MSF/HAI/Oxfam
February 10, 2003
The solution to the problem raised by paragraph 6 of the Doha declaration
on
TRIPS and Public Health must:
>From Doha 2001 to Geneva 2002: background:
In November 2001, following intense negotiations, the 142 members of the
WTO
signed the Doha declaration on TRIPS and public health - a text that gives
countries clear rights to prioritise public health over intellectual
property.
This represented a huge step forward for access to medicines in developing
countries.
Mr. Lamy welcomed the agreement: "I am glad we have clarified that WTO
Members
have the right to grant compulsory licenses to produce medicines and the
freedom
to determine the grounds, such as public health interests, upon which such
licenses are granted."
The Doha declaration left one key issue unsolved: countries were able to
decide
what public health problem warranted issuing a compulsory license, but to
whom
would a country with insufficient manufacturing capacity deliver the
license to?
Where could such a country import the product from?
The TRIPS agreement allows a country to produce a generic version of a
patented
product under compulsory license, but this production has to be
"predominantly
for the domestic market". This quantity may not be sufficient to ensure
production of a product and/or there may not be a market at all in the
potential
producing country that would justify the local industry engaging in such a
process. It is simply economically inefficient to have domestic productions
for
every medicine a country may need. The problem of these restricted
possibilities
of importing - exporting needed medical products was recognized in Doha in
the
paragraph 6 of the declaration.
Proposed solutions to the paragraph 6 issue were reviewed in increasingly
intense negotiations throughout 2002. TRIPS Council's Chairman Motta's 16th
December text was the last proposal to be discussed. It was viewed by most
delegations as a compromise that was far from ideal, because it failed the
test
of being simple, workable and economically viable. In any event, on the eve
of
Christmas, negotiations failed: although other Members seemed ready to
compromise on Motta's proposal, the USA effectively blocked the agreement,
insisting that the scope of diseases covered by the text was too broad.
The Motta text and Commissioner Lamy's proposal:
Médecins Sans Frontières (MSF), HAI and Oxfam and the World Health
Organization
(WHO) have come to the same conclusions in terms of what solution is needed
to
address public health concerns.
In its intervention at the TRIPS Council on September 17, 2002, the
WHO
stated
that the features of a solution which are desirable from a public health
perspective must be:
Among the solutions being proposed, the limited exception under Article 30
is
the most consistent with this public health principle."
Chairman Motta's text of the 16th December already did not meet these
requirements, and the proposal by EU Commissioner Lamy could in fact make
matters worse. What are some of the problems with Motta's text and Lamy's
proposal?
Disease Scope
The scope of diseases was already extensively discussed in Doha. The
consensus
was that there would be no limitations on diseases, and the 142 countries
agreed
to use the non-restrictive term "public health problem". Paragraph 4 of the
Declaration gives the important general principle: "the Agreement can and
should
be interpreted and implemented in a manner supportive of WTO Members' right
to
protect public health and, in particular, to promote access to medicines
for
all." Countries have a right to decide for themselves what constitutes a
public
health problem and how to address it. Paragraph 6 makes no reference to
limitation on diseases.
Developed countries are trying to slip back in the language that was kept
out in
Doha by introducing different rules for different diseases. The US has been
most
obvious in this respect, demanding that the whole solution be limited to
applying to "AIDS, TB, Malaria or other infectious epidemics of comparable
scale
and gravity".
Commissioner Lamy's proposal reads:
Lamy's proposal suggests that for any public health problem not included on
the
list, countries could consult with the WHO. In effect, this means that
while WTO
Members with manufacturing capacity have the right to use compulsory
licensing
to combat any public health problem they choose, WTO Members without this
capacity could end up under pressure to let WHO make their public health
decisions for them. What individual countries regard as a public health
problem
should be a sovereign decision for them alone, and the WHO itself has said
this
very clearly. This proposal therefore fails to honour the Doha commitment.
Both MSF and WHO reject the very idea of a list. A list of diseases, even
if it
is only supposed to be by way of example, will always be used with a
presumption
against diseases not included. If any list were to be considered though, a
"negative" list of diseases which are not covered by the agreement would be
best. Let the US and the EU justify why they can have access to effective
compulsory licensing provisions to address asthma and diabetes, for
example, but
developing countries cannot.
Economic viability
An annex in the Motta text includes definitions relating to manufacturing
capacity and whether or not a country can use the proposed solution. As it
stands, the draft text could be taken to mean that any domestic
manufacturing
capacity that could make the drug, however inefficiently, could be regarded
as
sufficient for a country's needs. The tremendous success of producing
generic
ARVs for US$300 per patient per year only came about because a market of
the
size and comparative wealth of Brazil was able to do the purchasing.
Without the
pull of a viable market for generic versions of pharmaceutical products, no
manufacturer can rationally be expected to take part in the production for
export system, and WTO Members hoping to use the solution will be unable to
find
a product source for import. The system will have failed them.
Procedure
Under the current Motta text, the compulsory license system is far more
complicated than the "ordinary" TRIPS rules. The TRIPS Agreement lays out
the
process to be followed when a country decides to issue a compulsory
license.
Under certain circumstances it also states that a product manufactured
under
compulsory license may be exported. Nowhere does it mention an obligation
to
notify the WTO about type of product, quantities, and duration of the
license.
Complicated, expensive, burdensome procedures of the sort that Motta calls
for
could make the solution to paragraph 6 impractical and inefficient, and
will
fail the requirement to put all WTO Members on an equal footing.
Prejudice to other solutions
The Motta text does not make clear that other alternative solutions, such
as
exceptions under Article 30 mentioned above (e.g. the amendment 196 of the
review of the pharmaceutical legislation), could be used if the Motta text
is
adopted. This should be explicitly stated in the agreement.
The World Health Organization
In Lamy's proposal, the EU recognises WHO's role and expertise on the issue
of
access to essential medical products. We welcome this recognition, and
regret
that WHO's earlier intervention on this issue was considered inappropriate
by
the EU. WHO should be more firmly involved in WTO discussions and decisions
which affect public health. This May, the World Health Assembly will
discuss
access, TRIPS and innovation. This will be an excellent opportunity to
discuss
how the TRIPS agreement affects the availability of affordable generic
medicines, and measures countries can take to protect public health from
the
effects of stronger patent protection.
For any additional information, please contact:
"simple and speedy legal procedures in the exporting and importing
countries;
equality of opportunities for countries in need of medicines,
even for
products
not patented in the importing country; facilitation of a multiplicity of
potential suppliers of the required medicines, both from developed and
developing countries; and broad coverage in terms of health problems and
the
range of medicines.
Thus, the basic public health principle is clear: the people of a country
which
does not have the capacity for domestic production of a needed product
should be
no less protected by compulsory licensing provisions (or indeed other TRIPS
safeguards), nor should they face any greater procedural hurdles, compared
to
people who happen to live in countries capable of producing the product.
"This [agreement] 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
Organization shall give its advice as to the occurrence in an importing
Member,
or the likelihood thereof, of any other public health problem."
Lamy's suggested list includes only infectious diseases (i.e. it excludes
non-infectious diseases) and, apart from HIV/AIDS, the diseases chosen are
those
for which there is either no treatment, or for which the treatment is so
old
that patent protection no longer applies. In other words, this long list of
diseases can easily be added to the US proposal without inconveniencing
patent-holders.
Seco GERARD, Médecins Sans Frontières
Access Campaign EU Liaison Officer
MSF International Office
Rue de la Tourelle 39, 1040 Brussels
Tel. +32 2 234 62 52
email : seco.gerard@msf.org
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