By James C. Greenwood and John
J. Castellani —

How
do we create success in an age of fierce competition and accelerating
globalization?  America no longer has a lock on any industry or technology.  That
is why it is important to do all we can to sustain America's global leadership
in biopharmaceutical research and development which provides quicker access to
innovative medicines, jobs and economic growth to build stronger communities,
and new technologies, spin-off industries and a stream of exports to keep
America competitive for decades to come.

To
secure America's continuing biopharmaceutical leadership, policymakers must not
trade away the economic and systemic advantages that made our sector the
world-leader.  We need public policies and incentives that support and grow the
biopharmaceutical sector domestically and promote access to global markets.

The
Obama Administration must protect intellectual property (IP) in ongoing trade
negotiations.  A critical issue at the center of far-reaching Trans-Pacific Partnership (TPP) negotiations
is biologics data protection.  Biologics are pharmaceutical products that are
generally derived from living material — human, animal, or microorganism.  Many
future therapies will depend on the ability of our innovative companies to
produce these complex, life-saving medicines.  This was recognized by
overwhelming bipartisan support for a provision in the healthcare reform law
that provided a 12-year period during which competitors' products may not be
approved on the basis of the complex scientific data generated by a biologic
product's inventor.  This provision fosters new biopharmaceutical R&D by
giving companies time to recoup their significant investment while providing
patients with access to innovative biopharmaceutical products.

As
U.S. negotiators sit down with other TPP parties and those who may soon join
these talks, including Canada and Mexico, it is essential that they secure
strong IP provisions that reflect U.S. law, including the 12 years of data
protection for biologics.  For decades, U.S. negotiators have worked tirelessly
to bring other countries up to the IP protection standards that we have in the
U.S. This is no time to change course.

There
is a lot at stake in these negotiations.

First
is America's global leadership in developing innovative medicines.  Since 2000,
the U.S. Food and Drug Administration (FDA) has approved nearly 400 new
medicines for patient use — most pioneered in the U.S.  There are more than
3,000 new medicines to treat a wide range of conditions and rare diseases in
late-stage development or pending FDA approval.  These include therapies to
treat the diseases that plague us and our loved ones, including Alzheimer's,
cancer, HIV/AIDS and many more.  These compounds are being developed across the
country by literally hundreds of American companies, from large global firms to
small biotech start-ups.

Next,
there is the economic impact.  A National Academy of Sciences study shows this
sector's R&D investment represents an astonishing 20% of all domestic
R&D funded by U.S. businesses.  This investment supports 4 million direct
and indirect American jobs.  These are good-paying jobs that help to build and
grow local, state and the national economies.

Finally,
there is the contribution to America's exports.  Today, nearly 60 % of U.S.
trade is with countries in the Asia-Pacific market.  This will grow so long as
American companies can compete and their IP is respected.  Holding firm on 12
years of biologics data protection is a four-fold win:  bringing cutting-edge
medicines to patients, fostering a critical American industry, bolstering
exports, and keeping America competitive in global markets.

Strong
IP protections are not barriers to access.  The progress made in
developing new HIV/AIDS treatments and their wide availability globally help
demonstrate how IP protections can simultaneously reward R&D investment and
improve therapies available to patients worldwide.  As our trading partners,
through contexts like the TPP, work to strengthen their IP systems, they will
provide the necessary platforms for local innovators, spurring greater global
competition that will ultimately benefit the world's patients.

The
bottom-line is that the biopharmaceutical research sector is a national asset
and is essential to our health and economic future.  If we fail to act,
including in the current TPP negotiations, there will be profound consequences — for patient access to innovative medicines as well as for our economy.

American
global leadership in biopharmaceutical research is not a given.  Our
international competitors understand the value of a strong biopharmaceutical
research sector, the patients it helps and the jobs it creates.  They are doing
all they can to encourage domestic production and R&D.  Our companies at
home work hard to stay the best and compete globally, but they can only
continue doing so if American trade policies support and defend innovation and
progress.

James C. Greenwood is the President & CEO
of the Biotechnology Industry Organization
(BIO) and John J. Castellani is the President & CEO of the Pharmaceutical Research and Manufacturers of
America (PhRMA)