What rights do donors have?
Collaboration is worthwhile. A joint LUMC and Leiden Law School project has received €142,500 from the Dutch Research Council (NWO). This grant will advance research into the law and ethics of regenerative medicine.
Martine de Vries, Professor of Normative Aspects of Medicine, emphasises the importance of regenerative medicine. Body material, such as stem cells, can be used to repair damaged tissue. ‘Growing cell lines from stem cells opens up unprecedented opportunities,’ she explains. ‘You can make a mini-organ outside the body and test drugs on it, for example. That research can then be done without laboratory animals and test subjects.’
The legal and ethical side of regenerative medicine keeps De Vries busy. For instance, what rights do donors have when they donate blood, skin biopsies or urine for research? Or how do researchers deal with chance findings in genetic research? For instance, if a donor turns out to be a carrier of a certain disease.
‘Who will own that new organ and what will be the rights of a donor’s next of kin?’
Mirjam Sombroek-van Doorm, Associate Professor of Health Law at the Leiden Law School, says she relishes the legal and ethical questions that regenerative medicine can raise, such as about the use of stem cells. ‘What is allowed, also given patient and donor privacy?’ she wonders. ‘Not only Dutch law plays a role in this, but European law too. And what about more philosophical questions that arise with regenerative medicine, for example the commodification of human beings? There are also questions of “ownership”: who will own the new organ and what are the rights of a donor’s next of kin? Can they withdraw their consent? Do they have the right to have all “material” destroyed?’
The principle of informed consent requires researchers to inform patients or donors about what awaits them. Only when they have been informed in a comprehensive and intelligible way can they consent to cooperation. In legal terms, it is then legally valid.
De Vries – a paediatrician and also an ethicist – prefers to use the term ‘morally right’. As a member of the LUMC’s Department of Ethics and Law, she has an eye for medical as well as ethical and legal points of view. Like Sombroek, De Vries emphasises the benefits of interdisciplinary cooperation. ‘The LUMC already had a department of ethics and law, but our lawyers mainly specialise in health law in a narrower sense. The law school can take an even broader view of topics and from all sorts of angles, for example from the angle of patent law.’
‘If regenerative medicine is the breakthrough it thinks it is, you have to do justice to all involved.’
Involved in decision-making
Sombroek points out that regenerative medicine is about not just stem cells, but also people ‘who probably have an opinion about our research’. By joining forces with colleagues from the LUMC and other scientific disciplines, they hope to avoid any delay. Sombroek: ‘In today’s society, you see that people want to be involved, want to have a say and participate in decision-making. If regenerative medicine is the breakthrough it thinks it is, you have to do justice to all involved.’
Departments at Leiden University joining forces in law and health is part of a tradition, says Sombroek. For instance, Professor by Special Appointment of Health Law Jaap Rang put forward ideas on legislating patients’ rights as early as 1973. Three years ago, the University boosted interdisciplinary cooperation in regenerative medicine with extra funding for collaboration with the Faculty of Science’s Leiden Academic Centre for Drug Research.
‘The LUMC was looking for partners from other disciplines,’ says Sombroek. ‘That tied in perfectly with the Law School’s desire to do even more work on health law. Doctors and lawyers have been studying each other’s working methods ever since. Leiden is such a fantastic place for understanding each other. It takes just five minutes to cycle from my law school to the LUMC.’
Text: Tim Brouwer de Koning