Public health groups on Thursday warned that “absurd” patent and data protection clauses pushed by U.S. lawmakers during the final negotiations of the 12-nation Trans-Pacific Partnership (TPP) in Maui, Hawaii could hike prices for life-saving drugs and stifle innovation.
Doctors Without Border (MSF) and the Generic Pharmaceutical Association are most concerned with measures such as the extension of intellectual property rights on drug patents and increased damages for the infringement of patents. They also worry that TPP will enshrine test data exclusivity for a new class of drugs, known as biologics, used in treatments against diseases such as cancer, and for which often no other remedies exist.
Judit Rius Sanjuan, a policy adviser at MSF, said a lengthy exclusivity window promoted by TPP would rob millions of people from affordable vaccines and other therapies against diseases that often affect the world’s poorest and eldest populations.
“Everyone will have to wait eight years to have access to biologics just to protect pharmaceutical companies,” she said. “That’s just unacceptable.”
Data exclusivity blocks companies from launching products based on previously generated data, forcing competitors to duplicate test results and setting back the development of drugs for many years, health experts say. The TPP’s data exclusivity provision, and other measures discussed by negotiators, violates existing trade agreements that safeguard the fair use of intellectual rights, according to MSF.
“The TPP is a precedent-setting blueprint for future trade deals that will deny countries their right to balance business interests with the public health needs of people — a right that is ingrained in international trade rules,” Rius Sanjuan said in a statement last week.
The United States accounts for more than half of all drugs currently being developed in TPP countries, according to a statement from Sen. Orrin Hatch, R-Utah, chairman of the Senate Finance Committee, which has aggressively pushed for a 12-year data protection timeframe and other restrictions within TPP to “promote the development and launch of new drugs.”
Manon Rass, director of the advocacy group Union for Affordable Cancer Treatment, said she feared the TPP agreement would increase prices for cancer drugs in the 11 partner countries and elsewhere, as the provisions risk becoming international standards.
A stage-4-cancer patient, Rass said the development of new drugs has become stifled by overly prohibitive U.S. patent laws that block innovative research for years. She traveled to Maui to press lawmakers and lobbyists to shorten patent and data exclusivity windows.
“It’s heartbreaking for someone like me to think that someone can’t get that drug,” she said, referring to the cancer-fighting drug Herceptin, which she has taken. “I need innovation. I don’t have much time to waste.”
The Generic Pharmaceutical Association, a U.S. based federation of drug companies, earlier this week raised alarm in a nationwide ad campaign regarding the TPP’s provisional restrictions on patients’ access to generic products in the U.S. and abroad. Generic drugs have already saved U.S. taxpayers nearly $1.5 trillion in the last decade, according to a GPA statement.
On Tuesday, World Hepatitis Day, the New York-base non-profit Treatment Action Group (TAG) urged governments and pharmaceutical companies to facilitate access to treatments for hepatitis C, a disease that kills more than 700,000 people around the world annually and is a major public health priority in the U.S. At an average cost of $1,000 per pill, chronic infections weigh heavily on health care budgets — a burden that could be alleviated by loosening patent laws and ensuring fair pricing, according to TAG.
Earlier this month, the Department of Veteran Affairs warned that a budgetary crisis might force it to shut down hospitals following an influx of veterans seeking care for hepatitis C infections and other expensive conditions, according to The Associated Press.
“If medicines are expensive, people are just going to die,” said MSF’s Rius Sanjuan.
With The Associated Press