Public Citizen Testimony: 2025 Special 301 Review
Update: On April 29, 2025, the Trump administration released the 2025 Special 301 Report. Read Public Citizen's response here.
On February 19, 2025, Peter Maybarduk, Access to Medicines Director at Public Citizen testified at the Office of the U.S. Trade Representative for their review process to inform the annual “Special 301 Report.” Maybarduk’s testimony is transcribed below.
Public Citizen is a consumer advocacy organization with over a half a million supporters and members across the United States. We have a 50-year history of protecting the public interest before agencies, the courts, and Congress. And my testimony is rooted in years of providing technical assistance to developing countries that are working to overcome price, supply and patent barriers to access to medicines. But we work equally here in the United States where we have given quite a bit of technical assistance to Congress and federal agencies to promote access to medicine here at home, given the pain that people are feeling from high medicine prices and the epidemic of treatment rationing where one-in-four, one-in-three Americans, depending on which survey you follow have failed to access medicines due to cost, have self-rationed their own access to treatment.
I will make three points.
The first is that health security is national security. And even in the present shakeup, biosecurity is an articulated priority of this White House. Even the President’s recent order on WHO includes a focus on the U.S. biosecurity chain of command. And a credentialed leader has been appointed to the White House Office of Pandemic Preparedness in Gerald Parker. Now collectively, we want countries to be able to adapt quickly and in locally effective ways to pandemics to stop their spread. This means having the flexibility to move quickly with different products. And that means, for us, refraining from using U.S. power in a way that would deter countries from finding the most expeditious and workable solution. Nearly half of U.S. COVID deaths were from variants, meaning that if a more aggressive equity and access strategy had been pursued abroad, we may have averted quite a good deal of death here in the United States.
The second point. Raising drug prices abroad does nothing to lower them at home. The U.S. and most governments recognize that expansive patent monopolies facilitate manufacturers’ high prices. Congress, federal agencies and the states, like many U.S. trading partners, are reexamining how to protect health under IP regimes. North Carolina, with a Republican state treasurer recently asked HHS to intervene regarding weight loss and obesity drugs with a compulsory license, if necessary, if Novo Nordisk would not provide a voluntary license, because it is bankrupting the state health plan. And even Elon Musk has voiced his support for making new diabetes and obesity drugs “super low cost to the public” noting his agreement with Senator Bernie Sanders.
Now, there was a time when the Special 301 Report was used to fault other countries for high drug prices here at home. There is no logical reason, let alone evidence, to think that Americans will pay less for medicine if the U.S. government bullies other countries into paying more. Drug corporations are working to maximize revenues in every country in the world. Of course they are. Like every other business. That is how business works. The difference with pharmaceuticals is that patents insulate drug companies from meaningful competition. They are not priced to recover research and development costs. That has been studied by the U.S. government. And they will charge Americans as much as they can no matter what happens abroad. All we do by pressuring other countries to raise prices is hurt their most vulnerable people. In some cases, if you think about the extraordinary price of the NIH-Moderna vaccine in South Africa, which limited access at a critical time, we can worsen pandemic spread.
An example of why this indeed matters is Colombia, which has been mentioned, and I noticed the Chamber, which I think is following me, commented in the press today about this. Colombia, under its compulsory license is importing a lifesaving first-line HIV regimen to expand the treatment it can provide, including to address the migration crisis from Venezuela. It is purchasing through the Pan American Health Organization (PAHO), which already provides generic dolutegravir to most of Latin America. But Colombia was excluded from the voluntary license in ViiV’s license territory. We have supported that process, and I can tell you it was not short. It took a year and a half. There were hundreds of pages of documents, several administrative studies, much to our dismay at the long delay to get to a license. Pharma had opportunity and opportunity and opportunity to comment and challenge the proposal not only in national courts but at the Andean Community’s IP tribunal. They have their own regional intellectual property tribunal.
Colombia had failed meetings ViiV and GSK. Health groups tried to get a voluntary license first and tried to get Colombia included in the Medicines Patent Pool license. I am on the board of the Medicines Patent Pool. I support voluntary solutions. They were denied. If Colombia isn’t free to grant a license in this case, then TRIPS is meaningless. And U.S. commitments to the Doha Declaration are effectively meaningless if we are criticizing them. Fortunately, PAHO generics arrived in Colombia last week. And they can get to the business of addressing their health challenges.
Let me just say, we have noticed in recent years there has been progress in the Special 301 Report. We appreciate it. Let’s not unmake it. It is coherent to respect the rule of law and pursue our trade commitments, respect our trade commitments, enforce our trade commitments to partners, and respect access to medicines at the same time. In practice, it looks like 301 has been sticking to TRIPS or FTAs focusing on criminal markets, focusing on rule of law issues, not challenging countries’ public health policy.