管理入境协议的条款和缔结此类协议的程序的特点

O.M. Zosymenko
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引用次数: 1

摘要

本文致力于研究管理访问协议及其结论程序的一些特点。作者分析了管理入境协议必须包括的条件和管理入境协议程序的主要阶段的现行立法。本文作者着重指出,在全球药品特别是创新药品价格不断上涨的趋势下,各国在实践中使用有管理的准入协议达到了一个新的水平。在预算成本不断上升的情况下,实现医疗保健支出和获得新药之间的平衡是许多国家政府面临的一项挑战,这表明这一问题具有全球性。使用这种类型的协议有助于控制保健费用,节省预算资金,并为人民提供获得创新药物治疗的机会。预算的节省是通过在合同中确定价格来实现的。管理准入协议的价格和其他条款的确定程序是协议各方协商的结果,从组建谈判小组、准备签订管理准入协议的谈判、进行磋商、谈判、确定管理准入协议的类型和条款等阶段开始。作者确立了合同前工作,即签订管理准入协议的程序。管理准入协议的条款本身也有其特殊性。在本文中,作者对管理进入协议的条款和条件进行了分类:1)大多数协议中常见的一般条款和条件;2)因在托管访问协议中使用而具有特殊性的特殊条款和条件;3)某些协议中使用的条款和条件,特别是供应协议、药品供应协议等。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Terms of the managed entry agreement and particularities of the procedure for concluding such agreements
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.
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