[Ip-health] KEI Comments to DHHS on WHA Agenda 17.5 (Global Strategy and Plan of Action on Public Health, Innovation and IP)

Manon Ress manon.ress at keionline.org
Mon May 11 10:42:14 PDT 2015


KEI Comments to DHHS on WHA Agenda 17.5 (Global Strategy and Plan of Action
on Public Health, Innovation and IP)

http://keionline.org/node/2226

Submitted by KEI Staff on 8. May 2015

On Friday May 8, 2015, the US Department of Health and Human Services held
a listening session to solicit input on the agenda items for the upcoming
68th World Health Assembly. KEI delivered five interventions covering a
range of critical WHA topics. The full provisional agenda of the 68th WHA
can be accessed here.

Andrew Goldman delivered the third intervention for KEI. His comments on
agenda item 17.5 Global strategy and plan of action on public health,
innovation, and intellectual property, focused on the harm of the TPP IP
Chapter text and their inconsistency with the WHO Global Strategy and Plan
of Action on Public Health, Innovation and Intellectual Property. The
relevant WHO documents are A68/35 and EB136/2015/REC/1, decision136(17).

His oral intervention ended with this statement:

"Mr. Ambassador, I ask you: will you take the opportunity to rectify these
issues and be remembered for having the courage to stand against the
pharmaceutical industry? Or do you intend for your long tenure in the field
to be remembered for standing in opposition to global norms and trampling
on public health?"

His full comments are included below:

Andrew Spencer Goldman
Knowledge Ecology International
May 8, 2015

My name is Andrew Spencer Goldman, and I am an attorney with Knowledge
Ecology International, a non-profit organization that among other topics,
focuses on innovation and access to medical technologies.

On behalf of KEI, I wish to comment on the WHO's Global Strategy and Plan
of Action on Public Health, Innovation and Intellectual Property provisions
on trade agreements, and in particular, the provisions in the Trans-Pacific
Partnership (TPP) that are in conflict with goals and aims of the Global
Strategy.

Principle 18 of the Global Strategy states that, "Intellectual property
rights do not and should not prevent Member States from taking measures to
protect public health."

This principle is further supported by Element 5 ("Application and
management of intellectual property to contribute to innovation and promote
public health"), particularly section 5.2, which, in subsections (a)
through (e) is explicit in its support for the right of countries to use
the space in the WTO TRIPS agreement for limitations and exceptions to
intellectual property rights.

Section 5.2 also calls for an accounting of the "impact on public health
when considering adopting or implementing more extensive intellectual
property protection than is required by the Agreement on Trade-Related
Aspects of Intellectual Property Rights, without prejudice to the sovereign
rights of Member States."

The current text of the IP chapter of the TPP Agreement -- only available
to the public because it has been leaked -- directly conflicts with the
Global Strategy.

The TPP will have harmful effects on public health, and constricts TRIPS
flexibilities by altogether eliminating the broad compulsory licensing
provisions of TRIPS Article 31 and leaving only the far narrower three-step
test of Article 30, and by requiring member states to adopt a large number
of TRIPS+ provisions on medical technologies, including patent extensions,
exclusive rights in drug test data, obligations to grant patents on new
uses of old drugs, and linkage of drug registration to patent status, even
in countries that have a low capacity to distinguish between patents that
are relevant or valid, and patents that are neither.

KEI would like DHHS to reflect upon the gap between the language in the
Global Strategy, and the proposals in the TPP. Mr. Ambassador, I ask you:
will you take the opportunity to rectify these issues and be remembered for
having the courage to stand against the pharmaceutical industry? Or do you
intend for your long tenure in the field to be remembered for standing in
opposition to global norms and trampling on public health?

Annex 1 - Global Strategy and Plan of Action on Public Health, Innovation
and Intellectual Property
Element 5. Application and management of intellectual property to
contribute to innovation and promote public health
...
34. The actions to be taken in relation to this element are as follows:
...
(5.2) providing as appropriate, upon request, in collaboration with other
competent international organizations, technical support, including, where
appropriate, to policy processes, to countries that intend to make use of
the provisions contained in the Agreement on Trade-Related Aspects of
Intellectual Property Rights, including the flexibilities recognized by the
Doha Declaration on the TRIPS Agreement and Public Health and other WTO
instruments related to the Agreement on Trade-Related Aspects of
Intellectual Property Rights, in order to promote access to pharmaceutical
products:

(a) consider, whenever necessary, adapting national legislation in order to
use to the full the flexibilities contained in the Agreement on
Trade-Related Aspects of Intellectual Property Rights, including those
recognized by the Doha Declaration on the TRIPS Agreement and Public Health
and the WTO decision of 30 August 2003;

(b) take into account, where appropriate, the impact on public health when
considering adopting or implementing more extensive intellectual property
protection than is required by the Agreement on Trade-Related Aspects of
Intellectual Property Rights, without prejudice to the sovereign rights of
Member States;

(c) take into account in trade agreements the flexibilities contained in
the Agreement on Trade-Related Aspects of Intellectual Property Rights,
including those recognized by the Doha Declaration on the TRIPS Agreement
and Public Health and the WTO decision of 30 August 2003;

(d) consider, where appropriate, taking necessary measures in countries
with manufacturing capacity to facilitate, through export, access to
pharmaceutical products in countries with insufficient or no manufacturing
capacity in the pharmaceutical sector in a manner consistent with the
Agreement on Trade-Related Aspects of Intellectual Property Rights, the
Doha Declaration on the TRIPS Agreement and Public Health and the WTO
decision of 30 August 2003;

(e) encourage finding ways, in ongoing discussions, to prevent
misappropriation of health-related traditional knowledge, and consider,
where appropriate, legislative and other measures to help to prevent
misappropriation of such traditional knowledge.

Annex 2 - TRIPS Article 30 and 31

Article 30. Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights conferred by
a patent, provided that such exceptions do not unreasonably conflict with a
normal exploitation of the patent and do not unreasonably prejudice the
legitimate interests of the patent owner, taking account of the legitimate
interests of third parties.
Article 31: Other Use Without Authorization of the Right Holder
Where the law of a Member allows for other use of the subject matter of a
patent without the authorization of the right holder, including use by the
government or third parties authorized by the government, the following
provisions shall be respected:

(a) authorization of such use shall be considered on its individual merits;

(b) such use may only be permitted if, prior to such use, the proposed user
has made efforts to obtain authorization from the right holder on
reasonable commercial terms and conditions and that such efforts have not
been successful within a reasonable period of time. This requirement may be
waived by a Member in the case of a national emergency or other
circumstances of extreme urgency or in cases of public noncommercial use.
In situations of national emergency or other circumstances of extreme
urgency, the right holder shall, nevertheless, be notified as soon as
reasonably practicable. In the case of public noncommercial use, where the
government or contractor, without making a patent search, knows or has
demonstrable grounds to know that a valid patent is or will be used by or
for the government, the right holder shall be informed promptly;

(c) the scope and duration of such use shall be limited to the purpose for
which it was authorized, and in the case of semi-conductor technology shall
only be for public non-commercial use or to remedy a practice determined
after judicial or administrative process to be anti-competitive;

(d) such use shall be non-exclusive;

(e) such use shall be non-assignable, except with that part of the
enterprise or goodwill which enjoys such use;

(f) any such use shall be authorized predominantly for the supply of the
domestic market of the Member authorizing such use;

(g) authorization for such use shall be liable, subject to adequate
protection of the legitimate interests of the persons so authorized, to be
terminated if and when the circumstances which led to it cease to exist and
are unlikely to recur. The competent authority shall have the authority to
review, upon motivated request, the continued existence of these
circumstances;

(h) the right holder shall be paid adequate remuneration in the
circumstances of each case, taking into account the economic value of the
authorization;

(i) the legal validity of any decision relating to the authorization of
such use shall be subject to judicial review or other independent review by
a distinct higher authority in that Member;

(j) any decision relating to the remuneration provided in respect of such
use shall be subject to judicial review or other independent review by a
distinct higher authority in that Member;

(k) Members are not obliged to apply the conditions set forth in
subparagraphs (b) and (f) where such use is permitted to remedy a practice
determined after judicial or administrative process to be anti-competitive.
The need to correct anti-competitive practices may be taken into account in
determining the amount of remuneration in such cases. Competent authorities
shall have the authority to refuse termination of authorization if and when
the conditions which led to such authorization are likely to recur;

(l) where such use is authorized to permit the exploitation of a patent
("the second patent") which cannot be exploited without infringing another
patent ("the first patent"), the following additional conditions shall
apply:

(i) the invention claimed in the second patent shall involve an important
technical advance of considerable economic significance in relation to the
invention claimed in the first patent;

(ii) the owner of the first patent shall be entitled to a cross-licence on
reasonable terms to use the invention claimed in the second patent; and

(iii) the use authorized in respect of the first patent shall be
non-assignable except with the assignment of the second patent.

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