Tag Archives: 12 years exclusivity

Bi-partisan Senate Letter asking for 12 years of Data Protection in TPP

u.s. capitol

Senators Hatch and Kerry, along with 35 other Senators, sent a letter to Ambassador Kirk asking for 12 years of regulatory data protection consistent with U.S. law in the Trans Pacific Partnership Agreement. We are united in urging you to propose a strong minimum term of regulatory data protection for biologics consistent with U.S. law. As you are aware, U.S. law provides for a 12-year term of regulatory data protection for biologics and we believe that should serve Read More >

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Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity Read More >

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