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Biomedical subjects

F G van Andel

Publications and source records attributed to F G van Andel.

3 recordsLinked to original sources

[Does self involvement promote self medication? A comparative study of 6 countries of the European community].

Discussing cost-sharing in health care as a means to arrive at certain cost retrenchments is nowadays a popular topic in Switzerland. This also holds true for patient part-payment of medicines, through which the level of reimbursement of prescription medicines by sick-funds may be decreased. This paper reviews recent changes in the patient part-payment system for drugs in 6 countries of the European Community. It is investigated whether the rate of self-medication increases, when patient part-payment systems for drugs are intensified. Especially the English situation seems to prove the validity of this correlation. However, one should be cautious, because many other factors--such as whether a medicine has a prescription-only status or not--may also play a prominent role.

Costs and Cost Analysis↗

The legal mandate of drug registration authorities in theory and practice.

In the course of this century all industrial nations witnessed a growth in the influence of the state over the individual. Usually, state intervention in private life is justified by the state's mandate to protect the health and security of its constituents, either through general, uniform precepts such as laws or decrees, or through individual arrangements such as licences or subsidies. The principle of state protection has also long been established in the pharmaceutical sector, and entails that regulatory agencies should only approve those drugs for market use, which--according to scientific knowledge--have benefits which outweigh their potential harmful effects. Although 'the state of scientific knowledge' seems to imply that safety decisions concerning drugs are predominantly based on medical, scientific criteria, it is argued in this paper, that regulatory agencies nevertheless have wide discretionary margins, which allow for a political dimension to such decisions. For this reason it is briefly examined how drug authorities react under political pressure, i.e. when a drug has become a public problem. Additionally, the issue is considered why especially so-called non-steroidal anti-inflammatory drugs (NSAID's) have recently been the focus of controversy in the media. This attention has led to a situation in which it seems that regulatory agencies only accept drugs for market use with zero risk. The paper concludes by recommending that safety decisions of health authorities should involve two expert levels: in order to make precise risk assessments on the scientific level all relevant information about risks and benefits of drugs should be collated, whereas safety decisions should be taken by experts knowledgeable in the field of societal proportions.

Drug Evaluation↗

On regulating perceived risk.

Modern society increasingly depends on government regulation to manage risks. Until recently, evaluation of risks of technology was primarily considered a technical problem. However, public controversy has politicized the issue of risk, raising questions about the role of experts. This paper briefly explores the nature of technical risks of aircraft, nuclear energy and medicines. It is contended that in the case of aircraft intensive regulation has led to a measurable improvement of its safety record. The constant call for more regulation in the areas of medicines and nuclear energy on the other hand seems more the result of public controversy, since the actual effect of regulatory measures on safety is too difficult to show. This stresses the important role of the media, a theme, which is elaborated by reviewing a number of cases. The general conclusion is concerned with the notion that public pressure is the only rationale which makes regulators step in. Regulatory decision-making about risk, then, is more anecdotal than systematic, because public controversy is unpredictable. As a consequence regulators can no longer seek to minimize harm, but must now move towards the aim of minimizing perceived harm. Finally, in the light of this assumption, some thought is given to costs and benefits of medicines and nuclear energy. It is appropriate to make a strong case for medicines in this context, for, as opposed to nuclear energy, alternatives are usually not available.

Aircraft↗