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Summary

INTRODUCTION

Fundamental rights are protected in a very different framework by the EU as compared to the Council of Europe. The EU is not of itself a human rights organisation and it has never been given a general competence to protect fundamental rights. At the same time, the EU has adopted one of the most modern collections of fundamental rights. The EU is legally bound to comply with the Charter, and it has agreed to accede to the Convention. As a result of these (and other) developments, fundamental rights have been given an important place within the EU legal order.

This chapter aims to set out the main principles of the EU ‘ s system of fundamental rights protection. This mainly serves as an introduction to this system so that a selection of topics, which are of particular importance to further examine the concept and the doctrine of positive obligations, can be studied further in the next chapters.

First, a brief explanation of how fundamental rights have come to be recognised within the EU legal order and the EU Treaties is provided (section 6.2.). The next section points out that there are in fact several rationales for the protection of fundamental rights under EU law which are of importance in order to understand the further development of fundamental rights protection within this system (section 6.3.). Subsequently, the recent important institutional developments in the field of EU fundamental rights protection that have taken place are addressed (section 6.4.). Aft er that, the content and the specific status of the Charter are explained (section 6.5.), while the general principles of EU law are also examined, since they continue to provide a basis for the protection of fundamental rights by the EU (section 6.6.). Then, the specific topics of the scope of application of the Charter (section 6.7.), the relationship between the protection of fundamental rights at EU level and at national level (section 6.8.), and the relationship between the EU and the Convention are discussed (section 6.9.). Some brief attention is also paid to the specific distinction that applies between rights and principles under the Charter (section 6.10.). Lastly, the the main findings of this chapter are set out (section 6.11.).

Summary

INTRODUCTION

In order to understand the meaning of the recognition of positive obligations under the Convention, it is first important to take into account the particularities of the Convention system. This is because a positive obligation may bear different meanings for each court or body and legal system in which it is applied. The ECtHR, in particular, has derived positive obligations from a catalogue of mainly civil and political rights under the Convention. These rather negatively formulated rights are understood by the ECtHR, principally, as obligations for states to refrain from taking action. How has this system thus allowed for the recognition of positive obligations, which demand an active interference by states?

This chapter provides a further background to the Convention system, which, as such, will be helpful for those looking for some general context of the Convention. It is also of interest for the analysis of the development of positive obligations within this system in the following chapters. Specific topics that are dealt with in this chapter are the background and purpose of the Convention (section 2.2.); its enforcement mechanisms (section 2.3.); the subsidiarity principle (section 2.4.); the role of the ECtHR (section 2.5.); the tools of interpretation of the ECtHR (section 6.); the effects of the Convention in the national legal order (section 2.7.); and the horizontal effect of Convention provisions (section 2.8.). The discussion of these topics is followed by a brief conclusion (section 2.9.).

BACKGROUND AND PURPOSE OF THE EUROPEAN CONVENTION ON HUMAN RIGHTS

The Convention was adopted in 1950. It was draft ed within the Council of Europe, an international organisation that was established to achieve peace and unity in Europe aft er the Second World War. At around the same time the European Coal and Steel Community and the European Atomic Energy Community, and later the European Economic Community, were established. These predecessors of the current EU essentially had the same ideal as the Council of Europe; however, they have mainly sought an economic form of cooperation between states. The Convention was, instead, oriented towards the protection of human rights.

Summary

THE SPECIFIC PARAMETERS OF EU LAW DEFINING THE SCOPE AND THE LIMITS FOR THE DEVELOPMENT OF POSITIVE OBLIGATIONS

In this chapter, the main findings of the analysis undertaken in part II are presented. This part has studied the specific system of fundamental rights protection in the EU to find out whether it allows for any development of positive obligations by the ECJ. The Charter provides some potential for the recognition of positive obligations. It contains a great variety of fundamental rights which could require active measures to be taken by the EU institutions as well as by the member states. The Charter also, however, lays down some important conditions for protecting such fundamental rights in the EU context. It determines inter alia that the Charter only applies to the actions of the EU institutions and the member states in so far as they are implementing EU law. This important condition necessarily limits the scope for a development of positive obligations. However, as has also been explained, it does not exclude such development altogether. There are various other conditions that can be expected to be of influence in the development of positive obligations in the context of EU law.

In this chapter, it is first of all explained that the use of the preliminary reference procedure plays an important role in the (potential) development of positive obligations by the ECJ (section 10.2.). Aft er that, the main relevant legal bases for a development of positive obligations on the basis of EU law are indicated (section 10.3.). Then it is explained how the limited competences of the EU, in combination with the limited scope of application of EU fundamental rights, can allow for the recognition of a concept of positive obligation by the ECJ, albeit to a limited extent (section 10.4.). In this section in particular, the conclusions following from chapters 8 and 9 are drawn together. Lastly, a few other, more specific factors that can influence the degree to which the ECJ could be expected to further develop positive obligations in its case-law are addressed. These mainly concern the specific institutional position of the ECJ and the role it can be expected to play in protecting fundamental rights (section 10.5.).

The concept of positive obligations is familiar to various legal systems which seek to protect fundamental rights. This concept means that states are required to take active measures to protect fundamental rights, such as, for example, adopting a general legal framework to regulate same-sex relationships in order to ensure protection of the right to private life. In Europe, positive obligations have, in particular, been developed in the case-law of the European Court of Human Rights (ECtHR) from the 1970s onwards. The ECtHR has explained that positive obligations are necessary to ensure that fundamental rights are of practical value and effective for everyone.The ECtHR is not the only supranational court in Europe that protects fundamental rights. The Court of Justice of the European Union (ECJ) also protects fundamental rights within the scope of EU law. So far, no concept of positive obligations has been developed by this Court, and the question has been asked whether such a development can indeed occur under EU law. After all, the EU is a rather special international organisation which has specific, mainly economic, interests to protect. It is also unclear whether the EU has competence to undertake regulatory action to actively protect fundamental rightsBased on the insights obtained from the development of positive obligations by the ECtHR, this volume analyses whether and how positive obligations could be incorporated into EU law. The relevant provisions laid down in the EU Treaties and the EU Charter, the case-law of the ECJ and the specificities of the EU system are studied to find out where there is scope for recognition of the concept of positive obligations under EU law, and what limitations would apply to this.

Summary

INTRODUCTION

It has previously been demonstrated that the fault rule can be justified as a relatively efficient mechanism in that the deterrence benefits that it generates are likely to exceed the tertiary costs that it incurs. As far as compensation is concerned, however, the fault-based malpractice liability alone is inefficient because it cannot guarantee swift and sufficient compensation whenever a patient suffers an iatrogenic injury. Many eligible victimised patients do not sue and many patients who did file a claim may still face tremendous difficulties in establishing fault and causation and may not obtain compensation until several years later.

There are also deficiencies in compensation mechanisms relying on the tort regime such as self-insurance and liability insurance, not only because of the deficiencies of the traditional malpractice liability but also because they have problems of their own. While self-insurance does not work well in the case of insolvency risks, liability insurance suffers from problems such as moral hazard, adverse selection, and severe underwriting cycles. Hence, one may wonder whether there is any alternative mechanism that can achieve the three goals of accident law simultaneously: (1) optimal deterrence (primary cost avoidance), (2) optimal compensation (secondary cost avoidance), and (3) being administratively cost-effective (tertiary cost avoidance).

For this reason, many scholars proposed and several legal systems have already developed the so-called “no-fault” compensation system (or scheme) (hereinafter NFCS) as an alternative to the traditional fault-based malpractice liability regime. Broadly speaking, NFCSs denote insurance programs that “provide compensation on proof of loss without any need to identify another party that caused the loss or prove their fault.” Two common features are characteristic of these no-fault schemes: first, victimised patients normally do not have to prove providers’ fault to obtain compensation; and second, costly malpractice lawsuits can usually be avoided. In a broad sense, no-fault schemes include first-party patient insurance, a special compensation fund covering iatrogenic injuries or social security that provides benefits for patients and the disabled in general. In practice, however, an NFCS specifically refers to a compensation fund that provides cover for personal injuries or iatrogenic injuries.

The NFCS should be distinguished from strict liability. Strict liability is usually described as “liability without fault,” meaning that the defendant will be held liable for any damage that he/she has caused irrespective of whether he/she was at fault or not.

Summary

Recalling the questions and ambitions of this book

Concerned with the access to controlled essential medicines under the interplay of human rights and drug-control norms, this study explored a human rights approach to the international drug-control system. Analysing the availability and accessibility of these medicines in theory and practice, the book used morphine as essential paincontrol medicine as leading example. In its analysis, both a general focus on controlled essential medicines, as well as a more applied focus on pain-control medicines, was employed.

As described in Chapter 1, Remedios was lucky to receive palliative care and paincontrol treatment at Mexico's National Cancer Institute. Unlike Remedios, millions of patients around the world continue to suffer in dire conditions, as pain-control medicines like morphine and codeine remain largely unavailable or inaccessible. In fact, despite their multifaceted need, Duthey and Scholten concluded that 66 per cent of the global population are unable to access, for whatever reason, opioid analgesics. Even though the authors found the global unavailability of opioid analgesics to affect all levels of development, the deficit is worst in Low- and Middle-Income Countries and, in particular, in the Sub-Saharan region. The suffering caused by the unavailability and inaccessibility of pain-control treatment raises serious concerns in light of human rights protection. States, after all, have the obligation to respect, protect, and fulfil the right to health and the prohibition of torture and cruel, inhuman, and degrading treatment (CIDT).

While there are many general and substance-specific factors challenging the access to medicines, the provision of controlled essential medicines is particularly influenced by the international drug-control treaties. Taking into account the multifaceted complexity of health-service provision, and the general and specific conditions in which to provide for pain-control medicines, this book examined the international drug-control treaties as a potential barrier. Despite States’ obligation to ensure access to medicines in adherence to the regulatory monitoring requirements enshrined in the international drug-control system, the normative foundation, interpretation, application and implementation of said system may raise questions regarding States’ obligations under human rights law.

The dual nature of controlled substances makes it imperative to regulate their production, manufacturing, import/export, distribution, and use. The question being, however, how far regulation should and can go, both in terms of scope and level, to ensure the availability of controlled essential medicines. This issue was found particularly acute for two distinct reasons.

Summary

INTRODUCTION

After describing all the Chinese legal remedies related to medical quality assurance and victim compensation, one may wonder how these systems perform. However, before conducting any meaningful evaluation, one needs to make clear the benchmarks against which the legal remedies will be evaluated.

There are at least three doctrinal benchmarks that are widely used in China – legal certainty, effectiveness, and fairness, which are defined as follows:

Summary

INTRODUCTION

Chapter 8 is aimed at answering the questions whether the fault-based medical malpractice liability is efficient at deterring medical errors in practice and what implications there will be for the economic model of malpractice liability after reviewing relevant empirical evidence (part of Sub-question (2- a)). Hence, in order to answer this question, it is essential to examine available empirical studies pertaining to medical malpractice issues.

The majority of the studies reviewed in this Chapter are primarily USbased. Several rounds of the “malpractice crisis” and tort reforms in the US have encouraged many scholars to research into medical malpractice issues. Hence, the largest category of the economic literature on malpractice is of empirical nature, which has developed considerably in the past two decades. Since the malpractice system in both China and the US is a fault-based tort system, these empirical findings may have high referential meaning for China. Nonetheless, empirical studies in other legal systems may also be included in the analysis if relevant.

The remainder of this Chapter is organised as follows. Section 2 will review empirical studies concerning the performance of the medical malpractice system. Section 3 will examine empirical evidence on the causes of iatrogenic injuries and point out its implications for the economic model of medical malpractice liability. The final Section 4 concludes.

EMPIRICAL EVIDENCE: IATROGENIC INJURY, MALPRACTICE LITIGATION, AND DETERRENT EFFECT

INTRODUCTION

The question with regard to the performance of medical malpractice liability can be divided into three sub-questions. First, whether the input system (liability and quantum rules) is effective as a fact, i.e. whether all meritorious claims are filed (Section 2.3) and whether the court system is effective at sorting out meritorious claims from non-meritorious claims (Section 2.4). Second, whether behavioural changes do exist and whether it is attributed to the threat of medical malpractice liability (Section 2.5). Third, whether the deterrence benefits generated by the medical malpractice system justifies the costs of the system (Section 2.6). Before that, Section 2.2 will describe the epidemiology of iatrogenic injuries in order to provide a context for subsequent discussions.

INCIDENCE, SEVERITY, AND COSTS OF IATROGENIC INJURIES

Introduction

Empirical evidence shows that iatrogenic or medical injuries are not rare events and many injuries result from substandard care in the US and elsewhere.

Summary

1. Title of the Study: ‘Advancing Access to Opioid Analgesics’

2. Principle Investigator: M.E.C. (Marie Elske) Gispen, LLM, Ph.D. Researcher at the Netherlands Institute of Human Rights (SIM), Utrecht University. Ph. +31(0)6 43 43 99 18; E-mail: m.e.c.gispen@uu.nl

3. Context and Justification

You are asked to participate in a research, which sets out to analyse a human-rights based model of drug-control to advance access to opioid analgesics such as morphine. This research is carried out under the supervision of Professor J.E. (Jenny) Goldschmidt (Director of the Netherlands Institute of Human Rights, Utrecht University) and Professor M. (Marcus) Düwell (Director of the Ethics Institute, Utrecht University), by Ms. M.E.C. (Marie Elske) Gispen, LLM. Before you decide, you can talk to anyone you would feel comfortable with about the research. This consent form may contain elements you do not fully understand. Please ask me to stop as we go through all the information and I will take the time to explain anything you do not clearly understand. Also, should you have any questions later, you can ask me at any time.

The purpose of the study is to get insight in Latvia's present regulatory system of controlled substances applying to morphine, and to map the link between the regulatory demands of the procedural obligations anchored in international drug control treaties and morphine availability in the country. If relevant, this study also purposes to gain insight in any reform processes. In doing so, the study will also compare access to morphine with an uncontrolled medicine necessary for pain treatment. We believe that you can help us better understand the regulatory chain of morphine in Latvia by telling your experience as one of the actors in the system.

4. Research participation and procedures

Your participation will comprise of one, one-on-one interview lasting for approximately one hour, with the possibility of a follow-up interview for clarification purposes if mutually agreed upon between the PI and the participant. You are being invited to take part in this research because the you have been recommended as relevant actor in the regulatory chain of morphine.

If you decide to participate you will be asked questions about your role in the regulatory chain of morphine, the pros and cons of the present system and the way it affects delivering adequate standards of palliative care and pain treatment in particular.

Summary

Introduction

Various schools of thought claim that international law in general and human rights law in particular are fraught with imperialist and postcolonial incoherencies. Partly building on the traditional discussion on the universality and cultural relativity of human rights, international law is accused of structurally reinforcing the subordinate position of Low and Middle-Income Countries (LMICs). In this respect, Rajagopal considers that the ‘human rights discourse and the leading spokespersons for human rights [to] have failed to stop the consolidation of hegemonic international law and [to] have rather been complicit in it.’ In light of these concerns, the question is whether new interpretations of existing fields of law, such as the one presented in this book, may also fall victim to similar structural constraints. While this book is neither primarily concerned with the ‘colonialist’ nature of international law, nor the universality and cultural relativity of human rights per se, these discussions signal the need to continue a more contextual approach.

In this third part of the book, the study takes an ‘empirical turn’, for as Schaffer and Ginsburg observe, ‘international law is the product of specific forces and factors; it accomplishes its ends under particular conditions’. In fact, focusing on local conditions and on implementation is vital because, from a governance perspective, ‘the successful delivery of collective goods and services is not only a question of political preference and public choice, but also a question of the ability of State institutions to function at all’. Part 3, therefore, presents the results of two qualitative country studies conducted in Uganda and Latvia. These studies (Chapters 6 and 7) explore the interplay of the human rights and drug-control frameworks in practice, which may assist in revealing the complexities of and gaps in the international drugcontrol system with respect to human-rights compliant medicine provision, if any exist at all.

The present chapter provides a brief introduction in terms of design and methodology of this third part, commencing with a description of the research design, which includes the research approach used, the central research question, and the methods of data collection and analysis (Section 5.2). Next, the chapter expands on the rationale behind the country selection (Section 5.3). Finally, it points out various limitations that one must take into account (Section 5.4).

Summary

Introduction

This chapter investigates whether Latvia is able to implement the administrative and procedural requirements of the 1961 Single Convention on Narcotic Drugs in a human rights compliant manner. Similarly to Chapter 6, it deals more specifically with understanding the issues, if any exist, in implementing a special administration, data collection and management, and specific trade and distribution requirements in relation to the Availability, Accessibility, Acceptability, and Quality (AAAQ) standard of healthcare. As indicated in Chapter 5, the objective of the empirical analysis is to explore the interplay of the human rights and drug-control frameworks in practice. In doing so, this chapter aims to reveal the complexities and gaps that may be found in the international drug-control system in terms of human rights compliant medicine provision. As was also highlighted in Chapter 5, Latvia is a high-income country with a seriously constrained health system. As a result, the population is faced with the repercussions of inadequate access to opioid analgesics, including morphine for pain treatment.

This chapter first elaborates briefly on the research design and methodology introduced in Chapter 5 and presents an anonymized chart that outlines all the respondents that participated in the study (Section 7.2). Next, the chapter provides background information on Latvia so as to ensure that the reader is able to contextualize the findings (Section 7.3). Focusing on the real-life experience of those working with the specific drug-control requirements, this chapter finally discusses the experiences of and context in which the provision of pain-control medicine takes place in Latvia (Section 7.4).

Design and methodology

As for the country study conducted in Uganda, the question central to the empirical analysis is:

How, if at all, can States prioritize, promote, and uphold the AAAQ standard of healthcare of medicines in accordance with human rights theory and law, whilst implementing the administrative and procedural requirements of the international drug-control system?

Answering such a question presupposes twofold insight. First, one needs to generate an in-depth understanding of the context in which the administrative and procedural requirements of the international drug-control system come into play in Latvia. This requires one to understand Latvia's ‘regulatory chain’ of pain-control medicines, its institutional and regulatory structure, and the experiences of those working within the system.

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Chapter 6 - Main Principles of the EU System of Fundamental Rights Protection

Summary

Frontmatter

Acknowledgements

Chapter 2 - The System of Fundamental Rights Protection Under the European Convention on Human Rights

Summary

Chapter 10 - Part II – Conclusions

Summary

Limits of Fundamental Rights Protection by the EU

Curriculum Vitae

Chapter 11 - Medical Compensation Mechanisms Not Based on Fault

Summary

Part I - Legal Remedies for Medical Malpractice in China

Part 4 - Conclusions and Recommendations

Chapter 8 - Conclusions and Recommendations

Summary

List of Figures and Tables

Frontmatter

Chapter 6 - A Doctrinal Evaluation and Tentative Conclusions

Summary

Chapter 8 - Preventing Medical Errors through Tort Law – Empirical Evidence and Updated Models

Summary

Appendix II - Interview Protocol Latvia

Summary

Chapter 5 - Bridging Theory and Practice: Introduction to the Country Studies

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Bibliography

Contents

Chapter 7 - Country Study II: Latvia

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Limits of Fundamental Rights Protection by the EU

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