A comment to Anita Hardon’s critical look at GAVI

By Tore Godal, Executive Secretary, GAVI

This requires further thinking, critical analysis and debate. We welcome HAI’s interest in immunization in general and in GAVI in particular.

Let me give some background to GAVI. The Alliance was formed and started to develop in 1999, the year before its official launch at Davos. Its history goes back to a meeting initiated by the head of the World Bank, Jim Wolfensohn, in 1998. The reason for these meetings among concerned partners was the issues that Hardon mentions; immunization rates in the poorest countries stagnating or going down after the earlier successes of EPI which raised the global immunization rates from below 5% in the early 1970s to around 80% in 1990. In addition it was found that the divide between the industrialised countries and the low-income countries in the number of vaccines offered to their children was growing. In most high-income countries today children get 11 or 12 immunizations while most low-income countries still stay with the traditional 6 EPI antigens.

These concerns and the will to change the downward trends led to the establishment of the Alliance. This was before any promise of grants from the Gates’ Foundation or from anybody else. The Alliance would have been established regardless of these funds. However, after the actual establishment of the Alliance, in 1999, the Bill and Melinda Gates Foundation provided their initial contribution as a result of which the Global Fund for Children’s Vaccines (the Fund) was established. This fund which has grown further after additional large contributions from a number of governments, including Norway and the Netherlands, has provided the Alliance with a powerful tool in its quest to revitalise immunization.

In addition to its support to countries the Fund also serves as a catalyst leveraging additional technical and financial contributions from the Alliance partners. It has been specifically designed not to replace investments from others nor to support all of the activities that are required.

It is important to note that the Alliance is more than the Fund. The Alliance partners share a common vision and are working to establish common priorities and plans. This is done through in-depth analysis in areas of mutual interest e.g. safety of injections and sustainability and the subsequent establishment of common Alliance policies and guidelines. Common agendas are thus promoted and duplication of efforts avoided.

Equity

The Alliance has a broad and inclusive definition of equity with its ultimate aim being that all children in all countries should have access to all immunizations that are epidemiologically justified.

Firstly inequities between countries are addressed by providing the poorest countries with support (eligibility defined as GNP/cap below 1,000 $). The idea is to make the immunization systems as part of primary health care more robust, help countries to increase their coverage to at least 80% and assist them to introduce the newer vaccines that are justified on the basis of disease burden and cost-effectiveness.

Secondly, inequities within countries are addressed through the one of the milestones of the Alliance which states that one objective should be that 80% of countries should reach 80% coverage in all districts. Country averages of immunization coverage will not be sufficient to monitor this milestone, district information will be required to ensure that countries move towards this equity objective.

Support to health services strengthening and new vaccines

A main role of the Alliance is to challenge all partners to work together to strengthen and expand immunization programmes as part of national health systems to reach more children with more antigens.

In order to obtain support from the Fund countries are required to ensure a well-functioning mechanism for co-ordinating all of their partners in their support for the national immunisation programmes. Partners are currently investing in strengthening these co-ordination mechanisms. Countries are also encouraged to work with their partners to conduct assessments of the national programs and develop long-term plans to improve and expand their programmes.

Countries may apply for support which is adapted to the strength of their health and immunization services. Countries with weak health systems are only eligible for support from the sub-account for immunization services. This is a financial support which can be used to strengthen their health systems in whichever way is most effective. When countries reach a DTP3 coverage of 50% they are also eligible for support for new and under-used vaccines.

No country will be awarded support unless they fulfil basic criteria such as having a recent immunization assessment, a multi-year plan and a functioning Inter-agency Co-ordinating Committee. They are also required to have targets for increased coverage and, if eligible, plans for the introduction of the new vaccines. The assessment of country proposals is done by an independent review committee composed principally of developing country experts with significant experience of managing and evaluating immunization and health programmes.

The Alliance initially focused its efforts are supporting the poorest performing countries. It is currently exploring the optimum way for the partners and the Fund to support countries with strong programmes (DTP3>80%) in their efforts to expand their programmes.

After the first three rounds of reviews and decisions approximately 28% of commitments are provided from the sub-account for immunization services and 72% from the sub-account for new and under-used vaccines. With present policies it is likely that the funding of immunization services will rise to about 1/3 of total commitments.

Our experience to date suggests that countries have set their priorities based on disease burden, the cost of the different interventions and the availability of funding. As indicated above most eligible countries have chosen to introduce hepB vaccine with its relatively well recognised disease burden and a price within the range of the traditional EPI vaccines. On the other hand few countries have chosen to introduce the more expensive Haemophilus influenzae type b, Hib, vaccine. Data on the disease burden of Hib is often not available and may be difficult to determine. As a result many countries have requested support for rapid assessment of Hib disease burden in order to get a scientific basis for making any decision on the introduction of Hib vaccine.

Partnership with industry

At the beginning of this century new ways are being sought to forge public-private sector partnerships in order to reach the internationally agreed development goals. In the area of immunization the partnership with industry is an effort to explore if such a relationship can assist in providing the children in the developing world with more vaccines, and with newer vaccines in presentations that facilitate the delivery of vaccines in low-capacity countries, more rapidly and at lower cost than otherwise would be the case.

The particular difficulty in this case is to combine the lowest-cost-for-the-poorest-countries approach with a stimulus for industry to increase their investment in research for orphan drugs or vaccines. When diseases are heavily concentrated in poor countries, the incentives for R&D are extremely weak with the result that today these diseases are far from receiving the research investment that is epidemiologically justified.

So far the most effective method to gain the lowest possible price for the developing world has appeared to be through the vehicle of tiered pricing. The GAVI Board has adopted this system whereby vaccines for the poorest countries will be obtained at the lowest prices.This means in practice that individual vaccine manufacturers have discounted their prices in response to the unique economic conditions of the developing countries.

For example monovalent hepB vaccine can now be obtained for a price below 30 cents a dose, almost half of what it was previously.

The multinational pharmaceutical industry, as a member of the Alliance, has one seat on the GAVI Board. In addition the developing country industry has got one seat, presently representing the (state owned) Cuban pharmaceutical industry. Thus currently the public sector has got 12 seats plus the chair, the NGOs 2 seats and the private industry 1 seat on the Board.

It could also be noted that out of 8 contracts awarded in the first tendering procedure, 6 went to producers in low- and middle-income countries (South Korea, India, Indonesia).

Subsidies to specific companies are not being considered.

Sustainability

This is an issue of great concern to the Alliance. Obviously there is a potential goal conflict between on one hand the equity objective of providing all children as soon as possible with the immunizations we believe they have the right to get and on the other ensuring that poor countries are not forced into later costly undertakings which they can ill afford to sustain.

The Alliance has tried to deal with these issues in the following way:

• Providing firm five year commitments for contributions to countries (this is a longer time perspective than most if not all donor agencies would apply);
• Broadening the sustainability perspective to encompass also long-term stable commitments from other partners, including MDB loans;
• Exploring new instruments for long-term financing such as trust funds;
• Requiring countries to take steps to plan for sustainability and ultimately specific financial sustainability plans;
• Exploring the potential of new indicators of sustainability;
• Monitoring financing of immunization by governments and partners.

Accountability

The Alliance has instituted a new method of supporting countries that firmly puts the governments in the drivers’ seat and makes them accountable for performance. Only governments can apply for support from the Fund. The innovative aspects are that;

• governments have the liberty to use the support in whatever way that leads to the planned result, and
• through a strict performance based award system they will be held accountable for outcomes.

The review process has demonstrated that governments in general are conscious of their responsibility, apply for support and go to work to improve their systems with a great sense of seriousness and urgency.

For countries which are not by their own able to improve their immunization services special mechanisms are being put in place by the partners to provide additional support and capacity strengthening. A special analysis of need is currently undertaken for countries in complex emergency situations.

Accountability within the Alliance itself is a function of the fact that the Board members each represent constituencies with various means of ensuring their accountability. For the multilateral organisations their representatives Dr. Gro Harlem Brundtland, Ms. Carol Bellamy and Mr. Jim Wolfensohn obviously are accountable to their member states through the various governance mechanisms of each organisation.

Transparency

The Alliance is in favour of and tries to adhere to principles of maximum transparency. Board minutes as well as other documents that could be of general interest are posted on the GAVI website: www.vaccinealliance.org.

At Nordwiijk the GAVI Board meeting was videotaped and could be followed live in a neighbouring room by any participant.

Results of the first tendering process including prices obtained and quantities ordered will be made public.