Opinion

Protecting Biomedical Innovation in the Trans Pacific Partnership is Critical to New Drug Development

As Congress continues debating Trade Promotion Authority (TPA) legislation to allow President Obama to complete negotiations on two free trade agreements (FTA), it is imperative that policymakers don’t lose sight of the bigger picture: the underlying trade agreements at stake that could propel American prosperity in the 21st Century.

Indeed, TPA is only the first step, giving the president authority to bring trade agreements to Congress for approval. One of these agreements, the Trans-Pacific Partnership (TPP), could be the most significant FTA ever, comprising 12 countries that represent 40 percent of the world’s GDP. Because of the TPP’s magnitude and potential for the U.S. economy, it’s easy to see why President Obama has been fighting to enact TPA legislation for the better part of the last two years.

At this point, it’s certainly fair to say that those who either support or oppose TPA have had more than ample time to argue its merits, and there is no doubt that any trade agreements submitted to Congress by the president will be subject to vigorous, contentious and extensive debate on their own. This is exactly how our government should consider issues of such importance, and also why Congress should pass TPA and allow the president to finish the TPP negotiations.

The TPP will affect every sector of our economy. The Asia-Pacific region has long been seen as a growth area for U.S. enterprises looking to expand their reach, and the TPP will be a vital tool for unlocking new markets that have historically imposed steep barriers to entry for American businesses. The TPP could also redefine how we approach trade agreements in the future, which is why opening new markets is only half of the equation, and why the TPP must contain provisions for intellectual property (IP), labor and environmental protections.  IP protections in particular must be a major component of the TPP, as the United States increasingly becomes a knowledge-based economy dependent upon innovation to create opportunity and enhance prosperity.

America’s innovative biopharmaceutical industry has much at stake in the TPP, as one of the key items remaining to be finalized in the TPP is clinical data protection for biologic medicines. Biologics are already used to treat diseases like cancer and rheumatoid arthritis, and many researchers think biologics could help us eventually discover revolutionary treatments for debilitating illnesses like Alzheimer’s or Parkinson’s. Biologics require significant investments and intense R&D, and because of the promise they hold, the U.S. and other nations must encourage and incentivize the continued innovation that will turn today’s potential into tomorrow’s cures.

Ensuring IP protections and enforcement is a critical component of our industry’s core mission: discovery. New medicines do not simply appear. They are the result of up to 15 years of painstaking research and development at an average cost of $2.6 billion. For each new medicine that comes to market, there are hundreds of other potential compounds that failed somewhere along the line. And yet, the process of discovery often forces us to rethink and reshape the direction of our research and approach to fighting a disease. The important role of IP, including a 12-year data protection period for biologics, was enshrined in the Affordable Care Act, and endorsed by a strong bipartisan contingent of Congress.  This standard must be reflected in in the TPP.  This would not only follow the letter of TPA, but would prime the innovative lifecycle that brings new medicines to market for the world’s patients while at the same time bolstering U.S. jobs.

Yet there remain critics of the TPP and trade agreements in general who fail to grasp the importance of IP protections for biopharmaceuticals in terms of human and economic impact. The evidence is overwhelming that the U.S. model works. It’s why the U.S. continues to dominate the pipeline of new drugs in development, and why generics now comprise nearly 85 percent of the market here. In that same vein, establishing IP norms with our partners in the TPP incentivizes the development of innovative medicines in those countries while also providing a pathway to competition.

As the TPP progresses toward its endgame, our negotiators must keep in mind how the United States became the world’s leader in innovation, and how we can maintain our position in the future.

For American consumers, patients, workers and businesses to reap the full benefits of the TPP, the U.S. cannot afford to lose sight of the big picture at this critical juncture.

John Castellani is president and CEO of PhRMA.

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