Ethical and societal considerations

In this chapter I have outlined broad ethical and societal considerations which impact on pharmacovigilance. In terms of ethics, a balance is required between protecting individuals and the common good. To support system credibility, the need for transparency of drug safety information and processes is increasingly being recognised. It would be in everyone s interest if society... 

Science, technology and decisions Science and technology are distinguished, and the difference from value-laden considerations in personal and societal decision making about scientific issues in everyday life is dealt with. Socio-scientific issues, e.g. the use of bio-fuels, are not only dealt with concerning their scientific and technological background, but also ethical and societal values of their use and consequences to society are reflected. 

Parallel to many technological developments, the twentieth century saw an evolution of medical ethics and medical legislation that went way beyond the content of the Hippocratic Oath. The need for all these considerations was precisely because the Hippocratic Oath provided no guidance to twentieth and early twenty-first century issues, such as the patient s rights, the ethics of experimentation, team care, and a medical researcher s or healthcare practitioner s societal or legal responsibilities. 

The accepted risk is a risk inferior to a level defined in advance either by law, technical, economical, or ethical considerations. The risk analysis, as it will be described in the following sections, has essentially a technical orientation. The minimal requirement is that the process fulfils requirements by the local laws and that the risk analysis is carried out by an experienced team using recognized methods and risk-reducing measures that conform to the state of the art It is obvious that non-technical aspects may also be involved in the risk acceptation criteria. These aspects should also cover societal aspects, that is, a risk-benefit analysis should be performed... 

Via Negativa. Reflection on the possible implications and consequences for any proposed solution are explored. What are the ethical considerations involved The societal implications The global consequences The effects... 

Care for children who are dependent on technology requires consideration of societal and psychological factors. These include financial support, medicolegal discussions, ethical, social, and educational challenges, and communicating innovations in care. Some of these important issues are starting to he addressed. 

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