Back in 2001, a major ruling took place at the World Trade Organization (WTO) to increase access–at least theoretically–to generic pharmaceuticals for patients in poor countries. The WTO signed a pact known as “The Doha Declaration“, indicating that intellectual property rights (patents) should not stand in the way of public health; that is, expensive brand-name drugs that were still under patent could be substituted for with cheaper generic alternatives when epidemic diseases were affecting a country. But has this provision worked to improve medicine access?
TRIPS, compulsory licensing and parallel importation
While most people believe the World Health Organization (WHO) would be the major arbiter of medication dispensation rules worldwide, the reality is that the WTO controls most of the pharmaceutical regulations. That’s because the WTO’s major provision known as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement governs patent protection on thousands of inventions, including pharmaceuticals. It allows a patented drug to stay in monopoly status on a market for decades–unless the patent-owner decides to release the patent to allow generic drug makers to copy the pill. In a previous post, we addressed some common fallacies about patent protections in pharmaceuticals, such as the idea that they are related to research and development investments, or that generics are undermining the drug industry. Here, we assume readers will have seen that data and have a bigger question–how much generic access does the world really have?
Worldwide, most generics are produced in countries like India that have a strong and clean, heavily regulated pharmaceutical production systems. Two provisions of TRIPS allowed Indian manufacturers to supply many other countries like South Africa with cheaper antiretroviral drugs while HIV medicines were priced out of reach for most patients. These provisions–known as compulsory licensing and parallel importation–allowed countries in a public health crisis to either grant a license to a generic producer to make a cheaper pill, or import generics made in another country to drive down local prices through competition.
The problem with these provisions was that they were often dishonored by the United States. The White House under Bill Clinton threatened trade sanctions against countries like Brazil and Thailand when they attempted to access HIV drugs under these provisions. And so the WTO–after literally years of wrangling and protest–met in Doha, Qatar and clarified that in fact, countries did have the right to use these provisions for public health benefit. “TRIPS Agreement does not and should not prevent members from taking measures to protect public health,” the WTO declared.
Did the “Doha Declaration” help?
For some of us who actively lobbied the WTO to enact this “clarification”, the question arises as to whether people actually got better access to medications as a result of all this effort. The short answer is “yes”, but the long answer appears to be “yes, but not for long.”
A pair of researchers at the University of Denver recently performed a systematic review of compulsory licenses, and found that the Doha Declaration may have had a limited and short-term benefit, but mostly for HIV drugs. The researchers identified 24 verified compulsory licensing episodes in 17 nations that occurred between January 1995 and June 2011. Half of these episodes ended with an announcement of a compulsory license, and the majority ended in a price reduction for a specific pharmaceutical product for the potential issuing nation through a compulsory license, a voluntary license, or a negotiated discount (e.g., the threat of the government issuing a compulsory license convinced the original manufacturer to lower the price). Sixteen of the compulsory licensing episodes involved drugs for HIV/AIDS, four involved drugs for other communicable diseases, and four involved drugs for non-communicable diseases such as cancer. More than half the compulsory licensing episodes occurred in upper-middle-income countries (such as Brazil and Thailand). Finally, most compulsory licensing episodes occurred between 2003 and 2005. There was a smaller peak of activity in the months leading up to the Doha conference, but after 2006 activity declined substantially.
These findings suggest that the Doha Declaration had an impressive short-term impact on HIV drug access, but perhaps the long-term impact was limited. There was no evidence of a spike in compulsory licensing episodes immediately after the Doha Declaration, and a lagged spike between 2003 and 2005 was probably from global HIV campaigns. Most importantly, compulsory licensing activity has diminished greatly since 2006.
Should we license more?
Particularly as chronic diseases that will likely require sustained access to medicines have come to dominate the epidemiology of several poor countries, the question arises whether compulsory licensing may be needed more extensively. In a recent review of pharmaceutical access in poor countries, the RAND Corporation concluded that patents were not a major barrier to access for non-communicable diseases. Of note, the study was funded by the major international pharmaceutical lobby just prior to a major global conference on the topic. One of the additional flaws in the summary of that report is that the conclusion contains many caveats. First of all, the data was very poor and mostly from countries like India that already have a lot of generic domestic production of key chronic disease drugs. Furthermore, the analysis put a big asterick next to key drugs for conditions like cancer and diabetes–that is, while a lot of heart disease drugs like aspirin and most beta-blockers have been off-patent for years, many of the key medicines for diabetes and cancers are still on patent. So the question of whether licensing would be useful is highly specific to what diseases are being referred to, and what level of quality of care we wish to achieve in poor countries.
One notable finding from nearly any review of patent-based pharmaceuticals is that they tend to be produced through public taxpayer dollars at major universities. So campaigns like Universities Allied for Essential Medicines offer an opportunity for universities to change their licensing policies–such that they don’t simply sell their research at poor kickback rates to patent-based pharmaceutical producers, but actually include provisions to increase the accessibility of their products for public health benefit. (For those who want full background data on this topic, here are the slides from my presentation to the Rebellious Lawyers’ Conference on this topic a few years ago).
A number of newer pharmaceutical companies are also taking steps to reorient their business model, with the hope that patent wars over pharmaceutical access won’t be the norm in the future. OneWorld Health, for example, has created a business model to support drug development and easier access to medicines for neglected diseases. And Thomas Pogge and others at Yale have devised some strategies to potentially incentivize better innovations and greater access through a Health Impact Fund.
As chronic conditions become more prominent, and as middle-income countries like Brazil and India play a bigger part in both need and pharmaceutical production, it will be interesting to see whether these novel proposals take root. In the meantime, the Doha Declaration still gives theoretical leverage for poor country governments to give better access to medications for their population, if they’re willing to take on the political risk. Recently, India issued a compulsory license on a major new drug, and declared that–at least as a pilot project–it would attempt to give complete pharmaceutical coverage to poor people in several regions, relying on its strong domestic production ability, and in light of growing demand and an emerging plan for a free public sector health system.