Table 1

Leveraging the lessons learnt from previous AMCs to new models

Key factorAMC pilot for pneumococcal vaccinesMVAC for TB
Time frame for meeting the TPPShort, as products were in late stage of developmentLong, as potential candidates are in pre-clinical/early stage of development
TPPProduct specifications defined by WHO experts including minimal characteristics to get rewardProduct specifications defined by country payers, drawing on expert advice. Expert group to decide (as part of the governance) the minimum characteristics to get some reward. There are proposals around the minimum TPP, but these need to be reviewed and endorsed by the technical committee and ultimately by the countries.
PriceInitial AMC price (paid by donors to recover manufacturing investment) of $7, subsequently reduced to a tail price of $3.50, set at an estimate of the marginal cost of production. The $3.50 became the minimum price.Price based on health technology assessment (HTA) value assessment of the TPP and on local ability to pay of BRICS. Different prices in different countries. Prices adjusted to reflect percentage of TPP met in practice by the products.
  •  Non-exclusive scheme to cover first-generation and second-generation products

  •  Initial contract not to take all of the commitment

  •  Companies could compete on price and quality

  •  Effectively, however, rewarded two companies

  •  Non-exclusive scheme to cover first-generation and second-generation products

  •  Companies can in principle compete on price and quality; however, complexity of meeting TPP means combinations are likely and competition unlikely.

Countries it is designed forDesigned to engage donor countriesAll except HICs, with a focus on large MICs, but in particular countries transitioning away from aid; TB burden concentrated in large MICs and low-income countries
  •  WHO experts defined the TPP

  •  Gavi served as secretariat and supported eligible countries to purchase the product

  •  The World Bank guaranteed the AMC fund

  •  UNICEF managed the supply agreements

  •  Global secretariat (to be determined) and decision-making function on key scheme elements

  •  Advisory/expert committee (with MICs, global TB and HTA experts, donors, other stakeholders) to provide recommendations on the extent to which the new product meets the TPP

Role of companies (developers and/or manufacturers)
  •  Enter the AMC Registered Manufacturers Agreement

  •  Scale up manufacturing capacity to meet Gavi-eligible countries’ demand for 10 years

  •  Register interest at an early stage

  •  Develop and submit regulatory and HTA dossiers for the new product

  •  Commit to developing manufacturing capacity for the agreed period of time and price

  •  Show willingness to engage in a commercial agreement involving post-launch evidence collection

Who bears the risk?
  •  Manufacturer bore R&D and manufacturing risk, donor bore volume risk

  •  Multilateral development banks (MDBs) underwrite, companies bear R&D risk, countries bear volume risk (ie, commit to buying a certain value of the product)

Role of donors
  •  AMC definition and governance (WHO, Gavi, UNICEF)

  •  Price top-up to reward innovation (global donors)

  •  Facilitate scheme establishment

  •  Help mobilise political support for the proposal

  •  Potentially help cover costs for MVAC secretariat; subsidise or cover commitment fees for MDB guarantees; provide research grant funding for BRICS research bodies

Role of LMICs
  •  Originally expected to contribute with a co-pay as a share of the tail price but in practice this has been met by global donors

  •  Actively involved in the definition of the scheme

  •  Committing to pay a predefined price for a predefined volume based on their budget constraints and value offered by the prospective intervention(s)

Role of financing intermediaries
  •  Donors guaranteed funding to Gavi. No intermediary.

  •  Potential role for an MDB to provide loan financing to assist in guaranteeing the recipient commitments

  • AMC, Advanced Market Commitment; BRICS, Brazil, Russia, India, China and South Africa; HICs, high-income countries; LMICs, low- and middle-income countries; MICs, middle-income countries; MVAC, market-driven, value-based advance commitment; R&D, research and development; TB, tuberculosis; TPP, target product profile.