[Ip-health] Text version of the Zambian compulsory license

[Mike Palmedo]

Republic of Zambia
Ministry of Commerce, Trade, and Industry


COMPULSORY LICENSE No. CL 01/2004

The Government of Zambia, 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 Zambia among the ten countries in Africa most hit by this
disease. Current estimates are that, at the end of 2003, over 917,718
Zambians were infected by HIV, of whom an unestimated number are
suffering from full-blown AIDS. The AIDS death toll is so far in excess
of 835,904 and about 750,504 children have been orphaned by this
pandemic, creating a situation where 75% of households in Zambia are
caring for at least one orphan, and that children aged below 14 years
headed more than 130,000 poverty stricken households out of a total of
1,905,000, and that;

in spite of the multiplicity and diversity of vigorous prevention
campaigns, the spread of the virus is still on an upward trend as shown
by the high number of infections;

Taking into account the gravity of the situation being faced by most
African Countries, including Zambia, the need to ensure access to drugs
at affordable prices, while respecting the protection of intellectual
property, is well recognized. For this reason;

On 14 November, 2001 the World Trade Organization, while recognising
Members=92 commitment to the TRIPS Agreement, declared the right of each
Member State to take measures aimed at protecting public health and in
particular to promote access to medicines for all, by utilising to the
full, the flexibilities in the TRIPS Agreement relating to among others,
the granting of compulsory licenses, in cases which constitute a
national emergency or other circumstances of extreme urgency and of
public health crises including those relating to HIV/AIDS, tuberculosis,
malaria, or other epidemics which 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 treatments, but that the three different international
owners of such single drugs failed to reach an agreement to produce this
combination, and therefore;

The Ministry of Commerce, Trade and Industry of the Republic of Zambia,
making use of the provisions of Section forty of the Patent Act, Chapter
400 of the Laws of Zambia, and Statutory Instrument No 83 of 2004 titled
=93The Patents (Manufacture of Patented Antiretroviral Drugs)
(Authorization) Regulations, 2004=94 Regulation 3, has decided to grant a
Compulsory License No. DC 01/2004 to PHARCO, LTD, a company incorporated
in Zambia, which has already presented a project proposal for the local
manufacture of the mentioned triple compound under the names of Normavir
30 and Normavir 40.

It is further understood that the use or vending of the above mentioned
drugs is subject to Regulation 4 of Statutory Instrument No 83 of 2004,
titled =93The Patents (Manufacture of Patented Antiretroviral Drugs)
(Authorization) Regulations, 2004,=94 and therefore cannot be exported to
any place outside Zambia.

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

In consideration that the mentioned product, a triple combination of
drugs, is not marketed in Zambia by the international Patent owners and
that it is in the national interest to keep the final price as low as
possible, the total amount of royalties due to the patent owner shall
not exceed 2.5% of the total turnover of the mentioned products at the
end of each financial year of PHARCO LTD.

The Ministry of Commerce, Trade and Industry, shall in accordance with
Section forty one of the Patent Act 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, or upon the expiry of the period of national
emergency stipulated in Statutory Instrument No 38 of 2004 titled =93The
Patents (Manufacture of Patented Antiretroviral Drugs) (Authorization)
Regulations, 2004.=94

The Government of the Republic of Zambia reserves the right to review
this Compulsory License should the conditions and circumstances under
which it is granted should change.

Dipak K. Patel, MP
MINISTER

Ref: MCT1/104/1/1c
Date: 21/09/2004