[Ip-health] Pink Sheet article on the LDC drug patent waiver negotiation.

Jamie Love james.love at keionline.org
Wed Oct 14 16:35:45 PDT 2015

The Pink Sheet has an article on the LDC drug patent waiver negotiation.

  *  It quotes PhRMA's position on the waiver issue as follows:

"We believe strongly that robust IP enforcement and protection is essential
to driving innovation and economic growth in developing and developed
countries, " PhRMA spokesperson Mark Grayson said. He added that the
association believes full implementation of TRIPS by all parties "should be
time based."

*   The article makes reference NGOs claiming USTR has told WTO negotiators
it wants to block the LDC drug patent waiver in order to avoid further
conflicts with PhRMA.

*  The Pink Sheet says the White House declined to comment on the issue.

*  The article quotes the European Commission in support of a permanent WTO
drug patent waiver, and notes that several members of the US congress
support the permanent waiver.

*  The article notes UNDP and UNAIDS both support the permanent waiver.

Global Patents: Poorest Countries Seek Permanent Waiver; PhRMA Wants Time

By Brenda Sandburg

October 13 2015

Executive Summary

World Trade Organization to hear request by least developed countries for
exemption from pharmaceutical patent protections until they lose LDC
status; current waiver under TRIPS expires Jan. 1.

There is a fierce campaign by a group of least developed countries – backed
by the European Commission, members of Congress and nongovernmental
organizations – to obtain permanent exemption from issuing pharmaceutical
patents as long as they hold least developed status.

The group submitted the request to the World Trade Organization, which is
to take it up during the WTO’s TRIPS Council meeting in Geneva Oct. 15-16.
Least developed countries (LDCs) are currently exempt from the
pharmaceutical patent obligations of the Trade-Related Aspects of
Intellectual Property Rights (TRIPS) agreement under a transition period
that is set to expire on Jan. 1. In force since 1995, the TRIPS agreement
requires WTO member countries to follow minimum standards for protecting
and enforcing IP rights.

There are currently 48 countries designated as LDCs, 34 of which are
members of WTO.

The Pharmaceutical Research and Manufacturers of America is not opposed to
extending the waiver but believes there should be a time limit. LDCs are
exempt from TRIPS requirements broadly until 2021.

"We believe strongly that robust IP enforcement and protection is essential
to driving innovation and economic growth in developing and developed
countries, " PhRMA spokesperson Mark Grayson said. He added that the
association believes full implementation of TRIPS by all parties "should be
time based."

US Opposition Follows Concessions On Trade Deal, MSF Says

Médecins Sans Frontières and the nongovernmental group Knowledge Ecology
International have reported that the United States is opposed to the
permanent exemption. MSF linked US opposition to the concessions it made in
negotiating the Trans-Pacific Partnership (TPP) agreement. The trade pact
aims to provide eight years of biologics data protection rather than the 12
years industry sought ("Trade Deal Looking Worse For Pharma As More Details
Emerge" — "The Pink Sheet" DAILY,Oct. 9, 2015). "Information has emerged
that US Ambassador to the World Trade Organization, Michael Punke, met with
representatives of 15 LDCs last Friday in Geneva, where he noted that the
US could not agree to an indefinite exemption due to pressure from some US
stakeholders who are upset with the US government’s intellectual property
concessions on the recently-completed Trans-Pacific Partnership trade
agreement," MSF said in an Oct. 12 release.

The White House did not immediately respond to a request for the
administration’s views on the waiver request. Grayson said PhRMA does not
know anything about the meeting cited by MSF.

James Love, director of Knowledge Ecology International, said a temporary
waiver will not be useful because countries will not amend their patent
laws to eliminate infringement liability unless the waiver is permanent.
"It is a consequential negotiation," Love stated. "About a billion people
would be in the patent free zone with regard to pharmaceuticals."

Bangladesh Has Launched Generic Sovaldi

The exemption request was put forward by Bangladesh on behalf of the LDC
group and formally presented to the WTO’s TRIPS Council in June. At that
time the World Health Organization urged the council to favorably consider
the request. It said that being exempted from granting patents allows least
developed countries to either locally produce or to import generic products
even when they are still under patent in other countries. The European
Commission issued a statement on Sept. 10 saying it agreed to support the
least developed countries’ call for easier access to cheaper medicines by
means of an indefinite exemption from WTO intellectual property rules for

"This exemption allows generic medicines to be imported, and produced
locally, regardless of patents, for example when licenses are not
available. It means producers of generics and international programmes can
supply drugs like HIV treatment in affected countries without fear of
patent infringement suits," the EC stated.

The United Nations Development Programme and the Joint United Nations
Programme on HIV/AIDS also back exemption of countries from patent and
clinical trial data protections until they are no longer deemed least
developed. The UN groups noted in a May 21 statement that access to
medicines like Gilead Sciences Inc.’s hepatitis C treatment Sovaldi
(sofosbuvir) "remains a grave challenge in LDCs because of high prices."

They said the drug could cost as much as $84,000 for a 12-week course in
developed countries and that while lower prices via generic licenses are
being offered by the patent holder in some developing countries, the cost
still places a burden on health budgets. They noted that Bangladesh had
taken advantage of its LDC status to launch its own version of the drug for
$900 for a 12-week course.

Sen. Sanders, House Reps Support Waiver

On Oct. 2, seven Democratic members of the US House of Representatives sent
a letter to US Trade Representative Michael Froman calling for a waiver of
WTO obligations to grant and enforce pharmaceutical patents until a country
is no longer classified as an LDC.

The 48 LDCs represent nearly 13% of the world’s population but only about
1% of the world’s income, with an average $928 per capita income in 2014,
the letter notes. Signatories include Reps. Jan Schakowsky, D-Ill., Rosa
DeLauro, D-Conn., Barbara Lee, D-Calif., and Jim McDermott, D-Wash.

Senator and Democratic presidential candidate Bernie Sanders, I-Vt., also
sent Froman a letter voicing support for the LDC group’s request.

The International Federation of Pharmaceutical Manufacturers & Associations
issued a statement saying it supported the existing waiver for LDC
implementation of the entire TRIPS agreement until 2021 and that
"additional waivers or extension do not appear to be necessary at this
stage." According to KEI, Australia, Canada, and Switzerland also oppose
indefinite exemption.

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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