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global pharmaceutical development and access critical issues
Special Article
Global Pharmaceutical Development and Access:
Critical Issues of Ethics and Equity
Agustín Lage MD PhD
Edited for publication from Dr Lage’s opening remarks at the Second International Symposium on Immunobiologicals in Rio de Janeiro, Brazil,
May 4–6, 2011, with permission from the author and symposium organizers, Bio-Manguinhos and Fiocruz (Fundação Oswaldo Cruz). Full text of the
oral presentation can be found at: .br/download/Lage.pdf
Deep concerns about access to medications have appeared in the
specialized literature since the 1990s. In 2001, the World Health
ABSTRACT
Assembly endorsed a resolution calling for development of stan-
The article presents global data on access to pharmaceuticals
and discusses underlying barriers. Two are highly visible: pricing dardized methods for measuring and monitoring pharmaceutical
policies and intellectual property rights; two are less recognized: prices, resulting in the launch of the WHO’s Health Action Inter-
the regulatory environment and scientifi c and technological ca- national Project on Medicine Prices and Availability.[3–5] The fi rst
pacities. Two ongoing transitions infl uence and even distort the draft of its manual was published in 2003. Since then, more than 50
problem of universal access to medications: the epidemiologic studies using the manual have been conducted on the affordability
transition to an increasing burden of chronic non-communicable and availability of essential medications, and on the special and
diseases; and the growing role of biotechnology products (e
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