[CTC] More on TPP and Health

[Arthur Stamoulis]

More great coverage of yesterday's medicines actions in Atlanta. Kudos to
Zahara Heckscher, Melinda St Louis and everyone else who pulled things
together so quickly.

Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826

http://www.wsj.com/articles/rift-over-drug-protections-complicates-trans-pacific-partnership-trade-talks-1443691801

Rift Over Drug Protections Complicates Trans-Pacific Partnership Trade Talks

Countries fight over how long to protect certain high-end drugs from
lower-cost imitators

The Wall Street Journal

By William Mauldin

October 1, 2015

A fight over how long to protect certain high-end drugs from lower-cost
imitators has emerged as the leading obstacle to negotiations aimed at
completing a 12-nation trade agreement spanning the Pacific.

While officials from the U.S. and other counties cite some progress on two
other thorny issues, the drug debate continues to divide Australia and
other countries from America in the high-level talks that began Wednesday
in Atlanta.

Backed by key lawmakers and leading pharmaceutical companies such as Pfizer
Inc. and Amgen Inc., U.S. negotiators are seeking an intellectual-property
rule in the pact that would grant brand-name biologic drugs a period of
exclusivity of up to 12 years, during which they are protected from generic
imitations, consistent with U.S. law. Japan is also backing a long period
of protection of biologic drugs.

Biologic drugs are complex medicines made from living cells, blood
components and tissue, in contrast to the “small molecules” that scientists
use to produce traditional drugs.

Countries such as Australia and New Zealand are pushing for just five years
of exclusivity, worried that a longer period of protection for the
big-ticket drugs could slow the arrival of generic imitators and add
significantly to the budgets of their national health systems.

On Wednesday, Australian Trade Minister Andrew Robb told Mike Froman, the
U.S. trade representative, at a bilateral meeting that longer periods of
exclusivity are unacceptable, according to an Australian official.

Australia currently has five years of standard protection with one
additional year of effective protection in its domestic law.

Mr. Robb has pushed back against a compromise proposal floated in the talks
that would require countries in the Trans-Pacific Partnership trade
agreement to give biologic drugs at least five years of basic exclusivity,
plus an additional three years of protection while regulators monitor the
drug’s safety, the official said.

Governments protect drug makers’ exclusivity in several ways for biologics,
including by preventing imitators from using data from the original drug’s
trials for a certain period, as well as temporarily blocking market entry
for imitations, known as biosimilars, under certain conditions.

The Pacific pact is meant to lower trade barriers across 12 countries,
including the U.S., Japan, Australia, Mexico and Canada.

Outside the Atlanta hotel where the U.S. is hosting the talks, protesters
said the Washington position would raise the price of lifesaving medicine
overseas and slow the introduction of useful generic alternatives.

“The policies they promote are supposed to represent the interests of the
people of the U.S., not just the short-term greed of the giant
pharmaceutical companies,” said Zahara Heckscher, 51, a breast-cancer
patient who said she has taken three biologic drugs.

A spokesman for Mr. Froman said the TPP will “help ensure that lifesaving
medicines are more widely available, while at the same time creating
incentives for the development of new treatments and cures.” U.S. officials
declined to discuss the latest negotiating positions.

The drug fight underscores the multiple challenges Mr. Froman faces in
finding balances that are acceptable both to the 11 other countries in the
talks as well as the U.S. Congress, where a majority vote is still needed
to enact a TPP deal reached in Atlanta or elsewhere.

Sen. Orrin Hatch (R., Utah), the chairman of the Senate committee that
oversees trade, has championed 12 years of protection for biologics and
warned Tuesday that it would be better to continue the talks than accept a
“less-than-optimal result for our country.”

U.S. lawmakers narrowly approved “fast track” legislation designed to
expedite the TPP this year, and foreign officials in Atlanta say they are
aware of the TPP’s uncertain fate in Congress, which complicates efforts to
reach a deal.

Many House Democrats, who are largely opposed to the TPP, want any
agreement the U.S. signs to allow generic versions to come to market more
quickly to put downward pressure on drug prices. The high cost of
prescription drugs is already shaping up to be a major political issue in
the 2016 election season.

Some U.S. officials, aware of drugs’ high cost to taxpayers, would like to
shift some of the expense of biologic drugs to other government health
systems through longer exclusivity periods abroad.

The big pharmaceutical companies say they need rules that protect them
against competitors because it costs well over $1 billion to bring a new
drug to market.

“We will evaluate the agreement, when and if it is reached, but we are very
clear that our position is that the U.S. law should be the standard for
trans-Pacific partners,” said John Castellani, president of industry group
PhRMA. “If we get a strong protection for our intellectual property, then
we will work very diligently to convince members of Congress that it’s good
for Americans.”

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http://www.smh.com.au/federal-politics/political-news/trade-deal-has-hit-hurdle-of-barack-obamas-making-says-andrew-robb-20151001-gjyrq0.html

Trade deal has hit hurdle of Barack Obama's making, says Andrew Robb

The Sydney Morning Herald

By Gareth Hutchens

October 1, 2015

Atlanta, Georgia. Trade Minister Andrew Robb says the attempt by US
President Barack Obama to force Congress to pass a huge multilateral trade
agreement more quickly may have backfired.

It has made it more difficult for US negotiators to cut last-minute deals
needed to finalise the agreement this week, he says, meaning the
President's hopes of finalising the deal in his final term may be fading
fast.

The world's biggest multilateral trade agreement, called the Trans-Pacific
Partnership, is being negotiated by global trade ministers over the next
two days in Atlanta, Georgia in the United States.

The massive deal will cover 40 per cent of the world's economy and bind 12
economies in the Pacific region more closely - Australia, New Zealand,
Canada, the United States, Mexico, Peru, Chile, Malaysia, Singapore,
Vietnam, Brunei and Japan.

It will also cement US labour and environmental practices within the
region's trade relationships, creating a blueprint for future trade
agreements with countries such as China.

Trade officials believe the negotiations have been nearing completion -
after five long years of talks - with only a few key sticking-points
preventing the agreement from being concluded this week.

But Mr Robb has told Fairfax Media that the attempt by US President Barack
Obama to get the deal done more quickly earlier this year has made it
harder for US negotiators to move past those sticking points.

President Obama has openly been pushing for the trade deal to be completed
quickly because he would like it to form part of his economic legacy, but
he needs to get it finalised and submitted to Congress as soon as possible
so it has time to pass before he leaves office next year.

In June this year he won the controversial power to send an eventual
finalised trade agreement to Congress for approval without Congress having
the power to make amendments to the bill, significantly reducing the time
it will take for the bill to pass once it gets to Congress.

But Mr Robb says President Obama had to make numerous promises to senators
to get that power, and a consequence of that is that US negotiators now say
they can't cede any more ground on key sticking points in the final crucial
stage of the negotiations.

"The [fast track authority] has a lot to answer for in all of this, because
a lot of the Congressmen said 'sure, you'll get our vote, as long as you do
X, Y and Z', which usually meant not opening up as much as the
administration would want to," Mr Robb said.

"It's tied their hands. They say 'Well, we can't move because of Congress,
and I say well, you know, you're not on your own, we all have politics to
deal with [back home]."

"Clearly a lot of commitments were made in order to get the votes to get
the [fast track authority] through, and it can be somewhat frustrating."

Mr Robb said he was still waiting to see what deal the Americans were going
to offer Australia on dairy products.

"We've put stuff forward to the Americans on biologics, and we're waiting
for them to come back with a response. And we're waiting on the Americans
[to come to us with something on] dairy, [but] they claim they're waiting
on others," he said.

"We're in that stage which can be quite frustrating."

Earlier in the morning, a dozen protesters were asked to leave the Westin
Hotel in downtown Atlanta, the site of the negotiations, after they walked
inside and began yelling in unison "Stop the TPP! No corporate greed!"

Cancer patient Zahara Heckscher, in a T-shirt reading "I HAVE CANCER. I
CAN'T WAIT 8 YEARS", was arrested for refusing to leave the hotel.

Ms Heckscher was demanding that trade officials show her the secret text of
the agreement so she could see if it included a 'death sentence clause' -
the text of the US proposal to extend de facto monopolies on biological
medicines from 5 to 8 years.
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