Strong Biologics Data Protection Should Be Non-Negotiable

In just a few weeks time, chief negotiators will re-engage in the Trans-Pacific Partnership (TPP) talks. We will also see a visit from Japanese Prime Minister Abe, who will also address Congress at the end of the month to discuss the elements of the agreement affecting the US and Japan.

To be sure, there has been significant progress in the negotiations thus far, with 10 out of the 29 chapters having been finalized. However, a crucial element of TPP negotiations that has not been dealt with adequately relates to the pharmaceutical industry.

Few would disagree that maintaining access to innovative medicines is critical. And strong data protection for biologics is central to making sure that we can accomplish this.

As part of President Obama’s budget this year, and in each of his budgets for that matter, he has suggested reducing biologic data protection from 12 years to only 7. In contrast, in TPP negotiations the administration has supported a position of arguing for 12 years of protection. This is surely the right way forward across the board.

Acting Deputy US Trade Representative Wendy Cutler (L) is escorted by Japan’s deputy chief negotiator Hiroshi Oe (R) prior to their talks for the Trans-Pacific Partnership (TPP) free trade negotiations at the Foreign Ministry in Tokyo on March 5, 2015. Washington has for years pushed the TTP, which proposes a loosening of trade restrictions. AFP PHOTO / Toru YAMANAKA (Photo credit should read TORU YAMANAKA/AFP/Getty Images)

Indeed, there are not too many areas of bipartisan agreement these days, but strong data protection for biologics has considerable support from both sides of the aisle in Congress.

Biologic data protections serve to ensure that when medical innovators invent new products—that is, invent new lifesaving medicines—they will retain the exclusive rights to sell those medicines. This is necessary to offset the enormous costs of research and development for these products.

Weakening biologic data protection puts lives at risk. Currently, pharmaceutical companies are working to develop products that attack cancers, heart disease, Alzheimer’s, and every other ailment one can think of. Indeed, there are over 800 medicines dedicated to treating cancers alone in development.