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Therapeutic
Goods Order No. 88 - Standards for donor selection, testing, and minimising
infectious disease transmission via therapeutic goods that are human blood and
blood components, human tissues and human cellular therapy products
FRLI: F2013L00854
Portfolio: Health and Ageing Summary of committee view
2.1
The committee
seeks further information in order to assess this instrument's compatibility
with the right to privacy and the rights of equality and non-discrimination. Overview
2.2
This instrument
specifies requirements relating to donor selection, donor testing and cell and
tissue management, as related to infectious agents during the collection and
processing for human blood, blood components, tissues and cellular therapy
products and associated critical materials.
2.3
The instrument
specifies the minimum donor screening and testing requirements considered
necessary for the safety of human blood, cell and tissue products and also
includes donor testing criteria.
2.4
The instrument also
requires that donor's medical and social history be obtained before the use of
any relevant products collected from the donor and specifies the minimum
physical assessment and testing that must be undertaken to evaluate donor
suitability. Compatibility with human
rights
2.5
The instrument
is accompanied by a self-contained statement of compatibility that states that
it is compatible with human rights as it does not raise any human rights
issues.
2.6
However, section
9 of the Order relating to 'Requirements in relation to the medical and social
history of prospective donors' is likely to engage the right to privacy
(article 17 of the International Covenant on Civil and Political Rights (ICCPR))
and the rights of equality and non-discrimination (article 26 of the ICCPR).
2.7
Subsection 9(1)
of the Order states:
In the case
of a living donor, the blood, blood components, cells or tissues must only be
collected from a living donor with whom an interview to obtain the donor's
medical and social history has been conducted and recorded...
2.8
Noting the
sensitivity of the information collected as part of this process (and any
associated physical assessment or testing) the committee considers that the
right to privacy is likely to be engaged.
2.9
The explanatory statement
explains that the process of obtaining a donor's medical and social history:
...is
important in order to be able to effectively assess the risk of infectious
disease transmission associated with the use of blood or blood components,
human tissues or human cellular therapy products from the donor.[1]
2.10
However, the
Order does not specify how the confidentiality of this information (and the
results of any physical assessment or testing) is to be protected or how (and
for how long) the information collected will be stored.
2.11
In addition, subsection
9(4) of the Order states that a donor who meets certain criteria[2]
is subject to a period of ineligibility prior to donation. This differential
treatment of potential donors is likely to engage the rights of equality and
non-discrimination and therefore an explicit explanation as to how the
differential treatment is justified needs to be provided.
2.12
The
committee intends to write to the Minister for Health to seek further information
in relation to:
- how the
confidentiality of information collected as part of the donor screening process
(including the results of any physical assessment or testing) is to be
protected and how (and for how long) the information collected will be stored,
and whether this is consistent with the right to privacy; and
- further
information as to how the differential treatment of individuals who meet one of
the 'donor medical and social history criteria' in column 1 of table 1 is
justifiable and consistent with the rights to equality and non-discrimination.
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