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.

Introduction

This chapter provides the introduction to the book. It sets out how it will explore the normative foundations of European contract law by addressing fundamental political questions on contract law in Europe from the perspective of leading contemporary political theories. It states the book’s main aims and starting points, and introduces its methodology. The chapter also explains how the approach and focus of this study differs from all other contributions to contract theory, private law theory, and the theory of European law—in particular how it aims to move the debate beyond acquis positivism, market reductionism, normative intuitionism, private law essentialism, and methodological nationalism.

Weaker Party Protection

This Chapter discusses the question of whether contract law can and should differentiate between different types of contracting parties according to their relational or social weakness. Should contract law protect certain weaker parties, through the implementation of measures ranging from general rules against unfair exploitation or abuse of circumstances to more specific sets of rules protecting certain categories of contracting parties, such as workers, tenants, and consumers? And if so, who should count as worthy of protection and what kinds of protection should they be granted? Given that consumer protection has been central to EU contract law, this question goes to the core of the justifiability of the European contract law acquis.

Context

The chapter presents the states of play in the two debates which this book aims to bring together, i.e. European contract law and political philosophy, and is intended for those readers who are not familiar with these debates. The first section offers an introduction to the Europeanization of contract law. Its main purpose is to set the scene, as it were, without unduly framing the argument. Thus, it introduces the main milestones, players, acts, and controversies. The objective is to provide the reader with a general but concrete sense of what is meant by ‘European contract law’. The second section, similarly, provides a brief introduction to normative political philosophy. It sketches the main traits of some of the leading contemporary political theories, with a special focus on aspects relevant for (European) contract law. Finally, a third section further sets the scene by briefly presenting the various pluralities with which any contemporary theory of contract law is confronted, i.e. the variety of contract types that parties may conclude, the different systems of contract law existing in the Member States of the EU, and the various roles that contract law plays in our lives. The section concludes by briefly introducing the main stances one may adopt, as a law maker or as a theorist, towards these pluralities, i.e. monism, pluralism (constrained or unconstrained), and neutralism.

Democratic Basis

This chapter concerns the relationship between contract law and democracy. The central question is whether contract law, in order to be legitimate, must have a democratic basis, and what this would entail. This leads to a normative institutional comparison between legislators, courts, legal academics, and economic-sectoral experts as the protagonists in contract law making. In addition, beyond the matter of institutional choice, the question of democratic legitimacy may lead to the question of whether there are any limits as to the kind of reasons (‘public reasons’) that can justify the law, in our case European contract law.

Justifying Contract in Europe

This book explores the normative foundations of European contract law. It addresses fundamental political questions on contract law in Europe from the perspective of leading contemporary political theories. Does the law of contract need a democratic basis? To what extent should it be Europeanized? What justifies the binding force of contract and the main remedies for breach? When should weaker parties be protected? Should market transactions be held legally void when they are immoral? Which rules of contract law should the parties be free to opt out of? Adopting a critical lens, the book interrogates utilitarian, liberal-egalitarian, libertarian, communitarian, civic republican, and discourse-theoretical political philosophies and analyses the answers they provide to these questions. It also situates these theoretical debates within the context of the political landscape of European contract law and the divergent views expressed by law makers, legal academics, and other stakeholders. The book moves beyond the acquis positivism, market reductionism, and private law essentialism that tend to dominate these conversations, and foregrounds normative complexity. It explores the principles and values behind various arguments used in the debates on European contract law and its future to highlight the normative stakes involved in the practical question of what we, as a society, should do about contract law in Europe. In so doing, it opens up democratic space for the consideration of alternative futures for contract law in the European Union, and for better justifications for those parts of the EU contract law acquis we wish to retain.