By Donald Zuhn —

Last week, in a letter sent
to the U.S. Trade Representative, Ambassador Michael Froman, the AARP asked
that the U.S. not sign onto the Trans-Pacific
Partnership Agreement (TPP) if the trade agreement includes a 12-year data
exclusivity period for biologics.  The
TPP is a multilateral free trade agreement currently being negotiated by
Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United
States, and Vietnam (Canada, Japan, the Philippines, South Korea, and Taiwan
have also expressed interest in participating in the agreement).

Indicating that it was the
AARP's "understanding that market exclusivity is one of the outstanding issues
negotiators are working to resolve with the goal of completing the trade
agreement before the end of the year," the letter declares that the AARP "strongly believes the final
trade agreement should not bind the U.S. to a 12-year market exclusivity period
for brand-name biologic drugs" (emphasis in original).  The group notes that its support for a
shorter exclusivity period is based on the high cost of biologic therapeutics,
which "can put these treatments out of reach for those who need
them most, even for those with comprehensive health insurance."  The letter points out that "[t]he daily
costs associated with biologics are approximately 22 times higher than the
daily costs associated with small-molecule drugs."

Although the AARP notes
that the Patient Protection and Affordable Care Act (ACA) recognized that
"there was a need for less expensive follow-on biologics, or biosimilars,
both to help ensure access to biologic drugs and to reduce the economic burden
they impose," the group also acknowledges that the PPACA created a 12-year
data exclusivity period for biologics. 
However, the letter indicates that the Federal Trade Commission "concluded
that no additional exclusivity beyond the term of the patent was necessary to
maintain innovation and competition in the industry" (see "No One Seems Happy with Follow-on Biologics According to
the FTC"),
and that the Obama Administration proposed reducing the exclusivity period from
12 years to 7 years in its most recent budget (see "Senators Back 12-Year Data Exclusivity Period for
Biosimilars and President Obama (Once Again) Does Not").  The AARP concludes the letter by expressing its
strong support for the President's proposal, as well as the group's belief that
"increasing the availability of biosimilars will be a critical element of
any comprehensive effort to contain health care costs."

For additional information
regarding this and other related topics, please see:

• "White Paper Asserts
That Existing Trade Agreements Provide No Data Exclusivity for Biologics,"
August 26, 2013
• "BIO
Reiterates Support for 12-Year Data Exclusivity Period for Biologics,"
August 20, 2013
• "Senators
Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once
Again) Does Not," May 9, 2013
• "U.S.
Negotiators on TPP — Don't Trade Away the Biopharmaceutical Research Sector,"
September 30, 2012
• "Senators
Support Inclusion of 12-Year Exclusivity Period in Free Trade Agreement,"
September 12, 2011
• "House
Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade
Agreement," August 11, 2011