Bioprinting technology, regulation and intellectual property: a ‘panel on paper’

In this combined interview, 3DMedNet spoke to the team behind the UK 'Biomodifying Technologies' project, specifically on what they have found regarding the practicalities in regulating and translating bioprinting technologies in clinical practice.

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Edison Bicudo

My name is Edison Bicudo, sociologist and geographer, currently a Research Fellow at the School of Global Studies, University of Sussex (UK). In 2012, I completed a PhD in international politics at King’s College London. As a researcher, I am interested in the social and geographical implications of health technologies, having focused on topics such as clinical trials, bioinformatics, neuroimaging and others. In 2019, I launched ‘Neuroimaging, software, and communication,’ a book that analyzes the social aspects of software development for neuroscience studies.

Phoebe Li

I am Phoebe Li, a Senior Lecturer in Law at the University of Sussex. My research has been focused on the regulation of new emerging technologies. My expertise lies on health technologies and international intellectual property. I have been working on regulations and intellectual property aspects of bioprinting since 2014. 

Alex Faulkner

And I’m Alex Faulkner, Professor in Sociology of Biomedicine and Healthcare Policy at the University of Sussex, School of Global Studies. I have over 20 years’ experience of researching the development, evaluation, regulatory innovation and possible healthcare adoption of a wide range of medical devices and regenerative medicine products in the UK, EU and India.

Could you tell us about any current (or recent) projects? 

 In a project funded by the UK’s Economic and Social Research Council called ‘Biomodifying technologies and experimental space (BioMod),’ which comes to an end in 2020, we studied scientific, regulatory, ethical and economic aspects of three biomedical technologies: gene editing, induced pluripotent stem cells and 3D bioprinting. This was done with colleagues based at the University of Oxford (UK) and the University of York (UK). Due to the complexities of the issues studied, we obtained funding from the Leverhulme Trust for a new project called ‘Biomodifying technologies: governing converging research in the life sciences (BioGov),’ which focuses on the same three technologies with the same collaborators, concentrating on a wide range of governance issues. In this new project, we are deepening our understanding of these technologies via various regulatory pathways, as well as looking at the UK’s insertion in the global scenario and examples of combinations of those three technologies.

How are 3D printing and bioprinting technologies involved with your work? 

3D bioprinting is one of the technologies analyzed in our current research. It was selected as a case study for two main reasons.

On the one hand, it is a relatively nascent technology, promising development and standardization in the field of tissue engineering, which entails many of important institutional, technical, scientific and regulatory challenges.

On the other hand, it is a highly complex technology, deriving from advances in different fields such as engineering, biology, microscopy, software development and others. Such complexity enables us to look at the intellectual and institutional combination of technologies and skills, which is one of the main topics of our project.

We have interviewed different professionals involved with bioprinting: academic researchers, entrepreneurs, and regulators. We will soon also be interviewing clinicians interested in taking bioprinting to clinical settings. In this way, we are gaining an understanding of the main challenges in terms of promoting further advances in the bioprinting technology, combining it with other biomedical approaches, taking it from laboratories to clinical practices and regulating all these activities.

What are the key challenges associated with regulating bioprinting technologies?

Nowadays, there is no country with clear and specific regulations for bioprinting. This regulatory gap and uncertainties are seriously limiting what can be done by academic researchers and companies alike. Moreover, it makes it difficult for companies and universities to engage in fruitful collaborations, especially outside the academic research environment. In order to tackle this regulatory gap, different actors, but mainly regulatory agencies, have to deal with three main challenges.

First, regulation has much to do with classification and it will be difficult to classify the products to be generated through bioprinting. A bioprinted product can be a tissue with modest bioactive properties or a tissue that can interact with bodily structures and even modify their functions. Between these two poles, there is a range of positions that can be occupied by bioprinted products. In this way, it is not simple to determine whether bioprinted tissues and organoids should be considered, from a legal point of view, as a drug, a medical device, a reagent and so on.

Second, it is not easy to determine the status that bioprinters themselves should assume. Such devices are produced, bought, and sold as laboratory or research tools. In the future, when the clinical potentialities of bioprinting have been further explored, such classification is likely to change. At that moment, it will be necessary to define how a bioprinter should be classified, as well as the implications of this new status. This will be crucial, for example, to determine the ways in which bioprinters might be used in a clinical setting.

Third, some countries have tried to sketch initial guidelines or regulations for bioprinting by means of advisory groups formed by academic researchers. However, such approach might be limited due to the lack of inputs from other stakeholders, such as entrepreneurs. In this way, we envisage co-regulation would serve as a platform for multiple stakeholders to engage in the decision-making of relevant law and policy. Various countries have to learn to formulate more specific regulations while considering the range of activities and interests present in their territories.

What are the key challenges associated with intellectual property and bioprinting technologies? 

Our study has shown that bioprinting-related patents have been consistently filed over the last few years, even though the number of such patents is still modest when compared with other fields such as pharmaceuticals or genome editing. What has become clear is that a small number of universities and companies (mainly in the United States and China) have taken the lead in this process. In this way, there seems to be a tendency towards the control of the bioprinting field by some players. If this tendency is consolidated, the bioprinting domain might eventually mirror the DNA sequencing domain, in which a handful of players come to dominate the technology and the global market.

At the same time, it is important to recognize that intellectual property is an important motivation for both large and small companies exploring bioprinting. Furthermore, it is sometimes a goal for academic researchers. Thus, it seems important to foster innovations (which are sometimes coupled with patent monopolies) while the dynamics of open innovations also exist. Our research shows that some academic researchers have joined an international open source bioprinting movement, which focuses mainly on the production of non-proprietary, low-cost bioprinters.

In Europe and in the UK we have a morality clause and a medical treatment exception excluding certain inventions from patentability. For example, bioink using human embryonic stem cells will be deemed an immoral product that will not be granted patent. The medical treatment exception also excludes patentability of bioprinting processes of surgical or therapeutic treatments practiced directly on human or animal bodies. That said, most bioprinting products are still likely to receive patent monopoly which is a 20 year protection. It will significantly have an impact on access and affordability of bioprinting technologies and products.

Would you say that complex regulatory or intellectual property challenges are deterring the uptake of the technology by researchers? 

On this point, the regulatory aspect seems to be different from the intellectual property one, though considering the above limitations, you can say the intellectual property regime is a reflective tool for regulation. On the regulatory side, the current position does tend to constitute a barrier, not so much in terms of the exploration of the technology but in terms of its translational potentialities. Academic researchers have brought about substantial experimental advances to bioprinting technology, including both its engineering dimension (CAM/CAD software, printing approaches, and so on) and its biological dimension (types of cells, development of bioinks and so on).

However, current regulations, when it comes to bioprinting, are still vague, which creates uncertainties when being translated into clinical applications. Generally, academic researchers license their inventions to companies or start up their own spin-out businesses. The ambiguities in translation and reconfiguration of regulations prove the uptake of bioprinting highly experimental. It may slow down these translational enterprises due to a lack clarity about how all these techniques will be legally framed in the future. On the other hand, we do observe a very high level of inter-academic and academic-commercial collaborations being formed, testimony to positive experimentational trends.

Regarding intellectual property, the current state of affairs does not constitute a deterrent as we have the research exemption clause in the patent law. Academics and companies have found suitable ways to protect their creations with patents. Indeed, there has been, over the last years, an increasing number of patents on bioprinters, bioprinting methods and even some simple bioprinted products such as skin tissues and organoids. Such phenomenon is likely to be reinforced as researchers and companies find some leeway to include new items in this list of protected creations, including, for example, software packages.

What’s next with your research? What should we be looking out for? 

So far our project has involved a comprehensive effort towards analyzing the routines of academic researchers, regulators, and entrepreneurs. In the coming months, we wish to devote our attention to the translational side of bioprinting, conducting interviews with professionals based in NHS settings, in the UK. Thus we will look at current efforts towards testing the viability of carrying out bioprinting activities in NHS sites. We will also identify the main legal and business challenges currently faced by those who try to promote such translation, and the initial efforts at development of norms and standards that can be observed in specific working groups and conferences where regulation is debated.

Where do you see bioprinting in the medical field in 5–10 years’ time? Are there any key hurdles that need to be overcome to progress the technology in the medical field? 

The main hurdle to be overcome has a scientific nature: scientists still need to refine theories and technologies in order to fully explore the medical potentialities of bioprinting. Vascularization remains a key challenge in tissue engineering. Apart from this challenge, there are two political or institutional challenges that can be addressed. On the one hand, government agencies have to deal with the regulatory overlaps and ambiguities mentioned above. On the other, the relations between universities and bioprinting companies can be streamlined, which seems to require, for example, more support to the technology transfer offices of universities.

In terms of the development of bioprinting in the short term, the technology is very likely to become a common tool in medical investigation. Nowadays, the pharmaceutical industry is becoming increasingly interested in the bioprinting of organoids (organ-on-chip) to assess the effects of new drugs. In this way, bioprinting, combined with other biotechnology approaches such as gene editing, might speed up the times of pharmaceutical experimentation and clinical trials. Finally, we are likely to witness the emergence of some simple therapeutic approaches drawing on bioprinting. There can emerge, for example, some market products for skin replacement or cornea transplantation.

Do you have any final comments about medical 3D printing, bioprinting or the regulation of these technologies in the medical field you would like to share?

It is important to pay attention to the ways in which the bioprinting market will evolve in the coming years. Our work has mapped out that a decentralized model, or a re-distributed manufacturing (RDM) model is likely to take place instead of a centralized one. There is a wider movement advancing point-of-care and near-patient technologies, which bioprinting is likely to become associated with. Nowadays, there is a situation in which small local companies coexist with larger companies which tend to become very large and multinational (such as Swedish Cellink and American Organovo). However, this global market can eventually incorporate strong tendencies towards concentration and intellectual protection, mirroring what happens in the pharmaceutical and the DNA sequencing markets. In bioprinting, such strong dominance without healthy market competition might slow down advances, make it difficult for researchers and hospitals to access the technology and create a segmented and exclusive market.

The opinions expressed in this feature are those of the interviewees/authors and do not necessarily reflect the views of 3DMedNet or Future Science Group.

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