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Forging a New Committment - Tackling the Diseases of PoevrtyIntroduction1. The developing world faces a health crisis. It is a crisis causing huge human misery and millions of premature deaths each year. Ill health is a consequence of poverty, and entraps families in poverty as a result of the loss of working capacity and the costs of health care. Without action it is likely to get worse.
2. Premature death and disease are both a result of poverty and a direct contributor to poverty. Action to improve health must therefore go hand-in-hand with action on debt reduction if we are to save lives and achieve the international development targets.
3. The new White Paper on International Development reaffirms the UK commitment to work to mobilise a stronger international effort to meet the international development targets, including a two-thirds reduction in the mortality rates for infants and children under 5 by 2015. Tackling the three biggest killers - HIV/AIDS, tuberculosis and malaria – is essential for achieving these objectives. The G8 Summit in July 2000 also set targets for substantial reductions in the prevalence or these diseases by 2010.
4. This paper invites views on the action needed by the international community, working in partnership with developing countries, civil society, private sector, industry and researchers, to achieve rapid improvements in health, with a focus on HIV/AIDS, tuberculosis and malaria. It suggests a package of measures to achieve a significant reduction in the prevalence of these diseases, which will brings benefits in tackling other diseases which afflict the world’s poorest countries. That must include action to ensure:
5. Effective health care systems have to be in place to deliver health care to the poorest people. Systems must be both physically accessible and socially acceptable to users, particularly for women and children. We must also improve the affordability and use of existing health care products. More than 90 per cent of the essential drugs to tackle the burden of diseases are generic, cheap and affordable yet do not reach most poor people. We also need to ensure that there are adequate incentives for the development of more effective health care interventions.
6. The challenge is immense, and requires resources, expertise and commitment on a global scale. Progress also requires commitment from developing country governments and the OECD countries, who need to explore imaginative partnerships between the roles of the national and international public and private sectors. It must also involve the World Bank, the IMF, the United Nations including the World Health Organisation, the OECD countries, the European Community, the pharmaceutical industry, voluntary organisations, and donors such as the Gates Foundation who all have a role to play in achieving these targets. All of us need to accept a share of the responsibility for tackling diseases of the poor, and our joint responsibility must reinforce and not diminish accountability for the outcome. So governments in the developed and developing world will need to show greater drive and leadership than ever before in the fight against disease and poverty.
7. The threat of preventable disease to millions of the world’s poorest people calls for coordinated action on a global scale. Major progress is possible if we can forge new global partnerships. Failure to act now will inflict suffering and poverty on millions of our fellow citizens across the world.
8. This challenge was among the issues discussed at a major international conference hosted by the Chancellor of the Exchequer Gordon Brown and the Secretary of State for International Development Clare Short[1]. In his address to that conference, the Chancellor of the Exchequer Gordon Brown highlighted a number of initiatives the UK government is prepared to take, in partnership with others, and as part of a global strategy. These steps will include:
9. This paper provides further background to those announcements, and highlights other areas where the government aims to consult with others, and to build a coalition in support of action. The paper:
Health and poverty10. Three diseases – HIV/AIDS, tuberculosis and malaria - are having devastating effects on the developing world. Together they are responsible for the deaths of approximately 6 million people a year. They have a long-term debilitating effect on many more, reducing their ability to support themselves and their dependants. These diseases are linked to poverty, because they are seriously damaging economic development, and because poverty significantly affects exposure to the diseases and prospects for treatment.
11. HIV/AIDS has infected more than 47 million people since the onset of the epidemic in the mid-1980s. More than 5 million people were infected in the year 2000 alone, and in that year there were 3 million deaths. 95 per cent of HIV/AIDS cases and deaths occur in the developing world. Tuberculosis kills about 2 million people each year; it is particularly acute in sub-Saharan Africa, where the HIV/AIDS epidemic is exacerbating the problem. Multi-drug resistant TB strains are emerging as a result of people failing to complete the intensive treatment regimes. 3,000 people a day die from malaria. The vast majority of them are in sub-Saharan Africa. Resistance to anti-malaria drugs is also increasing, and the need for multi-drug therapy is increasingly acute which raises the cost of treatment. More details on the scale of the disease burden can be found in the annex.
12. The impact of these diseases goes beyond the terrible suffering of individuals and their families. They also have a devastating effect on the economies of developing countries. Correspondingly, the gains from addressing them are also very large. If it were possible to control malaria alone this could translate into an additional 20 per cent growth in Africa over a 15-year period.
13. The potential social and economic benefits from tackling these diseases are therefore enormous. For example, it is estimated that if an AIDS vaccine were available now it could prevent 2 million deaths a year, rising to 5 million a year within the next decade. A malaria vaccine could save 1 million deaths a year and prevent 1 million episodes of severe illness, mostly in Africa.
What are the challenges in tackling these diseases?14. Three requirements need to be met for health solutions to have a major impact on diseases of the poor:
15. Inadequate delivery systems, affordability and incentives lie at the heart of the imbalance between the burden of diseases in the developing world and the small impactscale of current action to address them.
Health delivery systems in developing countries are often not adequate to ensure that existing products get to those who need them most. Systems have to be appropriately organised, managed and financed to deliver pro-poor health outcomes. Systems have to be staffed with skilled motivated individuals, that are prepared to work with poor communities often in remote areas. In a world of scare resources, the efficiency and effectiveness of such systems is critical. The role of government is to support the strengthening of such systems in both the public and private sectors. Health education: As in the developed world, there is often poor understanding amongst people at risk both of the causes of disease, and the connections between behaviour and risk of infection. This inhibits the take-up of treatments, as well as other highly effective preventative solutions such as use of condoms against HIV/AIDS, and use of bednets against malaria-carrying mosquitoes.
Costs,
risks
and
uncertainties
involved
in
developing
more
effective
drugs
and
vaccines
can
be
daunting,
both
for
industry
and
for
independent
researchers.
Estimates
of
the
costs
of
developing
a
typical
new
product
and
bringing
it
to
the
market
vary
enormously,
but
range
between
$350
million
and
$2.5
billion.
Moreover
perhaps
only
one
in
ten
products
which
enter
development
result
in
a
successful,
effective
product
being
brought
to
the
market.
The
combined
costs
and
risks
make
it
all
the
more
important
for
developers
to
be
sure
that
there
is
a
willing
buyer
for
their
product,
giving
them
a
prospect
of
covering
their
costs
and
earning
a
reasonable
return,
before
embarking
on
complex
and
lengthy
development
work.
The
current
lack
of
incentives
to
develop
effective
health
products
to
tackle
diseases
of
the
poor
is
reflected
in
the
predominance
of
research
and
development
activity
on
addressing
the
health
priorities
of
the
developed
world.
For
instance,
only
10
per
cent
of
all
international
research
on
health
goes
toward
diseases
which
make
up
90
per
cent
of
the
world’s
disease
burden,
mainly
affecting
developing
countries.[The
current
lack
of
incentives
to
develop
effective
health
products
to
tackle
diseases
of
the
poor
is
reflected
in
the
predominance
of
research
and
development
activity
on
addressing
the
health
priorities
of
the
developed
world.
For
instance,
only
10
per
cent
of
all
international
research
on
health
goes
toward
diseases
which
make
up
90
per
cent
of
the
world’s
disease
burden,
mainly
affecting
developing
countries.
16. A further factor which needs to be addressed is the ability of the diseases to overcome health interventions. For each of the diseases, development and deployment of a single pharmaceutical solution is not the end of the story. Each disease evolves in response to the deployment of new drugs and vaccines, and new strains resistant to treatments develop. This means that there is no once-and-for-all solution, and that an ongoing search for new and more effective solutions is needed if health improvements are to be sustained.
How can these problems be addressed?17. Action on a global scale will be needed:
Progress
is
already
being
made.
18.
19. This wide range of efforts involving a range of different players points to the potential for a new model of global partnership for the 21st Century, in which the public sectors and others contribute resources and take a stake in the initiative, and the private sector and research bodies contribute expertise. Partnership also provides a model in which the private sector can share in the costs, as well as the rewards, of developing a solution.
20. Yet with all this activity, 6 million people a year are dying from HIV/AIDS, malaria and tuberculosis. Moreover where treatments are on the market, they are too expensive for those who need them most. We need to find ways to intensify and accelerate progress to achieve rapid improvements in delivery systems, increased access to existing interventions and rapid progress in the search for more effective products against these diseases and other diseases of the poor, but also to make sure that solutions that emerge are affordable in developing countries.
Possible new approaches21. The UK Government is keen to play a bigger role in the global effort to tackle HIV/AIDS, tuberculosis and malaria in developing countries. The Department for International Development is working to improve delivery systems and health education, in partnership with others. In addition, i In November 2000 the Prime Minister asked the Performance and Innovation Unit (PIU), working closely with HM Treasury and the Department for International Development, to look at the issues of affordability and incentives and to come forward with new proposals for further action which could be taken by the UK and which could be discussed with the international community.
Improving health care22. The UK government, through its bilateral co-operation, has committed £1 billion to strengthen primary health care since 1997. Stronger, more effective and accessible primary health care systems are essential if the burden of disease is to be reduced. Without these systems drugs (whatever their price) will remain forever inaccessible to the majority of poor people in developing countries. Sadly in all too many countries the weakness of health systems has just such an effect.
23. Drugs and vaccines are an important and essential component of a health care system, but they are only one part. Effective systems have to be both physically and socially accessible to the users of such systems, particularly for women and children. Systems have to be appropriately organised, managed and financed to deliver pro-poor health outcomes. Systems have to be staffed with skilled motivated individuals, that are prepared to work with poor communities often in remote areas.
24. In a world of scarce resources, the efficiency and effectiveness of such systems is critical. The role of government is to support the strengthening of such systems in both the public and the private sectors. In Africa delivery of health care and increasing coverage to poor people depends increasingly on the private for-profit and non-profit sectors - whether through social marketing of bed nets and condoms, or district health services provided by mission hospitals and clinics. Many governments are poorly equipped to manage these new public/private relationships, and reluctant to transfer resources from a cash-starved poorly functioning public sector.
25. Further progress still needs to be made in improving accessibility and ensuring that health care reaches the poorest. This requires strengthening access to care, services and products. Under country-led strategies, coverage needs to be rolled out using both the public and private sector as necessary. This needs to be on a country by country basis, supporting national priorities, capacity and leadership.
26. Developing country governments need to take the lead in determining how best systems can be upgraded and coverage expanded. The developed world must provide support, resources, practical help and training where it is needed. The willingness of all governments to contribute to partnership and collective leadership will be an essential component in a new global partnership against HIV/AIDS, malaria and tuberculosis.
Measures to improve affordability and incentives27. Health systems need affordable and effective health interventions to deliver. Following discussion with a wide range of our partners in multilateral institutions, other governments, NGOs, industry, research and funding bodies and academic institutions, the UK Government’s Performance and Innovation Unit is now assessing a wide range of possible measures (listed in full in the annex) These initiatives will need to improve both affordability, and incentives to develop new and more effective drugs, vaccines and other products. Our preliminary analysis identifies instruments likely to improve either affordability or incentives or both (though some of these improve one at the expense of worsening the other). This suggests that the packaging together of instruments will be as important as the effects of each instrument on its own.
28. The measures fall into three main groups:
These offer a range of potential ways to address the blockages to affordability and incentives of health improvements described above.
cost/risk delivery and education
29. The key emerging findings include:
disease-by-disease approach is likely to be needed, reflecting the different levels of progress towards bringing effective interventions to the market; "pull" instruments, which provide incentives for development of new products by guaranteeing a market, are promising and appear under-used compared with “push” instruments, and might offer a significant new way to get results: however these approaches are relatively untried in practice; it seems unlikely that any single instrument will deliver both adequate incentives and health interventions which are affordable in developing countries – suggesting that a package of instruments will be required; the likely responses to different instruments vary in their timing and size – again suggesting that we need to investigate the implications of using measures in combination to get the right overall results; and
Issues to be considered further and next steps
30. The 26 February conference represents a staging post in a process which will build up a coalition of support for measures to tackle the diseases of poverty. We therefore invite views on the announcements made by the Chancellor of the Exchequer, and the analysis summarised in this paper. In particular, we welcome opinions on the appropriate balance of effort between strengthening health delivery systems and health education, and improving incentives for the development of new, affordable drugs, vaccines and other health interventions.
31. The PIU is currently in the process of undertaking consultation and detailed analytical work to work-up the detailed specifications of a package of measures. The consultation process has so far involved a wide range of individuals and organisations who have a close interest and/or are undertaking work in this area, including the WHO, World Bank, EC, UNAIDS, governments of developing countries and representatives from the pharmaceutical industry. G8 health experts are being consulted through the health experts’ network.
32. A fuller consultation paper with more detailed analysis will be available in April. An interim paper setting out in more detail the analysis we are undertaking can be found on our website at: http://www.cabinet-office.gov.uk/innovation/2001/health/mainpage.htm. or via: Global Health Team Performance and Innovation Unit Cabinet Office Admiralty Arch London SW1A 2WH. Tel: (0044) (0)20 - 7276 – 1464 Fax: (0044) (0)020 – 7276 - 1430 Email: global.health@cabinet-office.x.gsi.gov.uk If you would like to discuss any of the issues raised in the paper, please contact the Global Health Team via the above contact points.
DEPARTMENT FOR INTERNATIONAL DEVELOPMENTHM TREASURY PERFORMANCE AND INNOVATION UNIT, CABINET OFFICE London, 26 February 2001
ANNEX : The diseases and their impactHIV/AIDS, tuberculosis, and malaria: the current situationThe toll of these diseasesThese three diseases alone are responsible for about 6 million deaths world-wide each year. HIV/AIDS has infected more than 47 million people since the onset of the epidemic in the mid 1980s. More than 5 million people were infected in the year 2000 alone, and in that year there were 3 million deaths. 95% of HIV/AIDS cases and deaths occur in the developing world. Tuberculosis kills about 2 million people each year; it is particularly acute in sub-Saharan Africa, where the HIV/AIDS epidemic is exacerbating the problem. Multi-drug resistant TB strains are emerging, caused by people failing to complete the intensive treatment regimes. It is estimated that 3 thousand people a day die from malaria. The vast majority of them are in sub-Saharan Africa. Resistance to drugs is increasing, and multi-drug therapy is needed more and more.
Prospects for irradiationTwo major barriers to a reduction in HIV/AIDS are the fact that existing prevention technologies, such as condoms, are not being used by the target groups (especially in remote rural and poor urban communities) due to lack of education on risks and significant barriers to changing personal behaviour, often for religious reasons. Secondly, there is no cure nor a vaccine for HIV/AIDS, and existing treatment drugs are expensive and complicated to administer in developing countries; Although an effective vaccine for TB does exist (BCG), it only works in children, and it is not suitable for most TB strains found in the developing world. The DOTS (Directly Observed Treatment) programme is very efficient at curing TB, and scientists do not feel they could develop a drug that is significantly more effective – the issue is over the intensive nature (several doses a week for six months) of DOTS. Developing countries’ health systems are rarely capable of sustaining such intensive treatments. Meanwhile the intensive nature of the existing treatment means that it is often not completed, and thus drug-resistant strains of TB are developing. A vaccine for malaria is thought to be a remote possibility, due to the scientific difficulties and new treatments are not a high R&D priority. Personal prevention of malaria is through the use of insecticide-treated bed nets and targeted vector spraying. However, these measures are not widely used because of a lack of understanding among the people in developing countries about the connection between malaria and mosquitoes and anyway mosquitoes are developing resistance to sprays and larvicidal measures. Unregulated private sector systems lead to inappropriate drug prescribing, poor quality drugs and poor compliance, which is in turn resulting in increased drug resistance. While existing malaria drugs are cheap, resistant parasite strains need combination therapies, which become much more expensive and, if not properly used, can exacerbate the problem in the long run.
Existing actionHIV/AIDSThe United Nations Programme on HIV/AIDS (UNAIDS) co-ordinates, rather than directly funding or implementing, action on AIDS. Other funders of vaccine development include the US and the International AIDS Vaccine Initiative (IAVI). Beyond providing funds, IAVI also brings in expertise, as needed, in areas ranging from project management to regulatory affairs and infrastructure for clinical trials. IAVI, UNICEF, the US, and the International Partnership against AIDS in Africa (IPAA) are also promoting behavioural change and the use of other prevention methods such as condoms. Pharmaceutical companies are also working with the UN and other partners to make drugs for the treatment of HIV/AIDS more widely available in Africa. Other partners support other aspects of care and treatment.
TBThe World Health Organisation’s (WHO) Stop TB initiative provides an overarching framework for mobilising support and resources to tackle the disease. The EC, WHO, Research and Training into Tropical Diseases (TDR), the US, and Japan provide fundamental support for vaccine development. Important work on diagnostics is being taken forward under the TDR programme. With regard to the development of new treatments, the work of the EC, TDR and the US is being supplemented by the Global Alliance on TB which was set up under the Stop TB initiative to accelerate the development of new TB drugs. A whole range of organisations including the Global Drug Facility, part of the Stop TB initiative, the World Bank, WHO and Japan are promoting the expansion of DOTS, particularly within developing countries.
MalariaIn 1998, the WHO, UN organisations, and the World Bank launched Roll Back Malaria (RBM). It is a social movement that is part of a broader action for health and human development. Each partner contributes within the context of its own mandate. Within Africa its main focus is on building partnerships between key organisations, the use of impregnated nets and the setting up of a resource network to forecast malaria epidemics and monitor the supply of drugs. RBM aims to mobilise the developing and the developed world to tackle malaria. Many other initiatives link themselves to the RBM branding. A number of international bodies support significant vaccine research, including the later stages of vaccine development. In conjunction with the Multilateral Initiative on Malaria (MIM), the TDR has set up a task force to build malaria research capability in Africa. Access to, and research into, other prevention technologies (such impregnated bednets) is promoted by UNICEF, RBM and the TDR . The US also conducts research into insecticides and is exploring the scope for altering the biology of the mosquito. TDR, in conjunction with RBM and USAID, is sponsoring work around the introduction of rapid diagnostic tests. However, more needs to be done to increase the use of, and reduce the cost of, such tests. The US, TDR and WHO (through the Medicines for Malaria Venture), are supporting the development of new anti-malarials. WHO is working with IFPMA on projects to improve access to anti-malarials and UNICEF is working to ensure that pregnant women and children have access to front line treatment. The European Malaria Vaccine Initiative aims to address identified structural deficiencies in publicly-funded malaria vaccine development and the EC and the World Bank make a vital contribution to the development of health care systems in developing countries. This is crucial to the successful delivery and implementation of prevention and treatment methods.
Gaps in existing actionAction against all three diseases suffers from a lack of financial resources. The Commission on Macroeconomics and Health (CMH) states that the international community fails to follow through on pledges of support for public health in developing countries. The amount of money needed to fight these diseases is much greater than current levels, and it needs better targeting. In 1998, according to the OECD, of $3.8 billion given by all international donors for all health, nutrition, and population programmes, only $106 million was specifically for infectious disease control in low-income developing countries ($0.16 per recipient). Only 10% of global health research funds (totalling more than $3 billion) are presently targeted at 90% of the global disease burden. WHO’s decision to launch its new ‘Massive Effort’ initiative reflects concerns about the ability of existing initiatives to lever in the required level of additional resources. CMH’s interim report states that most participants in international aid programs emphasise that donor-supported programs are characterised by excessive fragmentation and much too little scrutiny by independent experts. Much of the funding comes in unhelpful forms such as tied aid and unneeded technical assistance – rather than cash to procure supplies and services. High profile initiatives such as Stop TB are designed to provide an overarching framework for measures to tackle the diseases, but there is a danger that a proliferation of such initiatives will compete and that promotion efforts will lead to distortion. Stop TB’s objective is to build ‘partnerships for action against one of the world’s most devastating diseases’. It is not responsible for reviewing the appropriateness or effectiveness of existing initiatives and it is unclear what the WHO’s Massive Effort initiative aims to achieve other than raising awareness. The proliferation of global partnership initiatives, such as the Global Alliance for TB, is increasing the complexity of the situation and raising concerns about lines of accountability, which are still being defined. Concerns about accountability and roles may hamper efforts to lever in additional resources from donors. Roll Back Malaria aims to provide an overarching framework for measures to tackle malaria. However, independent foundations have launched other initiatives such as the Malaria Vaccine Initiative and it is not always clear how such initiatives link into RBM. Moreover, RBM is not responsible for reviewing the appropriateness, affordability, or effectiveness of existing initiatives.
An urgent gap in existing initiatives against HIV/AIDS is access to patent-protected drugs in developing countries. Attempts to tackle this problem are being made but in a piecemeal manner. Support for basic research is not the key issue, the graveyard for new technologies is the stage between basic science and large-scale product development. Certain features of the regulatory framework relating to clinical trials may also be hindering development of new vaccines and drugs. DOTS provides an effective drug treatment regime for TB but new drugs that can reduce treatment time would have a bigger impact in developing countries. However, without being able to prove the superiority of new anti-TB agents when DOTS have been proven to be up to 95% effective when properly administered, the R&D community feel that any improvements will be only marginal and therefore not likely to attract investment. The Medicines for Malaria Venture is designed to act as a bridge between basic research and product development. Its goal is to develop a new anti-malarial drug every 5 years from 2010. This would require funding of around $30 million a year, using substantial ‘in-kind’ support from the pharmaceutical industry. So far this scale of resources has not been forthcoming from the international aid community. Moreover, the MMV has had to adjust its programme because the pharmaceutical companies remain reluctant to provide their own resources for product development. Building trial and research capacity in developing countries is vital to the testing of new vaccines and products. A range of initiatives are in place but a recent report by MIM concluded that the current training offered by higher income countries to developing country scientists is generally fragmented and inadequately monitored.
[1] “International Action Against Child Poverty – Meeting the 2015 Targets”, 26 February 2001, Westminster, London [2] Global Forum for Health Research, 1999: The 10/90 Report on Health Research. [3] Trade-related aspects of Intellectual Property |
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London
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