[Ip-health] RE: Pascal Lamy on earlier efforts to limit the scope of diseases for compulsory licenses

[James Packard Love]

I will respond to Jean-Charles' note, which says "These assertions
are misleading.  . . we have never sought to limit the use of the
para 6 decision to certain diseases, at the expense of others." and
"contrary to what Jamie is trying to pretend, we have made a proposal
that does not affect the disease scope."    First, quoting from his
note:

On Feb 5, 2007, at 8:48 AM, <Jean-Charles.Van-Eeckhaute@ec.europa.eu>
<Jean-Charles.Van-Eeckhaute@ec.europa.eu> wrote:

> (Please post this message on the IP-Health mail list)
>
> I would like to react to Jamie's recurring assertions that the EU
> has sought to limit the scope of diseases during the para 6
> negotiations.  These assertions are misleading.  None of the
> documents referred to by Jamie support his position.
>
> I was in the EU negotiating team at that time; we have never sought
> to limit the use of the para 6 decision to certain diseases, at the
> expense of others.
>
> Most of the documents referred to by Jamie relate to the EU's
> compromise proposal of January 2003.  This proposal was an attempt
> to overcome the deadlock around the December 2002 proposal of
> TRIPs- Council chairman Perez-Motta. In December 2002, most WTO
> Members, including the EU, had accepted the text proposed by Mr.
> Perez-Motta, Chair of the TRIPs Council.  The US could not agree
> with this text, notably because it thought that the disease scope
> was not well defined.
>
> In order to find a way out, the EU proposed, in January 2003, a
> compromise position, consisting of two main elements :
>
> 1) for a number of diseases, enumerated in a list that had been
> circulated by a WTO Member in December 2002 (and that Member was
> not the EU) and of which we knew that the US could agree with, the
> "Perez-Motta Decision" would apply as it is
>
> 2) for any other diseases, the Perez-Motta decision would also
> apply, be it with one additional modality, i.e. that the advice of
> the WHO would be sought.
>
> So, contrary to what Jamie is trying to pretend, we have made a
> proposal that does not affect the disease scope. The whole idea was
> to add one additional modality  to the draft decision, so as to
> make it acceptable for all, while safeguarding the scope of
> diseases covered. There may be a discussion on whether this
> modality was appropriate or not ( we were fully confident that the
> WHO would provide the appropriate advice), but there should be no
> discussion as to our objective to safeguard the disease scope of
> the Perez-Motta text.

    [snip]

I am grateful that as a key member of the EC negotiating team, Jean-
Charles has taken the time to post a note to ip-health, particularly
given the recent FT editorial about the "consensus" that compulsory
licensing would not extend to heart disease drugs.   I think everyone
involved in the negotiations agrees that the final outcome  -- the 30
August 2003 decision and the subsequent proposal for a TRIPS
amendment -- did *not* limit the scope of diseases for compulsory
licensing of medicines for export.    The US, Japan, Switzerland, the
EC and indeed every WTO member of course formally agreed by consensus
to the final text, which did not provide a limitation on the scope of
diseases.   I think it is also true that in early 2002, the EC
position on the scope of diseases and technologies was to refer to
the texts of paragraphs 1 and 6 of the Doha Declaration, which also
did not limit the scope of diseases.  That said, what was the
significance of the several proposals from the fall of 2002 to the
spring of 2003 to limit the scope of diseases, and what role did the
EU play?

As some have noted elsewhere, the private negotiations in Sydney and
Geneva on this topic cannot be verified, but I don't think there is
any dispute that the Sydney 2002 meeting involved a major effort to
limit the scope of diseases, in some way, and that negotiations on
the scope of diseases went on for months afterwards.   It is also
true that at some point, the EC took to making a formal proposal to
endorse a list of 22 diseases, as well as a process under which that
list could be expanded, involving the WHO.    The list in the Lamy
proposal to delegates, which was widely publicized at the time,
included these diseases:

----
"HIV/AIDS, malaria, tuberculosis, yellow fever, plague,
cholera,meningococcal disease, African trypanosomiasis, dengue,
influenza, leishmaniasis, hepatitis, leptospirosis, pertussis,
poliomyelitis, schistosomiasis, typhoid fever, typhus, measles,
shigellosis, haemorrhagic fevers, and arboviruses."
----

This list did not include any non-communicable diseases.   Lamy
described the list as follows:

"You will find attached a list of infectious epidemics which are
generally recognised by health experts as those which have the most
damaging impact on developing countries. We assume that all WTO
Members agree that these diseases are without doubt effectively
covered by the solution proposed by the Chairman, but we understand
that certain Members still have concerns as regards other potential
public health problems."

At the time, not a single health expert would actually vouch for this
list, or for that matter, the idea of even having a list.   The
January 2003 Lamy proposal did, however, offer a process under which
the list could be expanded:

---
"When requested by a Member, the World Health Organisation shall give
its advice as to the occurrence in an importing Member, or the
likelihood thereof, of any other public health problem."
----

Jean-Charles sees this as proof the EC did not endorse a limit of the
scope of diseases, because in principle, the WHO could add anything
to the list.

So, what was the effect of having the list of 22 diseases in the
first place?   And why were there only infectious diseases included?
And how were these chosen?

If you follow the current debate over the Thail CL on Plavix, and the
Canadian Paragraph 6 legislation, you can see how a list might be used.

I was not "trying to pretend" that the EC proposal(s) would limit the
scope of diseases.  I was stating that they would, in practical
terms, unless the WHO would simply declare that all diseases belonged
on the list, which seemed like an odd and unlikely outcome.  Just
about everyone else thought the EC proposal would politically have
the effect of limiting the use of compulsory licenses, by creating
yet another hurdle (and lobbying battle) to overcome.   Some of the
criticism was quite pointed.  Terms like racism were thrown around
during the discussions.  There was even a Doha Curse (http://
www.youtube.com/watch?v=3DLmmfX4_-BOY).

More politely, there was considerable commentary on the lack of
evidence to support the notion that health problems in developing
countries did not include non-communicable diseases.

One such commentary was the May 2003 analysis by MSF: (http://
www.accessmed-msf.org/documents/renegingondoha.pdf).

  Reneging on Doha - An MSF analysis of recent attempts to restrict
developing countries=92 use of compulsory licensing to a set list of
diseases. May 2003. [This report was prepared by Dr Mary `, M=E9decins
Sans Fronti=E8res. Thanks to Associate Professor Richard Laing (Boston
University School of Public Health) and Professor Alimuddin Zumla
(Centre for Infectious Diseases and International Health, University
College London) for reviewing this article. Thanks also to MSF
colleagues Daniel Berman, Pascale Boulet, Ingrid Cox, Dr Tom Ellman,
Christopher Garrison, Seco Gerard, Dr Bernard P=E9coul and Ellen 't
Hoen for their input.]

 From the MSF report:

------------------
"The following analysis shows that proposals to restrict the scope of
the =93paragraph 6 solution=94 of the Doha Declaration to a set list of
diseases are deeply flawed. The disease lists which have so far been
put forward do not correlate with the major causes of morbidity and
mortality in Africa: many public health threats have been omitted
from the list. In particular, virtually all major African diseases
for which there are patented medicines have been excluded from the
list. Almost all the list=92s =93approved=94 diseases are those for which
there is no drug treatment, or where existing treatments are already
off patent.  In other words, diseases for which there is neither
=93risk=94 nor opportunity to issue a compulsory license.

"This approach looks like an attempt to protect Western drug company
interests, rather than a genuine effort to improve access to the
medicines needed to save millions of lives in developing countries.

Table 1 below shows what diseases Africans die of, and whether these
are included in the =93approved disease=94 list. This table shows that:

* Apart from HIV/AIDS, the list bears little relationship to common
causes of mortality in Africa;

* Two of the four top causes of mortality for children under five in
Africa are either omitted (pneumonias) or restricted (several common
causes of diarrhoeal disease are excluded).

* The list excludes all non-infectious diseases, even though WHO
statistics show that nearly  half of the top 20 killer diseases in
Africa are the same diseases or conditions that kill people in the
West. All of these diseases (highlighted in grey in table 2) have a
range of patented drugs available for their management in the West,
and all have been omitted from the approved disease list. Let=92s take
just one example: pneumonias are the second major cause of death in
Africa, killing over one million people a year: the first
pneumococcal vaccine for use in children was registered in the US in
2000. Yet pneumonias are not included in the approved disease list.
This means developing countries would be unable to issue a compulsory
license to access affordable sources of a patented pneumococcus
vaccine, for instance.

"...... the list is clearly not based on any public health rationale.

"In other terms, this =93compulsory licensing=94 list includes mostly
commercially irrelevant diseases, and excludes many commercially
important diseases for which treatments could require a compulsory
license. Any agreement based on such a list would clearly create
false assurances, as it consists primarily of diseases for which
patent barriers are not an issue.
-----------------------------

Perhaps the EC negotiators are fair to to say they were proposing the
list combined with the WHO mechanism in order to salvage a difficult
negotiation, and that all of the blame for the limitations on the
scope of diseases should be attributed to the US, or perhaps Japan or
Switzerland, countries that were more explicit in their views.

Finally, I am delighted that Jean-Charles has reminded the readers of
this list that that EC does not support a limitation on the scope of
diseases.  In that regard, it would be helpful if the EC would write
to the FT or communicate that to other journalists who are suggesting
that efforts to use compulsory licenses for heart disease drugs are
an abuse of the WTO's compulsory licensing rules.   I would also urge
countries like Canada to abandon the use of lists for diseases or drugs.

  Jamie

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"