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COMMENTARY

GLOBAL HEALTH | July 21, 2007

Simple Math

Pharma should partner with industry in developing nations to create cost-scaled markets within the world's emerging economies.

LISA CONTE

Court cases in developing nations around the world are pitting western pharmaceutical companies against the lives and health of those nations' citizens. Companies like Merck, Abbott and Novartis have argued for broad interpretation of their patents in emerging economies. As a result, they've landed in fierce battles that include threats of infringement on one side and threats of pulling products from the market on the other.

Unfortunately, these battles often portray multinational pharmaceutical companies as profiteers that restrict delivery of crucial medicines to the developing world. This conjures images of 1997, when Novartis sued Nelson Mandela for signing a law that allowed South Africa to import cheaper HIV-fighting medications. These destructive battles are the predictable and unnecessary results of shortsighted pharmaceutical industry strategies in the developing world.

It doesn't have to be that way. Intellectual property rights and access to affordable medicines in less developed countries are not mutually exclusive.

Nobody disputes that R&D for new drugs is a long, risky and expensive enterprise that requires the market exclusivity that patents provide to assure an adequate return on investment. But in a process known as "evergreening," big pharma obtains extensions on patent life with sometimes medically irrelevant patent "tweaks" contrived to endlessly extend the company's monopoly.

The bad news for big pharma is that companies on the ground in developing nations are adapting and producing generic versions of the drugs at significantly lower costs. Novartis wants to shut down Indian production, arguing that poor populations can still receive drugs, including its own Gleevec product, through broad donation programs offered by the pharmaceutical industry. But philanthropy is neither a sustainable business model nor a workable answer to global access to lifesaving medicines.

The good news, however, is that about 80 percent of the world's population lives in non-Western territories. The math is simple: one-tenth the price sold to eight times the population provides the basis for a healthy return on investment. Local pharmaceutical companies in emerging economies such as India, Brazil, China and South Africa have already figured out that there's big business in serving large populations with an affordable product. The Clinton Foundation has invoked this rationale to negotiate for bulk purchases of antiretrovirals. Big pharma's actions indicate their recognition that an issue exists, but a solution that works for both sides also exists.

Novartis, Abbott and their peers in the pharma industry should partner with industry in creating cost-scaled markets within the world's emerging economies. If the big companies can't yet stomach a business model of large volumes of patients from the non-traditional Western pharma population, they should find local licensees that understand the business model and have both the ability and desire to serve that population. So long as the local licensees are making money, the licensors will profit from royalties, margin on manufacturing, additional cost savings from benefits of scale and more.

That's the approach we've taken at Napo Pharmaceuticals. We've incorporated this philosophy throughout our evolution and formed development partnerships for our gastrointestinal product candidates in India and China. This enables the company to share clinical and commercialization risk and, at the same time, leverage expertise and capability in manufacturing, local market registration and distribution capabilities. The company will realize revenue in these high-volume markets through royalties and will take a more traditional approach in Western markets.

If the rest of the pharmaceutical industry follows this lead, millions of people will once again appreciate the pharmaceutical industry for saving lives rather than only knowing the industry through headlines that portray it as greedy, heartless and imperiling the lives of the planet's poorest victims.

Lisa Conte is CEO and founder of South San Francisco, California-based Napo Pharmaceuticals.

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