PROPOSED DESIGN FEATURES

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In 2005, the Report of the Center for Global Development’s (CGD) AMC Working Group recommended the creation of an AMC, which attempted to replicate the pharmaceutical market conditions and incentives existing in developed countries, in order to incentivize commercial research, development and production of vaccines targeting developing country diseases (Barder, Levine, and Kremer 2005).

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The AMC proposal had the following key elements: creating an approximately USD 3 billion-worth market for suppliers, providing a guaranteed floor price for a fixed quantity as well as co-payments from sponsors topping-up the amounts purchased by developing countries, defining the specifications for the expected vaccine, committing the suppliers to a specified long-term selling price for the vaccines, making vaccine purchase dependent on actual demand from developing countries, and having an “independent adjudication committee” to resolve potential disputes.

 

The AMC was intended to address both the lack of R&D for vaccines targeting developing country health needs and the problem of low manufacturing volumes and high prices of vaccines, both linked to the limited expected market size in developing countries (Barder, Levine, and Kremer 2005).

 

Berndt et al. (2007) calculated that, for an AMC to offer comparable revenues as generated by commercial pharmaceutical products, it should offer an estimated net present value of USD 3.1 billion  in revenues (Berndt et al. 2007).  Barder, Kremer, and Williams (2006) argued that the AMC was a cost-effective means of addressing the lack of R&D on vaccines for neglected diseases (Barder, Kremer, and Williams 2006).

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DESIGN ISSUES

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Some papers identified and examined issues concerning the conceptual design of AMCs, such as: (i) credibility of offer, (ii) identifying in advance the product requirements, purchase price and quantity,  (iii) handling products developed after the first entrant, (iv) susceptibility to politically-motivated influence and (v) limited to pre-selected targeted diseases and treatments (Towse and Kettler 2005;  Berndt and Hurvitz 2005; Ravvin 2008). Whether the products dealt with are “technologically close” or “technologically distant” has been noted to affect the ideal design of AMCs (Kremer and Williams 2010; Kremer, Levin, and Snyder 2015)

 

Sonderholm (2010, 2011) argued against the AMC recommended by the CGD based on the following rationale: (i) it is demand-based, which can lead to wasting of funds on “medically inferior products” if demanded by governments for “non-medical reasons”, e.g. cultural norms, instead of a similarly priced “medically superior product” in the situation of multiple licensed products (Sonderholm 2010), and (ii) it has features amounting to a “winner takes all” situation observed in prize proposals (Sonderholm 2011). Light (2005) argued that the CGD’s AMC model would fail to ensure the sustainability of the supply of vaccines (Light 2005). Light (2009) also argued that the pilot AMC was in reality an “advanced purchase commitment,” which did not address the need for R&D efforts for new vaccines, and maintained the status quo of strong intellectual property monopolies over medicines (Light 2009).

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IMPLEMENTATION OF PILOT AMC

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In 2009, the pilot AMC for pneumococcal vaccines (PCV) was launched. It had a funding pledge amounting to USD 1.5 billion from 5 governments and the Bill and Melinda Gates Foundation (BMGF), and was implemented by GAVI, the World Bank, United Nations Children’s Fund and World Health Organization. The AMC was legally binding in character, and invited vaccine producers to bid to supply a share of the annual estimated demand of 200 million doses of PCV for a period of 10 years. Chosen producers were bound to set their vaccine purchase price, paid for by GAVI and participating countries, at a maximum amount of USD 3.50 per dose, which is referred to as the “tail price.” Further, for about 20% of the initial supply, the producers were additionally compensated through AMC funds in order to bring the total vaccine price to USD 7. A notable feature of the AMC was that payment would only be triggered if a vaccine was actually developed, manufactured and subsequently purchased by developing countries (Hargreaves et al. 2011).  Annual reports on the pilot AMC covering the period between 2009 to 2017 are available here: https://www.gavi.org/funding/pneumococcal-amc/. GAVI commissioned evaluations of the performance of the pilot AMC in 2016 as well as its process and design in 2013, which are available here: https://www.gavi.org/library/gavi-documents/evaluations/.

 

Hargreaves et al. (2011) noted that, while the AMC was originally conceptualized to promote R&D for malaria, tuberculosis and HIV vaccines, the pilot AMC focused on PCV which had either already been marketed or was about to obtain regulatory approval in the US; therefore, the AMC could facilitate access for developing countries by encouraging regulatory compliance and manufacturing capacity among PCV suppliers (Hargreaves et al. 2011). Cernuschi et al. (2011) discussed two challenges of the pilot AMC: encouraging effective participation among developers of first and second-generation vaccines, and dealing with uncertainties in demand and donor-reliant funding (Cernuschi et al. 2011). In conducting an initial economic evaluation of the pilot AMC, Synder, Begor, and Berndt (2011) concluded that AMCs offering higher profit margins would proportionately increase manufacturers’ interest in R&D of new pharmaceutical products (Snyder, Begor and Berndt 2011).

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CRITICISMS OF PILOT AMC

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The AMC has also been critiqued. Plahte (2012) provided initial findings on the impact of the pilot AMC, and concluded that the design of the AMC was unsuitable to vaccine producers from developing countries, the development of the PCV vaccines manufactured by GlaxoSmithKline (GSK) and Pfizer were not induced by the creation of the AMC and that there was a lack of evidence to back the creation of subsequent AMCs (Plahte 2012). Wilson (2010) argued that the vaccines procured through the AMC could also have been bought at a lower price with existing procurement mechanisms, i.e. through UNICEF. Médecins Sans Frontières (2011) noted that the pilot AMC was not only purchasing the vaccines from GSK and Pfizer at £2 per dose but also subsidizing each company with £137 million. MSF argued that these subsidies were unwarranted considering that these vaccines were sold in both developed and developing countries, and had long been commercially available (Médecins Sans Frontières 2011). Light (2011) argued that the AMC faced a funding challenge because that GAVI agreed to (i) decrease the co-payment amounts by the majority of eligible countries to about $0.30 and (ii) to shoulder a “tail price ceiling” of $3.50, which was too high (Light 2011).

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OTHERS

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Some authors view the Health Impact Fund as an expanded form of AMC (Hollis 2008; Banerjee, Hollis, and Pogge 2010).

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RESEARCH GAPS

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• Study of effectiveness of AMCs in driving early-stage and/or late-stage R&D for vaccines and other pharmaceutical products

• Analysis of AMC’s ability to incentivize supplier competition and provide security of supply

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CITED PAPERS WITH ABSTRACTS​