Deane Marchbein is President of the Doctors Without Borders USA Board of Directors
May 8, 2015
Lost in the political discussions over the passage of the Trans-Pacific Partnership (TPP)—a trade agreement currently being negotiated in secret between the U.S. and 11 other Pacific-Rim nations—is the very real negative impact it would have on global health.
Doctors Without Borders/Médecins Sans Frontières (MSF) works in over 60 countries, and our medical teams rely on access to affordable medicines and vaccines. We are deeply concerned that the TPP, in its current form, will lock-in high, unsustainable drug prices, block or delay the availability of affordable generic medicines, and price millions of people out of much-needed medical care.
The public health repercussions of this deal could be massive. The negotiating countries represent at least 700 million people, and U.S. negotiators refer to the TPP as a “blueprint” for future trade deals. The TPP attempts to rewrite existing global trade rules and would dismantle legal flexibilities and protections afforded for public health.
We have concerns with several U.S. government demands in the TPP. For example, the TPP would lower the standard for patentability of medicines. It would force TPP governments to grant pharmaceutical companies additional patents for changes to existing medicines, even when the changes provide no therapeutic benefit to patients. These provisions would facilitate “evergreening” and other forms of abuse of the patent system by lengthening monopolies and delaying access to generic competition.
Another concerning provision in the TPP involves so-called “data exclusivity” for biologics, a new class of medicines that includes vaccines and drugs used for cancer and multiple sclerosis treatment. Data exclusivity blocks competing firms from using previously generated clinical trial data to gain approval for generic versions of these drugs and vaccines. If pharmaceutical companies have their way, the TPP will block generic producers of biologics from entering the market for at least 12 years, during which patients would be forced to endure astronomical prices.
The rationale given for such an exclusivity period is that it will promote innovation by allowing originator companies enough time to charge high prices and recoup their research and development investment. This simply isn’t supported by the evidence. On the contrary, the Federal Trade Commission finds that no years of data exclusivity were necessary to promote innovation in biologic drugs.
Twelve years of data exclusivity is not only unprecedented in any trade agreement, it is not the law in any of the TPP negotiating countries outside of the U.S., and it would keep lifesaving medicines out of reach of millions of people. The Obama Administration has actually called for data exclusivity to be reduced to seven years at home, so it is puzzling that the U.S. Trade Representative would be aggressively pushing for these terms in the TPP.
These provisions and others currently included in the TPP are at direct odds with the U.S. government’s own long-standing commitments to global health. U.S. taxpayer-supported initiatives like PEPFAR, the Global Fund for AIDS, TB and Malaria, and Gavi, the Vaccine Alliance, rely on affordable, generic medicines in order to operate effectively.
Research And Development
As an organization caring for patients worldwide, Doctors Without Borders understands that there should be incentives to recover research and development investments and to promote innovation. Unfortunately, the public is in the dark on what this research and development truly costs. We are told that it costs billions to research and develop a new medicine, although a significant amount of early research and development actually happens at publicly funded centers and universities.
We are told that the only way to ensure that people receive the medicines they need is by increasing intellectual property provisions, such as those encapsulated in the TPP. In reality, the existing monopoly-based innovation system that the TPP is attempting to standardize has left us with more patents and fewer medical breakthroughs.
The most recent and dramatic example of this failure in innovation played out just last year, when Ebola raged through West Africa. Doctors Without Borders and other global health actors were ill-equipped to fight a disease that was identified 40 years ago but for which there are still no adequate diagnostics, treatments, or vaccines.
As TPP countries aim to conclude negotiations in the next few months, it is essential that the United States and other negotiating countries work to protect existing access to medicines’ safeguards and to promote a public-health driven biomedical innovation system.
Tags: Doctors Without Borders, fair trade, generic drugs, Global Health, obama trade deal, TPP, Trans-Pacific Trade Partnership