[e-drug] Mozambique issues a compulsory license for ARVs

E-DRUG: Mozambique issues a compulsory license for ARVs
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[Another country that uses the flexibilities permitted under Doha to address
the AIDS crisis. However, in this case I am a bit puzzled, as I thought that
Mozambique didn't have patents... So why was it needed to issue a compulsory
license? International patents don't exist! WB]

Dear E-druggers,

* Mozambique has issued a compulsory license for AIDS medicine. The
license defensive in nature, providing that if any patents exist on the
AIDS product in mozambique, the generic drug compay can use the patents
for 2 percent of the generic price. I believe the license was effective
29 Mar 04, but signed 5 April 04. Jamie

* "The Ministry of Commerce and Industry of the Republic of
Mozambique, making use of the provision of article 70 no.1
point b), of Decree no. 18/99 of 4 May, has decided to grant
the compulsory license no. 1/MIC/04 to the company Pharco
Mo�ambique Lda, which has already presented a project for
local manufacture of the mentioned triple compound under the
names of PHARCOVIR 30 and PHARCOVIR 40."

* "In consideration that the mentioned product, a triple
combination of drugs, is not marketed in Mozambique by the
international patent owners and that it is in the national
interest to keep the final price as lowest as possible, the
total amount of royalties due to the patent owners shall not
exceed 2% of the total turnover of the mentioned products,
at the end of each financial year of Pharco Mo�ambique Lda."

http://www.cptech.org/ip/health/c/mozambique/4apr04-moz-cl.pdf
http://www.cptech.org/ip/health/c/mozambique/moz-cl-en.pdf
http://www.cptech.org/ip/health/c/mozambique/moz-decree-18-99.pdf

English translation............

               COMPULSORY LICENCE no. 01/MIC/04

The Government of Mozambique, conscious that the HIV/AIDS
pandemic constituted a serious handicap in the national
struggle against hunger, illness, under-development and
misery and,

taking into consideration that.

high rates of morbidity and mortality have put Mozambique
among the ten countries in Africa worst hit by this disease.
Current estimates are that at the end of 2002 over 1,5
million Mozambicans were infected by HIV, of whom more than
100.000 are suffering from full-blown AIDS. The AIDS death
toll is so far well over 200.000 and about 360.000 children
have been orphaned by the pandemic,

and that,

In spite of multiplication and diversification of vigorous
prevention campaigns the spread of the virus is still on a
climbing trend as shown by the high number of infections,

considering further that,

Anti-retroviral drugs are already available, which prolong
lives of those infected with HIV/AIDS, and that until now,
at this day, the international patent owners have failed to
make such drugs accessible at affordable prices to most of
the Mozambican people,

and for such reason

on 14 November 2001 the World Trade Organization declared
the right of each Member State to protect public health and
in particular to promote access for medicines for all, by
granting compulsory licenses in cases which constitute a
national emergency or other circumstances of extreme urgency
and of public health crisis, including those relating to
HIV/AIDS, tuberculosis, malaria or other epidemics can
represent a national emergency or other circumstances of
extreme urgency.

Considering further that

a triple compound of lamivudine, stavudine and nevirapine
has proved, in the last few years, to be one of the most
effective and economical anti-retroviral treatment, but the
three different international owners of such single drugs
failed to reach an agreement to produce this combination,

therefore,

The Ministry of Commerce and Industry of the Republic of
Mozambique, making use of the provision of article 70 no.1
point b), of Decree no. 18/99 of 4 May, has decided to grant
the compulsory license no. 1/MIC/04 to the company Pharco
Mo�ambique Lda, which has already presented a project for
local manufacture of the mentioned triple compound under the
names of PHARCOVIR 30 and PHARCOVIR 40.

Communication of this decision will be given to the
applicant and to the patent owners.

In consideration that the mentioned product, a triple
combination of drugs, is not marketed in Mozambique by the
international patent owners and that it is in the national
interest to keep the final price as lowest as possible, the
total amount of royalties due to the patent owners shall not
exceed 2% of the total turnover of the mentioned products,
at the end of each financial year of Pharco Mo�ambique Lda.

This Ministry of Industry and Commerce, in accordance to
provisions of Art. 70 point 6 of Decree no. 18/99 will
notify the concerned parties of the expiration of the
present compulsory license as soon as conditions of national
emergency and extreme urgency created by the HIV/AIDS
pandemic will come to an end.

The Government of the Republic of Mozambique reserves the
right to review this compulsory license, in case the
conditions in which it was issued are changed.

signed by

Salvador Namburete
Deputy Minister

--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040
james.love@cptech.org

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