Sending Office: Honorable Anna G. Eshoo
Sent By:
Matthew.McMurray@mail.house.gov

Current signers: Eshoo, Barton, Speier, Lance, Foster

Dear Colleague,

As the Trump Administration continues to engage Canada and Mexico on the renegotiation and modernization of the North American Free Trade Agreement (NAFTA), we invite you to join us in writing to United States Trade Representative Robert E. Lighthizer urging
him to ensure any renegotiated NAFTA agreement upholds existing U.S. law with respect to regulatory data protection for new biologic medicines.

In 2010 Congress passed the Biologics Price Competition and Innovation Act (P.L. 111 – 148), which provides 12 years of regulatory data protection for new biologic drugs. Bringing to market a biologic drug, which are large, complex molecules “grown” in living
systems such as a microorganism, a plant or animal cell, requires billions of dollars in research and development costs and can take several years. Strong data protections ensure the developers of these critical life-saving cures are able to recoup their costly
investments.

Canada currently provides eight years of regulatory data protection for new biologic drugs, while Mexico offers five years of regulatory data protection. Failure to secure adequate data protection consistent with current U.S. law could jeopardize future
innovation in lifesaving biologic medicines and threaten U.S. global leadership in this critical industry.

We urge you to join us in sending the attached letter to U.S. Trade Representative Robert Lighthizer highlighting the importance of upholding existing U.S. law in with respect to regulatory data protection for new biologic medicines.

If you have any questions or you would like to sign on, please contact Matt McMurray in Rep. Eshoo’s office at (202) 225-8104.

Sincerely,

 

Anna G. Eshoo                                                            Joe Barton
Member of Congress                                                   Member of Congress

 

Jackie Speier                                                               Leonard Lance
Member of Congress                                                   Member of Congress

 

LETTER TEXT 

September xx, 2017

The Honorable Robert E. Lighthizer
United States Trade Representative
600 17th Street N.W.
Washington, D.C. 20508

Dear Ambassador Lighthizer,

As you continue to engage with your counterparts in Canada and Mexico on the renegotiation and modernization of the North American Free Trade Agreement (NAFTA), we write to urge you to ensure any renegotiated NAFTA agreement upholds existing U.S. law with
respect to regulatory data protection for new biologic medicines.

In 2010 Congress passed the Biologics Price Competition and Innovation Act (P.L. 111 – 148). This important legislation provides 12 years of regulatory data protection for new biologic drugs which are large, complex molecules “grown” in living systems such
as a microorganism, a plant or animal cell.  They are far larger and considerably more complex in structure than chemical drugs, and bringing a biologic to market can require billions of dollars in research and development costs and can take several years.
For every successful biologic, there are another 10 or 20 that do not pan out, making the incentives for investment in this field extremely sensitive to any regulatory changes.

The Biologics Price Competition and Innovation Act established 12 years of regulatory data protection based on a study by the Congressional Budget Office that found that 11.5 years is the average time period drugs are marketed under patent in the United
States. However, Canada currently provides eight years of regulatory data protection for new biologic drugs, while Mexico offers five years of regulatory data protection. Failure to secure adequate data protection consistent with current U.S. law could jeopardize
future innovation in lifesaving biologic medicines and threaten U.S. global leadership in this critical industry. The biotechnology industry spends billions of dollars to develop, test and bring their products to market and relies on an established period
of data exclusivity to recoup their costly investments. In fact, biologics now account for over a third of all new drugs in clinical trials or awaiting FDA approval. Weakening existing data exclusivity protections will restrict investment in new drugs and
discourage new and innovative companies from entering the market.

The first objective listed in USTR’s Negotiating Objectives for NAFTA is to “Improve the U.S. trade balance and reduce the trade deficit with the NAFTA countries.” It is important to note that the U.S. currently maintains a trade surplus with both NAFTA
partners Mexico and Canada in biologic drugs. For example, in 2016, the U.S. trade surplus for biotech products with Canada amounted to $700 million while the U.S. trade surplus for biotech products with Mexico in 2016amounted to $357 million. Furthermore,
this critical industry supports 1.6 million direct jobs across 32 states and 7.53 million indirect jobs throughout the rest of the U.S. economy. It is critical that we maintain this trade surplus and continued U.S. leadership in this vital industry.

Thank you for your attention to these issues and we look forward to receiving your timely response.

Sincerely,

Related Legislative Issues
Selected legislative information: HealthCare, Trade
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