WIPO NATIONAL SEMINAR
ON INTELLECTUAL PROPERTY RIGHTS AND
THE PROTECTION OF PHARMACEUTICAL
PRODUCTS
Damascus, April 25 and 26, 2005
Current issues on Intellectual
Property Protection and Access
to Medicines
WIPO Secretariat
Current issues
The problem:
TRIPS Article 31: “Where the law of a Member
allows for other use of the subject matter of a
patent without the authorization of the right
holder, including use by the government or
third parties authorized by the government, the
following provisions shall be respected:
[…]
(f) any such use shall be authorized
predominantly for the supply of the domestic
market of the Member authorizing such use;”
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Current issues
The problem (cont.):
1. WTO Member A is in need of a certain medicine which is not
available on the international market (or which is, but at
unaffordable prices)
2. But in A there is no company with technical knowledge and/or
manufacturing capacity to manufacture that medicine; therefore
there is no purpose for the government of A to issue a a c.l. for
the local manufacture of the medicine in need
3. Besides, and because of Article 31(f), A cannot ask another WTO
Member that it grants a c.l. with the exclusive or predominant
purpose of exporting that medicine to its territories
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Current issues
The mandate:
Doha Declaration on the TRIPS Agreement and Public Health
(November, 2001):
“1.We recognize the gravity of the public health problems afflicting
many developing and least-developed countries, especially those
resulting from HIV/AIDS, tuberculosis, malaria and other
epidemics.
[…]
“6.We recognize that WTO Members with insufficient or no
manufacturing capacities in the pharmaceutical sector could face
difficulties in making effective use of compulsory licensing under
the TRIPS Agreement. We instruct the Council for TRIPS to find
an expeditious solution to this problem and to report to the
General Council before the end of 2002.”
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Current issues
Solution:
Decision of the General Council of August 30, 2003:
a) Under certain conditions and circumstances WTO
Members may grant c.l. of patents for medicines (or
for processes for making medicines) with the
exclusive or predominant purpose of exporting to
other WTO Members with no manufacturing capacity
b) The remuneration of c.l. will take into consideration its
economic value in the importing country. The
remuneration is not supposed to be paid twice.
c) The Decision is indefinitely valid until the TRIPS
Agreement is amended.
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Current issues
Prospects:
In December 2004 (with a Rev. in March 2005) Nigeria, on behalf of the
African Group of countries, submitted a proposal aimed at amending the
TRIPS Agreement (the proposal consists of adding a second paragraph to
Article 31, which would transpose a summarized version of the General
Council’s Decision into the Agreement; the proposal eliminates some of
the transparency measures contained in the Decision).
The US opposed. Any amendment must reflect the Decision fully as well as
the Chairman’s statement (probably a footnote would be more adequate)
There are divergences as to the nature of the amendment to the TRIPS
Agreement (should it be limited by the scope of the decision? Should it
incorporate the Chair’s statement? Could the Decision be modified?)
The second deadline for the amednment (end of March 2005 has been
missed)
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Current issues
Thank you.
Nuno Pires de Carvalho
Acting Director-Advisor
Industrial Property Legislation for Development
If you have any questions regarding this
presentation do not hesitate to contact me at
nuno.carvalho@wipo.int
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