RISK MANAGEMENT: REGULATORY EXPECTATION, RISK PERCEPTION, AND ORGANIZATIONAL INTEGRATION - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 64

a variety of stakeholders, including patients and medical practitioners as well as
government and industry, the protection of the patient by managing the risk to quality
should be considered of prime importance [32].
It is echoed in the introduction and preamble of ISO 14971 Medical Devices
— Application of risk Management to Medical Devices :
The concepts of risk management are particularly important in relation to medical
devices because of the variety of stakeholders including medical practitioners, the
organizations providing health care, governments, industry, patients, and members
of the public. All stakeholders need to understand that the use of a medical device
entails some degree of risk. The acceptability of a risk to a stakeholder is influenced
by the components listed above and by the stakeholders' perception of the risk. Each
stakeholders' perception of the risk can vary greatly depending on their cultural back-
ground, the socio-economic and educational background of the society concerned, the
actual and perceived state of health of the patient, and many other factors [33].
The principle's philosophy states that unacceptable risks should be targeted
and prevented from occurring before damage occurs, even if knowledge about
the risk is unknown. It is closely aligned with the decision theory's Maximin
Principle that states that the best decision maximizes the minimal output of a
specific hazard .
There is much debate regarding the principle and its impact on trade. The
disputes revolve around the amount of weight that should be given to moral,
political, ethical, and lifestyle objections to technologies or products and the
costs incurred to reduce those potential risks. These discussions emerge from a
culture or society's approach and perception to risk aversion. These perceptions
can create moving frames of trust with members of that society. The trust is
gained or lost by industry and regulators as a result of issues with products such
as Vioxx and Avandia and the consent decrees with companies such as Johnson
and Johnson [34-38].
The precautionary principle is embedded within the European Community
and defines the level of acceptable risk in uncertain situations as an inherently
political matter [39].
Implementation of the precautionary principle is based on the potential sever-
ity of the risk and the response required. These are also known as the societal
trigger level and the societal response [40]. The trigger and response are defined
by the Commission of the European Communities' 2000 document, Communica-
tion from the Commission on the Precautionary Principle . The trigger level is a
decision for “Recourse to the precautionary principle.” This trigger requires both
an “identification of potentially negative effects resulting from a phenomenon,
product, or process” and a “scientific evaluation of the risk which because of the
insufficiency of the data, their inconclusive or imprecise nature, makes it impos-
sible to determine with sufficient certainty the risk in question.” The societal
response is political and temporal where “the appropriate response in a given