Re: [Ip-health] Bush, Congress Agree On Trade Standards Here is the text on medicines from the outline of "A New Trade Policy for
America" announced yesterday by Speaker Pelosi.  Note that this is still
an outline - I have not yet seen the actual text:


Generic Medicines
-  Change the "data exclusivity" provision (period in which a generic
manufacturer may not use clinical test data of an innovative drug
manufacturer) to allow generics to enter the market more quickly than
under the old provision (by having "concurrent period" of data
exclusivity).
-  Include exception in FTAs that the "data exclusivity" provision does
not preclude FTA countries from taking measures to protect public health
and from utilizing the WTO "health solution."
-  Eliminate requirement that a drug regulatory agency withold approval of
a generic until it can certify that no patent would be violated if the
generic were marketed; strengthen and expedite judicial processes in
countries to ensure patent rights of innovative drug companies are
respected.
-  Eliminate requirement that an FTA country extend the term of a patent
on a pharmaceutical product for delays in the patent and regulatory
approval process.  Instead, ensure expeditious patent and regulatory
approval process.



> 
>
> The agreement -- announced last night by House Speaker Nancy Pelosi,
> Treasury Secretary Henry Paulson and other top officials and lawmakers
> -- clears a hurdle to the passage of some small bilateral trade deals.
> And it could ultimately smooth the way for broader trade measures such
> as renewing President Bush's soon-to-expire authority to negotiate
> trade deals without threat of congressional amendments, as well as a
> new global trade agreement now being negotiated in the Doha Round of
> world trade talks.
>
> Lawmakers said the agreement would help provide broad bipartisan
> support in Congress for pending agreements with Peru and Panama. But,
> they said other trade measures, including pacts with Colombia and South
> Korea, involve other issues that haven't been worked out.
>
> In addition to including new labor and environmental principles, the
> deal calls for expanded access for developing countries to generic
> drugs, a priority for Democrats, who say efforts by brand-name drug
> makers to protect their markets have put many medicines out of reach in
> poor countries.
>
> "This is a major breakthrough in what we've been fighting for ... to be
> sure that globalization opens up for many more people, including
> workers," said Rep. Sander Levin (D., Mich.), one of the negotiators.
> Before Democrats were in a position to influence the debate, he said,
> "I think Republicans were resisting a necessary trend to spread the
> benefits of trade."
>
> 
>
> The drug industry trade group, Pharmaceutical Research and
> Manufacturers of America, declined to comment until it has reviewed the
> final agreement. But objections from the powerful lobby -- which
> succeeded this week in killing a proposal to ease rules for
> pharmaceutical imports -- would complicate prospects for passage.
>
> U.S. Trade Representative Susan Schwab said, even with the changes
> related to generic drugs, pending trade agreements would improve
> protections for intellectual property abroad, including brand-name
> pharmaceuticals. "This is a compromise," she said. The drug provisions
> apply to the pacts with Panama, Peru and Colombia, but not Korea, she
> said.
>
>
> -----------------
>
> http://online.wsj.com/article/SB117883999169399217.html
>
> Bush, Congress Agree
> On Trade Standards
> By SARAH LUECK, JOHN D. MCKINNON and GREG HITT
> May 11, 2007; Page A2
>
> WASHINGTON -- After months of standstill, the White House and
> congressional Democrats agreed to strengthen labor and environmental
> standards in free-trade pacts, signaling a new bipartisan consensus
> aimed at shoring up crumbling U.S. public support for economic
> globalization.
>
> The agreement -- announced last night by House Speaker Nancy Pelosi,
> Treasury Secretary Henry Paulson and other top officials and lawmakers
> -- clears a hurdle to the passage of some small bilateral trade deals.
> And it could ultimately smooth the way for broader trade measures such
> as renewing President Bush's soon-to-expire authority to negotiate
> trade deals without threat of congressional amendments, as well as a
> new global trade agreement now being negotiated in the Doha Round of
> world trade talks.
>
> Lawmakers said the agreement would help provide broad bipartisan
> support in Congress for pending agreements with Peru and Panama. But,
> they said other trade measures, including pacts with Colombia and South
> Korea, involve other issues that haven't been worked out.
>
> In addition to including new labor and environmental principles, the
> deal calls for expanded access for developing countries to generic
> drugs, a priority for Democrats, who say efforts by brand-name drug
> makers to protect their markets have put many medicines out of reach in
> poor countries.
>
> "This is a major breakthrough in what we've been fighting for ... to be
> sure that globalization opens up for many more people, including
> workers," said Rep. Sander Levin (D., Mich.), one of the negotiators.
> Before Democrats were in a position to influence the debate, he said,
> "I think Republicans were resisting a necessary trend to spread the
> benefits of trade."
>
> The deal also shows that, for all the squabbling between the White
> House and Capitol Hill on Iraq, the two sides have continued to find
> ways to work together on other issues. Beyond trade, administration and
> congressional leaders are feverishly negotiating to try and reach an
> agreement this month on immigration overhaul.
>
> While the trade pact has the solid backing of congressional leaders,
> any specific trade legislation could still face strong opposition among
> rank-and-file lawmakers and labor groups.
>
> The drug industry trade group, Pharmaceutical Research and
> Manufacturers of America, declined to comment until it has reviewed the
> final agreement. But objections from the powerful lobby -- which
> succeeded this week in killing a proposal to ease rules for
> pharmaceutical imports -- would complicate prospects for passage.
>
> U.S. Trade Representative Susan Schwab said, even with the changes
> related to generic drugs, pending trade agreements would improve
> protections for intellectual property abroad, including brand-name
> pharmaceuticals. "This is a compromise," she said. The drug provisions
> apply to the pacts with Panama, Peru and Colombia, but not Korea, she
> said.
>
> The push for free trade has been complicated by the rising U.S. trade
> deficit. Yesterday, the Commerce Department said the country's overall
> deficit surged to a six-month high of $63.9 billion in March, party
> because of a jump in oil imports. The report is causing economists to
> scale back estimates of first-quarter growth -- and is fueling new
> criticism from Democratic lawmakers of the Bush administration's trade
> policies.
>
> The deal would require that core international labor standards be
> incorporated into trade pacts and would enforce those commitments with
> the same sanctions used to back up business-backed priorities. In the
> case of Peru, the changes will be accomplished through amendments that
> won't require already agreed-to texts to be reopened, a congressional
> official said. The Panama deal, though largely completed, was left open
> to accommodate any compromise that might be struck by the White House
> and Democratic leaders.
>
> The agreement isn't meant to open U.S. laws to challenge under the
> strengthened labor commitments. But it doesn't include a specific
> assurance against that, according to the congressional official.
>
> --John McCary contributed to this article.
>
> ---------------------------------
> Thiru Balasubramaniam
> Geneva Representative
> Knowledge Ecology International (KEI)
> voice +41.22.791.6727
> fax +41.22.723.2988
> mobile +41 76 508 0997
> thiru@keionline.org
>
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