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

[Jean-Charles.Van-Eeckhaute@ec.europa.eu]

(Please post this message on the IP-Health mail list)

I would like to react to Jamie's recurring assertions that the EU has sough=
t to limit the scope of diseases during the para 6 negotiations.  These ass=
ertions 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 limi=
t the use of the para 6 decision to certain diseases, at the expense of oth=
ers.

Most of the documents referred to by Jamie relate to the EU's compromise pr=
oposal of January 2003.  This proposal was an attempt to overcome the deadl=
ock around the December 2002 proposal of TRIPs- Council chairman Perez-Mott=
a. In December 2002, most WTO Members, including the EU, had accepted the t=
ext 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 wh=
ich 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 sou=
ght.

So, contrary to what Jamie is trying to pretend, we have made a proposal th=
at does not affect the disease scope. The whole idea was to add one additio=
nal modality  to the draft decision, so as to make it acceptable for all, w=
hile safeguarding the scope of diseases covered. There may be a discussion =
on whether this modality was appropriate or not ( we were fully confident t=
hat the WHO would provide the appropriate advice), but there should be no d=
iscussion as to our objective to safeguard the disease scope of the Perez-M=
otta text.

This is explained in unambiguous terms by the then-Commissioner for Trade P=
ascal Lamy in his letter to Buko (document 3 in Jamie's posting)-.  The let=
ter (of which I recommend the full reading) say, among others : "I fully co=
ncur with you that the disease scope of the decision on
compulsory licensing for countries without manufacturing capacity
should be that of the Doha Declaration. Therefore, I fear that the
concerns you raise in your letter are based on a misunderstanding of
the EU's position. The EU is by no means trying to limit the diseases
covered by, the system. " The last sentence is sufficiently clear, it seems=
.

I don't know on what basis Jamie continues pretending that the EU has tried=
 to restrict the disease scope of the para 6 decision. The simple truth is =
that the EU has not.

Everybody has the right not to agree with what the EC has effectively propo=
sed in that debate; but no-one has the right to criticise us for positions =
we have never taken - especially on a mailing list which frequently condemn=
s misleading information...


Jean Charles Van Eeckhaute, Brussels




-----Original Message-----
From: James Packard Love [mailto:james.love@keionline.org]
Sent: Monday, February 05, 2007 1:49 PM
To: Ip-health
Subject: Pascal Lamy on earlier efforts to limit the scope of diseases for =
compulsory licenses

I was asked off-line to provide more evidence to support the
statement that the European Commission had at one point sought limits
on the scope of diseases covered by the solution to "Paragraph 6"  of
the Doha Declaration on TRIPS and Public Health.  Some of this debate
occured in private negotiations, particularly those involving a 2002
mini-ministerial in Sydney and in December of 2002, where the EC
presented proposals to limit the scope of diseases.  Part of this
debate occurred in newspaper articles, when some trade negotiations
made frequent references to drugs like Viagra, or suggested
treatments for cancer, heart disease or asthma should not be
excluded, or that only infectious diseases and/or major epidemics
should be covered.

The following documents concern on such "compromise" on the scope of
diseases backed by Pascal Lamy, then head of DG Trade for the EC.
This proposal started with a list of diseases, and a process by which
the WHO might expand the list.

"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."

Note the absence of heart disease, diabetes, asthma, cancer or other
"Type I" diseases with large commercial markets, and which
empirically present large health problems in developing countries.
There was enormous opposition to this approach from public health
groups and developing country negotiators.   In the end, all efforts
to limit the scope of diseases were defeated.   (Something not
mentioned in the FT reporting on this topic).

       Jamie

DOCUMENT 1

http://www.europaworld.org/week114/speechpascallamy31103.htm

31/1/2003
Speech by Pascal Lamy, European Commissioner for Trade: "The Doha
Round: Assessment and Prospects in the European Perspective" Getulio
Vargas Foundation, Center for Studies on International Economy. Rio
de Janeiro, 30 January 2003

"So we need rapid progress on issues such as the outstanding
negotiations on TRIPS and health, where we are trying to fulfil the
Doha mandate to find the right mechanism by which developing
countries with no pharmaceutical manufacturing capacity themselves
can use the TRIPS provisions on compulsory licensing of necessary
drugs, whilst safeguarding the importance of the research and
development base of the international pharmaceutical industry. And
unfortunately, we are blocked at the moment - every country except
the US was ready to accept a compromise at the end of last year on
the list of medicines which would be covered, and more importantly,
the mechanism for considering which new diseases would be covered."

"The EU, for its part, is absolutely determined to find a
multilateral solution which is workable, sustainable, and legally
secure. We cannot rely for very long on individual unilateral waivers
or on private donations. Recent announcements are of course welcome,
but we need absolute clarity that the deal covers the widest possible
list of major infectious diseases and is not a restrictive list.
Hence our own proposal which we floated three weeks ago to give the
World Health Organisation a role in assessing additional coverage. I
will continue to push forward this idea. And to address a Brazilian
concern, which we share in Europe, let me say that in case of doubt
asking for WHO advice is not in our view a breach of national
sovereignty. So, I look forward to hearing the views of the Brazilian
government on this vital issue, as much as visiting the Osvaldo Cruz
Foundation this afternoon. Brazilian experience in fighting against
communicable diseases is extremely valuable to the rest of the world."


DOCUMENT 2

PASCAL LAMY RUE DE LA LOI. 200
MEMBRE DE LA COMMISSION EUROPENNNE B-1049 BRUXELLES
Brussels, 7 January 2003
S/6

Dear Minister,

At the meeting of the TRIPs Council of 20 December 2002, the Chairman
of the TRIPs Council urged WTO Members to resume as soon as possible
the work pursuant to paragraph 6 of the Doha Declaration on TRIPs and
Public Health and to report to the TRIPs Council of 10 February 2003.

The EU continues to want a multilateral agreement on this matter as
soon as possible, and regrets that no consensus could be achieved on
the text submitted by the Chairman on 16 December 2002. For the EU,
this text remains acceptable. It strikes  a fair and delicate balance
between all the interests involved and provides for a solution that
is workable, sustainable and legally secure. For our part, we do not
believe that unilateral and non-binding measures -however well
intentioned =96offer such a solution.

In that spirit, I wanted to begin the year with a proposal for a
multilateral solution, which is outlined below.

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.

For these problems, we therefore need to find a mechanism to ensure
that the Doha Declaration can be used in good faith. I return to an
idea which we have already floated in Geneva during the course of the
discussions. Since there is a global organisation dedicated to health
questions, the World Health Organisation, we should encourage Members
to seek advice from the WHO and we should entrust the WHO with the
task of assessing the occurrence of other public health problems. To
this effect, I attach a possible wording on the involvement of the WHO.

/.

TELEPHONE: LIGNE DIRECTE 298 13 00 =96 FAX 298 13 99

This way forward could, in my view, produce an overall WTO decision
with comprehensive scope but differentiated modalities of
application. This seems to us to  be an approach fully in line with
the Doha Declaration and able to deliver what is most urgently
needed: a strong focus on major diseases afflicting the developing
world, but offering sufficient flexibility to tackle other public
health problems should they arise.

In the meantime, and as a purely stop-gap, temporary measure, we will
ourselves  refrain from challenging any Member which would want to
export medicines according to the terms and modalities set out in the
draft decision of 16 December  2002.

I am writing in similar terms to all WTO Trade Ministers, and to Dr.
Supachai.

Yours sincerely,

Pascal LAMY

Enc. 1 TELEPHONE: LIGNE DIRECTE 298 13 00 =96 FAX 298 13 99
Attachment
Draft proposa for a compromise solution, which should take the form
of a footnote to
the draft prtosal of 16 December 2002
1 (a) "pharmaceutical product" means any patented product, or product
manufactured through a patented process, of the pharmaceutical sector
needed to address the public health problems as recognised in
paragraph 1 of the Declaration (1). It is understood that active
ingredients necessary for its manufacture and diagnostic kits needed
for its use would be included;
(1) This covers at least 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. 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


DOCUMENT 3
BUKO PHARMA EXCHANGE WITH LAMY

http://www.bukopharma.de/frame.html?http://www.bukopharma.de/Service/
Archiv/EU_Lamy_2003.html


Letter from Pascal Lamy 27 February 2003

(received by BUKO 5 March 2003)

PASCAL LAMY
MEMBRE DE LA COMMISSION EUROPEENNE
RUE DE LA LOI, 200, B-1049 BRUXELLES
Brussels, 27 February 2003 IG/mc D (2003) 829

Dear Dr. Dabade,
Thank you for your letter of 13 February 2003 on the issue of TRIPS
and Public health.

I fully concur with you that the disease scope of the decision on
compulsory licensing for countries without manufacturing capacity
should be that of the Doha Declaration. Therefore, I fear that the
concerns you raise in your letter are based on a misunderstanding of
the EU's position. The EU is by no means trying to limit the diseases
covered by, the system. What the EU is trying to do is to propose a
solution that would allow for a quick resolution of this matter.

The EU has accepted the draft agreement of 16 December 2002 in its
entirety, including its scope, which is based entirely on the Doha
Declaration. I regret that no consensus could be found around this
text, and I cannot countenance the possibility that the TRIPS health
negotiations might end in failure. I remain convinced that a
multilateral solution must be found as soon as possible, and that the
16 December text remains the best basis for a deal. This is the
concern underlying my 7 January proposal.

I would like to make one thing quite clear from the outset: for the
EU the Doha mandate is deliberately broad in its scope and that
breadth must be respected. In short, the WTO mechanism for gaining
access to medicines can and must be activated whenever there is a
serious public health problem.

However, we must not lose sight of the political reality. The fact of
the matter is that there is one WTO Member that does not trust other
WTO members to use the system in good faith. This demands a neutral
arbiter, which is why I have proposed to involve the WHO, whose
experience in public health matters is undisputed.

This would give us an agreement offering the coverage called for in
the Doha Declaration. As for the practicalities of the agreement's
implementation, there would henceforth be a universally recognised
presumption that AIDS, malaria and a long list of other diseases are
normally covered by the agreement.

This list is not, however, exhaustive or restrictive. It is just a
list of diseases which even the US has in the past admitted should be
covered by the system, a list that could be applied without
objections from any quarter. But the system's use would not and
should not be confined to the diseases on that list. This is very
important, and there must be no misunderstanding on this score.

In the event of any other serious public health problem, the
implementing arrangements would be slightly different : wherever
there were doubts about a measure's legitimacy, WTO members could
turn to the WHO for an expert medical opinion. The possibility of
obtaining an opinion (not a binding ruling) from the WHO should help
dispel the US=92s misgivings about the system's use by the developing
countries. I must underline that this would be and advice, not an
arbitrage, in full conformity with WYO [should read WHO; comment by
BUKO] role to give advice to governments.

My 7 January proposal has led to further discussions in Geneva, which
was one of its objectives. Discussions are continuing, and the EU is
making all efforts it can to restore a climate of confidence among
parties.

Finally, I have to admit that I am a little bit perplexed by the
content of your letter. When I launched my proposal, I have made my
intention very clear, and these intentions have been further
clarified by myself and by my services at several occasions, be it in
the press, the European Parliament and, last but not least, in the
context of the Commission's meeting with civil society on 30 January
2003, which you attended yourself. I therefore regret that there have
been continuing attempts to mislead the public on the positions taken
by the EU and on the reservations underlying its action. I sincerely
hope that this letter contributes to dispelling any misunderstanding
that may still exist.

I am copying this letter to European Public Health Alliance, M=E9decins
sans Fronti=E8res and Oxfam International and I will publish it on the
website of the Commission's Directorate General for Trade.
Yours sincerely,
Pascal LAMY

DOCUMENT 4

http://ec.europa.eu/archives/commission_1999_2004/lamy/
speeches_articles/artla05_en.htm

Speeches and articles by Pascal Lamy
Access to Medicines: Time for a Multilateral Conclusion
Article in Herald Tribune (11-12 January)

"I am sure we can find agreement in the WTO on the twenty or so most
likely epidemics."

......

But for which diseases ? Clearly we could not exclude others which
could pose enormous problems in the future. And which countries ? The
problems multiplied, and all the while, the concerns of the global
pharmaceutical companies that this had the potential to weaken
research into new medicines became ever more strident. In the EU
view, and most other players, these concerns, if not unfounded in
some cases, were exaggerated. And if the poor countries are unable in
any case to buy the medicines, where are the lost profits for the
industry, where is the opportunity cost, where is the problem ?

Despite that, we came very close to agreement. At the end, on 20
December of last year, only the US delegation was unable to join the
consensus on which diseases would be covered. I am sure we can find
agreement in the WTO on the twenty or so most likely epidemics. But
more importantly, what to do with other serious public health
problems for developing countries ? Since then, there has been plenty
of talk of voluntary moratoriums to give a degree of legal comfort
for developing countries who took steps to licence drugs when faced
with such epidemics that they would not face WTO-endorsed
retaliation. But although we for our part certainly won't challenge
any developing country which is operating along the lines of the
compromise of December 2002, what is needed is a multilateral,
binding solution: one which provides the necessary legal certainty
for both industry and developing countries.

In my view, the elusive solution is staring us in the face. For other
serious public health problems, and in order to make absolutely sure
that the system would be used in good faith, why not allow countries
to ask for guidance from the World Health Organisation ? With their
experience in assessing public health problems in developing
countries, the WHO could be entrusted with assessing the situation
and giving its advice. Such a solution would secure, with absolute
clarity, that we have covered the widest possible range of major
diseases, but without a finite, and potentially restrictive list. In
other words, effective legal certainty for all, but with sufficient
flexibility to tackle other problems as they arise. And all within
the framework of the agreement thrashed out in Doha, to allow the
compulsory licensing mechanism to be used in good faith.

   ....

DOCUMENT 5

http://search.ft.com/nonFtArticle?id=3D030128000348

WORLD NEWS: WTO tries to break deadlock on medicines access

By Frances Williams, Financial Times
Published: Jan 28, 2003

World Trade Organisation members will meet today to try to break the
deadlock over access to medicines for poor countries for the first
time since the US vetoed a draft agreement late last year.

All acknowledge that failure to reach agreement by the new deadline
of February 10-11 would be a serious setback for crucial negotiations
in the Doha "development" round leading up to the next WTO
ministerial meeting in Cancun, Mexico in September. "The accord is
symbolically important, and failure would give a very bad signal,"
says a Latin American WTO envoy. "It's a test of whether the WTO can
deliver on developing country issues."

Wrangling over disease coverage has been the main obstacle to
reaching a deal, which would waive WTO intellectual property rules
preventing exports of generic copies of patented drugs to countries
unable to make the drugs themselves.

Following heavy lobbying by its powerful pharmaceuticals industry,
Washington said in December it could only accept the proposed accord
if it was restricted to Aids, tuberculosis, malaria and a score of
other infectious diseases typical of the poorest countries.

All other WTO members were prepared to go along with a reference to a
landmark ministerial declaration on patents and public health at
Doha, Qatar, in 2001 referring simply to "the gravity of the public
health problems afflicting many developing and least-developed
countries, especially those resulting from HIV/Aids, tuberculosis,
malaria and other epidemics".

A compromise proposed by the European Union earlier this month, which
would give an advisory role to the World Health Organisation on the
scope of diseases covered, has met with a sceptical response from
developing countries resistant to any attempt to list diseases
covered. And though Robert Zoellick, US trade representative, called
the proposal "constructive", it has aroused little enthusiasm in
Washington.

The patent-based industry claims the envisaged accord threatens the
very foundations of the international patent protection system. "It
would basically wipe out protection for all drugs," says one industry
adviser.

Industry lobbyists and US trade officials have raised the spectre of
a flood of generic copies of blockbusting "lifestyle" drugs such as
Viagra or baldness cures, as generic producers in countries such as
China, India and Brazil tout for business in emerging markets.

Pascal Lamy, EU trade commissioner, who last week described the
industry's arguments as "purely hypothetical" and "stupid", says his
proposal would provide reassurance that the accord would be used only
for serious public health needs. It lists for automatic coverage the
22 infectious diseases acceptable to the US and suggests consulting
the WHO if countries want to break patents on other drugs.

However, the WHO has made clear that it considers a wide range of
diseases to be serious public health problems in poor countries,
which account for 60 per cent of deaths worldwide from non-infectious
diseases.

Countries "should be careful about excluding certain areas when one
discusses what are major public health threats," Gro Harlem
Brundtland, WHO director-general, said earlier this month. The need
for lower prices for medicines was not restricted only to "major
problems like Aids, tuberculosis and malaria".

This could make the EU compromise unacceptable to US pharmaceutical
groups. Industry representatives claim that making it easier to break
patents on new cancer, diabetes or asthma drugs costing hundreds of
millions of dollars to develop will destroy incentives to discover
new medicines.

But these fears are almost certainly exaggerated, trade experts say.
In reality, the proposed accord will apply mostly to poor countries
with very limited drugs budgets, which cannot afford even adequate
supplies of cheap essential off-patent medicines for killer diseases.

"I'm not convinced that in the foreseeable future there will be
disputes about drugs that go beyond the list [of 22 diseases]," Carlo
Trojan, EU WTO ambassador, says.

Moreover, the proposed WTO accord is hedged with safeguards to
prevent abuse on top of the normal restrictions applying to
compulsory licensing. These include onerous notification requirements
and measures to stop diversion of cheap copies to rich-country markets.

Even developing countries with bigger budgets are unlikely to want to
use the mechanism except as a last resort, trade officials argue.
"People are not going to use it much and they are going to use it
responsibly," says Antonio Patriota, Brazil's negotiator. Instead,
say trade diplomats, the real value of the draft accord lies in the
extra bargaining power it gives poor countries to press for lower
prices for branded drugs.

"Many countries will say they have no intention of using this
mechanism - but that doesn't mean it's not valuable," says a senior
trade official. "African countries want to buy American and European
branded drugs at affordable prices. What this agreement does is
introduce some competition - and that will bring prices down."

----------------------------------------------
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"