[Ip-health] Trade Talk Documents Suggest Access to Medicines May Become Harder

Claire Cassedy claire.cassedy at keionline.org
Thu Oct 16 04:36:29 PDT 2014


Trade Talk Documents Suggest Access to Medicines May Become Harder

7:22 am ET
Oct 16, 2014



As the latest round of talks for the Trans-Pacific Partnership agreement
begins in Australia next week, negotiators will be discussing revisions in
a key document that consumer advocacy groups say would strengthen patent
rights for drug makers at the expense of patients in poor countries.

The 77-page document, which was obtained by WikiLeaks and reviewed by The
Wall Street Journal, contains proposals made at the last round of talks in
May, according to people familiar with the document. The TPP is a trade
agreement that is under negotiation to lower tariffs and open markets by 12
countries in the Asia and Pacific regions.

The pharmaceutical industry trade group believes a trade deal should offer
“strong intellectual property protections,” and has received backing from
members of Congress. Patient advocacy groups have openly fretted the deal
may limit access to medicines for people in poor countries.

The revisions address some of the most contentious topics batted around by
drug makers and advocates. For instance, the document does not include a
specific reference concerning compulsory licensing that appeared in an
earlier version of the draft document following TPP talks that were held
last year.

Countries may issue compulsory licenses to a generic drug maker allowing it
to copy a patented medicine without the consent of the pharmaceutical
company that owns the patent. This right was memorialized in a World Trade
Organization agreement known as Trade-Related Aspects of Intellectual
Property Rights, or TRIPS.

Pharmaceutical industry officials have frequently voiced concern that
licenses may be issued inappropriately. Drug makers, in fact, have battled
over licenses issued in Thailand and India. Bayer, for instance, lost a
legal battle in India last year over a license awarded to a generic drug
maker that wanted to make a copy of a cancer medicine.

Following trade talks in August 2013, New Zealand, Canada, Chile and
Malaysia proposed a passage that stated “nothing in this chapter shall
limit a party’s rights and obligations under Article 31 of TRIPS agreement
or any amendment thereto.”

This article spells out various rights and conditions for countries that
wish to issue a compulsory license, but the reference was removed from the
May document. By removing this passage, the latest draft may leave
countries with a more restrictive series of steps before a license can be
issued, one patient advocate says.

“This is a pretty big deal, because outside of the U.S., pretty much all
compulsory licenses on drug patents have been [issued] under Article 31,”
says Jamie Love of Knowledge Ecology International, a non-profit that
tracks patent and access issues, who has reviewed the latest document.

A spokesman for U.S. Trade Representative Michael Froman declined to
discuss or confirm details of any documents, but notes a report issued
earlier this year on intellectual property and health policy includes
language supporting the right of countries to issue compulsory licenses.

It is worth noting that draft versions of trade talks typically change as
discussions evolve, which can also make the documents challenging to read
as language is massaged and passages come and go.

The May document also contains the first written reference to the amount of
marketing exclusivity that may be awarded biologics, which are typically
more expensive injectable medicines used for combating such hard-to-treat
illnesses as cancer. The document offers a range – from zero to five to
eight to 12 years – for negotiation.

The U.S. Trade Rep spokesman says the Affordable Care Act calls for 12
years of exclusivity. And a spokesman for the Pharmaceutical Research and
Manufacturers of America, the industry trade group, says “more than half
the Congress and a number of governors have written to the Administration
that it is important that the U.S. push for the 12-year period, consistent
with U.S. law.”

Although the U.S. trade rep never publicly confirmed its negotiating
position, the specter of 12 years of exclusivity has riled consumer groups.
Last year, more than a dozen groups, including AARP and Consumers Union,
wrote the White House over concerns expensive biologics will be out of
reach for many Americans.

They also noted the White House budget regularly seeks a 7-year exclusivity
period. “This would be better than the status quo, but still impose
needless costs on the system and suffering on U.S. citizens,” says Peter
Maybarduk, who heads the Global Access to Medicines Campaign at Public
Citizen, a consumer advocacy group, who has reviewed the document.

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