[Ip-health] IP Watch: WHO Members Inch Toward Consensus On IP, Innovation And Public Health

[Judit Rius Sanjuan]

http://www.ip-watch.org/weblog/index.php?p=3D1024

Intellectual Property Watch
2 May 2008
WHO Members Inch Toward Consensus On IP, Innovation And Public Health

By Kaitlin Mara and William New

Members of the World Health Organization (WHO) gathered this week to
address innovation and intellectual property issues in public health
saw hope for agreement on a strategy paper focused on the needs of
developing countries, particularly on neglected diseases. But with two
days remaining in the negotiations, difficult issues on intellectual
property rights and the action plan remained unresolved.

The WHO Intergovernmental Working Group on Public Health, Innovation
and Intellectual Property (IGWG) is meeting from 28 April to 3 May, as
a part of its resumed second session (the second session begin in
November 2007)(IPW, WHO, 9 November 2007). The current round of
negotiations is under mandate to create a consensus document for
presentation at the World Health Assembly, which will take place later
this month.

In her opening remarks to the IGWG, WHO Director-General Margaret Chan
said that an =93agreed framework can make the cycle of product
discovery, development and delivery more efficient and more sensitive
to health needs in the developing world=94 by giving the international
community a =93common tool=94 to leverage against health problems. She
stressed the importance of the negotiations moving forward =93as rapidly
and efficiently as possible,=94 and urged a continuation of the =93sense
of urgency=94 seen in past months.

Further pressure for resolution has been placed on negotiators by some
developed countries who would like to see the IGWG discussions end
this week, and to pull the WHO back from involvement with IP issues,
according to some participants. Others thought that the negotiations
should not be rushed, and one developing country official said, =93I
hope we don=92t do in haste what we will repent later.=94

This week=92s debate is the result of several years of intensive
discussion at the WHO on policies to address the problem that the
existing intellectual property system lacks economic incentives for
the private sector to invest in research and development (R&D) for
diseases primarily affecting those who cannot afford to pay the higher
prices necessary to recover R&D costs.

But a larger issue of the role of the WHO in discussions relating to
intellectual property is underlying the talks. Many feel the issues
belong primarily in the World Trade Organization, World Intellectual
Property Organization, or in national laws. But others see the WHO
with the lead on public health issues as having been sidelined in
global debates as they relate to IP and public health, even as those
debates have resulted in rules that have possibly had a pejorative
effect on public health.

=93The IGWG is a historic opportunity and this should not become a
historic failure for lack of response,=94 M=E9dicins sans Fronti=E8res=92 T=
ido
von Schoen-Angerer told the plenary. =93Governments, and the WHO, must
not abdicate from their responsibilities, or pass the buck to others.
We are asking you to strengthen WHO=92s role in intellectual property
and health, to change the way R&D is prioritised and financed so that
paying for the research does not equal prohibitive prices, and to take
measures to increase generic competition.=94

Draft Text Taking Shape

While most negotiations have happened behind closed doors, on 1 May
WHO members met as a whole in an attempt to hammer out consensus on
the draft global strategy on public health. The talks were able to
cover elements two, three and four out of the eight-element draft
strategy - covering, respectively, promoting research and development,
building and improving innovative capacity, and transfer of technology
- and had begun to discuss element five, on the application and
management of intellectual property to contribute to innovation and
promote public health.

Remaining aspects of element five are expected to be contentious,
according to some participants. In general, consensus is being
achieved through a relative weakening of provisions, often, but not
always, along north-south lines. Compromises involved the insertion of
phrases like =93possible=94 and =93appropriate.=94

The morning=92s negotiations focussed on element two, promotion of
research and development. Convergence was reached on accessibility to
libraries and technical support to create compound libraries in
developing countries (Article 2.2.b), and the related article (2.4.c)
on the creation of open databases and compound libraries. The United
States sought to delete the second article as it felt it was
redundant, sparking discussion on the issue.

The dissemination of publicly or donor-funded medical inventions and
know-how (Article 2.4.d), and the =93incorporation of research
exemptions in legislation of developing countries=94 for public health
purposes (Article 2.4.e) were both contested by the United States.
Korea agreed with the US on 2.4.d, as one of the suggested ways to
disseminate medical know-how was through open licensing and the Korean
delegate was unsure if his country had a policy allowing for such
licensing. Brazil and India felt that open licensing was a useful
addition to the paragraph, and India mentioned that the use of open
source technologies in India was very effective. Jamaica supported
India and Brazil. A distinction also was made between proprietary and
non-proprietary databases. A compromise was reached with the language
=93including but not limited to open licensing.=94

On 2.4.e, which reads =93consider the incorporation of research
exemptions in legislation of developing countries to address public
health needs, consistent with the TRIPS and the Doha declaration on
TRIPS and Public Health,=94 the United States asked for the paragraph to
be deleted, as such issues would be dealt with in the IP chapter
(element 5). Delegations pointedly asked the US delegation to explain
its problem with research exemptions, as they are covered in both the
TRIPS agreement and in US legislation. Japan supported the United
States, which argued that the term =91research exemptions=92 was not well-
defined, and it was unclear as to its actual scope.

The encouragement and promotion of traditional knowledge (and
traditional medicines) was another key debate. Suriname wanted to
ensure that traditional medicine is protected from being carried away
from its nations of origin and brought back as patented matter. The
traditional knowledge clause in element 5, Article 5.1.f, on the
creation of digital libraries of traditional knowledge in order to
prevent misappropriation, caused much disagreement. Some delegates
were uncertain if discussions on traditional knowledge even belonged
in the WHO negotiation. Others could not see how a digital database
could prevent misappropriation, as it would offer greater access to
the knowledge. Several new suggestions were offered, but after lengthy
discussion no convergence was forthcoming so the chair suggested
interested parties meet outside the plenary. Kenya is chairing this
side session.

Another discussion in element 5 reflected a debate that has arisen at
other institutions in Geneva that the training on IP in developing
countries, such as of patent examiners, should fully reflect public
health priorities.

Element 5 seems likely to be difficult to negotiate, with upcoming
discussions on provisions such as how to address research involving
humans. Delegates on 1 May discussed Article 5.1 and several of its
subsections, but had trouble reaching consensus on several topics. In
addition to traditional knowledge, a clause on strengthening
=93education and training in the granting, application and management of
intellectual property from a public health perspective=94 also presented
a problem. The US wanted to strike the word =93granting=94 from the
paragraph, and other members proposed adding specific references to
flexibilities contained in the TRIPS agreement and other instruments.
Consensus was unable to be reached.

Under Article 5.1, on the management of intellectual property in a
manner that maximises health-related innovation, Suriname was
concerned about the ethics of clinical trials, citing examples in
which such trials have been conducted in developing countries, aiding
medical innovation on drugs that were subsequently out of the price
range of individuals who had participated in trials. Suriname wishes
to add =93maximises health related innovation and access=94 to the clause;
consensus is pending agreement on that addition.

Civil Society Views

The hottest points of disagreement have tended to arise over practical
solutions for solving this problem, reflected in the wide variation in
proposals from civil society groups addressing negotiators. Public
interest advocacy group Knowledge Ecology International=92s Jamie Love
has suggested prizes and prize funds replace patents for neglected
diseases, and expressed disappointment that most references to such
systems in the strategy paper appeared to be surrounded by brackets
indicating lack of consensus on their presence in the text. Love
suggested that if the governments are not ready at this point in time
to achieve real improvements, then perhaps the process should wait for
another time.

International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) Director General Harvey Bale said the industry
group wants to preserve strong intellectual property protection, which
it says promotes innovation, and instead focus on market incentives
outside of IP, such as advanced market commitments (AMC) and =93fast
track=94 approval for drugs targeting developing country diseases. An
AMC is a guarantee of a market in the event a medication or vaccine is
developed in order to incentivise the development of health solutions
in diseases or for areas where the existence of a market is uncertain
or too small to compensate for R&D costs.

Health Action international also said that WHO must have a clear
mandate to work in IP and health, and that the final draft strategy
should not dilute flexibilities in IP enforcement already guaranteed
under the WTO=92s Trade-Related Aspects of Intellectual Property Rights
Agreement. The European Generic Medicines Association and the
International Generic Pharmaceutical Alliance, represented by Greg
Perry, said data exclusivity must not be used to create market
exclusivity beyond patent protection.

=93IGWG must systematically address innovation and access to medicines=94
and should =93delink the cost of research and development from the price
of developed products,=94 said Sarah Rimmington of Churches=92 Action for
Health. The role of WHO should be strengthened on IP and issues in
health, and the organisation should =93provide active guidance,
specifically on TRIPS flexibilities.=94

The International Alliance of Patients Organizations called for IGWG
recognise patients and patient organisations as key stakeholders.

MSF=92s von Schoen-Angerer urged that the medical R&D process be
government-led, and said it appeared wealthy countries objected to a
proposed R&D fund without offering alternatives.

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


Judit Rius Sanjuan
Attorney at Knowledge Ecology International
www.keionline.org / www.cptech.org
Phone: +1.202.332.2670, x18
Email: judit.rius@keionline.org