Pharmaceutical Law as a Phenomenon

Abstract

The article takes a look at the approaches to a new category in domestic jurisprudence - 'pharmaceutical law'. The author defines the domain area of pharmaceutical law in Russia, and proposes to consider the body of norms governing relations in the sphere of circulation of medicines as a separate group, claiming the relative autonomy. On the one hand, the rules governing legal relations at separate phases of the lifecycle of medicines (clinical trials, medical use), have a genetic affinity with medicine, therefore, with medical law, intended to comprehensively and consistently regulate the given group of relations. On the other hand, they are adherent to economic activity (industrial - relationship to drug manufacture, and trade - movement of medicines from a producer to the end (citizen) or intermediate (represented by a medical institution, medical worker) consumer). Finally, they are a form of economic activity, therefore, have a relationship with business (economic) law. The article also draws attention to the unresolved question of the referral of the rules, governing the relative by their characteristics and purpose of medical products (medical devices, dietary supplements, etc.), to one or the other branch of law. By virtue of unity or substantial proximity of approaches to the legal regulation of the circulation of such goods, it is proposed to refer respective rules to substantive field of the nascent pharmaceutical law.