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Value-based pricing aims to optimize incentives for pharmaceutical companies making drug development investment decisions. To promote alignment of prices and value, this chapter recommends that Medicare, Medicaid, and commercial insurers build value assessment into their coverage decisions. Before doing so, it explores alternatives that purport to make this alignment unnecessary. The first, cost-recovery pricing, reimburses drug companies for only their costs, rather than for value. While cost-recovery prices can be low, they reward high internal costs rather than better drugs. Prizes and subscription plans pay a lump sum, rather than paying for each treated patient, but they still require value assessment to set the size of the prize or subscription fee. Radical alternatives suggest having the government develop new drugs. Whether the government would be effective remains unknown. Nonetheless, it would, like private companies, have to prioritize investments, requiring something like value assessment to do so.

Civil society action in national policies in response to the AIDS epidemic since the 1980s, one of the prime examples of successful policy combining government capability and societal activism in Brazil, is examined by Elize Massard Fonseca and Francisco Inácio P. Bastos. As the basis for analysing the overall policy, they focus on government policies to guarantee access to anti-retroviral drugs, looking at the role of advocacy groups in the debate over ownership of drug patents and harm reduction policies for drug users. The World Bank's strong support for AIDS control favoured the agenda of groups and experts concerned to produce policy analyses and solutions, such as needle exchange programmes as harm reduction policy. Activism connected with the epidemic and AIDS control played an important role in information production for, and influence on, government decision-making, particularly in promoting universal access to drugs, in discussion forums on intellectual property and in the clash with laboratories over prices and local production rights.

This chapter examines bioethics issues as they have been seen by judges, most especially by the Justices of the U.S. Supreme Court and by the members of Congress, with particular emphasis on death from cancer. Dying of cancer has been considered a “hard death,” a worst-case scenario, for at least a century. Efforts sponsored by the federal government to find cures for cancer date from the establishment of the National Cancer Institute (NCI) in 1937. This chapter considers the question of whether terminally ill adult patients with cancer for whom there are no effective treatments have a constitutional right of access to investigational cancer drugs that their physicians think might be beneficial. It discusses the ruling of the Court of Appeals for the District of Columbia in the case pitting the Abigail Alliance for Better Access to Developmental Drugs against the Food and Drug Administration.