Scribd
Upload
21 views25 pages

Ethical and Legal Issues in HTA

This document discusses ethical, legal, and social issues that health technology assessment (HTA) bodies must consider when analyzing new health technologies. It outlines key areas like the use of technologies, conducting research, and allocating resources where ethical issues commonly arise. HTA involves comprehensive assessments that examine impacts on both individuals and broader health systems/societies. Consideration of diverse perspectives is important to ensure technologies are implemented and resources allocated in a just, equitable manner.

Uploaded by

laxman kavitkar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
21 views25 pages

Ethical and Legal Issues in HTA

This document discusses ethical, legal, and social issues that health technology assessment (HTA) bodies must consider when analyzing new health technologies. It outlines key areas like the use of technologies, conducting research, and allocating resources where ethical issues commonly arise. HTA involves comprehensive assessments that examine impacts on both individuals and broader health systems/societies. Consideration of diverse perspectives is important to ensure technologies are implemented and resources allocated in a just, equitable manner.

Uploaded by

laxman kavitkar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 25

Ethical and Legal issues

in Health Technology
Assessment

Dr. Devi Nair


 Assessing the impact of any technology
requires comprehensive information that
reflects what is likely to happen in a health
system or society.
 Good analysis requires the use of expert
advice and methods from the various
disciplines that are used as inputs.

2
 Health technology assessment (HTA)
bodies must take a broad range of issues
into account during their analyses,
including ethical, social, and legal issues
that arise from the use (or non-use) of
health technologies.

3
Ethical issues in HTA
 Ethical issues arising from health technologies have
become more prominent over the last several decades.
This is due to a combination of factors including:
 Increasingly complex systems for delivering
increasingly complex care
• A reappraisal of the assumption that all technology is
good
• Recognition of the difficult choices that must be made
in allocating resources for health.

4
 In the field of HTA, ethical issues arise in
particular around the following areas:
• Use of technology
• Conduct of research
• Allocating resources

5
Use of technology

 The practice of HTA focuses on responding


to existing or emerging technologies. How a
technology is used will determine the scope
of the ethical issues associated with that
technology. If a technology is used in a
different way or setting, the scope of ethical
issues associated with it will likely vary.

6
 For example, genetic testing to see how
likely an individual might be to develop a
disease has potentially different ethical
implications in healthy adults than in
unborn babies (prenatal testing).

7
 While guidelines from an HTA bodies may define
medically appropriate care, individual
practitioners and patients are the ultimate
decision-makers regarding whether a technology
will be used or not in a particular case.
 Assessing a technology can provide important
information about the balance between 
beneficence (benefit) and non-maleficence (doing
no harm).
8
 Using technologies that provide no benefit would
be inconsistent with the principle of beneficence. 
HTA reports can identify situations where the use
or the absence of use of technology may run
counter to the principle of justice and give
appropriate recommendations for its use.
 The same principles that are relevant to research in
humans are also relevant to technology use.

9
Conducting research

 HTA involves gathering information and in some


cases conducting original research, not just about the
science that underlies and supports a health
technology, but also about the preferences or values of
patients who may use it. Some HTA organizations
may explore patient preferences or values directly
through qualitative methods. This is particularly
relevant for technologies with both significant
 desirable and adverse health effects that must be
weighed in decisions about using the technology. 
10
 From an ethics perspective, research on patient
preferences is no different from research on
health effects. Therefore, it must conform to
the standards for doing research, and be
consistent with the principles as laid out in the
Declaration of Helsinki of 
 respect for persons, beneficence, and justice.

11
Allocating resources

 HTA assessments are often used to make


decisions about the allocation of resources
pertaining to healthcare.
 When allocating resources, care must be
taken to distinguish between equal access
and equitable access:

12
• In discussions of resource allocation, equity
has come to mean fair allocation
• The distinction between equal and equitable
access depends on whether allocation
should reflect the need of the individual
patient (equity) or equal access by all
(equal)

13
 The principle of equal allocation can lead to
an inequitable distribution of health
resources if those resources are limited.
 For example: If a certain pill is distributed
equally, everyone in the population receives
one pill regardless of their need.

14
However, there may be some in the 
population who need ten of the pills, but
who would be unable to get them because
of the limited amount of pills available.
 Equitable distribution seeks to ensure that
those who most require the health
technology can access it.

15
Social issues in HTA

 Society and culture shape both ethical norms and


how decisions are made, meaning that decisions
about the same technology may differ in different
places. It is important to remember that ethical
and social issues may not be the same.
 Some aspects of social outcomes, such as anxiety
associated with technology use or human
integrity, may overlap with clinical and ethical
outcomes.
16
 Social effects can be researched by a review
of existing literature or through original
study. However, the studies carried out to
understand what social effects may occur
do not borrow from epidemiology but rather
from other disciplines – such as sociology,
medical anthropology, and society and
technology.
17
 These studies are typically qualitative. Often, they
try to discover which outcomes are relevant,
rather than identifying the outcomes ahead of
time.
 These studies rely on patient experiences in order
to understand the social and cultural effects of
new technologies, this is a growing area where
patients can play a real role in shaping
existing HTA processes.
18
Legal issues in HTA

 Legal systems vary the world over, but certain


aspects of technology use may draw the attention
of legal systems regardless of their cultural basis.
At the level of professional practice, ethics and the
law are linked because unethical practice is illegal.
 Illegal practice can lead to criminal or civil
proceedings against individual healthcare
practitioners and also the institutions and
organizations where they work.
19
 In general, legal aspects that are relevant
to HTA relate to responsibility and its legal
counterpart, liability. 
 HTA bodies need to consider legal issues
and a framework for considering them is
important in any assessment of a health
technology.

20
 Additionally, HTA bodies must be aware that
stakeholders who disagree with an assessment’s
conclusions may turn to the courts.
 Therefore, an HTA body that does not take
reasonable steps to ensure a high quality
assessment may itself be at risk of legal action
for failing to perform a responsible assessment.

21
Ethical, Legal, and Social
Issues (ELSI) checklist
1. Ethical
1.Does the introduction of the new medicine and
its potential use/non-use instead of the defined,
existing comparator(s) give rise to any new
ethical issues?
2.Does comparing the new medicine to the
defined, existing comparators point to any
difference that may be ethically relevant?

22
1. Organisational
1.Does the introduction of the new medicine and
its potential use/non-use instead of the defined,
existing comparators point to any differences
that may be organisationally relevant?
2.Does comparing the new medicine to the
defined, existing comparator(s) point to any
differences that may be organisationally
relevant?
23
1. Social
1.Does the introduction of the new medicine and
its potential use/non-use instead of the defined
existing comparator(s) give rise to any new
social issues?
2.Does comparing the new medicine to the
defined, existing comparator(s) point to any
differences that may be socially relevant?

24
1. Legal
1.Does the introduction of the new medicine and
its potential use/non-use instead of the defined,
existing comparator(s) give rise to any legal
issue?
2.Does comparing the new medicine to the
defined, existing comparators point to any
differences that may be legally relevant?

25

You might also like