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pending issues facing negotiators is establishing a period of regulatory data protection before a competing firm may rely on an innovative manufacturer’s scientific data to develop and seek marketing approval of what many mistakenly call a generic version of the biologic.
Given the high costs of capital for startup and emerging biotech companies and the massive costs associated with building specialized manufacturing facilities for biologics, it stands to reason that an appropriate length of IP protection, in this case data protection, is both reasonable and necessary.
Congress agrees. As policymakers debated the Affordable Care Act, data protection was vigorously and thoroughly discussed, and Congress enacted the current U.S. law of 12 years biologics data protection in a bipartisan vote.
Shorter regulatory data protection periods could constrict the flow of domestic research dollars into new biologic drug development, as innovating companies and venture capital shift investments into friendlier markets. But even worse for the U.S. economy is the potential loss of jobs that could ensue as the best scientists conduct their groundbreaking research overseas. And it’s not just the R&D jobs that may suffer. Derailing the flow of innovation and stifling the new drug pipeline for biologics could also mean fewer facilities for research and manufacturing being built in the United States, resulting in a loss of high-paying construction and other good jobs that the labor market has come to depend upon.
The TPP has the potential to open new markets for the U.S. economy, spurring the innovation that will be needed to advance the field of biomedicine well into the 21st century and sustaining and generating valuable jobs here in the U.S. However, this will only happen if our foreign counterparts are playing by the same rules. The best way to safeguard this is to secure the strongest protections for American innovation by establishing an agreement that adheres to the laws already on our books.
Anything less will shortchange medical innovation R&D enterprises and nearly all other sectors of our economy, at a time when we need to be doing more to support them, their research, their employees and the countless U.S. communities they call home.