Biomedical Research in Developing Countries - UNICRI

developed countries sponsors would commit themselves to buy a product at a
minimum set price for a number of people. For additional purchases, the price
would progressively drop. Should no suitable product be developed, no payment
would be made. This type of R&D financing has been considered a viable instrument
in the latest years and taken into consideration within the 2006 G8 policy
implementation. By estimating the offer size which would make revenue similar to
the revenues made from investiments in typical commercial pharmaceutical
products, it has been shown that a commitment comparable in value to that would
be a highly cost-effective way to address the main diseases affecting developing
countries and reduce the risk related to developing new products. 34
Voluntary licenses have been also explored as a means to allow developing countries
to sustain their efforts to allow broader and cheaper production and access to
medicines for their populations, especially in the case of antiretrovirals. Although
they impose payment of royalties, these licenses are based on a direct agreement
between the patent holder and the generic producer. In comparison to compulsory
licences, they do not require any change in the national legislation and they include
non exclusivity, access to the owner’s data as well as permission for export.
Voluntary licences are also useful for boosting technology transfer and for creating
the conditions for developing countries to create their own pharmaceutical
production infrastructure and home-based factories. South-South co-operation
seems to be especially promising in this field as China and India, currently the
biggest producers of generic drugs, are capable of selling at very affordable prices
the active pharmaceutical ingredients to produce antiretrovirals to Sub Saharan
countries and assist in building their plants. WHO could play an essential role in
assisting the negotiation of this type of commercial deal in developing settings. 35
The debate surrounding the need for protection of intellectual property rights are
mainly challenging the industry’s capacity and willingness to balance trade concern
and protection of economic interests with the moral obligation that calls for
facilitating the access to essential medicines, in settings where low resources are
threatening the very existence of persons. In 2006, a group of countries presented
to the UN General Assembly a programme, UNITAID, to establish an international
drug purchase facility based on a patent pool to manage patent rights collectively
in order to increase access and reduce prices of drugs for treatment of AIDS, malaria
and tubercolosis. In October 2008, the United Nations Secretary-General met with
seventeen of the world’s research-based and generic pharmaceutical and diagnostic
companies to review progress on strengthening efforts to expand access to HIV
services in low- and middle-income countries. The meeting took place immediately
after the high-level gathering on the Millennium Development Goals where Member
34 Berndt E., Glennerster R. Kremer M. et al., Advance Market Commitments for vaccines against neglected diseases:
estimating costs and effectiveness, Health Econ., 2007, Vol. 16, Pages 491-511
35 Dionisio D., Profit rules and the right to appropriate antiretroviral treatments: suitability of incentive-bound WHOmediated
voluntary licenses for equitable long-term solutions, WHO Intergovernmental Working Group on Public
Health, Innovation and Intellectual Property (IGWG), Web-based public hearing, 1-15 November 2006.
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