U.S., Australia Agree on Complicated Compromise on Biologic Drugs, Sources Say -- Update
October 04 2015 - 4:21PM
Dow Jones News
By William Mauldin
ATLANTA--The U.S. and Australia are in agreement on an elaborate
compromise within the Trans-Pacific Partnership to protect the
intellectual property of complex drugs known as biologics,
according to industry officials and an organization following the
talks.
Under the bilateral deal, whose exact language is believed to be
incomplete, countries in the trade bloc would have an alternative
of either providing eight years of exclusivity to biologic drugs,
or providing five years of so-called data exclusivity plus up to
three more years under a regulatory framework in the TPP, the
people said.
The outline of the U.S.-Australia deal agrees with a document a
government official showed The Wall Street Journal at talks in
Atlanta and was confirmed by a source briefed overnight on the
latest language.
It wasn't immediately clear whether the other 10 countries had
signed onto the deal or whether it could change before the entire
TPP trade agreement is completed.
Asked about the language, a major pharmaceutical company
executive, business group official and leading opponent of
prolonged exclusivity for such drugs each said it was unclear
whether the deal would essentially give biologic drug producers a
full eight years of exclusivity or whether some countries could
effectively offer just 5 years of data exclusivity in the 12-nation
trade bloc, with the option of additional time under a regulatory
framework.
The U.S. has 12 years of exclusivity for biologics, a period
that limits the introduction of generic imitations called
biosimilars, but Australia, Chile, Peru and other countries are
hesitant to back more than five years because of concerns it would
add to the cost of medicine. The compromise will help both sides to
claim a measure of victory in the bitter medicine dispute,
according to people following the talks.
Trade ministers scheduled a news conference for 6 p.m. eastern
time in Atlanta to discuss the overall outcome of their efforts to
agree on the TPP. Business leaders and officials said the ministers
are close to a deal, but some people following the talks said
sensitive language may have to be worked out over time.
Major U.S. drug companies are backing 12 years of exclusivity
for biologics to boost revenue and allow for the development of
major new drugs. Their position on the U.S.-Australia compromise is
unclear and may depend on the final language, the people said.
Other groups--including Doctors Without Borders--are pressing
for less protection to boost the affordability of medicine in
poorer countries.
Developing countries in the TPP may have more time to adopt the
measures on intellectual property for pharmaceuticals, officials
have said.
Write to William Mauldin at william.mauldin@wsj.com
(END) Dow Jones Newswires
October 04, 2015 16:06 ET (20:06 GMT)
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