Patient and worker advocates on Monday warned President Obama that prospective language in a major international trade deal could limit access to healthcare, and lock in high costs for popular biologic medicines.
Negotiators are close to wrapping up talks in support of the Trans-Pacific Partnership, a 12-nation pact that would have wide-reaching impacts on numerous federal policies and regulations.
Among the issued on the table is the length of time that drug-makers can retain exclusive rights to test data for brand-name biologics, thereby keeping generic versions off the market.
Pharmaceutical industry groups are pushing for a 12-year window, which they say is needed for the company to recoup the costs of research and development of the products.
Biologics — drugs developed through biological processes — are used to treat a variety of ailments, including multiple sclerosis, rheumatoid arthritis and different forms of cancer.
But the drugs often cost far more than conventional “small-molecule” drugs, making them prohibitively expensive for even patients with comprehensive insurance policies.
Incorporating a 12-year exclusivity period into the TPP would essentially cement those high prices, according to a coalition of groups including American Federation of State, County and Municipal Employees (AFCME) and AARP, among others.
In a letter to President Obama, the groups acknowledge that international trade “has the potential to raise the standard of living and quality of life” for Americans.
“However, the proposals that have been advanced by the USTR related to the pharmaceutical, biologic and medical device industries could do the opposite by undermining access to affordable health care for millions in the United States and around the world,” the groups charged.
The groups argue in favor of a seven-year exclusivity period, which is in line with the president’s own 2014 budget proposal. The administration estimates the reduction from 12 to seven years could save billions of dollars for federal health programs.
The groups echoed concerns from a growing number of lawmakers in Congress, who have accused the administration of keeping key details of the negotiations secret.
They note that the U.S. Trade Representative has worked closely with pharmaceutical companies, but say healthcare advocates and the broader public have been shut out of the process.
“Lastly, we urge the Administration to make the negotiating process transparent,” the groups wrote.
Trade talks spur fears of unchecked drug prices
By Benjamin Goad - 11/18/13 04:52 PM EST