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?

  • Project Leaders: Prof. Marcus Duwell, Dr Brianne McGonigle Leyh
  • Staff: Dr Marie Elske Gispen (RUG), Inez Braber LL.M. MA
  • 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, (in cooperation with Veterinary Medicine)
  • Consortium partners: BioXpert BV, ProQR Therapeutics BV
  • Duration: 2015-2019
  • 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.

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.  

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.