Dear Mr. President:
We are writing on behalf of Médecins Sans Frontières/Doctors Without Borders (MSF) to express our deep concern over provisions under negotiation in the Trans-Pacific Partnership Agreement (TPP)
that threaten to restrict access to affordable medicines and much-needed innovation for millions of people, and for treatment providers like MSF and Ministries of Health.
MSF is an independent international medical humanitarian organization that delivers medical care to people affected by armed conflict, epidemics, natural disasters and exclusion from healthcare in nearly 70 countries. Our ambition to provide quality health care to these populations requires constant access to affordable, quality medicines and vaccines, and patient-focused innovation.
In July 2013, MSF sent an open letter
to all heads of government, Ministers of Health and lead negotiators for countries involved in the TPP negotiations expressing concerns regarding the impact that provisions in the TPP could have on access to medicines. Unless certain damaging provisions are removed, the TPP could be the most harmful trade pact ever for access to medicines, we warned in the letter.
Despite our numerous attempts to engage constructively with various U.S. government constituencies on this issue, our concerns remain largely unaddressed. The ongoing TPP negotiations have been conducted in secret, without opportunity for public scrutiny. However, leaked texts indicate that intellectual property (IP) provisions proposed by the United States go well beyond rules established by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These demands will roll back public health safeguards and flexibilities enshrined in international and national laws, and put in place far-reaching monopoly protections that will restrict generic competition and keep medicine prices unaffordable in the long run.
Generic competition has proven to be the best way to reduce drug prices and improve access to treatment. Ministries of Health, humanitarian medical treatment providers like MSF, and donor-supported global health institutions routinely rely on affordable quality generic medicines to treat a variety of health needs. Two important U.S.-funded programs, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria, are salient examples of this, saving hundreds of millions of dollars a year and reaching more patients by purchasing generic medicines.
We have several concerns
with the text under negotiation. For example, the TPP proposes to lower the bar of patentability and mandate the granting of secondary patents for modifications to existing treatments even in the absence of therapeutic benefit for patients (a practice known as patent “evergreening”). The agreement would also impose an unprecedented extended period of exclusivity for clinical data required to prove the safety and efficacy of drugs and vaccines that are “biologic” products. Both provisions would perpetuate monopolies and prevent generic competition, making medicines and vaccines more expensive for longer.
Both provisions contradict the Administration’s own priorities in the United States. The White House has proposed restricting some abusive evergreening practices in each budget proposal sent to the United States Congress since the beginning of your Presidency. The White House has also proposed reducing the period of exclusivity for biologics, citing the need to facilitate faster development of generic biologics and cost savings of up to billions of dollars over the next decade.
Other provisions proposed in the TPP, including patent term extensions, patent linkage, additional intellectual property enforcement measures and investor-state dispute settlements, are equally concerning from a public health and access to medicines perspective.
If these provisions are included in the final text of the agreement, they will represent a direct threat to the future availability of affordable medicines and vaccines for millions of patients in the Asia-Pacific region, as well as for MSF and governments in the region. In Mexico, a TPP-negotiating country, we are currently providing medical support to migrants and mental health services to victims of violence. But the TPP could have effects far beyond the current twelve negotiating countries. Because the TPP is billed as a 21st century model trade agreement that aims at becoming a global standard, it could have damaging repercussions for access to treatment and innovation worldwide.
We urge the United States to remove provisions that will harm access to medicines and to ensure that the final text is aligned with relevant global public health commitments. Such commitments include the 2001 WTO Doha Declaration on TRIPS and Public Health; the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property; and the bipartisan United States May 10 Agreement, also known as the New Trade Policy.
The current biomedical innovation system is highly dysfunctional and unable to deliver affordable and needs-based medical tools for many of our medical operations. We are witnessing this in practice with the lack of appropriate medical tools to respond to the Ebola outbreak in West Africa. We also see the innovation challenges here in the U.S. For example, the United States government is working to respond to the growing threat of antibiotic resistance and the insufficient pipeline of new antibiotics. The President’s Council of Advisors on Science and Technology (PCAST) has advised that major changes are needed to address these challenges and has suggested reforming the innovation system. By contrast, promoting longer monopolies through the TPP only reinforces and facilitates abuse of the current research and development system.
The United States government, under your leadership, should introduce global norms which reaffirm a public health imperative and promote balanced implementation of current intellectual property obligations. MSF believes this is essential to closing the gap in access to medicines for millions of people around the world. The TPP could be an opportunity to make significant progress toward these goals. Instead, in its current state, the TPP is a threat to the health of millions.
Thank you for your attention. We are available to discuss these issues further at your convenience.
Executive Director, MSF USA
Médecins Sans Frontières/Doctors Without Borders
Dr. Manica Balasegaram
Executive Director, MSF Access Campaign
Médecins Sans Frontières/Doctors Without Borders
Sylvia Mathews Burwell, Secretary of Health and Human Services
Deborah Birx, Ambassador-at-Large and Coordinator of United States Government Activities to Combat HIV/AIDS Globally
Michael Froman, United States Trade Representative
Ron Wyden, Chairman, United States Senate Committee on Finance
Orrin Hatch, Ranking Member, United States Senate Committee on Finance
Dave Camp, Chairman, United States House of Representatives Committee on Ways and Means
Sander Levin, Ranking Member, United States House of Representatives Committee on Ways and Means