Growing expectations that these R&D partnerships will yield effective vaccines and drugs during the coming decade is prompting
some organizations to address anticipated manufacturing needs. AERAS is testing multiple TB vaccine candidates in a new $10-million
research and manufacturing facility in Maryland, which can produce candidate vaccines that meet GMP standards for use in clinical
trials. Sadoff acknowledges that a new vaccine may not be available for widespread use until 2012, but believes that these
early efforts will set the stage for scaling up to produce the 150 million doses or more that would be needed annually of
a successful product.
Ensuring drug quality
While pharmaceutical companies and research entities seek new treatments for disease, other organizations are helping third-world
nations establish systems for monitoring and ensuring the quality and safety of new and existing medicines. An April report
from the World Health Organization's (WHO) Commission on Intellectual Property Rights, Innovation, and Public Health supports
efforts to build third-world regulatory capacity as one of its many recommendations for expanding access to needed medicines
in developing countries. The report, which was presented to the World Health Assembly in May, notes the need to strengthen
oversight of clinical trials conducted in poorer countries, ensure adherence to GMPs, and manage supply chains effectively
to ensure product quality and curb the circulation of counterfeit products.
WHO also assists developing nations in obtaining high-quality and effective medicines through its prequalification program
for ensuring that drugs to treat AIDS, malaria, and TB meet established standards. WHO reviews manufacturer dossiers, inspects
production facilities for GMP compliance, and conducts surveillance to detect substandard or counterfeit drug production.
Since 2001, WHO has prequalified 152 products, almost all for treating AIDS, explained WHO program coordinator Lembit Rago
at the Drug Information Association annual meeting in June. As many dossiers are now in the pipeline, including more for TB
and malaria treatments.
USP goes global
To help developing countries establish effective registration and inspection programs, the US Pharmacopeia issued a guide
for "Ensuring the Quality of Medicines in Low-Income Countries" last fall (see sidebar, "Promoting global drug quality oversight").
This project is part of USP's expanding international program for promoting the quality and proper use of medicines around
the world. For the last decade, USP has worked with the US Agency for International Development (USAID) to develop a Drug
Quality and Information (USP DQI) program, which now has projects in 31 countries in four regions.
A recent project has established standards for ensuring the quality of zinc supplements now considered important for reducing
childhood diarrhea. USP also is working with the Medicines for Malaria Venture and manufacturers to develop monographs and
reference standards for malaria treatments. Tests of antimalarial drug samples in Guyana and other countries found high rates
of substandard and counterfeit products. Similarly, USP may develop monographs for TB therapies and drugs for other neglected
diseases not marketed in the United States. These monographs will be posted on the USP Web site, but not published in official
USP publications. In Asia, USP is participating in a drug quality monitoring project in five countries in the Mekong subregion
and has provided technical assistance on similar activities in China. A new Asian Network of Excellence in Quality Assurance
of Medicines, which is supported by USP DQI, will promote technical expertise, skills, and information-sharing on drug quality.
USP also is expanding its own program for testing the quality and consistency of medicines, dietary supplements, and active
pharmaceutical ingredients around the world. Last February, USP Executive Vice-President Roger Williams cut the ribbon on
a USP office and laboratory in India. The site will be used for testing and establishing reference standards on active ingredients
and drugs produced in India. A similar operation is slated to open early next year in Shanghai.
Push for funding
The limiting factor on all these initiatives still is inadequate funding from most wealthy nations. The Moran report notes
that more than half of the nearly $255 million contributed to PPPs as of April 2005 came from the Gates Foundation. The United
States provided $16 million, more than other governments, but still very little.
Most of the public funding for third-world health currently goes to treatment programs such as the Global Fund to Fight AIDS,
Tuberculosis, and Malaria and the President's Emergency Plan for AIDS Relief, which is providing $15 billion over five years
to support prevention, antiretroviral treatment, and patient care in 16 target nations in Africa and elsewhere.