II 'criterio urbanistico' e il decentramento delle farmacie: Problematiche e soluzioni regionali

In Italy the number of open pharmacies in every town is established according to the number of inhabitants. As population can change during the years the correlation between number of pharmacies and number of inhabitants can become unrepresentative. When populations grow new pharmacies are opened, but if populations decrease this can result in a surplus of pharmacies. In 1991 a new law (n. 362) introduced the possibility of changing the disposition of pharmacies following the changes in population. The regulation of this provision is demanded to the regional power. The most correct principles to be considered when more than one pharmacy owner asks to move are the shorter distance among pharmacies, the decrease of population and the reduction of the proceeds of sales. Furthermore any chosen criterion has to be clear, objective and related to the concrete situation, in order to guarantee citizens a correct service. Aim of the present work was to analyse the different regional choices and to verify the real meaning of this new law

La definizione di medicinale secondo il diritto positivo e l'elaborazione giurisprudenziale

Controls operated by public administration depend on the classification of a product as a medicinal or as an healthy product. In some cases this classification is not easy, even because the interpretation of the different definitions is sometime difficult; thus very similar products are included in different categories. For these products, the so-called 'borderline products', the public administration, or even the magistrature, has to assess the correct classification. These uncertain situations, and the risk to incur in unlawful situations, can lead the manufactures to release the marketing of their products, furthermore the continuous appealing to the magistrature could also result in a different classification of the product itself, or of the same products of different origin, not only in the EU nations, but even within the same country

A proposal to improve the supply of orphan drugs

Industrial medicinal products are not always available for the treatment of some specific patients or diseases. Appropriate research on orphan drugs, neglected doses or administration routes and patients' sensitivity to excipients, as an example, might lead to interesting results in this respect. In the United States, a specific legislation on orphan drugs dates back to 1983; in the European Union, regulations are currently being studied. The industrial production of orphan drugs might be improved following the adoption of adequate incentives. New regulations should also take care of neglected doses, and stimulate the preparation of galenic products, as an example by including a number of monographs on orphan drugs in Pharmacopoeias and National Formularies. As a matter of fact, magistral and officinal preparations made in community and hospital pharmacies in accordance with a medical prescription or with the prescription of a Pharmacopoeia or an Official Formulary, can represent an effective alternative. In this paper, the regulations enforced in the USA and Japan, the European situation, possible incentives to the industry and the role of galenic products will be discussed. (C) 2000 Academic Press

Monitoraggio Corte Edu Maggio 2013

Monitoraggio mensile delle più importanti sentenze e decisioni della Corte EDU, afferenti il diritto penale sostanziale e il diritto penale processuale. All'introduzione - contenente la presentazione ragionata dei casi di maggior interesse decisi dalla Corte nel periodo di riferimento - segue la sintesi delle pronunce più rilevanti, presentate in ordine cronologico