Managed entry agreementsas a new legal framework for access to medicines

Key words: managed entry agreements, availability of medicines, original medicines,purchase of medicines, medicinal immunobiological drugs The article concerns the new provisions of national legislativea legal mechanism for access to medicines, namely managed entry agreements. Theuse of managed entry agreements in European contract practice is widespread.Ukraine, in responding to the COVID-19 pandemic, has reviewed the legal mechanismsfor access to medicines contained in national legislation and had taken the firststeps towards implementing managed access agreements.Ukrainian legislation did not contain such a concept as a managed entry agreementby March 2020, and such agreement was never used in Ukrainian contract practicefor the purchase of medicines. On March 17, 2020, changes were made to the nationallegislation, namely the Law of Ukraine «On amendments to certain laws ofUkraine aimed at increasing the availability of medicines, medical products and theiraccessories, which are purchased by the person authorized to carry out purchases inthe field of health care» which were amended, in particular, to the Law of Ukraine«Fundamentals of the legislation of Ukraine on health care» and supplemented by article791 of which a managed entry agreement to national legislation was introduced. The provision of Article 79-1 of the Fundamentals of the legislation of Ukraine onhealth care regarding the parties, subject matter, content of managed entry agreementsis analysed.January 27, 2021, the Cabinet of Ministers of Ukraine adopted a decision approvingthe procedure for the negotiation, execution, modification and termination ofmanaged entry agreement. A standard form of agreement for a managed entry agreementhas been approved. The managed entry agreements procedure has been introducedin Ukraine February 15, 2021.The legal and regulatory provisions concerning managed entry agreements havebeen analysed and highlighted their particularities.