ACTION: ORGANIZATIONAL SIGN-ON: Brazil compulsory license petition

[Guest guest]

On Behalf Of Asia

Please sign this statement below regarding Brazil and access to Kaletra as

soon as possible, Brazilian organizations are asking for international

support. Send your endorsements to: claudio@...

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Dear all

To sign it, please e-mail to claudio@...

Best,

Alessandra Nilo

GESTOS

From: GTPI/REBRIP

Dear Colleagues,

Contrary to what was widely published last Friday 24th of June 2005, the

Brazilian government has not issued a compulsory license (break the patent)

of Lopinavir/Ritonavir. This information is not really accurate. As we

understand, the Act nº 985, signed by the Minister of Health Mr. Humberto

Costa, only declared of public interest the medicines related to the

association of two active principles listed above. Although this is a very

important step that gives a legal framework to a future compulsory license,

it is not yet a compulsory license, and it can very well happen that the

government comes up with an agreement with Abbott, using this Act only as a

formally pressure on the company to providing a discount.

Therefore, through the attached petition, the Brazilian Network

of Peoples' Integration (REBRIP), and more specifically its Intellectual

Property Working Group urges the Executive Power to issue the compulsory

license the Lopinavir/Ritonavir medicine.

The organizations and networks of civil society (Brazilian and

International) that are willing to co-sign the petition are encouraged to

send an email with the name of your association and email it to ABIA

(e-mail: abia@...).

Best regards,

Claudio Oliveira

Associação Brasileira Interdisciplinar de AIDS

Rua da Candelária, 79/10º andar - Centro - Rio de Janeiro

Tel. 21 22231040

Fax. 21 22538495

Endereço eletrônico: www.abiaids.org.br

We, the undersigned Brazilian and international Civil Society Organizations

and Networks, urge the Brazilian government immediately to authorize a

compulsory license on lopinavir/ritonavir and begin local generic

production of this important AIDS medicine without delay. This step would

be historic, not only for Brazil but for the entire developing world.

Brazil has for years contemplated issuing compulsory licenses on various

antiretrovirals (ARVs), and most recently, in March 2005, announced a

three-week deadline for negotiating a voluntary license for three ARVs that

together consume more than 70 % of the AIDS drug budget of the Brazilian

National AIDS Program - lopinavir/ritonavir (marketed by Abbott

Laboratories as Kaletra®), efavirenz (marketed in the developing world by

Merck & Co., Inc. as Stocrin®), and tenofovir disoproxil fumarate (marketed

by Gilead Sciences, Inc. as Viread®).

Nearly three months after the end of the deadline, President Luiz Inácio

(Lula) da Silva and Minister of Health Humberto Costa, announced a public

interest declaration (Act No. 985) as a precursor to the issuance of a

compulsory license. The declaration includes a 10-day deadline for Abbott

to lower the price of Kaletra® and match Farmanguinhos' price before the

government authorizes a compulsory license. If Abbott responds to this

final ultimatum by 6th of July, there will be no compulsory license and the

government will have short-term benefits - the price of Kaletra® could drop

from 2,628 US$ per patient per year to 1,056 US$ per patient per year.

However, this will not provide a long-term, sustainable solution for

Brazil. Rather than being satisfied with short-term compromises, the

Brazilian government must follow through on its long-standing commitment to

overcome patent barriers to access to ARVs and other essential medicines

through compulsory licensing. Compulsory licensing is a measure that is

fully compliant with the World Trade Organization (WTO) Agreement on

Trade-related Aspects of Intellectual Property Rights (TRIPS) and permitted

under Brazilian law.

Only with generic competition will the price of lopinavir/ritonavir and

other important antiretrovirals continue to decrease in the future, because

of economies of scale. After the full implementation of the TRIPS

agreement in all developing countries with drug manufacturing capacities,

only compulsory licensing will allow for generic competition.

A compulsory license on lopinavir/ritonavir in Brazil will progressively

decrease worldwide prices of the active pharmaceutical ingredients (APIs),

which can constitute 60-80% of the cost of a drug. This will allow not

only Farmanguinhos to eventually achieve prices below those offered by

Abbott, but will also enable other manufacturers outside of Brazil to

produce this urgently-needed medicine more affordably. This phenomenon will

not take place if the Brazilian government reaches a mere price agreement

which is a palliative solution that is not sustainable.

The prices of first-generation ARVs have fallen dramatically - by more than

98% - due to international generic competition. While companies in India

are the largest suppliers of generic ARVs worldwide, the single most

important factor in reducing the price of first-generation ARVs globally

was the fact that they were also produced in Brazil. The economies of

scale that followed from Brazil's large-scale purchases of APIs made the

remarkable worldwide generic price reductions possible.

Moreover, while there may be restrictions on exporting under a license for

government use, it is nevertheless important to note that Brazil can,

according to the TRIPS Agreement, export under certain conditions and it

should explore all options to enable other countries to benefit from the

generic competition and price reductions that will be achieved in Brazil.

It has been nearly four years since all WTO members unanimously adopted the

Doha Declaration on TRIPS and Public Health, and yet very few countries

have been able or willing to actually implement its provisions. Brazil's

action could reinforce the importance of these legal public health

safeguards as vital tools in the fight for access to essential medicines

throughout the developing world.

Finally, a compulsory license in Brazil will send a powerful message to the

rest of the world that public health can and must be prioritized ove