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Analysis: A Research Revolution

01.01.70

By OLGA PIERCE

In the past five years, a quiet revolution has taken place in the search for cures for some of the world's most common diseases.

Public-private partnerships(PPPs) now account for three-quarters of all new projects to develop treatments for neglected diseases -- sicknesses like tuberculosis and malaria -- which affect millions of the world's poor and thus provide little profit motive to look for a cure.

Research in neglected diseases is happening and partnerships are working away on new products, said Mary Moran, a researcher at the London School of Economics, discussing her recent study, The New Landscape: Drug Development for Neglected Diseases, Monday at the Brookings Institution.

Concerned about the difficulty, high cost and liability issues associated with large-scale clinical trials on children and pregnant women around the world, most large drug manufacturers had almost entirely pulled out of the market for neglected disease treatments.

In the past 30 years, only 13 new such drugs have been developed, despite overwhelming need driven by large-scale human suffering. Now, according to Moran's estimate, there are 60 neglected disease drugs in development, including 18 in clinical trials, expected to yield eight or nine new drugs in the next 5 years.

And the reason for the surge is largely PPPs. But new partnerships have key differences from past models that make them cheaper and faster, Moran said.

One key difference is what is meant by the word public. Governments have taken a back seat to philanthropist members of the public, a phenomenon known as the Gates effect. The effect is named after Microsoft founder Bill Gates, who has contributed almost 60 percent of all such funding in the world since 2000, compared to about 6 percent from the United States government, the world's largest government donor.

Though the G8 leaders committed to the idea of such partnerships at their most recent summit, corresponding surges in funding have yet to materialize.

Another change is that the public and private partners have almost completely switched roles. In old-model ventures, the public partner would invest in research and development, and then hand the result over to a manufacturer to make into a marketable product.

But that eliminated manufacturers' expertise from the research process and forced them to conduct Third World clinical trials -- exactly the area they were trying to avoid and where their skills were lacking.

In the new model, exactly the opposite happens. Drug companies use their drug-development expertise to create new ways of combating the diseases, and then hand them over to public partners who can effectively navigate the process of testing and marketing in the developing countries where they are so desperately needed.

The model, allowing each partner to specialize in what it does best, results in more innovative drugs with a faster timeline and stronger health effects than either public or private entities alone would be able to achieve, Moran said.

The drugs are also much less expensive, with development costing tens of millions of dollars instead of hundreds.

Partnerships that work have a few characteristics in common, including a focus on solutions for the developing world's needs, industrial involvement from an early stage, large portfolios, and, importantly, adequate funding.

To ensure that those that get funding have these key elements of success, Moran and her colleagues have proposed a solution called the Industry R&D Facilitation Fund, which would reimburse PPPs for their payments to their industry partners. Just $7 million per year from each of the 30 OECD countries would cover current shortfalls, and the number of collaborations, with all their efficiency and innovation benefits, could be greatly increased.

The fund could also help donors, Moran said, by serving as a go-between and freeing them from having to gauge individual projects on their own. The funding that is available would thus be steered toward projects that have the greatest likelihood of success.

In addition, it could harness the efficiency of the partnership model to make it as easy as possible for drug companies to participate in neglected disease drug development, she said. The cost of getting someone to do what they don't want to do and aren't very good at is very high.

But in the case of public-private partnerships, drug companies -- who have become increasingly interested in finding ways to participate in the process without having to go it alone -- see many of the barriers that previously existed lowered or removed.

This is truly a situation that can be made to be win-win, she told United Press International. Companies can find many ways to benefit. Even just having the company's name on a drug that saves millions of lives for $20 million. That's cheaper than an ad campaign.

Companies are looking for ways to participate, Lynn Marks, senior vice-president of the GlaxoSmithKline Medicine Development Center, told UPI.

With so many companies getting out of infectious disease, we need to find a way to keep them involved and these partnerships seem to be a way to do that, Marks said. The company has built a tuberculosis research center in Spain that will likely participate in such projects in the future.

There's plenty of room for recognizing that some companies have the will to participate, he said. It's just about helping them overcome those barriers.

Given the success of such ventures, and the small amounts of money required, the real question is why governments have not contributed more, said Moran, It's clear the time is ripe for a lot of lobbying, she said. It's clear to me government is not playing its role in this field.

Expert opinion

Halter Marek

02.12.06

Halter Marek
Le College de France
Olivier Giscard dEstaing

02.12.06

Olivier Giscard dEstaing
COPAM, France
Mika Ohbayashi

02.12.06

Mika Ohbayashi
Institute for Sustainable Energy Poliy
Bill Pace

02.12.06

Bill Pace
World Federalist Movement - Institute for Global Policy
Peter I. Hajnal

01.12.06

Peter I. Hajnal
Toronto University, G8 Research Group