AMC Structure

AMC Structure

The Advance Market Commitment pilot will engage donors (five nations plus the Bill & Melinda Gates Foundation), developing country governments, the World Bank, and the GAVI Alliance partners (including the World Health Organization and UNICEF) in a program that will bring millions of pneumococcal vaccines to the children that need them, 15-20 years before these life-saving vaccines would ordinarily have been accessible to developing country markets.

The AMC Structure section of the website contains information on the groups engaged in the pilot AMC, the processes and legal agreements involved, and how the AMC pilot will be managed.

AMC Donors

click to enlarge

Donors to the pneumococcal pilot will subsidize the cost of vaccines during the AMC period.

On 9 February 2007, Canada, Italy, Norway, Russia, the United Kingdom, and the Bill & Melinda Gates Foundation committed US$1.5 billion to launch the first Advance Market Commitment (AMC) to help speed the development and availability of pneumococcal vaccines which are expected to save the lives of 5.8 million children by 2030.

AMC Donor Committee

Following the launch event, donors have formed a committee to establish the AMC structure and guide the development of the AMC. The Donor Committee has been established to allow AMC sponsors to efficiently provide input into the technical design and processes for the AMC during the establishment phase and to allow monitoring of its implementation and progress toward the AMC’s objectives.

World Bank

The World Bank is the world’s largest source of development assistance, providing nearly $30 billion in loans annually to its client countries. The Bank uses its financial resources, its highly trained staff, and its extensive knowledge base to individually help each developing country onto a path of stable, sustainable, and equitable growth.

The World Bank and GAVI

The World Bank is a partner in the GAVI Alliance. The Bank is committed to increasing its contribution to immunization through (i) enhancing its policy dialogue with ministries of finance and ministries of health and other partners to encourage recognition of the value of immunization and new vaccine development; (ii) expanding its loans and credits in support of immunization; and (iii) consulting and working with public and private sector partners to create new financing options to accelerate the development of an HIV/AIDS vaccine and other priority vaccines, such as against malaria or tuberculosis.

The World Bank’s role in the Advance Market Commitment

The GAVI Alliance and the World Bank will be responsible for supporting the programmatic and financial functions of the AMC. Specifically, the World Bank will:

• Provide financial and fiduciary administration.
• Manage donor commitments and AMC disbursements.

Developing Countries

click to enlarge

Developing country governments participating in the pneumococcal pilot will cover an increasing proportion of the cost of vaccines during the AMC period and beyond.

Countries are put into one of four mutually exclusive groupings.

Poorest

Latest GNI under $1000/capita
Classified by the UN as "least developed country"

Intermediate

Latest GNI under $1000/capita
NOT classified by the UN as "least developed country"

Least Poor

Latest GNI over $1000/capita
Eligible GAVI countries which had a GNI number under $1000 in 2003, have gone above in 2005.

Post conflict / Fragile

GAVI eligible country meeting post conflict/countries in crisis criteria. This is independent of the GNI/capita.

The GAVI Alliance

click to enlarge

GAVI's contribution will be through co-financing during the AMC period. The co-financing amount paid by GAVI is based on 1) the total price of the vaccine, 2) the number of vaccines demanded by a country, and 3) which category of GAVI-eligibility the country falls under (see "Developing Countries").

GAVI helps support needed associated activities to strengthen the delivery and health systems that ensure the vaccines get to the children who need them. GAVI, with its immunization mandate, is the programmatic leader on AMCs, ensuring technical support to developing countries and providing linkages with immunization stakeholders. GAVI’s work includes hosting the AMC Secretariat, linking with countries to assess demand, managing the procurement process, and supporting the establishment and the on-going processes of the Independent Assessment Committee.

GAVI Co-financing policy

The objective of co-financing is to encourage rigorous evidence-based national decision-making, greater investments in immunization from governments and partners and to help countries aim at financial independence, given that GAVI support is time-limited. The financing requirements of the vaccine and co-financing commitments of the country should be included in the application to GAVI and corresponding national immunization program comprehensive multi-year plan.

Vaccine Approval Process

There are two important bodies involved in the process of determining AMC vaccine eligibility: the World Health Organization (WHO) and the Independent Assessment Committee (IAC). The WHO will facilitate the establishment of the Target Product Profile (TPP) and assess the quality, safety and immunogenicity of AMC vaccines. The IAC is a group of experts responsible for deciding whether a product meets the TPP standards and is eligible for AMC funding.

Supply Agreement

A supply agreement is a binding agreement between GAVI, a vaccine supplier, and the vaccine procurement organization that specifies:

• Post-AMC Price
• Post-AMC supply period duration and volume commitments (formula based on rolling demand average)
• Supplier reporting obligations and change request procurement
• Fulfillment arrangements, GAVI Fund Liabilities, and payment arrangements

After the AMC’s funds have been spent there will be a “tail period” during which time the manufacturer will continue to supply vaccines at a pre-established price. During the tail period and beyond it is expected that the prices will be lower since firms will have recouped their investments to supply the developing countries, and perhaps due to additional competition from developing country suppliers.

Other Agreements

The specific legal agreements will include:

click to enlarge

• AMC Terms & Conditions (will be attached to other AMC legal documents)
• Offer Agreement
• Stakeholders Agreement
• Donor Grant Agreements
• GAVI-WHO Memorandum of Understanding
• IAC Charter
• IAC Bylaws

Click on the chart for a larger view with descriptions of each agreement and the parties involved.

Vaccine Procurement

Following the signing of a supply agreement with a manufacturer that is deemed to have an eligible product for AMC support, procurement of the vaccine will occur through UNICEF. As a core GAVI partner UNICEF has carried out vaccine procurement for GAVI since the inception of the Alliance in 2000. The UNICEF Supply division is based in Copenhagen.

The supply contract with the given manufacturer will include the procurement period of the AMC period as well as the post-AMC (“tail”) period and will require manufacturers to make a long-term commitment to availing the vaccine. The AMC fund provides for the cost of the vaccine – the syringe and shipping charges are provided by GAVI which also provides a procurement fee to UNICEF for its services. The coordination of the procurement is done through GAVI’s country support unit, which works with the countries to determine the exact number of doses and schedule delivery of the vaccine. UNICEF is responsible for delivering the vaccine to the port of entry. Following that, countries together with their partners in country ensure the vaccine is delivered to health clinics.

WHO

The World Health Organization (WHO) is the directing and coordinating authority on international health within the United Nations’ system. WHO experts produce health guidelines and standards, and help countries to address public health issues. WHO also supports and promotes health research. WHO is a key player in global immunization through its network of nearly 450 immunization professionals present in headquarters, six regional offices and 67 countries. WHO’s Department of Immunization, Vaccines and Biologicals is charged with ensuring that all people at risk are protected against vaccine-preventable diseases. The Department’s work covers a range of activities including standard-setting, research and development, vaccine regulation and quality, vaccine supply and immunization financing, and immunization system strengthening.

For every new vaccine, The Strategic Advisory Group of Experts (SAGE) is charged with advising WHO on overall global policies and strategies. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases. The only difference between SAGE endorsement of AMC-funded vaccines and the traditional vaccine evaluation process is that in the case of the AMC, candidates must meet additional criteria specified in the target product profile.

In the case of the AMC, three major roles were identified for WHO: (i) to provide SAGE approved recommendations on the vaccine target product profile (ii) to conduct the prequalification process for AMC-eligible products to be purchased through United Nations agencies; and (iii) to provide technical advice on evidence-based decision-making, priority setting, the introduction of new vaccines, and health-system financing to governments of AMC-eligible countries.

Target Product Profile (TPP)

In order for a vaccine to be considered eligible for GAVI support, it needs to meet Target Product Profile criteria and be approved by the IAC. The TPP is under development for pneumococcal vaccines. The work is being undertaken by an ad-hoc expert advisory committee assembled by the World Health Organization (WHO).

The TPP will be described in terms of public health impact (level of effectiveness or efficacy, as appropriate, in the target population against a defined endpoint). Limits will be set on minimum duration of immunity and maximum required effectiveness against invasive disease isolates. The TPP will take into consideration available delivery systems in terms of immunization schedule (number of doses and timing of vaccination), route of administration, temperature sensitivity of the product, presentation, and absence of interference with other essential health interventions in the target population.

Once a vaccine is provided, the Independent Assessment Committee (IAC) would determine whether or not it met the TPP, making it eligible for AMC funding. Approval by the IAC would enable a manufacturer to sign on to the Supply Agreement.

SAGE

The Strategic Advisory Group of Experts (SAGE) is an immunization advisory group established by the WHO. In the context of the pilot AMC, SAGE recommended that pneumococcal conjugate vaccine in national immunization programs should be a priority.

Going forward, the role of SAGE is to review and endorse the TPP. Once the TPP working group recommendations are confirmed by SAGE, they become official WHO policy.

Pre-qualification

click to enlarge

A vaccine is submitted for prequalification when there is an interested UN procurement agency buyer. The product is prequalified using an established process and based on three criteria:

1. meeting the specifications (for presentation, packaging, shipping criteria, etc.)
2. meeting the specifications of the relevant WHO “requirement” or ECBS guideline. (The ECBS guideline is a guideline outlining production requirements developed through WHO’s Expert Committee on Biological Standardization.)
3. for newer vaccines, meeting the performance standards outlined in the WHO policy recommendation, developed generally through expert consultation and approved by the SAGE, relevant to field performance.*

* Modifications to current WHO process will be considered to accommodate the AMC process.

Independent Assessment Committee (IAC)

The Independent Assessment Committee (IAC) is the principal decision-making group regarding the eligibility of a vaccine for the Advance Market Commitment. The IAC is the cornerstone of this process and is responsible for determining the Target Product Profile (TPP) evaluation process. The IAC ensures that the decision of whether a product meets the TPP (and is eligible for AMC funding) is fair, transparent, and credible to all signatories of the Framework Agreement and other stakeholders.

Functions of the IAC

The specific responsibilities of the IAC include (i) oversight of the establishment of TPPs; (ii) monitoring and reporting scientific progress throughout the process; (iii) modification of TPPs if appropriate; (iv) oversight of the determination of whether a product meets the TPP; (v) resolving disputes.

Expertise

The IAC reflects a balance of significant experience in several areas of expertise deemed necessary to carry out the duties of the IAC, including public health, health economics, vaccine business development, contract law, and clinical performance and delivery systems.

Membership

Evaluation of candidates has been undertaken by a selection panel composed of five international leaders on global health issues.
IAC Selection Process (PDF, 175Kb)

IAC TORs

IAC TORs (PDF, 180Kb)

Vaccine Delivered

Photo credit: UNICEF 2006, Josh Estey

With its long-term, sustainable impact, the AMC would prevent 500,000-700,000 deaths during the AMC itself and roughly 5.8 million deaths by 2030.

The current donor commitment will make $1.5 billion available to purchase country-demanded pneumococcal vaccines that meet pre-determined performance standards at a pre-established price. Purchases would continue until the AMC fund is exhausted in 9 or 10 years time. After the AMC’s funds have been spent there will be a “tail period” during which time the manufacturer will continue to supply vaccines at a pre-established price.

AMC Secretariat

The AMC Secretariat will provide all the necessary operational support required to manage all phases of the AMC pilot project lifecycle.

Responsibilities of the Secretariat

The AMC Secretariat, in collaboration with the members of the GAVI Secretariat will:

• Provide operational support for the functions of the AMC Disease Expert Group.
• Provide support for the establishment and operational of the Independent Advisory Committee.
• Convene the AMC Disease Expert Group and Donor Group Meetings.
• Report to donors regularly and periodically on the progress of the AMC pilots.
• Liaise with WHO on the prequalification of the vaccines, aggregation of country demand.
• Liaise with UNICEF Supply Division on the procurement of vaccines and other associated supplies.
• Track country co-payments.
• Submit to external monitoring and evaluation of the AMC pilots.
• In consultation with the five principals of the AMC, develop and support the implementation of the long- term strategy for AMC vaccine candidates.

Management

The AMC Secretariat will be managed by two key personnel: the AMC Manager and the AMC Technical Officer. As part of the GAVI Secretariat, they will be housed within the strategy and policy section, overseen by the Deputy Executive Secretary.

Contact the AMC Secretariat

Catherine Wachira, AMC Manager
cwachira@gavialliance.org
+41 22 909 7168

Tania Cernuschi, AMC Technical Officer
tcernuschi@gavialliance.org
+41 22 909 7167