manufacturing practice standards. Ongoing quality control is critical in vaccine manufacture, since tests of the final product may not detect certain deficiencies.

Even if the technological feasibility of a vaccine product is established, commercial manufacturers may be unwilling to pursue development. The anticipated costs associated with R&D may be too high, patent issues may be too complex, the licensing process may present unacceptable obstacles, and the risks of liability may appear too great.

MARKET CONSIDERATIONS

Private-sector vaccine manufacturers in the United States pursue the development of vaccines that are both technologically feasible and that have a profitable market in industrialized countries (see Table 4-12). No additional incentives are needed, provided that companies are assured an adequate return on their investments.

In some instances, a company may be willing to undertake the development of a vaccine that is needed primarily in the developing world, provided that there are predictable markets of sufficient size and profitability. Such markets include U.S. armed forces, U.S. travelers, and wealthy segments of indigenous populations. In other instances, the development of new vaccines or improvements in existing vaccines cannot be justified economically or legally by commercial vaccine manufacturers.

Commercial enterprises cannot be expected to engage fully in a venture, such as the Children's Vaccine Initiative (CVI), that does not offer much hope of a return on investment. The primary objective of any business corporation, including pharmaceutical companies, is to enhance returns for its shareholders (American Law Institute, 1992). The legal system once forbade corporations from diverting resources away from maximizing returns for any reason at all. For example, in 1919, the Michigan Supreme Court rejected an effort by Henry Ford to reduce the price of his cars to benefit consumers, articulating the then prevailing view on corporate responsibility: "A business corporation is organized and carried on primarily for the profit of the stockholders. The powers of the directors is to be exercised in the choice of means to attain that end, and does not extend to a change in the end itself, to the reduction of profits, or to the nondistribution of profits among stockholders in order to devote them to other purposes" (Dodge v. Ford Motor Co., 204 Mich. 459, 507, 170 N.W. 668, 684, 1919). The legal system has evolved to accept that corporations "may devote a reasonable amount of resources to public welfare, humanitarian, educational, and philanthropic purposes" (American Law Institute, 1992). Many pharmaceuti-



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