[Ip-health] UNDP, Unitaid, and WHO caught in Big Pharma's crosshairs

Thiru Balasubramaniam thiru at keionline.org
Thu Mar 7 03:36:34 PST 2019

UNDP, Unitaid, and WHO caught in Big Pharma’s crosshairsPosted on March 6,
2019 by ThiruPhRMA’s Special 301 submissions are part of a yearly ritual to
shape the “Special 301” Report, an annual review of the global state of
intellectual property rights (IPR) protection and enforcement, conducted by
the Office of the United States Trade Representative (USTR) pursuant to
Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and
Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted
in 1994).

Not content with the naming and shaming countries deemed deficient in their
protection of intellectual property rights, PhRMA’s 2019 Special 301
submission trains its sights on multilateral organizations and UN agencies
including the World Health Organization the United Nations Development
Program (UNDP), the United Nations Conference on Trade and Development
(UNCTAD), and Unitaid.

What appears to gall PhRMA is the work of WHO, UNDP, UNCTAD and Unitaid in
providing the technical assistance on the application and use of WTO TRIPS
flexibilities to promote access to medicines and safeguard public health.

In the words of PhRMA:

Multilateral organizations that once served as custodians of the
international rules-based system increasingly are seeking to undermine and
even eliminate intellectual property protections that drive and sustain
biopharmaceutical innovation in the United States and around the world. By
reinterpreting international agreements and through meetings, reports,
guidelines and training programs, the WHO, the United Nations Development
Program (UNDP), the United Nations Conference on Trade and Development
(UNCTAD), Unitaid and other organizations are promoting acts, policies and
practices globally and in specific countries that prevent biopharmaceutical
innovators from securing and maintaining patents, protecting regulatory
test data and from enjoying fair and equitable market access.

PhRMA specifically targeted UNDP and Unitaid for promoting strict
patentability criteria. In a fit of pique, PhRMA described UNDP as not
appearing to have “specialized expertise on intellectual property matters”
in relation to UNDP’s 2016 publication, Guidelines for the Examination of
Patent Applications relating to Pharmaceuticals
PhRMA trained its crosshairs on Unitaid
funding the work of the International Treatment Preparedness Coalition
(ITPC), South Centre, and Third World Network to work on the “flexibilities
and provisions under global intellectual property agreements and laws to
improve access to affordable medicines in order to safeguard public
health.” (Source: Unitaid)

In addition, multilateral organizations such as UNDP and Unitaid advocate
actively for patentability restrictions and additional patentability
requirements that are inconsistent with international practice. For
example, although UNDP does not appear to have specialized expertise on
intellectual property matters, it issued patent examination guidelines in
2016 that, if followed, would prevent innovators from securing patents on
many kinds of biopharmaceutical inventions. Similarly, Unitaid partnered
with various non-governmental organizations in 2018 to launch a campaign to
erode intellectual property policies and laws globally.

In its 220 page submission, PhRMA calls for the “[f]ostering and
strengthening” of coalitions to support innovation at multilateral fora
including the World Trade Organization (WTO) and the World Intellectual
Property Organization (WIPO) noting that even these fora are vulnerable to
work “inappropriately focused on limitations and exceptions to intellectual
property rights, if not actively seeking to undermine and even eliminate
the intellectual property protections that drive America’s innovation

All this provides a valuable foundation on which to build in the coming
year and beyond. Fostering and strengthening coalitions that support
innovation will be particularly critical in multilateral organizations,
such as the WHO, the World Intellectual Property Organization (WIPO),the
WTO, UNDP, UNCTAD and Unitaid, where work can be inappropriately focused on
limitations and exceptions to intellectual property rights, if not actively
seeking to undermine and even eliminate the intellectual property
protections that drive America’s innovation economy. This is even the case
at WIPO – an organization that was created to “encourage creative activity”
and to “promote the protection of intellectual property throughout the

While PhRMA has trained its sights on the development work of multilateral
institutions including UNDP, UNCTAD, Unitaid, WHO, and even WIPO and WTO,
it remains to be seen how USTR will respond in its 2019 Special 301 Report.

James Love, Director, Knowledge Ecology International, provided the
following comment.

PhRMA is seeking to use its immense power and influence with President
Trump to twist the mission of UN agencies and intergovernmental bodies like
Unitaid, on matters involving access for billions of persons living in
developing countries. President Trump should reject this pressure, from an
industry that is “getting away with murder” on a regular basis, and sees
itself as a regulator of governments, not an industry to be regulated.

Ellen ‘t Hoen, LLM, PhD. Director, Medicines Law & Policy, provided the
following response.

One wonders what the pharmaceutical industry has to gain from going after
institutions that do so much to prevent disease, promote health and access
to care. We have seen pharma attacks on global health institutions for
decades. But this time around it seems more deliberate and coordinated.

Diarmaid McDonald, Lead Organiser, Just Treatment, provided this comment:

The US pharmaceutical industry is going after the World Health Organisation
– and other important international bodies – for promoting lifesaving legal
routes to affordable medicines. Remember, if @PhRMA are pissed off with
you, you’re doing something right. As pressure grows on the US
pharmaceutical industry with broad congressional support for legislative
efforts to curb the high drug prices crippling American healthcare Phrma
and Trump seem to be focused not on solving the problem, but exporting it
around the world. Everything these important institutions are doing is good
for global health and completely legal. They should stand strong for
patients against US and industry aggression.

Brook K. Baker, Senior Policy Analyst Health GAP (Global Access Project),

The U.S. government has not waited for PhRMA’s formal Special 301
submission to start exerting pressure on multilateral institutions to stop
all work supporting adoption, use, and protection of public health
flexibilities allowed under international law. These flexibilities –
negotiated within the World Trade Organization and signed onto by the U.S.
– give countries policy options for rejecting weak patents, denying
monopolies on test data, and allowing competition from generics to increase
access to affordable medicines. NGO activists know about U.S. backroom
pressure on the Global Fund to Fight AIDS, Tuberculosis and Malaria, which
the U.S. funds, and even on Unitaid, which it does not fund. The
“flexibilities” that PhRMA complains about are integral features of the
international IP bargain, and thankfully PhRMA did not get everything it
wanted in the TRIPS Agreement. PhRMA likes to think that the U.S. should be
its strike force to expand its bloated monopoly profits and to silence IP
reformers pursuing fully lawful ends. All too often the U.S. follows the
orders of its PhRMA puppet masters with no regard for the legality of its
efforts or the morality of pricing billions of people out of access to
life-saving medicines.

Katy Athersuch, Senior Policy Adviser – Medical Innovation & Access,
Médecins Sans Frontières- Access Campaign, provided this response:

The overreach of PhRMA in attacking multilateral organisations mandated to
promote health and safe lives is astonishing. To read their submission is
to imagine a dystopian reality where the 2001 WTO Doha Declaration on the
TRIPS Agreement and Public Health never existed. The work done by UNITAID,
WHO and UNDP to support countries in their legal rights to use the
flexibilities outlined in the TRIPS Agreement to ensure that the right to
health takes precedent over other private rights is essential lifesaving

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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