|| Checking for direct PDF access through Ovid
1. In pharmaceutical medicine, benefit and risk are fundamental, intangible ethical commodities determined normatively in recourse to empirically proven preparation characteristics. As normative value judgements, benefit and risk cannot be offset against each other. For this reason it is proposed to replace the term ‘benefit/risk-balance’ by the term ‘benefit/risk-relationship’. The logical gap left by the comparison of benefit and risk is closed by another normative determination: their relationship is judged to be favourable, unfavourable, or unacceptable.2. For the management of uncertainty, ethical principles are important decision-/action-guiding tools. As a general ethical model for pharmaceutical medicine, a three-tiered construction is proposed:The justification tier forms the basis of the construction and contains the culture-defining principle of human dignity that should be viewed as an absolute, unrestrictable, transcendental and universal principle. Within the framework of ethical deliberation, the principle of human dignity systematically holds open the door to recourse and may be seen as a pragmatic substitute for metaphysics.The justification tier holds up the general action tier, which involves the implementation of actions once they have been decided upon. This second tier is characterized by the cardinal principle of responsibility – which is absolute and unrestrictable. As a primarily amoral principle, responsibility is initially ethically neutral, requiring a specific context to acquire its function as a moral philosophical ‘stabilizer’ for the consistent implementation and defence of decisions reached.The construction's roof is the special action tier, at which morally relevant decisions to act are reached de facto. Ethical reflection draws here on the action-guiding principles of respect for beneficence, for non-maleficence, for autonomy and for justice. These traditional principles have a relative status; they are always valid prima facie and remain so provided that, in a specific situation, they are not forced to retire behind another, overriding principle or do not become restricted in an individual case. It is proposed to apply these principles only in the context of responsibility of the decision-maker, and this in turn should have its foundation in the principle of human dignity.