U.S. Negotiators on TPP -- Don't Trade Away the Biopharmaceutical Research Sector

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

[authors: James C. Greenwood and John J. Castellani]

Biotechnology Industry Organization (BIO)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.

PhRMA #2To 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)

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.