New Society Values: Better Be In Line Than In Limbo

New Society Values: Better Be In Line Than In Limbo.

Johan Vanhemelrijck, Consultant: European Public Affairs Food and Pharmaceuticals.

In the European Society affluence and security has lead to aversion of taking risk in normal human activities such e.g. as eating, resulting in increasing demands on Food safety. Trust in professionals, politicians, ngos and churches has constantly declined in the last years. Minimizing risk is now a major goal for all in Society, eagerly taken over by politicians, civil servants and scientific committees. For public goods such as air, water, food there is a full delegation of responsibility and control to the “competent authorities”. Over and above the civil servants of the competent authorities the politicians make promises of reducing risk, increasing safety.

Although they claim that zero risk does not exist, they promise something in that neighborhood.

Following those promises, they produce legal language that makes professionals liable. In those circumstances innovation becomes a risk factor not a progress factor. ¨Prevention is better than precaution and precaution is considered better than risk acceptance. Zero risk is an objective, so why increase risk by innovation? In order to handle the wish of reducing risk, also the perceived risk or the “feared risk, which is not occurring but could occur, it is necessary to split completely the risk assessment from the risk management. In risk management it is possible to deal with other legitimate factors, such as consumer acceptance, ethical values, and many other notions that are resulting from aversion of risk. This gives the image that the authorities are listening to society and that they react personally in order to protect the public from the risk increase resulting from innovation and that they invest in minimizing risk. It could be that this way of handling risks, makes our society less competitive, in the world market. The authorities try to internationalize the “other legitimate factors” through Codex Alimentarius.

Also product approval is nowadays dependent on the prediction that the product cannot be used for other purposes than the authorized one. This leads to real efforts to improve “ good usage principles” and “prudent uses”. Corporate responsibility is moving from safe products to safe products that are used safely. Those new liabilities and responsibilities have to be taken into account in product design, product presentation, product development, marketing plans and post marketing surveillance. In order to convince the authorities of the safe use of products, new goals are traceability, increased control, individual targeted treatments, monitoring, full documentation and precaution. A list of those new values will be compared to product lines that did not make it to the market place, or that where removed from the market. The attendees of the conference can then as an exercise test products that they would like to continue to use against these new values, and decide for themselves what more should be done to keep the availability of those products.

Lately, the Scientific Steering Committee of DG SANCO of the European Commission, fearing to loose control has issued a report, that is considering “ quality of life” as a decisive element in the risk assessment.

Here are some quotes out of the report:

“ FINAL REPORT ON SETTING THE SCIENTIFIC FRAME FOR THE INCLUSION OF NEW QUALITY OF LIFE CONCERNS IN THE RISK ASSESSMENT PROCESS

ADOPTED BY THE SCIENTIFIC STEERING COMMITTEE AT ITS MEETING OF 10-11 APRIL 2003

….. An enlargement of the scope of the scientific assessment is proposed by including elements defining the quality of life. The framework of the areas to be considered in the quality of life assessment is provided by starting off from the health definition of WHO as "a state of complete physical, social and mental well being, and not merely the absence of disease or infirmity…" (WHO,

1992). As a consequence a wide range of traits need to be analyzed. Apart from the classical medicinal, physical and chemical scientific areas, psychological, and social issues have to be dealt with. Cultural and economic analyses and last not least the ethical values, which can be different regionally and individually and which can even change in time are parts of the approach…..

The analysis should not only take in account the usual objective risks but also the fact that a substantial part of the population is sensitive from a perception point of view to threats even from risks, which have not been shown to exist, but are only assumed or presented as hypothetic. Such a perception has a direct impact on the well being by its psychological component, but it can also have a psychosomatically induced physical health effect. One major reason for the perception of threats is that – admittedly - there is so far no consequent and systematic dealing in the scientific risk assessments with uncertainties that cover a wide range of evidence to non-evidence……. More than for other more classical risk analysis, those type of question addressed to the assessor by the manager is loaded with an ethical background and framed by cultural values. Those points should be made explicit prior to data collections and analyses in particularly for the quality of life assessment that relates to individual, collective and historical backgrounds……. This evaluation is a process which to be able to end up with a cost benefit analysis need to assign negative or positive values to those different items. However not all questions can be subjected to a cost benefit analysis and for example it can be accepted that ethical concerns are more especially expressed when something should not be the object of a trade-off because it would result in a decrease in human (or animal) dignity……..”

With those examples from the “Risk Assessors” I rest my case.

All stakeholders that want to have long-term activity in Europe need to know about those new values and have very astute people helping in adapting, products, marketing plans and post marketing surveillance systems that take into account those values. We don’t sell products for their efficacy we sell products as part of a program to reduce risk of lack of activity, and to reduce the use of product, which in itself could be perceived as a risk.

If time permits we can during the discussion illustrate some of these approaches.

Contact: Johan Van Hemelrijck, A. Leynhenslaan 44, Keerbergen, 3140, Belgium, johan.vanhemelrijck@pandora.be