[e-drug] WHO CIPR debate

["Wilbert Bannenberg" <wjb@wxs.nl>]

E-DRUG: WHO CIPR debate
-----------------------

The following contribution from James Boyle of Duke University has been
posted on the new discussion forum of the WHO Commission on Intellectual
Property Rights, Innovation and Public Health.

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-----Original Message-----
From: CIPIH
To: Commission on Intellectual Property Rights, Innovation and Public
Health
Sent: 9/29/04 10:45 PM
Subject: [cipih] Commission Task

Commission on Intellectual Property Rights, Innovation and Public Health
Open Discussion Forum
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This posting was submitted by: "James Boyle" <boyle@law.duke.edu>

First of all let me heartily endorse the Commissions activities,
particularly given the breadth of its task.  Both pre and post Doha,
much of the policy debate has been on the question of how to distribute
existing drugs, and under what terms, leaving largely untouched the
utterly crucial question of how to spur new innovation in treatments for
the most neglected diseases.  The policy choices have been stereotyped
into pro or anti patent, pro or anti drug company, despite the fact that
almost all participants have much more complex ideas than that. Indeed
this stereotyped opposition may actually have diverted attention from
the question of how to develop *new*  treatments for the diseases of the
global poor.  
 		
Second, let me restate a point that those who work in this field know
well, and which the Commissions Framework Paper implicitly acknowledges,
but which perhaps has implications that run further than we are used to
taking them.    

Even when the system of  intellectual property works just as it is
supposed to, it will not solve  certain pressing human problems. 

The single greatest weakness behind a  patent driven drug development
policy is this; such a system for drug  development will, *if working
correctly,* deliver drugs on which there is  a high social valuation -
measured in this case by ability and  willingness to pay. To put it
another way, to have a patent-driven drug  policy is to choose to
deliver drugs that deal with male-pattern baldness, but also with real
and important diseases: rheumatoid  arthritis, various cancers and heart
disease.  It is to choose NOT to  have a system that reliably or
regularly delivers drugs for tropical  diseases, or indeed for any
disease which is suffered overwhelmingly by  the global poor.     

One might frame the Commissions task baldly thus: If we choose to focus
our innovation policy in the  pharmaceutical area SOLELY on the
provision of patent incentives, we are CHOOSING to have children die of
malaria and leishmaniasis. 

This is not a  criticism of drug companies, or even of the current
system of patents - both  are working as they are designed to. It is a
criticism of the belief that  this system is the ONLY way to produce
innovation.  As a result, *whatever* ones views about the patent system
from the most optimistic defender to the most ardent critic  one should
be able to agree that there are some problems it will not solve as
presently constituted.  If this point is accepted, it suggests two lines
of inquiry  the Commission must therefore pursue, and a third more
general attitude to its task.      

1.)  I would strongly encourage the Commission to focus a great deal of
its time on the question of appropriate funding and incentive mechanisms
for the creation of new medicines and other products against diseases
that disproportionately affect developing   countries..." focusing
specifically on proposals that attempt  to supplement the intellectual
property system, and offer additions and alternatives to it.  Two
obvious examples are state or charitably  funded prizes or bounties on
the one hand, or direct governmental  research support through human
trials, followed by distribution at  marginal cost on the other. There
are many more. Professor Hollis describes a variant of such system in an
earlier message, and there are others   including Love and Hubbards plan
in PloS Biology, Shavell and van Yperseles, and so on.  I find some of
these plans intriguing and others to be beset by flaws, but the point is
that we need to look for alternatives.  The conventional reaction is to
pooh-pooh such plans as radical and without precedent, when in reality,
they are anything but.  True, such systems require careful institutional
design, both in terms of the innovation process and in terms of
distribution vehicles, but they are not merely theoretical
possibilities;  we have a lot of history to draw on.    For example, a
number of the tropical disease drugs we DO have were  developed in
projects supported by the armed forces of the first world to  deal with
illnesses suffered by their personnel during conflicts in the  region!
Reaching further back, I have to say that it is tragic that it has taken
120 years for us to return to the  exploration of mechanisms for
encouraging innovation that were widely discussed and even sometimes
practiced in the years before  the Paris and Berne conventions. Sadly,
that history - and the many  thoughtful criticisms of the limits of
intellectual property policy that it  was part of - seem to be lost to
contemporary debates on intellectual  property.     

2.)  I would also encourage the Commission to explore other ways of
managing the innovation  process even in the *absence* of major
institutional change.  There has  been very interesting recent work  for
example by Rai, Sali and Maurer,  on so-called "open source drug
discovery" -- a  procedure loosely based on so-called  "open source" or
free software  development, that seeks to identify promising drug
targets through a  decentralised and non proprietary combination of
computer simulation and  targeted wet lab work.  Such a procedure would
be unlikely to produce  the final drug, still less to test it in human
subjects, but it might  get close enough to lower dramatically the
expected costs of the final  stages of development.  The point is that
"reform" efforts cannot be limited to trying to distribute  low cost
versions of existing drugs developed within the existing patent  system.
We must also pay attention to the future pattern of pharmaceutical
innovation, a future that cannot be entirely left to the patent system,
for  all that system's strengths, nor left entirely to our current
procedures and  methods for developing drugs.  The answer to the child
with malaria or  leishmaniasis cannot be "our tools do not solve your
problems."  We need to  think innovatively about innovation.   This is
the heart of the Commissions role, surely.     

3.)  My final point is the a more abstract corollary of the first.  When
it  thinks about innovation and progress in the intellectual property
system, the Commission should avoid substituting some universal imagined
ideal of Progress for the actual specific version of "progress" towards
which our current distribution of entitlements and rights will push us.
Many policies that might seem justified by the promotion of large "P"
progress, seem more questionable if they instead push us towards the
specific vision of progress held latently within the pattern of demand
established by our current distribution of rights and wealth.  Amartya
Sen,  the Nobel prize winning economist, put it this way "there are
plenty of  Pareto optimal societies which would be perfectly horrible
places to live."   To put it in more familiar terms -- we must have
criteria of justice and  importance that are outside as well as inside
the economic analysis.   Right  now we have an intellectual property
system that measures desirable  innovation by the likely future
projected ability and willingness to pay for  that innovation.  It is a
remarkable system.  I count myself as one of its  defenders.  But it
cannot provide us with our only ideals of progress or  innovation, still
less our only tools to reach those goals, or we can  look forward to a
world with wonderful hair loss and impotence medicines,  together with
clot-busters and cholesterol reducers that truly save lives,  but in
which the diseases of the global poor remain largely untreated.

---
A posting from the Commission on Intellectually Property Rights,
Innovation and Public Health e-Forum 


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