Today, NGOs at the WHO IGWG had an opportunity to give statements to the plenary session. Below are a number of statements made by civil society organizations, including the collaborative statement of the Churches delegation in which we participated.

Joint Statement of Churches Delegation

This statement was written by delegation members from Essential Action,
Third World Network, and Universities Allied for Essential Medicines.

1 May 2008

Statement of CMC - Churches’ Action for Health at WHO IGWG II bis

My name is Sarah Rimmington, and I am speaking on behalf of the CMC
Churches’ Action for Health delegation. We are pleased to address the
WHO Intergovernmental Working Group (IGWG) on public health, innovation
and intellectual property.

Medical research and development breakthroughs have made the world a
better and healthier place, thus serving the mission of justice, peace
and integrity of creation. Vaccines, antibiotics and drugs for
conditions such as HIV/AIDS have kept countless millions alive and
reduced untold suffering.

The world — and especially developing countries — needs more
innovation. To have public health benefit, however, the fruits of the
innovative process must be available to the people who need them.

The current patent monopoly-based system of R&D has proven inefficient
at advancing a needs-driven public health agenda. This is particularly
true regarding the needs of the vast majority of the world’s population
who live in developing countries.

The patent monopoly-based system of R&D has also resulted in excessively
high prices for important health products, creating serious access
problems particularly for developing countries.

The global strategy and plan of action that comes out of the IGWG
process thus must systemically address both innovation and access to
medicines – “I plus A”.

To address the challenges of I plus A, we strongly believe the strategy
and plan of action must promote incentive proposals that de-link the
cost of R & D from the price of the products developed. This approach
has also been strongly endorsed by a group of Nobel laureates and
academics earlier this week.

Health products must be widely accessible if R&D is to be relevant for
developing countries.

It is also of critical importance for member states to strengthen the
role of the WHO with respect to intellectual property issues as they
relate to public health.

WHO is the leading multilateral institution on public health. It has for
many years been providing guidance, technical and policy support to
developing countries, and should continue to do so proactively.

In this respect, we hope to see the global strategy and plan of action
take a step forward to address developing country needs for WHO
guidance, technology and policy support to achieve innovation plus access.

We strongly encourage this body to agree that the WHO must provide
proactive guidance, particularly in the use of the TRIPS flexibilities
to promote access, including compulsory licensing and exceptions to
patent rights; the implementation of policies on strict patentability
criteria to achieve public health objectives; implementing policies to
prevent and remedy anti-competitive practices pertaining to patents for
health products; and promoting licensing and technology transfer
strategies that make medicines available at the lowest possible cost in
the developing world.

Developed countries - in particular the EU and the US - make frequent
use of these measures, but developing countries need assistance from a
public health perspective. We see the WHO as being the appropriate lead
institution on these matters.

We further support the inclusion in the strategy and plan of action the
CIPIH report recommendation that encourages member states to avoid the
incorporation of “TRIPS-plus” provisions in trade agreements and
national legislation, because of their well-known negative impact on
access to medicines.

MEDECINS SANS FRONTIERES INTERVENTION AT IGWG 2.2
Thursday 1st May 2008

Thank you Chair.

My name is Dr. Tido von Schoen-Angerer and I am speaking on behalf of
Médecins Sans Frontières. Thank you for the opportunity to address this
important gathering.

In 2000, I was working in one of MSF’s AIDS projects. Our response to the
pandemic was one based on a simple medical decision: faced with the urgency
of patients dying, the only acceptable response was to treat. This was an
ethical imperative, to treat, regardless of the difficulties.

A treatment that then cost over ten thousand dollars for each patient for
one year has now plummeted to under one hundred dollars. This 99% drop –
which opened up the possibility of life-saving treatment to millions –
happened only thanks to competition between manufacturers, which put an end
to monopolies.

But we cannot hope for this to happen again for newer drugs in the future.
With TRIPS implementation causing the source of generic medicines to dry
up, governments now have to resort to deliberate, complex strategies to
keep the price of medicines down.

These strategies are a source of conflict, both between governments, and
between governments and drug developers. That such conflicts have
multiplied in recent years across the globe, from South Africa to Brazil to
Thailand, shows that something is wrong.

I have also seen time and again incontestable evidence of a second failure
of the medical research and development system: that it fails to respond to
diseases that affect people in developing countries. Tuberculosis provides
a perfect example for this.

Treating standard TB was difficult already: the most common test to detect
TB misses more patients than it actually detects, and the treatment regimen
is lengthy and cumbersome.

What was a difficult disease to treat then, has now become a public health
emergency through the effect of the HIV pandemic, and the spread of
resistant strains.

The problem lies squarely with the lack of tools at our disposal: no
simple, rapid test to better detect TB in field clinics; drugs that must be
taken for up to 24 months and that cause the most terrible side effects;
and practically no treatment options at all for XDR-TB.

The current R&D system has the wrong priorities: it is unable to respond to
the health needs of millions of people across the developing world. The
scale of the problem is so immense, that putting all our faith in
philanthropic organisations alone would be foolish. The likelihood of
having a novel TB regimen with at least two new drugs by 2015 is less than
1%.

What we need from you, governments here at the IGWG, is to address these
fundamental problems with both medical R&D and access to the products of
innovation. You are tasked with changing the current situation and you
need to have the courage to do so. This is, and must remain, a
government-led process.

I understand that rich countries objected to an R&D fund without putting
alternatives on the table. The IGWG is a historic opportunity and this
should not become an historic failure for lack of response.

Governments, and the WHO, must not abdicate from their responsibilities, or
pass the buck to others. We are asking you to strengthen WHO role in
intellectual property and health, to change the way R&D is prioritised and
financed so that paying for the research does no equal prohibitive prices,
and to take measures to increase generic competition.

We are asking you, then, to rise to the challenge and change the rules to
ensure access and innovation. Because we need both.

Thank you.

HAI statement on IGWG

Thank you chair, Christian Wagner-Ahlfs speaking on behalf of Health Action
International.
Health Action International is following the IGWG process with great
interest and supports all approaches to transfer the outcome of the CIPIH
report into action.
Health Action International is a global network of over 200 members in more
than 70 countries. Our work in the area of access to medicine for the last
30 years, has shown us that the existing IP based system of R&D has failed
to meet people’s needs. There is extensive evidence to show that very little
innovation is taking place that address the Health needs of the developing
countries and the poor across the globe. Clearly, we need a system that
places people’s real health needs above the interests of commerce. We need
innovation, but more importantly, we need access to innovation.
Therefore, from a public health perspective we would like to focus on two
key points:

· Public responsibility
As the CIPIH report shows, there is clear relationship between IP and access
to health products. Given this, we would strongly propose that the WHO must
have a clear mandate to work in the area of IP and innovation. We thus ask
for the recognition of WHO as the leading stakeholder for realizing the
Global Strategy and Plan of Action.
By no means should the Draft strategy dilute the flexibilities in TRIPS that
have been established in various forums. This means, explicitly, no TRIPS
plus provisions in Free Trade Agreements, such as for example, provisions
relating to data exclusivity.

· Incentives for pushing R&D:
The negotiations are an opportunity to explore and put in place new
mechanisms for doing Research on Health Products that are outside the TRIPS
framework. We ask to explore all possible incentives mechanism for Research
and Development that consider both: innovation and access to this
innovation. Here we ask all governments to show openness for breaking new
grounds. We need willingness to fund new approaches that are not focused on
commercial interest but on public health needs. This also includes a
rethinking of how to deal with public funded research that is licensed to
commercial partners. One possibility among others is to use open licensing
for public funded research.
If we want to solve the problems related to access and innovation that has
existed for long, it is not enough to stop at the IGWG negotiations. The
plan of action has to be filled with life. This will only be possible if all
governments accept this challenge as their responsibility. Health is a
public responsibility and we look forward to country governments rising up
to the challenge of redeeming this responsibility in full.
Thank you.