Meanwhile, vaccine researchers have made little progress developing an AIDS vaccine. AIDS treatment as it is carried out today is unsustainable, noted Tadataka (Tachi) Yamada, president of the Gateses' Global Health Program; 45 million individuals are infected with the disease, and all ultimately will need second-line treatment, a situation that already is creating tension about access to these more effective therapies. It will be a "great failure of modern medicine," Yamada commented at BIO, if collaborative efforts do not succeed in this area.

Ensuring Access

While new vaccine development is encouraging, these successes also raise concerns about global distribution and access. Most vaccine manufacturing takes place in Europe and the United States, which will demand first access to products in the case of disease outbreak. Indonesian health officials recently raised the issue by demanding access to vaccines developed with the help of bird flu viral samples collected from the country's sick patients.

National leaders at the G8 summit in Germany last month pledged added support to fight AIDS and other third world diseases, spurred partly by President Bush's proposal to double funding of the President's Emergency Plan for AIDS Relief (PEPFAR) to $30 billion over five years. The G8 members urged the pharmaceutical industry to provide access to HIV medicines at affordable prices and to support local production by voluntary license.

Such comments reflect growing international support for compulsory licensing of critical drugs considered too expensive for global use. To avoid such demands, Yamada advised, industry must articulate clear, rational pricing policies based on no-profit pricing. He advised manufacturers to make treatments available in the poorest regions at $1 or less a dose, with price differentiation for rich, poor, and in-between nations. There's no reason, said Yamada, why a more industrialized nation such as Brazil should demand the same price as, say, Rwanda. But failure to make drugs and vaccines affordable in a rational way, he said, "could be the death knell of this industry."

Merck's "affordable pricing" policy, for example, offers no-profit prices for its antiretrovirals to those countries ranked lowest on the United Nations Development Program's Human Development Index (HDI)—a category that does not include Brazil or Thailand. Most pharma companies similarly offer no-profit prices and free technology transfer to help local drug manufacturers produce generic medicines.

Even no-profit prices, however, may be too high for many poor nations. Most large-scale vaccination programs require subsidies from donor organizations to ensure a large market for lower-priced treatments. PATH has launched a program to provide HPV vaccines to developing nations where cervical cancer screening is sparse and the disease highly lethal. The initiative involves pilot programs to test effective educational and distribution approaches for HPV vaccines from both Merck and Glaxo, which will set the stage for GAVI (Global Alliance for Vaccines and Immunization), UNICEF, and other donors to negotiate prices they hope will be much lower than current US rates.

One test of international vaccine-pricing policy may involve Prevnar, which had sales of nearly $2 billion in 2006 in the United States and other industrial countries. Wyeth wants to expand sales to the developing world, but at its "normal price." GAVI and the World Bank hope to generate competition by establishing an advance market commitment backed by several donor countries and the Gateses' foundation that guarantees purchase of a new vaccine against pneumococcus more specific to Africa, at an affordable price.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com