Lisa Diependaele

Raising the barriers to access to medicines in the developing world : the relentless push for data exclusivity

Abstract Since the adoption of the WTO‐TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originators data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industrys arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industrys appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others.

Similar or the Same? Why Biosimilars are not the Solution

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as “biosimilars.” Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist. This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologics cell line at the stage of the regulatory approval as the most effective remedy.

Assessing the Normative Legitimacy of Investment Arbitration: The EU’s Investment Court System

ABSTRACT The inclusion of an investment chapter in the Comprehensive Economic and Trade Agreement (CETA) and the Transatlantic Trade and Investment Partnership (TTIP) has encountered significant opposition, especially in relation to Investor-State Dispute Settlement (ISDS). In this context, the EU has proposed several changes to the traditional procedures, including the creation of an investment court. The need to reform ISDS has long been recognised, but the key question remains: What is required for such a dispute settlement mechanism to have legitimate authority? Drawing from insights in legal theory and political philosophy, we examine what could be adequate criteria for the normative legitimacy of ISDS. We argue that ISDS can only be minimally legitimate if there are sufficient procedural safeguards to ensure fair access to the proceedings and equal consideration of their interest for all those affected by investment tribunals’ or courts’ decisions. Furthermore, we emphasize the need to look beyond what potential beneficial and adverse consequences of ISDS are, and explain that the appointment of the judges by the state parties and the reintroduction of some control of the state parties over dispute settlement outcomes are not sufficient to guarantee the normative legitimacy of ISDS.

Climate Change, Human Rights and Moral Responsibility

This chapter sketches the problems of climate change and allocation of the responsibility for tackling it. In view of the threats to key human rights posed by observed and projected climatic changes, climate change is conceptualized as a moral harm. We explore how the burdens involved in remedying the problem should be allocated, focusing on the principle of moral responsibility that plays a central role in common-sense morality. The responsibilities of individual emitters have been underestimated because important doubts exist about the agency of individuals in complex global dynamics such as climate change. We contrast this view with the observation that people can psychologically reconstruct their contribution to climate change, in order to evade moral responsibility for it.

Understanding the Motivational Gap

This chapter explores two complementary explanations for the motivational gap. We argue that the first explanation — referring to the inadequacy of our moral framework to capture climate change as an important moral problem — remains incomplete, since individuals can effectively be identified as morally responsible for their luxury emissions. Second, the complexity of climate change and doubts about individual agency are overly emphasized, enabling emitters to act out of self-interest. Through the influence of the prevailing liberal-capitalist worldview, self-interested pursuits have become equated with wealth accumulation and consumption. Climate change challenges the inviolable status conferred to these materialistic freedoms, requiring emitters to resort to moral disengagement in order to be able to maintain a consumptive lifestyle without having to accept moral responsibility for the resultant harms.

The Phenomenology of Agency in Climate Change

Most objections against holding individual emitters responsible for climate change are closely related to the characteristic way in which people experience themselves as agents with causal powers. Within this phenomenology of agency, acts have primacy over omissions; near effects have primacy over remote effects; and individual effects have primacy over group effects. We describe how these features affect our thinking about individual responsibility for climate change and argue that the predominant characterization of climate change as a matter of omissions, remote effects and group effects is deceitful. Arguments along these lines do not convincingly exonerate individual emitters from moral responsibility for their luxury emissions; although the complexity of climate change undeniably challenges our moral judgement system, it also provides a convenient opportunity for moral disengagement.

Addressing the Motivational Gap and Tackling Moral Disengagement

In this chapter, we tentatively suggest some strategies to increase emitters’ motivation to accept moral responsibility for the consequences of their luxury emissions, and to accordingly acknowledge their remedial responsibility for tackling climate change. First, emitters’ motivation can be increased by enhancing their moral judgement on the basis of common-sense morality, or by invoking alternative moral values. Second, the motivational force of the underlying reasons for deploying mechanisms of moral disengagement can be reduced by encouraging people to evaluate and redefine their self-interested motives or by addressing the perceived demandingness of morality. Third, we argue that the propensity for moral disengagement should itself be tackled as well.

Globalization and Responsibility for Human Rights

In this article, we examine to what extent globalization has altered responsibilities for human rights. We give priority to negative human rights and take the violation of these rights as the baseline for determining harm and injustice. We will focus on the global economic order and on climate change and examine whether these aspects of globalization provide us with new reasons to value our relationships with distant others. We argue that, if a relationship of harm is established, fulfilling positive duties is no longer a matter of general charity but has become a special obligation of justice. Accordingly, human rights and corresponding obligations gain important normative weight. We propose to use the “vulnerability presumption principle” as a guideline in determining whether or not such a relationship of harm is established.