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.
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.
The World Health Organization (WHO) is responding with collaborative efforts to expand global vaccine-production capacity
in Latin America and Asia. WHO is exploring a vaccine stockpile for developing nations and has urged increased use of seasonal
flu vaccine to develop the delivery infrastructure in anticipation of a pandemic.
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 email@example.com