Why IP and Data Confidentiality Need Protection

Today's guest blog post comes from Dr. Robert Freeman, a Professor of Pharmacy Administration (health services research) in the Department of Pharmacy Practice & Administration at the University of Maryland Eastern Shore School of Pharmacy.  He has over 20 years’ experience in the global pharmaceutical industry.

The Trans-Pacific Partnership (TPP) is an ongoing series of trade negotiations involving The United States, Canada, Mexico and nine other countries in the Pacific Rim. The TPP seeks to provide a level playing field by eliminating tariffs and other anti-competitive national laws. Of particular importance to the pharmaceutical sector and other innovative industries are the terms in the TPP agreement regarding intellectual property protection (IP) and the protection of regulatory data (RDP).

But, for the United States, as for other nations, a variety of competing interests are balanced in these negotiations including those of the public, labor, agriculture and business. The interests of the pharmaceutical industry do not always win out when considered in the context of other business sectors’ priorities.

As is customary in international negotiations, the specific details of the discussions are not disclosed publically until a final agreement is reached and presented to national governments for ratification.

When a generic drug manufacturer seeks to copy a medication coming off patent, that company must also seek regulatory approval. The generic manufacturer can either produce its own safety and efficacy data through research, or use the information in the safety and efficacy data package the original innovator provided regulators to support the product. Generic manufacturers clearly prefer to access the innovator’s data because it is significantly less expensive to use existing data instead of conducting original research.

Patents are absolutely essential to encouraging innovation. Without patents, innovators cannot ensure their ability to recoup sufficient capital to sustain research and support development. But patents are only one part of the equation. Just as important is the protection of regulatory data. These are the studies and collection of proprietary information that a company shares with regulators about a new drug’s or biologic’s safety and efficacy.. This original research is conducted over a period of ten years or more at a cost of hundreds of millions of dollars of investment at the innovating company’s financial risk.

For patients and consumers, as well as for health industries, IP and RDP protections encourage and support investment in the development of new treatments and cures. Ensuring that both are taken into consideration is an essential part of the TPP negotiations.

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