Medical R&D That Works in the Developing World
Can the world settle on a medical research and development (R&D) system that develops medicines and other products to meet priority health needs and makes those products available on an affordable basis?
Developing a strategy to meet these twin goals is the task of World Health Organization (WHO) negotiations in their final phase this week.
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property is finishing talks to create a global strategy and plan of action to spur medical R&D focused on the health needs of developing countries, and to ensure that poor populations get access to important pharmaceuticals and other medical technologies.
The world — and especially developing countries — needs more innovation. To have public health benefit, however, the fruits of the innovative process must be available to people who need them.
The current patent monopoly-based system of R&D has proven inefficient at advancing a needs-driven public health agenda. This is true for rich countries as well as poor, but the situation is much worse in poor countries. This has nothing to do with the ethics of Big Pharma. It is how the system is designed.
The current corporate sector system of R&D is driven by the prize offering of a patent monopoly. Patents are not worth much if they offer monopolies on sales to a population that — no matter how large — has little buying power. And if the prize incentive is too small, it will not induce R&D, no matter how much it may be needed as a public health matter.
Here’s what this means in practice: Developing countries comprise 80 percent of the world’s population but amount to only 13 percent of the global market for medical products. A review by Doctors Without Borders of new drugs introduced between 1975 and 2004 found that of 1,556 new drugs put on the market, only 21 were for "neglected diseases" — diseases endemic to developing countries.
The value of the patent monopoly is based on the holder using it to profit maximize as a monopolist. It is therefore no surprise that companies holding patent monopolies charge high prices. This is what the patent enables. High prices are an increasing problem in rich countries, but the brand-name pharmaceutical industry’s current pricing model — which commonly runs into the thousands of dollars a year for a single medicine, and may involve charges of more than $100,000 — leaves new medicines completely out of reach of the vast majority in developing countries.
How to respond to these problems? There are two basic alternatives. One is to rely on charity. Private foundations and companies seeking good will may contribute to R&D for products targeting diseases in developing countries. They may offer discounted versions of their drugs, or give some away. Charitable initiatives may accomplish quite a bit, but in general they suffer from being ad hoc, unsustainable, erratic, episodic, short-lived and insufficiently resourced. Charity may be helpful, but it is no solution to meeting public health priorities on a sustained basis.
The second option is to examine systemic approaches to support R&D that do not rely on patent monopolies or the prospect of charging high drug prices as a reward, and to identify mechanisms to make the fruits of R&D widely accessible.
There are a lot of good ideas, large and small, about how to do this. Notably at the WHO talks, Bolivia and Barbados have put forward a series of concrete proposals for non-patent prizes to incentivize R&D, with the resulting fruits of the innovation made available at competitive prices.
One of the Bolivia/Barbados proposals is for a Priority Medicines and Vaccines Prize Fund. The fund would offer large cash prizes to entities developing new products for neglected diseases, antibiotics or products for emerging public health threats (like avian flu or SARS). It would offer smaller prizes to parties that made advances toward these goals, meeting benchmarks short of bringing new products to market. It would also offer separate prize money to parties that openly published and shared their research. A condition of receiving the prizes would be licensing all resulting patent, data and know-how so that end products could be made available immediately on a competitive basis. In other words, there would immediately be generic competition and low-cost pricing.
There is no guarantee that the prize fund would work in creating innovation where now there is none or much too little. But it is an interesting and provocative proposal.
There is no legitimate rationale, on the merits, to oppose ongoing discussion of this prize proposal. Remember, in keeping with the focus of the WHO talks, the Bolivia/Barbados proposal focuses on health problems specific to developing countries. It involves areas where there is no effective market (or, in the case of antibiotics, special market problems) to incentivize R&D. So, there is nothing for Big Pharma to lose here.
But the industry and its allies are viewing this and similar proposals very cautiously. Some ideologues oppose any tinkering with the patent monopoly system. The industry is concerned that tinkering in the case of health problems related to developing countries will eventually threaten the patent monopoly system in the rich world, or interfere with its ability to expand sales to the wealthy in middle-income countries. (More on the role of Big Pharma and its proxies in my next column.)
Will country negotiators at the WHO talks ignore those who would subordinate public health to patent veneration or commercial concerns? Will they instead advance experiments with new institutional arrangements to promote the complementary public health objectives of innovation and access? We will know by the end of the week.