Biology Reference
In-Depth Information
agreement (SMTA)
40
for shipment of materials outside the country
(Sedyaningsih et al.
2008
: 487).
Aware of the problem since 2006, the WHO issued a report on 'Best practice
for sharing influenza viruses and sequence data' in January 2007 (WHO
2007a
).
The report emphasized that the 'timely sharing of influenza viruses and the associ-
ated genetic and antigenic information is essential for developing the diagnostic
tests, vaccines, and strategies necessary to protect populations' (WHO
2007a
: 1).
However, it also recognized that developing countries carried a disproportionate
disease burden without the appropriate means to protect their populations' health,
a clear sign of vulnerability (see
Chap. 2
). For this reason, it noted, it was impor-
tant that the 'benefits derived from this global system [of virus sharing], including
better access to influenza vaccines, must be shared (WHO
2007a
: 2).
Following a two-day meeting organized by the WHO in Jakarta in March 2007,
the Indonesian government resumed sending occasional virus samples to the WHO
(Revill
2008
). This decision followed agreement among members of the WHO
'on a timetable to make the changes necessary to accomplish … [the] objective
of achieving equitable and affordable access to vaccines for developing countries
around the world' (Wulandari and Pathoni
2007
).
In April 2011, after four years of negotiations, the WHO's Open-Ended Working
Group of Member States on Pandemic Influenza Preparedness reached agreement
on an alternative framework for influenza virus sharing. The Pandemic Influenza
Preparedness Framework (also called PIP Framework), ratified by the WHO at the
May 2011 World Health Assembly (WHA), is meant to be responsive to the concerns
raised by the Indonesian government (WHO
2011a
). Importantly, it recognizes the
'sovereign right of States over their biological resources' (WHO
2011a
: PP11). To
protect this right, the framework includes the requirement for two binding SMTAs
(WHO
2011a
: paragraph 5.4). The first SMTA applies to institutions within the GISN
and contains terms and conditions which prohibit laboratories from making intellec-
tual property claims in relation to the samples shared with them. In this regard, the
first SMTA does not impose any requirements for benefit sharing but rather ensures
that no relevant patents are being applied for. The second SMTA applies to those out-
side the GISN system and imposes two benefit-sharing conditions, selected from a
list of options which include: giving developing countries 10% of the resulting vac-
cines and/or anti-virals; selling 10% of these at an affordable price; or granting man-
ufacturing companies within developing countries licences to produce vaccines or
antivirals at affordable royalties, or royalty-free (TWN
2011b
; WHO
2011a
).
On the whole, the framework is 'an important step forward towards a system for the
sharing of influenza viruses and resulting benefits'. In particular, it is 'a milestone as
it obliges pharmaceutical industry and other entities (that benefit from the WHO virus
sharing scheme) to engage in sharing of benefits (TWN
2011a
). In particular, the bind-
ing language and the compulsory nature of SMTA 2 is to be welcomed (Wilke
2011
).
40
An SMTA is a legal contract that governs the transfer of materials - typically biological mate-
rials - between two parties. An SMTA specifies the rights and obligations of provider and recipi-
ent, binding both to certain terms and conditions of transfer.
