[Ip-health] Patent Pool Controversies and the Real Battle Ahead

Jamie Love james.love at keionline.org
Tue Nov 22 02:14:58 PST 2011

Gregg, thank you for this message.

It might be useful to have some information on the status of various
non-patent pool strategies to overcome patent monopolies, including
challenges to patent validity, changes in national laws, compulsory
licensing and other voluntary licensing efforts.    My own impression is
that these activities at present are stronger in some countries than
others, and information also about the time and resources required for such
efforts, and the number of countries where such battles have to be fought,
should inform everyone as to the broader context.

I would also point out that a private listserve on patent pool policy
exists, one that has not been that active, but which could explore some of
the issues you have raised, if people wanted to.  Activists or experts who
work with NGOs who are interested can let us know if they want to
participate.   If there are other listserves where these issues are
discussed, we would like to participate, particularly if there is an
opportunity for discussion of technical and strategic issues, not all of
which are best suited for public lists.

The negotiations with Gilead and several other companies have been going on
since 2008, including the discussions over the geographic scope of the
license.   It would be good to share information on objectives and insights
about such negotiations.

On Tue, Nov 22, 2011 at 4:27 AM, Gregg Gonsalves
<gregg.gonsalves at gmail.com>wrote:

> Dear Colleagues:
> Over the past few months, a coalition of groups working on AIDS and
> other related issues, primarily based in the global South, have raised
> a set of questions about the licenses recently negotiated with Gilead
> Sciences, Inc. by the Medicines Patent Pool (MPP)
> The basis of these questions is not new and is rooted in larger
> concerns that groups from India, Thailand, Latin America, North Africa
> and elsewhere have raised with UNITAID, and then with the MPP, since
> 2009.  A history of this issue, based on primary documents is
> available here at:
> http://itpc.wikispaces.com/meeting_between_CS_reps_and_MPP_UNITAID
> and a newly released report of a 2 October 2011 meeting with the MPP is
> here at:
> http://www.itpcglobal.org/index.php?option=com_content&task=view&id=136&Itemid=
> Since this initial critique there have been charges that this
> coalition of groups wants to shut down the MPP, that the real business
> of civil society is to get other companies to join the pool process,
> or that the criticisms of the Gilead-MPP license have been made and
> it's time to move on and stop any further debate.
> Whether or not one agrees with the critique of the Gilead-MPP
> license--and more and more groups are finding fault with the agreement
> or at least parts of it--we probably all could agree that these
> licenses raise critical questions about how we all pursue access to
> AIDS medicines and other drugs.
> These questions have an impact on many, many people, both in terms of
> access to medicines themselves for patients, and in terms of the work
> of advocating for the drugs by activists.
> The issues raised by the coalition of groups earlier this year--no
> matter on which side of the issues one ultimately comes down on--are
> not trivial.
> Even with a civil society delegation and a then-ad-hoc expert advisory
> group, a fairly restricted group within the MPP made decisions on
> strategies and on what were the non-negotiables in the discussions
> about the license with Gilead.
> The tone of the interactions with the MPP from this coalition--which
> yes, have perhaps been strident--reflect the frustrations of a large
> group of activists from the global South and others left out of these
> crucial discussions about the Gilead-MPP license and the future of
> access to medicines.
> Furthermore, even some of the groups more recently expressing support
> for the MPP are just having the chance to engage with the process;
> they are new to the table as well.
> No one is suggesting that license agreements can be done by consensus
> or out in the open in a general assembly.
> However, critical issues at stake could have been raised for the
> widest possible discussion before entering into an agreement with
> Gilead.  In fact, broader discussions about the role of voluntary
> licenses in access to medicines and their impact could have been
> raised in advance as well.
> Instead, the license agreement with Gilead is now mired in
> controversy--with some people saying it is a terrific advance for
> people with HIV and others casting it as a step-backwards and some
> sitting right in the middle on its strengths and weaknesses.
> It didn't have to be this way.
> I keep comparing this current situation to one some of us dealt with
> many years ago, when activists first came on the scene in the world of
> biomedical research.  We issued reports criticizing institutions like
> the US National Institutes of Health, even dying-in and demonstrating
> on their door-steps.
> While I am sure some of these officials cried out that we were trying
> to destroy the NIH and the world of clinical research, the head of the
> NIH's AIDS institute--Dr. Anthony Fauci--realized that dissent was
> actually a powerful tool to improve AIDS research, that our critiques
> though imperfect were part of the iterative process of learning from
> others, which makes great scientists, better science.  He brought his
> critics to the table.
> The MPP may be hunkering down, trying to whether the storm, its staff
> traveling around trying to recruit allies to take on their critics,
> but the leadership of the MPP could learn from Dr. Fauci and the NIH:
> the activists may be unpleasant, but criticism is a critical way of
> learning and doing better the next time around. I believe the MPP will
> eventually come around and open its doors even to those who are
> criticizing it today.
> As for the activists: the way forward is not to minimize the
> criticisms of the license or the MPP by your colleagues, but to engage
> with these critiques together, grapple with the implications as a
> community of activists, interrogate the details.  Again, to use the
> clinical research analogy: if a clinical trial protocol is flawed and
> needs improvement, we don't say, "hush, now, don't criticize the
> study, it will bring down the NIH"--we roll up our sleeves and push to
> make it better and those interactions (particularly in the old days)
> are sometimes tough and sometimes confrontational.  And guess
> what--activists have come down on different sides of research
> protocols down the years; disagreement among ourselves aren't the end
> of the world.
> Over 200 leading activists and legal experts from around the world,
> from groups like Lawyers Collective, the Asia Pacific Network of
> People Living with HIV/AIDS, the Brazilian Working Group on
> Intellectual Property, Third World Network, ITPC, I-MAK, the AIDS
> Access Foundation of Thailand, Latin American Council of AIDS Service
> Organizations, the Egyptian Initiative for Personal Rights, the
> Treatment Action Movement in Nigeria have put a set of issues and
> concerns on the table.
> At the very least, criticisms of these groups should be based on a
> thorough reading of the license agreement and the various
> documentation and analyses that these groups have generated.  I am not
> sure that this has actually been done by all of those who have rallied
> to the defense of the MPP, though a few have done so.
> For instance, on the day the Gilead-MPP license was announced, the
> company cut 4 separate side-deals with generic producers, undercutting
> the MPP.   The total number of countries newly covered by the
> Gilead-MPP license is sixteen, eight of which don't have reliable
> epidemiological data. Thus, the best estimate of the number of PLWHIVs
> covered in these 16 countries is around 15,000.  But the press
> releases around the announcement of the Gilead-MPP license made
> inflated claims, which gave Gilead a lot of good PR, while the fact is
> that the Gilead-MPP license's coverage is dwarfed by the number of
> patients covered by the other existing agreements. Who is getting
> played here?  Gilead was able to concede very little in its agreement
> with the MPP and get a whole lot of praise.
> If you disagree with this assessment or others made in the materials
> this coalition has provided--walk with us point-by-point through the
> issues, together.  In doing this, we'll have discussed some of the
> issues at the heart of access to medicines as a community, learned
> from each other, no matter where we end up in the final analysis.
> It's not OK not to do your homework and simply say "we need the MPP to
> work."
> Furthermore, this isn't about supporting the MPP or not supporting the
> MPP--none of our allegiances should be to institutions and framing
> this discussion in this way is as unproductive as positing that one is
> for or against the NIH or the UK or South African Medical Research
> Council, or the ANRS in France.
> Voluntary licenses have to be the best they can be and institutions
> like the MPP, have to be responsive to those affected by their
> decisions--it's our job to scrutinize the MPP and its work, not
> express our unconditional allegiance to it as a vehicle nor make
> blanket statements that it is important to get other companies into
> the patent pool as a matter of priority without any knowledge of or
> template for what future licenses might look like.
> Sadly, what have been attempts to raise honest criticisms have been
> labeled as personal attacks or obstructionism, thus taking emphasis
> off the real issues at hand and transferring the debate to 'whose side
> are you on?' or making it seem as if the entire debate is really a
> spat between colleagues. Dismissing their claims so casually
> trivializes the work of many activists around the world who have spent
> their lives fighting for access to medicines.
> We are wasting time--the MPP-Gilead license SHOULD be open to wide
> scrutiny as should the work of the MPP in general. It doesn't have to
> be done in back-room meetings and there is no need to tip-toe around
> the issues. The MPP now joins the NIH, WHO, UNAIDS, EMEA, ANRS, MRC,
> MCC--the alphabet soup of institutions we've worked with and
> criticized now for decades.  Since when did any institution get a free
> pass from us?
> What this discussion needs to be about now is the larger context: the
> field of access to medicines passed its high water mark several years
> ago, we are on the defensive with the multinational drug companies and
> the countries that support policies that favor them over the right to
> health for all.  Many of the organizations weighing in on this debate
> largely ignore IP and trade issues on a day-to-day basis--the
> engagement here is with a controversy not with a common, proactive
> agenda.
> In addition, IP and trade are but one part of our work: we've dropped
> the ball on a lot of the things we used to do very well.
> With the economic crisis and the rise of austerity policies in the USA
> and in Europe, donations and support for the Global Fund and other
> critical funding vehicles for ART access are in jeopardy.  Countries
> in Africa, Asia, Latin America, the Caribbean and Eastern Europe
> themselves are reeling from the crisis and aren't going to fix the
> stock-outs and the waiting lists for ARVs.
> The real crisis today isn't about criticism of the MPP and the
> solution isn't simply about collecting multi-national pharmaceutical
> companies to put their IP into the pool in Geneva.
> There is so much more, so much other work to do.
> Geneva isn't the center of the universe, what happens there isn't the
> heart of our work.
> Let's talk about what we need to do to sustain scale-up of access to
> ARVs and drugs and treatments for other diseases, go step-by-step
> through the tasks we need to take up, the strategies we need to use at
> national, regional and international levels with institutions, with
> governments, with drug companies, with our local clinics.  That
> discussion will have to include the role of voluntary licenses and the
> MPP, but at least it will be done in the context of a broader agenda
> for access to medicines, a part of the larger work we need to do.
> We'll need to re-build trust at first--there have been a lot of
> unfortunate things said over the past few months--but many of us have
> worked together for a long time and we can get over it and we will.
> Political leaders who consistently fail to step up on AIDS, TB or
> health, drug companies who still gouge patients with inflated prices
> for medicines, institutions that don't do their jobs and where
> incompetence, laziness and corruption are rife must be laughing their
> asses off, if they are even paying attention.
> Here we are fighting among ourselves, because we can't get it together
> to have an open, substantive conversation about the issues at stake.
> We're so obsessed with our little projects and fiefdoms that we no
> longer even see the need to revive the grand coalition that brought us
> the successes we have today, with 6.6 million people on AIDS
> treatment, but with half of those who need it, dying without.  We
> surround ourselves with our friends and fellow-travelers and have lost
> the patience and ability to work together with others even if we don't
> share the same opinions on each and every issue.  We're often in a
> state of perpetual annoyance with those we have to learn to work with
> again.
> These are tough times for millions of people, where banks get bailed
> out but poor people get hung out to dry.
> Our survival depends on moving past this--not by squelching dissent
> and thus dividing the movement--but by struggling together to try to
> bridge the divide, to bring us all back together, to fight for what
> really matters.
> I hope for all our sakes, we're up to the task.
> Gregg
> --
> Gregg Gonsalves
> 100 York Street
> University Towers, 10-D
> New Haven, CT 06511
> Email: gregg.gonsalves at gmail.com or gregg.gonsalves at yale.edu
> Mobile: +1-203-606-9149
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James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
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