Terms of the managed entry agreement and particularities of the procedure for concluding such agreements

Abstract

The article is devoted to the study of managed access agreements and some peculiarities of the procedure for their conclusion. The author analyses the current legislation on the terms and conditions that must be included in a managed entry agreement and the main stages of the managed entry agreement procedure.The article’s author focuses on the fact that in the context of the global trend of increasing prices for medicines, particularly for innovative medicines, the use of managed entry agreements in the practice of states is reaching a new level. Achieving a balance between healthcare expenditures and access to new medicines in the face of rising budgetary costs is a challenge for many national governments, indicating this issue’s global nature.The use of this type of agreement helps to curb healthcare costs, save budgetary funds and provide the population with access to treatment with innovative medicines.Budgetary savings are achieved by, among other things, setting the price in the contract. The procedure for determining the price and other terms of the managed entry agreement is the result of agreements between the parties to the agreement, starting from the stage of forming a negotiation team, preparing for negotiations on the conclusion of the managed entry agreement, holding consultations, negotiations, determining the type and terms of such an agreement, etc.The author establishes that pre-contractual work, the procedure for concluding this type of agreement, and the terms of the managed entry agreement itself have their own peculiarities.In this article, the author classifies the terms and conditions of a managed entry agreement: 1) general terms and conditions that are common to most agreements; 2) special terms and conditions that are special due to their use in managed access agreements; 3) terms and conditions used in certain agreements, in particular, supply agreements, agreements for the supply of medicines, etc.