Biology Reference
In-Depth Information
medical follow up and care to be provided to the subjects of research, as well as the
identity of those responsible for such actions … (National Health Council
1996
: article
IV.2(d)).
Again however, this is not explicitly linked to post-study access to successful
medical interventions, given that some trials include medical follow-up or care as
part of the research.
A year later, the National Health Council issued a supplementary resolution
(No.251/97), which focuses on new pharmaceutical products, medicines, vaccines
and diagnostic tests. This 1997 resolution clarifies who should meet the obligation
for post-study access.
Access to the medicine being tested must be assured by the sponsor or by the institution,
researcher, or promoter, if there is no sponsor, in the event its superiority to the conven-
tional treatment is proven (National Health Council
1997
: article IV.1(m)).
Brazilian legislation is very clear about benefit sharing. Research sponsors
(or other specified groups) have an obligation to provide Brazilian research par-
ticipants with post-study access to drugs which were tested on research subjects
in Brazil (assuming, of course, that the results of the trials confirmed their safety
and efficacy). The more general demands in the 1996 resolution - that there should
be a return of benefits to communities where research takes place, covering issues
drawn as broadly as 'social return, access to procedures, products or research agents'
(National Health Council
1996
: article III.3(p)) and 'changes in practices or behav-
iours' (National Health Council
1996
: article III.3(n)) - which also considers peo-
ple's different needs, mean that these more general benefit-sharing obligations are
due not only to individual research participants but to the wider community as well.
Since then the National Health Council has issued two more resolutions which
are relevant here, Resolution No. 292/99 and Resolution No. 304/00.
Resolution 292/99 (National Health Council
1999
) covers research with foreign
cooperation. According to article II, it is mandatory for any research involving for-
eign collaborators
II.1 - to prove the Brazilian participation and to identify the co-responsible national
researchers and institutions; and
II.2 - to set forth the responsibilities, rights and obligations through an agreement of the
parts involved [in the research] (National Health Council
1999
: article II).
The burden and benefits of research involving foreign cooperation must be dis-
tributed fairly, according to article IV, and details must be described in protocols
for submission to ethical review. One could say that the resolution sets a broad
requirement for equal partnership, as opposed to narrow benefit sharing, after for-
eign research has been concluded.
Following on from this requirement, Resolution 404/2008 issued in 2008
18
pro-
nounces most clearly on post-study obligations by noting the following:
18
Thanks to Bruno Schlemper Junior for providing an up-date on Brazilian national legislation
to DS.
