The PhRMA trade group is urging the US Trade
Representative to go beyond provisions contained in the Korea-US trade deal,
known as KORUS, and include 12 years of data exclusivity for biologics in the
Trans-Pacific Partnerships talks that are under way, according to Inside US
Trade.
The push contrasts with a White House proposal earlier this year to shrink
exclusivity to seven years from 12 years, a move that would roll back a
provision in health care reform. You may recall that brand-name drugmakers won
a 12-year exclusivity period last year as part of an effort to create a
so-called FDA approval pathway for biosimilars. Generic drugmakers, of course,
wanted a shorter term.
The issue is new, however, for US trade agreements. Drugmakers usually want the
USTR to replicate patent provisions found in KORUS into the TPP context, but
KORUS did not contain 12 years of data exclusivity for biologics. Why? This
provision was not part of US law when KORUS was negotiated, Inside US Trade
notes.
“The recent passage of a biosimilars regulatory pathway in the United States
recognizes the importance of data protection and the evolution of the
innovative biopharmaceutical industry,” PhRMA wrote in this document that is
used for TPP lobbying. “Protection consistent with US law – ie, at least 12
years for biologics and at least 5 years for nonbiologics, with adjustments to
be made for future indications, is essential.”
“We think anything that is agreed to in any agreement, including TPP, has got
to meet the level of US law,” Harrison Cook, an Eli Lilly vp of international
government affairs tells Inside US Trade. Twelve years of data exclusivity for
biologics is important because it “creates parity with the strong patent protection
you would expect to have on a chemical drug.” He added that KORUS is still
considered a “gold standard” for IP protections, but data protection could be
improved.
The newsletter goes on to note the US has demanded trading partners agree to
provide five years of data exclusivity for drugs in past free-trade deals,
although data exclusivity provisions of trade deals with Panama, Colombia, and
Peru were altered in response to objections from public health advocates.
However, until last year, there was no provision for a specific data
exclusivity period for biologics.
Public health advocates do not want the provision to appear in the TPP
agreement and warn that if the US obtains a 12-year exclusivity period,
biosimilar producers would not only be barred from producing biosimilars in the
US for that period of time, but also in other countries, the newsletter writes.
“This is not about rational standards. Its simply about a powerful lobby taking
anything and everything it can get,” Peter Maybarduk, who heads the Access to
Medicines Program at Public Citizen, writes us. “Twelve-year government-issued
monopoly protection is a terrible idea here at home that will help keep
healthcare costs high. But applied to developing countries through a
Trans-Pacific FTA, its simply cruel. This shows PhRMAs hubris and sense of
entitlement, given that the Obama administration has recently proposed reducing
the term of years for exclusive protection of biologics in the US.”
Brand-name drugmakers argue that 12 years of data exclusivity is needed to
recover R&D investments and that additional protection is needed for
biologics because of the nature of patent protections. Thye note that, under
the new regulatory pathway, biosimilars do not have to be identical and patents
may be circumvented because these are not technically the same as the original
drugs.
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