While many parts of the Trans-Pacific Partnership agreement will positively impact bio innovation and the societal benefits it can bring around the world, other provisions fall short and will inhibit the development of the next generation of breakthrough medicines, said Stephen Ezell in testimony before the House Ways and Means Committee Democratic Members. In particular, biologics are the next frontier in medical innovation, but they are also enormously risky, time-consuming, and expensive to develop. It’s important to strike an appropriate balance between promoting competition and providing adequate incentives to support continued innovation of new treatments and cures. Unfortunately, the TPP fails to secure 12 years of data exclusivity protection from the clinical trial data that validates the safety and efficacy of novel biologic drugs.
