[Ip-health] Brazilian MoH questions the constitutionnality of two articles that created the "pipeline" mechanism for patents application prior to the TRIPS agreement

[MSF Michel Lotrowska]

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O ESTADO DE S. PAULO - SP

Editoria:

VIDA

Data:

22/04/2008








Health Questions items from the patent Law

MoH wants to cancel articles from the legislation that created the
=93pipeline=94, and  facilitate  the manufacturing of generics against Canc=
er
and AIDS.

Fabiane Leite

The Minister of Health considers that two articles of the Brazilian Patent
Law hurt the access to medicines that are important for public health, such
as medicines against cancer and AIDS, and defends that both are removed fro=
m
the legislation to facilitate the manufacturing of cheaper generic versions=
.
For the MoH, it is possible to question the constitutionality of article 23=
0
and 231 of the law, that created in 1996 a mechanism called =93pipeline=94,=
 or
revalidation, in which patents granted in other countries were recognized i=
n
Brazil. The production and marketing of certain medicines in Brazil became
therefore the monopoly of certain companies without having a deep analysis
by the government to check if theses medicines were real innovations and
deserved a patent, say entities that defend the scaling up of access to
medicines. Until now, around 700 patents of medicines and other products,
such as food, were granted on the basis of these two articles =96 and even
items that were not yet patents outside Brazil were protected in Brazil.

=93From the point of view of the MoH, the Pipeline brings prejudice to the
development of the country and has a series of impacts on the Brazilian
public heat, we are sure of that=94, affirms Dirceu  Barbano, director of t=
he
Department of Pharmaceutical Assistance and Strategic health tools of the
MoH. The statement, nevertheless, only has a political value for the moment=
,
as the removal of these articles will depend on the direct
unconstitutionality action (Adin). This means that the articles will only b=
e
removed if the Federal Supreme Court (STF) agrees =96 and possibly after a
judicial fight.

 The MoH had already indicated its position on this in a recent public
audience on patents of medicines and also brought the issue to a group that
discusses, within the government, questions of industrial property, that is
composed of the MoH, the Ministry of Science and Technology, the National
Institute of Industrial Property, and the Civil House, says Barbano, that,
nevertheless, didn=92t give any deadline for the discussion.  In case the M=
oH
position is agreed upon by others, the Government will send a request to th=
e
Adin and to the General Advocacy of the Union, that can still decide if it
enter or not with an action.

Barbano calculates that, taking into account one medicine, Gleevec, against
cancer, the government could reduce in 90% the cost of the pill if the
patent didn=92t exist. Today, the MoH pays 40 reais (1 US$ =3D 1,6 reais) p=
er
pill, buying from only one producer, while laboratories make generics in
Asia for a bit more than 4 reais. Important drugs of the anti-Aids cocktail=
,
such as Abacavir, also were protected by the Mechanism. =93from a point of
view of the law, we understand that there might be a fragility in regard to
the Constitution. and that the mechanism can be considered as an
exaggeration in the Brazilian patent law, because it doesn=92t bring any
benefit for the Country=94, he says.

R&D based Pharmaceutical Industry, that gathers the labs that invest in API=
,
says that the revalidation mechanism fo parent we introduced after a long
discussion. =93we know there are disagreements, natural in a democratic
process, but we speak about a law that was approved after a long
discussions. If they think that the National Congress doesn=B4t have the
authority and if there is a legal basis for questioning, it is another
story, affirms Gabriel Tannus, president of Interfarma.

The position of the MoH goes in line with the National Federation fo
Pharmacists which, in February of this year, sent a representation file to
the General Attorney of the Republic defending the fact that revalidation o=
f
patents are hurting constitutional principles of social interest in the
search for technological development, that must be taken into consideration
in the issues of industrial property.

The Federation, that acted in partnership with the Brazilian Network for
People=B4s Integration (REBRIP) mentioned that the pipeline is against the
principle of equality of all in relation to the law, because the law
privileged only some products. The MoH, nevertheless, didn=B4t want to
subscribe this representation =96 which was done by the entities- because i=
t
believes the issue must be first discussed within the government and then
take a decision to forward this to the General Advocacy of the Union.

IMPACT OF THE PIPELINE

1.182 patent applications for different products, amongst them medicines,
were filed between 1996 and 1997, deadline given by the national law to
producers that wanted to benefit from the mechanism.

700 applications aproximatly were granted

US$ 420 millions in losses is the estimates on the negative impact of the
pipeline on public health finances between 2001 and 2007, when an evaluatio=
n
is made on governmental purchases of medicines against AIDS, according to
the National Federation of Pharmacists.





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