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Increasing access to medicines 151
bodies such as the US FDA. However, the extreme inefficiency of the
MCC means that drugs which have already been registered for use
in the US, EU and Japan wait an average 39 months for approval in
the South African system.
Another example comes from Namibia, which announced in
2002 that all medicines registered in the country prior to independence
(1990) should be re-registered (Bate et al., 2005).
The low purchasing power of the majority of citizens in poor
countries means they do not constitute significant markets for
foreign manufacturers. In the face of such non-tariff barriers, companies
will often forego the regulatory complexity and expense of
registering their products in that country (and will instead invest
their resources elsewhere). The result is that fewer medicines are
approved – even when they are desperately needed – and there is a
lower level of local competition in the marketplace which would
otherwise drive prices down and increase access.
To make matters worse, many governments now adopt the
WHO’s list of ‘essential medicines’ as the basic formulary, denying
their citizens access to medicines not on the list (see Box).
WHO Essential medicines list
Dr John Kilama, Director, Global Bioscience Development
Institute
If poor people in the U.S. and the EU had access only to
the limited range of options on the World Health
Organization’s Model List of Essential Medicines (EML),
most doctors would denounce that situation as
unacceptable. So, too, would most healthcare workers in
other developed countries around the world. Why then has
no one questioned the rationale behind the WHO’s List of
Essential Medicines – frequently the authority that dictates
the drug selection process for many health Ministries in
poorer countries?
The WHO EML represents the most comprehensive