[Ip-health] IPWatch: WHO IP And Health Group Concludes With Progress; Tough Issues Remain For Assembly

[Sarah Rimmington]

http://www.ip-watch.org/weblog/index.php?p=3D1027
Intellectual Property Watch
6 May 2008
WHO IP And Health Group Concludes With Progress; Tough Issues Remain For
Assembly

Posted by William New @ 11:00 am


By Kaitlin Mara and William New
The World Health Organization (WHO) negotiations on public health,
intellectual property and innovation ended Saturday with substantial
progress toward consensus on a draft strategy but with a plan of action
remaining and the most contentious articles in the strategy still under
brackets - indicating lack of agreement - as the paper goes to the World
Health Assembly.

The air in the room was cautiously optimistic as WHO Director General
Margaret Chan=92s closing comments praised the assembled delegates at the
28 April to 3 May Intergovernmental Working Group on Public Health,
Innovation, and Intellectual Property (IGWG) for reaching consensus on
107 paragraphs (many through deletions) that had been unresolved at the
meeting=92s start Monday.

The group=92s mandate from the 2006 Health Assembly was to agree on a
strategy and plan of action to boost research and development of, and
access to, treatments for diseases disproportionately affecting
developing countries, in time for this year=92s annual assembly. If
sufficient agreement is reached on the remaining items and the plan of
action, implementation of the strategy should follow.

But there was also a sense from many delegates that substantive work
lies ahead, and some nongovernmental organisations expressed
disappointment at the IGWG=92s perceived lack of strong commitment to
public health, and the potential lost opportunity to make a profound
difference.

While the global strategy being drafted by the group is not legally
binding, it is being taken seriously by governments and other
stakeholders because it could have a significant impact on policy. =93It
is a political document,=94 said one official. =93It can have a lot of weig=
ht.=94

Both developing and developed countries representatives found positive
things to highlight about the IGWG, though it is clear that outcomes are
not yet guaranteed and large gaps remain between what different
stakeholders want from the draft strategy. Much of the work was done in
closed informal sessions, often into the night, participants said.

Some key outcomes or debates were the proposed creation of an expert
group on financing and the coordination of R&D, a mention of prizes as a
possible alternative incentive for research and development, and
policies on human clinical trials, competition, counterfeit medicines,
and the role of the WHO on international IP and innovation issues.

Also significant was the apparent removal of advance market commitments,
which would have created a mechanism for ensuring a market for new
drugs, sources said. One source also said there was now a separation of
provisions relating to access from those relating to intellectual
property rights.

Ambassador Tom Mboya Okeyo of Kenya said the outcome=92s impact will take
time to see but that it was a good step. He noted consensus on
provisions on access to medicines, and on flexibilities in the
international IP system to accommodate access. Also agreed were several
provisions that could strengthen innovation on essential medicines and
encourage sustainable financing mechanisms, and provisions that could
help protect traditional medical knowledge, all of which are important
to developing countries, he said. The next challenges are in ensuring
the key actions outlined in the strategy are implemented quickly, he
said, adding that he hoped the WHO director general could mobilise funds
for that purpose.

Suriname delegate Miriam Naarendorp called the week=92s outcome the =93star=
t
of the battle,=94 with the plan of action and implementation issues still
to come. However, it was an important start, as, Naarendorp said, the
IGWG was able to identify issues important to developing countries, and
that the developing nations =93stood firm on things that mattered=94 and ha=
d
created a document that the WHO could not ignore.

An official from a leading developing country praised the outcome as
successful as =93so many member states agreed on so many things.=94 And a
third developing nation delegate added that =93we=92ve made tremendous
progress here [and] I expect we will get it finished at the World Health
Assembly.=94 The assembly meets from 19 to 24 May.

A key developed country source was more concerned that the IGWG seemed
to have averted potential negative consequences, saying that =93the
possibility of impact on the IP system has been reduced=94 and that =93ther=
e
were a lot of proposals that could have undermined innovation.=94

Nongovernmental groups had higher hopes going into the meeting, for an
outcome with profound effects on health product development for the
poor. Over one hundred civil society organisations and patients groups
signed a =93joint declaration=94 (pdf) stating that =93health is a fundamen=
tal
human right and a necessary condition for human dignity=94 and calling for
the IGWG to find sustainable solutions to encourage both innovation in
healthcare and access to the fruits of that innovation, and several
eminent academics signed a similar statement asking for IGWG delegates
to consider =93the exploration of new and innovative mechanisms that seek
to correct the deficiencies of the current system=94 of drug development
and delivery.

Draft Strategy Text Advances

The latest available version of the draft strategy was from the start of
the last day, 3 May. Click here to read the 3 May version [pdf].

Delegates were able to reach full consensus on five out of eight
elements within the draft global strategy, which includes principles for
using the intellectual property system to maximise public health impact,
particularly in innovation related to developing country diseases. Full
consensus sections were element 1, on prioritising research and
development needs; element 2, on promoting research and development; and
element 3, on building and improving innovative capacity.

Article 3.4 outlines ways to support =93policies that will promote
innovation based on traditional medicine,=94 as well as Article 3.5.b,
which encourages =93the establishment of award schemes for health-related
innovation.=94

Article 5.3.a, which also saw consensus, mentions prizes as an
innovation incentive, an issue important to developing countries and
some nongovernmental participants. Barbados and Bolivia submitted a
document at the outset of the week=92s meeting proposing alternative
incentive schemes for drug innovation in the form of prize funds for
inexpensive tuberculosis diagnostic testing, for a Chagas disease
treatment, for priority medicines and vaccines, and for cancer
treatments. The document also calls for a global agreement on funding
clinical trials as public goods.

Element 4, on transfer of technology, was largely agreed upon, with the
exception only of element 4.1.b, which reads =93promote transfer of
technology and production of health products in developing countries
through investment and capacity building, including by providing
guidance on appropriate technologies.=94 As of the end of 2 May, this
article was listed =93consensus pending USA.=94 One developing country
official said that in general the United States was =93a bit tough=94 in
negotiation, referring to the fact that the country was often the sole
voice blocking consensus (though there may have been others unspoken).
The US delegation included an IP negotiator from the US Trade
Representative=92s office.

Element 7, on promoting sustainable financing mechanisms, also reached
full consensus, as did element 8, on the establishment of monitoring and
reporting systems. The agreement on element 7 was reached only after a
lengthy debate, Barbados said during the IGWG=92s closing plenary session.
Article 7.3, which detailed several strategies for the establishment of
a global R&D fund to address gaps in diseases affecting developing
countries, including the use of prizes and rewards as well as earmarked
funds for patent buyouts to ensure access to medicines, was deleted by
consensus.

Barbados asked during the final plenary that it be officially noted that
this consensus was predicated on an understanding by Barbados and the
rest of the Caribbean group, as well as Bolivia, that these issues be
addressed under 7.1.a. That article calls for the establishment of a
=93results-oriented and time-limited expert working group under the
auspices of the WHO and linking up with other relevant groups to examine
current financing and coordination of research and development, as well
as proposals for new and innovative sources of financing to stimulate
research and development=94 relevant to developing countries.

Element 5, on the application and management of intellectual property to
contribute to innovation and promote public health, and element 6, on
improving delivery and access, proved the hardest on which to reach
consensus.

Still remaining to be resolved are issues of data-sharing, specifically
through the creation of easy-to-use global databases on the status
health-related patents (under article 5.1.c); on the training of patent
examiners in intellectual property application and management, and
possibly on TRIPS flexibilities (under article 5.1.e); on promoting
competition to increase availability of health products under article
6.3, and particularly on support for the production/introduction of
generic medicines (under 6.3.a). Another issue under debate in the
strategy related to agreements that impose stricter intellectual
property standards than agreements in the multilateral system (so-called
TRIPS-plus provisions).

On 5.1.h, which originally stated, =93establish measures to avoid
unethical experiments involving human beings as a requirement for
registration of medicines and technologies,=94 sparked a lengthy
discussion on 2 May on the nature of ethics in human testing. Points
discussed included: the difference between clinical tests for new drugs,
or the bioequivalence tests done when generics are marketed, the ethics
of testing new drugs against placebos when existing treatments are
available for comparative testing (the Declaration of Helsinki, which
lays out ethics of healthcare research, and says that new methods of
treatment should be tested against the best existing treatments, where
available, and not placebos), and the ethics of repeating a clinical
test because the original tester has exclusive control over the results
of first test and will not make the data public. Also of interest,
especially to developing countries, was ensuring post-trial access to
drugs by study participants, which the Declaration of Helsinki calls
=93necessary.=94

The article eventually passed consensus on the condition it be moved
from element 5.1 on information sharing and capacity building on
health-related innovation to element 6.2, which covers ethical review
and quality/safety regulation. The final text reads: =93promote ethical
principles for clinical trials involving human beings as a requirement
of registration of medicines and health-related technologies, with
reference to the Declaration of Helsinki, and other appropriate texts,
on ethical principles for medical research involving human subjects,
including good clinical practice guidelines.=94

Other debates under element 5 included a provision on preventing
anti-competitive practices related to IP rights, language on encouraging
respect for flexibilities in the World Trade Organization Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS), and a
possible clause on counterfeit health products, including a definition.
Some sources said an effort is being made to clarify the distinction
between counterfeit products and generic products.

Also under element 5, a discussion was held on the role of the WHO on
IP-related matters. Officials present from the World Intellectual
Property Organization and the World Trade Organization signalled
resistance to a proposal to create a formal coordinating body between
agencies under Article 5.1.i. Creating a formal coordination effort
would, a WIPO official said, just =93add governance issues=94 to the alread=
y
functioning informal collaboration that currently exists.

One participant said an informal relationship was seen as possibly
minimising interagency turf battles. Still, some participants viewed the
outcome as having strengthened the role of the WHO in IP issues.
Consensus Article 5.1.f states, =93strengthen efforts to effectively
coordinate work relating to intellectual property and public health
among the secretariats and governing bodies of relevant regional and
international organizations (including WHO, WIPO and WTO) to facilitate
dialogue and dissemination of information to countries.=94

The traditional knowledge debate discussed earlier in the week (IPW,
Public Health, 1 May 2008) was resolved after the Kenyan-led informal
session came up with the text =93facilitate, where feasible and
appropriate, possible access to traditional medicinal knowledge for use
a s prior art in examination of patents, including, where appropriate,
the inclusion of traditional knowledge information in digital libraries.=94

Lost Opportunities and Some Progress

Concerned entities and other nongovernmental organisations participating
at the event were not entirely pleased with the outcome of the
negotiating process.

M=E9decins Sans Fronti=E8res (MSF) sharply criticised the IGWG, saying it
had =93failed to take concrete action towards reforming a medical
innovation system that largely disregards the health needs of millions
of people in developing countries.=94 Tido von Schoen-Angerer, director of
MSF=92s access to medicines campaign said that negotiators had not =93risen
to the challenge=94 of =93prescrib[ing] change to a broken system.=94 He
called the working group a =93lost opportunity,=94 particularly because
there had been no consensus on the development of alternative research
and development incentives.

Ethan Guillen, executive director of Universities Allied for Essential
Medicines (UAEM) also expressed surprise at =93the lack of bold commitment
by most of the rich countries=94 and said =93that there had to be stiff
negotiations on the idea that the cost of medicines impedes access in
the developing world makes you wonder if some negotiators hadn=92t noticed
that busloads of American retirees have to hop across the US border to
Canada to get drugs they can afford.=94

Sarah Rimmington, an attorney at public interest organisation Essential
Action, said IGWG was meant to address how =93the current corporate sector
system of medical R&D, which is based on patent monopolies, has largely
failed people in developing countries.=94 Rimmington said while the IGWG
had taken an =93important first step by agreeing to explore some common
sense measures to address this failure,=94 such as innovation incentives
not reliant on patent monopolies, consensus on actual implementation
processes was not reached. This lack of agreement was, she added,
largely due to =93resistance from developed countries such as the United
States, the EU, and Canada=94 and added that it =93is hard not to wonder if
pressure from the brand-name pharmaceutical industry - which is based in
developed countries and remains ideologically committed to patent
monopolies - influenced this disappointing outcome.=94

Jamie Love of Knowledge Ecology International said the IGWG =93did next to
nothing on identifying R&D priorities, estimating funding needs, or
creating a framework for sustainable funding for priority R&D, three
tasks central to its mission.=94

Harvey Bale, director general of the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA), when asked about
whether this meeting represented progress toward the goal of addressing
the problem of neglected diseases, said it =93has lost focus on that,=94 bu=
t
added that there was hope it could come back. He stressed the importance
of advanced market commitments, or guarantees of a market in the event a
medication or vaccine is developed (which were deleted from the draft
strategy). He also stressed the importance of partnerships for
development that link companies and the public sector in coordinated
research efforts.

But there were also some positive views. Guillen said his group was
=93pleased to see the advancement=85 of important issues like technology
transfer=94 in the draft strategy and said UAEM is =93hopeful that consensu=
s
recommendations on open licensing and other technology transfer
provisions agreed to during this round will send a strong message to
universities=85 to adopt policies that will free up the tools of
innovation and make medicines discovered on campuses available at
low-cost in the developing world.=94

Love was pleased to see that advanced market commitments had come out of
the draft strategy and prizes had been included.

Nicoletta Dentico, policy and advocacy manager at the Drugs for
Neglected Diseases Initiative (DNDi) said =93the outcome of this intense
week-long negotiation shows that some uncertain lights are looming, but
still in a forest of thick shadows=94 that research on essential medicines
still faces the =93resistance of those who have set the direction of
innovation so far=94 but that hopefully the =93"spirit of Geneva=94 [would]
clear, in the face of poor people=92s needs, the shadows.=94

MSF has said that, as the IGWG failed to arrive at strong conclusions,
it is now up to the World Health Assembly =93to translate bold ideas into
concrete action.=94

Kaitlin Mara may be reached at kmara@ip-watch.ch. William New may be
reached at wnew@ip-watch.ch.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/