Delivering the promise: through new markets, new money and new partnerships for development - Julian Lob-Levyt, GAVI Alliance Executive Secretary

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Speech by Dr Julian Lob-Levyt, GAVI Alliance Executive Secretary at the Sir Mark Oliphant Conference on Vaccine and Immunotherapy Technologies, Canberra

Geneva, 10 April 2008 - It is a great pleasure to participate in this gathering with its focus on the best of new developments in the vaccine world. There is enormous potential for global health benefits from this most efficient of therapies. We share the urgent wish to confront and remedy a gross inequity: that most applied health research and product development still does not address the primary global health burdens.

Even where new vaccine technologies exist that are applicable to diseases of the developing world (and there is certainly some promise here in vaccines against pneumococcal disease, HPV, and malaria), getting the science and technology right is just one part of the story.

Beyond this, the finance and delivery systems are two further hugely significant elements for poor countries. All too often, these are the two missing ingredients that mean the first one -vaccines appropriate to developing country needs - never see the light of day.

Today I want to describe some of the ways which the GAVI Alliance brings together resources to change that.

GAVI's promise is to save children's lives and protect people's health by increasing access to immunisation in poor countries. GAVI was established to do development business better: creating and using new markets, finding and using new money, and building and using new partnerships to achieve this.

Each year 9.7 million children under five die. Almost all of these are in the poorest countries in the world.

GAVI was formed in 2000 for those poor countries - for the poorest of the poor - the 70-odd countries with a gross national income of under US$ 1000. They are not the traditional view of a promising market. Especially not for any product which requires enormous upfront investment in research development and testing.

New markets

What happens when you change perspective - when you view the disease burden of the developing world as the market and the people of that world as worthy of investment?

What happens when you consolidate all those populations into one giant market and relocate your view of purchasing power - from them, to GAVI?

It means that you gain market shaping capability.

It means you can create new dynamics of supply and demand that get the newest vaccines to the countries that need them most. - Much, much sooner.

It means not waiting up to 20 years for traditional market mechanisms to bring prices down to a level affordable in poor countries.

Instead, prices decline as the volume of demand, consolidated through GAVI, makes production investment worthwhile for manufacturers. More manufacturers enter the market with better demand forecasts, and a beneficial cycle begins.

The result is a more secure product supply, and competitive pricing reflecting economies of scale and the entry of emerging market vaccine manufacturers.

We did this first with hepatitis B vaccine. Within the eight years of our existence, 67 countries (all but two of those eligible) have been approved for support for hepatitis B vaccine. The weighted average price of hepatitis B vaccine has dropped from 33 cents per dose to 20 cents since 2001 (over seven years).

Over the same seven-year timeframe the weighted average price of combination DTP-Hep B vaccine has dropped from $1.10 per dose to 70 cents.

And since 2000, 158.6 million children have been immunised against hepatitis B and possible fatal liver cancer as an adult through GAVI support.

Similarly, as part of our support for immunisation safety, we have supported the distribution and use of more than 2 billion autodisable syringes globally. In the process we have seen prices almost halve since 1997.

Hib vaccine was the next new vaccine we offered. Instructively for introduction of future new vaccines, uptake was slower.

Several factors changed this: In 2006 WHO recommended that all countries introduce Hib vaccine into routine immunisation. It became available in a new, convenient liquid 5-in-1 pentavalent formulation. The GAVI-funded Hib Initiative delivered powerful and influential advocacy messages, and new financing mechanisms such as IFFIm generated a new dimension of funding stability and predictability.

Demand has accelerated. The number of countries approved by GAVI for funding to introduce Hib vaccine has almost doubled in the last 12 months, from a total of 28 to 44.

The new pentavalent vaccine has been very popular with countries. 38 countries are currently using or have been approved to introduce the vaccine. This means that each year a birth cohort of 26.5 million children are simply and effectively covered against hepatitis B, Hib, diphtheria, pertussis and tetanus all in one shot.

Hib's excellent efficacy is attracting attention in many countries, such as Uganda. A rapid assessment conducted in Uganda in 2000 estimated Hib meningitis incidence to range between 44 and 59 cases per 100,000 children under five years of age with more than 12,500 cases due to pneumonia annually.

In five years, Hib vaccine introduction virtually eliminated Hib meningitis in children under five years of age nationwide, preventing almost 30,000 cases of severe Hib disease and 5,000 child deaths (under five years) annually.

In the Uganda study, Hib vaccine effectiveness was 98%. In the Gambia, Hib meningitis fell from 60 cases to zero per 100,000 children under five years within a decade of introduction. In Kenya, Kilifi District Hospital reported an 84-87% reduction in invasive Hib disease after national introduction of Hib vaccine (through GAVI).

The Uganda experience - and others - show that remarkable results can be achieved in a relatively short space of time. Progress is not always so straight-forward. But with the right tailored approach, success is achievable.

The newest vaccines in the GAVI portfolio - against rotavirus and pneumococcal disease - have similarly needed specific dedicated approaches to getting them ready for use in the developing world, and supporting their introduction.

That work has been handled by new partnerships, assembled with the specific aim of implementing "Accelerated Development and Introduction Plans" (ADIPs), and funded by GAVI. These address the significant technical, epidemiological and financial challenges involved in making new vaccines available that are to be used primarily in developing countries.

These new vaccines are vital to making serious inroads in child mortality. Serious pneumococcal infections and rotavirus are a major global health problem and are both vaccine preventable. WHO estimates that some 800,000 children under five die each year from pneumococcal infections, and 500,000 from rotavirus.

Together, the vaccines against pneumococcal disease and Hib will protect children against two of the most important causes of pneumonia. Pneumonia is the single biggest killer of young children at 2 million deaths a year - more than AIDS, malaria and measles combined.

The PneumoADIP has increased demand for the vaccines from developing countries, and emerging suppliers are investing in significant new production capacity. The vaccine will be available for these markets at least five years sooner than would otherwise be expected. A vaccine for Streptococcus pneumoniae has been available to adults in the US since 2000, but only recently developed for infants and toddlers as the pneumococcal conjugate vaccine.

Two rotavirus vaccines are now authorised for marketing and have already begun to be introduced in a number of countries as a result of the RotaADIP. Only a year after approval in developed countries, rotavirus vaccine is reaching developing countries. The ADIP has worked with existing and emerging manufacturers to ensure competition and supply.

Perhaps the most dramatic example of GAVI's work with markets to stimulate the vaccines that are needed is the US$ 1.5 billion Advance Market Commitment for pneumococcal vaccines.

This is a pilot project, and is still evolving. It takes the "consolidated market" shaping principle and applies it to attracting development of completely new vaccines - that are specifically designed for the disease burden in the poorest countries. The new pneumococcal vaccines that are being stimulated by the AMC, once in use, are expected to save an estimated 5.4 million lives by 2030.

New financing

In addition to market shaping through demand creation, GAVI's generous donors and new financing mechanisms have brought a scale of funds for immunisation that has a dynamic of its own. It's a dynamic based on solidity and predictability, on a consistent mission, and on the pulling power of sheer volume.

The resources are substantial: pledges and long-term commitments from donors exceed US$ 7.5 billion. By the end of 2007, GAVI had committed a total of US$ 3.5 billion in support to poor countries for the period 2000 to 2015, allocated in multi- year tranches, and aligned with the countries' own planning cycles.

Aid flows have traditionally been fairly volatile, project based, according to the varied interests of the donors, and often with short timeframes.

Countries told us that many of the solutions to their immunisation coverage issues were long-term issues, like health worker training. They needed to know that support would not stop mid-way through. They needed to know that GAVI was a secure, stable and predictable source of grants, with consistent programmes that would work within their own plans for immunisation.

In November 2006, the International Finance Facility for Immunisation (IFFIm) piloted a completely new way of using the capital markets for financing development.

In much the same way as GAVI is able to consolidate the vaccine demand from the developing world and present it as a coherent market, IFFIm takes the ODA commitments of sovereign governments over 20 years, consolidates them, and sells bonds against that combined commitment, producing immediate, upfront funds.

The first, hugely successful bond issuance brought one billion dollars to GAVI. With it came the imperative to invest that money prudently, in tactical immunisation programmes against specific diseases, and support to countries to strengthen their ability to deliver those vaccines. At the same time, each of those activities had to be designed to build the overall health service capacity that supports long-term sustainability.

It is not just IFFIm that is long-term and predictable - though it is the most remarkable example of this. In 2007, 67% of donor government contributions to the GAVI Alliance were multi-year in nature, bringing a different dynamic to country planning - where whole cycles can be supported.

New partnerships

The GAVI Alliance is both itself a new kind of public-private partnership, and stimulates the pulling together of other, specific task-oriented partnerships to achieve its goals. Each combines traditional resources in a new way, for example, the ADIPs, the AMC, and IFFIm.

GAVI is a new type of international entity - a global alliance of leading stakeholders in immunisation that allows each partner to lend to the process the strength of its authority, knowledge and specialised skills.

GAVI's lightweight and flexible alliance structure reflects private sector efficiency yet is invested with heavyweight, top-level and diverse resources,

For example: WHO's technical expertise in public health; the vaccine purchasing power of UNICEF; the financial security and development know-how of the World Bank; the R&D market knowledge and performance of the vaccine industry; and the voices and experience of the developing countries themselves.

In each instance GAVI draws directly on the most authoritative voice in the field, such as the Director-General of WHO, Ministers of Health and Finance, or leading independent experts from the banking or manufacturing industries.

Together these voices provide balance through challenge, and solutions through engagement and experience.

Delivering the promise

This month, the first child in Papua New Guinea will get the Hib vaccine. Hib causes meningitis and pneumonia, two of the commonest causes of death in children in PNG. Australian children have received Hib vaccine routinely since 1992, and, as in Uganda, disease from Hib has been virtually eliminated.

Sixteen years on, and with GAVI's support, PNG's children have this opportunity too.

The Alliance has significantly increased the number of children worldwide who have access to immunisation. WHO estimates that this work has averted 2.9 million premature deaths, so far.

Increasing access is not simply increasing the volume and affordability of vaccines. It is also, crucially, about

Resolving bottlenecks in delivery

GAVI's business model involves a rigorous application process which deliberately stimulates and supports effective immunisation planning and rewards countries that succeed in raising immunisation coverage.

This approach asks countries to behave entrepreneurially, proposing solution to the perceived bottlenecks and applying cash support tactically in order to raise immunisation coverage.

GAVI's "Immunisation Services Support" was started in 2000 and continues today. It provides flexible cash support for immunisation systems through performance-based awards.

Countries can use this funding to support their national immunisation plans in a variety of ways - to train immunisers, buy refrigerators and vehicles, improve the data collection system, fund outreach to remote villages. They keep receiving awards as long as immunisation coverage continues to rise.

A recent evaluation of the first five years of this kind of pioneering support found that this approach allowed nearly 2.4 million children to be immunised with DTP3 who would have not otherwise have been had ISS expenditures been zero.

The second programme, Health System Strengthening, initiated in 2006, allows countries to address broader systems constraints through their individual health sector development plans (HSDP). GAVI HSS is also a flexible cash-based programme, offering long-term and predictable financing. It is based on plans and budgets developed by the countries themselves, and can help them implement the systems improvements they need to make sure that all children receive immunisations and other critical health services.

Both programmes are grounded in the principles of country ownership, partnership, innovation and flexibility. They too reflect market ideas of getting incentive structures right and a results orientation.

Long-lasting health service delivery platforms which are able to deliver immunisation and support child survival are a shared goal with countries and many other partners in the development field.

Recent developments suggest a unique opportunity to scale up investments - so essential to success in sustainable combat against killer diseases. The large investments in disease programmes in recent years (e.g. AIDS, malaria) have highlighted substantial neglect and under-resourcing of underlying health service delivery systems.

We are therefore also supporting the development of a more connected and coordinated international effort - the International Health Partnership. This needs concerted commitment and significant financing.

In summary

Developing vaccines is just one part of the answer - the vaccines need to be administered to the children that need them. To pay for this means predictable long-term finance. And to be sustainable, it needs prices to be affordable, and countries to commit to allocating funds to immunisation and to build enduring health service delivery platforms.

The GAVI experience is illuminating - and intended to be - we are a pilot for new ways of doing development business, and many of the programmes we operate are also pilots (like IFFIm and the AMC).

This new way of doing development business shows the power of public-private partnership to be profound. This approach needs to be extended to the broader health sector, which remains massively under-resourced in most poor countries.

Vaccines have a central, cost effective, and transforming role to play in this new approach. Bill & Melinda Gates - founder donors and creators of the GAVI Alliance - said that "childhood immunisation is undoubtedly the best investment we have ever made".

Lives can be saved, illness and disability prevented, and potential realised for educated and productive future populations. These are the healthier families that can lift their communities and countries out of poverty.

This is the promise that we all seek to fulfil.

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