Chimeras and the future of medicine – Balancing medical innovation with moral boundaries

Research Stream: Social Technologies

Author: Sharon Adedapo, Research Assistant, PatentsInHumans Project, ALL Institute and Department of Law and Criminology

In September 2024, the European Patent Office (EPO) denied the University of Minnesota’s patent application (EPO decision T 1553/22) for developing human-animal chimeras by putting human stem cells into animal embryos, such as pigs. It would empower pigs with the ability to produce human stem cells and blood vessels, thus facilitating the harvest of organs that are compatible with humans. The main goal was to address the severe lack of suitable donor organs, and in turn, lessening the long waiting lists seen worldwide.   While this case focused on the patentability of the technology, it raises broader debates about the ethical boundaries of human-animal chimera research and morality.

Piglets sleeping on a stack of hay
Image by MabelAmber via Pixabay

The EPO cited ethical concerns under  Article 53(a) of the European Patent Convention (EPC). Article 53(a) expressly prohibits patents that violate “ordre public or morality”. Put simply, ‘ordre public’ refers to the protection of the environment, public safety, and individuals. ‘Morality’ pertains to behaviours that are deemed to be right or acceptable according to deeply ingrained European cultural values. Article 53(a) is complemented with the EU Biotechnology Directive which explicitly states that “processes, the use of which offend against human dignity, such as processes to produce chimeras from germ cells or totipotent cells of humans and animals, are obviously also excluded from patentability”. It is important to note that these provisions address concerns related to the commercial exploitation of morally contentious technologies, not specifically their scientific use. The EPO’s remit is limited to patent law and does not regulate the use of the technology.

In Greek mythology, a ‘chimera’ was a fire-breathing hybrid mythical creature with the head of a lion, the body of a goat, and the tail of a serpent. Today, the term has taken a completely different meaning in science. In simple terms, a ‘chimera’ is now used to describe an organism composed of cells from two or more genetically distinct entities. Human-animal chimeras have been widely used in research to study neurodegenerative diseases, genetic disorders, and cancer treatments, and to grow transplantable organs. There is considerable research or interest around the potential for the use of human-animal chimeras for organ transplant in the future. However, significant ethical and moral considerations and scientific challenges arise in this context. The primary question, being: Where should the line be drawn between scientific progress and moral/ethical responsibility?

The field of biotechnology combines biology with technology to develop innovative solutions that improve human health and sustain the environment. It has transformed sectors such as healthcare, agriculture, and diagnostics, playing a vital role in the development of new medications, life-saving vaccines, and advanced medical tools. One emerging application is the development of human-animal chimeras. Scientists have introduced human stem cells into animal embryos, such as pigs, with the aim of growing organs compatible with humans for transplantation. This process, which uses techniques, such as genetic engineering and stem cell manipulation, is driven by the urgent  need to address the global shortage of donor organs.. Thousands die each year while waiting for organ transplants, and chimeras may offer a promising solution by producing organs less likely to be rejected by the recipient’s immune system. Despite the potential, the science remains complex and uncertain, with many questions around feasibility and long-term outcomes. Moreover, the development or use of human-animal are not currently permitted in many jurisdictions due to ethical and legal concerns.

Despite the potential medical benefits of human-animal chimeras, they raise significant ethical concerns such as; cognitive enhancement and human-like consciousness, the development of human physical traits in animals, the production of human gametes in animals, the risk of new diseases, and moral and species boundaries. A key concern for the EPO in the 2024 case was the possibility of human cells integrating into an animal’s brain or reproductive system, leading to unforeseen consequences. The EPO’s Board of Appeal (BOA) held that patenting such technology may violate human dignity if they make a substantial contribution to a chimera’s cognitive development. They found that despite the potential therapeutic and medical benefits of the invention, they could not dismiss ethical concerns relating to the patentability of this type of technology under European patent law.  Another major issue is the precedent that such research would set for the monetisation of human biological material. Critics argue that the development of human-compatible organs in animals blurs the line between species, presenting difficult questions regarding control, exploitation, and ownership of partial human life forms. The tension between ethical responsibility and scientific innovation is not a new debate in the field of biotechnology. Past cases, such as the Oncomouse/Harvard University case (T 19/90) illustrate the EPO’s attempt to strike a balance between medical benefits and ethical issues.

Ethical objections to human-pig chimeras remain strong, particularly because of the concern regarding cognitive humanisation and the potential for the development of ethically significant features. To prevent chimeric organisms from developing consciousness or self-awareness, many bioethicists support strict safeguards, such as ensuring that human cells do not fuse into brain tissue. Many researchers and scientists argue that scientific research should be conducted with caution until we can conclusively determine the moral status of chimeras. Others suggest that the speculative ethical concerns are outweighed by the life-saving potential of these advancements. However, without clear and explicit safeguards, the scientific community seems to still be unsure as to how much chimera research should be conducted.

Just as the ALL Institute is committed to interdisciplinary research that enhances the lived experiences of individuals, the research on chimeras calls us to consider not only medical advancements but also the social and moral implications of these breakthroughs. At the heart of the ALL Institute’s approach is a commitment to people-centered care that addresses clinical, emotional, and social needs, which is particularly relevant when we look at chimeric research. Can chimeric research strike a balance between the pursuit of medical progress and the protection of human values, ensuring that innovation in one area does not unintentionally harm others?

What Role is There for Artificial Intelligence in the Assessment of Neurodiversity?

Research Stream: Social Technologies

Author: Emily McConway, Undergraduate Intern in Psychology, Maynooth University and Mac MacLachlan, Professor of Psychology & Social Inclusion, and Co-Director of the ALL Institute, Maynooth University

Early assessment and intervention are vital in facilitating positive developmental and behavioural outcomes for children with neurodevelopmental conditions. Early intervention has a positive long-term effect on both autistic children and their caregivers. The current process of assessing the needs of children with possible autistic traits focuses on the use of behavioural clinical diagnostic instruments such as Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R). Both instruments require direct clinician-to-child observation and can take hours to administer and score. In many countries, long waiting lists, coupled with social, economic and geographic barriers hinders timely assessment of neurodiverse children. The ALL Institute is interested in pragmatic ways to streamline access to services, including assessing a person’s needs for services and supports.   

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Exploring the Impact of the EU ‘Draft AI Act’ on Democracy: A Timely Discussion with the ‘Draft Compromise Text’ of the European Parliament

Social Structures

Author: Gizem Yardimci, Early Career Researcher at ADVANCE CRT, PhD Student in Law, Maynooth University

Gizem Yardimci
Gizem Yardimci

The Draft Artificial Intelligence Act (Draft AI Act) for the European Union (EU) represents a significant milestone towards the regulation of technologies employing AI within the EU. Since the zero version of the Draft AI Act was released on 21 April 2021, it has been discussed extensively by academics, policymakers and professionals  who are involved in the decision-making processes within the EU. In May of this year, the European Parliament released a Draft Compromise Text with significant amendments on the Draft AI Act. Therefore, the European Parliament is in a position to launch ‘trialogues’ with the European Commission and the Council of the European Union. Overall, this development represents a formal step towards finalising the regulation for AI systems in the EU.

The main goal of the Draft AI Act is to improve the functioning of the internal market and to advance the creation of a digital single market as indicated in the Digital Single Market Strategy.

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SFI ADVANCE CRT: Interdisciplinary Research for a Connected Society that Promotes Independent Living and the Rights of the Individual

Social Structures

Author: Matthew McKenna, PhD Researcher at Maynooth University’s Assisting Living and Learning Institute (ALL) Institute, Research Funded through the Science Foundation of Ireland (SFI) Centre for Research Training in Advanced Networks for Sustainable Societies (ADVANCE CRT)

Matthew McKenna Profile Picture
Matthew McKenna

The Science Foundation of Ireland (SFI) Centre for Research and Training in Advanced Networks for Sustainable Societies (ADVANCE CRT) is a multidisciplinary research project focused on ‘Future Networks and the Internet of Things (IoT) with applications in independent and sustainable living’. ADVANCE CRT aims to fund and train 120 PhD students in four annual cohorts in five partner universities, including Maynooth University, across a multitude of academic disciplines and through engagement and cooperation with industry partners. In the words of the ADVANCE CRT:

‘Our vision is to train the next generation of researchers who will seek solutions to the technical and societal challenges of global hyper-connectivity between large numbers of People and Things’.

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A Matter of Trust: Accepting Artificial Intelligence and Robotics-Aided Care to Enhance Independent Living for Persons with Disabilities

Social Structures

Author: Matthew McKenna, PhD Researcher at Maynooth University’s Assisting Living and Learning Institute (ALL Institute)

Matthew McKenna Profile Picture
Matthew McKenna

The European Union (EU) is arguably emerging as a global leader in the ethical and human rights-based regulation and deployment of Artificial Intelligence (AI) in healthcare, domestic and wider societal settings in the twenty-first century. On the 8th of April 2019, the EU High-Level Expert Group on AI presented ‘Ethics Guidelines for Trustworthy Artificial Intelligence’. This followed the publication of the guidelines’ first draft in December 2018 on which more than five hundred comments were received through an open consultation.

According to the Guidelines, trustworthy AI should be:

(1) Lawful – Respecting all applicable laws and regulations

(2) Ethical – Respecting ethical principles and values

(3) Robust – Both from a technical perspective while taking into account its social environment

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15th June 2021, United Nations World Elder Abuse Awareness Day, Fostering Accessible Assistive Technology for Older Persons with Disabilities

Social Structures

Author: Matthew McKenna, PhD Researcher at Maynooth University’s Assisting Living and Learning Institute (ALL Institute)

Matthew McKenna Profile Picture
Matthew McKenna

The World Health Organisation (WHO) Department of Data and Analytics published a technical report in December of 2020 yielding data which highlights the need for increased global awareness of the importance of healthy ageing in the twenty-first century. The report found that global life expectancy increased by more than six years between 2000 and 2019; from 66.8 years in 2000 to 73.4 years in 2019. However, it was found that increased life expectancy did not entail a corresponding reduction in the number of years lived with a disability among older persons. In addition, the United Nations (UN) Department of Economic and Social Affairs estimates a 56 percent global increase, from 901 million to 1.4 billion, in the number of people aged 60 years or over in the 2015-2030 timeframe; this figure is predicted to rise to almost 2.1 billion by 2050 based on current data.

Human society must adapt to support and engage with older persons so that nobody is left behind in an older society. In that regard, the promotion of active, healthy, engaged and independent living for older persons above the age of 65 is key.

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