Immunization, Vaccines and Biologicals

Advanced Market Commitments for vaccines

19 July 2006

What are Advanced Market Commitments for vaccines (AMCs)?

An AMC is a legally-binding agreement for an amount of funds to subsidize the purchase, at a given price, of an as yet unavailable vaccine against a specific disease causing high morbidity and mortality in developing countries. The establishment of AMCs should encourage the development of future generations of vaccines and in particular accelerate the development and availability of priority new vaccines to developing countries.

Why are AMCs needed?

Millions of people die each year from infectious diseases such as pneumococcal disease, malaria and HIV/AIDS, mostly in developing countries. However, investment by the pharmaceutical industry in the development of vaccines against such diseases is very small in relative terms. This is due to the high cost of research and development and the concern that developing countries will not be able to pay the vaccine prices required for offsetting development costs.

How will AMCs work?

The purpose of an AMC is to provide incentives to vaccine manufacturers to invest in the necessary research and manufacturing capacity needed to bring a vaccine for the developing world to market. It is envisaged that AMCs could be designed both for products at an early stage of development (such as malaria, HIV/AIDS and tuberculosis vaccines) and for late stage products (such as vaccines against rotavirus, human papillomavirus, and pneumococcal disease). A commitment of US$ 1-6 billion for each priority disease selected is considered to be an appropriate figure to ask of donors.

Concretely, through the AMC mechanism, donors would subsidize the purchase of vaccines by developing countries, up to a fixed number of sales or a fixed total amount. Once this fixed number of sales or total amount has been reached, manufacturers having benefited from the subsidy would be contractually obliged to either sell to developing countries at a price affordable over the long term or to license their technology to other manufacturers.

It is envisaged that the AMC framework will encourage not only the discovery and development of first-generation vaccines, but also the development of subsequent improved vaccines, which are more efficacious and/or are easier to distribute and use.

Donor pledges would be underpinned by national financial commitments and would complement existing public funds for research.

What are the challenges?

Among the challenges of operationalizing the AMCs in a fair and effective manner are ensuring the supply of vaccines at affordable prices and in sufficient quantities once the commitment is exhausted, and creating an appropriate balance of incentives for manufacturers of first and second-generation products. A further challenge is the development of independent, transparent and accountable public financial management and procurement systems.

It is envisaged that an Independent Assessment Committee will play a key role in ensuring that these challenges are met.

What is the position of the World Health Organization (WHO)?

  • WHO is encouraged by the AMC approach, but recognizes that it is likely to be one of a number of solutions to ensure introduction of new vaccines into developing countries.
  • WHO supports the implementation of pilot programmes for one or two vaccines to determine the effectiveness of the AMC concept.
  • WHO recommends the avoidance of duplication with existing regulatory and qualification processes and the refinement of operating mechanisms such that potential obstacles to effective implementation are addressed.
  • WHO proposes taking responsibility for: 1) establishing the criteria with which vaccines would need to comply in order to be funded through the AMC mechanism - through a transparent process of consultation which includes developing countries; and 2) verification prior to sale that candidate products meet these pre-established criteria.