Дослідження біоеквівалентності як необхідна складова державної політики щодо забезпечення населення лікарськими засобами

In the paper some economic legislation challenges concerning the access to essential medicines have been reviewed. The basic goal of national drug policy is to provide access to needed medicines and ensure the quality, safety and efficacy of medicines. The state plays a vital role in providing high-quality affordable medicines to millions of Ukrainian people and stimulating competitiveness and innovation in the national pharmaceutical sector. The expenditure on pharmaceutical products is a significant component of total healthcare costs and the search for less expensive therapeutic alternatives has shown the importance of generic medicines in lowering these costs. It can be argued that sustainable healthcare systems can only be achieved through the increased use of generic medicines. Generic medicines are well-known medicines with proven therapeutic value available at affordable prices which consequently translate into savings for both healthcare systems and patients. Essential medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, comparative cost-effectiveness and bioavailability studies. The National list of essential medicines as the essential part of national drug policy should be based on comparative bioavailability studies. A generic product can only qualify for authorisation if it is «bioequivalent» to he originator product—i.e. it must work in essentially the same way in the patient’s body.Bioequivalence means that, when compared scientifically, the generic medicine and the originator product demonstrate essentially the same rate and extent of biological availability of the active substance in the body when administered in the same dose. In modern world national legal framework should be harmonized with international practice. Some corresponding conclusions have been formulated by the authors in this paper.