New strategies to help developing countries address neglected diseases

For the health challenges facing developing countries, the numbers alone are staggering. Every day, 40,000 people - enough to fill a sports stadium - die from preventable infectious diseases and malnutrition. Entire generations of human potential are perishing.

Given the scope of these challenges, is there a way for developing countries to solve health disparities and bootstrap these efforts into economic growth? In an article published recently in the journal Science, Biodesign Institute researchers Rich Mahoney and Anatole Krattiger, along with a large, international group of collaborators, have outlined new strategies to help developing countries address neglected diseases.

"Many developing countries are attempting to solve the health problems facing their own populations, and they are rapidly increasing investments in science and technology infrastructure," said Mahoney.

In addition to their research roles in the institute's Center for Infectious Diseases and Vaccinology, Mahoney and Krattiger also serve as advisors to the Rockefeller Foundation. The Foundation asked Mahoney to help organize an international meeting to address how disadvantaged countries could better foster scientific and technology innovation to directly impact health issues. Conducted in Bellagio, Italy in April, the meeting led to development of the Science article.

Participants concluded that the best approach for developing countries may be to pool their resources through "health innovation networks." By working together, the poorest countries stand a better chance of fostering innovation and building economic strength.

The recommended approach sets a top priority of developing public-private partnerships to address these needs. The group suggests that harmonized development in each of six sectors is essential to success in developing innovation systems: manufacturing, domestic markets, export markets, research and development (R&D), intellectual property (IP) systems, and drug regulatory systems.

Mahoney and Krattiger have expertise in one of these crucial aspects: intellectual property (IP).

"Innovation has to include strong public-private collaboration with a clear understanding of the comparative advantages of each sector," said Mahoney. "The big question regarding IP is: How can the public sector better manage IP to help ensure affordable medicines for the poor in developing countries?"

One important component, they say, is improving the linkages between developing and developed countries. Recognizing that global health is critical from both a humanitarian and pragmatic standpoint, philanthropic and government agencies are stepping up to the plate, donating more than $1 billion by 2003 in global product develop partnerships (PDPs) for new drugs, vaccines and diagnostics for diseases of the poor.

Another promising sign is the success being realized by some countries, despite both their relatively low economic strength and per capita income when compared to the U.S., Japan and Europe. These "rising stars" are called innovative developing countries, or IDCs, where recent and rapid increases in R&D investments, longer-term investments in science and engineering education, and increased manufacturing capacity are leading to favorable trends in patents and research citations.

For example, thanks to major investments, China is now the leading manufacturer of penicillin and India, by volume, is now the fourth largest producer of pharmaceuticals in the world.

In fact, the pooled national health research assets of IDCs including Argentina, Brazil, Cuba, China, Indonesia, Malaysia, Mexico, South Africa and Thailand were a combined $2.3 billion in 1998 compared to the U.S. National Institutes of Health's $13.6 billion.

While this is a step in the right direction, Mahoney and Krattiger point out a major concern. Companies within IDCs are growing rapidly, but all are being driven to maximize a direct economic return of investment, rather than the specific health needs of their populations. As a result, the poor in these countries are not yet benefiting from the new science practiced in their own countries.

"We don't believe that economic development and addressing national health needs must be mutually exclusive," said Krattiger "There are tensions between the two, but the group concurred that the two are reconcilable."

Several networks have already been formed to leverage the capabilities of these IDCs in ways that benefit a country's public health and economy. The Developing Country Vaccine Manufacturers' Network, formed in November 2000, includes state and private owned producers involving Brazil, Cuba, China, India, Indonesia, and Mexico who can sell products through the World Health Organization (WHO) to United Nations agencies. Additional R&D efforts and regulatory networks have followed suit.

Brazil's human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) program is one of the standout successes of such an approach, with a local manufacturing base to produce antiretroviral drugs combined with a government financing program to provide free access to all who need the drugs.

IDCs can also mimic wealthier countries' efforts to increase the number of public-private partnerships by providing catalysts for university discovery. For U.S. IP development, the Bayh-Dole Act of 1980 has had an enormously positive impact on technology transfer by universities. This single piece of legislation allowed universities to license more than 3,000 patents, which translated into $40 billion worth of new products and 270,000 jobs created since 2000.

Whether or not something similar to the Bayh-Dole act will work in developing countries is the subject of some debate. "Smaller countries seem to think it can't work because of the expense of maintaining technology transfer offices in each university," said Mahoney, "but larger countries, e.g. India, seem to think it can work. Korea adopted a Bayh-Dole type of policy some time ago and it seems to work quite well."

In 1954, Korea was one of the two poorest countries in the world. Now, Korea is a high middle-income country with membership in OECD (Organization for Economic Cooperation and Development) and a per capita gross domestic product exceeding $10,000.

Krattiger added that "Whether or not Bayh-Dole type of legislation should be introduced in developing countries misses the key point. The real issue is whether public sector institutions can own inventions, whether they have the freedom to make informed decisions, and whether market type considerations can be allowed to play. That's what Bayh-Dole really introduced in the U.S. and it has done wonders."

Many of the group's proposals will require future study, yet there is reason for optimism, as one trend that will continue to grow unabated is the increased connectivity of the world. "In the long term, there will be a global pharmaceutical industry that is extraordinarily more efficient in innovation than it is now and developing countries will be much more effective in innovating to meet the needs of their populations including the poor," said Mahoney.