Legal and ethical aspects of global drug development from a human rights perspective

The development, registration, price and actual availability and accessibility of (new) medicines is increasingly complex and problematic. Throughout the entire ‘lifeline’ of medicines (development – registration – patient use), various multisectoral problems arise which raise multidisciplinary questions, including from a human rights perspective.

Issues raise such as: when is decision-making legitimate in the field of drug development? Is it problematic if scientific evidence underpinning regulatory decision-making includes (unknown) risks? How should one deal with both manifest and non-manifest conflicts between various sources of regulation influencing the entire pharma lifeline? But also, what is the responsibility of actors such as the Big Pharma and the Dutch Medicines Evaluation Board? And, what does it imply to regard patients as rights-holders?

  • Main researchers: Prof. Marcus Duwell, Dr Brianne McGonigle Leyh, Dr Marie Elske Gispen (RUG)
  • Participants: Mr Inez Braber
  • Collaboration with the Global Health Law Groningen Research Centre of the University of Groningen
  • Duration: one year
  • Funded by the Dutch Medicines Evaluation Board
Liberalism in China

Values such as individual freedom, societal pluralism and tolerance have become increasingly important in China in the past few decades. Yet there is a clear difference from Western societies in the interpretation of such values. In the project ‘Liberalism in China’, Dutch and Chinese humanities scholars and political scientists are collaborating to come to a better understanding of the hermeneutical, intercultural and institutional questions pertaining to this matter.

Innovative animal research

Over the past decades animal experiments have contributed to a better understanding of disease and an improved treatment, but they have also resulted in discussions about the ethical acceptability and the reliability of such experiments. This public debate has led to new, improved research models. However innovations in animal research do not always lead to the desired health benefit. This project will investigate the reasons for this problem and will propose a new approach: formulation of 'translational strategies'.

With this approach the entire research chain (both people and animals) is involved in determining the ideal research strategy and it places the patient at the centre. Based on case studies about cystic fibrosis and rheumatism the research team will explore the possibilities of good translational strategies. The results will be used amongst other things in education and for a contribution to standard protocols for research and ethical testing.

  • Project Leader: Dr Franck Meijboom
  • Consortium partners: BioXpert BV, ProQR Therapeutics BV
  • Duration: 2015-
  • Funding: NWO Responsible Innovation
A Role for Mental Content in Empirical Psychology

This project explores interpretivistic theories, according to which mental states such as thoughts and emotions are not ‘in our head’ but rather should be understood as elements of interpretation. The project focuses on the central issue of how mental states (understood in this way) can play a causal role and how they can be investigated in empirical psychological research.

  • Project Coordinator: Dr Annemarie Kalis
  • Duration: 2015-2018
  • Funding: NWO/VENI
Evolutionary Ethics? The (Meta-)Ethical Implications of Evolutionary Explanations of Morality

The human capacity to form moral judgements has its origin in the history of evolution. What significance does this have in terms of the value and appraisal of moral judgements? Does the history of morality undermine the possibility that value judgements are true? And what can we learn from science about the evolution of morality? This project explores these and many other questions.

Human Dignity as the Basis for Human Rights

What exactly does it mean to ascribe human dignity to another person? And how does this human dignity relate to human rights? This project explores various interpretations of dignity and studies how human dignity could form the normative basis for human rights. To produce relevant insights, links are formed between debates in legal theory, political philosophy and meta-ethics.  

Promoting Effective Intentions: Volitional Scaffolding, Implementation Intentions, and Bedtime Procrastination

This project, part of the Healthy Lifestyle Solutions Partnership programme, is being conducted by an interdisciplinary team of researchers made up of experimental psychologists affiliated to Utrecht University’s Self-Regulation Lab and members of the Ethics Institute who specialise in moral psychology, personal autonomy and the ethics of human-machine interaction. In consultation with researchers from Philips Research, this project focuses on the development of effective and ethically-responsible applications that individuals can use to prevent unnecessary procrastination concerning health-related behaviours, such as going to bed later than intended.

What Contribution can the Humanities Make Towards our Practical Self-Understanding?

As well as being biological entities, humans are also social beings capable of actions with a moral status. This project explores the extent to which all these different perspectives of humanity can be integrated and raises the question of whether the Humanities have a specific role to play here.

Whole Exome Sequencing (WES): Exploring the Ethics of an Innovative Genetic Tool in Paediatric Practice

The Ethics Institute is working together with Wilhelmina Kinderziekenhuis UMCUtrecht on a project about the ethical aspects of a new genetic technology (Whole Exome Sequencing). WES is used to find an explanation for previously unexplained illnesses and diseases but can also deliver more information than specifically necessary. This raises ethical questions relating to such themes as 'the right to an open future' and 'informed consent'. This project encompasses an explorative empirical ethical study into the way in which WES can be responsibly introduced into paediatric practice.

Limits to the Free Market

The operation of the free market meets with objections in a range of contexts. For this reason, markets are often regulated in order to protect vulnerable public interests. However, the way this is done is not always consistent or convincing. This research studies the underlying normative criteria for regulation. The aim is to develop a political and philosophical theory that legitimises intervention in the free market.

  • Project Coordinator: Dr Rutger Claassen
  • Duration: 2012-2015
  • Funding: NWO/VENI
Rights to a Green Future

Issues relating to climate and the sustainability relate to long-term responsibilities. This European network programme places a human rights approach to these issues at centre stage. What answers to these questions can we provide in terms of human rights, and what implications does this have for existing institutions?

  • Project Coordinator: Prof. Marcus Düwell
  • Senior Project Coordinator: Dr Gerhard Bos
  • Partner institutions: Karl-Franzens-Universität Graz, Universite Catholique de Louvain, University of Copenhagen, Åbo Akademi University, University of Bergen, University of Bucharest, University of Zurich, University of Düsseldorf, Norwegian University of Science and Technology, Sustainable Europe Research Institute (SERI)
  • Duration: 2011-2015
  • Funded by European Science Foundation
Chinese and Western Conceptions of Human Dignity

This China Exchange Programme involves researchers from Utrecht and Beijing Normal University, China Agricultural University, Tsinghua University and Renmin University (Beijing, China) It is designed to culminate in a comparative book project in which the Chinese and Western conceptions of human dignity are explored.

  • Project Coordinator: Prof. Marcus Düwell
  • Senior Project Coordinator: Dascha Düring
  • Duration: 2012-2014
  • Funded by the Royal Netherlands Academy of Arts and Sciences (KNAW)