will help eradicate pneumococcal diseases in the
world’s poorest children and foster economic growth.
According to Light (2007), only a quarter of the money
was spent on covering the costs of vaccines—three-
quarters went towards extra profits for vaccines that
are already profitable. Light (2007) argues that ‘... by
commercializing vaccines for poor people, the AMC
approach is making the culture of the GAVI Alliance
more commercially oriented than it previously was, and
it is shifting the Alliance towards becoming the vehicle
for making vaccines for poor individuals into the next
main market for the drug industry’. In a review of five
immunisation initiatives, Hardon and Blume (2005)
concluded that the GAVI Alliance is more corporate-
led, less transparent, not really accountable outside of
itself, and more oriented to paying profitable prices than
were previous initiatives.
Underestimating Costs
Light (2007) points out that the criticism of GAVI
AMC for pneumococcal vaccine is covered up by the
Alliance’s claim that the AMC will prevent 5·4 million
child deaths—89 per cent of which are projected
to take place after the donors’ money has been spent
This claim is itself dubious. According to WHO, the
vaccine saves only 3.6 lives for every 1,000 children
vaccinated (Madhi et al. 2008).
The cost per life saved
is often underestimated. Farlow (2011) points out that
the cost per death averted from the initial $5.6 billion
investment on pneumococcal vaccine is about $2,000.
Light’s (2011) figure, based on non-GAVI studies, is $4,722 per death averted. The projection of Light
(2011) had a decimal place error and the actual cost
per life saved is $47,220 (Puliyel 2011)! Looking at
opportunities foregone because of the programme, in
comparison, the cost per death averted from the use of
Expanded Programme of Immunization (EPI) vaccines
(diptheria, pertussis, tetanus [DPT] vaccine, oral polio
vaccine measles vaccine and Bacillus Calmette-Guerin
[BCG] vaccine) is $205 in South Asia and Sub-
Saharan Africa. GAVI faces a stark choice between
promoting the use of new and more expensive vaccines,
and improving access to inexpensive vaccines for polio,
measles, yellow fever and hepatitis, to millions not yet
reached (Farlow 2011, Light 2011).
Safety Concerns
Safety concerns have got short shrift in the push for
introducing new vaccines. Telling examples are the
deaths surrounding the use of pentavalent vaccine (which
combines Hepatitis B and H influenza B vaccines with
the older DPT Triple Antigen. The vaccine is promoted
mostly in the developing countries by GAVI and WHO.
It is not used in the West because the combination
vaccine is less effective than the components used
separately (Bar-On et al. 2009). In these circumstances
the safety of the combination vaccine has not yet been
tested in the developed countries, known for their strong
surveillance systems.
The Pentavalent vaccine has been associated with
deaths soon afterwards in many countries where it
has been administered. The deaths have been sporadic
and as in deaths following allergic reactions to drugs,
others vaccinated from the same multi-dose vial remain
unscathed.
When deaths occur soon after the administration of a
vaccine, the investigating team looks for other plausible
explanations for the reaction. The vaccine is considered
as probably the cause of the adverse event only when
there is no alternate explanation (according to WHO’s
Brighton classification) (WHO 2005).
As described in the case studies above (Box 16.1), in Sri
Lanka the WHO experts found no alternate explanation
for the deaths following use of the pentavalent vaccine so
they deleted the categories ‘possibly related and probably
related’ from the Brighton Classification and certified
that the adverse event following immunisation (AEFI)
was unlikely to be related to immunisation (WHO
2008)
The vaccine was introduced in Kerala in December
2011. Within 6 months there were 5 deaths. It was apparent that 1 child in 10,000 vaccinated children, died
as the result of an AEFI (Puliyel 2013).
In the context of all these deaths, the Council for
International Organizations of Medical Sciences
(CIOMS)/WHO Working Group on Vaccine
Pharmacovigilance got together to alter the way AEFI
are reported and investigated (CIOMS/WHO 2012).
The presumption that any AEFI must be considered
as ‘probably’ related to vaccine if there is no alternate
explanation for the adverse event has been done away
with. The new algorithm suggests that only reactions
that meet ‘AEFI-specific case definitions’ will be classified
as AEFI and investigated. If the vaccine is new, like the
pentavalent vaccine, deaths following vaccination may
be classified as ‘[Not an AEFI]’ (ibid., see p. 170 notes
for guidelines). Using this new method of evaluating
causality, all the deaths that have occurred have been
classified as ‘Not an AEFI’.
This last step of designating an AEFI as ‘not an
AEFI’ is patently unscientific, illogical and nearly
Orwellian. King (2012) has pointed out that the agenda
of the Global Advisory Committee on Vaccine Safety
(GACVS) is to develop a system that will minimise the
reporting of AEFI, especially those considered severe,
to minimise the risk that the reporting of AEFI will be
‘programmatically disruptive’. Of the 40 members on
the CIOMS/WHO committee, 19 were private partner
representatives of vaccine manufacturers.
In Vietnam, 61 children have died so far following
use of the pentavalent vaccine (Tuoitrenews 2013).
In March 2013, the WHO-AEFI group was called to
investigate a spate of 12 deaths following pentavalent
vaccine use in Vietnam. Armed with the new COIMS/
WHO tool, its Vietnam report stated, ‘... no fatal AEFI
has ever
been associated with this vaccine’ (WHO 2013).
This suggests that even deaths recorded previously by
experts in Sri Lanka as ‘AEFI—unlikely to be related
to vaccine’ has been changed to ‘Not an AEFI’. The
new scheme is discussed extensively on the PubMed
Commons (Tozzi 2013).
Increasing Health Inequities
Interestingly, Hardon (2001) has pointed out that by
spending such a large amount of its resources on new
vaccines, GAVI and the Global Fund run the risk of
compounding health inequities in the poorest countries
which they have prioritised for support. In nine of
the countries selected for support in the first round,
immunisation coverage remains below 75 per cent.
‘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, expensive and
under-used vaccines. Those children not reached by
current immunization programmes will probably lose
out again. As inequity in access to vaccines persists, they
will remain the losers’ (ibid.).
AMC as Incentive for Vaccine
Research
In the face of the mounting criticism of AMCs and
the AMC for pneumococcal vaccine, Kane (2011) has
defended the need for an AMC incentive to promote
vaccine research. He feels that the vaccine industry needs a
signal that GAVI is capable of raising billions of dollars to
buy vaccines like PCV and Rotavirus vaccines. He writes,
‘Every health worker in the developing world understands
the importance of pneumonia (the number one cause of
death in children) and diarrhoea (the number two cause
of death in children in many countries). GAVI, to remain
relevant, has no choice but to try to raise the resources to
make these vaccines available to children in the poorest
countries, and to continue its efforts to solve the financial
problems of getting new and underutilized vaccines to the
poor’ (ibid.).
Paradoxically Kane’s (2011) defence exposes the flaw
in GAVI’s logic for disease amelioration. Pneumonia
and diarrhoea are caused by numerous pathogens.
Just because there is a vaccine available for a limited
number of strains of one of the many pathogens causing
pneumonia and in the same way for diarrhoea, it cannot
be the justification for spending billions of dollars on
vaccines as if that would tackle the problem of diarrhoea
and pneumonia entirely. The unrealistic expectation
propagated by such propaganda will ultimately erode
the very credibility of the organisation and vaccination
programmes in general.
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The relevance of vaccines depend on local factors,
especially the prevalence and magnitude of the problem
in a locality. Data on usefulness has to be generated
locally and market commitment must depend on this.
An AMC on the other hand by implication assumes
that the prevalence of serotypes is the same worldwide
and the same vaccine will be considered as the priority
intervention in all countries. To assume that GAVI or any other organisation can make one decision for the
whole world is presumptuous. Having committed to
an AMC, international organisations are placed in the
unenviable position of selling this around the world.
This puts them in the embarrassing situation described
at the start of this article.
Fiona Godlee, the editor of the
British Medical
Journal
, started a campaign suggesting that researchers
must report data in terms of absolute risk reduction
(ARR) rather than relative risk. She points out that
‘... impressive sounding reductions in relative risk can
mask much smaller reductions in absolute risk’ (Godlee
2008). Data on ARR must be used to decide about
vaccine selection for different regions.
ARR describes the difference between two treatments.
It tells actual numbers (or rates) of people who experience
harms or benefits as compared with another treatment.
In the case of pneumococcal vaccine, suppose a vaccine
prevents 50 per cent of the strain-related disease, the
relative risk (or proportional difference) of 50 per cent
can sound impressive. However, if the strain itself is rare,
say 2 per cent of the population has the disease due to
the strain, a 50 per cent risk reduction will work out to
be a 1 per cent absolute risk reduction— meaning that
there will be 1 person saved from pneumonia in 100
people taking the drug. Once this data is available, it is
easy to calculate the numbers needed to treat (NNT)
to prevent one case of disease or death. The numbers
needed to vaccinate (NNV) to prevent one case of
pneumonia is 100 in the illustration above. The cost per
disease avoided or death averted, can then be calculated
easily. In the case of the pneumococcal vaccine, Madhi
et al. (2008) have reported that 3.6 children avoid
pneumonia per 1,000 children vaccinated in the areas
where it was studied. This will differ by region and so a
blanket prescription of AMC drugs is inappropriate. A
detailed discussion on how to estimate the affordability
of the intervention against the gross national product
(GNP) of the country is available elsewhere (Dhanasiri
and Puliyel 2007, Tyagi et al. 2003).
Dhanasiri and
Puliyel (2007) also discuss how to compare cost-utility
of the programme against utility of other programmes
which may compete for scarce heathcare budgets.
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GAVI must be credited with increasing international
interest in vaccines. A new model of PPP is emerging
called public-private community partnership (PPCP)
where the government and the private players work
together for social welfare eliminating the prime focus of private players for profit (CARD, undated, Cohesion
Foundation Trust, undated). Health and vaccines are
suitable candidates for PPCP. Given the persuasive abilities of GAVI in raising funds for immunisation,
it must work to shed its conflicts of interests and
endeavour in a PPCP to promote child health.
BOX
16.1
Cases Studies
H.influenza B (Hib) is a bacterial pathogen that can cause pneumonia and meningitis in children. A vaccine against Hib
is now available. However, studies done by the World Health Organisation (WHO) in Indonesia (Gessner et al. 2005) and
Bangladesh (Baqui et al. 2007) looking at Hib disease prevented by Hib vaccine found that there was no statistically
significant difference among those full vaccinated compared to those not immunised. The press release about the study
jointly issued by the WHO, Johns Hopkins Bloomberg School of Public Health, The GAVI Alliance, The Hib Initiative, USAID,
Government of Bangladesh (JHSPH 2007), however, misleadingly states that the study shows Hib vaccine protects children
from a significant burden of life-threatening pneumonia and meningitis (Puliyel et al. 2010, Puliyel 2010).
Hepatitis B virus causes inflammation of the liver and in some; it causes a chronic hepatitis that may progress to liver cancer
and death. A vaccine against Hepatitis B is available. Mark Miller (of the Children’s Vaccine Initiative of the WHO and the
National Institute of Health, Bethesda) claimed that 250,000 persons die in India each year due to Hepatitis B-related liver
disease (Miller 2000). Initially, Dr Miller wrote that a model ‘stratified by income group and geographic region’ was used to
arrive at this estimate of deaths. However, data from well-maintained cancer registries suggests that the number of deaths
from Hepatitis B-related cancers was about 5,000 per year (Dhir et al. 1998). When challenged to publish his model, Dr Miller
claimed his model was lost (Puliyel 2004). The paper was not retracted.
Soon after the Pentavalent Vaccine was introduced in Sri Lanka there was a series of five deaths. A WHO group of experts
investigated the deaths. They could find no alternate explanation for three deaths. Using the Brighton Protocol they were
bound to have classified these deaths as ‘probably related to the Pentavalent vaccine’ (WHO 2008). The experts modified
the Brighton Protocol and removed the categories ‘probably related’ and ‘possibly related’ from the classification. Their
report states that although they could find no alternate explanation for the events, the deaths were classified as unlikely to
be related to the vaccine using their modified Brighton classification (ibid.).
210
India Infrastructure Report 2013|14
of private players for profit (CARD, undated, Cohesion
Foundation Trust, undated). Health and vaccines are
suitable candidates for PPCP. Given the persuasive
abilities of GAVI in raising funds for immunisation,
it must work to shed its conflicts of interests and
endeavour in a PPCP to promote child health.
BOX
16.2
Selecting Vaccines for Universal Programme of Immunisation in India
Vaccines are introduced into the national programme of countries based on the burden and seriousness of disease to be
prevented, the safety and efficacy of the vaccine and its economic affordability in the context of the national economy.
Feasibility for inclusion in the routine immunisation schedule and acceptance of the people at large also needs to be
considered. Resolution 45.17 of the World Health Assembly mandates that member countries integrate cost effective ‘newer
vaccines’ into the national immunisation programmes. However, of late, the WHO has been making recommendations for
universal inclusion of vaccines like the rotavirus vaccine without regard to local cost effectiveness. Organisations like the
GAVI have been persuading the developing countries to use new vaccines by providing donor grants (effectively driving
costs to nearly zero in the initial stages). The full cost implications are realised once funding is withdrawn, after the vaccine
has been included in the universal immunisation programme (UIP) of the country. This form of pressure on governments to
introduce new vaccines into their UIP without evaluating the local burden of disease or cost-benefits, in effect perverts the
intention of the World Health Assembly (Resolution 45.17).
For vaccine selection, the process can be logical and mathematical and so it is particularly easy to present the data to the
public to garner their support. This has been described elsewhere. Briefly, the general guideline is that interventions that
cost less than the per capita gross national product (GNP), per quality adjusted life years (QALY) saved, are considered
cost effective.
Data on absolute risk reduction by the intervention in the country must be sought and from this, the numbers needed
to treat (NNT) (number of individuals who must be vaccinated) to avoid 1 case of disease can be derived. The cost of
immunisation to avoid 1 case of disease can then be calculated easily. Evaluations up to this point are mathematical.
Interventions that have poor risk-benefit ratio, those that are not cost-effective or affordable cannot be recommended.
If, however, the intervention is both cost-effective and affordable, there is also the need to evaluate efficiency of the
programme—whether it is capable of providing better returns than other uses of this resource.
If a cost-utility assessment has been done, the ‘optimum decision rule’ involves ranking the incremental cost-utility ratios of
different interventions and selecting those with the lowest ratio (‘best value’) until the budget is depleted.
A hypothetical example may be used to clarify this. Assume polio control costs Rs 350 crore and saves 1 QALY per Rs 10,000
spent, rotavirus control costs Rs 200 crore and saves one QALY per Rs 20,000 spent, and tuberculosis control costs Rs 700
crore and saves one QALY per Rs 5,000 spent. Assume also a budgetary constraint of Rs 1,000 crores. The first programme
to be accepted should be TB control as it provides the best utility (1 QALY/Rs 5,000). Once this is accepted, there is only
Rs 300 crore remaining in the budget. The next programme to be accepted must be polio control. Rotavirus control
costs only Rs 200 crore, which is less than the cost of polio control (Rs 350 crore), but polio control takes precedence as it
provides more utility.
Source
:
Puliyel (2014)
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