[Ip-health] Drug Firms Look To Limit Deal's Impact

[Benjamin Krohmal]

<But drug manufacturers also want to ensure that the new compromise
provisions apply only to the three pending Latin American bilateral
trade deals, and will not carry over to future trade agreements or any
new grant of presidential trade negotiating authority.>

Congress Daily AM - May 17, 2007
TRADE
Drug Firms Look To Limit Deal's Impact
      Pharmaceutical firms and their allies on Capitol Hill are
hoping to
limit the impact of a bipartisan agreement to relax requirements in
trade agreements to protect drug patents, which are part of a broader
deal to unblock trade deals with Peru, Panama and potentially Colombia.
      Business groups have hailed the overall agreement as providing a
boost to the Bush administration's trade agenda, with one caveat: the
portion covering intellectual property.
      The drug industry is widely viewed as having been sacrificed to
achieve progress on broader trade goals, as the White House bowed to
Democratic demands to roll back the IP protections in the name of
providing greater access to life-saving medicines in poor countries.
      Some lawmakers who are sympathetic to the industry's bid to
protect
their innovative products say they will be closely watching how the
actual language of the agreements is drafted, to ensure it does not
undermine drug patent protections.
      "I have some concerns about how they were handling the
pharmaceutical aspect of it, and the notion that [IP protections] should
be significantly reduced in these agreements with developing countries,"
said Rep. Adam Smith, D-Wash., a leader of the New Democrat Caucus.
      Smith said that the conceptual language that the White House and
lawmakers unveiled last week was "by and large, OK. It's not finalized,
and we will continue to have that discussion," he said.
      Another New Democrat, Rep. Melissa Bean, D-Ill., said in a
statement, "I look forward to working with my colleagues to improve
patent protections and ensure the competitiveness of America's
innovators."
      Ways and Means ranking member Jim McCrery, R-La., said Monday that
the main concepts have already been agreed upon among Republicans,
Democrats and the Bush administration, and that translating those
concepts into legal text will not give rise to many problems. "I don't
think there will be a lot of haggling over the language. We've hammered
this thing out nine ways to Sunday already," he said.
      But drug manufacturers also want to ensure that the new compromise
provisions apply only to the three pending Latin American bilateral
trade deals, and will not carry over to future trade agreements or any
new grant of presidential trade negotiating authority.
      One key part of the compromise aims to ensure that generic drugs
will be able to be offered in developing countries when those generics
are already available in the United States.
      It keeps intact the five years of "exclusivity" for clinical test
data that innovative drug companies enjoy under recent trade agreements.
But it seeks to ensure that brand-name drugmakers are not able to extend
that period in the developing country longer than the clinical test data
is protected in the United States, subject to certain conditions.
      Health activists have derided that portion of the deal, saying
that
it changes little from the current U.S. policy. "The preservation of
data exclusivity alone is a gigantic gift to Big Pharma," the groups
Health GAP, Essential Action, and the Student Global AIDS Campaign said
in a statement Monday.
      More significant, and potentially damaging for the innovative drug
firms, is the removal of a requirement that countries extend the term of
patents to compensate for delays in the patent approval or marketing
approval process.
      U.S. trade officials said in a conference call last week that the
intellectual property changes are limited to pending trade deals but
said they did not know the extent to which the changes would also become
a part of future trade deals.
      "That's to be determined when we get down to the next [trade
promotion authority]," a trade official said. "When they starting
writing TPA, it wouldn't surprise me at all if that's where [House Ways
and Means Chairman] Rangel started from."    By Martin Vaughan

Benjamin Krohmal
Coordinator - Project on Medical Innovation
Knowledge Ecology International
Tel: +1-202-332-2670 ex. 17
Fax: +1-202-332-2673
ben.krohmal@keionline.org