Discussion of tax credits as a means of encouraging research into otherwise unprofitable vaccines for AIDS, tuberculosis, and malaria.
For a general program to combat communicable diseases of the poor to stimulate research, it must include an explicit commitment to help finance the purchase of new vaccines if and when they are developed. Without an explicit commitment along the lines proposed by Wolfensohn, it is unlikely that the large scale investments needed to develop vaccines will be undertaken.
Malaria, tuberculosis, and the strains of HIV common in Africa kill approximately 5 million people each year. Yet research on vaccines for these diseases remains minimal—largely because potential vaccine developers fear that they would not be able to sell enough vaccine at a sufficient price to recoup their research expenditures. Enhancing markets for new vaccines could create incentives for vaccine research and increase accessibility of any vaccines developed. For example, the World Bank has proposed establishing a fund to help developing countries finance purchases of specified vaccines if they are invented. The U.S. administration’s budget proposal includes a tax credit for new vaccines that would match each dollar of vaccine sales with a dollar of tax credits. This paper examines the rationale for such proposals. Private firms currently conduct little research on vaccines against malaria, tuberculosis, and the strains of HIV common in Africa. This is not only because these diseases primarily affect poor countries, but also because vaccines are subject to severe market failures. Once vaccine developers have invested in developing vaccines, government are tempted to use their powers as regulators, major purchasers, and arbiters of intellectual property rights to force prices to levels that do not cover research costs. Research on vaccines is an international public good, and none of the many small countries that would benefit from a malaria, tuberculosis, or HIV vaccine has an incentive to encourage research by unilaterally offering to pay higher prices. In fact, most vaccines sold in developing countries are priced at pennies per dose, a tiny fraction of their social value. More expensive, on–patent vaccines are typically not purchased by the poorest countries. Hence, private developers lack incentives to pursue socially valuable research opportunities. Large public purchases could potentially enlarge the market for vaccines, benefiting both vaccine producers and the public at large.
Several programs have been proposed to improve incentives for research on vaccines for malaria, tuberculosis, and HIV, and to help increase accessibility of vaccines once they are developed. The U.S. administration's budget proposes a tax credit that would match each dollar of vaccine sales with a dollar of tax credit. The World Bank has proposed a $1 billion fund to provide concessional loans to countries to purchase vaccines if and when they are developed. European political leaders have spoken favorably about the concept of a vaccine purchase fund. This paper explores the design of such programs, focusing on commitments to purchase new vaccines.
For vaccine purchase commitments to spur research, potential vaccine developers must believe that the sponsor will not renege on the commitment once vaccines have been developed and research costs sunk. Courts have ruled that similar commitments are legally binding contracts. Given appropriate legal language, the key determinant of credibility will therefore be eligibility and pricing rules, rather than whether funds are physically set aside in separate accounts. The credibility of purchase commitments can be enhanced by specifying rules governing eligibility and pricing of vaccines in advance and insulating those interpreting these rules from political pressure through long terms. Requiring candidate vaccines to meet basic technical requirements, normally including approval by some regulatory agency, such as the U.S. FDA, would help ensure that funds were spent only on effective vaccines. Requiring developing to contribute co–payments would help ensure that they felt that the vaccines were useful given the conditions in their countries. The U.S. Orphan Drug Act's success in stimulating research and development is widely attributed to a provision awarding market exclusivity to the developer of the first drug for a condition unless subsequent drugs are clinically superior. Purchases under a vaccine purchase program could be governed by a similar market exclusivity provision.
A purchase commitment program could start by offering a fairly modest price. If this proved inadequate to spur sufficient research, the promised price could be increased. This procedure mimics auctions, which are often efficient procurement methods when costs are unknown. As long as prices do not rise at a rate substantially greater than the interest rate, vaccine developers would not have incentives to withhold vaccines from the market.
The World Bank has termed health interventions costing less than $100 per year of life saved as highly cost effective for poor countries. If donors pledge approximately $250 million per year for each vaccine for ten years, vaccine purchases would cost approximately $10 per year of life saved. It is unlikely that vaccines for all three diseases would be developed simultaneously, but if donors wanted to limit their exposure, they could cap their total promised vaccine spending under the program, for example at $520 million annually. No funds would be spent or pledges called unless a vaccine were developed.
The Vaccines for the New Millennium Act (HR 3812; SR 2132) includes both enhanced R&D tax credits and a tax credit for sales of vaccines to non–profits and international organizations. The combination is likely to be effective. The enhanced R & D tax credit will provide an immediate benefit for firms doing research in the area. The tax credits for sales will provide incentives for firms to follow through by designing appropriate vaccines for the regions where the diseases are most deadly and will help increase accessability of any vaccines developed. There are several reasons why tax credits for sales of vaccines are an essential element of any package to promote vaccine R&D.
