Biomedical Research in Developing Countries - UNICRI

Thailand, Brazil and partially South Africa, that can count on their national
pharmaceutical base to manufacture generics. Developing countries with no
manufacturing capabilities still rely mostly on direct negotiation for lower prices
with pharmaceutical companies.
It should be noted, in fact, that, although the 2003 WTO Declaration was issued in
order to facilitate export of medicines to those countries declaring a drug to be of
national interest, but not being able to produce it themselves, the bureaucratic
procedures for its implementation are so complex, that, at the end of 2007, only one
country in Africa, Rwanda, had successfully implemented the decision by importing
AIDS drugs generic versions from Canada. In addition, developing countries with
pharmaceutical capabilities, like Kenya, feel the WTO Decision will eventually curb
the growth of their own pharmaceutical industry, by forcing them to sell only to
countries with declared sanitary emergency 20 .
The implementation of the TRIPS Agreement is currently under scrutiny within the
UN Sub-Ccommission on the Promotion and Protection of Human Rights, which,
in a Resolution issued in 2000, had already recognized how the intellectual property
regime embodied in the TRIPS was in conflict with the international human rights
law, for the practical difficulties it raises in connection with both granting broader
access to medicines for countries in need, and in the obstacles it puts to the
development of new generic formulations for ARV treatments, in particular second
line treatments. 21
Logically, in a developing context, patenting issues have a direct influence over
access to medicines. On the one side, pharmaceutical companies recognize the
growing importance of emerging market economies and their potential as new drug
markets. For example, already in 2000, Brazil ranked sixth in the global market
sales for medicines consumption. On the other side, to protect their profits and
products, pharmaceutical companies are forced to keep under control the potential
for internal production of developing market economies.
In fact, when the TRIPS Agreement went into force, disputes focused on the use of
compulsory licenses for import of generic versions of patented products. More
recently, the focus has turned to preventing emerging economies from getting
patenting grants. India, for example, is currently considered the “pharmacy of the
developing world” as being the country where most of the generic versions of
antiretroviral drugs are produced. In August 2007, an Indian High Court ruling
upheld India’s Patent Act against Novartis, a Swiss pharmaceutical company, that
had sued the Indian government declaring its 2005 Patent Act uncostitutional and
not granting enough protection to intellectual property. India recognizes patent
20 Novak K., The WTO balance act, J. Clin. Invest., 2003, Vol. 112, No. 9, Pages 1269-1273
21 United Nations, Commission on Human Rights, Sub-Commission on the Promotion and Protection of Human
Rights, Resolution 2000/7 of 17 August 2000, Intellectual property and human rights, UN Doc.
E/CN.4/Sub.2/2000/7
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