[Ip-health] Ip-health Digest, Vol 102, Issue 1

Light, Donald W lightdo at rowan.edu
Mon Oct 1 19:28:50 PDT 2018

Further to Peter's point, data exclusivity has been created as an artificial "right" enclosing testing data for a public regulator and for patient safety, as if safety tests on your car were not publicly available but owned by the manufacturer, rather than being owned by the body protecting safety. For a detailed account of how this "right" was extended in Europe without any independent evidence that it incentivizes R&D or better medicines, put " Adamini JHPPL  data exclusivity" in a search bar for a PDF free copy. 

Donald W. Light
Cell: 1-609-216-0071
Professor, Rowan University School of Osteopathic Medicine
Google citation h-index: 96th percentile
Guest researcher: Princeton & NYU
Distinguished career award 2013 American Sociological Association
Edmund Pellegrino Medal in Bioethics, 2016 
On 10/1/18, 3:00 PM, "Ip-health on behalf of ip-health-request at lists.keionline.org" <ip-health-bounces at lists.keionline.org on behalf of ip-health-request at lists.keionline.org> wrote:

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    Today's Topics:
       1. United States-Mexico-Canada Agreement Text (Thiru Balasubramaniam)
       2. New NAFTA text released: Potentially lethal IP chapter
          requires 10-year biologics monopolies (worst such rule in a U.S.
          FTA) (Peter Maybarduk)
    Message: 1
    Date: Mon, 1 Oct 2018 07:46:41 +0200
    From: Thiru Balasubramaniam <thiru at keionline.org>
    To: a2k at lists.keionline.org,  "ip-health at lists.keionline.org"
    	<Ip-health at lists.keionline.org>
    Subject: [Ip-health] United States-Mexico-Canada Agreement Text
    	<CANi=seJKtqQgpsPqOtjpYgUQV2FYsjSy9Pj7Eme5JPvAihMUrA at mail.gmail.com>
    Content-Type: text/plain; charset="UTF-8"
    Chapter 20 -  Intellectual Property
    Chapter 21 - Competition Policy
    Chapter 31 - Dispute Settlement
    US - Mexico Side Letter on Biologics
    Thiru Balasubramaniam
    Geneva Representative
    Knowledge Ecology International
    41 22 791 6727
    thiru at keionline.org
    Message: 2
    Date: Mon, 1 Oct 2018 05:49:01 +0000
    From: Peter Maybarduk <pmaybarduk at citizen.org>
    To: "ip-health at lists.keionline.org" <ip-health at lists.keionline.org>
    Subject: [Ip-health] New NAFTA text released: Potentially lethal IP
    	chapter requires 10-year biologics monopolies (worst such rule in a
    	U.S. FTA)
    Message-ID: <62b1a35cad7b4209a7dbc93251599b96 at citizen.org>
    Content-Type: text/plain; charset="us-ascii"
    The renegotiated NAFTA intellectual property text is available here: https://ustr.gov/sites/default/files/files/agreements/FTA/USMCA/20%20Intellectual%20Property.pdf
    The revised rules would further strain health care budgets, contribute to people's suffering and family financial hardship, and most likely cost people their lives.
    The rules go significantly beyond the original NAFTA text in their government-sponsored patent and exclusivity protections for corporate monopoly control over needed medicines. Their purpose is to better insulate expensive new medicines from generic competition; helping pharmaceutical corporations keep the prices of at least some new medicines higher for longer.
    Canada and Mexico should be embarrassed - perhaps even ashamed - for agreeing to such terms.  At least as regards their own peoples' access to medicines and health, Mexico and Canada have failed to stand up to North America's neighborhood bully.
    This is especially sad given it has been just three years since eleven countries including Canada and Mexico rejected many of these same ideas in the Trans-Pacific Partnership negotiations. That was a significant victory for health; this is a somewhat less pronounced defeat.
    The revised rules are worse than the original NAFTA in that they require, among other harmful measures:
    *         A minimum ten years of government-granted marketing exclusivity - that is, monopoly - for biologics (which include many of the most important and expensive new medical technologies). This is the worst such rule yet negotiated in a U.S. trade agreement.
    *         Special marketing exclusivity periods for either new uses and forms or new combinations of older medicines.
    *         The granting of patents for at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product.
    *         Offering multi-year extensions on patent terms when reviews at the regulatory or patent office take longer than terms deemed "unreasonable." (Note that the public gets no reduction in patent terms when these processes move quickly.)
    *         Linking regulatory safety and efficacy reviews to patent disputes, which can mistakenly delay generic competition.
    We are happy to comment further.
    Peter Maybarduk
    Director, Access to Medicines Program
    Public Citizen
    Washington, DC
    +1 202 588 7755
    Subject: Digest Footer
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    End of Ip-health Digest, Vol 102, Issue 1

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