[Ip-health] Ip-health digest, Vol 1 #2619 - 12 msgs
Roman Macaya
rmacaya@rimacsa.com
Wed May 21 05:40:21 2008
Este es un mensaje con varias partes en formato MIME.
--
Dear Jamie,
I am attaching a Press Release (which is a few days old) regarding the
formation of a new global generic agrochemical Association named Agro-Care,
in case you would like to distribute it. At a time when the world faces its
worst food crisis in decades, we strongly believe that generic farm
chemicals are an important part of the solution. Agrochemicals are the
major production cost item for most crops in developing countries with
tropical agriculture. Therefore, the timely introduction of competition
into the market of agrochemicals creates significant cost savings for
farmers. This is a particularly relevant topic at a time of runaway
agricultural production costs.
Unfortunately, the multinationals in this field are employing the same
tactics to block generic agrochemicals from the market as the pharmaceutical
multinationals use to block generic drugs, namely overprotection of
intellectual property and registration barriers.
In any case, I hope you are doing well and hope to see you in the near
future.
Best regards,
Roman Macaya
-----Mensaje original-----
De: ip-health-admin@lists.essential.org
[mailto:ip-health-admin@lists.essential.org] En nombre de
ip-health-request@lists.essential.org
Enviado el: martes, 20 de mayo de 2008 10:00 a.m.
Para: ip-health@lists.essential.org
Asunto: [!! SPAM] Ip-health digest, Vol 1 #2619 - 12 msgs
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Today's Topics:
1. WHO Director General address to 61st WHA (Judit Rius Sanjuan)
2. FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped
By Counsel (Joana Ramos)
3. Waxman letter on WHO Publications Policy (robert weissman)
4. FULL TEXT OF Note for IGWG: Use of Competition Policy to
prevent/remedy
anti-competitive practices re pharma patents (Sarah Rimmington)
5. FULL TEXT of Note: The importance of a global patent database for
pharmaceuticals (Sarah Rimmington)
6. IP-Watch: IP Issues Come to a Head at World Health Assembly (Sarah
Rimmington)
7. IPWatch: World Health Assembly Opens On Note Of Global Crises, Hope
For IP (Sarah Rimmington)
8. WHA: IGWG report and draft resolution (Judit Rius Sanjuan)
--__--__--
Message: 1
From: Judit Rius Sanjuan <judit.rius@keionline.org>
To: ip-health@lists.essential.org
Date: Mon, 19 May 2008 21:35:27 +0200
Subject: [Ip-health] WHO Director General address to 61st WHA
--
[ Picked text/plain from multipart/alternative ]
Dr Margaret Chan
Director-General of the World Health Organization
http://www.who.int/dg/speeches/2008/20080519/en/index.html
Mister President, honourable ministers, excellencies, distinguished
delegates, ladies and gentlemen,
We are meeting at a time of tragedy. Let me express my deep
condolences to the millions of people who have lost their loved ones,
their homes, and their livelihoods following the recent cyclone in
Myanmar and the earthquake in China.
In China, I was especially touched by the images of a collapsed school
and hospital, and some of the stunning rescues made in these settings.
Every death is tragic, but the deaths of students and patients touch
me most especially.
In Myanmar, WHO has 17 surveillance teams currently distributing
medical supplies in the delta region. At present, the most pressing
health concerns are diarrhoeal disease, dysentery, acute respiratory
infections, malaria, and dengue fever. A surveillance system for
outbreaks has been established. Sensitive surveillance, with rapid
alerts and response, becomes extremely important as the monsoon season
sets in.
Crises of this nature show the great generosity of the international
community. They also demonstrate the vital importance of early warning
systems, and preparedness to reduce risks in advance.
Among its various activities, WHO is promoting the construction of
hospitals and health facilities that can survive the impact of natural
disasters, including high-intensity earthquakes and tropical storms.
In most cases, a very small increase in construction costs is
sufficient to give health facilities this survival capacity, when
their services and staff are most needed. AMRO, in particular, has
pursued this approach.
Unfortunately, as we look ahead, we must all brace ourselves for more
humanitarian crises in the immediate and near future.
Ladies and gentlemen,
Three global crises are looming on the horizon. All three are
international security threats. Two are beyond the direct control of
the health sector. But for all three, human health will bear the brunt.
Food security is in a crisis. As the experts tell us, the crisis
arises from a so-called =93perfect storm=94 of converging factors. Enough
food is produced to feed the world population. In fact, far too many
people are overfed. Yet we abruptly face a crisis of soaring food
prices that hits the poor the hardest. It also hits their governments.
Personally, I have no illusions. The crisis is suddenly upon us, but
the causes are complex and long in the making. The consequences will
be with us for some time to come.
Adequate nutrition is the absolute foundation for health throughout
the lifespan. The world is already confronted with an estimated 3.5
million deaths each year from undernutrition. Poor households spend,
on average, from 50=9675% of disposable income on food. More money spent
on food means less money available for health care, especially for the
many millions of poor households who rely on out-of-pocket payments
when they fall ill.
The UN system has responded very quickly. WHO is part of a high-level
task force on the global food security crisis, led by the Secretary-
General. To guide priority action, WHO has identified 21 =93hot spots=94
around the world which are already experiencing high levels of acute
and chronic undernutrition.
This Assembly will address the second global crisis: climate change.
Throughout the course of this century, the warming of the planet will
be gradual. But the effects of extreme weather events will be abrupt
and acutely felt.
Again, the poor will be the first and hardest hit. Climate change is
already adding an additional set of stresses in areas that are already
fragile, with marginal livelihoods and thin margins of survival when
shocks occur.
The implications are clear. More droughts, floods, and tropical storms
mean greater demands for humanitarian assistance. These added demands
will come at a time when all countries are stressed, to a greater or
lesser degree, by the effects of climate change.
The international community will also have to cope with a growing
number of environmental refugees. If land is parched or salinated, if
coastal and low-lying areas are permanently under water, these people
cannot simply go home. Environmental refugees thus become a new wave
of settlers, possibly adding to international tensions.
You have before you a draft resolution on climate change which gives
WHO some clear responsibilities. We will do our utmost to meet your
expectations in this critical area.
Pandemic influenza is the third global crisis looming on the horizon.
The threat has by no means receded, and we would be very unwise to let
down our guard, or slacken our preparedness measures. As with climate
change, all countries will be affected, though in a far more rapid and
sweeping way.
You will be addressing some of these issue in the coming days.
Fortunately, this is one global crisis where the health sector can
directly shape policies that govern preparedness and response.
Given the protective power in your hands, it is vital for public
health to present a united front. I urge you to keep this necessity in
mind as you consider the draft resolution on the sharing of influenza
viruses and access to vaccines and other benefits.
These three critical events, these clear threats to international
security, have the potential to undo much hard-won progress in public
health. In all cases, those countries with solid health
infrastructures and efficient mechanisms for reaching vulnerable
populations will be in the best position to cope.
On one hand, these events could set back progress in reducing poverty
and hunger and reaching the health-related Millennium Development
Goals. On the other hand, reaching the Millennium Development Goals
would vastly increase the world=92s capacity to cope with these
international threats.
Ladies and gentlemen,
We have reached the second phase in the global drive to achieve the
Millennium Development Goals. The goals address a central challenge:
to ensure that the benefits of globalization are evenly and fairly
distributed. As stated in the Millennium Declaration, this is a call
for global solidarity based on the principles of equity and social
justice. These principles echo the value system that captured world
attention when the Declaration of Alma-Ata was signed 30 years ago.
You have before you a report on the monitoring of achievements. As you
all know, I have made the health of the African people and of women my
two overriding priorities when measuring the effectiveness of our
work. And rightly so. Progress is least in Africa. Progress for women
is hardest.
Let me comment on overall progress.
At the end of last year, better data and statistical methods allowed
WHO and UNAIDS to chart the evolution of the HIV/AIDS epidemic with
greater precision. HIV incidence peaked in the late 1990s. Prevalence
has been level since 2001. In a significant trend, deaths from AIDS
have declined during the past two years.
Evidence now allows us to conclude, with confidence, that this decline
in mortality is linked to dramatic recent increases in access to
antiretroviral drugs. The access of women to treatment is at least as
good as that for men. Globally, close to three quarters of people
receiving antiretroviral drugs are in Africa, where the epidemic is
disproportionately severe.
This demonstrates that something as complex as antiretroviral therapy
can indeed be introduced in resource-constrained settings. But we are
still running behind this devastating, unforgiving epidemic. The
numbers remain staggering: an estimated 33.2 million people living
with HIV and 2.5 million newly infected in 2007 alone. Clearly, we
must seize every opportunity for prevention. This is the only way to
catch up and eventually get ahead.
Tuberculosis has a good diagnostic and treatment strategy, and we have
solid evidence that the approach works. Progress remains steady,
though the rate of case detection has slowed compared with recent years.
Poor medical practices, which contribute to the development of drug
resistance, are a major concern. Earlier this year, WHO issued a
report showing that multi-drug resistant TB has reached the highest
levels ever recorded.
Even more worrisome is the continuing occurrence of extensively drug-
resistant TB, which is virtually impossible to treat. To allow this
form of TB to become widespread would be a setback of epic
proportions. For these patients, our treatment options effectively go
back to the era that predates the advent of antibiotics.
Next month, I will be joining the UN Secretary-General at the first-
ever global leadership forum on scaling up the response to the co-
epidemics of HIV and TB. This is yet another example of the growing
engagement of world leaders in health issues.
The forum takes place at a time when several high-burden countries are
showing very promising increases in the numbers of people accessing
integrated HIV/TB services. Leadership, also from the Secretary-
General=92s Special Envoy to Stop TB, former president Mr Jorge Sampaio
of Portugal, can take this momentum a step further.
For malaria, we are finally seeing solid progress. Rapid declines in
mortality in parts of Africa show the power of recommended strategies
to deliver dramatic results. This year we commemorated the first-ever
world malaria day, a sign of global commitment to tackle this disease.
On that occasion, the Secretary-General and his Special Envoy, Mr Ray
Chambers, challenged the international community to embark on an
ambitious plan to reduce malaria deaths by the end of 2010. If we can
do this, we will boost the prospects for better health in Africa in a
tremendous way.
Last year, global mortality of young children dipped below 10 million
for the first time in recent years. You will be considering a report
on the global immunization strategy, one of the best success stories
in public health. I want to thank all partners concerned, also in the
Measles Initiative, and extend my very special appreciation to UNICEF
and the GAVI Alliance.
Also, we are clearly seeing the broad-based impact of the Integrated
Management of Childhood Illness, which has now been adopted as the
principal child survival strategy in 100 countries. Of these, 49 have
extended coverage to more than half of the country=92s districts. In
just two years, the number of countries reaching this level of
coverage has doubled. I congratulate these countries on their great
efforts.
Research has given us an additional boost towards achievement of the
goal for reducing childhood mortality. The use of zinc to treat
diarrhoea, along with a new formula of oral rehydration salts, will
help save the lives of millions of children.
Earlier this year, research coordinated by WHO demonstrated that home-
based treatment of pneumonia =96 the number one killer of young children
=96 is just as effective as hospital care, and possibly even safer.
Given my commitment to primary health care, evidence that supports
community- and home-based care pleases me most especially.
Yet, as is so often the case in public health, when one thick layer of
morbidity and mortality begins to thin, it reveals more starkly
another critical problem. This is the case with newborn mortality,
another big problem we need to address. Once again, research has
demonstrated that something as simple as skin-to-skin contact with
mothers =96 so-called =93kangaroo=94 mother care =96 can save the lives of =
pre-
term babies.
We also need to save the lives of mothers. As the report before you
notes, progress in improving women=92s health is disappointingly slow.
This is especially true for maternal health, where mortality has
remained stubbornly high despite more than 20 years of efforts. I
personally find this lack of progress outrageous. Is the value society
places on women so small that their lives are simply dismissed as
expendable? If the answer is no, then we absolutely must double our
efforts to make sure that the health of women is protected.
I know that social and cultural changes take time. But I have also
seen some studies of microfinancing schemes for women that have
produced rapid improvements in their social status, in their control
over household decisions, and in their spending on family health. In
some studies, an unexpected bonus has been a decline in domestic
violence.
I firmly believe we need to explore every option that can potentially
raise the status of women, protect their health, and free them to
realize their human potential and their great capacity as agents of
change.
Mr President, I agree with your views: any discussion of health
development must include the chronic noncommunicable diseases. Heart
disease and cancer now rank as leading killers in all parts of the
world, regardless of a country=92s income status. Diabetes and asthma
are on the rise everywhere. Even low-income countries are seeing
shocking increases in obesity, especially in urban areas and often
starting in childhood.
The action plan, which you will be discussing, deserves our urgent
attention. Fortunately, these disease share a limited number of risk
factors linked to behaviours that can be modified: tobacco use,
improper diet, lack of physical activity, and the harmful use of
alcohol. Prevention must be given top priority.
As a significant step in this direction, WHO, supported by the
Bloomberg Foundation, launched the first-ever report on the global
tobacco epidemic in February. The report sets out country-specific
data on tobacco use, but also on the use of proven control measures.
Of these, tobacco taxes are by far the most powerful. It comes as no
surprise that taxes are fiercely resisted by the tobacco industry.
This industry has long described WHO as its biggest enemy. I am
pleased by every opportunity to enhance this reputation.
Ladies and gentlemen,
I have mentioned at least one =93perfect storm=94 brewing on the horizon.
I believe that control of the neglected tropical diseases represents
the opposite: a =93perfect rainbow=94.
We now see a whole spectrum of opportunities that have converged in a
most harmonious way. Safe and powerful drugs are being donated or made
available at very low cost. Integrated approaches have been devised
for tackling several diseases at once.
A strategy of mass preventive chemotherapy, aimed at reaching all at
risk, rivals the protective power of immunization. Research continues
to document the improvements in poverty reduction and economic
productivity when these diseases are controlled. A perfect rainbow
really can end in a pot of gold.
With a comparatively modest, time-limited financial push, many of
these diseases can be controlled by 2015. Some can even be eliminated
by that date. In this regard, let me thank the government of the
United States of America for its commitment of funds to control the
neglected tropical diseases. I hope many other countries will show a
similar commitment. If we can bring these diseases under control, that
will be a contribution to poverty alleviation on a truly grand scale.
As you know, we are on the brink of eradicating guinea-worm disease,
and funds are being secured to ensure this happens.
Polio is, of course, also slated for eradication. In our global
efforts, we are seeing renewed international action coming out of an
urgent global stakeholder consultation I convened early last year. I
have visited each of the four remaining polio-endemic countries, in
Asia and Africa, to observe first-hand the tremendous efforts being
undertaken, often under very challenging conditions. Let me thank the
efforts of the dedicated front-line troops.
In Asia, type 1 polio =96 the most dangerous strain of the virus =96 is
today on the verge of elimination. But just as we are seeing record-
lows in Asia, Africa is witnessing a dramatic upsurge of this strain
in the northern states of Nigeria, while previously polio-free
countries on the continent are still struggling to stop viruses that
were reintroduced more than two years ago. As I have said before, we
must finish the job. We are too close to allow success to slip through
our fingers.
Ladies and gentlemen,
I have referred to the second phase in our efforts to reach the
Millennium Development Goals. For health, this second phase is defined
not just by the midpoint in the countdown, but also by a shift in our
approach.
Progress stalled, and we now see one reason why. Investment in
technology and interventions alone will not automatically =93buy=94 better
health outcomes. We must also invest more in human and institutional
capacity, in health information, and in systems for delivery.
Fortunately, this need is now recognized in approaches, such as the
International Health Partnership launched last year, and in the
policies of the major funding agencies, including the Global Fund and
the GAVI Alliance, many donors, and UN agencies working in health.
When I took office at the start of last year, I called for a return to
primary health care as an approach to strengthening health systems. My
commitment has deepened. If we want to reach the health-related Goals,
we must return to the values, principles, and approaches of primary
health care.
Fortunately, the Commission on Social Determinants of Health will be
releasing its report later this year. The findings should help us
address the root causes of inequities with greater precision.
In this regard, I want to commend you for the tremendous progress made
in meetings of the Intergovernmental Working Group on Public Health,
Innovation, and Intellectual Property. This is one of those rare
opportunities when public health can take a proactive role in shaping
at least some of the forces that influence equity in health.
Your negotiations began with consideration of nearly 200 paragraphs in
the main negotiating text. The document now comes to this Assembly
with only 18 paragraphs where consensus needs to be reached. I urge
you to continue the =93spirit of Geneva=94 and the flexibility shown by so
many countries. In doing so, you are helping the poor populations of
this world.
This year, the World Health Report is devoted to primary health care.
It will be released in mid-October, to coincide with the 30th
anniversary of the Declaration of Alma-Ata. This report has undergone
unprecedented peer review from top experts in every region,
representing the most intensive consultation process since the first
World Health Report was issued in 1995. The report will, I believe,
help concretize my commitment to primary health care, while giving
policymakers a realistic assessment of what can be achieved and how it
can be done.
Ladies and gentlemen,
The World Health Organization was established 60 years ago. The
constitution mandated WHO to act as the directing and coordinating
authority on international health work. At that time, the Organization
faced the daunting task of restoring basic health services in a world
devastated by war.
The landscape of public health is vastly different now. WHO is not
alone in the drive to improve health. Leadership is not mandated. It
is earned. This is a time of unprecedented global interest and
investment in health. But it is also a time of unprecedented challenges.
Increasingly, we face problems that can be effectively addressed only
through well-directed and coordinated global collaboration. And this
gives WHO a clear role.
Increasingly, all around the world, health is being shaped by the same
powerful forces. Increasingly, an event in one part of the world can
quickly ricochet throughout the international system to affect us all.
Increasingly, the world=92s electronic transparency amplifies the social
concern following disasters, and the social and economic disruption
following outbreaks.
When I addressed the Health Assembly for the first time, immediately
following my appointment, I expressed my intention not to follow a
full-menu approach. In my capacity as chief technical officer, I have
a duty to steer the work of this Organization into areas where our
leadership offers a unique advantage, in ways that have a distinct and
measurable impact.
In my capacity as chief administrative officer, I have a duty to
oversee managerial and administrative reforms that make WHO a fit-for-
purpose organization given the challenges that lie ahead. We must be
fast, flexible, and bureaucratically lean, with all three levels of
the Organization working together seamlessly. I want to thank the
Regional Directors for their major contribution to this corporate
objective.
Of the reforms being introduced, the Global Management System will
take us a huge step forward in terms of improving efficiency and
transparency. As with every big move forward, there are bound to be
some setbacks, which I will be monitoring very closely.
These are some of my personal commitments as WHO moves forward to meet
the goals set by the international community and the priorities you as
Member States give us.
Your guidance matters greatly, for health but also for our collective
security. Good health is a foundation for prosperity and contributes
to stability, and these are assets in every country. A world that is
out of balance in matters of health is neither stable nor secure.
Thank you.
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
--__--__--
Message: 2
Date: Mon, 19 May 2008 08:50:53 -0700
From: Joana Ramos <jdr@ramoslink.info>
To: ip-health@lists.essential.org
Subject: [Ip-health] FDA Staff Efforts To Issue Warning Letters On Procrit
Ads Were Stopped
By Counsel
From 9 May 2008 issue of The Cancer Letter, full text available by
subscription only.
Joana
-------------------
http://www.cancerletter.com/tcl-blog/copy47_of_whats-going-on-with-nih
FDA Staff Efforts To Issue Warning Letters On Procrit Ads Were Stopped
By Counsel
From The Cancer Letter, May 9, 2008:
Internal FDA documents
<http://www.cancerletter.com/publications/special-reports/FDA_ProcritDTC.pd=
f>
show that the agency made a series of unsuccessful attempts to stop a
direct-to-consumer advertising campaign that claimed that Johnson &
Johnson=92s erythropoiesis-stimulating agent Proctit (epoetin alfa)
improved =93fatigue=94 associated with chemotherapy-induced anemia.
The advertising campaign, which is widely credited with making ESAs into
the biggest-selling class of oncology drugs, was allowed to proceed with
relatively minor changes after the FDA Office of Chief Counsel became
involved in the controversy.
The details of the doomed effort by FDA staff to modify the Procrit
campaign emerged in the documents that were placed in the public record
at the May 8 hearing of the Subcommittee on Oversight and Investigation
of the House Committee on Energy and Commerce.
Click on The Cancer Letter Archive at left to download the May 9 issue
(subscription required).
--------------------
Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org
--__--__--
Message: 3
Date: Mon, 19 May 2008 13:17:32 -0400
From: robert weissman <rob@essential.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Waxman letter on WHO Publications Policy
House Oversight and Government Reform Chairman Henry Waxman has today
sent a letter to World Health Organization Director General Margaret
Chan regarding the WHO's proposed publication policy.
Waxman writes, "I am writing to express my hope that any new policies
adopted will be designed in a manner that is not politicized and
continues to prioritize scientific and intellectual freedom."
We have posted a pdf version at <essentialaction.org/access>. The direct
link is:
<http://www.essentialaction.org/access/index.php?/archives/154-Waxman-letter
-on-WHO-Publications-Policy.html>
The text of the letter follows
Congress of the United States
House of Representatives
Committee on Oversight and Government Reform
2157 Rayburn House Office Building
Washington, DC 20515-6143
May 19, 2008
Dr. Margaret Chan
Director-General
World Health Organization
Avenue Appia 20
CH - 1211 Geneva
Switzerland
Dear Dr. Chan:
It has come to my attention that the World Health Organization (WHO) may
soon be adopting and implementing a new policy regarding publications. I
am writing to express my hope that any new policies adopted will be
designed in a manner that is not politicized and continues to prioritize
scientific and intellectual freedom.
My understanding is that the proposed policy would provide special
review for publications that "describe the workings of a particular
government" or discuss "controversial" issues. I am concerned about
this change because of past demands by the current U.S. Administration
that WHO withdraw a publication perceived to be critical of U.S.
policy.[1] At the time, U.S. officials also called for "a full review"
of WHO's publication policy.[2] Though the publication in question was
not withdrawn, the proposed changes could increase the likelihood of
inappropriate interference with the work of 'WHO in the future.
WHO publications cover a broad range of medical and scientific issues
and range from journal articles to reports to technical guidance
documents. They are an important resource for policymakers, health care
professionals, and public health advocates around the world.
Under current policy, as described in a WHO Secretariat report,
documents are reviewed by appropriate WHO offices and by independent
experts, under the supervision of assistant directors-general and
regional directors.[3] Documents are "expected to reflect the latest
scientific and medical research" and those designed to "facilitate
debate" are to be "evidence-based. balanced and constructive."[4]
At recent meetings, the WHO Executive Board has discussed proposals to
change the publication process. Stated objectives include minimizing
costs, maximizing the availability of documents, and ensuring the
reliability and validity of scientific information in WHO documents.[5]
These are important objectives.
However, I urge you to oppose additional changes that could increase the
risk of politicization of the WHO publication process. For example,
extra review of publications that address "the workings of a particular
government or national health service" could invite protest and
interference from any country that feels it has been criticized, no
matter how valid the policy analysis. Similarly, extra review of
publications on "controversial health-related issues" could introduce a
similar level of protest, obstruction, or delay. Moreover, this kind of
scrutiny of publications could produce a chilling effect on researchers
and experts, discouraging the exploration of topics that could trigger
an extra layer of review.
The WHO is a crucial and trusted source of medical and health
information for governments, health professionals, and the public in
every corner of the world. I urge the organization to continue to
prioritize scientific independence and minimize the possibility of
inappropriate political interference with the publication process.
Sincerely,
Henry A. Waxman
Chairman
[1] Letter from Sen. Edward M. Kennedy and Rep. Henry A. Waxman to
Secretary Michael Leavitt, U.S. Department of Health and Human Services
(Oct. 13, 2006) (online at
http://oversight.house.gov/documents/20061013142520-31371.pdf); citing
letter from William R. Steiger, HHS Special Assistant for International
Affairs, to Acting Director General Anders Nordstrom, World Health
Organization (Aug. 18, 2006).
[2] Id.
[3]World Health Organization, Programme Budget and Administration,
Committee of the Executive Board, Provisional Agenda Item 3.2, WHO
publication policy: Report by the Secretariat (May 3, 2007).
[4] Id.
[5] World Health Organization Executive Board, l23nd Session,
Provisional Agenda Item 6.2, WHO Publications Policy: Guidance on
implementation and evaluation, Report from the Secretariat (Apr. 14, 2008).
--__--__--
Message: 4
Date: Mon, 19 May 2008 07:16:32 +0200
From: Sarah Rimmington <srimmington@essentialinformation.org>
To: Ip-health@lists.essential.org
Subject: [Ip-health] FULL TEXT OF Note for IGWG: Use of Competition Policy
to prevent/remedy
anti-competitive practices re pharma patents
Dear all - sincere apologies - this list does not allow attachments. As
such, here is a link the the executive summary and full text of the
Essential Action Competition Policy briefing note for the World Health
Organization (WHO) Intergovernmental Working Groups on Public Health,
Innovation and Intellectual Property (IGWG) talks this week in Geneva.
http://www.essentialaction.org/access/index.php?/archives/153-U.S.-Competit=
ion-Policy-and-Pharmaceutical-Patents.html
> --
> ESSENTIAL ACTION BRIEFING NOTE FOR WHO IGWG
> U.S. COMPETITION POLICY FREQUENTLY DEPLOYED TO REMEDY ANTI-COMPETITIVE
> PRACTICES RELATED TO PHARMACEUTICAL PATENTS
>
> Following is an Excerpt of this briefing note. The read the entire
> document, please download the attached document.
>
> During the during the 2008 World Health Assembly, the World Health
> Organization's Intergovernmental Working Group on Public Health,
> Innovation and Intellectual Property (IGWG) is considering various
> proposals for WHO to assist developing countries in adopting and
> implementing competition policies to prevent or remedy anti-competitive
> practices related to the use of medicinal patents.
>
> Reportedly, some rich country delegations are objecting to these
> proposals, which is why the relevant text remains bracketed (reflecting
> a lack of consensus) in the most recent version of the IGWG Draft Global
> Strategy[1]. This is surprising, because rich countries themselves
> commonly make aggressive use of competition policy to remedy abuses
> related to medicinal patents.
>
> For a short overview of U.S. practice in this area, refer to the
> attached briefing note, or go to www.essentialaction.org/access/
>
> Reference:
> [1] See Elements 5.3 (c), 5.3(e) and 6.3(f) of World Health Organization
> (WHO), =93The White Paper (Advance copy in English only) of the IGWG
> "Outcome Document at 14.00 hours, Saturday 3 May 2008, Draft global
> strategy on public health, innovation and intellectual property,"
> available at,
> http://www.who.int/phi/documents/IGWG_Outcome_document03Maypm.pdf
> ---------
> For More Information, Contact:
>
> Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562,
> srimmington@essentialinformation.org
>
> Robert Weissman, (Washington, DC) (+1) 202-387-8030, rob@essential.org
>
> Essential Action
> PO Box 19405, Washington, DC USA 20036
> www.essentialaction.org/access
>
> --
> Sarah Rimmington
> Attorney
> Essential Action, Access to Medicines Project
> Washington, DC
> Tel: (202) 387-8030
> Cell: (202) 422-2687
> www.essentialaction.org/access/
>
> --
> [ USCompetitionPolicyBriefingrevised.rtf of type application/rtf deleted =
]
> _______________________________________________
> Ip-health mailing list
> Ip-health@lists.essential.org
> http://lists.essential.org/mailman/listinfo/ip-health
>
>
>
--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/
--__--__--
Message: 5
Date: Mon, 19 May 2008 07:20:21 +0200
From: Sarah Rimmington <srimmington@essentialinformation.org>
To: Ip-health@lists.essential.org
Subject: [Ip-health] FULL TEXT of Note: The importance of a global patent
database for
pharmaceuticals
Apologies again, colleagues. Here is a link to the FULL text of
Essential Action's Briefing note on The Importance of a Global Patent
Database for pharmaceuticals, for participants in the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property talks this week in Geneva. The full text did not
accompany yesterday's post, as this list does not take attacments.
http://www.essentialaction.org/access/index.php?/archives/152-The-Importanc=
e-of-a-Global-Patent-Database-for-Pharmaceuticals.html#extended
Sarah Rimmington wrote:
> This is a multi-part message in MIME format.
> --
> ESSENTIAL ACTION BRIEFING NOTE FOR WHA IGWG:
> THE IMPORTANCE OF A GLOBAL PATENT DATABASE FOR PHARMACEUTICALS
>
> Following is an Excerpt from the briefing note. To read the entire
> brief, please download the attached document.
>
> A proposal before the WHO's Intergovernmental Working Group on Public
> Health, Innovation and Intellectual Property (IGWG) at the 2008 World
> Health Assembly is to "[to compile, maintain and update user friendly
> global databases on the status of health-related patents in all
> countries and facilitate widespread access to the databases, in
> particular by developing countries and to strengthen national capacities
> of analysis and the quality of patents.] "[1]
>
> Adoption and implementation of such a global patent database on
> health-related inventions would advance important public health
> objectives, including the promotion of innovation, and facilitating
> access to medicines in developing countries. Although there are
> technical challenges in compiling such a database, these can be
> overcome. As a policy matter, it is very hard to imagine a legitimate
> basis for opposing such a proposal.
>
> Essential Action has worked with numerous national patent offices in
> developing countries to investigate the patent status of important
> medicines, and it is frequently the case that the patent offices cannot
> identify patents related to particular products, or can only do so with
> enormous difficulty. Patent and registration information is important
> for a variety of reasons. Examples include:
>
> - Government agencies, NGOs or others cannot make determinations about
> efficient procurement options if they cannot ascertain patent status;
> and inadequate information on patent status has in some cases interfered
> with efficient procurement of HIV/AIDS medicines.
>
> - Generic firms are unable to determine when they can enter the market
> (whether they have "freedom to operate") if they do not know whether
> products are patented.
>
> - Researchers may be inhibited from investigating certain areas if they
> cannot identify whether patents cover information in their field of
> inquiry. [2]
>
> ***Essential Action recommends that WHO member countries agree to the
> proposed - and currently bracketed - language in Element 5.1(c) of the 3
> May 2008 White paper of the IGWG Draft global strategy, which proposes a
> user-friendly global patent database be compiled, maintained and updated
> to contribute to innovation and promote public health.***
>
> For a more complete analysis of this issue, refer to the full briefing
> note, attached.
>
> References:
> [1] See Element 5.1 (c), World Health Organization (WHO), =93The White
> Paper (Advance copy in English only) of the IGWG "Outcome Document at
> 14.00 hours, Saturday 3 May 2008, Draft global strategy on public
> health, innovation and intellectual property," available at,
> http://www.who.int/phi/documents/IGWG_Outcome_document03Maypm.pdf
>
> [2]Professor Frederick Abbott, Florida State University College of Law,
> "Patent Landscaping in the Field of Medicines: Policy and Technical
> Options," World Intellectual Property Organization (WIPO) Symposium on
> Public Policy Patent Landscaping in the Life Sciences: Provisional
> Program, April 8, 2008, available at:
> <www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/program.ht=
ml>.
>
> ---------
> For More Information, Contact:
>
> Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562,
> srimmington@essentialinformation.org
>
> Robert Weissman, (Washington, DC) (+1) 202-387-8030, rob@essential.org
>
> Essential Action
> PO Box 19405, Washington, DC USA 20036
> www.essentialaction.org/access
>
> --
> Sarah Rimmington
> Attorney
> Essential Action, Access to Medicines Project
> Washington, DC
> Tel: (202) 387-8030
> Cell: (202) 422-2687
> www.essentialaction.org/access/
>
> --
> [ PatentDatabaseRevised.rtf of type application/rtf deleted ]
> _______________________________________________
> Ip-health mailing list
> Ip-health@lists.essential.org
> http://lists.essential.org/mailman/listinfo/ip-health
>
>
>
--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/
--__--__--
Message: 6
Date: Mon, 19 May 2008 12:23:42 +0200
From: Sarah Rimmington <srimmington@essentialinformation.org>
To: Ip-health@lists.essential.org
Subject: [Ip-health] IP-Watch: IP Issues Come to a Head at World Health
Assembly
http://www.ip-watch.org/weblog/index.php?p=3D1052
Intellectual Property Watch
19 May 2008
Intellectual Property Issues Come To A Head At World Health Assembly
By William New
Member governments of the World Health Organization will try this week
to finalise a strategy and plan of action to stimulate innovation on
diseases disproportionately affecting poor populations. The members also
will discuss the WHO=92s latest efforts on counterfeit medicines, the
impact of intellectual property rights on pandemic influenza outbreaks,
and may be asked to reconsider a proposed change in its publication policy.
Official documents for the Health Assembly are here:
http://www.who.int/gb/e/e_wha61.html. However, the IGWG documents are
not yet available.
But IP issues are likely to be contentious at the annual World Health
Assembly, and appear to be headed for continued discussion in the coming
year, according to official sources. The assembly will be held from 19
to 24 May, followed by a meeting of the WHO Executive Board.
Health ministers at the assembly will review the two years of work of
the Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG), whose mandate was to deliver this week a
recommended global strategy and plan of action for neglected diseases.
At its latest session earlier this month (IPW, WHO, 6 May 2008), the
IGWG resolved over 100 provisions that had been bracketed (meaning not
agreed), earning the praise of WHO Director General Margaret Chan.
But IGWG participants left at least about a dozen brackets, and these
are among the most critical for the strategy. Bill Kean of the WHO
secretariat told reporters last week that he expected some brackets
would be =93sorted out=94 but probably not all the IP provisions in the
global strategy, especially relating to financing and costs. The plan of
action also could be unfinished by the end of the week as well, sources
said.
Kean said a working group is likely to be formed quickly in the week to
work alongside the assembly during the week, doing the best possible
that it can to resolve matters. The assembly then could give the right
to the WHO secretariat to take the work forward, he said. It is possible
that non-governmental groups and the media could be excluded from the
working group if it operates in the same way as the IGWG, which involved
closed subgroups with very few outside stakeholders present.
Draft Resolution: Another Year for Action Plan, Experts=92 Group
The draft resolution on the draft global strategy envisions the adoption
of the global strategy pending discussion at the assembly and with
language on the plan of action to be developed. The draft resolution
also urges members to adopt and implement the strategy, and would extend
discussion of the plan of action until the 62nd Health Assembly in May 2009=
.
The draft resolution also includes a mandate for a budgeted =93Quick Start
Programme=94 to guide implementation of the strategy. This would include
mapping global research and development activities; supporting R&D and
standard-setting for traditional medicines in developing countries;
strengthening regulatory capacity, and supporting information-sharing
and capacity building on management of IP for health innovation and
public health; and urgently establish an expert working group to look at
financing and coordination of R&D, to report to the 2009 assembly.
The draft resolution foresees the strategy and action plan reflected in
the WHO programme budget, and the monitoring of implementation reporting
next year and then every two years =96 through the Executive Board. The
resolution appears to reflect the draft report by the IGWG to the Health
Assembly.
Michel Lotrowska of nongovernmental M=E9decins sans Fronti=E8res told an NG=
O
gathering on 18 May that the World Trade Organization Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS), which
sets the standard for IP and public health among other things, has
brought no gain for public health, only high prices for pharmaceuticals.
He warned that the outcome of the IGWG negotiation could lead to
language more restrictive than the TRIPS agreement, usually referred to
as TRIPS-plus measures. He noted the already significantly weakened
language in the draft global strategy on alternative methods for
stimulating and finding funding for research and development for
neglected diseases.
Expanding Efforts against Counterfeiting?
The WHO has stepped up its involvement in the fight against counterfeit
medicines, and the Health Assembly draft agenda item on counterfeit
likely will be discussed next to the IGWG, Kean said.
The assembly is expected to hear an update on the work of the
International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a
global coalition it established in 2006. The IMPACT team within WHO has
recently added an official from international police force Interpol who
is now situated within WHO.
The WHO has been working to help clarify that counterfeit medicine does
not equate to generic medicine, and has focussed on counterfeits from a
public health standpoint rather than, say, an IP standpoint, according
to sources. It will try to work more with governments on their efforts.
Another topic that may come up is a possible new definition of
counterfeit under the IMPACT programme that sources said could represent
a significant expansion of the term.
According to an informal document circulated at the recent IGWG meeting,
the current WHO definition is: =93A medicine which is deliberately and
fraudulently mislabelled with respect to identity and/or source.
Counterfeiting can apply to both branded and generic products and
counterfeit products may include products with the correct ingredients
or with the wrong ingredients, without active ingredients, with
insufficient active ingredients or with fake packaging.=94
The proposed IMPACT definition is said to be: =93A medical product is
counterfeit when there is a false representation in relation to its
identity, history, or source. This applies to the product, its
container, packaging or other labelling information. Counterfeiting can
apply to both branded and generic products. Counterfeits may include
products with correct ingredients/components, with wrong
ingredients/components, without active ingredients, with incorrect
amounts of active ingredients, or with fake packaging.=94
Avian Flu Pandemic and Patents
Yet another key issue with IP elements on the draft WHA agenda is the
sharing of viruses and access to the vaccines and other benefits in
relation to pandemic influenza preparedness. The main issue is that
there would not be enough treatments for everyone in the world should a
pandemic break out, and developing countries, including those sharing
their strains of the flu, do not appear to be assured sufficient
treatments. Part of the access issue relates to patenting of vaccines
developed from the shared viruses.
WHO members held a meeting (IPW, WHO, 14 December 2007) on the pandemic
flu issue last November, but did not resolve differences, planning
another meeting for later this year. Kean said it was =93unrealistic=94 to
think they could resolve the issue in one meeting, and the group has
made =93frustratingly slow progress.=94 There is a =93huge amount=94 of wor=
k to
go, he said, and the Health Assembly will receive a progress report. In
the meantime, the WHO has an internal tracking system for viruses shared
into its programme for vaccine development, and the director general is
developing an advisory mechanism for avian flu.
A key concern of developing countries has been that they may not have
access to the vaccines developed from viruses they share into the WHO
system, which is based primarily in developed countries. Patents related
to avian flu research are on the rise, according to studies (including
by the World Intellectual Property Organization).
Developing countries have offered several proposals on improving the
system to ensure equitable benefit-sharing, such as using standard
material transfer agreements, and point to international rules under the
UN Convention on Biological Diversity. A key effort is to ensure
developing countries get their right to access and benefits rather than
receive a sort of charity, said Sangeeta Shashikant of the Third World
Network.
The sustainability of the WHO sharing system relies on the sharing of
virus strains, which relies on equitable sharing of benefits, Shashikant
told the 18 May event. She also said the WHO tracking website showing
which country shared a virus and who is using it is a =93very good first
start=94 toward transparency, but that it also should show what they are
doing with it and how much they are profiting.
Shashikant called the pandemic flu issue an opportunity to explore new
ideas on how research can be done collaboratively with the results being
shared with all countries and with the aim to build capacity in
developing countries.
Tighter Central Control Of WHO Publication Policy
Another controversy at the WHO is a proposed change by the director
general to channel all WHO publications through her office for approval.
This change arose after the United States complained about a study that
reflected unfavourably on the effect of its trade policy on public
health (IPW, Public Health, 26 September 2006). It is unclear whether
there were other members who had complaints as well, but the director
general=92s office is proceeding with the plan and it is not on the Health
Assembly draft agenda. Rather it will be addressed by the Executive
Board next week, according to the WHO.
Kean said at the briefing that the intent of the secretariat is to
ensure quality and accuracy in its publications, which are widely used
and relied upon by a variety of stakeholders. =93It=92s important that we
get it right,=94 he said. It also is to watch for duplication in publicatio=
ns.
But some have asked how the director general=92s office will determine
quality and accuracy as well as identify publications considered
possibly controversial. Martin Khor of the Third World Network said at
an 18 May event that this could lead to all sides of the issues to cast
publications into doubt.
A group of more than 40 civil society members sent a letter dated 15 May
to WHO Director General Margaret Chan raising concern about the
publication policy that may amount to =93self-censorship.=94 The letter
cites possible differential treatment of some publications, as those
describing the activities of a particular government or with policy
implications for the WHO in controversial areas would be subject to
additional clearance by Chan=92s office. Chan urged the Executive Board
earlier this year to trust her office not to be unduly influenced by any
particular side. Civil society says her office should only look at
technical issues in publications.
Another concern of civil society is subjecting publications by regional
offices to scrutiny by Chan=92s office. Other concerns are a proposal for
a master list of planned publications subject to influence by the
director=92s office, and the possibility that the new policy might
=93de-motivate=94 staff from preparing the best publications possible.
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/
--__--__--
Message: 7
Date: Tue, 20 May 2008 09:13:48 +0200
From: Sarah Rimmington <srimmington@essentialinformation.org>
To: Ip-health@lists.essential.org
Subject: [Ip-health] IPWatch: World Health Assembly Opens On Note Of Global
Crises, Hope
For IP
http://www.ip-watch.org/weblog/index.php?p=3D1057
Intellectual Property Watch
20 May 2008
World Health Assembly Opens On Note Of Global Crises, Hope For IP
By William New
The 61st annual World Health Assembly on Monday opened auspiciously with
speeches on the world=92s biggest political issues, current disasters and
looming global threats, but little room for intellectual property issues.
IP issues did arise in a press briefing with US Health and Human
Services Secretary Michael Leavitt, however.
Some 2,500 people from around the world are at the UN in Geneva for the
19-24 May assembly, according to the WHO.
WHO Director General Margaret Chan in her afternoon opening speech
highlighted the health problems of the natural disasters in Myanmar and
China, praising the outpouring of support but cautioning, =93We must all
brace ourselves for more humanitarian crises in the immediate and near
future.=94
Chan also warned of the coming negative health effects, especially on
the poor, of looming global crises in food security, climate change and
pandemic influenza.
She raised IP issues optimistically, as an opportunity for the
organisation to make a difference. Chan highlighted a report due out
later this year from the Commission on Social Determinants of Health,
which she =93should help us address the root causes of inequities with
greater precision.=94
She then commended members for the =93tremendous progress=94 made in
meetings of the Intergovernmental Working Group on Public Health,
Innovation, and Intellectual Property (IGWG).
=93This is one of those rare opportunities when public health can take a
proactive role in shaping at least some of the forces that influence
equity in health,=94 she said, noting the reduction from nearly 200 to 18
unresolved paragraphs in the mandated global strategy for stimulating
research on neglected diseases predominantly affecting poor countries.
It is unclear when the assembly will start work on the remaining IP
paragraphs, however (IPW, WHO, 19 May 2008).
Chan raised the many other diseases and health matters facing the world,
saving perhaps her toughest talk for tobacco. =93This industry has long
described WHO as its biggest enemy,=94 she said. =93I am pleased by every
opportunity to enhance this reputation.=94
Leavitt Stresses IP, Trade Issues
Meanwhile, US Health Secretary Leavitt accentuated the IP issues
underlying the assembly. He said the US is willing to show flexibility
in its positions on the IP provisions of the global strategy.
Asked why the US has stood alone in obstructing the most provisions in
the global strategy, Leavitt said, =93We obviously have very strong views
that intellectual property is the seed or foundation for innovation, and
that compromising to the point that innovation is in any way stymied
will ultimately cost lives, and that=92s not an area where we think
compromise should be made.=94
But, he said, =93We also recognise that we need to come to an agreement,=94
he said. =93As I indicated, we will work hard during the rest of the week
to assure we=92re able to do that.=94
Leavitt said the US is hopeful work on the global strategy can be
completed. =93We think that within the context of what=92s been presented
that we could find agreement. So we=92ll be pursuing that hard during the
balance of this week,=94 he said.
Asked about US flexibility on the IP issues, he said: =93We have a well
defined position. We think we are flexible. We want to find a way to
resolve this. There are certain principles, of course, that we have to
maintain. But we=92re committed over the course of the remaining days here
to find a solution.=94
Separately, Leavitt referred at length to efforts to create an
international certification process for verifying the quality and safety
of products entering countries like the United States, in part to catch
counterfeits. The US imports from 825,000 different sources, coming into
more than 300 different ports of entry and valued at nearly two trillion
dollars a year, he said. Any shipments that without the certification
could be subjected to additional scrutiny at the border, he said.
He said that on a recent visit to India he became aware of how closely
integrated the American pharmaceutical industry has become with
production facilities in India. =93There are 90 to 100 facilities
producing drugs for consumption in the United States,=94 he said. =93We nee=
d
to inspect those facilities on a regular basis.=94 Similar economies like
Canada, Australia and Europe likely also would like to inspect them, so
they are discussing a unified approach, he said.
=93There is need here for us to begin working together to determine how
best to accomplish this type of independent certification,=94 he said. =93W=
e
are inventing new tools for the global economy. This is pioneering.=94
Along that line, the US recently set up a Food and Drug Administration
office in China, he said.
Some have raised concern that this new approach could be used to impair
imports from competing foreign firms. But Leavitt downplayed concerns,
encouraging government collaboration. A government role would be to
accredit certifiers, he said. In general, he predicted a greater
emphasis on standards related to health products.
Avian Flu Virus Sharing
Another key issue for the United States is the sharing of avian
influenza virus samples with the established WHO system for developing
vaccines. Some developing countries, led by Indonesia, have raised
strong concerns that when they share their virus samples into the
system, all the labs are controlled by developed countries and lead to
the developed countries lining up sufficient quantities for their own
populations while even the hardest hit developing countries have had
trouble getting access or sharing the benefits from avian flu treatments
even as patent filings rapidly rise. Such developing countries are
arguing for a firm arrangement on access and benefit sharing.
Leavitt generally agreed with the characterisation of their concern, but
firmly disagreed with connecting sharing with compensation. =93We have
engaged in and will continue to engage in finding solutions to that
dilemma,=94 he said, but there is =93a separate discussion in our mind
related to the sharing of samples.=94
=93We have a desire to be involved in both conversations,=94 he added. =93W=
hat
we object to is linking them.=94 Leavitt held a bilateral meeting this
week with the Indonesian health minister, a follow-on meeting from one
he had earlier with the minister and the Indonesian president, he said.
But there has been little change in positions so far.
A WHO meeting on the pandemic flu issue last November did not achieve
any breakthroughs, and plans to meet again next November. A meeting is
expected on Thursday as part of the multilateral process where
governments are working to develop the specifics of how an improved
system could work, Leavitt said.
=93There are many parts of the sample sharing process that need to be
improved. We=92re open to that improvement,=94 Leavitt said. =93What we are=
n=92t
willing, of course, to do is to engage in any system that would involve
compensation for virus samples. This is based on a 60-year tradition
[referring to the WHO system]. That=92s one of the great public health
successes in history. We=92re anxious to not see that compromised in any wa=
y.=94
WHO Publication Policy
A background issue this week is a proposal to increase scrutiny of WHO
publications that has stirred concern. The publication topic did not
come up on the first day of the assembly, including in the agenda
adoption or the Executive Board report, according to sources.
On Monday, US Representative Henry Waxman (Democrat-California),
chairman of the House Committee On Oversight and Government Reform, sent
a letter, available here, to Chan raising concern about the proposed
tightening of the WHO publication policy. Waxman, an influential
congressional watchdog, said the new policy of exercising greater
central control over publications would politicise WHO=92s publications
process.
Waxman supported the WHO objectives of minimising costs, maximising
availability, and ensuring the reliability and validity of scientific
information in WHO documents. But he warned against an extra layer of
review for publications naming specific national policies or addressing
potentially controversial topics, which Waxman said =93could introduce a
similar level of protest, obstruction, or delay.=94 This kind of scrutiny
of publications, he said, =93could produce a chilling effect on
researchers and experts, discouraging the exploration of topics that
could trigger an extra layer of review.=94
Sarah Rimmington, a staff attorney at public health group Essential
Action echoed this concern. =93The WHO publications policy discussion is a
US power play disguised as a bureaucratic nicety,=94 she said in a
statement. =93Over the years, the United States has repeatedly interfered
in WHO efforts to advance a public health agenda where it conflicts with
commercial or ideological interests.=94
The extra layer of review for controversial topics would be an
=93invitation for further US interference,=94 Rimmington said, and would
=93subvert WHO=92s ability to issue evidence-based public health materials,
undermine the agency=92s flexibility, and interfere with country offices=92
ability to respond quickly to local circumstances. It should be redrafted.=
=94
The policy change, which appears to have been initiated by a 2006 US
government complaint, is not slated for discussion during this week=92s
assembly but rather for the Executive Board meeting that follows next week.
Side events
Government delegates are being kept busy with a steady stream of
bilateral meetings, receptions and information sessions.
One such information session is planned by M=E9decins Sans Fronti=E8res on
Wednesday evening entitled, =93Putting IGWG into action: Harnessing
alternative mechanisms to boost R&D for tuberculosis.=94
Industry groups also are reportedly holding events, including a
pharmaceutical industry reception also on Wednesday evening.
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/
--__--__--
Message: 8
From: Judit Rius Sanjuan <judit.rius@keionline.org>
To: ip-health@lists.essential.org
Date: Tue, 20 May 2008 10:41:14 +0200
Subject: [Ip-health] WHA: IGWG report and draft resolution
Today, second day of the World Health Assembly, the secretariat has
distributed a report on the IGWG that contains the current language
for the global strategy and the plan of action and a draft WHA
resolution on public health, innovation and intellectual property.
A separate drafting group has been created to negotiate the remaining
bracketed text in the global strategy. The negotiation started at
10.30 am and will be chaired by Dr. Viraj from the Thailand delegation.
The report and draft resolution are available here:
http://www.who.int/gb/ebwha/pdf_files/A61/A61_9-en.pdf
I copied the text of the DRAFT WHA RESOLUTION (without footnotes) below:
Draft global strategy on public health, innovation and intellectual
property
The Sixty-first World Health Assembly,
Recalling the establishment pursuant to resolution WHA59.24 of an
intergovernmental working group to draw up a global strategy and plan
of action in order to provide a medium-term framework based on the
recommendations of the Commission on Intellectual Property, Innovation
and Public Health, and to secure, inter alia, an enhanced and
sustainable basis for needs-driven, essential health research and
development relevant to diseases that disproportionately affect
developing countries, proposing clear objectives and priorities for
research and development, and estimating funding needs in this area;
Recalling resolution WHA60.30 which provided support to and further
guidance on the work of the Intergovernmental Working Group;
Further recalling resolutions WHA49.14 and WHA52.19 on revised drug
strategy, WHA53.14 and WHA54.10 and WHA57.14 on HIV/AIDS, WHA56.27 on
intellectual property rights, innovation and public health, , WHA58.34
on the Ministerial Summit on Health Research, and WHA59.26 on
international trade and health;
Having considered the report of the Intergovernmental Working Group on
Public Health, Innovation and Intellectual Property;1
Welcoming the progress made by the Intergovernmental Working Group in
elaborating a global strategy and plan of action,
1. ADOPTS the Global strategy on public health, innovation and
intellectual property;2 (Note: Pending discussion at the Sixty-first
World Health Assembly, language referring to the plan of action may be
developed)
2. URGES Member States:
(1) to adopt and implement the specific actions recommended in the
Global strategy on public health, innovation and intellectual property;
(2) to support actively the wider implementation of the Global
strategy on public health, innovation and intellectual property, in
particular by providing adequate resources for its implementation;
3. CALLS UPON other relevant international organizations and bodies to
give priority within their respective mandates and programmes to
implementing the Global strategy on public health, innovation and
intellectual property;
4. REQUESTS the Director-General:
(1) to provide support for Member States, upon request, in
implementing the Global strategy on public health, innovation and
intellectual property and in monitoring and evaluating its
implementation;
(2) to support effective promotion and implementation of the Global
strategy on public health, innovation and intellectual property and,
when approved, the plan of action;
(3) to finalize urgently the outstanding components of the draft plan
of action, including progress indicators and estimated funding needs,
and to submit the final draft plan of action for consideration by the
Sixty-second World Health Assembly through the Executive Board.
(4) Notwithstanding the request in subparagraph (3) above, to prepare
a Quick Start Programme with adequate budget provision and begin
immediately to implement the elements of the Global strategy on public
health, innovation and intellectual property that fall under the
responsibility of WHO, starting with the following actions:
(i) map global research and development activities, establish
baselines and identify research gaps ( linked to global strategy 1.1,
7.1 (c), 7.2 (a ,b) and 8.1 (e));
(ii) improve cooperation, collaboration and information-sharing in
health research and development (linked to global strategy 1.3 (d),
2.1 (a), 2.3, 2.4 (b), 3.3 (b));
(iii) support research and development and promote standard setting
for traditional medicines in developing countries (linked to global
strategy 1.3, 3.4);
(iv) develop and strengthen regulatory capacity, including safety,
efficacy, quality and ethical review (linked to global strategy 3.2
(a), 6.2 ); and
(v) support information sharing and capacity building in the
application and management of intellectual property for health
innovation and public health, in collaboration with other relevant
international agencies (linked to global strategy 5.1);
(5) to establish urgently a results-oriented and time-limited expert
working group to examine current financing and coordination of
research and development, as well as proposals for new and innovative
sources of funding to stimulate research and development related to
Type II and Type III diseases and the specific research and
development needs of developing countries in relation to Type I
diseases, and to report on its work to the Sixty-third World Health
Assembly through the Executive Board;
(6) to reflect the Global strategy on public health, innovation and
intellectual property and, when approved, the plan of action in
forthcoming WHO Programme budgets;
(7) to monitor performance and progress in implementing the Global
strategy on public health, innovation and intellectual property and
plan of action, and to report progress to the Sixty-third World Health
Assembly through the Executive Board, and subsequently every two years
to the Health Assembly, through the Executive Board.
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
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