Pharmaceutical Law and Patent Law

The patent law and pharma laws and regulations need to be coordinated. The interpretative proposal of the author is that a patent claim aiming at protecting the invention as a medicinal product must necessarily be expressed using the appropriate terms provided for by the laws and regulations concerning the industrial medicinal product, such as “medicinal product” and “active substance”; otherwise the patent may not be considered as covering a “medicinal product” or an “active substance”. Moreover, as a consequence, the presentation of a product in a patent claim as a medicinal product or an active substance implies that the enforceability of such claim is conditioned upon the demonstration of the efficacy and safety of the product through the preparation and approval by the competent authorities of a dossier of pharmacological and clinical trials. The legal system taken into consideration by the author is the European one, but the interpretative proposal is, mutatis mutandis, applicable to other systems of law.

Pharmacovigilance Awareness and Interpretation towards Patient Safety by Community Pharmacists: A Review across various Geographies

The pharmacist’s contribution will remain an important element in effective healthcare system. Pharmacists have a critical role in patient drug safety by contributing to the identification, documentation and reporting of adverse drug reactions. Pharmacists have key roles to play in establishing benefits and risks profile of a marketed medicine. Country level drug ADR monitoring and programs throughout the world differ in their way of collecting ICSR reports by healthcare professionals specially pharmacist. In contrast to North American continent countries like Canada or the US, where the majority of the reports come from licensed pharmacists, some European and Asian countries, such as UK, France, Ireland, Malaysia have the maximum contribution of ADR reports coming from practicing physicians.