Print me an organ? Regulatory and legal considerations of 3D printed medical products

Antonia Horst1

1Queensland University Of Technology, Kelvin Grove, Australia

3D printing in biomedical applications as well as Bioprinting are discussed throughout scientific literature to potentially solve unmet problems in healthcare and even to change healthcare as we know it. The computer driven layer-by-layer manufacturing process allows for unseen three-dimensional structures as well as personalised medical products, which can be perfectly matched to a particular patient’s anatomy. While the scientific progress has been rapidly developing over the last decade, legal and regulatory discussions as well as frameworks at all levels of governance are lacking far behind. International regulators, such as the Australian Therapeutic Goods Administration and the Food and Drug Administration involved stakeholders to assess the new possibilities this technology enables and evaluate, whether the current regulatory frameworks are equipped to govern them. While regulators already voiced concerns regarding 3D printed personalised medical device and pre-market regulation thereof, bioprinting has not yet been addressed by any international regulator. This talk aims to firstly address the status quo of 3D printing of personalised medical products at this point in time to build a realistic foundation for the subsequently presented legal, regulatory, and ethical challenges, which are expected to arise as personalised 3D printed products make their way into hospitals. Current medical products regulations are set out to govern mass-produced medical products. This begs the question, whether they are fit to regulate highly personalised 3D printed medical products. Regulators, such as the Australian Therapeutic Goods Administration and the US Food and Drug Administration involved stakeholders to assess the new possibilities this technology enables and evaluate, whether the current regulatory frameworks are equipped to govern them. Chances as well as barriers and loopholes in current regulatory frameworks will be presented in this talk using a comparative law lens, contrasting the regulatory and legislative approaches in the US, the EU and Australia.


Biography:

Antonia is a PhD candidate at the Centre for Regenerative Medicine, QUT, and the Intellectual Property and Innovations Law Group, QUT. She is working towards regulatory and legislative change with regards to 3D printed, personalised medical products. In particular, her research centres on how legal and regulatory frameworks enable, shape and potentially hinder innovation in medical 3D printing. Her project’s approach is highly transdisciplinary. She works alongside a team of researchers working on innovation in additive manufacturing. Their work, and her own, forms part of the ARC ITTC in Additive Biomanufacturing, of which she is a scholarship holder. This transdisciplinary approach ensures a deep reciprocal understanding of different disciplines which allows for effective, evidence-based regulation, policy and lawmaking. Antonia holds a law degree from Ludwig Maximilians University Munich in Germany.

About the Association

The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

The AABHL seeks to foster a distinctive Australasian voice in bioethics, and provide opportunities for international engagement through its membership, journal and conferences.

Members come from all the contributing humanities, social science and science disciplines that make up contemporary bioethics.

Many members have cross-disciplinary interests and all seek to broaden the dialogues in which all members of the wider community ultimately have an interest.

The AABHL is a supportive, creative and challenging community that provides a rich source of continuing academic refreshment and renewal.

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