[Ip-health] Views on the 61st World Health Assembly adoption of Global Strategy on Public Health, Innovation and Intellectual Property

[Thiru Balasubramaniam]

http://www.keionline.org/index.php?option=3Dcom_jd-wp&Itemid=3D39&p=3D121

Views on the 61st World Health Assembly adoption of Global Strategy on
Public Health, Innovation and Intellectual Property
June 2nd, 2008 by Thiru Balasubramaniam

On 24 May 2008, the 61st World Health Assembly, the World Health
Organization=92s highest governing body, adopted the Global Strategy on
Public, Innovation and Intellectual Property. As stated by James Love
(Director, Knowledge Ecology International) in his random-bits posting
(31 May 2008)

     [t]his has been a long and difficult negotiation at the WHO. KEI
invested enormous effort into the negotiations, and we are very
pleased with the outcome. The official documents are long, and will
not be published until next week. As the story by William New [IP-
Watch] reports, the negotiation covered a wide range of topics
covering both innovation and access in the field of medicine and
medical devices. The ambition of the negotiation was unique in that it
sought to reconcile both innovation and access in the same policy
document, and to move governments and stakeholders toward new
paradigms for supporting both.

Santiago Luis Bento Fernandez Alcazar, Minister, Head of the
Department of International Affairs, Ministry of Health Brazil

     Perhaps the most important result of the adoption of the Global
Strategy and Plan of Action by the 61st World Health Assembly is a
mind shift in the perception of the complex relation of public health
and intellectual property. There has been and undeniable advance in
accepting concepts that will have a profound consequence on how to
deal with important matters such as, for example, the recognition that
the IP regime is limited in its scope to deliver products that are
crucial for developing countries, as well as the urgent need to
rethink the basis for innovation. There is in this recognition an
undisclosed acceptance of a crisis in the R&D and innovation cycle in
which WHO, in its strengthened role, will have a strategic and central
role. And all this was agreed by consensus, which shows the workings
of the empowerment of developing countries in delicate and difficult
matters in multilateral diplomacy.

Dr. Kumariah Balasubramaniam, Advisor and Coordinator, Health Action
International Asia - Pacific

     =93Following the Doha Declaration in 2001, the outcome of 61st WHA
and the adoption of the WHO global strategy on public health,
innovation and intellectual property is yet another phase in the
ongoing peaceful revolution that will shift the focus of R & D in
pharmaceuticals towards meeting the priority needs of developing
countries. This also moves WHO towards the central stage in
international intellectual property policy making. Hopefully WHO will
soon regain its role as the lead UN agency in international public
health.

Dr. Margaret Chan, Director-General, World Health Organization

     You have taken a huge step forward with the item on Public
Health, Innovation, and Intellectual Property. With this, public
health leaps ahead in addressing two fundamental and long-standing
needs: to improve access to existing interventions, and to include
diseases of the poor in the drive to develop new products.

     This is a major breakthrough for public health, and I
congratulate you all. This is a breakthrough that will benefit many
millions of people for many years to come. This is a contribution to
fairness in health, and this is pro-active public health at its very
best.

Erika Due=F1as, Economic and Trade Counselor Embassy of Bolivia in
Washington, DC

     Strengthening the role of WHO and its regional offices on the
complex interaction between public health, innovation and intellectual
property is vital to appropriately implement the Global Strategy and
Plan of Action. The results of the 61 WHA are only good steps in order
to achieve essential health innovation and access to lifesaving
medicines or medical technologies. There is no doubt that this
negotiation process was an enormous challenge, particularly for an
active participation of small developing countries, but at the same
time we realized a valuable world recognition of this responsibility.
We further encourage small countries to constantly follow the
effective implementation of all WHA Resolutions on this topic and the
recommendations of the CIPIH Report.

     This is comparable to the victory of the Doha Declaration because
we still need practical solutions, change directions when necessary,
and that is an important part of the IGWG results, to reaffirm the
principles of Doha but also explore sustainable alternatives to
promote innovation and fill the acknowledged gaps of the current
patent system. We need to promote a new umbrella for the coming
negotiations or domestic legislations taking into consideration basic
health concerns.

Dr Huda Gashut. Minister Counsellor (Health Affairs). Permanent
Mission of the Libyan Arab Jamahiriya and Chair of the WHO IGWG Sub-
group of Drafting Group B on the Plan of Action

     The 61st WHA has been an intensive work experience. The drafting
group that negotiated the completion of the strategy and plan of
action on public health, innovation and intellectual property,
represented at least 3 different views.

     There have been many objectives that were impossible to achieve
for some, there have been some concessions that were impossible to be
made by others, In spite of these differences, I felt that everyone
wanted to alleviate the suffering and the death of the most in need.

     The CONTROVERSY between these groups views was clearly the how
much each group was ready to pay to achieve this.

     Our expectations were high , still not high enough for the needs
of poor and sick people.

     I learned that to reach the top you have to climb step by step,
working hard and as long as it takes. I think that our resolution is
the beginning of a long way to go, and that we are on the right path.

     Now we all, recognize we need to share some of the knowledge. How
much knowledge need to be shared to achieve our objectives remains our
next issue .

     Developed countries and developing countries need, not only to
increase cooperation, They need to learn to share.

     We need to share the right for health and the right for life.

Prangtip Kanchanahattakij, First Secretary, Permanent Mission of
Thailand to the United Nations and other International Organizations
in Geneva

     Not only developing countries, but also developed countries
should be applauded for this achievement. It=92s a collective effort to
reflect a fundamental problem. For the unfinished business, it=92s only
a matter of time.

James Love, Director, Knowledge Ecology International

     Six and a half years after the Doha Declaration, and five years
after the CIPIH was created, the WHO has taken a big step forward to
change the way we think about innovation and access to medicines. In a
lengthy and substantive document, the World Health Assembly has
reached consensus on a plethora of difficult and important topics,
sometimes with impressive detail and clarity, on topics that were
considered controversial only a short time ago. We are particularly
impressed that the WHA was:

         strong on the use of compulsory licensing and other
flexibilities in protecting public health,

         recommended that drug registration requirements confirm to
the Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human Subjects,and continues and expands its support for

         work on a biomedical R&D treaty,

         the collective management of intellectual property rights, and

         the use of new mechanisms, like prizes, to provide innovative
incentives that are not linked to product prices.

     It is unfortunate that the WHA has yet to address the estimation
of funding needs for priority R&D, or created a framework for
sustainable sources of funding. Also, the WHO Secretariat has yet to
engage on the issue of new mechanisms that de-link R&D incentives from
product prices. These and other issues will be the subject of the next
round of negotiations, which will begin very soon.=94

Greg Perry, director-general, The European Generic medicines
Association (EGA)

     EGA director-general Greg Perry welcomes a commitment to =93take
into account, where appropriate, the impact on public health when
considering adopting or implementing more extensive intellectual-
property protection than is required by [the World Trade
Organization=92s agreement on] trade-related aspects of intellectual-
property rights (TRIPS)=94. The measure to avoid TRIPS-plus provisions,
he believes, includes reviewing the impact of data exclusivity.

     EGA is also pleased by an explicit pledge to support Bolar-type
early-working legislation in developing countries, as well as by an
acknowledgement that measures might need to be taken to avoid abuse of
intellectual-property rights. It is also welcomed that counterfeiting
and information-sharing on data exclusivity had been dropped from the
global strategy and plan of action.

Tim Reed, Director, HAI Global

     The fact that there is now a resolution which sets out a global
strategy is very positive. It represents a momentous paradigm shift
that should translate theories into action around innovation and
intellectual property. So, we are now soundly on the right track. But
there is still a long way to go and the enthusiasm and energy of past
effort must not be lost if the resolution is to lead to real outcomes
that change the lives of those in need of innovative treatments.

     Moreover, WHO needs a clear mandate to lead the way forward, to
uphold the agreed strategy, and offer Member States support and
technical capacity. And let us not forget the vital role of Civil
Society Organisations as this plan evolves =96 Civil Society has the
technical expertise and political will to contribute to every aspect
of the roll-out and hold to account those who hinder its progress.

Sarah Rimmington, Attorney, Essential Action

     The world community has taken a bold step today by agreeing on a
way forward to reform a global system of medical research and
development that has largely failed to meet the needs of people in
developing countries.

     After a difficult round of negotiations, countries have finalized
a very good global strategy aimed at spurring the development of
medicines and other products that will meet priority health needs, and
make those products available on an affordable basis. Up until now the
current patent-monopoly based system of R&D has treated innovation and
access as contradictory objectives that must be counterbalanced to
each other. Because of IGWG, the nations of the world have for the
first time acknowledged that innovation and access are complementary
public health objectives; that we can have =93innovation plus access.=94

     The WHO has a crucial role to play regarding health-related
implications of patent and related intellectual property rules, and in
particular in proactively providing technical assistance to developing
countries that promotes the use of existing flexibilities in
international trade rules, to expand access to new and existing
patented treatments where there are price barriers.

     At the same time there is critical work that remains to be done
to promote R&D models that will work for the developing world. Member
countries must actually implement the innovative approaches to R&D
agreed upon today at the WHA. For the promise of IGWG to be realized,
it is crucial that countries take concrete steps to advance
experiments with new institutional arrangements for R&D, such as the
non-patent prize proposals to address priority health needs of
developing countries put forward earlier this month by Bolivia and
Barbados. This work will begin very soon when the WHO convenes the R&D
financing working group mandated by the WHA.

Sangeeta Shashikant, Third World Network

     The Global Strategy was an achievement in the sense that concepts
such as open licensing, open source approaches, need for new
incentives and a concrete role for WHO in the area of public health
and IP were accepted by the developed countries after about 2 years of
debate. Now it is time for WHO to show leadership in developing
solutions on innovation and access to overcome health problems in
developing countries.

Ellen F.M. =91t Hoen LL.M. Director, Policy Advocacy, Medecins sans
Frontieres Access to Essential Medicines Campaign

     The Doha Declaration was historical because it outlined the
mechanisms to address high medicines prices and patent monopolies. The
IGWG has gone a few steps further by also addressing the need for
changing the way research
     and development of essential health products is financed. The
IGWG has in particular highlighted the need to look at de-linking
paying for the R&D cost from the price of the product.

     The WHO now has to play a central role in the implementation of
the strategy which varies from immediate action such as determining
the priorities for essential health R&D and find new ways to finance
the R&D and support to countries that struggle to bring the cost of
patented medicines down by using the TRIPS/Doha flexibilities, to
taking the lead in political processes with a more long term effect
such as, the essential R&D treaty. The Strategy does not lack action
points, but national and international policy makers need to deliver
to make sure access and innovation become reality.



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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997