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Introduction<br />

Type I<br />

Type II<br />

Type III<br />

Prevalent in both rich <strong>and</strong> poor countries, with large<br />

numbers of vulnerable population in each.<br />

Prevalent in both rich <strong>and</strong> poor countries, but with a<br />

substantial proportion of <strong>the</strong> cases in poor countries.<br />

Overwhelmingly or exclusively prevalent in<br />

developing countries.<br />

Box 1: Categories of diseases according <strong>to</strong> <strong>the</strong>ir relative<br />

prevalence in higher- <strong>and</strong> lower-income countries<br />

The role of <strong>health</strong> systems 7 in challenging inequity has<br />

been <strong>the</strong> subject of study by <strong>the</strong> CSDH Knowledge Network<br />

on Health Systems. The report of this Knowledge Network 8<br />

syn<strong>the</strong>sises a large amount of available evidence on how<br />

<strong>health</strong> systems can contribute <strong>to</strong> reducing <strong>health</strong> inequities<br />

<strong>and</strong> provides a policy guide on actions that can be taken <strong>to</strong><br />

address <strong>the</strong>se inequities, including mobilizing intersec<strong>to</strong>ral<br />

relationships, facilitating <strong>social</strong> empowerment, building up<br />

universal coverage, revitalizing primary <strong>health</strong> care,<br />

streng<strong>the</strong>ning <strong>the</strong> process of developing <strong>and</strong> implementing<br />

policies, <strong>and</strong> securing international support for nationally-led<br />

<strong>health</strong> system transformation <strong>and</strong> action. While <strong>the</strong> focus of<br />

<strong>the</strong> report is on <strong>the</strong> use of existing knowledge, it identifies<br />

many gaps <strong>and</strong> also serves as a stepping off point for an<br />

extensive agenda of new research. This is especially<br />

important in <strong>the</strong> light of <strong>the</strong> fact that, as <strong>the</strong> report itself notes,<br />

<strong>the</strong> experience of <strong>health</strong> systems is always context-specific.<br />

Innovation<br />

Research <strong>to</strong> improve <strong>health</strong> is best unders<strong>to</strong>od as a process<br />

within a chain of <strong>health</strong> innovation that begins with a<br />

concept, question or observation <strong>and</strong> proceeds through<br />

experimental investigation <strong>to</strong>wards <strong>the</strong> eventual application of<br />

<strong>the</strong> results <strong>to</strong> <strong>the</strong> use of a new process or product in <strong>the</strong> field.<br />

Innovation for <strong>health</strong> equity should not be regarded as being<br />

restricted <strong>to</strong> <strong>the</strong> creation of affordable <strong>and</strong> appropriate<br />

medical products <strong>and</strong> technologies 9 . It also includes<br />

developing <strong>and</strong> applying underst<strong>and</strong>ing of how <strong>to</strong> improve<br />

equitable access through novel <strong>health</strong> policies, services <strong>and</strong><br />

systems, interventions <strong>and</strong> support mechanisms; <strong>and</strong><br />

encompasses <strong>the</strong> application of <strong>health</strong> technology<br />

assessment <strong>to</strong> assist in selecting <strong>the</strong> most appropriated <strong>and</strong><br />

cost-effective technologies <strong>to</strong> meet <strong>health</strong> needs, especially of<br />

<strong>the</strong> poor <strong>and</strong> vulnerable. And it includes innovations in<br />

underst<strong>and</strong>ings <strong>and</strong> measurements of <strong>health</strong> <strong>and</strong> <strong>health</strong><br />

equity.<br />

Pharmaceutical products for diseases<br />

endemic in developing countries<br />

Diseases have been categorized in<strong>to</strong> Types I <strong>to</strong> III according<br />

<strong>to</strong> <strong>the</strong>ir relative prevalence in higher- <strong>and</strong> lower-income<br />

countries 10 (Box 1).<br />

For a range of diseases that substantially or predominantly<br />

occur in poorer countries (Types II <strong>and</strong> III), access <strong>to</strong><br />

pharmaceutical products for prevention, diagnosis <strong>and</strong><br />

treatment has often been very poor. Two major elements of<br />

this limited access can be identified:<br />

1.For many of <strong>the</strong> diseases which have little or no prevalence<br />

in high-income countries, <strong>the</strong>re has been a dearth of<br />

research <strong>and</strong> development (R&D) resulting in <strong>the</strong><br />

registration of new products. Thus, of <strong>the</strong> new<br />

pharmaceutical products registered for human use in <strong>the</strong><br />

period 1975–1997, only 13 (around 1%) were for tropical<br />

parasitic infections 11 . As a result, treatments are ei<strong>the</strong>r not<br />

available or depend on very old generic drugs that may<br />

have significant side effects <strong>and</strong> efficacies that are limited<br />

<strong>and</strong> declining due <strong>to</strong> emerging resistance. Where<br />

diagnostic <strong>to</strong>ols for <strong>the</strong>se diseases exist, <strong>the</strong>y may be slow,<br />

insensitive or unsuited <strong>to</strong> field conditions prevailing in <strong>the</strong><br />

disease-endemic countries, requiring highly skilled<br />

personnel or sophisticated labora<strong>to</strong>ry settings.<br />

2.In cases where newer <strong>and</strong> more effective drugs, vaccines<br />

<strong>and</strong> diagnostics are available, <strong>the</strong>se have sometimes found<br />

relatively low levels of uptake <strong>and</strong> use in developing<br />

countries, due <strong>to</strong> fac<strong>to</strong>rs including affordability <strong>and</strong> <strong>the</strong><br />

availability of <strong>health</strong> systems for <strong>the</strong>ir delivery.<br />

It is clear that, <strong>to</strong> a large extent, <strong>the</strong>se two elements are<br />

related <strong>to</strong> a common problem – that of market failure.<br />

Substantial R&D investments are needed <strong>to</strong> create new<br />

pharmaceutical products <strong>and</strong> <strong>the</strong>se are unlikely <strong>to</strong> be made<br />

by <strong>the</strong> private sec<strong>to</strong>r where <strong>the</strong>re is not seen <strong>to</strong> be a good<br />

market for recouping <strong>the</strong> investments. Drugs created for a<br />

market in high-income countries, where per capita<br />

expenditures on <strong>health</strong> run in<strong>to</strong> thous<strong>and</strong>s of dollars per year,<br />

may prove <strong>to</strong>o expensive for use in low-income countries<br />

whose <strong>health</strong> expenditures are far less than 100 dollars per<br />

capita per year.<br />

Several different approaches have been explored or<br />

proposed <strong>to</strong> solve <strong>the</strong> problem, varying according <strong>to</strong> <strong>the</strong> stage<br />

in <strong>the</strong> chain of innovation <strong>and</strong> product delivery/uptake at<br />

which <strong>the</strong> market failure is perceived <strong>to</strong> be occurring:<br />

✜ For a range of “neglected diseases” – especially tropical<br />

parasitic infections, but also HIV/AIDS <strong>and</strong> TB –<br />

investments in R&D for drugs, vaccines <strong>and</strong> diagnostics<br />

has come from <strong>the</strong> philanthropic sec<strong>to</strong>r, with <strong>the</strong><br />

Rockefeller Foundation taking a lead in <strong>the</strong> mid 1990s in<br />

<strong>the</strong> creation of product development public-private<br />

partnerships (PDPs) beginning with <strong>the</strong> International<br />

AIDS Vaccine Initiative. The Bill & Melinda Gates<br />

Foundation has made substantial contributions since<br />

2000. More recently, a number of bilateral donors (e.g.<br />

Irel<strong>and</strong>, Ne<strong>the</strong>rl<strong>and</strong>s, Norway, UK) have started <strong>to</strong><br />

become increasingly significant supporters of this<br />

approach 12 . PDPs have generally taken a portfolio<br />

approach, creating a pipeline of c<strong>and</strong>idate products in<br />

development, some of which are now in or about <strong>to</strong> enter<br />

clinical trials. Since <strong>the</strong> latter – especially Phase III trials<br />

<strong>to</strong> prove efficacy <strong>and</strong> involving large numbers of patients<br />

in <strong>the</strong> field – are very expensive, a major challenge now<br />

facing <strong>the</strong> world is how <strong>to</strong> provide adequate funding <strong>to</strong><br />

ensure that effective new products <strong>reach</strong> registration <strong>and</strong><br />

enter clinical use in disease-endemic countries. Across<br />

<strong>the</strong> range of diseases <strong>and</strong> products for which support is<br />

014 ✜ Global Forum Update on Research for Health Volume 4

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