From Our Affiliates

Biologics and TPP: Strong Protection of Proprietary Data is Necessary for the Development of Breakthrough Treatments


Jennifer Bernstein joins Global Genes as policy liaison, focusing on legislation and policy activities, covering topics pertinent to RARE disease

The Trans-Pacific Partnership (TPP) is probably one of the most important issues facing the patient community right now, yet nobody seems to be talking about it.

The Trans-Pacific Partnership (TPP) is probably one of the most important issues facing the patient community right now, yet nobody seems to be talking about it.  The Trans-Pacific Strategic Economic Partnership Agreement originated in 2005, and was intended to liberalize the economies of the Asia-Pacific region and lower barriers to expand trade.  Currently, membership consists of: Brunei, Chile, Singapore, New Zealand, United States, Australia, Peru, Vietnam, Malaysia, Mexico and Canada.  Taiwan, the Philippines, South Korea and Japan are considered potential future members.  The negotiations began in 2009 and will likely conclude by the end of this year.

One of the terms under negotiation is the length of data exclusivity protection for biologic medicines.  Current U.S. law provides for a 12-year period of data protection for biologics, and has strong bipartisan support in the U.S. Congress. However, the incentives under current intellectual property provisions found in the U.S. are at risk.  As patients, we need to be aware that this is happening and understand the potential impact.

Data protection allows innovator companies to protect their intellectual property, which is the most valuable asset to a company and perhaps the greatest incentive to research and innovate for new medicine.  Data protection help companies recoup the costs of their investment in the research, development, and ultimately (hopefully) FDA approval—which costs approximately $1 billion per product.  Eroding data protection for innovator companies is likely to slow innovation, which in turn will slow the development of new therapies for our patient community and many others.  We in the rare disease community are already at a disadvantage when it comes to incentivizing innovation.  Slowly but surely, we are making progress in this space.  However, decreasing data protection for innovator companies has the potential to move us backwards.

It is incredibly important that the Obama Administration use the TPP negotiations to bring the IP protections in partner countries up to the same level as in U.S. law.  Strong protection for proprietary data is necessary in order to maintain an environment ripe for the development of breakthrough treatments.

If you are interested in signing the  2012 Patient Declaration supporting an international innovative ecosystem for healthcare delivery, please contact Amy Grover, Director, Community Development of R.A.R.E. Project at amyg@rareproject.org.

The following article of a recent edition of the Wall Street Journal, will provide a further in-depth analysis of the importance of this issue. Article HERE.

Please join us in support of a patient declaration encouraging innovation in global trade agreements.

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