​US Tropical Disease Priority Review Vouchers: Lessons In Promoting Drug Development And Access.

The COVID-19 global pandemic has devastated lives and economies. It has served as a reminder of how critical it is to invest in preventing and treating infectious diseases. Until the COVID-19 pandemic, the largest US government-sponsored reward for infectious disease drug and vaccine development was the Tropical Disease Priority Review Voucher program. Under this program, the Food and Drug Administration awards a priority review voucher to the sponsor of a new drug or vaccine for tropical infectious diseases. The voucher then can be exchanged for the faster review of one drug. We provide case studies for tropical disease voucher recipients between 2007 and 2018, examine the effects of the voucher program on product innovation and access, and recommend that policy makers protect the voucher program while creating complementary incentives.

How Should the World Pay for a Coronavirus Disease (COVID-19) Vaccine?

The potential health and economic value of a vaccine for coronavirus disease (COVID-19) is self-evident given nearly 2 million deaths, "collateral" loss of life as other conditions go untreated, and massive economic damage. Results from the first licensed products are very encouraging; however, there are important reasons why we will likely need second and third generation vaccines. Dedicated incentives and funding focused explicitly on nurturing and advancing competing second and third generation vaccines are essential. This article proposes a collaborative, market-based financing mechanism for the world to incentivize and pay for the development of, and provide equitable access to, second and third generation COVID-19 vaccines. Specifically, we propose consideration of a Benefit-Based Advance Market Commitment (BBAMC). The BBAMC uses health technology assessment to determine value-based prices to guarantee overall market revenues, not revenue for any specific product or company. The poorest countries would not pay a value-based price but a discounted "tail-price." Innovators must agree to supply them at this tail price or to facilitate technology transfer to local licensees at low or zero cost to enable them to supply at this price. We expect these purchases to be paid for in full or large part by global donors. The BBAMC therefore sets prices in relation to value, protects intellectual property rights, encourages competition, and ensures all populations get access to vaccines, subject to agreed priority allocation rules.

Leave No One Behind: Using a Benefit-Based Advance Market Commitment to Incentivise Development and Global Supply of COVID-19 Vaccines

From the Executive Summary: The global effort to control the COVID-19 [coronavirus disease 2019] pandemic has seen an exceptional allocation of public and philanthropic funds to advance the development of diagnostics, therapeutics, and vaccines as quickly as possible. While critical, even these significant commitments represent only a 'down payment' on a price tag that could eventually exceed $50 billion just to scale the production of vaccines to control this global pandemic--amounts that cannot be raised through traditional donor and philanthropic commitments. High-income countries (HICs) can afford to compete for products, and if their taxpayers are willing to contribute, traditional donor funding approaches can help low-income countries (LICs) through mechanisms such as the GAVI [Gavi, the Vaccine Alliance]-proposed Advance Market Commitment (AMC). However, billions of poor people who live in middle-income countries (MICs) ineligible for donor funding are at risk of being left out. Any exclusion will undermine the effort to control the virus. Further, MICs are key actors in the global supply and production chain, and we will require an unprecedented level of collaboration between governments and with industry to develop and rapidly manufacture global supplies of a vaccine. No country has all the science, equipment, and capacity on its own soil to research, develop, manufacture, and supply a vaccine to all its citizens, let alone the whole world.COVID-19 (Disease);Vaccines;International cooperation