Dearest Readers: From time to time, it is our pleasure to bring you posts here on the Prescription Access Litigation blog written by guest bloggers. Our latest guest blog entry is by Sarah Rimmington of the consumer advocacy group Essential Action.
It’s safe to say that most Americans are blissfully unaware of negotiations that just recently went on at the World Health Organization (WHO) in Geneva to address how pharmaceutical research & development (R&D) can benefit the literally billions of people in developing countries who lack the resources (money) to pay for prescription drugs that in many cases cost more for a single pill than many of those people earn in a day, or even longer. The issue has been conveniently ignored by the mainstream media in the United States, despite the role that American drug companies play in opposing an agenda that would bring access to medicines to many of the world’s poorest people.
We here at the Prescription Access Litigation blog tend to cover only prescription drug issues here in the U.S. (and there’s plenty to cover just in this country, mind you). But occasionally we want to use our modest blog to call attention to issues outside the borders of the U.S. The pharmaceutical market has become truly a global market, with more and more clinical trials being conducted abroad, and more and more of our drugs being produced abroad, so we here in the U.S. couldn’t ignore these global issues even if we wanted to.
Without further ado, let me turn to Sarah Rimmington, for her report on the WHO’s recent negotiations and what they mean for the issue of access to medicines for the developing world:
On May 3, representatives of more than 100 nations finished what was supposed to be the final round of talks at the World Health Organization (WHO) in Geneva. These talks were meant to spur a medical research and development (R&D) system that works for the developing world.
The WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) was set up in 2006 to develop a plan to promote new medical research and development (R&D) mechanisms to serve the twin goals of promoting innovation to meet the particular needs of developing countries, and ensuring that important medicines are accessible to people in the developing world, regardless of their income.
Despite difficult and incomplete negotiations, delegates to the IGWG took an important first step by agreeing to explore some common sense measures to promote developing country-focused innovation that does not compromise access to medicines.
Patent monopolies result in high prices Why are R&D incentives that promote innovation plus access (“I plus A”) so important? 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. (For more information on the challenges faced by developing countries under the current R&D system, refer to this report.
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
It is also the case that the products developed to treat diseases that occur in all countries whether rich or poor (such as cancer, heart disease and HIV/AIDS) are often not appropriate for conditions in developing countries. For example, not enough R&D is invested in creating products that do not require refrigeration, an important feature for products to be used in countries with warm climates and unreliable electricity.
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, developed 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.
Spurring developing country-focused innovation plus access The WHO IGWG was set up to create a global strategy and plan of action focused on advancing developing country-focused innovation that also ensures the fruits of the innovative process are available to the people that need them.
Public health experts and advocates encouraged IGWG delegates to embrace this mandate and 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. See statements by Essential Action and Doctors without Borders.
There are a lot of good ideas, large and small, about how to do this. Notably at the IGWG talks that ended on May 3, Bolivia and Barbados put forward a series of concrete proposals for non-patent prizes to incentivize R&D, with the resulting products to be made immediately available in generic form at competitive prices. The prize proposals focus on incentivizing several priority health needs of developing countries, such as the development of a diagnostic test for tuberculosis, new treatments for Chagas disease, and priority medicines and vaccines. The countries were hoping that the final strategy that came out of the negotiations would reference the proposals as examples of the types of initiatives that countries should examine when implementing new R&D strategies for developing countries.
There is no guarantee that these types of prize funds would work in creating innovation where now there is none or much too little. But they are interesting and provocative proposals that, in keeping with the mandate of the WHO talks, concentrate on health problems specific to developing countries.
Progress and setbacks in Geneva; one more year for bold action on R&D The good news out of Geneva is that countries came to consensus on several important issues. These include an agreement to explore R&D incentives like prizes, and to encourage future discussions of an R&D Treaty, which would involve agreement that all countries should have to contribute to global R&D, or at least participate in the R&D system, but that there should be differential obligations based on degrees of wealth.
The bad news out of Geneva is that despite this progress, much work remains to be done to promote R&D models that will work for the developing world. IGWG delegates did agree to create a working group on financing for R&D. But one concern is that the draft strategy does not specifically reference the importance of examining the Bolivia and Barbados proposals — as well as proposals that may be developed by other countries – and that the new working group will not look at such proposals.
Another concern is that because of resistance from developed countries such as the United States, the EU, and Canada, consensus was not reached on concrete proposals to actually implement the urgently needed new incentive mechanisms. A significant amount of negotiating time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities available under international trade law to promote access to affordable generic medicines where patent protections remain a problem. A number of these issues remain unresolved and will be the subject of further talks, to take place at a later date and concluded by May 2009. For more information on the recently concluded talks see comments from Doctors without Borders and Knowledge Ecology International.
Of course, it is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in rich countries and which along with its allies remains ideologically committed to opposing any tinkering with patent monopolies – influenced the disappointing outcomes at IGWG. 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.
But it’s not too late. WHO member countries have another year to finalize the R&D agreement that comes out of the IGWG process; they must be encouraged to use this time wisely by taking concrete steps to advance experiments with new institutional arrangements to promote the complementary public health objectives of innovation and access. It is time to ignore those who would subordinate public health to patent veneration or commercial concerns, and enact bold solutions that have the potential to benefit us all.
For more information on the World Health Organization R&D talks see: